Pending: 32007L0053

                                January 16, 2026                            

30.8.2007
EN
Official Journal of the European Union
L 226/19

(1)
Fluorine compounds are currently listed in and subject to restrictions and conditions laid down in Annex III, Part 1 of Directive 76/768/EEC. The Scientific Committee on Consumer Products (SCCP) is of the opinion that if the sole source of fluoride exposure is toothpaste containing fluoride between 1 000 to 1 500 ppm, there is a minimal concern that children under the age of six will develop fluorosis, provided that such toothpaste is used as recommended. Therefore, reference numbers 26 to 43, and reference numbers 47 and 56 of Annex III, Part 1 should be amended accordingly.

(2)
Directive 76/768/EEC should therefore be amended accordingly.

(3)
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products(1), and in particular Article 8(2) thereof,

After consulting the Scientific Committee on Consumer Products,

(1) Fluorine compounds are currently listed in and subject to restrictions and conditions laid down in Annex III, Part 1 of Directive 76/768/EEC. The Scientific Committee on Consumer Products (SCCP) is of the opinion that if the sole source of fluoride exposure is toothpaste containing fluoride between 1 000 to 1 500 ppm, there is a minimal concern that children under the age of six will develop fluorosis, provided that such toothpaste is used as recommended. Therefore, reference numbers 26 to 43, and reference numbers 47 and 56 of Annex III, Part 1 should be amended accordingly.

(2) Directive 76/768/EEC should therefore be amended accordingly.

(3) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,

HAS ADOPTED THIS DIRECTIVE:
Article 1

Annex III of Directive 76/768/EEC is amended in accordance with the Annex to this Directive.
Article 2

1.   Member States shall adopt and publish, by 19 April 2008 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions together with a correlation table of those provisions and this Directive.

They shall apply those provisions from 19 January 2009.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field governed by this Directive.
Article 3

This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.
Article 4

This Directive is addressed to the Member States.
THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products(1), and in particular Article 8(2) thereof,

After consulting the Scientific Committee on Consumer Products,

(1) Fluorine compounds are currently listed in and subject to restrictions and conditions laid down in Annex III, Part 1 of Directive 76/768/EEC. The Scientific Committee on Consumer Products (SCCP) is of the opinion that if the sole source of fluoride exposure is toothpaste containing fluoride between 1 000 to 1 500 ppm, there is a minimal concern that children under the age of six will develop fluorosis, provided that such toothpaste is used as recommended. Therefore, reference numbers 26 to 43, and reference numbers 47 and 56 of Annex III, Part 1 should be amended accordingly.

(2) Directive 76/768/EEC should therefore be amended accordingly.

(3) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,

HAS ADOPTED THIS DIRECTIVE:
Annex III of Directive 76/768/EEC is amended in accordance with the Annex to this Directive.
1.   Member States shall adopt and publish, by 19 April 2008 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions together with a correlation table of those provisions and this Directive.

They shall apply those provisions from 19 January 2009.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field governed by this Directive.
This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States.
ANNEXIn reference numbers 26 to 43, and reference numbers 47 and 56 of Part 1 of Annex III to Directive 76/768/EEC, the following text is added after each entry in column f:
            ‘For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:

               “Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”

               ’

Pending: 32007L0047

                                January 16, 2026                            

21.9.2007
EN
Official Journal of the European Union
L 247/21



(1)
Council Directive 93/42/EEC(3)requires the Commission to submit a report to the Council, no later than five years from the date of implementation of that Directive, concerning: (i) information on incidents occurring following the placing of devices on the market, (ii) clinical investigation carried out in accordance with the procedure set out in Annex VIII to Directive 93/42/EEC, and (iii) design examination and EC type examination of medical devices that incorporate, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(4)and which is liable to act upon the body with action ancillary to that of the device.



(2)
The Commission brought forward the conclusions of that report in its Communication to the Council and the European Parliament on medical devices which, at the request of the Member States, was expanded to cover all aspects of the Community regulatory framework for medical devices.



(3)
This Communication was welcomed by the Council in its Conclusions on medical devices of 2 December 2003(5). It was also discussed by the European Parliament which on 3 June 2003 adopted a resolution on the health implications of Directive 93/42/EEC(6).



(4)
Following from the conclusions drawn in that Communication it is necessary and appropriate to amend Council Directive 90/385/EEC(7), Directive 93/42/EEC and Directive 98/8/EC of the European Parliament and of the Council(8).



(5)
To ensure consistency of interpretation and implementation between Directives 93/42/EEC and 90/385/EEC the legal framework related to issues such as authorised representative, the European databank, health protection measures, and the application of Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma, as introduced by Directive 2000/70/EC(9), should be extended to Directive 90/385/EEC. The application of the provisions on medical devices incorporating stable derivates of human blood or human plasma includes application of Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC(10).



(6)
It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is a medical device. Software for general purposes when used in a healthcare setting is not a medical device.



(7)
Particular care should be taken to ensure that the reprocessing of medical devices does not endanger patients’ safety or health. It is therefore necessary to provide clarification on the definition of the term ‘single use’, as well as to make provision for uniform labelling and instructions for use. Moreover, the Commission should engage in further analysis in order to see if additional measures are appropriate to ensure a high level of protection for patients.



(8)
In the light of technical innovation and the development of initiatives at the international level it is necessary to enhance the provisions on clinical evaluation, including clarification that clinical data is generally required for all devices regardless of classification and the possibility to centralise data on clinical investigations in the European databank.



(9)
In order to provide clearer evidence of the compliance of custom-made device manufacturers, an explicit requirement for a post market production review system involving incident reporting to authorities should be introduced, as is already in place for other devices, and to enhance patient information, a requirement should be introduced that the ‘Statement’ under Annex VIII to Directive 93/42/EEC should be available to the patient and that it should contain the name of the manufacturer.



(10)
In the light of technical progress in information technology and medical devices, a process should be provided to allow information supplied by the manufacturer to be available by other means.



(11)
Manufacturers of Class I sterile and/or measuring medical devices should be given the option of using the full quality assurance conformity assessment module in order to provide them with more flexibility in the choice of compliance modules.



(12)
In order to support market surveillance activities by Member States it is necessary and appropriate, in the case of implantable devices, to increase the time period for the retention of documents for administrative purposes to at least 15 years.



(13)
For the appropriate and efficient functioning of Directive 93/42/EEC as regards regulatory advice on classification issues arising at national level, in particular on whether or not a product falls under the definition of a medical device, it is in the interest of national market surveillance and the health and safety of humans to establish a procedure for decisions on whether or not a product falls under the medical device definition.



(14)
To ensure that, where a manufacturer does not have a registered place of business in the Community, authorities have a single individual person authorised by the manufacturer whom they can address in matters relating to the compliance of the devices with the Directives it is necessary to introduce an obligation for such manufacturers to designate an authorised representative for a device. This designation should be effective at least for all devices of the same model.



(15)
To further ensure public health and safety it is necessary to provide for a more consistent application of the provisions on health protection measures. Particular care should be taken to ensure that, when in use, the products do not endanger patients’ health or safety.



(16)
In support of transparency in Community legislation, certain information related to medical devices and their conformity with Directive 93/42/EEC, in particular information on registration, on vigilance reports and on certificates, should be available to any interested party and the general public.



(17)
To better coordinate the application and efficiency of national resources when applied to issues related to Directive 93/42/EEC, the Member States should cooperate with each other and at international level.



(18)
As design for patient safety initiatives play an increasing role in public health policy, it is necessary to expressly set out the need to consider ergonomic design in the essential requirements. In addition the level of training and knowledge of the user, such as in the case of a lay user, should be further emphasised within the essential requirements. The manufacturer should place particular emphasis on the consequences of misuse of the product and its adverse effects on the human body.



(19)
In the light of experience gained regarding activities of both the notified bodies and the authorities in the assessment of devices which require intervention of the appropriate authorities for medicines and human blood derivatives their duties and tasks should be clarified.



(20)
Taking account of the growing importance of software in the field of medical devices, be it as stand alone or as software incorporated in a device, validation of software in accordance with the state of the art should be an essential requirement.



(21)
In the light of the increased use of third Parties to carry out the design and manufacture of devices on behalf of the manufacturer, it is important that the manufacturer demonstrates that he applies adequate controls to the third party to continue to ensure the efficient operating of the quality system.



(22)
The classification rules are based on the vulnerability of the human body taking account of the potential risks associated with the technical design and manufacture of the devices. Explicit prior authorisation with regard to conformity, including an assessment of the design documentation, is required for Class III devices to be placed on the market. In performing its duties under the quality assurance and verification conformity assessment modules for all other classes of devices, it is essential and necessary for a notified body, in order to be assured of the compliance of the manufacturer with Directive 93/42/EEC, to review the design documentation for the medical device. The depth and extent of this review should be commensurate with the classification of the device, the novelty of the intended treatment, the degree of intervention, the novelty of the technology or construction materials, and the complexity of the design and/or technology. This review can be achieved by taking a representative example of design documentation of one or more type(s) of devices from those being manufactured. Further review(s), and in particular the assessment of changes to the design that could affect conformity with the essential requirements, should be part of the surveillance activities of the notified body.



(23)
It is necessary to remove the incoherence in the classification rules as a result of which invasive devices with respect to body orifices intended for connection to an active Class I medical device were not classified.



(24)
The measures necessary for the implementation of Directive 90/385/EEC and Directive 93/42/EEC should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(11).



(25)
In particular, power should be conferred on the Commission to adapt classification rules for medical devices, to adapt the means by which the information needed to use medical devices safely and properly may be set out, to determine conditions for making certain information publicly available, to adapt the provisions on clinical investigations set out in certain Annexes, to adopt particular requirements for placing certain medical devices on the market or putting them into service, and to take decisions to withdraw such devices from the market for reasons of protection of health or safety. Since those measures are of general scope and are designed to amend or supplement Directive 90/385/EEC and Directive 93/42/EEC by the modification or addition of non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.



(26)
When, on imperative grounds of urgency, the normal time limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to use the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for taking decisions on withdrawal of certain medical devices from the market and for the adoption of particular requirements for placing such devices on the market or putting them into service for reasons of protection of health or safety.



(27)
The Commission should give a mandate to CEN and/or Cenelec to specify technical requirements and a suitable specific label for phthalate-containing devices within 12 months after entry into force of this Directive.



(28)
Many Member States have established recommendations with the aim of reducing or limiting the use of medical devices containing critical phthalates on children, pregnant and nursing women and other patients at risk. To enable medical professionals to avoid such risks, devices which possibly release phthalates to the body of the patient should be labelled accordingly.



(29)
In accordance with the essential requirements on the design and manufacture of medical devices, manufacturers should avoid the use of substances that may possibly compromise the health of patients, in particular of substances which are carcinogenic, mutagenic or toxic to reproduction, and should, as appropriate, strive to develop alternative substances or products with a lower risk potential.



(30)
It should be clarified that alongside Directives 90/385/EEC and 93/42/EEC, in vitro diagnostic medical devices, which are the subject of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices(12), should also be excluded from the scope of Directive 98/8/EC.



(31)
In accordance with point 34 of the Interinstitutional agreement on better law-making(13), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.



(32)
Directives 90/385/EEC, 93/42/EEC and 98/8/EC should therefore be amended accordingly,



1.
Article 1 shall be amended as follows:(a)paragraph 2 shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’(ii)points (d), (e) and (f) shall be replaced by the following:‘(d)“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;(e)“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;(f)“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’(iii)the following points shall be added:‘(j)“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;(b)paragraph 3 shall be replaced by the following:‘3.   Where an active implantable medical device is intended to administer a substance defined as a medicinal product within the meaning of Article 1 of Directive 2001/83/EC(*1), that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.(*1)OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1)’ "(c)paragraph 4 shall be replaced by the following:‘4.   Where an active implantable medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device, that device shall be evaluated and authorised in accordance with this Directive.’;(d)the following paragraph shall be inserted:‘4a.   Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device, hereinafter referred to as a “human blood derivative”, that device shall be assessed and authorised in accordance with this Directive.’;(e)paragraph 5 shall be replaced by the following:‘5.   This Directive constitutes a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC(*2).(*2)Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility (OJ L 390, 31.12.2004, p. 24).’;"(f)the following paragraph shall be added:‘6.   This Directive shall not apply to:(a)medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;(b)human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a;(c)transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;(d)transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.’;
(a)
paragraph 2 shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’(ii)points (d), (e) and (f) shall be replaced by the following:‘(d)“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;(e)“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;(f)“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’(iii)the following points shall be added:‘(j)“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
(i)
point (a) shall be replaced by the following:‘(a)“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’
‘(a)
“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’
—
diagnosis, prevention, monitoring, treatment or alleviation of disease,
—
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
—
investigation, replacement or modification of the anatomy or of a physiological process,
—
control of conception,
(ii)
points (d), (e) and (f) shall be replaced by the following:‘(d)“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;(e)“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;(f)“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’
‘(d)
“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;
(e)
“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;
(f)
“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’
(iii)
the following points shall be added:‘(j)“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
‘(j)
“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;
(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
—
clinical investigation(s) of the device concerned, or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
(b)
paragraph 3 shall be replaced by the following:‘3.   Where an active implantable medical device is intended to administer a substance defined as a medicinal product within the meaning of Article 1 of Directive 2001/83/EC(*1), that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.(*1)OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1)’ "
(c)
paragraph 4 shall be replaced by the following:‘4.   Where an active implantable medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device, that device shall be evaluated and authorised in accordance with this Directive.’;
(d)
the following paragraph shall be inserted:‘4a.   Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device, hereinafter referred to as a “human blood derivative”, that device shall be assessed and authorised in accordance with this Directive.’;
(e)
paragraph 5 shall be replaced by the following:‘5.   This Directive constitutes a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC(*2).(*2)Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility (OJ L 390, 31.12.2004, p. 24).’;"
(f)
the following paragraph shall be added:‘6.   This Directive shall not apply to:(a)medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;(b)human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a;(c)transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;(d)transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.’;
(a)
medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;
(b)
human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a;
(c)
transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;
(d)
transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.’;

(a)
paragraph 2 shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’(ii)points (d), (e) and (f) shall be replaced by the following:‘(d)“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;(e)“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;(f)“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’(iii)the following points shall be added:‘(j)“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
(i)
point (a) shall be replaced by the following:‘(a)“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’
‘(a)
“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’
—
diagnosis, prevention, monitoring, treatment or alleviation of disease,
—
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
—
investigation, replacement or modification of the anatomy or of a physiological process,
—
control of conception,
(ii)
points (d), (e) and (f) shall be replaced by the following:‘(d)“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;(e)“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;(f)“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’
‘(d)
“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;
(e)
“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;
(f)
“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’
(iii)
the following points shall be added:‘(j)“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
‘(j)
“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;
(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
—
clinical investigation(s) of the device concerned, or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;

(i)
point (a) shall be replaced by the following:‘(a)“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’
‘(a)
“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’
—
diagnosis, prevention, monitoring, treatment or alleviation of disease,
—
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
—
investigation, replacement or modification of the anatomy or of a physiological process,
—
control of conception,

‘(a)
“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’
—
diagnosis, prevention, monitoring, treatment or alleviation of disease,
—
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
—
investigation, replacement or modification of the anatomy or of a physiological process,
—
control of conception,

—
diagnosis, prevention, monitoring, treatment or alleviation of disease,

—
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

—
investigation, replacement or modification of the anatomy or of a physiological process,

—
control of conception,

(ii)
points (d), (e) and (f) shall be replaced by the following:‘(d)“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;(e)“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;(f)“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’
‘(d)
“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;
(e)
“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;
(f)
“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’

‘(d)
“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;

(e)
“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;

(f)
“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’

(iii)
the following points shall be added:‘(j)“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
‘(j)
“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;
(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
—
clinical investigation(s) of the device concerned, or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;

‘(j)
“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;

(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
—
clinical investigation(s) of the device concerned, or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;

—
clinical investigation(s) of the device concerned, or

—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or

—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;

(b)
paragraph 3 shall be replaced by the following:‘3.   Where an active implantable medical device is intended to administer a substance defined as a medicinal product within the meaning of Article 1 of Directive 2001/83/EC(*1), that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.(*1)OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1)’ "

(c)
paragraph 4 shall be replaced by the following:‘4.   Where an active implantable medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device, that device shall be evaluated and authorised in accordance with this Directive.’;

(d)
the following paragraph shall be inserted:‘4a.   Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device, hereinafter referred to as a “human blood derivative”, that device shall be assessed and authorised in accordance with this Directive.’;

(e)
paragraph 5 shall be replaced by the following:‘5.   This Directive constitutes a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC(*2).(*2)Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility (OJ L 390, 31.12.2004, p. 24).’;"

(f)
the following paragraph shall be added:‘6.   This Directive shall not apply to:(a)medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;(b)human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a;(c)transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;(d)transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.’;
(a)
medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;
(b)
human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a;
(c)
transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;
(d)
transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.’;

(a)
medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;

(b)
human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a;

(c)
transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;

(d)
transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.’;



(a)
paragraph 2 shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’(ii)points (d), (e) and (f) shall be replaced by the following:‘(d)“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;(e)“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;(f)“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’(iii)the following points shall be added:‘(j)“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
(i)
point (a) shall be replaced by the following:‘(a)“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’
‘(a)
“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’
—
diagnosis, prevention, monitoring, treatment or alleviation of disease,
—
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
—
investigation, replacement or modification of the anatomy or of a physiological process,
—
control of conception,
(ii)
points (d), (e) and (f) shall be replaced by the following:‘(d)“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;(e)“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;(f)“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’
‘(d)
“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;
(e)
“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;
(f)
“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’
(iii)
the following points shall be added:‘(j)“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
‘(j)
“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;
(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
—
clinical investigation(s) of the device concerned, or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;

(i)
point (a) shall be replaced by the following:‘(a)“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’
‘(a)
“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’
—
diagnosis, prevention, monitoring, treatment or alleviation of disease,
—
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
—
investigation, replacement or modification of the anatomy or of a physiological process,
—
control of conception,

‘(a)
“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’
—
diagnosis, prevention, monitoring, treatment or alleviation of disease,
—
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
—
investigation, replacement or modification of the anatomy or of a physiological process,
—
control of conception,

—
diagnosis, prevention, monitoring, treatment or alleviation of disease,

—
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

—
investigation, replacement or modification of the anatomy or of a physiological process,

—
control of conception,

(ii)
points (d), (e) and (f) shall be replaced by the following:‘(d)“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;(e)“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;(f)“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’
‘(d)
“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;
(e)
“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;
(f)
“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’

‘(d)
“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;

(e)
“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;

(f)
“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’

(iii)
the following points shall be added:‘(j)“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
‘(j)
“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;
(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
—
clinical investigation(s) of the device concerned, or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;

‘(j)
“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;

(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
—
clinical investigation(s) of the device concerned, or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;

—
clinical investigation(s) of the device concerned, or

—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or

—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;



(i)
point (a) shall be replaced by the following:‘(a)“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’
‘(a)
“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’
—
diagnosis, prevention, monitoring, treatment or alleviation of disease,
—
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
—
investigation, replacement or modification of the anatomy or of a physiological process,
—
control of conception,

‘(a)
“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’
—
diagnosis, prevention, monitoring, treatment or alleviation of disease,
—
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
—
investigation, replacement or modification of the anatomy or of a physiological process,
—
control of conception,

—
diagnosis, prevention, monitoring, treatment or alleviation of disease,

—
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

—
investigation, replacement or modification of the anatomy or of a physiological process,

—
control of conception,



‘(a)
“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’
—
diagnosis, prevention, monitoring, treatment or alleviation of disease,
—
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
—
investigation, replacement or modification of the anatomy or of a physiological process,
—
control of conception,

—
diagnosis, prevention, monitoring, treatment or alleviation of disease,

—
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

—
investigation, replacement or modification of the anatomy or of a physiological process,

—
control of conception,



—
diagnosis, prevention, monitoring, treatment or alleviation of disease,



—
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,



—
investigation, replacement or modification of the anatomy or of a physiological process,



—
control of conception,



(ii)
points (d), (e) and (f) shall be replaced by the following:‘(d)“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;(e)“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;(f)“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’
‘(d)
“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;
(e)
“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;
(f)
“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’

‘(d)
“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;

(e)
“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;

(f)
“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’



‘(d)
“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;



(e)
“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;



(f)
“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’



(iii)
the following points shall be added:‘(j)“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
‘(j)
“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;
(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
—
clinical investigation(s) of the device concerned, or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;

‘(j)
“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;

(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
—
clinical investigation(s) of the device concerned, or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;

—
clinical investigation(s) of the device concerned, or

—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or

—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;



‘(j)
“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;



(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
—
clinical investigation(s) of the device concerned, or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;

—
clinical investigation(s) of the device concerned, or

—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or

—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;



—
clinical investigation(s) of the device concerned, or



—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or



—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;



(b)
paragraph 3 shall be replaced by the following:‘3.   Where an active implantable medical device is intended to administer a substance defined as a medicinal product within the meaning of Article 1 of Directive 2001/83/EC(*1), that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.(*1)OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1)’ "



(c)
paragraph 4 shall be replaced by the following:‘4.   Where an active implantable medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device, that device shall be evaluated and authorised in accordance with this Directive.’;



(d)
the following paragraph shall be inserted:‘4a.   Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device, hereinafter referred to as a “human blood derivative”, that device shall be assessed and authorised in accordance with this Directive.’;



(e)
paragraph 5 shall be replaced by the following:‘5.   This Directive constitutes a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC(*2).(*2)Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility (OJ L 390, 31.12.2004, p. 24).’;"



(f)
the following paragraph shall be added:‘6.   This Directive shall not apply to:(a)medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;(b)human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a;(c)transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;(d)transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.’;
(a)
medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;
(b)
human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a;
(c)
transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;
(d)
transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.’;

(a)
medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;

(b)
human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a;

(c)
transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;

(d)
transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.’;



(a)
medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;



(b)
human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a;



(c)
transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;



(d)
transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.’;



2.
Article 2 shall be replaced by the following:‘Article 2Member States shall take all necessary steps to ensure that the devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied, properly implanted and/or properly installed, maintained and used in accordance with their intended purposes.’;



3.
Article 3 shall be replaced by the following:‘Article 3The active implantable medical devices referred to in Article 1(2)(c), (d) and (e), hereinafter referred to as “devices”, shall satisfy the essential requirements set out in Annex 1 which apply to them, account being taken of the intended purpose of the devices concerned.Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery(*3)shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex 1 to this Directive.(*3)OJ L 157, 9.6.2006, p. 24.’;"



4.
in Article 4, paragraphs 1, 2 and 3 shall be replaced by the following:‘1.   Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices complying with the provisions of this Directive and bearing the CE marking provided for in Article 12, which indicates that they have been the subject of an assessment of their conformity in accordance with Article 9.2.   Member States shall not create any obstacles to:—devices intended for clinical investigations being made available to duly qualified medical practitioners or authorised persons for that purpose if they satisfy the conditions laid down in Article 10 and in Annex 6,—custom-made devices being placed on the market and put into service if they satisfy the conditions laid down in Annex 6 and are accompanied by the statement, which shall be available to the particular identified patient, referred to in that Annex.These devices shall not bear the CE marking.3.   At trade fairs, exhibitions, demonstrations, etc., Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that a visible sign clearly indicates that such devices do not conform and cannot be marketed or put into service until they have been made to comply by the manufacturer or his authorised representative.’;
—
devices intended for clinical investigations being made available to duly qualified medical practitioners or authorised persons for that purpose if they satisfy the conditions laid down in Article 10 and in Annex 6,
—
custom-made devices being placed on the market and put into service if they satisfy the conditions laid down in Annex 6 and are accompanied by the statement, which shall be available to the particular identified patient, referred to in that Annex.

—
devices intended for clinical investigations being made available to duly qualified medical practitioners or authorised persons for that purpose if they satisfy the conditions laid down in Article 10 and in Annex 6,

—
custom-made devices being placed on the market and put into service if they satisfy the conditions laid down in Annex 6 and are accompanied by the statement, which shall be available to the particular identified patient, referred to in that Annex.



—
devices intended for clinical investigations being made available to duly qualified medical practitioners or authorised persons for that purpose if they satisfy the conditions laid down in Article 10 and in Annex 6,



—
custom-made devices being placed on the market and put into service if they satisfy the conditions laid down in Annex 6 and are accompanied by the statement, which shall be available to the particular identified patient, referred to in that Annex.



5.
Article 5 shall be replaced by the following:‘Article 51.   Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices which are in conformity with the relevant national standards adopted pursuant to the harmonised standards the references of which have been published in the Official Journal of the European Union; Member States shall publish the references of such national standards.2.   For the purposes of this Directive, reference to harmonised standards also includes the monographs of the European Pharmacopoeia notably on interaction between medicinal products and materials used in devices containing such medicinal products, the references of which have been published in theOfficial Journal of the European Union.’;



6.
Article 6 shall be amended as follows:(a)in paragraph 1 the reference ‘83/189/EEC’ shall be replaced by the reference‘98/34/EC(*4)(*4)Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37). Directive as last amended by the 2003 Act of Accession.’;"(b)paragraph 2 shall be replaced by the following:‘2.   The Commission shall be assisted by a standing committee (hereinafter referred to as the Committee).3.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.4.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.5.   Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;
(a)
in paragraph 1 the reference ‘83/189/EEC’ shall be replaced by the reference‘98/34/EC(*4)(*4)Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37). Directive as last amended by the 2003 Act of Accession.’;"
(b)
paragraph 2 shall be replaced by the following:‘2.   The Commission shall be assisted by a standing committee (hereinafter referred to as the Committee).3.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.4.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.5.   Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;

(a)
in paragraph 1 the reference ‘83/189/EEC’ shall be replaced by the reference‘98/34/EC(*4)(*4)Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37). Directive as last amended by the 2003 Act of Accession.’;"

(b)
paragraph 2 shall be replaced by the following:‘2.   The Commission shall be assisted by a standing committee (hereinafter referred to as the Committee).3.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.4.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.5.   Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;



(a)
in paragraph 1 the reference ‘83/189/EEC’ shall be replaced by the reference‘98/34/EC(*4)(*4)Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37). Directive as last amended by the 2003 Act of Accession.’;"



(b)
paragraph 2 shall be replaced by the following:‘2.   The Commission shall be assisted by a standing committee (hereinafter referred to as the Committee).3.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.4.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.5.   Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;



7.
Article 8 shall be replaced by the following:‘Article 81.   Member States shall take the necessary steps to ensure that information brought to their knowledge regarding the incidents mentioned below involving a device is recorded and evaluated in a centralised manner:(a)any malfunction of or deterioration in the characteristics and performances of a device, as well as any inadequacy in the labelling or in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(b)any technical or medical reason in relation to the characteristics or performances of a device for the reasons referred to in point (a), leading to systematic recall of devices of the same type by the manufacturer.2.   Where a Member State requires medical practitioners or the medical institutions to inform the competent authorities of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorised representative, is also informed of the incident.3.   After carrying out an assessment, if possible together with the manufacturer or his authorised representative, Member States shall, without prejudice to Article 7, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise the recurrence of the incidents referred to in paragraph 1, including information on the underlying incidents.4.   The measures necessary for the implementation of this Article shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).’;
(a)
any malfunction of or deterioration in the characteristics and performances of a device, as well as any inadequacy in the labelling or in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(b)
any technical or medical reason in relation to the characteristics or performances of a device for the reasons referred to in point (a), leading to systematic recall of devices of the same type by the manufacturer.

(a)
any malfunction of or deterioration in the characteristics and performances of a device, as well as any inadequacy in the labelling or in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;

(b)
any technical or medical reason in relation to the characteristics or performances of a device for the reasons referred to in point (a), leading to systematic recall of devices of the same type by the manufacturer.



(a)
any malfunction of or deterioration in the characteristics and performances of a device, as well as any inadequacy in the labelling or in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;



(b)
any technical or medical reason in relation to the characteristics or performances of a device for the reasons referred to in point (a), leading to systematic recall of devices of the same type by the manufacturer.



8.
Article 9 shall be amended as follows:(a)paragraph 8 shall be replaced by the following:‘8.   Decisions taken by the notified bodies in accordance with Annexes 2, 3 and 5 shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both Parties, for further periods of a maximum length of five years.’;(b)the following paragraph shall be added:‘10.   The measures designed to amend non-essential elements of this Directive,inter aliaby supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex 1 Section 15 may be set out shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;
(a)
paragraph 8 shall be replaced by the following:‘8.   Decisions taken by the notified bodies in accordance with Annexes 2, 3 and 5 shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both Parties, for further periods of a maximum length of five years.’;
(b)
the following paragraph shall be added:‘10.   The measures designed to amend non-essential elements of this Directive,inter aliaby supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex 1 Section 15 may be set out shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;

(a)
paragraph 8 shall be replaced by the following:‘8.   Decisions taken by the notified bodies in accordance with Annexes 2, 3 and 5 shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both Parties, for further periods of a maximum length of five years.’;

(b)
the following paragraph shall be added:‘10.   The measures designed to amend non-essential elements of this Directive,inter aliaby supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex 1 Section 15 may be set out shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;



(a)
paragraph 8 shall be replaced by the following:‘8.   Decisions taken by the notified bodies in accordance with Annexes 2, 3 and 5 shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both Parties, for further periods of a maximum length of five years.’;



(b)
the following paragraph shall be added:‘10.   The measures designed to amend non-essential elements of this Directive,inter aliaby supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex 1 Section 15 may be set out shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;



9.
Article 9a shall be replaced by the following:‘Article 9a1.   A Member State shall submit a duly substantiated request to the Commission and ask it to take the necessary measures in the following situations:—that Member State considers that the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 9, by applying solely one of the given procedures chosen from among those referred to in Article 9,—that Member State considers that a decision is required as to whether a particular product or product group falls within the definition of Article 1(2)(a), (c), (d) or (e).Where measures are deemed necessary pursuant to the first subparagraph of this paragraph they shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).2.   The Commission shall inform the Member States of the measures taken.’;
—
that Member State considers that the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 9, by applying solely one of the given procedures chosen from among those referred to in Article 9,
—
that Member State considers that a decision is required as to whether a particular product or product group falls within the definition of Article 1(2)(a), (c), (d) or (e).

—
that Member State considers that the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 9, by applying solely one of the given procedures chosen from among those referred to in Article 9,

—
that Member State considers that a decision is required as to whether a particular product or product group falls within the definition of Article 1(2)(a), (c), (d) or (e).



—
that Member State considers that the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 9, by applying solely one of the given procedures chosen from among those referred to in Article 9,



—
that Member State considers that a decision is required as to whether a particular product or product group falls within the definition of Article 1(2)(a), (c), (d) or (e).



10.
Article 10 shall be amended as follows:(a)in paragraph 1, the word ‘his’ shall be replaced by the word ‘the’.(b)the second subparagraph of paragraph 2 shall be replaced by the following:‘Member States may, however, authorise manufacturers to start the clinical investigations in question before the expiry of the 60-day period, provided that the ethics committee concerned has issued a favourable opinion with respect to the investigation programme in question including its review of the clinical investigation plan.’;(c)paragraph 3 shall be replaced by the following:‘3.   The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.’;(d)the following paragraphs shall be added:‘4.   The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in point 2.3.7 of Annex 7 at the disposal of the competent authorities.5.   Clinical investigations shall be conducted in accordance with the provisions of Annex 7. The measures designed to amend non-essential elements of this Directive relating to the provisions on clinical investigation in Annex 7 shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;
(a)
in paragraph 1, the word ‘his’ shall be replaced by the word ‘the’.
(b)
the second subparagraph of paragraph 2 shall be replaced by the following:‘Member States may, however, authorise manufacturers to start the clinical investigations in question before the expiry of the 60-day period, provided that the ethics committee concerned has issued a favourable opinion with respect to the investigation programme in question including its review of the clinical investigation plan.’;
(c)
paragraph 3 shall be replaced by the following:‘3.   The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.’;
(d)
the following paragraphs shall be added:‘4.   The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in point 2.3.7 of Annex 7 at the disposal of the competent authorities.5.   Clinical investigations shall be conducted in accordance with the provisions of Annex 7. The measures designed to amend non-essential elements of this Directive relating to the provisions on clinical investigation in Annex 7 shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;

(a)
in paragraph 1, the word ‘his’ shall be replaced by the word ‘the’.

(b)
the second subparagraph of paragraph 2 shall be replaced by the following:‘Member States may, however, authorise manufacturers to start the clinical investigations in question before the expiry of the 60-day period, provided that the ethics committee concerned has issued a favourable opinion with respect to the investigation programme in question including its review of the clinical investigation plan.’;

(c)
paragraph 3 shall be replaced by the following:‘3.   The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.’;

(d)
the following paragraphs shall be added:‘4.   The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in point 2.3.7 of Annex 7 at the disposal of the competent authorities.5.   Clinical investigations shall be conducted in accordance with the provisions of Annex 7. The measures designed to amend non-essential elements of this Directive relating to the provisions on clinical investigation in Annex 7 shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;



(a)
in paragraph 1, the word ‘his’ shall be replaced by the word ‘the’.



(b)
the second subparagraph of paragraph 2 shall be replaced by the following:‘Member States may, however, authorise manufacturers to start the clinical investigations in question before the expiry of the 60-day period, provided that the ethics committee concerned has issued a favourable opinion with respect to the investigation programme in question including its review of the clinical investigation plan.’;



(c)
paragraph 3 shall be replaced by the following:‘3.   The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.’;



(d)
the following paragraphs shall be added:‘4.   The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in point 2.3.7 of Annex 7 at the disposal of the competent authorities.5.   Clinical investigations shall be conducted in accordance with the provisions of Annex 7. The measures designed to amend non-essential elements of this Directive relating to the provisions on clinical investigation in Annex 7 shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;



11.
the following Articles shall be inserted:‘Article 10a1.   Any manufacturer who, under his own name, places devices on the market in accordance with the procedure referred to in Article 9(2) shall inform the competent authorities of the Member State in which he has his registered place of business of the address of the registered place of business and the description of the devices concerned.Member States may request to be informed of all data allowing for the devices to be identified together with the label and the instructions for use when the devices are put into service within their territory.2.   Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union.For devices referred to in the first subparagraph of paragraph 1 the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of all details as referred to in paragraph 1.3.   The Member States shall on request inform the other Member States and the Commission of the details referred to in the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.Article 10b1.   Regulatory data in accordance with this Directive shall be stored in a European databank accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well-informed basis.The databank shall contain the following:(a)data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures as laid down in Annexes 2 to 5;(b)data obtained in accordance with the vigilance procedure as defined in Article 8;(c)data relating to clinical investigations referred to in Article 10.2.   Data shall be forwarded in a standardised format.3.   The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in particular paragraph 1(c), shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).Article 10cWhere a Member State considers in relation to a given product or group of products that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed, such products should be withdrawn from the market, or their placing on the market and putting into service should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures.The Member State shall then inform the Commission and all the other Member States of the transitional measures, giving the reasons for its decision.The Commission shall, whenever possible, consult the interested Parties and the Member States. The Commission shall adopt its opinion, indicating whether the national measures are justified or not. The Commission shall inform all the Member States and the consulted interested Parties.When appropriate, the necessary measures designed to amend non-essential elements of this Directive, by supplementing it, relating to withdrawal from the market, prohibition of placing on the market and putting into service of a certain product or group of products or to restrictions or introduction of particular requirements therefor, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 6(5).’;
(a)
data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures as laid down in Annexes 2 to 5;
(b)
data obtained in accordance with the vigilance procedure as defined in Article 8;
(c)
data relating to clinical investigations referred to in Article 10.

(a)
data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures as laid down in Annexes 2 to 5;

(b)
data obtained in accordance with the vigilance procedure as defined in Article 8;

(c)
data relating to clinical investigations referred to in Article 10.



(a)
data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures as laid down in Annexes 2 to 5;



(b)
data obtained in accordance with the vigilance procedure as defined in Article 8;



(c)
data relating to clinical investigations referred to in Article 10.



12.
Article 11 shall be amended as follows:(a)in paragraph 2, the following subparagraph shall be added: ‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex 8 to this Directive for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).’;(b)in paragraph 4, the words ‘agent established in the Community’ shall be replaced by the words ‘authorised representative’;(c)the following paragraphs shall be added:‘5.   The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.6.   Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or that a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer.In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof.The Member State shall inform the other Member States and the Commission.7.   The notified body shall, on request, supply all relevant information and documents, including budgetary documents, required to enable the Member State to verify compliance with the criteria laid down in Annex 8.’;
(a)
in paragraph 2, the following subparagraph shall be added: ‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex 8 to this Directive for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).’;
(b)
in paragraph 4, the words ‘agent established in the Community’ shall be replaced by the words ‘authorised representative’;
(c)
the following paragraphs shall be added:‘5.   The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.6.   Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or that a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer.In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof.The Member State shall inform the other Member States and the Commission.7.   The notified body shall, on request, supply all relevant information and documents, including budgetary documents, required to enable the Member State to verify compliance with the criteria laid down in Annex 8.’;

(a)
in paragraph 2, the following subparagraph shall be added: ‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex 8 to this Directive for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).’;

(b)
in paragraph 4, the words ‘agent established in the Community’ shall be replaced by the words ‘authorised representative’;

(c)
the following paragraphs shall be added:‘5.   The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.6.   Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or that a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer.In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof.The Member State shall inform the other Member States and the Commission.7.   The notified body shall, on request, supply all relevant information and documents, including budgetary documents, required to enable the Member State to verify compliance with the criteria laid down in Annex 8.’;



(a)
in paragraph 2, the following subparagraph shall be added: ‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex 8 to this Directive for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).’;



(b)
in paragraph 4, the words ‘agent established in the Community’ shall be replaced by the words ‘authorised representative’;



(c)
the following paragraphs shall be added:‘5.   The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.6.   Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or that a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer.In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof.The Member State shall inform the other Member States and the Commission.7.   The notified body shall, on request, supply all relevant information and documents, including budgetary documents, required to enable the Member State to verify compliance with the criteria laid down in Annex 8.’;



13.
Article 13 shall be replaced by the following:‘Article 13Without prejudice to Article 7(a)where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of this Directive, the manufacturer or his authorised representative established within the Community shall be obliged to end the infringement under conditions imposed by the Member State;(b)where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the device in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 7.Those provisions shall also apply where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive.’;
(a)
where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of this Directive, the manufacturer or his authorised representative established within the Community shall be obliged to end the infringement under conditions imposed by the Member State;
(b)
where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the device in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 7.

(a)
where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of this Directive, the manufacturer or his authorised representative established within the Community shall be obliged to end the infringement under conditions imposed by the Member State;

(b)
where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the device in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 7.



(a)
where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of this Directive, the manufacturer or his authorised representative established within the Community shall be obliged to end the infringement under conditions imposed by the Member State;



(b)
where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the device in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 7.



14.
Article 14 shall be amended as follows:(a)the first paragraph shall be replaced by the following:‘Any decision taken pursuant to this Directive(a)to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;or(b)to withdraw devices from the marketshall state the exact grounds on which it is based. Such a decision shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.’;(b)in the second paragraph the words ‘established in the Community’ shall be deleted;
(a)
the first paragraph shall be replaced by the following:‘Any decision taken pursuant to this Directive(a)to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;or(b)to withdraw devices from the marketshall state the exact grounds on which it is based. Such a decision shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.’;
(a)
to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;or
(b)
to withdraw devices from the market
(b)
in the second paragraph the words ‘established in the Community’ shall be deleted;

(a)
the first paragraph shall be replaced by the following:‘Any decision taken pursuant to this Directive(a)to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;or(b)to withdraw devices from the marketshall state the exact grounds on which it is based. Such a decision shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.’;
(a)
to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;or
(b)
to withdraw devices from the market

(a)
to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;or

(b)
to withdraw devices from the market

(b)
in the second paragraph the words ‘established in the Community’ shall be deleted;



(a)
the first paragraph shall be replaced by the following:‘Any decision taken pursuant to this Directive(a)to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;or(b)to withdraw devices from the marketshall state the exact grounds on which it is based. Such a decision shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.’;
(a)
to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;or
(b)
to withdraw devices from the market

(a)
to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;or

(b)
to withdraw devices from the market



(a)
to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;or



(b)
to withdraw devices from the market



(b)
in the second paragraph the words ‘established in the Community’ shall be deleted;



15.
Article 15 shall be replaced by the following:‘Article 151.   Without prejudice to the existing national provisions and practices on medical confidentiality, Member States shall ensure that all the Parties involved in the application of this Directive are bound to observe confidentiality with regard to all information obtained in carrying out their tasks.This does not affect the obligations of Member States and notified bodies with regard to mutual information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law.2.   The following information shall not be treated as confidential:(a)information on the registration of persons responsible for placing devices on the market in accordance with Article 10a;(b)information to users sent out by the manufacturer, authorised representative or distributor in relation to a measure in accordance with Article 8;(c)information contained in certificates issued, modified, supplemented, suspended or withdrawn.3.   The measures designed to amend non-essential elements of this Directive,inter aliaby supplementing it, relating to the determination of the conditions under which information other than that referred to in paragraph 2, and in particular concerning any obligation for manufacturers to prepare and make available a summary of the information and data related to the device, may be made publicly available shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;
(a)
information on the registration of persons responsible for placing devices on the market in accordance with Article 10a;
(b)
information to users sent out by the manufacturer, authorised representative or distributor in relation to a measure in accordance with Article 8;
(c)
information contained in certificates issued, modified, supplemented, suspended or withdrawn.

(a)
information on the registration of persons responsible for placing devices on the market in accordance with Article 10a;

(b)
information to users sent out by the manufacturer, authorised representative or distributor in relation to a measure in accordance with Article 8;

(c)
information contained in certificates issued, modified, supplemented, suspended or withdrawn.



(a)
information on the registration of persons responsible for placing devices on the market in accordance with Article 10a;



(b)
information to users sent out by the manufacturer, authorised representative or distributor in relation to a measure in accordance with Article 8;



(c)
information contained in certificates issued, modified, supplemented, suspended or withdrawn.



16.
the following Article shall be inserted:‘Article 15aMember States shall take appropriate measures to ensure that the competent authorities of the Member States cooperate with each other and with the Commission and transmit to each other the information necessary to enable this Directive to be applied uniformly.The Commission shall provide for the organisation of an exchange of experience between the competent authorities responsible for market surveillance in order to coordinate the uniform application of this Directive.Without prejudice to the provisions of this Directive, cooperation may be part of initiatives developed at an international level.’;



17.
Annexes 1 to 7 shall be amended in accordance with Annex I to this Directive.



1.
Article 1 shall be amended as follows:(a)paragraph 2 shall be amended as follows:(i)in point (a) the introductory phrase shall be replaced by the following:‘ “medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:’;(ii)in the third paragraph of point (d) the words ‘are not’ shall be replaced by the words ‘shall not be’;(iii)the following points shall be added:‘(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;(l)“device subcategory” means a set of devices having common areas of intended use or common technology;(m)“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;(n)“single use device” means a device intended to be used once only for a single patient.’;(b)paragraph 3 shall be replaced by the following:‘3.   Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 2001/83/EC(*5), that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by Directive 2001/83/EC. The relevant essential requirements of Annex I to this Directive shall apply as far as safety and performance-related device features are concerned.(*5)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). Directive as last amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).’;"(c)in paragraph 4:(i)the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;(ii)the words ‘that device must’ shall be replaced by the words ‘that device shall’;(d)in paragraph 4a:(i)the reference ‘89/381/EEC’ shall be replaced by the reference ‘2001/83/EC’;(ii)the words ‘that device must’ shall be replaced by the words ‘that device shall’;(e)paragraph 5 shall be amended as follows:(i)The introductory phrase shall be replaced by the following:‘This Directive shall not apply to:’;(ii)point (c) shall be replaced by the following:‘(c)medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;(iii)point (f) shall be replaced by the following:‘(f)transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;(f)paragraph 6 shall be replaced by the following:‘6.   Where a device is intended by the manufacturer to be used in accordance with both the provisions on personal protective equipment in Council Directive 89/686/EEC(*6)and this Directive, the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.(*6)Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (OJ L 399, 30.12.1989, p. 18). Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).’ "(g)paragraphs 7 and 8 shall be replaced by the following:‘7.   This Directive is a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC of the European Parliament and of the Council(*7).8.   This Directive shall not affect the application of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*8), nor of Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*9).(*7)Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility (OJ L 390, 31.12.2004, p. 24)."(*8)OJ L 159, 29.6.1996, p. 1."(*9)OJ L 180, 9.7.1997, p. 22.’ "
(a)
paragraph 2 shall be amended as follows:(i)in point (a) the introductory phrase shall be replaced by the following:‘ “medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:’;(ii)in the third paragraph of point (d) the words ‘are not’ shall be replaced by the words ‘shall not be’;(iii)the following points shall be added:‘(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;(l)“device subcategory” means a set of devices having common areas of intended use or common technology;(m)“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;(n)“single use device” means a device intended to be used once only for a single patient.’;
(i)
in point (a) the introductory phrase shall be replaced by the following:‘ “medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:’;
(ii)
in the third paragraph of point (d) the words ‘are not’ shall be replaced by the words ‘shall not be’;
(iii)
the following points shall be added:‘(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;(l)“device subcategory” means a set of devices having common areas of intended use or common technology;(m)“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;(n)“single use device” means a device intended to be used once only for a single patient.’;
‘(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
—
clinical investigation(s) of the device concerned; or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
(l)
“device subcategory” means a set of devices having common areas of intended use or common technology;
(m)
“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;
(n)
“single use device” means a device intended to be used once only for a single patient.’;
(b)
paragraph 3 shall be replaced by the following:‘3.   Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 2001/83/EC(*5), that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by Directive 2001/83/EC. The relevant essential requirements of Annex I to this Directive shall apply as far as safety and performance-related device features are concerned.(*5)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). Directive as last amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).’;"
(c)
in paragraph 4:(i)the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;(ii)the words ‘that device must’ shall be replaced by the words ‘that device shall’;
(i)
the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;
(ii)
the words ‘that device must’ shall be replaced by the words ‘that device shall’;
(d)
in paragraph 4a:(i)the reference ‘89/381/EEC’ shall be replaced by the reference ‘2001/83/EC’;(ii)the words ‘that device must’ shall be replaced by the words ‘that device shall’;
(i)
the reference ‘89/381/EEC’ shall be replaced by the reference ‘2001/83/EC’;
(ii)
the words ‘that device must’ shall be replaced by the words ‘that device shall’;
(e)
paragraph 5 shall be amended as follows:(i)The introductory phrase shall be replaced by the following:‘This Directive shall not apply to:’;(ii)point (c) shall be replaced by the following:‘(c)medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;(iii)point (f) shall be replaced by the following:‘(f)transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;
(i)
The introductory phrase shall be replaced by the following:‘This Directive shall not apply to:’;
(ii)
point (c) shall be replaced by the following:‘(c)medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;
‘(c)
medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;
(iii)
point (f) shall be replaced by the following:‘(f)transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;
‘(f)
transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;
(f)
paragraph 6 shall be replaced by the following:‘6.   Where a device is intended by the manufacturer to be used in accordance with both the provisions on personal protective equipment in Council Directive 89/686/EEC(*6)and this Directive, the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.(*6)Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (OJ L 399, 30.12.1989, p. 18). Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).’ "
(g)
paragraphs 7 and 8 shall be replaced by the following:‘7.   This Directive is a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC of the European Parliament and of the Council(*7).8.   This Directive shall not affect the application of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*8), nor of Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*9).(*7)Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility (OJ L 390, 31.12.2004, p. 24)."(*8)OJ L 159, 29.6.1996, p. 1."(*9)OJ L 180, 9.7.1997, p. 22.’ "

(a)
paragraph 2 shall be amended as follows:(i)in point (a) the introductory phrase shall be replaced by the following:‘ “medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:’;(ii)in the third paragraph of point (d) the words ‘are not’ shall be replaced by the words ‘shall not be’;(iii)the following points shall be added:‘(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;(l)“device subcategory” means a set of devices having common areas of intended use or common technology;(m)“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;(n)“single use device” means a device intended to be used once only for a single patient.’;
(i)
in point (a) the introductory phrase shall be replaced by the following:‘ “medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:’;
(ii)
in the third paragraph of point (d) the words ‘are not’ shall be replaced by the words ‘shall not be’;
(iii)
the following points shall be added:‘(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;(l)“device subcategory” means a set of devices having common areas of intended use or common technology;(m)“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;(n)“single use device” means a device intended to be used once only for a single patient.’;
‘(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
—
clinical investigation(s) of the device concerned; or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
(l)
“device subcategory” means a set of devices having common areas of intended use or common technology;
(m)
“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;
(n)
“single use device” means a device intended to be used once only for a single patient.’;

(i)
in point (a) the introductory phrase shall be replaced by the following:‘ “medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:’;

(ii)
in the third paragraph of point (d) the words ‘are not’ shall be replaced by the words ‘shall not be’;

(iii)
the following points shall be added:‘(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;(l)“device subcategory” means a set of devices having common areas of intended use or common technology;(m)“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;(n)“single use device” means a device intended to be used once only for a single patient.’;
‘(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
—
clinical investigation(s) of the device concerned; or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
(l)
“device subcategory” means a set of devices having common areas of intended use or common technology;
(m)
“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;
(n)
“single use device” means a device intended to be used once only for a single patient.’;

‘(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
—
clinical investigation(s) of the device concerned; or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

—
clinical investigation(s) of the device concerned; or

—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or

—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

(l)
“device subcategory” means a set of devices having common areas of intended use or common technology;

(m)
“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;

(n)
“single use device” means a device intended to be used once only for a single patient.’;

(b)
paragraph 3 shall be replaced by the following:‘3.   Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 2001/83/EC(*5), that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by Directive 2001/83/EC. The relevant essential requirements of Annex I to this Directive shall apply as far as safety and performance-related device features are concerned.(*5)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). Directive as last amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).’;"

(c)
in paragraph 4:(i)the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;(ii)the words ‘that device must’ shall be replaced by the words ‘that device shall’;
(i)
the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;
(ii)
the words ‘that device must’ shall be replaced by the words ‘that device shall’;

(i)
the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;

(ii)
the words ‘that device must’ shall be replaced by the words ‘that device shall’;

(d)
in paragraph 4a:(i)the reference ‘89/381/EEC’ shall be replaced by the reference ‘2001/83/EC’;(ii)the words ‘that device must’ shall be replaced by the words ‘that device shall’;
(i)
the reference ‘89/381/EEC’ shall be replaced by the reference ‘2001/83/EC’;
(ii)
the words ‘that device must’ shall be replaced by the words ‘that device shall’;

(i)
the reference ‘89/381/EEC’ shall be replaced by the reference ‘2001/83/EC’;

(ii)
the words ‘that device must’ shall be replaced by the words ‘that device shall’;

(e)
paragraph 5 shall be amended as follows:(i)The introductory phrase shall be replaced by the following:‘This Directive shall not apply to:’;(ii)point (c) shall be replaced by the following:‘(c)medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;(iii)point (f) shall be replaced by the following:‘(f)transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;
(i)
The introductory phrase shall be replaced by the following:‘This Directive shall not apply to:’;
(ii)
point (c) shall be replaced by the following:‘(c)medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;
‘(c)
medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;
(iii)
point (f) shall be replaced by the following:‘(f)transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;
‘(f)
transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;

(i)
The introductory phrase shall be replaced by the following:‘This Directive shall not apply to:’;

(ii)
point (c) shall be replaced by the following:‘(c)medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;
‘(c)
medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;

‘(c)
medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;

(iii)
point (f) shall be replaced by the following:‘(f)transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;
‘(f)
transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;

‘(f)
transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;

(f)
paragraph 6 shall be replaced by the following:‘6.   Where a device is intended by the manufacturer to be used in accordance with both the provisions on personal protective equipment in Council Directive 89/686/EEC(*6)and this Directive, the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.(*6)Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (OJ L 399, 30.12.1989, p. 18). Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).’ "

(g)
paragraphs 7 and 8 shall be replaced by the following:‘7.   This Directive is a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC of the European Parliament and of the Council(*7).8.   This Directive shall not affect the application of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*8), nor of Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*9).(*7)Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility (OJ L 390, 31.12.2004, p. 24)."(*8)OJ L 159, 29.6.1996, p. 1."(*9)OJ L 180, 9.7.1997, p. 22.’ "



(a)
paragraph 2 shall be amended as follows:(i)in point (a) the introductory phrase shall be replaced by the following:‘ “medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:’;(ii)in the third paragraph of point (d) the words ‘are not’ shall be replaced by the words ‘shall not be’;(iii)the following points shall be added:‘(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;(l)“device subcategory” means a set of devices having common areas of intended use or common technology;(m)“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;(n)“single use device” means a device intended to be used once only for a single patient.’;
(i)
in point (a) the introductory phrase shall be replaced by the following:‘ “medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:’;
(ii)
in the third paragraph of point (d) the words ‘are not’ shall be replaced by the words ‘shall not be’;
(iii)
the following points shall be added:‘(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;(l)“device subcategory” means a set of devices having common areas of intended use or common technology;(m)“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;(n)“single use device” means a device intended to be used once only for a single patient.’;
‘(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
—
clinical investigation(s) of the device concerned; or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
(l)
“device subcategory” means a set of devices having common areas of intended use or common technology;
(m)
“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;
(n)
“single use device” means a device intended to be used once only for a single patient.’;

(i)
in point (a) the introductory phrase shall be replaced by the following:‘ “medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:’;

(ii)
in the third paragraph of point (d) the words ‘are not’ shall be replaced by the words ‘shall not be’;

(iii)
the following points shall be added:‘(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;(l)“device subcategory” means a set of devices having common areas of intended use or common technology;(m)“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;(n)“single use device” means a device intended to be used once only for a single patient.’;
‘(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
—
clinical investigation(s) of the device concerned; or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
(l)
“device subcategory” means a set of devices having common areas of intended use or common technology;
(m)
“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;
(n)
“single use device” means a device intended to be used once only for a single patient.’;

‘(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
—
clinical investigation(s) of the device concerned; or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

—
clinical investigation(s) of the device concerned; or

—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or

—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

(l)
“device subcategory” means a set of devices having common areas of intended use or common technology;

(m)
“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;

(n)
“single use device” means a device intended to be used once only for a single patient.’;



(i)
in point (a) the introductory phrase shall be replaced by the following:‘ “medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:’;



(ii)
in the third paragraph of point (d) the words ‘are not’ shall be replaced by the words ‘shall not be’;



(iii)
the following points shall be added:‘(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;(l)“device subcategory” means a set of devices having common areas of intended use or common technology;(m)“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;(n)“single use device” means a device intended to be used once only for a single patient.’;
‘(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
—
clinical investigation(s) of the device concerned; or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
(l)
“device subcategory” means a set of devices having common areas of intended use or common technology;
(m)
“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;
(n)
“single use device” means a device intended to be used once only for a single patient.’;

‘(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
—
clinical investigation(s) of the device concerned; or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

—
clinical investigation(s) of the device concerned; or

—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or

—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

(l)
“device subcategory” means a set of devices having common areas of intended use or common technology;

(m)
“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;

(n)
“single use device” means a device intended to be used once only for a single patient.’;



‘(k)
“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
—
clinical investigation(s) of the device concerned; or
—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

—
clinical investigation(s) of the device concerned; or

—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or

—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;



—
clinical investigation(s) of the device concerned; or



—
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or



—
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;



(l)
“device subcategory” means a set of devices having common areas of intended use or common technology;



(m)
“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;



(n)
“single use device” means a device intended to be used once only for a single patient.’;



(b)
paragraph 3 shall be replaced by the following:‘3.   Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 2001/83/EC(*5), that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by Directive 2001/83/EC. The relevant essential requirements of Annex I to this Directive shall apply as far as safety and performance-related device features are concerned.(*5)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). Directive as last amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).’;"



(c)
in paragraph 4:(i)the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;(ii)the words ‘that device must’ shall be replaced by the words ‘that device shall’;
(i)
the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;
(ii)
the words ‘that device must’ shall be replaced by the words ‘that device shall’;

(i)
the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;

(ii)
the words ‘that device must’ shall be replaced by the words ‘that device shall’;



(i)
the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;



(ii)
the words ‘that device must’ shall be replaced by the words ‘that device shall’;



(d)
in paragraph 4a:(i)the reference ‘89/381/EEC’ shall be replaced by the reference ‘2001/83/EC’;(ii)the words ‘that device must’ shall be replaced by the words ‘that device shall’;
(i)
the reference ‘89/381/EEC’ shall be replaced by the reference ‘2001/83/EC’;
(ii)
the words ‘that device must’ shall be replaced by the words ‘that device shall’;

(i)
the reference ‘89/381/EEC’ shall be replaced by the reference ‘2001/83/EC’;

(ii)
the words ‘that device must’ shall be replaced by the words ‘that device shall’;



(i)
the reference ‘89/381/EEC’ shall be replaced by the reference ‘2001/83/EC’;



(ii)
the words ‘that device must’ shall be replaced by the words ‘that device shall’;



(e)
paragraph 5 shall be amended as follows:(i)The introductory phrase shall be replaced by the following:‘This Directive shall not apply to:’;(ii)point (c) shall be replaced by the following:‘(c)medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;(iii)point (f) shall be replaced by the following:‘(f)transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;
(i)
The introductory phrase shall be replaced by the following:‘This Directive shall not apply to:’;
(ii)
point (c) shall be replaced by the following:‘(c)medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;
‘(c)
medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;
(iii)
point (f) shall be replaced by the following:‘(f)transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;
‘(f)
transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;

(i)
The introductory phrase shall be replaced by the following:‘This Directive shall not apply to:’;

(ii)
point (c) shall be replaced by the following:‘(c)medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;
‘(c)
medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;

‘(c)
medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;

(iii)
point (f) shall be replaced by the following:‘(f)transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;
‘(f)
transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;

‘(f)
transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;



(i)
The introductory phrase shall be replaced by the following:‘This Directive shall not apply to:’;



(ii)
point (c) shall be replaced by the following:‘(c)medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;
‘(c)
medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;

‘(c)
medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;



‘(c)
medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;



(iii)
point (f) shall be replaced by the following:‘(f)transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;
‘(f)
transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;

‘(f)
transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;



‘(f)
transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;



(f)
paragraph 6 shall be replaced by the following:‘6.   Where a device is intended by the manufacturer to be used in accordance with both the provisions on personal protective equipment in Council Directive 89/686/EEC(*6)and this Directive, the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.(*6)Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (OJ L 399, 30.12.1989, p. 18). Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).’ "



(g)
paragraphs 7 and 8 shall be replaced by the following:‘7.   This Directive is a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC of the European Parliament and of the Council(*7).8.   This Directive shall not affect the application of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*8), nor of Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*9).(*7)Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility (OJ L 390, 31.12.2004, p. 24)."(*8)OJ L 159, 29.6.1996, p. 1."(*9)OJ L 180, 9.7.1997, p. 22.’ "



2.
in Article 3 the following paragraph shall be added:‘Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery(*10)shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to this Directive.(*10)OJ L 157, 9.6.2006, p. 24.’ "



3.
the second indent of Article 4(2) shall be replaced by the following:‘—custom-made devices being placed on the market and put into service if they meet the conditions laid down in Article 11 in combination with Annex VIII; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII, which shall be available to the particular patient identified by name, an acronym or a numerical code.’;
‘—
custom-made devices being placed on the market and put into service if they meet the conditions laid down in Article 11 in combination with Annex VIII; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII, which shall be available to the particular patient identified by name, an acronym or a numerical code.’;

‘—
custom-made devices being placed on the market and put into service if they meet the conditions laid down in Article 11 in combination with Annex VIII; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII, which shall be available to the particular patient identified by name, an acronym or a numerical code.’;



‘—
custom-made devices being placed on the market and put into service if they meet the conditions laid down in Article 11 in combination with Annex VIII; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII, which shall be available to the particular patient identified by name, an acronym or a numerical code.’;



4.
in Article 6(1) the reference ‘83/189/EEC’ shall be replaced by the reference‘98/34/EC(*11)



5.
Article 7 shall be replaced by the following:‘Article 71.   The Commission shall be assisted by the Committee set up by Article 6(2) of Directive 90/385/EEC, hereinafter referred to as “the Committee”.2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.3.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.4.   Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;



6.
In Article 8 paragraph 2 shall be replaced by the following:‘2.   The Commission shall enter into consultation with the Parties concerned as soon as possible. Where, after such consultation, the Commission finds that:(a)the measures are justified:(i)it shall immediately so inform the Member State which took the measures and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the Parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the advisory procedure referred to in Article 6(2);(ii)when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);(b)the measures are unjustified, it shall immediately so inform the Member State which took the measures and the manufacturer or his authorised representative.’;
(a)
the measures are justified:(i)it shall immediately so inform the Member State which took the measures and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the Parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the advisory procedure referred to in Article 6(2);(ii)when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);
(i)
it shall immediately so inform the Member State which took the measures and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the Parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the advisory procedure referred to in Article 6(2);
(ii)
when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);
(b)
the measures are unjustified, it shall immediately so inform the Member State which took the measures and the manufacturer or his authorised representative.’;

(a)
the measures are justified:(i)it shall immediately so inform the Member State which took the measures and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the Parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the advisory procedure referred to in Article 6(2);(ii)when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);
(i)
it shall immediately so inform the Member State which took the measures and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the Parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the advisory procedure referred to in Article 6(2);
(ii)
when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);

(i)
it shall immediately so inform the Member State which took the measures and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the Parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the advisory procedure referred to in Article 6(2);

(ii)
when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);

(b)
the measures are unjustified, it shall immediately so inform the Member State which took the measures and the manufacturer or his authorised representative.’;



(a)
the measures are justified:(i)it shall immediately so inform the Member State which took the measures and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the Parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the advisory procedure referred to in Article 6(2);(ii)when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);
(i)
it shall immediately so inform the Member State which took the measures and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the Parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the advisory procedure referred to in Article 6(2);
(ii)
when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);

(i)
it shall immediately so inform the Member State which took the measures and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the Parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the advisory procedure referred to in Article 6(2);

(ii)
when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);



(i)
it shall immediately so inform the Member State which took the measures and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the Parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the advisory procedure referred to in Article 6(2);



(ii)
when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);



(b)
the measures are unjustified, it shall immediately so inform the Member State which took the measures and the manufacturer or his authorised representative.’;



7.
In Article 9 paragraph 3 shall be replaced by the following:‘3.   Where a Member State considers that the classification rules set out in Annex IX require adaptation in the light of technical progress and any information which becomes available under the information system provided for in Article 10, it may submit a duly substantiated request to the Commission and ask it to take the necessary measures for adaptation of classification rules. The measures designed to amend non-essential elements of this Directive relating to adaptation of classification rules shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;



8.
Article 10 shall be amended as follows:(a)in paragraph 2, the words ‘established in the Community’ shall be deleted;(b)paragraph 3 shall be replaced by the following:‘3.   After carrying out an assessment, if possible together with the manufacturer or his authorised representative, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise the recurrence of the incidents referred to in paragraph 1, including information on the underlying incidents.’;(c)the following paragraph shall be added:‘4.   Any appropriate measures to adopt procedures to implement this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;
(a)
in paragraph 2, the words ‘established in the Community’ shall be deleted;
(b)
paragraph 3 shall be replaced by the following:‘3.   After carrying out an assessment, if possible together with the manufacturer or his authorised representative, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise the recurrence of the incidents referred to in paragraph 1, including information on the underlying incidents.’;
(c)
the following paragraph shall be added:‘4.   Any appropriate measures to adopt procedures to implement this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;

(a)
in paragraph 2, the words ‘established in the Community’ shall be deleted;

(b)
paragraph 3 shall be replaced by the following:‘3.   After carrying out an assessment, if possible together with the manufacturer or his authorised representative, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise the recurrence of the incidents referred to in paragraph 1, including information on the underlying incidents.’;

(c)
the following paragraph shall be added:‘4.   Any appropriate measures to adopt procedures to implement this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;



(a)
in paragraph 2, the words ‘established in the Community’ shall be deleted;



(b)
paragraph 3 shall be replaced by the following:‘3.   After carrying out an assessment, if possible together with the manufacturer or his authorised representative, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise the recurrence of the incidents referred to in paragraph 1, including information on the underlying incidents.’;



(c)
the following paragraph shall be added:‘4.   Any appropriate measures to adopt procedures to implement this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;



9.
Article 11 shall be amended as follows:(a)in paragraphs 8 and 9 the words ‘established in the Community’ shall be deleted;(b)in paragraph 11, the words ‘Annexes II and III’ shall be replaced by the words ‘Annexes II, III, V and VI’ and the words ‘for further periods of five years’ shall be replaced by the words ‘for further periods of a maximum length of five years’;(c)the following paragraph shall be added:‘14.   The measures designed to amend non-essential elements of this Directive, by supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex I Section 13.1 may be set out, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;
(a)
in paragraphs 8 and 9 the words ‘established in the Community’ shall be deleted;
(b)
in paragraph 11, the words ‘Annexes II and III’ shall be replaced by the words ‘Annexes II, III, V and VI’ and the words ‘for further periods of five years’ shall be replaced by the words ‘for further periods of a maximum length of five years’;
(c)
the following paragraph shall be added:‘14.   The measures designed to amend non-essential elements of this Directive, by supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex I Section 13.1 may be set out, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;

(a)
in paragraphs 8 and 9 the words ‘established in the Community’ shall be deleted;

(b)
in paragraph 11, the words ‘Annexes II and III’ shall be replaced by the words ‘Annexes II, III, V and VI’ and the words ‘for further periods of five years’ shall be replaced by the words ‘for further periods of a maximum length of five years’;

(c)
the following paragraph shall be added:‘14.   The measures designed to amend non-essential elements of this Directive, by supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex I Section 13.1 may be set out, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;



(a)
in paragraphs 8 and 9 the words ‘established in the Community’ shall be deleted;



(b)
in paragraph 11, the words ‘Annexes II and III’ shall be replaced by the words ‘Annexes II, III, V and VI’ and the words ‘for further periods of five years’ shall be replaced by the words ‘for further periods of a maximum length of five years’;



(c)
the following paragraph shall be added:‘14.   The measures designed to amend non-essential elements of this Directive, by supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex I Section 13.1 may be set out, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;



10.
Article 12 shall be amended as follows:(a)the title shall be replaced by ‘Particular procedure for systems and procedure packs and procedure for sterilisation’;(b)paragraph 3 shall be replaced by the following:‘3.   Any natural or legal person who sterilises, for the purpose of placing on the market, systems or procedure packs referred to in paragraph 2 or other CE-marked medical devices designed by their manufacturers to be sterilised before use, shall, at his choice, follow one of the procedures referred to in Annex II or V. The application of the abovementioned Annexes and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged. The person shall draw up a declaration stating that sterilisation has been carried out in accordance with the manufacturer's instructions.’;(c)in paragraph 4, the third sentence shall be replaced by the following:‘The declarations referred to in paragraphs 2 and 3 shall be kept at the disposal of the competent authorities for a period of five years.’;
(a)
the title shall be replaced by ‘Particular procedure for systems and procedure packs and procedure for sterilisation’;
(b)
paragraph 3 shall be replaced by the following:‘3.   Any natural or legal person who sterilises, for the purpose of placing on the market, systems or procedure packs referred to in paragraph 2 or other CE-marked medical devices designed by their manufacturers to be sterilised before use, shall, at his choice, follow one of the procedures referred to in Annex II or V. The application of the abovementioned Annexes and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged. The person shall draw up a declaration stating that sterilisation has been carried out in accordance with the manufacturer's instructions.’;
(c)
in paragraph 4, the third sentence shall be replaced by the following:‘The declarations referred to in paragraphs 2 and 3 shall be kept at the disposal of the competent authorities for a period of five years.’;

(a)
the title shall be replaced by ‘Particular procedure for systems and procedure packs and procedure for sterilisation’;

(b)
paragraph 3 shall be replaced by the following:‘3.   Any natural or legal person who sterilises, for the purpose of placing on the market, systems or procedure packs referred to in paragraph 2 or other CE-marked medical devices designed by their manufacturers to be sterilised before use, shall, at his choice, follow one of the procedures referred to in Annex II or V. The application of the abovementioned Annexes and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged. The person shall draw up a declaration stating that sterilisation has been carried out in accordance with the manufacturer's instructions.’;

(c)
in paragraph 4, the third sentence shall be replaced by the following:‘The declarations referred to in paragraphs 2 and 3 shall be kept at the disposal of the competent authorities for a period of five years.’;



(a)
the title shall be replaced by ‘Particular procedure for systems and procedure packs and procedure for sterilisation’;



(b)
paragraph 3 shall be replaced by the following:‘3.   Any natural or legal person who sterilises, for the purpose of placing on the market, systems or procedure packs referred to in paragraph 2 or other CE-marked medical devices designed by their manufacturers to be sterilised before use, shall, at his choice, follow one of the procedures referred to in Annex II or V. The application of the abovementioned Annexes and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged. The person shall draw up a declaration stating that sterilisation has been carried out in accordance with the manufacturer's instructions.’;



(c)
in paragraph 4, the third sentence shall be replaced by the following:‘The declarations referred to in paragraphs 2 and 3 shall be kept at the disposal of the competent authorities for a period of five years.’;



11.
The following Article shall be inserted:‘Article 12aReprocessing of medical devicesThe Commission shall, no later than 5 September 2010, submit a report to the European Parliament and to the Council on the issue of the reprocessing of medical devices in the Community.In the light of the findings of this report, the Commission shall submit to the European Parliament and to the Council any additional proposal it may deem appropriate in order to ensure a high level of health protection.’



12.
Article 13 shall be replaced by the following:‘Article 13Decisions with regard to classification and derogation clause1.   A Member State shall submit a duly substantiated request to the Commission and ask it to take the necessary measures in the following situations:(a)that Member State considers that the application of the classification rules set out in Annex IX requires a decision with regard to the classification of a given device or category of devices;(b)that Member State considers that a given device or family of devices should, by way of derogation from the provisions of Annex IX, be classified in another class;(c)that Member State considers that the conformity of a device or family of devices should, by way of derogation from Article 11, be established by applying solely one of the given procedures chosen from among those referred to in Article 11;(d)that Member State considers that a decision is required as to whether a particular product or product group falls within one of the definitions in Article 1(2)(a) to (e).The measures referred to in the first subparagraph of this paragraph shall, as appropriate, be adopted in accordance with the procedure referred to in Article 7(2).2.   The Commission shall inform the Member States of the measures taken.’;
(a)
that Member State considers that the application of the classification rules set out in Annex IX requires a decision with regard to the classification of a given device or category of devices;
(b)
that Member State considers that a given device or family of devices should, by way of derogation from the provisions of Annex IX, be classified in another class;
(c)
that Member State considers that the conformity of a device or family of devices should, by way of derogation from Article 11, be established by applying solely one of the given procedures chosen from among those referred to in Article 11;
(d)
that Member State considers that a decision is required as to whether a particular product or product group falls within one of the definitions in Article 1(2)(a) to (e).

(a)
that Member State considers that the application of the classification rules set out in Annex IX requires a decision with regard to the classification of a given device or category of devices;

(b)
that Member State considers that a given device or family of devices should, by way of derogation from the provisions of Annex IX, be classified in another class;

(c)
that Member State considers that the conformity of a device or family of devices should, by way of derogation from Article 11, be established by applying solely one of the given procedures chosen from among those referred to in Article 11;

(d)
that Member State considers that a decision is required as to whether a particular product or product group falls within one of the definitions in Article 1(2)(a) to (e).



(a)
that Member State considers that the application of the classification rules set out in Annex IX requires a decision with regard to the classification of a given device or category of devices;



(b)
that Member State considers that a given device or family of devices should, by way of derogation from the provisions of Annex IX, be classified in another class;



(c)
that Member State considers that the conformity of a device or family of devices should, by way of derogation from Article 11, be established by applying solely one of the given procedures chosen from among those referred to in Article 11;



(d)
that Member State considers that a decision is required as to whether a particular product or product group falls within one of the definitions in Article 1(2)(a) to (e).



13.
Article 14 shall be amended as follows:(a)in the second subparagraph of paragraph 1, the words ‘Classes IIb and III’ shall be replaced by the words ‘Classes IIa, IIb and III’;(b)paragraph 2 shall be replaced by the following:‘2.   Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union. For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.’;(c)paragraph 3 shall be replaced by the following:‘3.   The Member States shall on request inform the other Member States and the Commission of the details referred to in the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.’;
(a)
in the second subparagraph of paragraph 1, the words ‘Classes IIb and III’ shall be replaced by the words ‘Classes IIa, IIb and III’;
(b)
paragraph 2 shall be replaced by the following:‘2.   Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union. For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.’;
(c)
paragraph 3 shall be replaced by the following:‘3.   The Member States shall on request inform the other Member States and the Commission of the details referred to in the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.’;

(a)
in the second subparagraph of paragraph 1, the words ‘Classes IIb and III’ shall be replaced by the words ‘Classes IIa, IIb and III’;

(b)
paragraph 2 shall be replaced by the following:‘2.   Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union. For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.’;

(c)
paragraph 3 shall be replaced by the following:‘3.   The Member States shall on request inform the other Member States and the Commission of the details referred to in the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.’;



(a)
in the second subparagraph of paragraph 1, the words ‘Classes IIb and III’ shall be replaced by the words ‘Classes IIa, IIb and III’;



(b)
paragraph 2 shall be replaced by the following:‘2.   Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union. For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.’;



(c)
paragraph 3 shall be replaced by the following:‘3.   The Member States shall on request inform the other Member States and the Commission of the details referred to in the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.’;



14.
Article 14a shall be amended as follows:(a)the second subparagraph of paragraph 1 shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;(ii)the following point shall be added:‘(d)data relating to clinical investigations referred to in Article 15;’;(b)paragraph 3 shall be replaced by the following:‘3.   The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in particular paragraph 1(d), shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’(c)the following paragraph shall be added:‘4.   The provisions of this Article shall be implemented no later than 5 September 2012. The Commission shall, no later than 11 October 2012, evaluate the operational functioning and the added value of the databank. On the basis of this evaluation, the Commission shall, if appropriate, present proposals to the European Parliament and the Council or present draft measures in accordance with paragraph 3.’;
(a)
the second subparagraph of paragraph 1 shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;(ii)the following point shall be added:‘(d)data relating to clinical investigations referred to in Article 15;’;
(i)
point (a) shall be replaced by the following:‘(a)data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;
‘(a)
data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;
(ii)
the following point shall be added:‘(d)data relating to clinical investigations referred to in Article 15;’;
‘(d)
data relating to clinical investigations referred to in Article 15;’;
(b)
paragraph 3 shall be replaced by the following:‘3.   The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in particular paragraph 1(d), shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’
(c)
the following paragraph shall be added:‘4.   The provisions of this Article shall be implemented no later than 5 September 2012. The Commission shall, no later than 11 October 2012, evaluate the operational functioning and the added value of the databank. On the basis of this evaluation, the Commission shall, if appropriate, present proposals to the European Parliament and the Council or present draft measures in accordance with paragraph 3.’;

(a)
the second subparagraph of paragraph 1 shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;(ii)the following point shall be added:‘(d)data relating to clinical investigations referred to in Article 15;’;
(i)
point (a) shall be replaced by the following:‘(a)data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;
‘(a)
data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;
(ii)
the following point shall be added:‘(d)data relating to clinical investigations referred to in Article 15;’;
‘(d)
data relating to clinical investigations referred to in Article 15;’;

(i)
point (a) shall be replaced by the following:‘(a)data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;
‘(a)
data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;

‘(a)
data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;

(ii)
the following point shall be added:‘(d)data relating to clinical investigations referred to in Article 15;’;
‘(d)
data relating to clinical investigations referred to in Article 15;’;

‘(d)
data relating to clinical investigations referred to in Article 15;’;

(b)
paragraph 3 shall be replaced by the following:‘3.   The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in particular paragraph 1(d), shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’

(c)
the following paragraph shall be added:‘4.   The provisions of this Article shall be implemented no later than 5 September 2012. The Commission shall, no later than 11 October 2012, evaluate the operational functioning and the added value of the databank. On the basis of this evaluation, the Commission shall, if appropriate, present proposals to the European Parliament and the Council or present draft measures in accordance with paragraph 3.’;



(a)
the second subparagraph of paragraph 1 shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;(ii)the following point shall be added:‘(d)data relating to clinical investigations referred to in Article 15;’;
(i)
point (a) shall be replaced by the following:‘(a)data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;
‘(a)
data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;
(ii)
the following point shall be added:‘(d)data relating to clinical investigations referred to in Article 15;’;
‘(d)
data relating to clinical investigations referred to in Article 15;’;

(i)
point (a) shall be replaced by the following:‘(a)data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;
‘(a)
data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;

‘(a)
data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;

(ii)
the following point shall be added:‘(d)data relating to clinical investigations referred to in Article 15;’;
‘(d)
data relating to clinical investigations referred to in Article 15;’;

‘(d)
data relating to clinical investigations referred to in Article 15;’;



(i)
point (a) shall be replaced by the following:‘(a)data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;
‘(a)
data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;

‘(a)
data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;



‘(a)
data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;



(ii)
the following point shall be added:‘(d)data relating to clinical investigations referred to in Article 15;’;
‘(d)
data relating to clinical investigations referred to in Article 15;’;

‘(d)
data relating to clinical investigations referred to in Article 15;’;



‘(d)
data relating to clinical investigations referred to in Article 15;’;



(b)
paragraph 3 shall be replaced by the following:‘3.   The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in particular paragraph 1(d), shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’



(c)
the following paragraph shall be added:‘4.   The provisions of this Article shall be implemented no later than 5 September 2012. The Commission shall, no later than 11 October 2012, evaluate the operational functioning and the added value of the databank. On the basis of this evaluation, the Commission shall, if appropriate, present proposals to the European Parliament and the Council or present draft measures in accordance with paragraph 3.’;



15.
Article 14b shall be replaced by the following:‘Article 14bParticular health monitoring measuresWhere a Member State considers, in relation to a given product or group of products, that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed, such products should be withdrawn from the market, or their placing on the market and putting into service should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures.The Member State shall then inform the Commission and all other Member States, giving the reasons for its decision.The Commission shall, whenever possible, consult the interested Parties and the Member States.The Commission shall adopt its opinion, indicating whether the national measures are justified or not. The Commission shall inform all the Member States and the consulted interested Parties thereof.When appropriate, the necessary measures designed to amend non-essential elements of this Directive, relating to withdrawal from the market, prohibition of placing on the market and putting into service of a certain product or group of products or to restrictions or introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4).’;



16.
Article 15 shall be amended as follows:(a)paragraphs 1, 2 and 3 shall be replaced by the following:‘1.   In the case of devices intended for clinical investigations, the manufacturer or the authorised representative, established in the Community, shall follow the procedure referred to in Annex VIII and notify the competent authorities of the Member States in which the investigations are to be conducted by means of the statement mentioned in Section 2.2 of Annex VIII.2.   In the case of devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of 60 days after notification, unless the competent authorities have notified him within that period of a decision to the contrary based on considerations of public health or public policy.Member States may however authorise manufacturers to commence the relevant clinical investigations before the expiry of the period of 60 days, insofar as the relevant ethics committee has issued a favourable opinion on the programme of investigation in question, including its review of the clinical investigation plan.3.   In the case of devices other than those referred to in paragraph 2, Member States may authorise manufacturers to commence clinical investigations immediately after the date of notification, provided that the ethics committee concerned has issued a favourable opinion on the programme of investigation in question including its review of the clinical investigation plan.’;(b)paragraphs 5, 6 and 7 shall be replaced by the following:‘5.   The clinical investigations must be conducted in accordance with the provisions of Annex X. The measures designed to amend non-essential elements of this Directive, inter alia by supplementing it, relating to the provisions on clinical investigation in Annex X shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).6.   The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.7.   The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in Section 2.3.7 of Annex X at the disposal of the competent authorities.’;
(a)
paragraphs 1, 2 and 3 shall be replaced by the following:‘1.   In the case of devices intended for clinical investigations, the manufacturer or the authorised representative, established in the Community, shall follow the procedure referred to in Annex VIII and notify the competent authorities of the Member States in which the investigations are to be conducted by means of the statement mentioned in Section 2.2 of Annex VIII.2.   In the case of devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of 60 days after notification, unless the competent authorities have notified him within that period of a decision to the contrary based on considerations of public health or public policy.Member States may however authorise manufacturers to commence the relevant clinical investigations before the expiry of the period of 60 days, insofar as the relevant ethics committee has issued a favourable opinion on the programme of investigation in question, including its review of the clinical investigation plan.3.   In the case of devices other than those referred to in paragraph 2, Member States may authorise manufacturers to commence clinical investigations immediately after the date of notification, provided that the ethics committee concerned has issued a favourable opinion on the programme of investigation in question including its review of the clinical investigation plan.’;
(b)
paragraphs 5, 6 and 7 shall be replaced by the following:‘5.   The clinical investigations must be conducted in accordance with the provisions of Annex X. The measures designed to amend non-essential elements of this Directive, inter alia by supplementing it, relating to the provisions on clinical investigation in Annex X shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).6.   The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.7.   The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in Section 2.3.7 of Annex X at the disposal of the competent authorities.’;

(a)
paragraphs 1, 2 and 3 shall be replaced by the following:‘1.   In the case of devices intended for clinical investigations, the manufacturer or the authorised representative, established in the Community, shall follow the procedure referred to in Annex VIII and notify the competent authorities of the Member States in which the investigations are to be conducted by means of the statement mentioned in Section 2.2 of Annex VIII.2.   In the case of devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of 60 days after notification, unless the competent authorities have notified him within that period of a decision to the contrary based on considerations of public health or public policy.Member States may however authorise manufacturers to commence the relevant clinical investigations before the expiry of the period of 60 days, insofar as the relevant ethics committee has issued a favourable opinion on the programme of investigation in question, including its review of the clinical investigation plan.3.   In the case of devices other than those referred to in paragraph 2, Member States may authorise manufacturers to commence clinical investigations immediately after the date of notification, provided that the ethics committee concerned has issued a favourable opinion on the programme of investigation in question including its review of the clinical investigation plan.’;

(b)
paragraphs 5, 6 and 7 shall be replaced by the following:‘5.   The clinical investigations must be conducted in accordance with the provisions of Annex X. The measures designed to amend non-essential elements of this Directive, inter alia by supplementing it, relating to the provisions on clinical investigation in Annex X shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).6.   The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.7.   The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in Section 2.3.7 of Annex X at the disposal of the competent authorities.’;



(a)
paragraphs 1, 2 and 3 shall be replaced by the following:‘1.   In the case of devices intended for clinical investigations, the manufacturer or the authorised representative, established in the Community, shall follow the procedure referred to in Annex VIII and notify the competent authorities of the Member States in which the investigations are to be conducted by means of the statement mentioned in Section 2.2 of Annex VIII.2.   In the case of devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of 60 days after notification, unless the competent authorities have notified him within that period of a decision to the contrary based on considerations of public health or public policy.Member States may however authorise manufacturers to commence the relevant clinical investigations before the expiry of the period of 60 days, insofar as the relevant ethics committee has issued a favourable opinion on the programme of investigation in question, including its review of the clinical investigation plan.3.   In the case of devices other than those referred to in paragraph 2, Member States may authorise manufacturers to commence clinical investigations immediately after the date of notification, provided that the ethics committee concerned has issued a favourable opinion on the programme of investigation in question including its review of the clinical investigation plan.’;



(b)
paragraphs 5, 6 and 7 shall be replaced by the following:‘5.   The clinical investigations must be conducted in accordance with the provisions of Annex X. The measures designed to amend non-essential elements of this Directive, inter alia by supplementing it, relating to the provisions on clinical investigation in Annex X shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).6.   The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.7.   The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in Section 2.3.7 of Annex X at the disposal of the competent authorities.’;



17.
Article 16 shall be amended as follows:(a)the following subparagraph shall be added to paragraph 2:‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex XI for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;(b)in paragraph 4, the words ‘established in the Community’ shall be deleted;(c)paragraph 5 shall be replaced by the following:‘5.   The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.’;
(a)
the following subparagraph shall be added to paragraph 2:‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex XI for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;
(b)
in paragraph 4, the words ‘established in the Community’ shall be deleted;
(c)
paragraph 5 shall be replaced by the following:‘5.   The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.’;

(a)
the following subparagraph shall be added to paragraph 2:‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex XI for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;

(b)
in paragraph 4, the words ‘established in the Community’ shall be deleted;

(c)
paragraph 5 shall be replaced by the following:‘5.   The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.’;



(a)
the following subparagraph shall be added to paragraph 2:‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex XI for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;



(b)
in paragraph 4, the words ‘established in the Community’ shall be deleted;



(c)
paragraph 5 shall be replaced by the following:‘5.   The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.’;



18.
in Article 18 point (a) shall be replaced by the following:‘(a)where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of the Directive, the manufacturer or his authorised representative shall be obliged to end the infringement under conditions imposed by the Member State;’;
‘(a)
where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of the Directive, the manufacturer or his authorised representative shall be obliged to end the infringement under conditions imposed by the Member State;’;

‘(a)
where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of the Directive, the manufacturer or his authorised representative shall be obliged to end the infringement under conditions imposed by the Member State;’;



‘(a)
where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of the Directive, the manufacturer or his authorised representative shall be obliged to end the infringement under conditions imposed by the Member State;’;



19.
in Article 19(2), the words ‘established in the Community’ shall be deleted;



20.
Article 20 shall be replaced by the following:‘Article 20Confidentiality1.   Without prejudice to the existing national provisions and practices on medical confidentiality, Member States shall ensure that all the Parties involved in the application of this Directive are bound to observe confidentiality with regard to all information obtained in carrying out their tasks.This does not affect the obligation of Member States and notified bodies with regard to mutual information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law.2.   The following information shall not be treated as confidential:(a)information on the registration of persons responsible for placing devices on the market in accordance with Article 14;(b)information to users sent out by the manufacturer, authorised representative or distributor in relation to a measure according to Article 10(3);(c)information contained in certificates issued, modified, supplemented, suspended or withdrawn.3.   The measures designed to amend non-essential elements of this Directive,inter aliaby supplementing it, relating to determination of the conditions under which other information may be made publicly available, and in particular for Class IIb and Class III devices to any obligation for manufacturers to prepare and make available a summary of the information and data related to the device, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;
(a)
information on the registration of persons responsible for placing devices on the market in accordance with Article 14;
(b)
information to users sent out by the manufacturer, authorised representative or distributor in relation to a measure according to Article 10(3);
(c)
information contained in certificates issued, modified, supplemented, suspended or withdrawn.

(a)
information on the registration of persons responsible for placing devices on the market in accordance with Article 14;

(b)
information to users sent out by the manufacturer, authorised representative or distributor in relation to a measure according to Article 10(3);

(c)
information contained in certificates issued, modified, supplemented, suspended or withdrawn.



(a)
information on the registration of persons responsible for placing devices on the market in accordance with Article 14;



(b)
information to users sent out by the manufacturer, authorised representative or distributor in relation to a measure according to Article 10(3);



(c)
information contained in certificates issued, modified, supplemented, suspended or withdrawn.



21.
the following Article shall be inserted:‘Article 20aCooperationMember States shall take appropriate measures to ensure that the competent authorities of the Member States cooperate with each other and with the Commission and transmit to each other the information necessary to enable this Directive to be applied uniformly.The Commission shall provide for the organisation of an exchange of experience between the competent authorities responsible for market surveillance in order to coordinate the uniform application of this Directive.Without prejudice to the provisions of this Directive, cooperation may be part of initiatives developed at an international level.’;



22.
Annexes I to X shall be amended in accordance with Annex II to this Directive.



‘(s)
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices(*12).



1.
Annex 1 shall be amended as follows:(a)the following Section shall be inserted:‘5a.Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7.’;(b)in Section 8, the fifth indent shall be replaced by the following:‘—risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*1)and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*2).(*1)OJ L 159, 29.6.1996, p. 1."(*2)OJ L 180, 9.7.1997, p. 22.’;"(c)in Section 9, seventh indent, the following phrase shall be added:‘For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;(d)Section 10 shall be replaced by the following:‘10.Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*3)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance, including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.(*3)Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as last amended by Regulation (EC) No 1901/2006.’;"(e)Section 14.2 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;(ii)the following indent shall be added:‘—in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;(f)the following indent shall be added to the second paragraph of Section 15:‘—date of issue or the latest revision of the instructions for use.’;
(a)
the following Section shall be inserted:‘5a.Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7.’;
‘5a.
Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7.’;
(b)
in Section 8, the fifth indent shall be replaced by the following:‘—risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*1)and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*2).(*1)OJ L 159, 29.6.1996, p. 1."(*2)OJ L 180, 9.7.1997, p. 22.’;"
‘—
risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*1)and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*2).
(c)
in Section 9, seventh indent, the following phrase shall be added:‘For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;
(d)
Section 10 shall be replaced by the following:‘10.Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*3)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance, including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.(*3)Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as last amended by Regulation (EC) No 1901/2006.’;"
‘10.
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*3)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance, including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.
(e)
Section 14.2 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;(ii)the following indent shall be added:‘—in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;
(i)
the first indent shall be replaced by the following:‘—the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;
‘—
the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;
(ii)
the following indent shall be added:‘—in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;
‘—
in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;
(f)
the following indent shall be added to the second paragraph of Section 15:‘—date of issue or the latest revision of the instructions for use.’;
‘—
date of issue or the latest revision of the instructions for use.’;

(a)
the following Section shall be inserted:‘5a.Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7.’;
‘5a.
Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7.’;

‘5a.
Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7.’;

(b)
in Section 8, the fifth indent shall be replaced by the following:‘—risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*1)and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*2).(*1)OJ L 159, 29.6.1996, p. 1."(*2)OJ L 180, 9.7.1997, p. 22.’;"
‘—
risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*1)and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*2).

‘—
risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*1)and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*2).

(c)
in Section 9, seventh indent, the following phrase shall be added:‘For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;

(d)
Section 10 shall be replaced by the following:‘10.Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*3)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance, including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.(*3)Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as last amended by Regulation (EC) No 1901/2006.’;"
‘10.
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*3)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance, including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.

‘10.
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*3)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance, including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.

(e)
Section 14.2 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;(ii)the following indent shall be added:‘—in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;
(i)
the first indent shall be replaced by the following:‘—the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;
‘—
the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;
(ii)
the following indent shall be added:‘—in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;
‘—
in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;

(i)
the first indent shall be replaced by the following:‘—the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;
‘—
the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;

‘—
the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;

(ii)
the following indent shall be added:‘—in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;
‘—
in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;

‘—
in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;

(f)
the following indent shall be added to the second paragraph of Section 15:‘—date of issue or the latest revision of the instructions for use.’;
‘—
date of issue or the latest revision of the instructions for use.’;

‘—
date of issue or the latest revision of the instructions for use.’;



(a)
the following Section shall be inserted:‘5a.Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7.’;
‘5a.
Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7.’;

‘5a.
Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7.’;



‘5a.
Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7.’;



(b)
in Section 8, the fifth indent shall be replaced by the following:‘—risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*1)and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*2).(*1)OJ L 159, 29.6.1996, p. 1."(*2)OJ L 180, 9.7.1997, p. 22.’;"
‘—
risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*1)and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*2).

‘—
risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*1)and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*2).



‘—
risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*1)and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*2).



(c)
in Section 9, seventh indent, the following phrase shall be added:‘For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;



(d)
Section 10 shall be replaced by the following:‘10.Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*3)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance, including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.(*3)Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as last amended by Regulation (EC) No 1901/2006.’;"
‘10.
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*3)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance, including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.

‘10.
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*3)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance, including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.



‘10.
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*3)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance, including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.



(e)
Section 14.2 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;(ii)the following indent shall be added:‘—in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;
(i)
the first indent shall be replaced by the following:‘—the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;
‘—
the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;
(ii)
the following indent shall be added:‘—in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;
‘—
in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;

(i)
the first indent shall be replaced by the following:‘—the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;
‘—
the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;

‘—
the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;

(ii)
the following indent shall be added:‘—in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;
‘—
in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;

‘—
in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;



(i)
the first indent shall be replaced by the following:‘—the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;
‘—
the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;

‘—
the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;



‘—
the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;



(ii)
the following indent shall be added:‘—in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;
‘—
in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;

‘—
in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;



‘—
in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;



(f)
the following indent shall be added to the second paragraph of Section 15:‘—date of issue or the latest revision of the instructions for use.’;
‘—
date of issue or the latest revision of the instructions for use.’;

‘—
date of issue or the latest revision of the instructions for use.’;



‘—
date of issue or the latest revision of the instructions for use.’;



2.
Annex 2 shall be amended as follows:(a)in Section 2, the third paragraph shall be replaced by the following:‘This declaration shall cover one or more clearly identified devices by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;(b)in the second paragraph of Section 3.1, the first sentence of the fifth indent shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7.’;(c)Section 3.2 shall be amended as follows:(i)the following sentence shall be added to the second subparagraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;(ii)the following indent shall be added to point (b):‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;(iii)the following indents shall be added to point (c):‘—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7.’;(d)in Section 3.3, the last sentence of the second subparagraph shall be replaced by the following:‘The evaluation procedure shall include an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes.’;(e)Section 4.2 shall be amended as follows:(i)the first paragraph shall be replaced by the following:‘The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).’;(ii)in the fourth indent of the second paragraph, the word ‘data’ shall be replaced by the word ‘evaluation’;(f)in Section 4.3, the following paragraphs shall be added:‘In the case of devices referred to in Annex 1, Section 10, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex 1, Section 10, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion shall be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA.’;(g)in Section 5.2, the second indent shall be replaced by the following:‘—the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.’;(h)Section 6.1 shall be replaced by the following:‘6.1.For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:—the declaration of conformity,—the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,—the amendments referred to in Section 3.4,—the documentation referred to in Section 4.2,—the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;(i)Section 6.3 shall be deleted;(j)the following Section shall be added:‘7.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;
(a)
in Section 2, the third paragraph shall be replaced by the following:‘This declaration shall cover one or more clearly identified devices by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;
(b)
in the second paragraph of Section 3.1, the first sentence of the fifth indent shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7.’;
‘—
an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7.’;
(c)
Section 3.2 shall be amended as follows:(i)the following sentence shall be added to the second subparagraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;(ii)the following indent shall be added to point (b):‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;(iii)the following indents shall be added to point (c):‘—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7.’;
(i)
the following sentence shall be added to the second subparagraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;
(ii)
the following indent shall be added to point (b):‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;
‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;
(iii)
the following indents shall be added to point (c):‘—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7.’;
‘—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex 7.’;
(d)
in Section 3.3, the last sentence of the second subparagraph shall be replaced by the following:‘The evaluation procedure shall include an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes.’;
(e)
Section 4.2 shall be amended as follows:(i)the first paragraph shall be replaced by the following:‘The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).’;(ii)in the fourth indent of the second paragraph, the word ‘data’ shall be replaced by the word ‘evaluation’;
(i)
the first paragraph shall be replaced by the following:‘The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).’;
(ii)
in the fourth indent of the second paragraph, the word ‘data’ shall be replaced by the word ‘evaluation’;
(f)
in Section 4.3, the following paragraphs shall be added:‘In the case of devices referred to in Annex 1, Section 10, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex 1, Section 10, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion shall be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA.’;
(g)
in Section 5.2, the second indent shall be replaced by the following:‘—the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.’;
‘—
the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.’;
(h)
Section 6.1 shall be replaced by the following:‘6.1.For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:—the declaration of conformity,—the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,—the amendments referred to in Section 3.4,—the documentation referred to in Section 4.2,—the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;
‘6.1.
For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:—the declaration of conformity,—the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,—the amendments referred to in Section 3.4,—the documentation referred to in Section 4.2,—the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;
—
the declaration of conformity,
—
the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,
—
the amendments referred to in Section 3.4,
—
the documentation referred to in Section 4.2,
—
the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;
(i)
Section 6.3 shall be deleted;
(j)
the following Section shall be added:‘7.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;
‘7.
Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;

(a)
in Section 2, the third paragraph shall be replaced by the following:‘This declaration shall cover one or more clearly identified devices by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;

(b)
in the second paragraph of Section 3.1, the first sentence of the fifth indent shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7.’;
‘—
an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7.’;

‘—
an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7.’;

(c)
Section 3.2 shall be amended as follows:(i)the following sentence shall be added to the second subparagraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;(ii)the following indent shall be added to point (b):‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;(iii)the following indents shall be added to point (c):‘—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7.’;
(i)
the following sentence shall be added to the second subparagraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;
(ii)
the following indent shall be added to point (b):‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;
‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;
(iii)
the following indents shall be added to point (c):‘—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7.’;
‘—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex 7.’;

(i)
the following sentence shall be added to the second subparagraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;

(ii)
the following indent shall be added to point (b):‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;
‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;

‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;

(iii)
the following indents shall be added to point (c):‘—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7.’;
‘—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex 7.’;

‘—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

—
the pre-clinical evaluation,

—
the clinical evaluation referred to in Annex 7.’;

(d)
in Section 3.3, the last sentence of the second subparagraph shall be replaced by the following:‘The evaluation procedure shall include an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes.’;

(e)
Section 4.2 shall be amended as follows:(i)the first paragraph shall be replaced by the following:‘The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).’;(ii)in the fourth indent of the second paragraph, the word ‘data’ shall be replaced by the word ‘evaluation’;
(i)
the first paragraph shall be replaced by the following:‘The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).’;
(ii)
in the fourth indent of the second paragraph, the word ‘data’ shall be replaced by the word ‘evaluation’;

(i)
the first paragraph shall be replaced by the following:‘The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).’;

(ii)
in the fourth indent of the second paragraph, the word ‘data’ shall be replaced by the word ‘evaluation’;

(f)
in Section 4.3, the following paragraphs shall be added:‘In the case of devices referred to in Annex 1, Section 10, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex 1, Section 10, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion shall be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA.’;

(g)
in Section 5.2, the second indent shall be replaced by the following:‘—the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.’;
‘—
the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.’;

‘—
the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.’;

(h)
Section 6.1 shall be replaced by the following:‘6.1.For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:—the declaration of conformity,—the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,—the amendments referred to in Section 3.4,—the documentation referred to in Section 4.2,—the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;
‘6.1.
For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:—the declaration of conformity,—the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,—the amendments referred to in Section 3.4,—the documentation referred to in Section 4.2,—the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;
—
the declaration of conformity,
—
the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,
—
the amendments referred to in Section 3.4,
—
the documentation referred to in Section 4.2,
—
the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;

‘6.1.
For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:—the declaration of conformity,—the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,—the amendments referred to in Section 3.4,—the documentation referred to in Section 4.2,—the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;
—
the declaration of conformity,
—
the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,
—
the amendments referred to in Section 3.4,
—
the documentation referred to in Section 4.2,
—
the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;

—
the declaration of conformity,

—
the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,

—
the amendments referred to in Section 3.4,

—
the documentation referred to in Section 4.2,

—
the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;

(i)
Section 6.3 shall be deleted;

(j)
the following Section shall be added:‘7.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;
‘7.
Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;

‘7.
Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;



(a)
in Section 2, the third paragraph shall be replaced by the following:‘This declaration shall cover one or more clearly identified devices by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;



(b)
in the second paragraph of Section 3.1, the first sentence of the fifth indent shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7.’;
‘—
an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7.’;

‘—
an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7.’;



‘—
an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7.’;



(c)
Section 3.2 shall be amended as follows:(i)the following sentence shall be added to the second subparagraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;(ii)the following indent shall be added to point (b):‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;(iii)the following indents shall be added to point (c):‘—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7.’;
(i)
the following sentence shall be added to the second subparagraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;
(ii)
the following indent shall be added to point (b):‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;
‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;
(iii)
the following indents shall be added to point (c):‘—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7.’;
‘—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex 7.’;

(i)
the following sentence shall be added to the second subparagraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;

(ii)
the following indent shall be added to point (b):‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;
‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;

‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;

(iii)
the following indents shall be added to point (c):‘—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7.’;
‘—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex 7.’;

‘—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

—
the pre-clinical evaluation,

—
the clinical evaluation referred to in Annex 7.’;



(i)
the following sentence shall be added to the second subparagraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;



(ii)
the following indent shall be added to point (b):‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;
‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;

‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;



‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;



(iii)
the following indents shall be added to point (c):‘—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7.’;
‘—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex 7.’;

‘—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

—
the pre-clinical evaluation,

—
the clinical evaluation referred to in Annex 7.’;



‘—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,



—
the pre-clinical evaluation,



—
the clinical evaluation referred to in Annex 7.’;



(d)
in Section 3.3, the last sentence of the second subparagraph shall be replaced by the following:‘The evaluation procedure shall include an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes.’;



(e)
Section 4.2 shall be amended as follows:(i)the first paragraph shall be replaced by the following:‘The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).’;(ii)in the fourth indent of the second paragraph, the word ‘data’ shall be replaced by the word ‘evaluation’;
(i)
the first paragraph shall be replaced by the following:‘The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).’;
(ii)
in the fourth indent of the second paragraph, the word ‘data’ shall be replaced by the word ‘evaluation’;

(i)
the first paragraph shall be replaced by the following:‘The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).’;

(ii)
in the fourth indent of the second paragraph, the word ‘data’ shall be replaced by the word ‘evaluation’;



(i)
the first paragraph shall be replaced by the following:‘The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).’;



(ii)
in the fourth indent of the second paragraph, the word ‘data’ shall be replaced by the word ‘evaluation’;



(f)
in Section 4.3, the following paragraphs shall be added:‘In the case of devices referred to in Annex 1, Section 10, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex 1, Section 10, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion shall be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA.’;



(g)
in Section 5.2, the second indent shall be replaced by the following:‘—the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.’;
‘—
the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.’;

‘—
the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.’;



‘—
the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.’;



(h)
Section 6.1 shall be replaced by the following:‘6.1.For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:—the declaration of conformity,—the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,—the amendments referred to in Section 3.4,—the documentation referred to in Section 4.2,—the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;
‘6.1.
For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:—the declaration of conformity,—the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,—the amendments referred to in Section 3.4,—the documentation referred to in Section 4.2,—the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;
—
the declaration of conformity,
—
the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,
—
the amendments referred to in Section 3.4,
—
the documentation referred to in Section 4.2,
—
the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;

‘6.1.
For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:—the declaration of conformity,—the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,—the amendments referred to in Section 3.4,—the documentation referred to in Section 4.2,—the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;
—
the declaration of conformity,
—
the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,
—
the amendments referred to in Section 3.4,
—
the documentation referred to in Section 4.2,
—
the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;

—
the declaration of conformity,

—
the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,

—
the amendments referred to in Section 3.4,

—
the documentation referred to in Section 4.2,

—
the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;



‘6.1.
For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:—the declaration of conformity,—the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,—the amendments referred to in Section 3.4,—the documentation referred to in Section 4.2,—the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;
—
the declaration of conformity,
—
the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,
—
the amendments referred to in Section 3.4,
—
the documentation referred to in Section 4.2,
—
the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;

—
the declaration of conformity,

—
the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,

—
the amendments referred to in Section 3.4,

—
the documentation referred to in Section 4.2,

—
the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;



—
the declaration of conformity,



—
the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,



—
the amendments referred to in Section 3.4,



—
the documentation referred to in Section 4.2,



—
the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;



(i)
Section 6.3 shall be deleted;



(j)
the following Section shall be added:‘7.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;
‘7.
Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;

‘7.
Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;



‘7.
Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;



3.
Annex 3 shall be amended as follows:(a)Section 3 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the type, including any variants planned, and its intended use(s),’;(ii)the fifth to eighth indents shall be replaced by the following:‘—the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,—a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7,—the draft instruction leaflet.’;(b)the following paragraphs shall be added to Section 5:‘In the case of devices referred to in Annex 1, Section 10, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex 1, Section 10, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion shall be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA.’;(c)in Section 7.3, the words ‘five years from the manufacture of the last appliance’ shall be replaced by the words ‘15 years from the manufacture of the last product’;(d)Section 7.4 shall be deleted;
(a)
Section 3 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the type, including any variants planned, and its intended use(s),’;(ii)the fifth to eighth indents shall be replaced by the following:‘—the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,—a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7,—the draft instruction leaflet.’;
(i)
the first indent shall be replaced by the following:‘—a general description of the type, including any variants planned, and its intended use(s),’;
‘—
a general description of the type, including any variants planned, and its intended use(s),’;
(ii)
the fifth to eighth indents shall be replaced by the following:‘—the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,—a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7,—the draft instruction leaflet.’;
‘—
the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,
—
a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex 7,
—
the draft instruction leaflet.’;
(b)
the following paragraphs shall be added to Section 5:‘In the case of devices referred to in Annex 1, Section 10, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex 1, Section 10, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion shall be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA.’;
(c)
in Section 7.3, the words ‘five years from the manufacture of the last appliance’ shall be replaced by the words ‘15 years from the manufacture of the last product’;
(d)
Section 7.4 shall be deleted;

(a)
Section 3 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the type, including any variants planned, and its intended use(s),’;(ii)the fifth to eighth indents shall be replaced by the following:‘—the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,—a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7,—the draft instruction leaflet.’;
(i)
the first indent shall be replaced by the following:‘—a general description of the type, including any variants planned, and its intended use(s),’;
‘—
a general description of the type, including any variants planned, and its intended use(s),’;
(ii)
the fifth to eighth indents shall be replaced by the following:‘—the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,—a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7,—the draft instruction leaflet.’;
‘—
the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,
—
a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex 7,
—
the draft instruction leaflet.’;

(i)
the first indent shall be replaced by the following:‘—a general description of the type, including any variants planned, and its intended use(s),’;
‘—
a general description of the type, including any variants planned, and its intended use(s),’;

‘—
a general description of the type, including any variants planned, and its intended use(s),’;

(ii)
the fifth to eighth indents shall be replaced by the following:‘—the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,—a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7,—the draft instruction leaflet.’;
‘—
the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,
—
a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex 7,
—
the draft instruction leaflet.’;

‘—
the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,

—
a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

—
the pre-clinical evaluation,

—
the clinical evaluation referred to in Annex 7,

—
the draft instruction leaflet.’;

(b)
the following paragraphs shall be added to Section 5:‘In the case of devices referred to in Annex 1, Section 10, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex 1, Section 10, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion shall be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA.’;

(c)
in Section 7.3, the words ‘five years from the manufacture of the last appliance’ shall be replaced by the words ‘15 years from the manufacture of the last product’;

(d)
Section 7.4 shall be deleted;



(a)
Section 3 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the type, including any variants planned, and its intended use(s),’;(ii)the fifth to eighth indents shall be replaced by the following:‘—the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,—a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7,—the draft instruction leaflet.’;
(i)
the first indent shall be replaced by the following:‘—a general description of the type, including any variants planned, and its intended use(s),’;
‘—
a general description of the type, including any variants planned, and its intended use(s),’;
(ii)
the fifth to eighth indents shall be replaced by the following:‘—the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,—a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7,—the draft instruction leaflet.’;
‘—
the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,
—
a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex 7,
—
the draft instruction leaflet.’;

(i)
the first indent shall be replaced by the following:‘—a general description of the type, including any variants planned, and its intended use(s),’;
‘—
a general description of the type, including any variants planned, and its intended use(s),’;

‘—
a general description of the type, including any variants planned, and its intended use(s),’;

(ii)
the fifth to eighth indents shall be replaced by the following:‘—the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,—a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7,—the draft instruction leaflet.’;
‘—
the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,
—
a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex 7,
—
the draft instruction leaflet.’;

‘—
the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,

—
a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

—
the pre-clinical evaluation,

—
the clinical evaluation referred to in Annex 7,

—
the draft instruction leaflet.’;



(i)
the first indent shall be replaced by the following:‘—a general description of the type, including any variants planned, and its intended use(s),’;
‘—
a general description of the type, including any variants planned, and its intended use(s),’;

‘—
a general description of the type, including any variants planned, and its intended use(s),’;



‘—
a general description of the type, including any variants planned, and its intended use(s),’;



(ii)
the fifth to eighth indents shall be replaced by the following:‘—the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,—a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7,—the draft instruction leaflet.’;
‘—
the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,
—
a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex 7,
—
the draft instruction leaflet.’;

‘—
the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,

—
a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

—
the pre-clinical evaluation,

—
the clinical evaluation referred to in Annex 7,

—
the draft instruction leaflet.’;



‘—
the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,



—
a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,



—
the pre-clinical evaluation,



—
the clinical evaluation referred to in Annex 7,



—
the draft instruction leaflet.’;



(b)
the following paragraphs shall be added to Section 5:‘In the case of devices referred to in Annex 1, Section 10, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex 1, Section 10, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion shall be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA.’;



(c)
in Section 7.3, the words ‘five years from the manufacture of the last appliance’ shall be replaced by the words ‘15 years from the manufacture of the last product’;



(d)
Section 7.4 shall be deleted;



4.
Annex 4 shall be amended as follows:(a)in Section 4, the words ‘post-marketing surveillance system’ shall be replaced by the words ‘post-marketing surveillance system including the provisions referred to in Annex 7’;(b)Section 6.3 shall be replaced by the following:‘6.3.Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;(c)the following Section shall be added:‘7.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;
(a)
in Section 4, the words ‘post-marketing surveillance system’ shall be replaced by the words ‘post-marketing surveillance system including the provisions referred to in Annex 7’;
(b)
Section 6.3 shall be replaced by the following:‘6.3.Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;
‘6.3.
Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;
(c)
the following Section shall be added:‘7.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;
‘7.
Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;

(a)
in Section 4, the words ‘post-marketing surveillance system’ shall be replaced by the words ‘post-marketing surveillance system including the provisions referred to in Annex 7’;

(b)
Section 6.3 shall be replaced by the following:‘6.3.Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;
‘6.3.
Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;

‘6.3.
Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;

(c)
the following Section shall be added:‘7.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;
‘7.
Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;

‘7.
Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;



(a)
in Section 4, the words ‘post-marketing surveillance system’ shall be replaced by the words ‘post-marketing surveillance system including the provisions referred to in Annex 7’;



(b)
Section 6.3 shall be replaced by the following:‘6.3.Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;
‘6.3.
Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;

‘6.3.
Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;



‘6.3.
Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;



(c)
the following Section shall be added:‘7.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;
‘7.
Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;

‘7.
Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;



‘7.
Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;



5.
Annex 5 shall be amended as follows:(a)in Section 2, second paragraph, the words ‘identified specimens of the product and shall be kept by the manufacturer’ shall be replaced by the words ‘devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer’;(b)in the sixth indent of Section 3.1, the words ‘post-marketing surveillance system’ shall be replaced by the words ‘post-marketing surveillance system including the provisions referred to in Annex 7’;(c)in Section 3.2(b), the following indent shall be added:‘—where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;(d)in Section 4.2, the following indent shall be inserted after the first indent:‘—the technical documentation,’;(e)the following Section shall be added:‘6.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;
(a)
in Section 2, second paragraph, the words ‘identified specimens of the product and shall be kept by the manufacturer’ shall be replaced by the words ‘devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer’;
(b)
in the sixth indent of Section 3.1, the words ‘post-marketing surveillance system’ shall be replaced by the words ‘post-marketing surveillance system including the provisions referred to in Annex 7’;
(c)
in Section 3.2(b), the following indent shall be added:‘—where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;
‘—
where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;
(d)
in Section 4.2, the following indent shall be inserted after the first indent:‘—the technical documentation,’;
‘—
the technical documentation,’;
(e)
the following Section shall be added:‘6.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;
‘6.
Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;

(a)
in Section 2, second paragraph, the words ‘identified specimens of the product and shall be kept by the manufacturer’ shall be replaced by the words ‘devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer’;

(b)
in the sixth indent of Section 3.1, the words ‘post-marketing surveillance system’ shall be replaced by the words ‘post-marketing surveillance system including the provisions referred to in Annex 7’;

(c)
in Section 3.2(b), the following indent shall be added:‘—where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;
‘—
where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;

‘—
where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;

(d)
in Section 4.2, the following indent shall be inserted after the first indent:‘—the technical documentation,’;
‘—
the technical documentation,’;

‘—
the technical documentation,’;

(e)
the following Section shall be added:‘6.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;
‘6.
Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;

‘6.
Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;



(a)
in Section 2, second paragraph, the words ‘identified specimens of the product and shall be kept by the manufacturer’ shall be replaced by the words ‘devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer’;



(b)
in the sixth indent of Section 3.1, the words ‘post-marketing surveillance system’ shall be replaced by the words ‘post-marketing surveillance system including the provisions referred to in Annex 7’;



(c)
in Section 3.2(b), the following indent shall be added:‘—where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;
‘—
where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;

‘—
where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;



‘—
where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;



(d)
in Section 4.2, the following indent shall be inserted after the first indent:‘—the technical documentation,’;
‘—
the technical documentation,’;

‘—
the technical documentation,’;



‘—
the technical documentation,’;



(e)
the following Section shall be added:‘6.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;
‘6.
Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;

‘6.
Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;



‘6.
Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;



6.
Annex 6 shall be amended as follows:(a)Section 2.1 shall be amended as follows:(i)the first indent shall be replaced by the following two indents:‘—the name and address of the manufacturer,—the information necessary for the identification of the product in question,’;(ii)in the third indent, the word ‘doctor’ shall be replaced by the words ‘duly qualified medical practitioner’;(iii)the fourth indent shall be replaced by the following:‘—the specific characteristics of the product revealed by the prescription,’;(b)Section 2.2 shall be replaced by the following:‘2.2.For devices intended for clinical investigations covered in Annex 7:—data allowing the devices in question to be identified,—the clinical investigation plan,—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,—the opinion of the ethics committee concerned and details of the aspects covered by its opinion,—the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,—the place, date of commencement and duration scheduled for the investigations,—a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;(c)in Section 3.1, the first paragraph shall be replaced by the following:‘For custom-made devices, documentation, indicating manufacturing site(s) and enabling the design, manufacture and performances of the product, including the expected performances, to be understood, so as to allow conformity with the requirements of this Directive to be assessed.’;(d)in Section 3.2, the first paragraph shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the product and its intended use,’;(ii)in the fourth indent, the words ‘a list of the standards’ shall be replaced by the words ‘the results of the risk analysis and a list of the standards’;(iii)the following indent shall be inserted after the fourth indent:‘—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;(e)the following two sections shall be added:‘4.The information included in the declarations covered by this Annex shall be kept for a period of at least 15 years from the date of manufacture of the last product.5.For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;
(a)
Section 2.1 shall be amended as follows:(i)the first indent shall be replaced by the following two indents:‘—the name and address of the manufacturer,—the information necessary for the identification of the product in question,’;(ii)in the third indent, the word ‘doctor’ shall be replaced by the words ‘duly qualified medical practitioner’;(iii)the fourth indent shall be replaced by the following:‘—the specific characteristics of the product revealed by the prescription,’;
(i)
the first indent shall be replaced by the following two indents:‘—the name and address of the manufacturer,—the information necessary for the identification of the product in question,’;
‘—
the name and address of the manufacturer,
—
the information necessary for the identification of the product in question,’;
(ii)
in the third indent, the word ‘doctor’ shall be replaced by the words ‘duly qualified medical practitioner’;
(iii)
the fourth indent shall be replaced by the following:‘—the specific characteristics of the product revealed by the prescription,’;
‘—
the specific characteristics of the product revealed by the prescription,’;
(b)
Section 2.2 shall be replaced by the following:‘2.2.For devices intended for clinical investigations covered in Annex 7:—data allowing the devices in question to be identified,—the clinical investigation plan,—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,—the opinion of the ethics committee concerned and details of the aspects covered by its opinion,—the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,—the place, date of commencement and duration scheduled for the investigations,—a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;
‘2.2.
For devices intended for clinical investigations covered in Annex 7:—data allowing the devices in question to be identified,—the clinical investigation plan,—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,—the opinion of the ethics committee concerned and details of the aspects covered by its opinion,—the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,—the place, date of commencement and duration scheduled for the investigations,—a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;
—
data allowing the devices in question to be identified,
—
the clinical investigation plan,
—
the investigator's brochure,
—
the confirmation of insurance of subjects,
—
the documents used to obtain informed consent,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,
—
the opinion of the ethics committee concerned and details of the aspects covered by its opinion,
—
the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,
—
the place, date of commencement and duration scheduled for the investigations,
—
a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;
(c)
in Section 3.1, the first paragraph shall be replaced by the following:‘For custom-made devices, documentation, indicating manufacturing site(s) and enabling the design, manufacture and performances of the product, including the expected performances, to be understood, so as to allow conformity with the requirements of this Directive to be assessed.’;
(d)
in Section 3.2, the first paragraph shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the product and its intended use,’;(ii)in the fourth indent, the words ‘a list of the standards’ shall be replaced by the words ‘the results of the risk analysis and a list of the standards’;(iii)the following indent shall be inserted after the fourth indent:‘—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;
(i)
the first indent shall be replaced by the following:‘—a general description of the product and its intended use,’;
‘—
a general description of the product and its intended use,’;
(ii)
in the fourth indent, the words ‘a list of the standards’ shall be replaced by the words ‘the results of the risk analysis and a list of the standards’;
(iii)
the following indent shall be inserted after the fourth indent:‘—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;
‘—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;
(e)
the following two sections shall be added:‘4.The information included in the declarations covered by this Annex shall be kept for a period of at least 15 years from the date of manufacture of the last product.5.For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;
‘4.
The information included in the declarations covered by this Annex shall be kept for a period of at least 15 years from the date of manufacture of the last product.
5.
For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;
(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;

(a)
Section 2.1 shall be amended as follows:(i)the first indent shall be replaced by the following two indents:‘—the name and address of the manufacturer,—the information necessary for the identification of the product in question,’;(ii)in the third indent, the word ‘doctor’ shall be replaced by the words ‘duly qualified medical practitioner’;(iii)the fourth indent shall be replaced by the following:‘—the specific characteristics of the product revealed by the prescription,’;
(i)
the first indent shall be replaced by the following two indents:‘—the name and address of the manufacturer,—the information necessary for the identification of the product in question,’;
‘—
the name and address of the manufacturer,
—
the information necessary for the identification of the product in question,’;
(ii)
in the third indent, the word ‘doctor’ shall be replaced by the words ‘duly qualified medical practitioner’;
(iii)
the fourth indent shall be replaced by the following:‘—the specific characteristics of the product revealed by the prescription,’;
‘—
the specific characteristics of the product revealed by the prescription,’;

(i)
the first indent shall be replaced by the following two indents:‘—the name and address of the manufacturer,—the information necessary for the identification of the product in question,’;
‘—
the name and address of the manufacturer,
—
the information necessary for the identification of the product in question,’;

‘—
the name and address of the manufacturer,

—
the information necessary for the identification of the product in question,’;

(ii)
in the third indent, the word ‘doctor’ shall be replaced by the words ‘duly qualified medical practitioner’;

(iii)
the fourth indent shall be replaced by the following:‘—the specific characteristics of the product revealed by the prescription,’;
‘—
the specific characteristics of the product revealed by the prescription,’;

‘—
the specific characteristics of the product revealed by the prescription,’;

(b)
Section 2.2 shall be replaced by the following:‘2.2.For devices intended for clinical investigations covered in Annex 7:—data allowing the devices in question to be identified,—the clinical investigation plan,—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,—the opinion of the ethics committee concerned and details of the aspects covered by its opinion,—the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,—the place, date of commencement and duration scheduled for the investigations,—a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;
‘2.2.
For devices intended for clinical investigations covered in Annex 7:—data allowing the devices in question to be identified,—the clinical investigation plan,—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,—the opinion of the ethics committee concerned and details of the aspects covered by its opinion,—the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,—the place, date of commencement and duration scheduled for the investigations,—a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;
—
data allowing the devices in question to be identified,
—
the clinical investigation plan,
—
the investigator's brochure,
—
the confirmation of insurance of subjects,
—
the documents used to obtain informed consent,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,
—
the opinion of the ethics committee concerned and details of the aspects covered by its opinion,
—
the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,
—
the place, date of commencement and duration scheduled for the investigations,
—
a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;

‘2.2.
For devices intended for clinical investigations covered in Annex 7:—data allowing the devices in question to be identified,—the clinical investigation plan,—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,—the opinion of the ethics committee concerned and details of the aspects covered by its opinion,—the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,—the place, date of commencement and duration scheduled for the investigations,—a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;
—
data allowing the devices in question to be identified,
—
the clinical investigation plan,
—
the investigator's brochure,
—
the confirmation of insurance of subjects,
—
the documents used to obtain informed consent,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,
—
the opinion of the ethics committee concerned and details of the aspects covered by its opinion,
—
the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,
—
the place, date of commencement and duration scheduled for the investigations,
—
a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;

—
data allowing the devices in question to be identified,

—
the clinical investigation plan,

—
the investigator's brochure,

—
the confirmation of insurance of subjects,

—
the documents used to obtain informed consent,

—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,

—
the opinion of the ethics committee concerned and details of the aspects covered by its opinion,

—
the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,

—
the place, date of commencement and duration scheduled for the investigations,

—
a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;

(c)
in Section 3.1, the first paragraph shall be replaced by the following:‘For custom-made devices, documentation, indicating manufacturing site(s) and enabling the design, manufacture and performances of the product, including the expected performances, to be understood, so as to allow conformity with the requirements of this Directive to be assessed.’;

(d)
in Section 3.2, the first paragraph shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the product and its intended use,’;(ii)in the fourth indent, the words ‘a list of the standards’ shall be replaced by the words ‘the results of the risk analysis and a list of the standards’;(iii)the following indent shall be inserted after the fourth indent:‘—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;
(i)
the first indent shall be replaced by the following:‘—a general description of the product and its intended use,’;
‘—
a general description of the product and its intended use,’;
(ii)
in the fourth indent, the words ‘a list of the standards’ shall be replaced by the words ‘the results of the risk analysis and a list of the standards’;
(iii)
the following indent shall be inserted after the fourth indent:‘—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;
‘—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;

(i)
the first indent shall be replaced by the following:‘—a general description of the product and its intended use,’;
‘—
a general description of the product and its intended use,’;

‘—
a general description of the product and its intended use,’;

(ii)
in the fourth indent, the words ‘a list of the standards’ shall be replaced by the words ‘the results of the risk analysis and a list of the standards’;

(iii)
the following indent shall be inserted after the fourth indent:‘—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;
‘—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;

‘—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;

(e)
the following two sections shall be added:‘4.The information included in the declarations covered by this Annex shall be kept for a period of at least 15 years from the date of manufacture of the last product.5.For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;
‘4.
The information included in the declarations covered by this Annex shall be kept for a period of at least 15 years from the date of manufacture of the last product.
5.
For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;
(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;

‘4.
The information included in the declarations covered by this Annex shall be kept for a period of at least 15 years from the date of manufacture of the last product.

5.
For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;
(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;

(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;

(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;



(a)
Section 2.1 shall be amended as follows:(i)the first indent shall be replaced by the following two indents:‘—the name and address of the manufacturer,—the information necessary for the identification of the product in question,’;(ii)in the third indent, the word ‘doctor’ shall be replaced by the words ‘duly qualified medical practitioner’;(iii)the fourth indent shall be replaced by the following:‘—the specific characteristics of the product revealed by the prescription,’;
(i)
the first indent shall be replaced by the following two indents:‘—the name and address of the manufacturer,—the information necessary for the identification of the product in question,’;
‘—
the name and address of the manufacturer,
—
the information necessary for the identification of the product in question,’;
(ii)
in the third indent, the word ‘doctor’ shall be replaced by the words ‘duly qualified medical practitioner’;
(iii)
the fourth indent shall be replaced by the following:‘—the specific characteristics of the product revealed by the prescription,’;
‘—
the specific characteristics of the product revealed by the prescription,’;

(i)
the first indent shall be replaced by the following two indents:‘—the name and address of the manufacturer,—the information necessary for the identification of the product in question,’;
‘—
the name and address of the manufacturer,
—
the information necessary for the identification of the product in question,’;

‘—
the name and address of the manufacturer,

—
the information necessary for the identification of the product in question,’;

(ii)
in the third indent, the word ‘doctor’ shall be replaced by the words ‘duly qualified medical practitioner’;

(iii)
the fourth indent shall be replaced by the following:‘—the specific characteristics of the product revealed by the prescription,’;
‘—
the specific characteristics of the product revealed by the prescription,’;

‘—
the specific characteristics of the product revealed by the prescription,’;



(i)
the first indent shall be replaced by the following two indents:‘—the name and address of the manufacturer,—the information necessary for the identification of the product in question,’;
‘—
the name and address of the manufacturer,
—
the information necessary for the identification of the product in question,’;

‘—
the name and address of the manufacturer,

—
the information necessary for the identification of the product in question,’;



‘—
the name and address of the manufacturer,



—
the information necessary for the identification of the product in question,’;



(ii)
in the third indent, the word ‘doctor’ shall be replaced by the words ‘duly qualified medical practitioner’;



(iii)
the fourth indent shall be replaced by the following:‘—the specific characteristics of the product revealed by the prescription,’;
‘—
the specific characteristics of the product revealed by the prescription,’;

‘—
the specific characteristics of the product revealed by the prescription,’;



‘—
the specific characteristics of the product revealed by the prescription,’;



(b)
Section 2.2 shall be replaced by the following:‘2.2.For devices intended for clinical investigations covered in Annex 7:—data allowing the devices in question to be identified,—the clinical investigation plan,—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,—the opinion of the ethics committee concerned and details of the aspects covered by its opinion,—the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,—the place, date of commencement and duration scheduled for the investigations,—a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;
‘2.2.
For devices intended for clinical investigations covered in Annex 7:—data allowing the devices in question to be identified,—the clinical investigation plan,—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,—the opinion of the ethics committee concerned and details of the aspects covered by its opinion,—the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,—the place, date of commencement and duration scheduled for the investigations,—a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;
—
data allowing the devices in question to be identified,
—
the clinical investigation plan,
—
the investigator's brochure,
—
the confirmation of insurance of subjects,
—
the documents used to obtain informed consent,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,
—
the opinion of the ethics committee concerned and details of the aspects covered by its opinion,
—
the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,
—
the place, date of commencement and duration scheduled for the investigations,
—
a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;

‘2.2.
For devices intended for clinical investigations covered in Annex 7:—data allowing the devices in question to be identified,—the clinical investigation plan,—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,—the opinion of the ethics committee concerned and details of the aspects covered by its opinion,—the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,—the place, date of commencement and duration scheduled for the investigations,—a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;
—
data allowing the devices in question to be identified,
—
the clinical investigation plan,
—
the investigator's brochure,
—
the confirmation of insurance of subjects,
—
the documents used to obtain informed consent,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,
—
the opinion of the ethics committee concerned and details of the aspects covered by its opinion,
—
the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,
—
the place, date of commencement and duration scheduled for the investigations,
—
a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;

—
data allowing the devices in question to be identified,

—
the clinical investigation plan,

—
the investigator's brochure,

—
the confirmation of insurance of subjects,

—
the documents used to obtain informed consent,

—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,

—
the opinion of the ethics committee concerned and details of the aspects covered by its opinion,

—
the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,

—
the place, date of commencement and duration scheduled for the investigations,

—
a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;



‘2.2.
For devices intended for clinical investigations covered in Annex 7:—data allowing the devices in question to be identified,—the clinical investigation plan,—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,—the opinion of the ethics committee concerned and details of the aspects covered by its opinion,—the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,—the place, date of commencement and duration scheduled for the investigations,—a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;
—
data allowing the devices in question to be identified,
—
the clinical investigation plan,
—
the investigator's brochure,
—
the confirmation of insurance of subjects,
—
the documents used to obtain informed consent,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,
—
the opinion of the ethics committee concerned and details of the aspects covered by its opinion,
—
the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,
—
the place, date of commencement and duration scheduled for the investigations,
—
a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;

—
data allowing the devices in question to be identified,

—
the clinical investigation plan,

—
the investigator's brochure,

—
the confirmation of insurance of subjects,

—
the documents used to obtain informed consent,

—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,

—
the opinion of the ethics committee concerned and details of the aspects covered by its opinion,

—
the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,

—
the place, date of commencement and duration scheduled for the investigations,

—
a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;



—
data allowing the devices in question to be identified,



—
the clinical investigation plan,



—
the investigator's brochure,



—
the confirmation of insurance of subjects,



—
the documents used to obtain informed consent,



—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,



—
the opinion of the ethics committee concerned and details of the aspects covered by its opinion,



—
the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,



—
the place, date of commencement and duration scheduled for the investigations,



—
a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;



(c)
in Section 3.1, the first paragraph shall be replaced by the following:‘For custom-made devices, documentation, indicating manufacturing site(s) and enabling the design, manufacture and performances of the product, including the expected performances, to be understood, so as to allow conformity with the requirements of this Directive to be assessed.’;



(d)
in Section 3.2, the first paragraph shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the product and its intended use,’;(ii)in the fourth indent, the words ‘a list of the standards’ shall be replaced by the words ‘the results of the risk analysis and a list of the standards’;(iii)the following indent shall be inserted after the fourth indent:‘—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;
(i)
the first indent shall be replaced by the following:‘—a general description of the product and its intended use,’;
‘—
a general description of the product and its intended use,’;
(ii)
in the fourth indent, the words ‘a list of the standards’ shall be replaced by the words ‘the results of the risk analysis and a list of the standards’;
(iii)
the following indent shall be inserted after the fourth indent:‘—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;
‘—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;

(i)
the first indent shall be replaced by the following:‘—a general description of the product and its intended use,’;
‘—
a general description of the product and its intended use,’;

‘—
a general description of the product and its intended use,’;

(ii)
in the fourth indent, the words ‘a list of the standards’ shall be replaced by the words ‘the results of the risk analysis and a list of the standards’;

(iii)
the following indent shall be inserted after the fourth indent:‘—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;
‘—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;

‘—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;



(i)
the first indent shall be replaced by the following:‘—a general description of the product and its intended use,’;
‘—
a general description of the product and its intended use,’;

‘—
a general description of the product and its intended use,’;



‘—
a general description of the product and its intended use,’;



(ii)
in the fourth indent, the words ‘a list of the standards’ shall be replaced by the words ‘the results of the risk analysis and a list of the standards’;



(iii)
the following indent shall be inserted after the fourth indent:‘—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;
‘—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;

‘—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;



‘—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;



(e)
the following two sections shall be added:‘4.The information included in the declarations covered by this Annex shall be kept for a period of at least 15 years from the date of manufacture of the last product.5.For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;
‘4.
The information included in the declarations covered by this Annex shall be kept for a period of at least 15 years from the date of manufacture of the last product.
5.
For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;
(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;

‘4.
The information included in the declarations covered by this Annex shall be kept for a period of at least 15 years from the date of manufacture of the last product.

5.
For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;
(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;

(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;

(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;



‘4.
The information included in the declarations covered by this Annex shall be kept for a period of at least 15 years from the date of manufacture of the last product.



5.
For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;
(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;

(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;

(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;



(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;



(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;



7.
Annex 7 shall be amended as follows:(a)Section 1 shall be replaced by the following:‘1.   General provisions1.1.As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 2 of Annex 1 under the normal conditions of use of the device and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 5 of Annex 1, must be based on clinical data. The evaluation of this data (hereinafter referred to as clinical evaluation), where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:1.1.1.Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where:—there is demonstration of equivalence of the device to the device to which the data relates and,—the data adequately demonstrate compliance with the relevant essential requirements;1.1.2.Or a critical evaluation of the results of all the clinical investigations made,1.1.3.Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.1.2.Clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.1.3.The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.1.4.The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.1.5.Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.1.6.All data must remain confidential unless it is deemed essential that they be divulged.’(b)Section 2.3.5 shall be replaced by the following:‘2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’(c)In Section 2.3.6, the words ‘appropriately qualified medical specialist’ shall be replaced by the words ‘duly qualified medical practitioner or authorised person’.
(a)
Section 1 shall be replaced by the following:‘1.   General provisions1.1.As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 2 of Annex 1 under the normal conditions of use of the device and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 5 of Annex 1, must be based on clinical data. The evaluation of this data (hereinafter referred to as clinical evaluation), where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:1.1.1.Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where:—there is demonstration of equivalence of the device to the device to which the data relates and,—the data adequately demonstrate compliance with the relevant essential requirements;1.1.2.Or a critical evaluation of the results of all the clinical investigations made,1.1.3.Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.1.2.Clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.1.3.The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.1.4.The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.1.5.Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.1.6.All data must remain confidential unless it is deemed essential that they be divulged.’

1.1.
As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 2 of Annex 1 under the normal conditions of use of the device and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 5 of Annex 1, must be based on clinical data. The evaluation of this data (hereinafter referred to as clinical evaluation), where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:

1.1.1.
Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where:—there is demonstration of equivalence of the device to the device to which the data relates and,—the data adequately demonstrate compliance with the relevant essential requirements;
—
there is demonstration of equivalence of the device to the device to which the data relates and,
—
the data adequately demonstrate compliance with the relevant essential requirements;

1.1.2.
Or a critical evaluation of the results of all the clinical investigations made,

1.1.3.
Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.

1.2.
Clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.

1.3.
The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.

1.4.
The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.

1.5.
Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.

1.6.
All data must remain confidential unless it is deemed essential that they be divulged.’
(b)
Section 2.3.5 shall be replaced by the following:‘2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’
‘2.3.5.
All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’
(c)
In Section 2.3.6, the words ‘appropriately qualified medical specialist’ shall be replaced by the words ‘duly qualified medical practitioner or authorised person’.

(a)
Section 1 shall be replaced by the following:‘1.   General provisions1.1.As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 2 of Annex 1 under the normal conditions of use of the device and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 5 of Annex 1, must be based on clinical data. The evaluation of this data (hereinafter referred to as clinical evaluation), where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:1.1.1.Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where:—there is demonstration of equivalence of the device to the device to which the data relates and,—the data adequately demonstrate compliance with the relevant essential requirements;1.1.2.Or a critical evaluation of the results of all the clinical investigations made,1.1.3.Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.1.2.Clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.1.3.The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.1.4.The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.1.5.Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.1.6.All data must remain confidential unless it is deemed essential that they be divulged.’

1.1.
As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 2 of Annex 1 under the normal conditions of use of the device and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 5 of Annex 1, must be based on clinical data. The evaluation of this data (hereinafter referred to as clinical evaluation), where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:

1.1.1.
Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where:—there is demonstration of equivalence of the device to the device to which the data relates and,—the data adequately demonstrate compliance with the relevant essential requirements;
—
there is demonstration of equivalence of the device to the device to which the data relates and,
—
the data adequately demonstrate compliance with the relevant essential requirements;

1.1.2.
Or a critical evaluation of the results of all the clinical investigations made,

1.1.3.
Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.

1.2.
Clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.

1.3.
The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.

1.4.
The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.

1.5.
Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.

1.6.
All data must remain confidential unless it is deemed essential that they be divulged.’


1.1.
As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 2 of Annex 1 under the normal conditions of use of the device and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 5 of Annex 1, must be based on clinical data. The evaluation of this data (hereinafter referred to as clinical evaluation), where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:


1.1.1.
Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where:—there is demonstration of equivalence of the device to the device to which the data relates and,—the data adequately demonstrate compliance with the relevant essential requirements;
—
there is demonstration of equivalence of the device to the device to which the data relates and,
—
the data adequately demonstrate compliance with the relevant essential requirements;

—
there is demonstration of equivalence of the device to the device to which the data relates and,

—
the data adequately demonstrate compliance with the relevant essential requirements;


1.1.2.
Or a critical evaluation of the results of all the clinical investigations made,


1.1.3.
Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.


1.2.
Clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.


1.3.
The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.


1.4.
The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.


1.5.
Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.


1.6.
All data must remain confidential unless it is deemed essential that they be divulged.’

(b)
Section 2.3.5 shall be replaced by the following:‘2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’
‘2.3.5.
All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’

‘2.3.5.
All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’

(c)
In Section 2.3.6, the words ‘appropriately qualified medical specialist’ shall be replaced by the words ‘duly qualified medical practitioner or authorised person’.



(a)
Section 1 shall be replaced by the following:‘1.   General provisions1.1.As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 2 of Annex 1 under the normal conditions of use of the device and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 5 of Annex 1, must be based on clinical data. The evaluation of this data (hereinafter referred to as clinical evaluation), where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:1.1.1.Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where:—there is demonstration of equivalence of the device to the device to which the data relates and,—the data adequately demonstrate compliance with the relevant essential requirements;1.1.2.Or a critical evaluation of the results of all the clinical investigations made,1.1.3.Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.1.2.Clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.1.3.The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.1.4.The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.1.5.Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.1.6.All data must remain confidential unless it is deemed essential that they be divulged.’

1.1.
As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 2 of Annex 1 under the normal conditions of use of the device and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 5 of Annex 1, must be based on clinical data. The evaluation of this data (hereinafter referred to as clinical evaluation), where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:

1.1.1.
Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where:—there is demonstration of equivalence of the device to the device to which the data relates and,—the data adequately demonstrate compliance with the relevant essential requirements;
—
there is demonstration of equivalence of the device to the device to which the data relates and,
—
the data adequately demonstrate compliance with the relevant essential requirements;

1.1.2.
Or a critical evaluation of the results of all the clinical investigations made,

1.1.3.
Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.

1.2.
Clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.

1.3.
The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.

1.4.
The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.

1.5.
Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.

1.6.
All data must remain confidential unless it is deemed essential that they be divulged.’


1.1.
As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 2 of Annex 1 under the normal conditions of use of the device and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 5 of Annex 1, must be based on clinical data. The evaluation of this data (hereinafter referred to as clinical evaluation), where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:


1.1.1.
Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where:—there is demonstration of equivalence of the device to the device to which the data relates and,—the data adequately demonstrate compliance with the relevant essential requirements;
—
there is demonstration of equivalence of the device to the device to which the data relates and,
—
the data adequately demonstrate compliance with the relevant essential requirements;

—
there is demonstration of equivalence of the device to the device to which the data relates and,

—
the data adequately demonstrate compliance with the relevant essential requirements;


1.1.2.
Or a critical evaluation of the results of all the clinical investigations made,


1.1.3.
Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.


1.2.
Clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.


1.3.
The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.


1.4.
The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.


1.5.
Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.


1.6.
All data must remain confidential unless it is deemed essential that they be divulged.’




1.1.
As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 2 of Annex 1 under the normal conditions of use of the device and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 5 of Annex 1, must be based on clinical data. The evaluation of this data (hereinafter referred to as clinical evaluation), where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:




1.1.1.
Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where:—there is demonstration of equivalence of the device to the device to which the data relates and,—the data adequately demonstrate compliance with the relevant essential requirements;
—
there is demonstration of equivalence of the device to the device to which the data relates and,
—
the data adequately demonstrate compliance with the relevant essential requirements;

—
there is demonstration of equivalence of the device to the device to which the data relates and,

—
the data adequately demonstrate compliance with the relevant essential requirements;



—
there is demonstration of equivalence of the device to the device to which the data relates and,



—
the data adequately demonstrate compliance with the relevant essential requirements;




1.1.2.
Or a critical evaluation of the results of all the clinical investigations made,




1.1.3.
Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.




1.2.
Clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.




1.3.
The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.




1.4.
The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.




1.5.
Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.




1.6.
All data must remain confidential unless it is deemed essential that they be divulged.’



(b)
Section 2.3.5 shall be replaced by the following:‘2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’
‘2.3.5.
All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’

‘2.3.5.
All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’



‘2.3.5.
All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’



(c)
In Section 2.3.6, the words ‘appropriately qualified medical specialist’ shall be replaced by the words ‘duly qualified medical practitioner or authorised person’.



1.
Annex I shall be amended as follows:(a)Section 1 shall be replaced by the following:‘1.The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.This shall include:—reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and—consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;(b)the following Section shall be inserted:‘6a.Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.’;(c)in Section 7.1, the following indent shall be added:‘—where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.’;(d)Section 7.4. shall be replaced by the following:‘7.4.Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*1)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.(*1)Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as last amended by Regulation (EC) No 1901/2006.’ "(e)Section 7.5 shall be replaced by the following:‘7.5.The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(*2).If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.(*2)OJ 196, 16.8.1967, p. 1. Directive as last amended by Directive 2006/121/EC of the European Parliament and of the Council (OJ L 396, 30.12.2006, p. 850).’ "(f)in Section 8.2, the word ‘transferable’ shall be replaced by the word ‘transmissible’;(g)the following Section shall be inserted:‘12.1aFor devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;(h)in Section 13.1, the first paragraph shall be replaced by the following:‘13.1.Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.’;(i)Section 13.3 shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’(ii)point (b) shall be replaced by the following:‘(b)the details strictly necessary to identify the device and the contents of the packaging especially for the users;’(iii)point (f) shall be replaced by the following:‘(f)where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’(j)Section 13.6 shall be amended as follows:(i)the following subparagraph shall be added to point (h):‘If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;’(ii)point (o) shall be replaced by the following:‘(o)medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’(iii)the following point shall be added:‘(q)date of issue or the latest revision of the instructions for use.’;(k)Section 14 shall be deleted.
(a)
Section 1 shall be replaced by the following:‘1.The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.This shall include:—reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and—consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;
‘1.
The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.This shall include:—reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and—consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;
—
reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
—
consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;
(b)
the following Section shall be inserted:‘6a.Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.’;
‘6a.
Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.’;
(c)
in Section 7.1, the following indent shall be added:‘—where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.’;
‘—
where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.’;
(d)
Section 7.4. shall be replaced by the following:‘7.4.Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*1)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.(*1)Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as last amended by Regulation (EC) No 1901/2006.’ "
‘7.4.
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*1)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.
(e)
Section 7.5 shall be replaced by the following:‘7.5.The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(*2).If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.(*2)OJ 196, 16.8.1967, p. 1. Directive as last amended by Directive 2006/121/EC of the European Parliament and of the Council (OJ L 396, 30.12.2006, p. 850).’ "
‘7.5.
The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(*2).If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.
(f)
in Section 8.2, the word ‘transferable’ shall be replaced by the word ‘transmissible’;
(g)
the following Section shall be inserted:‘12.1aFor devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;
‘12.1a
For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;
(h)
in Section 13.1, the first paragraph shall be replaced by the following:‘13.1.Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.’;
‘13.1.
Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.’;
(i)
Section 13.3 shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’(ii)point (b) shall be replaced by the following:‘(b)the details strictly necessary to identify the device and the contents of the packaging especially for the users;’(iii)point (f) shall be replaced by the following:‘(f)where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’
(i)
point (a) shall be replaced by the following:‘(a)the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’
‘(a)
the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’
(ii)
point (b) shall be replaced by the following:‘(b)the details strictly necessary to identify the device and the contents of the packaging especially for the users;’
‘(b)
the details strictly necessary to identify the device and the contents of the packaging especially for the users;’
(iii)
point (f) shall be replaced by the following:‘(f)where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’
‘(f)
where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’
(j)
Section 13.6 shall be amended as follows:(i)the following subparagraph shall be added to point (h):‘If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;’(ii)point (o) shall be replaced by the following:‘(o)medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’(iii)the following point shall be added:‘(q)date of issue or the latest revision of the instructions for use.’;
(i)
the following subparagraph shall be added to point (h):‘If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;’
(ii)
point (o) shall be replaced by the following:‘(o)medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’
‘(o)
medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’
(iii)
the following point shall be added:‘(q)date of issue or the latest revision of the instructions for use.’;
‘(q)
date of issue or the latest revision of the instructions for use.’;
(k)
Section 14 shall be deleted.

(a)
Section 1 shall be replaced by the following:‘1.The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.This shall include:—reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and—consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;
‘1.
The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.This shall include:—reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and—consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;
—
reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
—
consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;

‘1.
The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.This shall include:—reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and—consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;
—
reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
—
consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;

—
reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and

—
consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;

(b)
the following Section shall be inserted:‘6a.Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.’;
‘6a.
Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.’;

‘6a.
Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.’;

(c)
in Section 7.1, the following indent shall be added:‘—where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.’;
‘—
where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.’;

‘—
where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.’;

(d)
Section 7.4. shall be replaced by the following:‘7.4.Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*1)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.(*1)Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as last amended by Regulation (EC) No 1901/2006.’ "
‘7.4.
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*1)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.

‘7.4.
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*1)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.

(e)
Section 7.5 shall be replaced by the following:‘7.5.The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(*2).If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.(*2)OJ 196, 16.8.1967, p. 1. Directive as last amended by Directive 2006/121/EC of the European Parliament and of the Council (OJ L 396, 30.12.2006, p. 850).’ "
‘7.5.
The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(*2).If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.

‘7.5.
The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(*2).If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.

(f)
in Section 8.2, the word ‘transferable’ shall be replaced by the word ‘transmissible’;

(g)
the following Section shall be inserted:‘12.1aFor devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;
‘12.1a
For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;

‘12.1a
For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;

(h)
in Section 13.1, the first paragraph shall be replaced by the following:‘13.1.Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.’;
‘13.1.
Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.’;

‘13.1.
Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.’;

(i)
Section 13.3 shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’(ii)point (b) shall be replaced by the following:‘(b)the details strictly necessary to identify the device and the contents of the packaging especially for the users;’(iii)point (f) shall be replaced by the following:‘(f)where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’
(i)
point (a) shall be replaced by the following:‘(a)the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’
‘(a)
the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’
(ii)
point (b) shall be replaced by the following:‘(b)the details strictly necessary to identify the device and the contents of the packaging especially for the users;’
‘(b)
the details strictly necessary to identify the device and the contents of the packaging especially for the users;’
(iii)
point (f) shall be replaced by the following:‘(f)where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’
‘(f)
where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’

(i)
point (a) shall be replaced by the following:‘(a)the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’
‘(a)
the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’

‘(a)
the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’

(ii)
point (b) shall be replaced by the following:‘(b)the details strictly necessary to identify the device and the contents of the packaging especially for the users;’
‘(b)
the details strictly necessary to identify the device and the contents of the packaging especially for the users;’

‘(b)
the details strictly necessary to identify the device and the contents of the packaging especially for the users;’

(iii)
point (f) shall be replaced by the following:‘(f)where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’
‘(f)
where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’

‘(f)
where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’

(j)
Section 13.6 shall be amended as follows:(i)the following subparagraph shall be added to point (h):‘If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;’(ii)point (o) shall be replaced by the following:‘(o)medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’(iii)the following point shall be added:‘(q)date of issue or the latest revision of the instructions for use.’;
(i)
the following subparagraph shall be added to point (h):‘If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;’
(ii)
point (o) shall be replaced by the following:‘(o)medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’
‘(o)
medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’
(iii)
the following point shall be added:‘(q)date of issue or the latest revision of the instructions for use.’;
‘(q)
date of issue or the latest revision of the instructions for use.’;

(i)
the following subparagraph shall be added to point (h):‘If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;’

(ii)
point (o) shall be replaced by the following:‘(o)medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’
‘(o)
medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’

‘(o)
medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’

(iii)
the following point shall be added:‘(q)date of issue or the latest revision of the instructions for use.’;
‘(q)
date of issue or the latest revision of the instructions for use.’;

‘(q)
date of issue or the latest revision of the instructions for use.’;

(k)
Section 14 shall be deleted.



(a)
Section 1 shall be replaced by the following:‘1.The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.This shall include:—reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and—consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;
‘1.
The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.This shall include:—reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and—consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;
—
reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
—
consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;

‘1.
The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.This shall include:—reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and—consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;
—
reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
—
consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;

—
reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and

—
consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;



‘1.
The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.This shall include:—reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and—consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;
—
reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
—
consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;

—
reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and

—
consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;



—
reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and



—
consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;



(b)
the following Section shall be inserted:‘6a.Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.’;
‘6a.
Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.’;

‘6a.
Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.’;



‘6a.
Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.’;



(c)
in Section 7.1, the following indent shall be added:‘—where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.’;
‘—
where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.’;

‘—
where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.’;



‘—
where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.’;



(d)
Section 7.4. shall be replaced by the following:‘7.4.Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*1)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.(*1)Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as last amended by Regulation (EC) No 1901/2006.’ "
‘7.4.
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*1)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.

‘7.4.
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*1)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.



‘7.4.
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*1)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.



(e)
Section 7.5 shall be replaced by the following:‘7.5.The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(*2).If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.(*2)OJ 196, 16.8.1967, p. 1. Directive as last amended by Directive 2006/121/EC of the European Parliament and of the Council (OJ L 396, 30.12.2006, p. 850).’ "
‘7.5.
The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(*2).If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.

‘7.5.
The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(*2).If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.



‘7.5.
The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(*2).If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.



(f)
in Section 8.2, the word ‘transferable’ shall be replaced by the word ‘transmissible’;



(g)
the following Section shall be inserted:‘12.1aFor devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;
‘12.1a
For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;

‘12.1a
For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;



‘12.1a
For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;



(h)
in Section 13.1, the first paragraph shall be replaced by the following:‘13.1.Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.’;
‘13.1.
Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.’;

‘13.1.
Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.’;



‘13.1.
Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.’;



(i)
Section 13.3 shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’(ii)point (b) shall be replaced by the following:‘(b)the details strictly necessary to identify the device and the contents of the packaging especially for the users;’(iii)point (f) shall be replaced by the following:‘(f)where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’
(i)
point (a) shall be replaced by the following:‘(a)the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’
‘(a)
the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’
(ii)
point (b) shall be replaced by the following:‘(b)the details strictly necessary to identify the device and the contents of the packaging especially for the users;’
‘(b)
the details strictly necessary to identify the device and the contents of the packaging especially for the users;’
(iii)
point (f) shall be replaced by the following:‘(f)where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’
‘(f)
where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’

(i)
point (a) shall be replaced by the following:‘(a)the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’
‘(a)
the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’

‘(a)
the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’

(ii)
point (b) shall be replaced by the following:‘(b)the details strictly necessary to identify the device and the contents of the packaging especially for the users;’
‘(b)
the details strictly necessary to identify the device and the contents of the packaging especially for the users;’

‘(b)
the details strictly necessary to identify the device and the contents of the packaging especially for the users;’

(iii)
point (f) shall be replaced by the following:‘(f)where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’
‘(f)
where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’

‘(f)
where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’



(i)
point (a) shall be replaced by the following:‘(a)the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’
‘(a)
the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’

‘(a)
the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’



‘(a)
the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’



(ii)
point (b) shall be replaced by the following:‘(b)the details strictly necessary to identify the device and the contents of the packaging especially for the users;’
‘(b)
the details strictly necessary to identify the device and the contents of the packaging especially for the users;’

‘(b)
the details strictly necessary to identify the device and the contents of the packaging especially for the users;’



‘(b)
the details strictly necessary to identify the device and the contents of the packaging especially for the users;’



(iii)
point (f) shall be replaced by the following:‘(f)where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’
‘(f)
where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’

‘(f)
where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’



‘(f)
where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;’



(j)
Section 13.6 shall be amended as follows:(i)the following subparagraph shall be added to point (h):‘If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;’(ii)point (o) shall be replaced by the following:‘(o)medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’(iii)the following point shall be added:‘(q)date of issue or the latest revision of the instructions for use.’;
(i)
the following subparagraph shall be added to point (h):‘If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;’
(ii)
point (o) shall be replaced by the following:‘(o)medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’
‘(o)
medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’
(iii)
the following point shall be added:‘(q)date of issue or the latest revision of the instructions for use.’;
‘(q)
date of issue or the latest revision of the instructions for use.’;

(i)
the following subparagraph shall be added to point (h):‘If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;’

(ii)
point (o) shall be replaced by the following:‘(o)medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’
‘(o)
medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’

‘(o)
medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’

(iii)
the following point shall be added:‘(q)date of issue or the latest revision of the instructions for use.’;
‘(q)
date of issue or the latest revision of the instructions for use.’;

‘(q)
date of issue or the latest revision of the instructions for use.’;



(i)
the following subparagraph shall be added to point (h):‘If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;’



(ii)
point (o) shall be replaced by the following:‘(o)medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’
‘(o)
medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’

‘(o)
medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’



‘(o)
medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’



(iii)
the following point shall be added:‘(q)date of issue or the latest revision of the instructions for use.’;
‘(q)
date of issue or the latest revision of the instructions for use.’;

‘(q)
date of issue or the latest revision of the instructions for use.’;



‘(q)
date of issue or the latest revision of the instructions for use.’;



(k)
Section 14 shall be deleted.



2.
Annex II shall be amended as follows:(a)Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;(b)in Section 3.1, second paragraph, the introductory part of the seventh indent shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;(c)Section 3.2 shall be amended as follows:(i)the following paragraph shall be inserted after the first paragraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;(ii)in point (b), the following indent shall be added:‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’(iii)point (c) shall be replaced by the following:‘(c)the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.(*3)Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).’ "(d)the second paragraph of Section 3.3 shall be replaced by the following:‘The assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an assessment, on a representative basis, of the documentation of the design of the product(s) concerned, an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes.’;(e)in Section 4.3, the second and third paragraphs shall be replaced by the following:‘In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA.In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the notified body must follow the procedures referred to in that Directive.’;(f)in Section 5.2, the second indent shall be replaced by the following:‘—the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,’;(g)Section 6.1 shall be amended as follows:(i)the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities:’;(ii)the following phrase shall be added to the second indent:‘and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,’;(h)Section 6.3 shall be deleted;(i)Section 7 shall be replaced by the following:‘7.Application to devices in Classes IIa and IIb.7.1.In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb. Section 4, however, does not apply.7.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.7.3.For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive.7.4.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.7.5.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 5.’;(j)in Section 8, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;
(a)
Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;
‘2.
The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;
(b)
in Section 3.1, second paragraph, the introductory part of the seventh indent shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;
‘—
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;
(c)
Section 3.2 shall be amended as follows:(i)the following paragraph shall be inserted after the first paragraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;(ii)in point (b), the following indent shall be added:‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’(iii)point (c) shall be replaced by the following:‘(c)the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.(*3)Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).’ "
(i)
the following paragraph shall be inserted after the first paragraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;
(ii)
in point (b), the following indent shall be added:‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
(iii)
point (c) shall be replaced by the following:‘(c)the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.(*3)Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).’ "
‘(c)
the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.
—
a general description of the product, including any variants planned, and its intended use(s),
—
the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,
—
the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,
—
if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),
—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex X,
—
the draft label and, where appropriate, instructions for use.
(d)
the second paragraph of Section 3.3 shall be replaced by the following:‘The assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an assessment, on a representative basis, of the documentation of the design of the product(s) concerned, an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes.’;
(e)
in Section 4.3, the second and third paragraphs shall be replaced by the following:‘In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA.In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the notified body must follow the procedures referred to in that Directive.’;
(f)
in Section 5.2, the second indent shall be replaced by the following:‘—the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,’;
‘—
the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,’;
(g)
Section 6.1 shall be amended as follows:(i)the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities:’;(ii)the following phrase shall be added to the second indent:‘and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,’;
(i)
the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities:’;
(ii)
the following phrase shall be added to the second indent:‘and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,’;
(h)
Section 6.3 shall be deleted;
(i)
Section 7 shall be replaced by the following:‘7.Application to devices in Classes IIa and IIb.7.1.In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb. Section 4, however, does not apply.7.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.7.3.For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive.7.4.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.7.5.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 5.’;
‘7.
Application to devices in Classes IIa and IIb.
7.1.
In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb. Section 4, however, does not apply.
7.2.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.
7.3.
For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive.
7.4.
In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.
7.5.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 5.’;
(j)
in Section 8, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;

(a)
Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;
‘2.
The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;

‘2.
The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;

(b)
in Section 3.1, second paragraph, the introductory part of the seventh indent shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;
‘—
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;

‘—
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;

(c)
Section 3.2 shall be amended as follows:(i)the following paragraph shall be inserted after the first paragraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;(ii)in point (b), the following indent shall be added:‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’(iii)point (c) shall be replaced by the following:‘(c)the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.(*3)Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).’ "
(i)
the following paragraph shall be inserted after the first paragraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;
(ii)
in point (b), the following indent shall be added:‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
(iii)
point (c) shall be replaced by the following:‘(c)the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.(*3)Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).’ "
‘(c)
the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.
—
a general description of the product, including any variants planned, and its intended use(s),
—
the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,
—
the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,
—
if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),
—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex X,
—
the draft label and, where appropriate, instructions for use.

(i)
the following paragraph shall be inserted after the first paragraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;

(ii)
in point (b), the following indent shall be added:‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’

‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’

(iii)
point (c) shall be replaced by the following:‘(c)the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.(*3)Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).’ "
‘(c)
the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.
—
a general description of the product, including any variants planned, and its intended use(s),
—
the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,
—
the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,
—
if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),
—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex X,
—
the draft label and, where appropriate, instructions for use.

‘(c)
the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.
—
a general description of the product, including any variants planned, and its intended use(s),
—
the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,
—
the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,
—
if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),
—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex X,
—
the draft label and, where appropriate, instructions for use.

—
a general description of the product, including any variants planned, and its intended use(s),

—
the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,

—
the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,

—
if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,

—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),

—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,

—
the pre-clinical evaluation,

—
the clinical evaluation referred to in Annex X,

—
the draft label and, where appropriate, instructions for use.

(d)
the second paragraph of Section 3.3 shall be replaced by the following:‘The assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an assessment, on a representative basis, of the documentation of the design of the product(s) concerned, an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes.’;

(e)
in Section 4.3, the second and third paragraphs shall be replaced by the following:‘In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA.In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the notified body must follow the procedures referred to in that Directive.’;

(f)
in Section 5.2, the second indent shall be replaced by the following:‘—the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,’;
‘—
the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,’;

‘—
the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,’;

(g)
Section 6.1 shall be amended as follows:(i)the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities:’;(ii)the following phrase shall be added to the second indent:‘and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,’;
(i)
the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities:’;
(ii)
the following phrase shall be added to the second indent:‘and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,’;

(i)
the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities:’;

(ii)
the following phrase shall be added to the second indent:‘and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,’;

(h)
Section 6.3 shall be deleted;

(i)
Section 7 shall be replaced by the following:‘7.Application to devices in Classes IIa and IIb.7.1.In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb. Section 4, however, does not apply.7.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.7.3.For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive.7.4.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.7.5.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 5.’;
‘7.
Application to devices in Classes IIa and IIb.
7.1.
In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb. Section 4, however, does not apply.
7.2.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.
7.3.
For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive.
7.4.
In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.
7.5.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 5.’;

‘7.
Application to devices in Classes IIa and IIb.

7.1.
In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb. Section 4, however, does not apply.

7.2.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.

7.3.
For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive.

7.4.
In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.

7.5.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 5.’;

(j)
in Section 8, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;



(a)
Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;
‘2.
The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;

‘2.
The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;



‘2.
The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;



(b)
in Section 3.1, second paragraph, the introductory part of the seventh indent shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;
‘—
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;

‘—
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;



‘—
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;



(c)
Section 3.2 shall be amended as follows:(i)the following paragraph shall be inserted after the first paragraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;(ii)in point (b), the following indent shall be added:‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’(iii)point (c) shall be replaced by the following:‘(c)the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.(*3)Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).’ "
(i)
the following paragraph shall be inserted after the first paragraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;
(ii)
in point (b), the following indent shall be added:‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
(iii)
point (c) shall be replaced by the following:‘(c)the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.(*3)Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).’ "
‘(c)
the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.
—
a general description of the product, including any variants planned, and its intended use(s),
—
the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,
—
the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,
—
if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),
—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex X,
—
the draft label and, where appropriate, instructions for use.

(i)
the following paragraph shall be inserted after the first paragraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;

(ii)
in point (b), the following indent shall be added:‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’

‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’

(iii)
point (c) shall be replaced by the following:‘(c)the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.(*3)Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).’ "
‘(c)
the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.
—
a general description of the product, including any variants planned, and its intended use(s),
—
the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,
—
the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,
—
if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),
—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex X,
—
the draft label and, where appropriate, instructions for use.

‘(c)
the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.
—
a general description of the product, including any variants planned, and its intended use(s),
—
the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,
—
the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,
—
if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),
—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex X,
—
the draft label and, where appropriate, instructions for use.

—
a general description of the product, including any variants planned, and its intended use(s),

—
the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,

—
the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,

—
if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,

—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),

—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,

—
the pre-clinical evaluation,

—
the clinical evaluation referred to in Annex X,

—
the draft label and, where appropriate, instructions for use.



(i)
the following paragraph shall be inserted after the first paragraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;



(ii)
in point (b), the following indent shall be added:‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’

‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’



‘—
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’



(iii)
point (c) shall be replaced by the following:‘(c)the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.(*3)Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).’ "
‘(c)
the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.
—
a general description of the product, including any variants planned, and its intended use(s),
—
the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,
—
the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,
—
if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),
—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex X,
—
the draft label and, where appropriate, instructions for use.

‘(c)
the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.
—
a general description of the product, including any variants planned, and its intended use(s),
—
the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,
—
the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,
—
if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),
—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex X,
—
the draft label and, where appropriate, instructions for use.

—
a general description of the product, including any variants planned, and its intended use(s),

—
the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,

—
the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,

—
if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,

—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),

—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,

—
the pre-clinical evaluation,

—
the clinical evaluation referred to in Annex X,

—
the draft label and, where appropriate, instructions for use.



‘(c)
the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.
—
a general description of the product, including any variants planned, and its intended use(s),
—
the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,
—
the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,
—
if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),
—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex X,
—
the draft label and, where appropriate, instructions for use.

—
a general description of the product, including any variants planned, and its intended use(s),

—
the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,

—
the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,

—
if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,

—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),

—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,

—
the pre-clinical evaluation,

—
the clinical evaluation referred to in Annex X,

—
the draft label and, where appropriate, instructions for use.



—
a general description of the product, including any variants planned, and its intended use(s),



—
the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,



—
the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,



—
if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,



—
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,



—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),



—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,



—
the pre-clinical evaluation,



—
the clinical evaluation referred to in Annex X,



—
the draft label and, where appropriate, instructions for use.



(d)
the second paragraph of Section 3.3 shall be replaced by the following:‘The assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an assessment, on a representative basis, of the documentation of the design of the product(s) concerned, an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes.’;



(e)
in Section 4.3, the second and third paragraphs shall be replaced by the following:‘In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA.In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the notified body must follow the procedures referred to in that Directive.’;



(f)
in Section 5.2, the second indent shall be replaced by the following:‘—the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,’;
‘—
the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,’;

‘—
the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,’;



‘—
the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,’;



(g)
Section 6.1 shall be amended as follows:(i)the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities:’;(ii)the following phrase shall be added to the second indent:‘and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,’;
(i)
the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities:’;
(ii)
the following phrase shall be added to the second indent:‘and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,’;

(i)
the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities:’;

(ii)
the following phrase shall be added to the second indent:‘and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,’;



(i)
the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities:’;



(ii)
the following phrase shall be added to the second indent:‘and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,’;



(h)
Section 6.3 shall be deleted;



(i)
Section 7 shall be replaced by the following:‘7.Application to devices in Classes IIa and IIb.7.1.In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb. Section 4, however, does not apply.7.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.7.3.For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive.7.4.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.7.5.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 5.’;
‘7.
Application to devices in Classes IIa and IIb.
7.1.
In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb. Section 4, however, does not apply.
7.2.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.
7.3.
For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive.
7.4.
In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.
7.5.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 5.’;

‘7.
Application to devices in Classes IIa and IIb.

7.1.
In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb. Section 4, however, does not apply.

7.2.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.

7.3.
For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive.

7.4.
In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.

7.5.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 5.’;



‘7.
Application to devices in Classes IIa and IIb.



7.1.
In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb. Section 4, however, does not apply.



7.2.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.



7.3.
For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive.



7.4.
In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.



7.5.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 5.’;



(j)
in Section 8, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;



3.
Annex III shall be amended as follows:(a)Section 3 shall be replaced by the following:‘3.The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular:—a general description of the type, including any variants planned, and its intended use(s),—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,—the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,—a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.’;(b)in Section 5, the second and third paragraphs shall be replaced by the following:‘In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA.In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the notified body must follow the procedures referred to in that Directive.’;(c)Section 7.3 shall be replaced by the following:‘7.3.The manufacturer or his authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least five years after the last device has been manufactured. In the case of implantable devices, the period shall be at least 15 years after the last product has been manufactured.’;(d)Section 7.4 shall be deleted;
(a)
Section 3 shall be replaced by the following:‘3.The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular:—a general description of the type, including any variants planned, and its intended use(s),—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,—the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,—a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.’;
‘3.
The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular:—a general description of the type, including any variants planned, and its intended use(s),—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,—the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,—a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.’;
—
a general description of the type, including any variants planned, and its intended use(s),
—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,
—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,
—
a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,
—
the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,
—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex X,
—
the draft label and, where appropriate, instructions for use.’;
(b)
in Section 5, the second and third paragraphs shall be replaced by the following:‘In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA.In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the notified body must follow the procedures referred to in that Directive.’;
(c)
Section 7.3 shall be replaced by the following:‘7.3.The manufacturer or his authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least five years after the last device has been manufactured. In the case of implantable devices, the period shall be at least 15 years after the last product has been manufactured.’;
‘7.3.
The manufacturer or his authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least five years after the last device has been manufactured. In the case of implantable devices, the period shall be at least 15 years after the last product has been manufactured.’;
(d)
Section 7.4 shall be deleted;

(a)
Section 3 shall be replaced by the following:‘3.The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular:—a general description of the type, including any variants planned, and its intended use(s),—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,—the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,—a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.’;
‘3.
The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular:—a general description of the type, including any variants planned, and its intended use(s),—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,—the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,—a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.’;
—
a general description of the type, including any variants planned, and its intended use(s),
—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,
—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,
—
a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,
—
the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,
—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex X,
—
the draft label and, where appropriate, instructions for use.’;

‘3.
The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular:—a general description of the type, including any variants planned, and its intended use(s),—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,—the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,—a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.’;
—
a general description of the type, including any variants planned, and its intended use(s),
—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,
—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,
—
a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,
—
the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,
—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex X,
—
the draft label and, where appropriate, instructions for use.’;

—
a general description of the type, including any variants planned, and its intended use(s),

—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,

—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,

—
a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,

—
the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,

—
a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,

—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,

—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,

—
the pre-clinical evaluation,

—
the clinical evaluation referred to in Annex X,

—
the draft label and, where appropriate, instructions for use.’;

(b)
in Section 5, the second and third paragraphs shall be replaced by the following:‘In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA.In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the notified body must follow the procedures referred to in that Directive.’;

(c)
Section 7.3 shall be replaced by the following:‘7.3.The manufacturer or his authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least five years after the last device has been manufactured. In the case of implantable devices, the period shall be at least 15 years after the last product has been manufactured.’;
‘7.3.
The manufacturer or his authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least five years after the last device has been manufactured. In the case of implantable devices, the period shall be at least 15 years after the last product has been manufactured.’;

‘7.3.
The manufacturer or his authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least five years after the last device has been manufactured. In the case of implantable devices, the period shall be at least 15 years after the last product has been manufactured.’;

(d)
Section 7.4 shall be deleted;



(a)
Section 3 shall be replaced by the following:‘3.The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular:—a general description of the type, including any variants planned, and its intended use(s),—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,—the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,—a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.’;
‘3.
The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular:—a general description of the type, including any variants planned, and its intended use(s),—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,—the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,—a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.’;
—
a general description of the type, including any variants planned, and its intended use(s),
—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,
—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,
—
a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,
—
the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,
—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex X,
—
the draft label and, where appropriate, instructions for use.’;

‘3.
The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular:—a general description of the type, including any variants planned, and its intended use(s),—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,—the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,—a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.’;
—
a general description of the type, including any variants planned, and its intended use(s),
—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,
—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,
—
a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,
—
the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,
—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex X,
—
the draft label and, where appropriate, instructions for use.’;

—
a general description of the type, including any variants planned, and its intended use(s),

—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,

—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,

—
a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,

—
the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,

—
a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,

—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,

—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,

—
the pre-clinical evaluation,

—
the clinical evaluation referred to in Annex X,

—
the draft label and, where appropriate, instructions for use.’;



‘3.
The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular:—a general description of the type, including any variants planned, and its intended use(s),—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,—the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,—a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.’;
—
a general description of the type, including any variants planned, and its intended use(s),
—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,
—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,
—
a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,
—
the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,
—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,
—
the clinical evaluation referred to in Annex X,
—
the draft label and, where appropriate, instructions for use.’;

—
a general description of the type, including any variants planned, and its intended use(s),

—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,

—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,

—
a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,

—
the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,

—
a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,

—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,

—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,

—
the pre-clinical evaluation,

—
the clinical evaluation referred to in Annex X,

—
the draft label and, where appropriate, instructions for use.’;



—
a general description of the type, including any variants planned, and its intended use(s),



—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,



—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,



—
a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,



—
the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,



—
a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,



—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,



—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,



—
the pre-clinical evaluation,



—
the clinical evaluation referred to in Annex X,



—
the draft label and, where appropriate, instructions for use.’;



(b)
in Section 5, the second and third paragraphs shall be replaced by the following:‘In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA.In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the notified body must follow the procedures referred to in that Directive.’;



(c)
Section 7.3 shall be replaced by the following:‘7.3.The manufacturer or his authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least five years after the last device has been manufactured. In the case of implantable devices, the period shall be at least 15 years after the last product has been manufactured.’;
‘7.3.
The manufacturer or his authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least five years after the last device has been manufactured. In the case of implantable devices, the period shall be at least 15 years after the last product has been manufactured.’;

‘7.3.
The manufacturer or his authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least five years after the last device has been manufactured. In the case of implantable devices, the period shall be at least 15 years after the last product has been manufactured.’;



‘7.3.
The manufacturer or his authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least five years after the last device has been manufactured. In the case of implantable devices, the period shall be at least 15 years after the last product has been manufactured.’;



(d)
Section 7.4 shall be deleted;



4.
Annex IV shall be amended as follows:(a)in Section 1, the words ‘established in the Community’ shall be deleted;(b)in Section 3, the first paragraph shall be replaced by the following:‘3.The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;(c)Section 6.3 shall be replaced by the following:‘6.3.Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;(d)in Section 7, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’;(e)in the introductory part of Section 8 the word ‘exemptions’ shall be deleted;(f)in Section 9, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;
(a)
in Section 1, the words ‘established in the Community’ shall be deleted;
(b)
in Section 3, the first paragraph shall be replaced by the following:‘3.The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;
‘3.
The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;
(c)
Section 6.3 shall be replaced by the following:‘6.3.Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;
‘6.3.
Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;
(d)
in Section 7, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’;
(e)
in the introductory part of Section 8 the word ‘exemptions’ shall be deleted;
(f)
in Section 9, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;

(a)
in Section 1, the words ‘established in the Community’ shall be deleted;

(b)
in Section 3, the first paragraph shall be replaced by the following:‘3.The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;
‘3.
The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;

‘3.
The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;

(c)
Section 6.3 shall be replaced by the following:‘6.3.Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;
‘6.3.
Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;

‘6.3.
Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;

(d)
in Section 7, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’;

(e)
in the introductory part of Section 8 the word ‘exemptions’ shall be deleted;

(f)
in Section 9, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;



(a)
in Section 1, the words ‘established in the Community’ shall be deleted;



(b)
in Section 3, the first paragraph shall be replaced by the following:‘3.The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;
‘3.
The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;

‘3.
The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;



‘3.
The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;



(c)
Section 6.3 shall be replaced by the following:‘6.3.Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;
‘6.3.
Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;

‘6.3.
Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;



‘6.3.
Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;



(d)
in Section 7, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’;



(e)
in the introductory part of Section 8 the word ‘exemptions’ shall be deleted;



(f)
in Section 9, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;



5.
Annex V shall be amended as follows:(a)Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and must be kept by the manufacturer.’;(b)in the eighth indent of the second paragraph of Section 3.1, the introductory part shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them;’;(c)in point (b) of the third paragraph of Section 3.2, the following indent shall be added:‘—where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’(d)in Section 4.2, the following indent shall be inserted after the first indent:‘—the technical documentation,’;(e)in Section 5.1, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’;(f)Section 6 shall be replaced by the following:‘6.   Application to devices in Class IIaIn line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:6.1.By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.6.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.6.3.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.6.4.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;(g)in Section 7, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;
(a)
Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and must be kept by the manufacturer.’;
‘2.
The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and must be kept by the manufacturer.’;
(b)
in the eighth indent of the second paragraph of Section 3.1, the introductory part shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them;’;
‘—
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them;’;
(c)
in point (b) of the third paragraph of Section 3.2, the following indent shall be added:‘—where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
‘—
where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
(d)
in Section 4.2, the following indent shall be inserted after the first indent:‘—the technical documentation,’;
‘—
the technical documentation,’;
(e)
in Section 5.1, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’;
(f)
Section 6 shall be replaced by the following:‘6.   Application to devices in Class IIaIn line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:6.1.By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.6.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.6.3.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.6.4.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;
6.1.
By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.
6.2.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.
6.3.
In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.
6.4.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;
(g)
in Section 7, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;

(a)
Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and must be kept by the manufacturer.’;
‘2.
The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and must be kept by the manufacturer.’;

‘2.
The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and must be kept by the manufacturer.’;

(b)
in the eighth indent of the second paragraph of Section 3.1, the introductory part shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them;’;
‘—
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them;’;

‘—
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them;’;

(c)
in point (b) of the third paragraph of Section 3.2, the following indent shall be added:‘—where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
‘—
where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’

‘—
where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’

(d)
in Section 4.2, the following indent shall be inserted after the first indent:‘—the technical documentation,’;
‘—
the technical documentation,’;

‘—
the technical documentation,’;

(e)
in Section 5.1, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’;

(f)
Section 6 shall be replaced by the following:‘6.   Application to devices in Class IIaIn line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:6.1.By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.6.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.6.3.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.6.4.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;
6.1.
By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.
6.2.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.
6.3.
In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.
6.4.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;

6.1.
By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.

6.2.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.

6.3.
In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.

6.4.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;

(g)
in Section 7, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;



(a)
Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and must be kept by the manufacturer.’;
‘2.
The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and must be kept by the manufacturer.’;

‘2.
The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and must be kept by the manufacturer.’;



‘2.
The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and must be kept by the manufacturer.’;



(b)
in the eighth indent of the second paragraph of Section 3.1, the introductory part shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them;’;
‘—
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them;’;

‘—
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them;’;



‘—
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them;’;



(c)
in point (b) of the third paragraph of Section 3.2, the following indent shall be added:‘—where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
‘—
where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’

‘—
where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’



‘—
where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’



(d)
in Section 4.2, the following indent shall be inserted after the first indent:‘—the technical documentation,’;
‘—
the technical documentation,’;

‘—
the technical documentation,’;



‘—
the technical documentation,’;



(e)
in Section 5.1, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’;



(f)
Section 6 shall be replaced by the following:‘6.   Application to devices in Class IIaIn line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:6.1.By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.6.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.6.3.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.6.4.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;
6.1.
By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.
6.2.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.
6.3.
In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.
6.4.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;

6.1.
By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.

6.2.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.

6.3.
In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.

6.4.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;



6.1.
By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.



6.2.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.



6.3.
In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.



6.4.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;



(g)
in Section 7, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;



6.
Annex VI shall be amended as follows:(a)Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and be kept by the manufacturer. The CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Annex.’;(b)in the eighth indent of the second paragraph of Section 3.1, the introductory part shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;(c)in Section 3.2, the following indent shall be added:‘—where the final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’(d)in Section 5.1, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’;(e)Section 6 shall be replaced by the following:‘6.   Application to devices in Class IIaIn line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:6.1.By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.6.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.6.3.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.6.4.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;
(a)
Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and be kept by the manufacturer. The CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Annex.’;
‘2.
The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and be kept by the manufacturer. The CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Annex.’;
(b)
in the eighth indent of the second paragraph of Section 3.1, the introductory part shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;
‘—
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;
(c)
in Section 3.2, the following indent shall be added:‘—where the final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
‘—
where the final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
(d)
in Section 5.1, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’;
(e)
Section 6 shall be replaced by the following:‘6.   Application to devices in Class IIaIn line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:6.1.By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.6.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.6.3.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.6.4.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;
6.1.
By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.
6.2.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.
6.3.
In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.
6.4.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;

(a)
Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and be kept by the manufacturer. The CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Annex.’;
‘2.
The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and be kept by the manufacturer. The CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Annex.’;

‘2.
The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and be kept by the manufacturer. The CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Annex.’;

(b)
in the eighth indent of the second paragraph of Section 3.1, the introductory part shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;
‘—
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;

‘—
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;

(c)
in Section 3.2, the following indent shall be added:‘—where the final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
‘—
where the final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’

‘—
where the final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’

(d)
in Section 5.1, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’;

(e)
Section 6 shall be replaced by the following:‘6.   Application to devices in Class IIaIn line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:6.1.By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.6.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.6.3.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.6.4.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;
6.1.
By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.
6.2.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.
6.3.
In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.
6.4.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;

6.1.
By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.

6.2.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.

6.3.
In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.

6.4.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;



(a)
Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and be kept by the manufacturer. The CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Annex.’;
‘2.
The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and be kept by the manufacturer. The CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Annex.’;

‘2.
The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and be kept by the manufacturer. The CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Annex.’;



‘2.
The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and be kept by the manufacturer. The CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Annex.’;



(b)
in the eighth indent of the second paragraph of Section 3.1, the introductory part shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;
‘—
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;

‘—
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;



‘—
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;



(c)
in Section 3.2, the following indent shall be added:‘—where the final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
‘—
where the final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’

‘—
where the final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’



‘—
where the final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’



(d)
in Section 5.1, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’;



(e)
Section 6 shall be replaced by the following:‘6.   Application to devices in Class IIaIn line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:6.1.By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.6.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.6.3.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.6.4.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;
6.1.
By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.
6.2.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.
6.3.
In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.
6.4.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;

6.1.
By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.

6.2.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.

6.3.
In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.

6.4.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;



6.1.
By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.



6.2.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.



6.3.
In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.



6.4.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;



7.
Annex VII shall be amended as follows:(a)Sections 1 and 2 shall be replaced by the following:‘1.The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.2.The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.’;(b)Section 3 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the product, including any variants planned and its intended use(s),’;(ii)the fifth indent shall be replaced by the following:‘—in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;(iii)the seventh indent shall be replaced by the following indents:‘—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,’;(iv)the following indent shall be inserted after the seventh indent:‘—the clinical evaluation in accordance with Annex X,’;(c)in Section 4, the introductory part shall be replaced by the following:‘4.The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. He shall notify the competent authorities of the following incidents immediately on learning of them:’;(d)in Section 5, the words ‘Annex IV, V or VI’ shall be replaced by the words ‘Annex II, IV, V or VI’;
(a)
Sections 1 and 2 shall be replaced by the following:‘1.The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.2.The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.’;
‘1.
The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.
2.
The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.’;
(b)
Section 3 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the product, including any variants planned and its intended use(s),’;(ii)the fifth indent shall be replaced by the following:‘—in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;(iii)the seventh indent shall be replaced by the following indents:‘—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,’;(iv)the following indent shall be inserted after the seventh indent:‘—the clinical evaluation in accordance with Annex X,’;
(i)
the first indent shall be replaced by the following:‘—a general description of the product, including any variants planned and its intended use(s),’;
‘—
a general description of the product, including any variants planned and its intended use(s),’;
(ii)
the fifth indent shall be replaced by the following:‘—in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;
‘—
in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;
(iii)
the seventh indent shall be replaced by the following indents:‘—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,’;
‘—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,’;
(iv)
the following indent shall be inserted after the seventh indent:‘—the clinical evaluation in accordance with Annex X,’;
‘—
the clinical evaluation in accordance with Annex X,’;
(c)
in Section 4, the introductory part shall be replaced by the following:‘4.The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. He shall notify the competent authorities of the following incidents immediately on learning of them:’;
‘4.
The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. He shall notify the competent authorities of the following incidents immediately on learning of them:’;
(d)
in Section 5, the words ‘Annex IV, V or VI’ shall be replaced by the words ‘Annex II, IV, V or VI’;

(a)
Sections 1 and 2 shall be replaced by the following:‘1.The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.2.The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.’;
‘1.
The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.
2.
The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.’;

‘1.
The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.

2.
The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.’;

(b)
Section 3 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the product, including any variants planned and its intended use(s),’;(ii)the fifth indent shall be replaced by the following:‘—in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;(iii)the seventh indent shall be replaced by the following indents:‘—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,’;(iv)the following indent shall be inserted after the seventh indent:‘—the clinical evaluation in accordance with Annex X,’;
(i)
the first indent shall be replaced by the following:‘—a general description of the product, including any variants planned and its intended use(s),’;
‘—
a general description of the product, including any variants planned and its intended use(s),’;
(ii)
the fifth indent shall be replaced by the following:‘—in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;
‘—
in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;
(iii)
the seventh indent shall be replaced by the following indents:‘—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,’;
‘—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,’;
(iv)
the following indent shall be inserted after the seventh indent:‘—the clinical evaluation in accordance with Annex X,’;
‘—
the clinical evaluation in accordance with Annex X,’;

(i)
the first indent shall be replaced by the following:‘—a general description of the product, including any variants planned and its intended use(s),’;
‘—
a general description of the product, including any variants planned and its intended use(s),’;

‘—
a general description of the product, including any variants planned and its intended use(s),’;

(ii)
the fifth indent shall be replaced by the following:‘—in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;
‘—
in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;

‘—
in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;

(iii)
the seventh indent shall be replaced by the following indents:‘—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,’;
‘—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,’;

‘—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,

—
the pre-clinical evaluation,’;

(iv)
the following indent shall be inserted after the seventh indent:‘—the clinical evaluation in accordance with Annex X,’;
‘—
the clinical evaluation in accordance with Annex X,’;

‘—
the clinical evaluation in accordance with Annex X,’;

(c)
in Section 4, the introductory part shall be replaced by the following:‘4.The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. He shall notify the competent authorities of the following incidents immediately on learning of them:’;
‘4.
The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. He shall notify the competent authorities of the following incidents immediately on learning of them:’;

‘4.
The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. He shall notify the competent authorities of the following incidents immediately on learning of them:’;

(d)
in Section 5, the words ‘Annex IV, V or VI’ shall be replaced by the words ‘Annex II, IV, V or VI’;



(a)
Sections 1 and 2 shall be replaced by the following:‘1.The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.2.The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.’;
‘1.
The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.
2.
The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.’;

‘1.
The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.

2.
The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.’;



‘1.
The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.



2.
The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.’;



(b)
Section 3 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the product, including any variants planned and its intended use(s),’;(ii)the fifth indent shall be replaced by the following:‘—in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;(iii)the seventh indent shall be replaced by the following indents:‘—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,’;(iv)the following indent shall be inserted after the seventh indent:‘—the clinical evaluation in accordance with Annex X,’;
(i)
the first indent shall be replaced by the following:‘—a general description of the product, including any variants planned and its intended use(s),’;
‘—
a general description of the product, including any variants planned and its intended use(s),’;
(ii)
the fifth indent shall be replaced by the following:‘—in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;
‘—
in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;
(iii)
the seventh indent shall be replaced by the following indents:‘—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,’;
‘—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,’;
(iv)
the following indent shall be inserted after the seventh indent:‘—the clinical evaluation in accordance with Annex X,’;
‘—
the clinical evaluation in accordance with Annex X,’;

(i)
the first indent shall be replaced by the following:‘—a general description of the product, including any variants planned and its intended use(s),’;
‘—
a general description of the product, including any variants planned and its intended use(s),’;

‘—
a general description of the product, including any variants planned and its intended use(s),’;

(ii)
the fifth indent shall be replaced by the following:‘—in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;
‘—
in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;

‘—
in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;

(iii)
the seventh indent shall be replaced by the following indents:‘—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,’;
‘—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,’;

‘—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,

—
the pre-clinical evaluation,’;

(iv)
the following indent shall be inserted after the seventh indent:‘—the clinical evaluation in accordance with Annex X,’;
‘—
the clinical evaluation in accordance with Annex X,’;

‘—
the clinical evaluation in accordance with Annex X,’;



(i)
the first indent shall be replaced by the following:‘—a general description of the product, including any variants planned and its intended use(s),’;
‘—
a general description of the product, including any variants planned and its intended use(s),’;

‘—
a general description of the product, including any variants planned and its intended use(s),’;



‘—
a general description of the product, including any variants planned and its intended use(s),’;



(ii)
the fifth indent shall be replaced by the following:‘—in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;
‘—
in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;

‘—
in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;



‘—
in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;



(iii)
the seventh indent shall be replaced by the following indents:‘—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,’;
‘—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
—
the pre-clinical evaluation,’;

‘—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,

—
the pre-clinical evaluation,’;



‘—
the solutions adopted as referred to in Annex I, Chapter I, Section 2,



—
the pre-clinical evaluation,’;



(iv)
the following indent shall be inserted after the seventh indent:‘—the clinical evaluation in accordance with Annex X,’;
‘—
the clinical evaluation in accordance with Annex X,’;

‘—
the clinical evaluation in accordance with Annex X,’;



‘—
the clinical evaluation in accordance with Annex X,’;



(c)
in Section 4, the introductory part shall be replaced by the following:‘4.The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. He shall notify the competent authorities of the following incidents immediately on learning of them:’;
‘4.
The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. He shall notify the competent authorities of the following incidents immediately on learning of them:’;

‘4.
The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. He shall notify the competent authorities of the following incidents immediately on learning of them:’;



‘4.
The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. He shall notify the competent authorities of the following incidents immediately on learning of them:’;



(d)
in Section 5, the words ‘Annex IV, V or VI’ shall be replaced by the words ‘Annex II, IV, V or VI’;



8.
Annex VIII shall be amended as follows:(a)in Section 1, the words ‘established in the Community’ shall be deleted;(b)Section 2.1 shall be amended as follows:(i)the following indent shall be inserted after the introductory phrase:‘—the name and address of the manufacturer,’;(ii)the fourth indent shall be replaced by the following:‘—the specific characteristics of the product as indicated by the prescription,’;(c)Section 2.2 shall be amended as follows:(i)the second indent shall be replaced by the following:‘—the clinical investigation plan,’;(ii)the following indents shall be inserted after the second indent:‘—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;(d)in Section 3.1, the first paragraph shall be replaced by the following:‘3.1.For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.’;(e)Section 3.2 shall be replaced by the following:‘3.2.For devices intended for clinical investigations, the documentation must contain:—a general description of the product and its intended use,—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,—the results of the design calculations, and of the inspections and technical tests carried out, etc.The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation referred to in the first paragraph of this Section.The manufacturer must authorise the assessment, or audit where necessary, of the effectiveness of these measures.’;(f)Section 4 shall be replaced by the following:‘4.The information contained in the declarations concerned by this Annex shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years.’;(g)the following section shall be added:‘5.For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;
(a)
in Section 1, the words ‘established in the Community’ shall be deleted;
(b)
Section 2.1 shall be amended as follows:(i)the following indent shall be inserted after the introductory phrase:‘—the name and address of the manufacturer,’;(ii)the fourth indent shall be replaced by the following:‘—the specific characteristics of the product as indicated by the prescription,’;
(i)
the following indent shall be inserted after the introductory phrase:‘—the name and address of the manufacturer,’;
‘—
the name and address of the manufacturer,’;
(ii)
the fourth indent shall be replaced by the following:‘—the specific characteristics of the product as indicated by the prescription,’;
‘—
the specific characteristics of the product as indicated by the prescription,’;
(c)
Section 2.2 shall be amended as follows:(i)the second indent shall be replaced by the following:‘—the clinical investigation plan,’;(ii)the following indents shall be inserted after the second indent:‘—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;
(i)
the second indent shall be replaced by the following:‘—the clinical investigation plan,’;
‘—
the clinical investigation plan,’;
(ii)
the following indents shall be inserted after the second indent:‘—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;
‘—
the investigator's brochure,
—
the confirmation of insurance of subjects,
—
the documents used to obtain informed consent,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;
(d)
in Section 3.1, the first paragraph shall be replaced by the following:‘3.1.For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.’;
‘3.1.
For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.’;
(e)
Section 3.2 shall be replaced by the following:‘3.2.For devices intended for clinical investigations, the documentation must contain:—a general description of the product and its intended use,—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,—the results of the design calculations, and of the inspections and technical tests carried out, etc.The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation referred to in the first paragraph of this Section.The manufacturer must authorise the assessment, or audit where necessary, of the effectiveness of these measures.’;
‘3.2.
For devices intended for clinical investigations, the documentation must contain:—a general description of the product and its intended use,—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,—the results of the design calculations, and of the inspections and technical tests carried out, etc.
—
a general description of the product and its intended use,
—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,
—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,
—
the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,
—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,
—
the results of the design calculations, and of the inspections and technical tests carried out, etc.
(f)
Section 4 shall be replaced by the following:‘4.The information contained in the declarations concerned by this Annex shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years.’;
‘4.
The information contained in the declarations concerned by this Annex shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years.’;
(g)
the following section shall be added:‘5.For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;
‘5.
For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;
(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;

(a)
in Section 1, the words ‘established in the Community’ shall be deleted;

(b)
Section 2.1 shall be amended as follows:(i)the following indent shall be inserted after the introductory phrase:‘—the name and address of the manufacturer,’;(ii)the fourth indent shall be replaced by the following:‘—the specific characteristics of the product as indicated by the prescription,’;
(i)
the following indent shall be inserted after the introductory phrase:‘—the name and address of the manufacturer,’;
‘—
the name and address of the manufacturer,’;
(ii)
the fourth indent shall be replaced by the following:‘—the specific characteristics of the product as indicated by the prescription,’;
‘—
the specific characteristics of the product as indicated by the prescription,’;

(i)
the following indent shall be inserted after the introductory phrase:‘—the name and address of the manufacturer,’;
‘—
the name and address of the manufacturer,’;

‘—
the name and address of the manufacturer,’;

(ii)
the fourth indent shall be replaced by the following:‘—the specific characteristics of the product as indicated by the prescription,’;
‘—
the specific characteristics of the product as indicated by the prescription,’;

‘—
the specific characteristics of the product as indicated by the prescription,’;

(c)
Section 2.2 shall be amended as follows:(i)the second indent shall be replaced by the following:‘—the clinical investigation plan,’;(ii)the following indents shall be inserted after the second indent:‘—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;
(i)
the second indent shall be replaced by the following:‘—the clinical investigation plan,’;
‘—
the clinical investigation plan,’;
(ii)
the following indents shall be inserted after the second indent:‘—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;
‘—
the investigator's brochure,
—
the confirmation of insurance of subjects,
—
the documents used to obtain informed consent,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;

(i)
the second indent shall be replaced by the following:‘—the clinical investigation plan,’;
‘—
the clinical investigation plan,’;

‘—
the clinical investigation plan,’;

(ii)
the following indents shall be inserted after the second indent:‘—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;
‘—
the investigator's brochure,
—
the confirmation of insurance of subjects,
—
the documents used to obtain informed consent,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;

‘—
the investigator's brochure,

—
the confirmation of insurance of subjects,

—
the documents used to obtain informed consent,

—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,

—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;

(d)
in Section 3.1, the first paragraph shall be replaced by the following:‘3.1.For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.’;
‘3.1.
For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.’;

‘3.1.
For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.’;

(e)
Section 3.2 shall be replaced by the following:‘3.2.For devices intended for clinical investigations, the documentation must contain:—a general description of the product and its intended use,—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,—the results of the design calculations, and of the inspections and technical tests carried out, etc.The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation referred to in the first paragraph of this Section.The manufacturer must authorise the assessment, or audit where necessary, of the effectiveness of these measures.’;
‘3.2.
For devices intended for clinical investigations, the documentation must contain:—a general description of the product and its intended use,—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,—the results of the design calculations, and of the inspections and technical tests carried out, etc.
—
a general description of the product and its intended use,
—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,
—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,
—
the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,
—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,
—
the results of the design calculations, and of the inspections and technical tests carried out, etc.

‘3.2.
For devices intended for clinical investigations, the documentation must contain:—a general description of the product and its intended use,—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,—the results of the design calculations, and of the inspections and technical tests carried out, etc.
—
a general description of the product and its intended use,
—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,
—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,
—
the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,
—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,
—
the results of the design calculations, and of the inspections and technical tests carried out, etc.

—
a general description of the product and its intended use,

—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,

—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,

—
the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,

—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

—
if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,

—
the results of the design calculations, and of the inspections and technical tests carried out, etc.

(f)
Section 4 shall be replaced by the following:‘4.The information contained in the declarations concerned by this Annex shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years.’;
‘4.
The information contained in the declarations concerned by this Annex shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years.’;

‘4.
The information contained in the declarations concerned by this Annex shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years.’;

(g)
the following section shall be added:‘5.For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;
‘5.
For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;
(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;

‘5.
For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;
(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;

(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;

(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;



(a)
in Section 1, the words ‘established in the Community’ shall be deleted;



(b)
Section 2.1 shall be amended as follows:(i)the following indent shall be inserted after the introductory phrase:‘—the name and address of the manufacturer,’;(ii)the fourth indent shall be replaced by the following:‘—the specific characteristics of the product as indicated by the prescription,’;
(i)
the following indent shall be inserted after the introductory phrase:‘—the name and address of the manufacturer,’;
‘—
the name and address of the manufacturer,’;
(ii)
the fourth indent shall be replaced by the following:‘—the specific characteristics of the product as indicated by the prescription,’;
‘—
the specific characteristics of the product as indicated by the prescription,’;

(i)
the following indent shall be inserted after the introductory phrase:‘—the name and address of the manufacturer,’;
‘—
the name and address of the manufacturer,’;

‘—
the name and address of the manufacturer,’;

(ii)
the fourth indent shall be replaced by the following:‘—the specific characteristics of the product as indicated by the prescription,’;
‘—
the specific characteristics of the product as indicated by the prescription,’;

‘—
the specific characteristics of the product as indicated by the prescription,’;



(i)
the following indent shall be inserted after the introductory phrase:‘—the name and address of the manufacturer,’;
‘—
the name and address of the manufacturer,’;

‘—
the name and address of the manufacturer,’;



‘—
the name and address of the manufacturer,’;



(ii)
the fourth indent shall be replaced by the following:‘—the specific characteristics of the product as indicated by the prescription,’;
‘—
the specific characteristics of the product as indicated by the prescription,’;

‘—
the specific characteristics of the product as indicated by the prescription,’;



‘—
the specific characteristics of the product as indicated by the prescription,’;



(c)
Section 2.2 shall be amended as follows:(i)the second indent shall be replaced by the following:‘—the clinical investigation plan,’;(ii)the following indents shall be inserted after the second indent:‘—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;
(i)
the second indent shall be replaced by the following:‘—the clinical investigation plan,’;
‘—
the clinical investigation plan,’;
(ii)
the following indents shall be inserted after the second indent:‘—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;
‘—
the investigator's brochure,
—
the confirmation of insurance of subjects,
—
the documents used to obtain informed consent,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;

(i)
the second indent shall be replaced by the following:‘—the clinical investigation plan,’;
‘—
the clinical investigation plan,’;

‘—
the clinical investigation plan,’;

(ii)
the following indents shall be inserted after the second indent:‘—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;
‘—
the investigator's brochure,
—
the confirmation of insurance of subjects,
—
the documents used to obtain informed consent,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;

‘—
the investigator's brochure,

—
the confirmation of insurance of subjects,

—
the documents used to obtain informed consent,

—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,

—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;



(i)
the second indent shall be replaced by the following:‘—the clinical investigation plan,’;
‘—
the clinical investigation plan,’;

‘—
the clinical investigation plan,’;



‘—
the clinical investigation plan,’;



(ii)
the following indents shall be inserted after the second indent:‘—the investigator's brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;
‘—
the investigator's brochure,
—
the confirmation of insurance of subjects,
—
the documents used to obtain informed consent,
—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,
—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;

‘—
the investigator's brochure,

—
the confirmation of insurance of subjects,

—
the documents used to obtain informed consent,

—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,

—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;



‘—
the investigator's brochure,



—
the confirmation of insurance of subjects,



—
the documents used to obtain informed consent,



—
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,



—
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;



(d)
in Section 3.1, the first paragraph shall be replaced by the following:‘3.1.For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.’;
‘3.1.
For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.’;

‘3.1.
For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.’;



‘3.1.
For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.’;



(e)
Section 3.2 shall be replaced by the following:‘3.2.For devices intended for clinical investigations, the documentation must contain:—a general description of the product and its intended use,—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,—the results of the design calculations, and of the inspections and technical tests carried out, etc.The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation referred to in the first paragraph of this Section.The manufacturer must authorise the assessment, or audit where necessary, of the effectiveness of these measures.’;
‘3.2.
For devices intended for clinical investigations, the documentation must contain:—a general description of the product and its intended use,—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,—the results of the design calculations, and of the inspections and technical tests carried out, etc.
—
a general description of the product and its intended use,
—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,
—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,
—
the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,
—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,
—
the results of the design calculations, and of the inspections and technical tests carried out, etc.

‘3.2.
For devices intended for clinical investigations, the documentation must contain:—a general description of the product and its intended use,—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,—the results of the design calculations, and of the inspections and technical tests carried out, etc.
—
a general description of the product and its intended use,
—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,
—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,
—
the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,
—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,
—
the results of the design calculations, and of the inspections and technical tests carried out, etc.

—
a general description of the product and its intended use,

—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,

—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,

—
the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,

—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

—
if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,

—
the results of the design calculations, and of the inspections and technical tests carried out, etc.



‘3.2.
For devices intended for clinical investigations, the documentation must contain:—a general description of the product and its intended use,—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,—the results of the design calculations, and of the inspections and technical tests carried out, etc.
—
a general description of the product and its intended use,
—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,
—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,
—
the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,
—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
—
if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,
—
the results of the design calculations, and of the inspections and technical tests carried out, etc.

—
a general description of the product and its intended use,

—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,

—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,

—
the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,

—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

—
if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,

—
the results of the design calculations, and of the inspections and technical tests carried out, etc.



—
a general description of the product and its intended use,



—
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,



—
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,



—
the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,



—
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,



—
if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,



—
the results of the design calculations, and of the inspections and technical tests carried out, etc.



(f)
Section 4 shall be replaced by the following:‘4.The information contained in the declarations concerned by this Annex shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years.’;
‘4.
The information contained in the declarations concerned by this Annex shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years.’;

‘4.
The information contained in the declarations concerned by this Annex shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years.’;



‘4.
The information contained in the declarations concerned by this Annex shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years.’;



(g)
the following section shall be added:‘5.For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;
‘5.
For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;
(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;

‘5.
For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;
(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;

(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;

(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;



‘5.
For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;
(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;

(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;

(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;



(i)
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;



(ii)
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;



9.
Annex IX shall be amended as follows:(a)Chapter I shall be amended as follows:(i)in Section 1.4, the following sentence shall be added:‘Stand alone software is considered to be an active medical device.’;(ii)Section 1.7 shall be replaced by the following:‘1.7.   Central circulatory systemFor the purposes of this Directive, “central circulatory system” means the following vessels:arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.’;(b)in Chapter II, Section 2, the following section shall be added:‘2.6.In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means “an uninterrupted actual use of the device for the intended purpose”. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.’;(c)Chapter III shall be amended as follows:(i)the introductory phrase of the first paragraph of Section 2.1 shall be replaced by the following:‘All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:’;(ii)Section 2.2 shall be replaced by the following:‘2.2.   Rule 6All surgically invasive devices intended for transient use are in Class IIa unless they are:—intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,—reusable surgical instruments, in which case they are in Class I,—intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,—intended to supply energy in the form of ionising radiation in which case they are in Class IIb,—intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,—intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;(iii)in Section 2.3, the first indent shall be replaced by the following:‘—either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;(iv)in Section 4.1, first paragraph, the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;(v)in Section 4.1, the second paragraph shall be replaced by the following:‘All devices incorporating, as an integral part, a human blood derivative are in Class III.’;(vi)in Section 4.3, second paragraph, the following phrase shall be added:‘unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.’;(vii)in Section 4.4, the words ‘Non-active devices’ shall be replaced by the word ‘Devices’;
(a)
Chapter I shall be amended as follows:(i)in Section 1.4, the following sentence shall be added:‘Stand alone software is considered to be an active medical device.’;(ii)Section 1.7 shall be replaced by the following:‘1.7.   Central circulatory systemFor the purposes of this Directive, “central circulatory system” means the following vessels:arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.’;
(i)
in Section 1.4, the following sentence shall be added:‘Stand alone software is considered to be an active medical device.’;
(ii)
Section 1.7 shall be replaced by the following:‘1.7.   Central circulatory systemFor the purposes of this Directive, “central circulatory system” means the following vessels:arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.’;
(b)
in Chapter II, Section 2, the following section shall be added:‘2.6.In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means “an uninterrupted actual use of the device for the intended purpose”. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.’;
‘2.6.
In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means “an uninterrupted actual use of the device for the intended purpose”. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.’;
(c)
Chapter III shall be amended as follows:(i)the introductory phrase of the first paragraph of Section 2.1 shall be replaced by the following:‘All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:’;(ii)Section 2.2 shall be replaced by the following:‘2.2.   Rule 6All surgically invasive devices intended for transient use are in Class IIa unless they are:—intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,—reusable surgical instruments, in which case they are in Class I,—intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,—intended to supply energy in the form of ionising radiation in which case they are in Class IIb,—intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,—intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;(iii)in Section 2.3, the first indent shall be replaced by the following:‘—either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;(iv)in Section 4.1, first paragraph, the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;(v)in Section 4.1, the second paragraph shall be replaced by the following:‘All devices incorporating, as an integral part, a human blood derivative are in Class III.’;(vi)in Section 4.3, second paragraph, the following phrase shall be added:‘unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.’;(vii)in Section 4.4, the words ‘Non-active devices’ shall be replaced by the word ‘Devices’;
(i)
the introductory phrase of the first paragraph of Section 2.1 shall be replaced by the following:‘All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:’;
(ii)
Section 2.2 shall be replaced by the following:‘2.2.   Rule 6All surgically invasive devices intended for transient use are in Class IIa unless they are:—intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,—reusable surgical instruments, in which case they are in Class I,—intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,—intended to supply energy in the form of ionising radiation in which case they are in Class IIb,—intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,—intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;
—
intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,
—
reusable surgical instruments, in which case they are in Class I,
—
intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,
—
intended to supply energy in the form of ionising radiation in which case they are in Class IIb,
—
intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,
—
intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;
(iii)
in Section 2.3, the first indent shall be replaced by the following:‘—either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;
‘—
either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;
(iv)
in Section 4.1, first paragraph, the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;
(v)
in Section 4.1, the second paragraph shall be replaced by the following:‘All devices incorporating, as an integral part, a human blood derivative are in Class III.’;
(vi)
in Section 4.3, second paragraph, the following phrase shall be added:‘unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.’;
(vii)
in Section 4.4, the words ‘Non-active devices’ shall be replaced by the word ‘Devices’;

(a)
Chapter I shall be amended as follows:(i)in Section 1.4, the following sentence shall be added:‘Stand alone software is considered to be an active medical device.’;(ii)Section 1.7 shall be replaced by the following:‘1.7.   Central circulatory systemFor the purposes of this Directive, “central circulatory system” means the following vessels:arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.’;
(i)
in Section 1.4, the following sentence shall be added:‘Stand alone software is considered to be an active medical device.’;
(ii)
Section 1.7 shall be replaced by the following:‘1.7.   Central circulatory systemFor the purposes of this Directive, “central circulatory system” means the following vessels:arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.’;

(i)
in Section 1.4, the following sentence shall be added:‘Stand alone software is considered to be an active medical device.’;

(ii)
Section 1.7 shall be replaced by the following:‘1.7.   Central circulatory systemFor the purposes of this Directive, “central circulatory system” means the following vessels:arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.’;

(b)
in Chapter II, Section 2, the following section shall be added:‘2.6.In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means “an uninterrupted actual use of the device for the intended purpose”. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.’;
‘2.6.
In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means “an uninterrupted actual use of the device for the intended purpose”. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.’;

‘2.6.
In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means “an uninterrupted actual use of the device for the intended purpose”. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.’;

(c)
Chapter III shall be amended as follows:(i)the introductory phrase of the first paragraph of Section 2.1 shall be replaced by the following:‘All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:’;(ii)Section 2.2 shall be replaced by the following:‘2.2.   Rule 6All surgically invasive devices intended for transient use are in Class IIa unless they are:—intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,—reusable surgical instruments, in which case they are in Class I,—intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,—intended to supply energy in the form of ionising radiation in which case they are in Class IIb,—intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,—intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;(iii)in Section 2.3, the first indent shall be replaced by the following:‘—either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;(iv)in Section 4.1, first paragraph, the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;(v)in Section 4.1, the second paragraph shall be replaced by the following:‘All devices incorporating, as an integral part, a human blood derivative are in Class III.’;(vi)in Section 4.3, second paragraph, the following phrase shall be added:‘unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.’;(vii)in Section 4.4, the words ‘Non-active devices’ shall be replaced by the word ‘Devices’;
(i)
the introductory phrase of the first paragraph of Section 2.1 shall be replaced by the following:‘All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:’;
(ii)
Section 2.2 shall be replaced by the following:‘2.2.   Rule 6All surgically invasive devices intended for transient use are in Class IIa unless they are:—intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,—reusable surgical instruments, in which case they are in Class I,—intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,—intended to supply energy in the form of ionising radiation in which case they are in Class IIb,—intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,—intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;
—
intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,
—
reusable surgical instruments, in which case they are in Class I,
—
intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,
—
intended to supply energy in the form of ionising radiation in which case they are in Class IIb,
—
intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,
—
intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;
(iii)
in Section 2.3, the first indent shall be replaced by the following:‘—either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;
‘—
either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;
(iv)
in Section 4.1, first paragraph, the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;
(v)
in Section 4.1, the second paragraph shall be replaced by the following:‘All devices incorporating, as an integral part, a human blood derivative are in Class III.’;
(vi)
in Section 4.3, second paragraph, the following phrase shall be added:‘unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.’;
(vii)
in Section 4.4, the words ‘Non-active devices’ shall be replaced by the word ‘Devices’;

(i)
the introductory phrase of the first paragraph of Section 2.1 shall be replaced by the following:‘All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:’;

(ii)
Section 2.2 shall be replaced by the following:‘2.2.   Rule 6All surgically invasive devices intended for transient use are in Class IIa unless they are:—intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,—reusable surgical instruments, in which case they are in Class I,—intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,—intended to supply energy in the form of ionising radiation in which case they are in Class IIb,—intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,—intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;
—
intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,
—
reusable surgical instruments, in which case they are in Class I,
—
intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,
—
intended to supply energy in the form of ionising radiation in which case they are in Class IIb,
—
intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,
—
intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;

—
intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,

—
reusable surgical instruments, in which case they are in Class I,

—
intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,

—
intended to supply energy in the form of ionising radiation in which case they are in Class IIb,

—
intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,

—
intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;

(iii)
in Section 2.3, the first indent shall be replaced by the following:‘—either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;
‘—
either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;

‘—
either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;

(iv)
in Section 4.1, first paragraph, the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;

(v)
in Section 4.1, the second paragraph shall be replaced by the following:‘All devices incorporating, as an integral part, a human blood derivative are in Class III.’;

(vi)
in Section 4.3, second paragraph, the following phrase shall be added:‘unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.’;

(vii)
in Section 4.4, the words ‘Non-active devices’ shall be replaced by the word ‘Devices’;



(a)
Chapter I shall be amended as follows:(i)in Section 1.4, the following sentence shall be added:‘Stand alone software is considered to be an active medical device.’;(ii)Section 1.7 shall be replaced by the following:‘1.7.   Central circulatory systemFor the purposes of this Directive, “central circulatory system” means the following vessels:arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.’;
(i)
in Section 1.4, the following sentence shall be added:‘Stand alone software is considered to be an active medical device.’;
(ii)
Section 1.7 shall be replaced by the following:‘1.7.   Central circulatory systemFor the purposes of this Directive, “central circulatory system” means the following vessels:arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.’;

(i)
in Section 1.4, the following sentence shall be added:‘Stand alone software is considered to be an active medical device.’;

(ii)
Section 1.7 shall be replaced by the following:‘1.7.   Central circulatory systemFor the purposes of this Directive, “central circulatory system” means the following vessels:arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.’;



(i)
in Section 1.4, the following sentence shall be added:‘Stand alone software is considered to be an active medical device.’;



(ii)
Section 1.7 shall be replaced by the following:‘1.7.   Central circulatory systemFor the purposes of this Directive, “central circulatory system” means the following vessels:arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.’;



(b)
in Chapter II, Section 2, the following section shall be added:‘2.6.In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means “an uninterrupted actual use of the device for the intended purpose”. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.’;
‘2.6.
In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means “an uninterrupted actual use of the device for the intended purpose”. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.’;

‘2.6.
In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means “an uninterrupted actual use of the device for the intended purpose”. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.’;



‘2.6.
In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means “an uninterrupted actual use of the device for the intended purpose”. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.’;



(c)
Chapter III shall be amended as follows:(i)the introductory phrase of the first paragraph of Section 2.1 shall be replaced by the following:‘All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:’;(ii)Section 2.2 shall be replaced by the following:‘2.2.   Rule 6All surgically invasive devices intended for transient use are in Class IIa unless they are:—intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,—reusable surgical instruments, in which case they are in Class I,—intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,—intended to supply energy in the form of ionising radiation in which case they are in Class IIb,—intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,—intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;(iii)in Section 2.3, the first indent shall be replaced by the following:‘—either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;(iv)in Section 4.1, first paragraph, the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;(v)in Section 4.1, the second paragraph shall be replaced by the following:‘All devices incorporating, as an integral part, a human blood derivative are in Class III.’;(vi)in Section 4.3, second paragraph, the following phrase shall be added:‘unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.’;(vii)in Section 4.4, the words ‘Non-active devices’ shall be replaced by the word ‘Devices’;
(i)
the introductory phrase of the first paragraph of Section 2.1 shall be replaced by the following:‘All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:’;
(ii)
Section 2.2 shall be replaced by the following:‘2.2.   Rule 6All surgically invasive devices intended for transient use are in Class IIa unless they are:—intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,—reusable surgical instruments, in which case they are in Class I,—intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,—intended to supply energy in the form of ionising radiation in which case they are in Class IIb,—intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,—intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;
—
intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,
—
reusable surgical instruments, in which case they are in Class I,
—
intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,
—
intended to supply energy in the form of ionising radiation in which case they are in Class IIb,
—
intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,
—
intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;
(iii)
in Section 2.3, the first indent shall be replaced by the following:‘—either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;
‘—
either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;
(iv)
in Section 4.1, first paragraph, the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;
(v)
in Section 4.1, the second paragraph shall be replaced by the following:‘All devices incorporating, as an integral part, a human blood derivative are in Class III.’;
(vi)
in Section 4.3, second paragraph, the following phrase shall be added:‘unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.’;
(vii)
in Section 4.4, the words ‘Non-active devices’ shall be replaced by the word ‘Devices’;

(i)
the introductory phrase of the first paragraph of Section 2.1 shall be replaced by the following:‘All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:’;

(ii)
Section 2.2 shall be replaced by the following:‘2.2.   Rule 6All surgically invasive devices intended for transient use are in Class IIa unless they are:—intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,—reusable surgical instruments, in which case they are in Class I,—intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,—intended to supply energy in the form of ionising radiation in which case they are in Class IIb,—intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,—intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;
—
intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,
—
reusable surgical instruments, in which case they are in Class I,
—
intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,
—
intended to supply energy in the form of ionising radiation in which case they are in Class IIb,
—
intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,
—
intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;

—
intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,

—
reusable surgical instruments, in which case they are in Class I,

—
intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,

—
intended to supply energy in the form of ionising radiation in which case they are in Class IIb,

—
intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,

—
intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;

(iii)
in Section 2.3, the first indent shall be replaced by the following:‘—either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;
‘—
either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;

‘—
either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;

(iv)
in Section 4.1, first paragraph, the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;

(v)
in Section 4.1, the second paragraph shall be replaced by the following:‘All devices incorporating, as an integral part, a human blood derivative are in Class III.’;

(vi)
in Section 4.3, second paragraph, the following phrase shall be added:‘unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.’;

(vii)
in Section 4.4, the words ‘Non-active devices’ shall be replaced by the word ‘Devices’;



(i)
the introductory phrase of the first paragraph of Section 2.1 shall be replaced by the following:‘All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:’;



(ii)
Section 2.2 shall be replaced by the following:‘2.2.   Rule 6All surgically invasive devices intended for transient use are in Class IIa unless they are:—intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,—reusable surgical instruments, in which case they are in Class I,—intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,—intended to supply energy in the form of ionising radiation in which case they are in Class IIb,—intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,—intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;
—
intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,
—
reusable surgical instruments, in which case they are in Class I,
—
intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,
—
intended to supply energy in the form of ionising radiation in which case they are in Class IIb,
—
intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,
—
intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;

—
intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,

—
reusable surgical instruments, in which case they are in Class I,

—
intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,

—
intended to supply energy in the form of ionising radiation in which case they are in Class IIb,

—
intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,

—
intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;



—
intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,



—
reusable surgical instruments, in which case they are in Class I,



—
intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,



—
intended to supply energy in the form of ionising radiation in which case they are in Class IIb,



—
intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,



—
intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;



(iii)
in Section 2.3, the first indent shall be replaced by the following:‘—either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;
‘—
either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;

‘—
either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;



‘—
either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;



(iv)
in Section 4.1, first paragraph, the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;



(v)
in Section 4.1, the second paragraph shall be replaced by the following:‘All devices incorporating, as an integral part, a human blood derivative are in Class III.’;



(vi)
in Section 4.3, second paragraph, the following phrase shall be added:‘unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.’;



(vii)
in Section 4.4, the words ‘Non-active devices’ shall be replaced by the word ‘Devices’;



10.
Annex X shall be amended as follows:(a)Section 1.1 shall be replaced by the following:‘1.1.As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referred to as “clinical evaluation”, where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:1.1.1.Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:—there is demonstration of equivalence of the device to the device to which the data relates, and—the data adequately demonstrate compliance with the relevant essential requirements.1.1.2.Or a critical evaluation of the results of all clinical investigations made.1.1.3.Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.’(b)The following Sections shall be inserted:‘1.1aIn the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.1.1bThe clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.1.1cThe clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.1.1dWhere demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.’;(c)in Section 2.2, the first sentence shall be replaced by the following:‘Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, as last amended by the World Medical Assembly.’;(d)Section 2.3.5 shall be replaced by the following:‘2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’.
(a)
Section 1.1 shall be replaced by the following:‘1.1.As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referred to as “clinical evaluation”, where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:1.1.1.Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:—there is demonstration of equivalence of the device to the device to which the data relates, and—the data adequately demonstrate compliance with the relevant essential requirements.1.1.2.Or a critical evaluation of the results of all clinical investigations made.1.1.3.Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.’
‘1.1.
As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referred to as “clinical evaluation”, where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:
1.1.1.
Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:—there is demonstration of equivalence of the device to the device to which the data relates, and—the data adequately demonstrate compliance with the relevant essential requirements.
—
there is demonstration of equivalence of the device to the device to which the data relates, and
—
the data adequately demonstrate compliance with the relevant essential requirements.
1.1.2.
Or a critical evaluation of the results of all clinical investigations made.
1.1.3.
Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.’
(b)
The following Sections shall be inserted:‘1.1aIn the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.1.1bThe clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.1.1cThe clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.1.1dWhere demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.’;
‘1.1a
In the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.
1.1b
The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.
1.1c
The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.
1.1d
Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.’;
(c)
in Section 2.2, the first sentence shall be replaced by the following:‘Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, as last amended by the World Medical Assembly.’;
(d)
Section 2.3.5 shall be replaced by the following:‘2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’.
‘2.3.5.
All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’.

(a)
Section 1.1 shall be replaced by the following:‘1.1.As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referred to as “clinical evaluation”, where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:1.1.1.Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:—there is demonstration of equivalence of the device to the device to which the data relates, and—the data adequately demonstrate compliance with the relevant essential requirements.1.1.2.Or a critical evaluation of the results of all clinical investigations made.1.1.3.Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.’
‘1.1.
As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referred to as “clinical evaluation”, where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:
1.1.1.
Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:—there is demonstration of equivalence of the device to the device to which the data relates, and—the data adequately demonstrate compliance with the relevant essential requirements.
—
there is demonstration of equivalence of the device to the device to which the data relates, and
—
the data adequately demonstrate compliance with the relevant essential requirements.
1.1.2.
Or a critical evaluation of the results of all clinical investigations made.
1.1.3.
Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.’

‘1.1.
As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referred to as “clinical evaluation”, where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:

1.1.1.
Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:—there is demonstration of equivalence of the device to the device to which the data relates, and—the data adequately demonstrate compliance with the relevant essential requirements.
—
there is demonstration of equivalence of the device to the device to which the data relates, and
—
the data adequately demonstrate compliance with the relevant essential requirements.

—
there is demonstration of equivalence of the device to the device to which the data relates, and

—
the data adequately demonstrate compliance with the relevant essential requirements.

1.1.2.
Or a critical evaluation of the results of all clinical investigations made.

1.1.3.
Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.’

(b)
The following Sections shall be inserted:‘1.1aIn the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.1.1bThe clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.1.1cThe clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.1.1dWhere demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.’;
‘1.1a
In the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.
1.1b
The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.
1.1c
The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.
1.1d
Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.’;

‘1.1a
In the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.

1.1b
The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.

1.1c
The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.

1.1d
Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.’;

(c)
in Section 2.2, the first sentence shall be replaced by the following:‘Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, as last amended by the World Medical Assembly.’;

(d)
Section 2.3.5 shall be replaced by the following:‘2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’.
‘2.3.5.
All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’.

‘2.3.5.
All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’.



(a)
Section 1.1 shall be replaced by the following:‘1.1.As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referred to as “clinical evaluation”, where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:1.1.1.Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:—there is demonstration of equivalence of the device to the device to which the data relates, and—the data adequately demonstrate compliance with the relevant essential requirements.1.1.2.Or a critical evaluation of the results of all clinical investigations made.1.1.3.Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.’
‘1.1.
As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referred to as “clinical evaluation”, where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:
1.1.1.
Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:—there is demonstration of equivalence of the device to the device to which the data relates, and—the data adequately demonstrate compliance with the relevant essential requirements.
—
there is demonstration of equivalence of the device to the device to which the data relates, and
—
the data adequately demonstrate compliance with the relevant essential requirements.
1.1.2.
Or a critical evaluation of the results of all clinical investigations made.
1.1.3.
Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.’

‘1.1.
As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referred to as “clinical evaluation”, where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:

1.1.1.
Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:—there is demonstration of equivalence of the device to the device to which the data relates, and—the data adequately demonstrate compliance with the relevant essential requirements.
—
there is demonstration of equivalence of the device to the device to which the data relates, and
—
the data adequately demonstrate compliance with the relevant essential requirements.

—
there is demonstration of equivalence of the device to the device to which the data relates, and

—
the data adequately demonstrate compliance with the relevant essential requirements.

1.1.2.
Or a critical evaluation of the results of all clinical investigations made.

1.1.3.
Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.’



‘1.1.
As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referred to as “clinical evaluation”, where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:



1.1.1.
Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:—there is demonstration of equivalence of the device to the device to which the data relates, and—the data adequately demonstrate compliance with the relevant essential requirements.
—
there is demonstration of equivalence of the device to the device to which the data relates, and
—
the data adequately demonstrate compliance with the relevant essential requirements.

—
there is demonstration of equivalence of the device to the device to which the data relates, and

—
the data adequately demonstrate compliance with the relevant essential requirements.



—
there is demonstration of equivalence of the device to the device to which the data relates, and



—
the data adequately demonstrate compliance with the relevant essential requirements.



1.1.2.
Or a critical evaluation of the results of all clinical investigations made.



1.1.3.
Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.’



(b)
The following Sections shall be inserted:‘1.1aIn the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.1.1bThe clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.1.1cThe clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.1.1dWhere demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.’;
‘1.1a
In the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.
1.1b
The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.
1.1c
The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.
1.1d
Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.’;

‘1.1a
In the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.

1.1b
The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.

1.1c
The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.

1.1d
Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.’;



‘1.1a
In the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.



1.1b
The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.



1.1c
The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.



1.1d
Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.’;



(c)
in Section 2.2, the first sentence shall be replaced by the following:‘Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, as last amended by the World Medical Assembly.’;



(d)
Section 2.3.5 shall be replaced by the following:‘2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’.
‘2.3.5.
All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’.

‘2.3.5.
All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’.



‘2.3.5.
All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’.

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee(1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),

(1) Council Directive 93/42/EEC(3)requires the Commission to submit a report to the Council, no later than five years from the date of implementation of that Directive, concerning: (i) information on incidents occurring following the placing of devices on the market, (ii) clinical investigation carried out in accordance with the procedure set out in Annex VIII to Directive 93/42/EEC, and (iii) design examination and EC type examination of medical devices that incorporate, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(4)and which is liable to act upon the body with action ancillary to that of the device.

(2) The Commission brought forward the conclusions of that report in its Communication to the Council and the European Parliament on medical devices which, at the request of the Member States, was expanded to cover all aspects of the Community regulatory framework for medical devices.

(3) This Communication was welcomed by the Council in its Conclusions on medical devices of 2 December 2003(5). It was also discussed by the European Parliament which on 3 June 2003 adopted a resolution on the health implications of Directive 93/42/EEC(6).

(4) Following from the conclusions drawn in that Communication it is necessary and appropriate to amend Council Directive 90/385/EEC(7), Directive 93/42/EEC and Directive 98/8/EC of the European Parliament and of the Council(8).

(5) To ensure consistency of interpretation and implementation between Directives 93/42/EEC and 90/385/EEC the legal framework related to issues such as authorised representative, the European databank, health protection measures, and the application of Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma, as introduced by Directive 2000/70/EC(9), should be extended to Directive 90/385/EEC. The application of the provisions on medical devices incorporating stable derivates of human blood or human plasma includes application of Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC(10).

(6) It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is a medical device. Software for general purposes when used in a healthcare setting is not a medical device.

(7) Particular care should be taken to ensure that the reprocessing of medical devices does not endanger patients’ safety or health. It is therefore necessary to provide clarification on the definition of the term ‘single use’, as well as to make provision for uniform labelling and instructions for use. Moreover, the Commission should engage in further analysis in order to see if additional measures are appropriate to ensure a high level of protection for patients.

(8) In the light of technical innovation and the development of initiatives at the international level it is necessary to enhance the provisions on clinical evaluation, including clarification that clinical data is generally required for all devices regardless of classification and the possibility to centralise data on clinical investigations in the European databank.

(9) In order to provide clearer evidence of the compliance of custom-made device manufacturers, an explicit requirement for a post market production review system involving incident reporting to authorities should be introduced, as is already in place for other devices, and to enhance patient information, a requirement should be introduced that the ‘Statement’ under Annex VIII to Directive 93/42/EEC should be available to the patient and that it should contain the name of the manufacturer.

(10) In the light of technical progress in information technology and medical devices, a process should be provided to allow information supplied by the manufacturer to be available by other means.

(11) Manufacturers of Class I sterile and/or measuring medical devices should be given the option of using the full quality assurance conformity assessment module in order to provide them with more flexibility in the choice of compliance modules.

(12) In order to support market surveillance activities by Member States it is necessary and appropriate, in the case of implantable devices, to increase the time period for the retention of documents for administrative purposes to at least 15 years.

(13) For the appropriate and efficient functioning of Directive 93/42/EEC as regards regulatory advice on classification issues arising at national level, in particular on whether or not a product falls under the definition of a medical device, it is in the interest of national market surveillance and the health and safety of humans to establish a procedure for decisions on whether or not a product falls under the medical device definition.

(14) To ensure that, where a manufacturer does not have a registered place of business in the Community, authorities have a single individual person authorised by the manufacturer whom they can address in matters relating to the compliance of the devices with the Directives it is necessary to introduce an obligation for such manufacturers to designate an authorised representative for a device. This designation should be effective at least for all devices of the same model.

(15) To further ensure public health and safety it is necessary to provide for a more consistent application of the provisions on health protection measures. Particular care should be taken to ensure that, when in use, the products do not endanger patients’ health or safety.

(16) In support of transparency in Community legislation, certain information related to medical devices and their conformity with Directive 93/42/EEC, in particular information on registration, on vigilance reports and on certificates, should be available to any interested party and the general public.

(17) To better coordinate the application and efficiency of national resources when applied to issues related to Directive 93/42/EEC, the Member States should cooperate with each other and at international level.

(18) As design for patient safety initiatives play an increasing role in public health policy, it is necessary to expressly set out the need to consider ergonomic design in the essential requirements. In addition the level of training and knowledge of the user, such as in the case of a lay user, should be further emphasised within the essential requirements. The manufacturer should place particular emphasis on the consequences of misuse of the product and its adverse effects on the human body.

(19) In the light of experience gained regarding activities of both the notified bodies and the authorities in the assessment of devices which require intervention of the appropriate authorities for medicines and human blood derivatives their duties and tasks should be clarified.

(20) Taking account of the growing importance of software in the field of medical devices, be it as stand alone or as software incorporated in a device, validation of software in accordance with the state of the art should be an essential requirement.

(21) In the light of the increased use of third Parties to carry out the design and manufacture of devices on behalf of the manufacturer, it is important that the manufacturer demonstrates that he applies adequate controls to the third party to continue to ensure the efficient operating of the quality system.

(22) The classification rules are based on the vulnerability of the human body taking account of the potential risks associated with the technical design and manufacture of the devices. Explicit prior authorisation with regard to conformity, including an assessment of the design documentation, is required for Class III devices to be placed on the market. In performing its duties under the quality assurance and verification conformity assessment modules for all other classes of devices, it is essential and necessary for a notified body, in order to be assured of the compliance of the manufacturer with Directive 93/42/EEC, to review the design documentation for the medical device. The depth and extent of this review should be commensurate with the classification of the device, the novelty of the intended treatment, the degree of intervention, the novelty of the technology or construction materials, and the complexity of the design and/or technology. This review can be achieved by taking a representative example of design documentation of one or more type(s) of devices from those being manufactured. Further review(s), and in particular the assessment of changes to the design that could affect conformity with the essential requirements, should be part of the surveillance activities of the notified body.

(23) It is necessary to remove the incoherence in the classification rules as a result of which invasive devices with respect to body orifices intended for connection to an active Class I medical device were not classified.

(24) The measures necessary for the implementation of Directive 90/385/EEC and Directive 93/42/EEC should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(11).

(25) In particular, power should be conferred on the Commission to adapt classification rules for medical devices, to adapt the means by which the information needed to use medical devices safely and properly may be set out, to determine conditions for making certain information publicly available, to adapt the provisions on clinical investigations set out in certain Annexes, to adopt particular requirements for placing certain medical devices on the market or putting them into service, and to take decisions to withdraw such devices from the market for reasons of protection of health or safety. Since those measures are of general scope and are designed to amend or supplement Directive 90/385/EEC and Directive 93/42/EEC by the modification or addition of non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(26) When, on imperative grounds of urgency, the normal time limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to use the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for taking decisions on withdrawal of certain medical devices from the market and for the adoption of particular requirements for placing such devices on the market or putting them into service for reasons of protection of health or safety.

(27) The Commission should give a mandate to CEN and/or Cenelec to specify technical requirements and a suitable specific label for phthalate-containing devices within 12 months after entry into force of this Directive.

(28) Many Member States have established recommendations with the aim of reducing or limiting the use of medical devices containing critical phthalates on children, pregnant and nursing women and other patients at risk. To enable medical professionals to avoid such risks, devices which possibly release phthalates to the body of the patient should be labelled accordingly.

(29) In accordance with the essential requirements on the design and manufacture of medical devices, manufacturers should avoid the use of substances that may possibly compromise the health of patients, in particular of substances which are carcinogenic, mutagenic or toxic to reproduction, and should, as appropriate, strive to develop alternative substances or products with a lower risk potential.

(30) It should be clarified that alongside Directives 90/385/EEC and 93/42/EEC, in vitro diagnostic medical devices, which are the subject of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices(12), should also be excluded from the scope of Directive 98/8/EC.

(31) In accordance with point 34 of the Interinstitutional agreement on better law-making(13), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

(32) Directives 90/385/EEC, 93/42/EEC and 98/8/EC should therefore be amended accordingly,

HAVE ADOPTED THIS DIRECTIVE:
Article 1

Directive 90/385/EEC is hereby amended as follows:

1.

Article 1 shall be amended as follows:

(a)

paragraph 2 shall be amended as follows:

(i)

point (a) shall be replaced by the following:

‘(a)

“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

—

diagnosis, prevention, monitoring, treatment or alleviation of disease,

—

diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

—

investigation, replacement or modification of the anatomy or of a physiological process,

—

control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’

(ii)

points (d), (e) and (f) shall be replaced by the following:

‘(d)

“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner’s written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;

(e)

“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.

For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;

(f)

“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’

(iii)

the following points shall be added:

‘(j)

“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this Directive;

(k)

“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:

—

clinical investigation(s) of the device concerned, or

—

clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or

—

published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;

(b)

paragraph 3 shall be replaced by the following:

‘3.   Where an active implantable medical device is intended to administer a substance defined as a medicinal product within the meaning of Article 1 of Directive 2001/83/EC(*1), that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.

(c)

paragraph 4 shall be replaced by the following:

‘4.   Where an active implantable medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device, that device shall be evaluated and authorised in accordance with this Directive.’;

(d)

the following paragraph shall be inserted:

‘4a.   Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device, hereinafter referred to as a “human blood derivative”, that device shall be assessed and authorised in accordance with this Directive.’;

(e)

paragraph 5 shall be replaced by the following:

‘5.   This Directive constitutes a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC(*2).

(f)

the following paragraph shall be added:

‘6.   This Directive shall not apply to:

(a)

medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;

(b)

human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a;

(c)

transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;

(d)

transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.’;

2.

Article 2 shall be replaced by the following:

Member States shall take all necessary steps to ensure that the devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied, properly implanted and/or properly installed, maintained and used in accordance with their intended purposes.’;

3.

Article 3 shall be replaced by the following:

The active implantable medical devices referred to in Article 1(2)(c), (d) and (e), hereinafter referred to as “devices”, shall satisfy the essential requirements set out in Annex 1 which apply to them, account being taken of the intended purpose of the devices concerned.

Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery(*3)shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex 1 to this Directive.

4.

in Article 4, paragraphs 1, 2 and 3 shall be replaced by the following:

‘1.   Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices complying with the provisions of this Directive and bearing the CE marking provided for in Article 12, which indicates that they have been the subject of an assessment of their conformity in accordance with Article 9.

2.   Member States shall not create any obstacles to:

—

devices intended for clinical investigations being made available to duly qualified medical practitioners or authorised persons for that purpose if they satisfy the conditions laid down in Article 10 and in Annex 6,

—

custom-made devices being placed on the market and put into service if they satisfy the conditions laid down in Annex 6 and are accompanied by the statement, which shall be available to the particular identified patient, referred to in that Annex.

These devices shall not bear the CE marking.

3.   At trade fairs, exhibitions, demonstrations, etc., Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that a visible sign clearly indicates that such devices do not conform and cannot be marketed or put into service until they have been made to comply by the manufacturer or his authorised representative.’;

5.

Article 5 shall be replaced by the following:

1.   Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices which are in conformity with the relevant national standards adopted pursuant to the harmonised standards the references of which have been published in the Official Journal of the European Union; Member States shall publish the references of such national standards.

2.   For the purposes of this Directive, reference to harmonised standards also includes the monographs of the European Pharmacopoeia notably on interaction between medicinal products and materials used in devices containing such medicinal products, the references of which have been published in theOfficial Journal of the European Union.’;

6.

Article 6 shall be amended as follows:

(a)

in paragraph 1 the reference ‘83/189/EEC’ shall be replaced by the reference

‘98/34/EC(*4)

(b)

paragraph 2 shall be replaced by the following:

‘2.   The Commission shall be assisted by a standing committee (hereinafter referred to as the Committee).

3.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

4.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

5.   Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;

7.

Article 8 shall be replaced by the following:

1.   Member States shall take the necessary steps to ensure that information brought to their knowledge regarding the incidents mentioned below involving a device is recorded and evaluated in a centralised manner:

(a)

any malfunction of or deterioration in the characteristics and performances of a device, as well as any inadequacy in the labelling or in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;

(b)

any technical or medical reason in relation to the characteristics or performances of a device for the reasons referred to in point (a), leading to systematic recall of devices of the same type by the manufacturer.

2.   Where a Member State requires medical practitioners or the medical institutions to inform the competent authorities of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorised representative, is also informed of the incident.

3.   After carrying out an assessment, if possible together with the manufacturer or his authorised representative, Member States shall, without prejudice to Article 7, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise the recurrence of the incidents referred to in paragraph 1, including information on the underlying incidents.

4.   The measures necessary for the implementation of this Article shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).’;

8.

Article 9 shall be amended as follows:

(a)

paragraph 8 shall be replaced by the following:

‘8.   Decisions taken by the notified bodies in accordance with Annexes 2, 3 and 5 shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both Parties, for further periods of a maximum length of five years.’;

(b)

the following paragraph shall be added:

‘10.   The measures designed to amend non-essential elements of this Directive,inter aliaby supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex 1 Section 15 may be set out shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;

9.

Article 9a shall be replaced by the following:

1.   A Member State shall submit a duly substantiated request to the Commission and ask it to take the necessary measures in the following situations:

—

that Member State considers that the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 9, by applying solely one of the given procedures chosen from among those referred to in Article 9,

—

that Member State considers that a decision is required as to whether a particular product or product group falls within the definition of Article 1(2)(a), (c), (d) or (e).

Where measures are deemed necessary pursuant to the first subparagraph of this paragraph they shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).

2.   The Commission shall inform the Member States of the measures taken.’;

10.

Article 10 shall be amended as follows:

(a)

in paragraph 1, the word ‘his’ shall be replaced by the word ‘the’.

(b)

the second subparagraph of paragraph 2 shall be replaced by the following:

‘Member States may, however, authorise manufacturers to start the clinical investigations in question before the expiry of the 60-day period, provided that the ethics committee concerned has issued a favourable opinion with respect to the investigation programme in question including its review of the clinical investigation plan.’;

(c)

paragraph 3 shall be replaced by the following:

‘3.   The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.’;

(d)

the following paragraphs shall be added:

‘4.   The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in point 2.3.7 of Annex 7 at the disposal of the competent authorities.

5.   Clinical investigations shall be conducted in accordance with the provisions of Annex 7. The measures designed to amend non-essential elements of this Directive relating to the provisions on clinical investigation in Annex 7 shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;

11.

the following Articles shall be inserted:

1.   Any manufacturer who, under his own name, places devices on the market in accordance with the procedure referred to in Article 9(2) shall inform the competent authorities of the Member State in which he has his registered place of business of the address of the registered place of business and the description of the devices concerned.

Member States may request to be informed of all data allowing for the devices to be identified together with the label and the instructions for use when the devices are put into service within their territory.

2.   Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union.

For devices referred to in the first subparagraph of paragraph 1 the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of all details as referred to in paragraph 1.

3.   The Member States shall on request inform the other Member States and the Commission of the details referred to in the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.

1.   Regulatory data in accordance with this Directive shall be stored in a European databank accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well-informed basis.

The databank shall contain the following:

(a)

data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures as laid down in Annexes 2 to 5;

(b)

data obtained in accordance with the vigilance procedure as defined in Article 8;

(c)

data relating to clinical investigations referred to in Article 10.

2.   Data shall be forwarded in a standardised format.

3.   The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in particular paragraph 1(c), shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).

Where a Member State considers in relation to a given product or group of products that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed, such products should be withdrawn from the market, or their placing on the market and putting into service should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures.

The Member State shall then inform the Commission and all the other Member States of the transitional measures, giving the reasons for its decision.

The Commission shall, whenever possible, consult the interested Parties and the Member States. The Commission shall adopt its opinion, indicating whether the national measures are justified or not. The Commission shall inform all the Member States and the consulted interested Parties.

When appropriate, the necessary measures designed to amend non-essential elements of this Directive, by supplementing it, relating to withdrawal from the market, prohibition of placing on the market and putting into service of a certain product or group of products or to restrictions or introduction of particular requirements therefor, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 6(5).’;

12.

Article 11 shall be amended as follows:

(a)

in paragraph 2, the following subparagraph shall be added: ‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex 8 to this Directive for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).’;

(b)

in paragraph 4, the words ‘agent established in the Community’ shall be replaced by the words ‘authorised representative’;

(c)

the following paragraphs shall be added:

‘5.   The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.

6.   Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or that a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer.

In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof.

The Member State shall inform the other Member States and the Commission.

7.   The notified body shall, on request, supply all relevant information and documents, including budgetary documents, required to enable the Member State to verify compliance with the criteria laid down in Annex 8.’;

13.

Article 13 shall be replaced by the following:

Without prejudice to Article 7

(a)

where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of this Directive, the manufacturer or his authorised representative established within the Community shall be obliged to end the infringement under conditions imposed by the Member State;

(b)

where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the device in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 7.

Those provisions shall also apply where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive.’;

14.

Article 14 shall be amended as follows:

(a)

the first paragraph shall be replaced by the following:

‘Any decision taken pursuant to this Directive

(a)

to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;

or

(b)

to withdraw devices from the market

shall state the exact grounds on which it is based. Such a decision shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.’;

(b)

in the second paragraph the words ‘established in the Community’ shall be deleted;

15.

Article 15 shall be replaced by the following:

1.   Without prejudice to the existing national provisions and practices on medical confidentiality, Member States shall ensure that all the Parties involved in the application of this Directive are bound to observe confidentiality with regard to all information obtained in carrying out their tasks.

This does not affect the obligations of Member States and notified bodies with regard to mutual information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law.

2.   The following information shall not be treated as confidential:

(a)

information on the registration of persons responsible for placing devices on the market in accordance with Article 10a;

(b)

information to users sent out by the manufacturer, authorised representative or distributor in relation to a measure in accordance with Article 8;

(c)

information contained in certificates issued, modified, supplemented, suspended or withdrawn.

3.   The measures designed to amend non-essential elements of this Directive,inter aliaby supplementing it, relating to the determination of the conditions under which information other than that referred to in paragraph 2, and in particular concerning any obligation for manufacturers to prepare and make available a summary of the information and data related to the device, may be made publicly available shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;

16.

the following Article shall be inserted:

Member States shall take appropriate measures to ensure that the competent authorities of the Member States cooperate with each other and with the Commission and transmit to each other the information necessary to enable this Directive to be applied uniformly.

The Commission shall provide for the organisation of an exchange of experience between the competent authorities responsible for market surveillance in order to coordinate the uniform application of this Directive.

Without prejudice to the provisions of this Directive, cooperation may be part of initiatives developed at an international level.’;

17.

Annexes 1 to 7 shall be amended in accordance with Annex I to this Directive.
Article 2

Directive 93/42/EEC is hereby amended as follows:

1.

Article 1 shall be amended as follows:

(a)

paragraph 2 shall be amended as follows:

(i)

in point (a) the introductory phrase shall be replaced by the following:

‘

                                                      “medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:’;

(ii)

in the third paragraph of point (d) the words ‘are not’ shall be replaced by the words ‘shall not be’;

(iii)

the following points shall be added:

‘(k)

“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:

—

clinical investigation(s) of the device concerned; or

—

clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or

—

published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

(l)

“device subcategory” means a set of devices having common areas of intended use or common technology;

(m)

“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;

(n)

“single use device” means a device intended to be used once only for a single patient.’;

(b)

paragraph 3 shall be replaced by the following:

‘3.   Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 2001/83/EC(*5), that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.

If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by Directive 2001/83/EC. The relevant essential requirements of Annex I to this Directive shall apply as far as safety and performance-related device features are concerned.

(c)

in paragraph 4:

(i)

the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;

(ii)

the words ‘that device must’ shall be replaced by the words ‘that device shall’;

(d)

in paragraph 4a:

(i)

the reference ‘89/381/EEC’ shall be replaced by the reference ‘2001/83/EC’;

(ii)

the words ‘that device must’ shall be replaced by the words ‘that device shall’;

(e)

paragraph 5 shall be amended as follows:

(i)

The introductory phrase shall be replaced by the following:

‘This Directive shall not apply to:’;

(ii)

point (c) shall be replaced by the following:

‘(c)

medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;

(iii)

point (f) shall be replaced by the following:

‘(f)

transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;

(f)

paragraph 6 shall be replaced by the following:

‘6.   Where a device is intended by the manufacturer to be used in accordance with both the provisions on personal protective equipment in Council Directive 89/686/EEC(*6)and this Directive, the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.

(g)

paragraphs 7 and 8 shall be replaced by the following:

‘7.   This Directive is a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC of the European Parliament and of the Council(*7).

8.   This Directive shall not affect the application of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*8), nor of Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*9).

2.

in Article 3 the following paragraph shall be added:

‘Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery(*10)shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to this Directive.

3.

the second indent of Article 4(2) shall be replaced by the following:

‘—

custom-made devices being placed on the market and put into service if they meet the conditions laid down in Article 11 in combination with Annex VIII; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII, which shall be available to the particular patient identified by name, an acronym or a numerical code.’;

4.

‘98/34/EC(*11)

5.

Article 7 shall be replaced by the following:

1.   The Commission shall be assisted by the Committee set up by Article 6(2) of Directive 90/385/EEC, hereinafter referred to as “the Committee”.

2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

4.   Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;

6.

In Article 8 paragraph 2 shall be replaced by the following:

‘2.   The Commission shall enter into consultation with the Parties concerned as soon as possible. Where, after such consultation, the Commission finds that:

(a)

the measures are justified:

(i)

it shall immediately so inform the Member State which took the measures and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the Parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the advisory procedure referred to in Article 6(2);

(ii)

when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);

(b)

the measures are unjustified, it shall immediately so inform the Member State which took the measures and the manufacturer or his authorised representative.’;

7.

In Article 9 paragraph 3 shall be replaced by the following:

‘3.   Where a Member State considers that the classification rules set out in Annex IX require adaptation in the light of technical progress and any information which becomes available under the information system provided for in Article 10, it may submit a duly substantiated request to the Commission and ask it to take the necessary measures for adaptation of classification rules. The measures designed to amend non-essential elements of this Directive relating to adaptation of classification rules shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;

8.

Article 10 shall be amended as follows:

(a)

in paragraph 2, the words ‘established in the Community’ shall be deleted;

(b)

paragraph 3 shall be replaced by the following:

‘3.   After carrying out an assessment, if possible together with the manufacturer or his authorised representative, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise the recurrence of the incidents referred to in paragraph 1, including information on the underlying incidents.’;

(c)

the following paragraph shall be added:

‘4.   Any appropriate measures to adopt procedures to implement this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;

9.

Article 11 shall be amended as follows:

(a)

in paragraphs 8 and 9 the words ‘established in the Community’ shall be deleted;

(b)

in paragraph 11, the words ‘Annexes II and III’ shall be replaced by the words ‘Annexes II, III, V and VI’ and the words ‘for further periods of five years’ shall be replaced by the words ‘for further periods of a maximum length of five years’;

(c)

the following paragraph shall be added:

‘14.   The measures designed to amend non-essential elements of this Directive, by supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex I Section 13.1 may be set out, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;

10.

Article 12 shall be amended as follows:

(a)

the title shall be replaced by ‘Particular procedure for systems and procedure packs and procedure for sterilisation’;

(b)

paragraph 3 shall be replaced by the following:

‘3.   Any natural or legal person who sterilises, for the purpose of placing on the market, systems or procedure packs referred to in paragraph 2 or other CE-marked medical devices designed by their manufacturers to be sterilised before use, shall, at his choice, follow one of the procedures referred to in Annex II or V. The application of the abovementioned Annexes and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged. The person shall draw up a declaration stating that sterilisation has been carried out in accordance with the manufacturer’s instructions.’;

(c)

in paragraph 4, the third sentence shall be replaced by the following:

‘The declarations referred to in paragraphs 2 and 3 shall be kept at the disposal of the competent authorities for a period of five years.’;

11.

The following Article shall be inserted:

The Commission shall, no later than 5 September 2010, submit a report to the European Parliament and to the Council on the issue of the reprocessing of medical devices in the Community.

In the light of the findings of this report, the Commission shall submit to the European Parliament and to the Council any additional proposal it may deem appropriate in order to ensure a high level of health protection.’

12.

Article 13 shall be replaced by the following:

1.   A Member State shall submit a duly substantiated request to the Commission and ask it to take the necessary measures in the following situations:

(a)

that Member State considers that the application of the classification rules set out in Annex IX requires a decision with regard to the classification of a given device or category of devices;

(b)

that Member State considers that a given device or family of devices should, by way of derogation from the provisions of Annex IX, be classified in another class;

(c)

that Member State considers that the conformity of a device or family of devices should, by way of derogation from Article 11, be established by applying solely one of the given procedures chosen from among those referred to in Article 11;

(d)

that Member State considers that a decision is required as to whether a particular product or product group falls within one of the definitions in Article 1(2)(a) to (e).

The measures referred to in the first subparagraph of this paragraph shall, as appropriate, be adopted in accordance with the procedure referred to in Article 7(2).

2.   The Commission shall inform the Member States of the measures taken.’;

13.

Article 14 shall be amended as follows:

(a)

in the second subparagraph of paragraph 1, the words ‘Classes IIb and III’ shall be replaced by the words ‘Classes IIa, IIb and III’;

(b)

paragraph 2 shall be replaced by the following:

‘2.   Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union. For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.’;

(c)

paragraph 3 shall be replaced by the following:

‘3.   The Member States shall on request inform the other Member States and the Commission of the details referred to in the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.’;

14.

Article 14a shall be amended as follows:

(a)

the second subparagraph of paragraph 1 shall be amended as follows:

(i)

point (a) shall be replaced by the following:

‘(a)

data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;

(ii)

the following point shall be added:

‘(d)

data relating to clinical investigations referred to in Article 15;’;

(b)

paragraph 3 shall be replaced by the following:

‘3.   The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in particular paragraph 1(d), shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’

(c)

the following paragraph shall be added:

‘4.   The provisions of this Article shall be implemented no later than 5 September 2012. The Commission shall, no later than 11 October 2012, evaluate the operational functioning and the added value of the databank. On the basis of this evaluation, the Commission shall, if appropriate, present proposals to the European Parliament and the Council or present draft measures in accordance with paragraph 3.’;

15.

Article 14b shall be replaced by the following:

Where a Member State considers, in relation to a given product or group of products, that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed, such products should be withdrawn from the market, or their placing on the market and putting into service should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures.

The Member State shall then inform the Commission and all other Member States, giving the reasons for its decision.

The Commission shall, whenever possible, consult the interested Parties and the Member States.

The Commission shall adopt its opinion, indicating whether the national measures are justified or not. The Commission shall inform all the Member States and the consulted interested Parties thereof.

When appropriate, the necessary measures designed to amend non-essential elements of this Directive, relating to withdrawal from the market, prohibition of placing on the market and putting into service of a certain product or group of products or to restrictions or introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4).’;

16.

Article 15 shall be amended as follows:

(a)

paragraphs 1, 2 and 3 shall be replaced by the following:

‘1.   In the case of devices intended for clinical investigations, the manufacturer or the authorised representative, established in the Community, shall follow the procedure referred to in Annex VIII and notify the competent authorities of the Member States in which the investigations are to be conducted by means of the statement mentioned in Section 2.2 of Annex VIII.

2.   In the case of devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of 60 days after notification, unless the competent authorities have notified him within that period of a decision to the contrary based on considerations of public health or public policy.

Member States may however authorise manufacturers to commence the relevant clinical investigations before the expiry of the period of 60 days, insofar as the relevant ethics committee has issued a favourable opinion on the programme of investigation in question, including its review of the clinical investigation plan.

3.   In the case of devices other than those referred to in paragraph 2, Member States may authorise manufacturers to commence clinical investigations immediately after the date of notification, provided that the ethics committee concerned has issued a favourable opinion on the programme of investigation in question including its review of the clinical investigation plan.’;

(b)

paragraphs 5, 6 and 7 shall be replaced by the following:

‘5.   The clinical investigations must be conducted in accordance with the provisions of Annex X. The measures designed to amend non-essential elements of this Directive, inter alia by supplementing it, relating to the provisions on clinical investigation in Annex X shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).

6.   The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.

7.   The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in Section 2.3.7 of Annex X at the disposal of the competent authorities.’;

17.

Article 16 shall be amended as follows:

(a)

the following subparagraph shall be added to paragraph 2:

‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex XI for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;

(b)

in paragraph 4, the words ‘established in the Community’ shall be deleted;

(c)

paragraph 5 shall be replaced by the following:

‘5.   The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.’;

18.

in Article 18 point (a) shall be replaced by the following:

‘(a)

where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of the Directive, the manufacturer or his authorised representative shall be obliged to end the infringement under conditions imposed by the Member State;’;

19.

in Article 19(2), the words ‘established in the Community’ shall be deleted;

20.

Article 20 shall be replaced by the following:

1.   Without prejudice to the existing national provisions and practices on medical confidentiality, Member States shall ensure that all the Parties involved in the application of this Directive are bound to observe confidentiality with regard to all information obtained in carrying out their tasks.

This does not affect the obligation of Member States and notified bodies with regard to mutual information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law.

2.   The following information shall not be treated as confidential:

(a)

information on the registration of persons responsible for placing devices on the market in accordance with Article 14;

(b)

information to users sent out by the manufacturer, authorised representative or distributor in relation to a measure according to Article 10(3);

(c)

information contained in certificates issued, modified, supplemented, suspended or withdrawn.

3.   The measures designed to amend non-essential elements of this Directive,inter aliaby supplementing it, relating to determination of the conditions under which other information may be made publicly available, and in particular for Class IIb and Class III devices to any obligation for manufacturers to prepare and make available a summary of the information and data related to the device, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;

21.

the following Article shall be inserted:

Member States shall take appropriate measures to ensure that the competent authorities of the Member States cooperate with each other and with the Commission and transmit to each other the information necessary to enable this Directive to be applied uniformly.

The Commission shall provide for the organisation of an exchange of experience between the competent authorities responsible for market surveillance in order to coordinate the uniform application of this Directive.

Without prejudice to the provisions of this Directive, cooperation may be part of initiatives developed at an international level.’;

22.

Annexes I to X shall be amended in accordance with Annex II to this Directive.
Article 3

In Article 1(2) of Directive 98/8/EC the following point shall be added:

‘(s)

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices(*12).
Article 4

1.   Member States shall adopt and publish by 21 December 2008 the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those measures.

They shall apply those measures from 21 March 2010.

When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 5

This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.
Article 6

This Directive is addressed to the Member States.
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee(1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),

(1) Council Directive 93/42/EEC(3)requires the Commission to submit a report to the Council, no later than five years from the date of implementation of that Directive, concerning: (i) information on incidents occurring following the placing of devices on the market, (ii) clinical investigation carried out in accordance with the procedure set out in Annex VIII to Directive 93/42/EEC, and (iii) design examination and EC type examination of medical devices that incorporate, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(4)and which is liable to act upon the body with action ancillary to that of the device.

(2) The Commission brought forward the conclusions of that report in its Communication to the Council and the European Parliament on medical devices which, at the request of the Member States, was expanded to cover all aspects of the Community regulatory framework for medical devices.

(3) This Communication was welcomed by the Council in its Conclusions on medical devices of 2 December 2003(5). It was also discussed by the European Parliament which on 3 June 2003 adopted a resolution on the health implications of Directive 93/42/EEC(6).

(4) Following from the conclusions drawn in that Communication it is necessary and appropriate to amend Council Directive 90/385/EEC(7), Directive 93/42/EEC and Directive 98/8/EC of the European Parliament and of the Council(8).

(5) To ensure consistency of interpretation and implementation between Directives 93/42/EEC and 90/385/EEC the legal framework related to issues such as authorised representative, the European databank, health protection measures, and the application of Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma, as introduced by Directive 2000/70/EC(9), should be extended to Directive 90/385/EEC. The application of the provisions on medical devices incorporating stable derivates of human blood or human plasma includes application of Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC(10).

(6) It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is a medical device. Software for general purposes when used in a healthcare setting is not a medical device.

(7) Particular care should be taken to ensure that the reprocessing of medical devices does not endanger patients’ safety or health. It is therefore necessary to provide clarification on the definition of the term ‘single use’, as well as to make provision for uniform labelling and instructions for use. Moreover, the Commission should engage in further analysis in order to see if additional measures are appropriate to ensure a high level of protection for patients.

(8) In the light of technical innovation and the development of initiatives at the international level it is necessary to enhance the provisions on clinical evaluation, including clarification that clinical data is generally required for all devices regardless of classification and the possibility to centralise data on clinical investigations in the European databank.

(9) In order to provide clearer evidence of the compliance of custom-made device manufacturers, an explicit requirement for a post market production review system involving incident reporting to authorities should be introduced, as is already in place for other devices, and to enhance patient information, a requirement should be introduced that the ‘Statement’ under Annex VIII to Directive 93/42/EEC should be available to the patient and that it should contain the name of the manufacturer.

(10) In the light of technical progress in information technology and medical devices, a process should be provided to allow information supplied by the manufacturer to be available by other means.

(11) Manufacturers of Class I sterile and/or measuring medical devices should be given the option of using the full quality assurance conformity assessment module in order to provide them with more flexibility in the choice of compliance modules.

(12) In order to support market surveillance activities by Member States it is necessary and appropriate, in the case of implantable devices, to increase the time period for the retention of documents for administrative purposes to at least 15 years.

(13) For the appropriate and efficient functioning of Directive 93/42/EEC as regards regulatory advice on classification issues arising at national level, in particular on whether or not a product falls under the definition of a medical device, it is in the interest of national market surveillance and the health and safety of humans to establish a procedure for decisions on whether or not a product falls under the medical device definition.

(14) To ensure that, where a manufacturer does not have a registered place of business in the Community, authorities have a single individual person authorised by the manufacturer whom they can address in matters relating to the compliance of the devices with the Directives it is necessary to introduce an obligation for such manufacturers to designate an authorised representative for a device. This designation should be effective at least for all devices of the same model.

(15) To further ensure public health and safety it is necessary to provide for a more consistent application of the provisions on health protection measures. Particular care should be taken to ensure that, when in use, the products do not endanger patients’ health or safety.

(16) In support of transparency in Community legislation, certain information related to medical devices and their conformity with Directive 93/42/EEC, in particular information on registration, on vigilance reports and on certificates, should be available to any interested party and the general public.

(17) To better coordinate the application and efficiency of national resources when applied to issues related to Directive 93/42/EEC, the Member States should cooperate with each other and at international level.

(18) As design for patient safety initiatives play an increasing role in public health policy, it is necessary to expressly set out the need to consider ergonomic design in the essential requirements. In addition the level of training and knowledge of the user, such as in the case of a lay user, should be further emphasised within the essential requirements. The manufacturer should place particular emphasis on the consequences of misuse of the product and its adverse effects on the human body.

(19) In the light of experience gained regarding activities of both the notified bodies and the authorities in the assessment of devices which require intervention of the appropriate authorities for medicines and human blood derivatives their duties and tasks should be clarified.

(20) Taking account of the growing importance of software in the field of medical devices, be it as stand alone or as software incorporated in a device, validation of software in accordance with the state of the art should be an essential requirement.

(21) In the light of the increased use of third Parties to carry out the design and manufacture of devices on behalf of the manufacturer, it is important that the manufacturer demonstrates that he applies adequate controls to the third party to continue to ensure the efficient operating of the quality system.

(22) The classification rules are based on the vulnerability of the human body taking account of the potential risks associated with the technical design and manufacture of the devices. Explicit prior authorisation with regard to conformity, including an assessment of the design documentation, is required for Class III devices to be placed on the market. In performing its duties under the quality assurance and verification conformity assessment modules for all other classes of devices, it is essential and necessary for a notified body, in order to be assured of the compliance of the manufacturer with Directive 93/42/EEC, to review the design documentation for the medical device. The depth and extent of this review should be commensurate with the classification of the device, the novelty of the intended treatment, the degree of intervention, the novelty of the technology or construction materials, and the complexity of the design and/or technology. This review can be achieved by taking a representative example of design documentation of one or more type(s) of devices from those being manufactured. Further review(s), and in particular the assessment of changes to the design that could affect conformity with the essential requirements, should be part of the surveillance activities of the notified body.

(23) It is necessary to remove the incoherence in the classification rules as a result of which invasive devices with respect to body orifices intended for connection to an active Class I medical device were not classified.

(24) The measures necessary for the implementation of Directive 90/385/EEC and Directive 93/42/EEC should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(11).

(25) In particular, power should be conferred on the Commission to adapt classification rules for medical devices, to adapt the means by which the information needed to use medical devices safely and properly may be set out, to determine conditions for making certain information publicly available, to adapt the provisions on clinical investigations set out in certain Annexes, to adopt particular requirements for placing certain medical devices on the market or putting them into service, and to take decisions to withdraw such devices from the market for reasons of protection of health or safety. Since those measures are of general scope and are designed to amend or supplement Directive 90/385/EEC and Directive 93/42/EEC by the modification or addition of non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(26) When, on imperative grounds of urgency, the normal time limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to use the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for taking decisions on withdrawal of certain medical devices from the market and for the adoption of particular requirements for placing such devices on the market or putting them into service for reasons of protection of health or safety.

(27) The Commission should give a mandate to CEN and/or Cenelec to specify technical requirements and a suitable specific label for phthalate-containing devices within 12 months after entry into force of this Directive.

(28) Many Member States have established recommendations with the aim of reducing or limiting the use of medical devices containing critical phthalates on children, pregnant and nursing women and other patients at risk. To enable medical professionals to avoid such risks, devices which possibly release phthalates to the body of the patient should be labelled accordingly.

(29) In accordance with the essential requirements on the design and manufacture of medical devices, manufacturers should avoid the use of substances that may possibly compromise the health of patients, in particular of substances which are carcinogenic, mutagenic or toxic to reproduction, and should, as appropriate, strive to develop alternative substances or products with a lower risk potential.

(30) It should be clarified that alongside Directives 90/385/EEC and 93/42/EEC, in vitro diagnostic medical devices, which are the subject of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices(12), should also be excluded from the scope of Directive 98/8/EC.

(31) In accordance with point 34 of the Interinstitutional agreement on better law-making(13), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

(32) Directives 90/385/EEC, 93/42/EEC and 98/8/EC should therefore be amended accordingly,

HAVE ADOPTED THIS DIRECTIVE:
Directive 90/385/EEC is hereby amended as follows:

1.

Article 1 shall be amended as follows:

(a)

paragraph 2 shall be amended as follows:

(i)

point (a) shall be replaced by the following:

‘(a)

“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

—

diagnosis, prevention, monitoring, treatment or alleviation of disease,

—

diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

—

investigation, replacement or modification of the anatomy or of a physiological process,

—

control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’

(ii)

points (d), (e) and (f) shall be replaced by the following:

‘(d)

“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner’s written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;

(e)

“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.

For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;

(f)

“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’

(iii)

the following points shall be added:

‘(j)

“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this Directive;

(k)

“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:

—

clinical investigation(s) of the device concerned, or

—

clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or

—

published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;

(b)

paragraph 3 shall be replaced by the following:

‘3.   Where an active implantable medical device is intended to administer a substance defined as a medicinal product within the meaning of Article 1 of Directive 2001/83/EC(*1), that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.

(c)

paragraph 4 shall be replaced by the following:

‘4.   Where an active implantable medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device, that device shall be evaluated and authorised in accordance with this Directive.’;

(d)

the following paragraph shall be inserted:

‘4a.   Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device, hereinafter referred to as a “human blood derivative”, that device shall be assessed and authorised in accordance with this Directive.’;

(e)

paragraph 5 shall be replaced by the following:

‘5.   This Directive constitutes a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC(*2).

(f)

the following paragraph shall be added:

‘6.   This Directive shall not apply to:

(a)

medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;

(b)

human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a;

(c)

transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;

(d)

transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.’;

2.

Article 2 shall be replaced by the following:

Member States shall take all necessary steps to ensure that the devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied, properly implanted and/or properly installed, maintained and used in accordance with their intended purposes.’;

3.

Article 3 shall be replaced by the following:

The active implantable medical devices referred to in Article 1(2)(c), (d) and (e), hereinafter referred to as “devices”, shall satisfy the essential requirements set out in Annex 1 which apply to them, account being taken of the intended purpose of the devices concerned.

Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery(*3)shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex 1 to this Directive.

4.

in Article 4, paragraphs 1, 2 and 3 shall be replaced by the following:

‘1.   Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices complying with the provisions of this Directive and bearing the CE marking provided for in Article 12, which indicates that they have been the subject of an assessment of their conformity in accordance with Article 9.

2.   Member States shall not create any obstacles to:

—

devices intended for clinical investigations being made available to duly qualified medical practitioners or authorised persons for that purpose if they satisfy the conditions laid down in Article 10 and in Annex 6,

—

custom-made devices being placed on the market and put into service if they satisfy the conditions laid down in Annex 6 and are accompanied by the statement, which shall be available to the particular identified patient, referred to in that Annex.

These devices shall not bear the CE marking.

3.   At trade fairs, exhibitions, demonstrations, etc., Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that a visible sign clearly indicates that such devices do not conform and cannot be marketed or put into service until they have been made to comply by the manufacturer or his authorised representative.’;

5.

Article 5 shall be replaced by the following:

1.   Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices which are in conformity with the relevant national standards adopted pursuant to the harmonised standards the references of which have been published in the Official Journal of the European Union; Member States shall publish the references of such national standards.

2.   For the purposes of this Directive, reference to harmonised standards also includes the monographs of the European Pharmacopoeia notably on interaction between medicinal products and materials used in devices containing such medicinal products, the references of which have been published in theOfficial Journal of the European Union.’;

6.

Article 6 shall be amended as follows:

(a)

in paragraph 1 the reference ‘83/189/EEC’ shall be replaced by the reference

‘98/34/EC(*4)

(b)

paragraph 2 shall be replaced by the following:

‘2.   The Commission shall be assisted by a standing committee (hereinafter referred to as the Committee).

3.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

4.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

5.   Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;

7.

Article 8 shall be replaced by the following:

1.   Member States shall take the necessary steps to ensure that information brought to their knowledge regarding the incidents mentioned below involving a device is recorded and evaluated in a centralised manner:

(a)

any malfunction of or deterioration in the characteristics and performances of a device, as well as any inadequacy in the labelling or in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;

(b)

any technical or medical reason in relation to the characteristics or performances of a device for the reasons referred to in point (a), leading to systematic recall of devices of the same type by the manufacturer.

2.   Where a Member State requires medical practitioners or the medical institutions to inform the competent authorities of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorised representative, is also informed of the incident.

3.   After carrying out an assessment, if possible together with the manufacturer or his authorised representative, Member States shall, without prejudice to Article 7, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise the recurrence of the incidents referred to in paragraph 1, including information on the underlying incidents.

4.   The measures necessary for the implementation of this Article shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).’;

8.

Article 9 shall be amended as follows:

(a)

paragraph 8 shall be replaced by the following:

‘8.   Decisions taken by the notified bodies in accordance with Annexes 2, 3 and 5 shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both Parties, for further periods of a maximum length of five years.’;

(b)

the following paragraph shall be added:

‘10.   The measures designed to amend non-essential elements of this Directive,inter aliaby supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex 1 Section 15 may be set out shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;

9.

Article 9a shall be replaced by the following:

1.   A Member State shall submit a duly substantiated request to the Commission and ask it to take the necessary measures in the following situations:

—

that Member State considers that the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 9, by applying solely one of the given procedures chosen from among those referred to in Article 9,

—

that Member State considers that a decision is required as to whether a particular product or product group falls within the definition of Article 1(2)(a), (c), (d) or (e).

Where measures are deemed necessary pursuant to the first subparagraph of this paragraph they shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).

2.   The Commission shall inform the Member States of the measures taken.’;

10.

Article 10 shall be amended as follows:

(a)

in paragraph 1, the word ‘his’ shall be replaced by the word ‘the’.

(b)

the second subparagraph of paragraph 2 shall be replaced by the following:

‘Member States may, however, authorise manufacturers to start the clinical investigations in question before the expiry of the 60-day period, provided that the ethics committee concerned has issued a favourable opinion with respect to the investigation programme in question including its review of the clinical investigation plan.’;

(c)

paragraph 3 shall be replaced by the following:

‘3.   The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.’;

(d)

the following paragraphs shall be added:

‘4.   The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in point 2.3.7 of Annex 7 at the disposal of the competent authorities.

5.   Clinical investigations shall be conducted in accordance with the provisions of Annex 7. The measures designed to amend non-essential elements of this Directive relating to the provisions on clinical investigation in Annex 7 shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;

11.

the following Articles shall be inserted:

1.   Any manufacturer who, under his own name, places devices on the market in accordance with the procedure referred to in Article 9(2) shall inform the competent authorities of the Member State in which he has his registered place of business of the address of the registered place of business and the description of the devices concerned.

Member States may request to be informed of all data allowing for the devices to be identified together with the label and the instructions for use when the devices are put into service within their territory.

2.   Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union.

For devices referred to in the first subparagraph of paragraph 1 the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of all details as referred to in paragraph 1.

3.   The Member States shall on request inform the other Member States and the Commission of the details referred to in the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.

1.   Regulatory data in accordance with this Directive shall be stored in a European databank accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well-informed basis.

The databank shall contain the following:

(a)

data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures as laid down in Annexes 2 to 5;

(b)

data obtained in accordance with the vigilance procedure as defined in Article 8;

(c)

data relating to clinical investigations referred to in Article 10.

2.   Data shall be forwarded in a standardised format.

3.   The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in particular paragraph 1(c), shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).

Where a Member State considers in relation to a given product or group of products that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed, such products should be withdrawn from the market, or their placing on the market and putting into service should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures.

The Member State shall then inform the Commission and all the other Member States of the transitional measures, giving the reasons for its decision.

The Commission shall, whenever possible, consult the interested Parties and the Member States. The Commission shall adopt its opinion, indicating whether the national measures are justified or not. The Commission shall inform all the Member States and the consulted interested Parties.

When appropriate, the necessary measures designed to amend non-essential elements of this Directive, by supplementing it, relating to withdrawal from the market, prohibition of placing on the market and putting into service of a certain product or group of products or to restrictions or introduction of particular requirements therefor, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 6(5).’;

12.

Article 11 shall be amended as follows:

(a)

in paragraph 2, the following subparagraph shall be added: ‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex 8 to this Directive for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).’;

(b)

in paragraph 4, the words ‘agent established in the Community’ shall be replaced by the words ‘authorised representative’;

(c)

the following paragraphs shall be added:

‘5.   The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.

6.   Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or that a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer.

In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof.

The Member State shall inform the other Member States and the Commission.

7.   The notified body shall, on request, supply all relevant information and documents, including budgetary documents, required to enable the Member State to verify compliance with the criteria laid down in Annex 8.’;

13.

Article 13 shall be replaced by the following:

Without prejudice to Article 7

(a)

where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of this Directive, the manufacturer or his authorised representative established within the Community shall be obliged to end the infringement under conditions imposed by the Member State;

(b)

where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the device in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 7.

Those provisions shall also apply where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive.’;

14.

Article 14 shall be amended as follows:

(a)

the first paragraph shall be replaced by the following:

‘Any decision taken pursuant to this Directive

(a)

to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;

or

(b)

to withdraw devices from the market

shall state the exact grounds on which it is based. Such a decision shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.’;

(b)

in the second paragraph the words ‘established in the Community’ shall be deleted;

15.

Article 15 shall be replaced by the following:

1.   Without prejudice to the existing national provisions and practices on medical confidentiality, Member States shall ensure that all the Parties involved in the application of this Directive are bound to observe confidentiality with regard to all information obtained in carrying out their tasks.

This does not affect the obligations of Member States and notified bodies with regard to mutual information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law.

2.   The following information shall not be treated as confidential:

(a)

information on the registration of persons responsible for placing devices on the market in accordance with Article 10a;

(b)

information to users sent out by the manufacturer, authorised representative or distributor in relation to a measure in accordance with Article 8;

(c)

information contained in certificates issued, modified, supplemented, suspended or withdrawn.

3.   The measures designed to amend non-essential elements of this Directive,inter aliaby supplementing it, relating to the determination of the conditions under which information other than that referred to in paragraph 2, and in particular concerning any obligation for manufacturers to prepare and make available a summary of the information and data related to the device, may be made publicly available shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;

16.

the following Article shall be inserted:

Member States shall take appropriate measures to ensure that the competent authorities of the Member States cooperate with each other and with the Commission and transmit to each other the information necessary to enable this Directive to be applied uniformly.

The Commission shall provide for the organisation of an exchange of experience between the competent authorities responsible for market surveillance in order to coordinate the uniform application of this Directive.

Without prejudice to the provisions of this Directive, cooperation may be part of initiatives developed at an international level.’;

17.

Annexes 1 to 7 shall be amended in accordance with Annex I to this Directive.
Directive 93/42/EEC is hereby amended as follows:

1.

Article 1 shall be amended as follows:

(a)

paragraph 2 shall be amended as follows:

(i)

in point (a) the introductory phrase shall be replaced by the following:

‘

                                                      “medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:’;

(ii)

in the third paragraph of point (d) the words ‘are not’ shall be replaced by the words ‘shall not be’;

(iii)

the following points shall be added:

‘(k)

“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:

—

clinical investigation(s) of the device concerned; or

—

clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or

—

published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

(l)

“device subcategory” means a set of devices having common areas of intended use or common technology;

(m)

“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;

(n)

“single use device” means a device intended to be used once only for a single patient.’;

(b)

paragraph 3 shall be replaced by the following:

‘3.   Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 2001/83/EC(*5), that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.

If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by Directive 2001/83/EC. The relevant essential requirements of Annex I to this Directive shall apply as far as safety and performance-related device features are concerned.

(c)

in paragraph 4:

(i)

the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;

(ii)

the words ‘that device must’ shall be replaced by the words ‘that device shall’;

(d)

in paragraph 4a:

(i)

the reference ‘89/381/EEC’ shall be replaced by the reference ‘2001/83/EC’;

(ii)

the words ‘that device must’ shall be replaced by the words ‘that device shall’;

(e)

paragraph 5 shall be amended as follows:

(i)

The introductory phrase shall be replaced by the following:

‘This Directive shall not apply to:’;

(ii)

point (c) shall be replaced by the following:

‘(c)

medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;

(iii)

point (f) shall be replaced by the following:

‘(f)

transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;

(f)

paragraph 6 shall be replaced by the following:

‘6.   Where a device is intended by the manufacturer to be used in accordance with both the provisions on personal protective equipment in Council Directive 89/686/EEC(*6)and this Directive, the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.

(g)

paragraphs 7 and 8 shall be replaced by the following:

‘7.   This Directive is a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC of the European Parliament and of the Council(*7).

8.   This Directive shall not affect the application of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*8), nor of Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*9).

2.

in Article 3 the following paragraph shall be added:

‘Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery(*10)shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to this Directive.

3.

the second indent of Article 4(2) shall be replaced by the following:

‘—

custom-made devices being placed on the market and put into service if they meet the conditions laid down in Article 11 in combination with Annex VIII; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII, which shall be available to the particular patient identified by name, an acronym or a numerical code.’;

4.

‘98/34/EC(*11)

5.

Article 7 shall be replaced by the following:

1.   The Commission shall be assisted by the Committee set up by Article 6(2) of Directive 90/385/EEC, hereinafter referred to as “the Committee”.

2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

4.   Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;

6.

In Article 8 paragraph 2 shall be replaced by the following:

‘2.   The Commission shall enter into consultation with the Parties concerned as soon as possible. Where, after such consultation, the Commission finds that:

(a)

the measures are justified:

(i)

it shall immediately so inform the Member State which took the measures and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the Parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the advisory procedure referred to in Article 6(2);

(ii)

when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);

(b)

the measures are unjustified, it shall immediately so inform the Member State which took the measures and the manufacturer or his authorised representative.’;

7.

In Article 9 paragraph 3 shall be replaced by the following:

‘3.   Where a Member State considers that the classification rules set out in Annex IX require adaptation in the light of technical progress and any information which becomes available under the information system provided for in Article 10, it may submit a duly substantiated request to the Commission and ask it to take the necessary measures for adaptation of classification rules. The measures designed to amend non-essential elements of this Directive relating to adaptation of classification rules shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;

8.

Article 10 shall be amended as follows:

(a)

in paragraph 2, the words ‘established in the Community’ shall be deleted;

(b)

paragraph 3 shall be replaced by the following:

‘3.   After carrying out an assessment, if possible together with the manufacturer or his authorised representative, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise the recurrence of the incidents referred to in paragraph 1, including information on the underlying incidents.’;

(c)

the following paragraph shall be added:

‘4.   Any appropriate measures to adopt procedures to implement this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;

9.

Article 11 shall be amended as follows:

(a)

in paragraphs 8 and 9 the words ‘established in the Community’ shall be deleted;

(b)

in paragraph 11, the words ‘Annexes II and III’ shall be replaced by the words ‘Annexes II, III, V and VI’ and the words ‘for further periods of five years’ shall be replaced by the words ‘for further periods of a maximum length of five years’;

(c)

the following paragraph shall be added:

‘14.   The measures designed to amend non-essential elements of this Directive, by supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex I Section 13.1 may be set out, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;

10.

Article 12 shall be amended as follows:

(a)

the title shall be replaced by ‘Particular procedure for systems and procedure packs and procedure for sterilisation’;

(b)

paragraph 3 shall be replaced by the following:

‘3.   Any natural or legal person who sterilises, for the purpose of placing on the market, systems or procedure packs referred to in paragraph 2 or other CE-marked medical devices designed by their manufacturers to be sterilised before use, shall, at his choice, follow one of the procedures referred to in Annex II or V. The application of the abovementioned Annexes and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged. The person shall draw up a declaration stating that sterilisation has been carried out in accordance with the manufacturer’s instructions.’;

(c)

in paragraph 4, the third sentence shall be replaced by the following:

‘The declarations referred to in paragraphs 2 and 3 shall be kept at the disposal of the competent authorities for a period of five years.’;

11.

The following Article shall be inserted:

The Commission shall, no later than 5 September 2010, submit a report to the European Parliament and to the Council on the issue of the reprocessing of medical devices in the Community.

In the light of the findings of this report, the Commission shall submit to the European Parliament and to the Council any additional proposal it may deem appropriate in order to ensure a high level of health protection.’

12.

Article 13 shall be replaced by the following:

1.   A Member State shall submit a duly substantiated request to the Commission and ask it to take the necessary measures in the following situations:

(a)

that Member State considers that the application of the classification rules set out in Annex IX requires a decision with regard to the classification of a given device or category of devices;

(b)

that Member State considers that a given device or family of devices should, by way of derogation from the provisions of Annex IX, be classified in another class;

(c)

that Member State considers that the conformity of a device or family of devices should, by way of derogation from Article 11, be established by applying solely one of the given procedures chosen from among those referred to in Article 11;

(d)

that Member State considers that a decision is required as to whether a particular product or product group falls within one of the definitions in Article 1(2)(a) to (e).

The measures referred to in the first subparagraph of this paragraph shall, as appropriate, be adopted in accordance with the procedure referred to in Article 7(2).

2.   The Commission shall inform the Member States of the measures taken.’;

13.

Article 14 shall be amended as follows:

(a)

in the second subparagraph of paragraph 1, the words ‘Classes IIb and III’ shall be replaced by the words ‘Classes IIa, IIb and III’;

(b)

paragraph 2 shall be replaced by the following:

‘2.   Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union. For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.’;

(c)

paragraph 3 shall be replaced by the following:

‘3.   The Member States shall on request inform the other Member States and the Commission of the details referred to in the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.’;

14.

Article 14a shall be amended as follows:

(a)

the second subparagraph of paragraph 1 shall be amended as follows:

(i)

point (a) shall be replaced by the following:

‘(a)

data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;

(ii)

the following point shall be added:

‘(d)

data relating to clinical investigations referred to in Article 15;’;

(b)

paragraph 3 shall be replaced by the following:

‘3.   The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in particular paragraph 1(d), shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’

(c)

the following paragraph shall be added:

‘4.   The provisions of this Article shall be implemented no later than 5 September 2012. The Commission shall, no later than 11 October 2012, evaluate the operational functioning and the added value of the databank. On the basis of this evaluation, the Commission shall, if appropriate, present proposals to the European Parliament and the Council or present draft measures in accordance with paragraph 3.’;

15.

Article 14b shall be replaced by the following:

Where a Member State considers, in relation to a given product or group of products, that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed, such products should be withdrawn from the market, or their placing on the market and putting into service should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures.

The Member State shall then inform the Commission and all other Member States, giving the reasons for its decision.

The Commission shall, whenever possible, consult the interested Parties and the Member States.

The Commission shall adopt its opinion, indicating whether the national measures are justified or not. The Commission shall inform all the Member States and the consulted interested Parties thereof.

When appropriate, the necessary measures designed to amend non-essential elements of this Directive, relating to withdrawal from the market, prohibition of placing on the market and putting into service of a certain product or group of products or to restrictions or introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4).’;

16.

Article 15 shall be amended as follows:

(a)

paragraphs 1, 2 and 3 shall be replaced by the following:

‘1.   In the case of devices intended for clinical investigations, the manufacturer or the authorised representative, established in the Community, shall follow the procedure referred to in Annex VIII and notify the competent authorities of the Member States in which the investigations are to be conducted by means of the statement mentioned in Section 2.2 of Annex VIII.

2.   In the case of devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of 60 days after notification, unless the competent authorities have notified him within that period of a decision to the contrary based on considerations of public health or public policy.

Member States may however authorise manufacturers to commence the relevant clinical investigations before the expiry of the period of 60 days, insofar as the relevant ethics committee has issued a favourable opinion on the programme of investigation in question, including its review of the clinical investigation plan.

3.   In the case of devices other than those referred to in paragraph 2, Member States may authorise manufacturers to commence clinical investigations immediately after the date of notification, provided that the ethics committee concerned has issued a favourable opinion on the programme of investigation in question including its review of the clinical investigation plan.’;

(b)

paragraphs 5, 6 and 7 shall be replaced by the following:

‘5.   The clinical investigations must be conducted in accordance with the provisions of Annex X. The measures designed to amend non-essential elements of this Directive, inter alia by supplementing it, relating to the provisions on clinical investigation in Annex X shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).

6.   The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.

7.   The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in Section 2.3.7 of Annex X at the disposal of the competent authorities.’;

17.

Article 16 shall be amended as follows:

(a)

the following subparagraph shall be added to paragraph 2:

‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex XI for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;

(b)

in paragraph 4, the words ‘established in the Community’ shall be deleted;

(c)

paragraph 5 shall be replaced by the following:

‘5.   The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.’;

18.

in Article 18 point (a) shall be replaced by the following:

‘(a)

where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of the Directive, the manufacturer or his authorised representative shall be obliged to end the infringement under conditions imposed by the Member State;’;

19.

in Article 19(2), the words ‘established in the Community’ shall be deleted;

20.

Article 20 shall be replaced by the following:

1.   Without prejudice to the existing national provisions and practices on medical confidentiality, Member States shall ensure that all the Parties involved in the application of this Directive are bound to observe confidentiality with regard to all information obtained in carrying out their tasks.

This does not affect the obligation of Member States and notified bodies with regard to mutual information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law.

2.   The following information shall not be treated as confidential:

(a)

information on the registration of persons responsible for placing devices on the market in accordance with Article 14;

(b)

information to users sent out by the manufacturer, authorised representative or distributor in relation to a measure according to Article 10(3);

(c)

information contained in certificates issued, modified, supplemented, suspended or withdrawn.

3.   The measures designed to amend non-essential elements of this Directive,inter aliaby supplementing it, relating to determination of the conditions under which other information may be made publicly available, and in particular for Class IIb and Class III devices to any obligation for manufacturers to prepare and make available a summary of the information and data related to the device, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;

21.

the following Article shall be inserted:

Member States shall take appropriate measures to ensure that the competent authorities of the Member States cooperate with each other and with the Commission and transmit to each other the information necessary to enable this Directive to be applied uniformly.

The Commission shall provide for the organisation of an exchange of experience between the competent authorities responsible for market surveillance in order to coordinate the uniform application of this Directive.

Without prejudice to the provisions of this Directive, cooperation may be part of initiatives developed at an international level.’;

22.

Annexes I to X shall be amended in accordance with Annex II to this Directive.
In Article 1(2) of Directive 98/8/EC the following point shall be added:

‘(s)

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices(*12).
1.   Member States shall adopt and publish by 21 December 2008 the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those measures.

They shall apply those measures from 21 March 2010.

When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States.
ANNEX IAnnexes 1 to 7 to Directive 90/385/EEC shall be amended as follows:
1. | Annex 1 shall be amended as follows:(a)the following Section shall be inserted:‘5a.Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7.’;(b)in Section 8, the fifth indent shall be replaced by the following:‘—risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*1)and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*2).(*1)OJ L 159, 29.6.1996, p. 1.”(*2)OJ L 180, 9.7.1997, p. 22.’;”(c)in Section 9, seventh indent, the following phrase shall be added:‘For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;(d)Section 10 shall be replaced by the following:‘10.Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*3)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance, including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.(*3)Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as last amended by Regulation (EC) No 1901/2006.’;”(e)Section 14.2 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;(ii)the following indent shall be added:‘—in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;(f)the following indent shall be added to the second paragraph of Section 15:‘—date of issue or the latest revision of the instructions for use.’; | (a) | the following Section shall be inserted:‘5a.Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7.’; | ‘5a. | Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7.’; | (b) | in Section 8, the fifth indent shall be replaced by the following:‘—risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*1)and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*2).(*1)OJ L 159, 29.6.1996, p. 1.”(*2)OJ L 180, 9.7.1997, p. 22.’;” | ‘— | risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*1)and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*2). | (c) | in Section 9, seventh indent, the following phrase shall be added:‘For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’; | (d) | Section 10 shall be replaced by the following:‘10.Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*3)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance, including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.(*3)Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as last amended by Regulation (EC) No 1901/2006.’;” | ‘10. | Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*3)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance, including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure. | (e) | Section 14.2 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;(ii)the following indent shall be added:‘—in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’; | (i) | the first indent shall be replaced by the following:‘—the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’; | ‘— | the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’; | (ii) | the following indent shall be added:‘—in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’; | ‘— | in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’; | (f) | the following indent shall be added to the second paragraph of Section 15:‘—date of issue or the latest revision of the instructions for use.’; | ‘— | date of issue or the latest revision of the instructions for use.’;

(a) | the following Section shall be inserted:‘5a.Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7.’; | ‘5a. | Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7.’;

‘5a. | Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7.’;

(b) | in Section 8, the fifth indent shall be replaced by the following:‘—risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*1)and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*2).(*1)OJ L 159, 29.6.1996, p. 1.”(*2)OJ L 180, 9.7.1997, p. 22.’;” | ‘— | risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*1)and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*2).

‘— | risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(*1)and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure(*2).

(c) | in Section 9, seventh indent, the following phrase shall be added:‘For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;

(d) | Section 10 shall be replaced by the following:‘10.Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*3)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance, including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.(*3)Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as last amended by Regulation (EC) No 1901/2006.’;” | ‘10. | Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*3)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance, including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.

‘10. | Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*3)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance, including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.

(e) | Section 14.2 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;(ii)the following indent shall be added:‘—in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’; | (i) | the first indent shall be replaced by the following:‘—the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’; | ‘— | the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’; | (ii) | the following indent shall be added:‘—in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’; | ‘— | in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;

(i) | the first indent shall be replaced by the following:‘—the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’; | ‘— | the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;

‘— | the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;

(ii) | the following indent shall be added:‘—in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’; | ‘— | in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;

‘— | in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;

(f) | the following indent shall be added to the second paragraph of Section 15:‘—date of issue or the latest revision of the instructions for use.’; | ‘— | date of issue or the latest revision of the instructions for use.’;

‘— | date of issue or the latest revision of the instructions for use.’;

2. | Annex 2 shall be amended as follows:(a)in Section 2, the third paragraph shall be replaced by the following:‘This declaration shall cover one or more clearly identified devices by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;(b)in the second paragraph of Section 3.1, the first sentence of the fifth indent shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7.’;(c)Section 3.2 shall be amended as follows:(i)the following sentence shall be added to the second subparagraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;(ii)the following indent shall be added to point (b):‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;(iii)the following indents shall be added to point (c):‘—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7.’;(d)in Section 3.3, the last sentence of the second subparagraph shall be replaced by the following:‘The evaluation procedure shall include an inspection on the manufacturer’s premises and, in duly substantiated cases, on the premises of the manufacturer’s suppliers and/or subcontractors to inspect the manufacturing processes.’;(e)Section 4.2 shall be amended as follows:(i)the first paragraph shall be replaced by the following:‘The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).’;(ii)in the fourth indent of the second paragraph, the word ‘data’ shall be replaced by the word ‘evaluation’;(f)in Section 4.3, the following paragraphs shall be added:‘In the case of devices referred to in Annex 1, Section 10, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex 1, Section 10, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion shall be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA’s scientific opinion is unfavourable. It will convey its final decision to the EMEA.’;(g)in Section 5.2, the second indent shall be replaced by the following:‘—the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.’;(h)Section 6.1 shall be replaced by the following:‘6.1.For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:—the declaration of conformity,—the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,—the amendments referred to in Section 3.4,—the documentation referred to in Section 4.2,—the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;(i)Section 6.3 shall be deleted;(j)the following Section shall be added:‘7.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’; | (a) | in Section 2, the third paragraph shall be replaced by the following:‘This declaration shall cover one or more clearly identified devices by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’; | (b) | in the second paragraph of Section 3.1, the first sentence of the fifth indent shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7.’; | ‘— | an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7.’; | (c) | Section 3.2 shall be amended as follows:(i)the following sentence shall be added to the second subparagraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;(ii)the following indent shall be added to point (b):‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;(iii)the following indents shall be added to point (c):‘—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7.’; | (i) | the following sentence shall be added to the second subparagraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’; | (ii) | the following indent shall be added to point (b):‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’; | ‘— | where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’; | (iii) | the following indents shall be added to point (c):‘—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7.’; | ‘— | a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device, | — | the pre-clinical evaluation, | — | the clinical evaluation referred to in Annex 7.’; | (d) | in Section 3.3, the last sentence of the second subparagraph shall be replaced by the following:‘The evaluation procedure shall include an inspection on the manufacturer’s premises and, in duly substantiated cases, on the premises of the manufacturer’s suppliers and/or subcontractors to inspect the manufacturing processes.’; | (e) | Section 4.2 shall be amended as follows:(i)the first paragraph shall be replaced by the following:‘The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).’;(ii)in the fourth indent of the second paragraph, the word ‘data’ shall be replaced by the word ‘evaluation’; | (i) | the first paragraph shall be replaced by the following:‘The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).’; | (ii) | in the fourth indent of the second paragraph, the word ‘data’ shall be replaced by the word ‘evaluation’; | (f) | in Section 4.3, the following paragraphs shall be added:‘In the case of devices referred to in Annex 1, Section 10, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex 1, Section 10, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion shall be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA’s scientific opinion is unfavourable. It will convey its final decision to the EMEA.’; | (g) | in Section 5.2, the second indent shall be replaced by the following:‘—the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.’; | ‘— | the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.’; | (h) | Section 6.1 shall be replaced by the following:‘6.1.For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:—the declaration of conformity,—the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,—the amendments referred to in Section 3.4,—the documentation referred to in Section 4.2,—the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’; | ‘6.1. | For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:—the declaration of conformity,—the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,—the amendments referred to in Section 3.4,—the documentation referred to in Section 4.2,—the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’; | — | the declaration of conformity, | — | the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2, | — | the amendments referred to in Section 3.4, | — | the documentation referred to in Section 4.2, | — | the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’; | (i) | Section 6.3 shall be deleted; | (j) | the following Section shall be added:‘7.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’; | ‘7. | Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;

(a) | in Section 2, the third paragraph shall be replaced by the following:‘This declaration shall cover one or more clearly identified devices by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;

(b) | in the second paragraph of Section 3.1, the first sentence of the fifth indent shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7.’; | ‘— | an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7.’;

‘— | an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7.’;

(c) | Section 3.2 shall be amended as follows:(i)the following sentence shall be added to the second subparagraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;(ii)the following indent shall be added to point (b):‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;(iii)the following indents shall be added to point (c):‘—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7.’; | (i) | the following sentence shall be added to the second subparagraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’; | (ii) | the following indent shall be added to point (b):‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’; | ‘— | where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’; | (iii) | the following indents shall be added to point (c):‘—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7.’; | ‘— | a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device, | — | the pre-clinical evaluation, | — | the clinical evaluation referred to in Annex 7.’;

(i) | the following sentence shall be added to the second subparagraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;

(ii) | the following indent shall be added to point (b):‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’; | ‘— | where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;

‘— | where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;

(iii) | the following indents shall be added to point (c):‘—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7.’; | ‘— | a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device, | — | the pre-clinical evaluation, | — | the clinical evaluation referred to in Annex 7.’;

‘— | a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

— | the pre-clinical evaluation,

— | the clinical evaluation referred to in Annex 7.’;

(d) | in Section 3.3, the last sentence of the second subparagraph shall be replaced by the following:‘The evaluation procedure shall include an inspection on the manufacturer’s premises and, in duly substantiated cases, on the premises of the manufacturer’s suppliers and/or subcontractors to inspect the manufacturing processes.’;

(e) | Section 4.2 shall be amended as follows:(i)the first paragraph shall be replaced by the following:‘The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).’;(ii)in the fourth indent of the second paragraph, the word ‘data’ shall be replaced by the word ‘evaluation’; | (i) | the first paragraph shall be replaced by the following:‘The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).’; | (ii) | in the fourth indent of the second paragraph, the word ‘data’ shall be replaced by the word ‘evaluation’;

(i) | the first paragraph shall be replaced by the following:‘The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).’;

(ii) | in the fourth indent of the second paragraph, the word ‘data’ shall be replaced by the word ‘evaluation’;

(f) | in Section 4.3, the following paragraphs shall be added:‘In the case of devices referred to in Annex 1, Section 10, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex 1, Section 10, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion shall be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA’s scientific opinion is unfavourable. It will convey its final decision to the EMEA.’;

(g) | in Section 5.2, the second indent shall be replaced by the following:‘—the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.’; | ‘— | the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.’;

‘— | the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.’;

(h) | Section 6.1 shall be replaced by the following:‘6.1.For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:—the declaration of conformity,—the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,—the amendments referred to in Section 3.4,—the documentation referred to in Section 4.2,—the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’; | ‘6.1. | For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:—the declaration of conformity,—the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,—the amendments referred to in Section 3.4,—the documentation referred to in Section 4.2,—the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’; | — | the declaration of conformity, | — | the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2, | — | the amendments referred to in Section 3.4, | — | the documentation referred to in Section 4.2, | — | the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;

‘6.1. | For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:—the declaration of conformity,—the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,—the amendments referred to in Section 3.4,—the documentation referred to in Section 4.2,—the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’; | — | the declaration of conformity, | — | the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2, | — | the amendments referred to in Section 3.4, | — | the documentation referred to in Section 4.2, | — | the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;

— | the declaration of conformity,

— | the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,

— | the amendments referred to in Section 3.4,

— | the documentation referred to in Section 4.2,

— | the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;

(i) | Section 6.3 shall be deleted;

(j) | the following Section shall be added:‘7.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’; | ‘7. | Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;

‘7. | Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;

3. | Annex 3 shall be amended as follows:(a)Section 3 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the type, including any variants planned, and its intended use(s),’;(ii)the fifth to eighth indents shall be replaced by the following:‘—the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,—a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7,—the draft instruction leaflet.’;(b)the following paragraphs shall be added to Section 5:‘In the case of devices referred to in Annex 1, Section 10, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex 1, Section 10, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion shall be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA’s scientific opinion is unfavourable. It will convey its final decision to the EMEA.’;(c)in Section 7.3, the words ‘five years from the manufacture of the last appliance’ shall be replaced by the words ‘15 years from the manufacture of the last product’;(d)Section 7.4 shall be deleted; | (a) | Section 3 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the type, including any variants planned, and its intended use(s),’;(ii)the fifth to eighth indents shall be replaced by the following:‘—the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,—a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7,—the draft instruction leaflet.’; | (i) | the first indent shall be replaced by the following:‘—a general description of the type, including any variants planned, and its intended use(s),’; | ‘— | a general description of the type, including any variants planned, and its intended use(s),’; | (ii) | the fifth to eighth indents shall be replaced by the following:‘—the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,—a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7,—the draft instruction leaflet.’; | ‘— | the results of design calculations, risk analysis, investigations and technical tests carried out, etc., | — | a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device, | — | the pre-clinical evaluation, | — | the clinical evaluation referred to in Annex 7, | — | the draft instruction leaflet.’; | (b) | the following paragraphs shall be added to Section 5:‘In the case of devices referred to in Annex 1, Section 10, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex 1, Section 10, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion shall be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA’s scientific opinion is unfavourable. It will convey its final decision to the EMEA.’; | (c) | in Section 7.3, the words ‘five years from the manufacture of the last appliance’ shall be replaced by the words ‘15 years from the manufacture of the last product’; | (d) | Section 7.4 shall be deleted;

(a) | Section 3 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the type, including any variants planned, and its intended use(s),’;(ii)the fifth to eighth indents shall be replaced by the following:‘—the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,—a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7,—the draft instruction leaflet.’; | (i) | the first indent shall be replaced by the following:‘—a general description of the type, including any variants planned, and its intended use(s),’; | ‘— | a general description of the type, including any variants planned, and its intended use(s),’; | (ii) | the fifth to eighth indents shall be replaced by the following:‘—the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,—a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7,—the draft instruction leaflet.’; | ‘— | the results of design calculations, risk analysis, investigations and technical tests carried out, etc., | — | a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device, | — | the pre-clinical evaluation, | — | the clinical evaluation referred to in Annex 7, | — | the draft instruction leaflet.’;

(i) | the first indent shall be replaced by the following:‘—a general description of the type, including any variants planned, and its intended use(s),’; | ‘— | a general description of the type, including any variants planned, and its intended use(s),’;

‘— | a general description of the type, including any variants planned, and its intended use(s),’;

(ii) | the fifth to eighth indents shall be replaced by the following:‘—the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,—a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex 7,—the draft instruction leaflet.’; | ‘— | the results of design calculations, risk analysis, investigations and technical tests carried out, etc., | — | a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device, | — | the pre-clinical evaluation, | — | the clinical evaluation referred to in Annex 7, | — | the draft instruction leaflet.’;

‘— | the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,

— | a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

— | the pre-clinical evaluation,

— | the clinical evaluation referred to in Annex 7,

— | the draft instruction leaflet.’;

(b) | the following paragraphs shall be added to Section 5:‘In the case of devices referred to in Annex 1, Section 10, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex 1, Section 10, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion shall be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA’s scientific opinion is unfavourable. It will convey its final decision to the EMEA.’;

(c) | in Section 7.3, the words ‘five years from the manufacture of the last appliance’ shall be replaced by the words ‘15 years from the manufacture of the last product’;

(d) | Section 7.4 shall be deleted;

4. | Annex 4 shall be amended as follows:(a)in Section 4, the words ‘post-marketing surveillance system’ shall be replaced by the words ‘post-marketing surveillance system including the provisions referred to in Annex 7’;(b)Section 6.3 shall be replaced by the following:‘6.3.Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;(c)the following Section shall be added:‘7.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’; | (a) | in Section 4, the words ‘post-marketing surveillance system’ shall be replaced by the words ‘post-marketing surveillance system including the provisions referred to in Annex 7’; | (b) | Section 6.3 shall be replaced by the following:‘6.3.Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’; | ‘6.3. | Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’; | (c) | the following Section shall be added:‘7.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’; | ‘7. | Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;

(a) | in Section 4, the words ‘post-marketing surveillance system’ shall be replaced by the words ‘post-marketing surveillance system including the provisions referred to in Annex 7’;

(b) | Section 6.3 shall be replaced by the following:‘6.3.Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’; | ‘6.3. | Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;

‘6.3. | Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;

(c) | the following Section shall be added:‘7.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’; | ‘7. | Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;

‘7. | Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;

5. | Annex 5 shall be amended as follows:(a)in Section 2, second paragraph, the words ‘identified specimens of the product and shall be kept by the manufacturer’ shall be replaced by the words ‘devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer’;(b)in the sixth indent of Section 3.1, the words ‘post-marketing surveillance system’ shall be replaced by the words ‘post-marketing surveillance system including the provisions referred to in Annex 7’;(c)in Section 3.2(b), the following indent shall be added:‘—where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;(d)in Section 4.2, the following indent shall be inserted after the first indent:‘—the technical documentation,’;(e)the following Section shall be added:‘6.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’; | (a) | in Section 2, second paragraph, the words ‘identified specimens of the product and shall be kept by the manufacturer’ shall be replaced by the words ‘devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer’; | (b) | in the sixth indent of Section 3.1, the words ‘post-marketing surveillance system’ shall be replaced by the words ‘post-marketing surveillance system including the provisions referred to in Annex 7’; | (c) | in Section 3.2(b), the following indent shall be added:‘—where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’; | ‘— | where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’; | (d) | in Section 4.2, the following indent shall be inserted after the first indent:‘—the technical documentation,’; | ‘— | the technical documentation,’; | (e) | the following Section shall be added:‘6.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’; | ‘6. | Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;

(a) | in Section 2, second paragraph, the words ‘identified specimens of the product and shall be kept by the manufacturer’ shall be replaced by the words ‘devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer’;

(b) | in the sixth indent of Section 3.1, the words ‘post-marketing surveillance system’ shall be replaced by the words ‘post-marketing surveillance system including the provisions referred to in Annex 7’;

(c) | in Section 3.2(b), the following indent shall be added:‘—where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’; | ‘— | where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;

‘— | where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.’;

(d) | in Section 4.2, the following indent shall be inserted after the first indent:‘—the technical documentation,’; | ‘— | the technical documentation,’;

‘— | the technical documentation,’;

(e) | the following Section shall be added:‘6.Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’; | ‘6. | Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;

‘6. | Application to the devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;

6. | Annex 6 shall be amended as follows:(a)Section 2.1 shall be amended as follows:(i)the first indent shall be replaced by the following two indents:‘—the name and address of the manufacturer,—the information necessary for the identification of the product in question,’;(ii)in the third indent, the word ‘doctor’ shall be replaced by the words ‘duly qualified medical practitioner’;(iii)the fourth indent shall be replaced by the following:‘—the specific characteristics of the product revealed by the prescription,’;(b)Section 2.2 shall be replaced by the following:‘2.2.For devices intended for clinical investigations covered in Annex 7:—data allowing the devices in question to be identified,—the clinical investigation plan,—the investigator’s brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,—the opinion of the ethics committee concerned and details of the aspects covered by its opinion,—the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,—the place, date of commencement and duration scheduled for the investigations,—a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;(c)in Section 3.1, the first paragraph shall be replaced by the following:‘For custom-made devices, documentation, indicating manufacturing site(s) and enabling the design, manufacture and performances of the product, including the expected performances, to be understood, so as to allow conformity with the requirements of this Directive to be assessed.’;(d)in Section 3.2, the first paragraph shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the product and its intended use,’;(ii)in the fourth indent, the words ‘a list of the standards’ shall be replaced by the words ‘the results of the risk analysis and a list of the standards’;(iii)the following indent shall be inserted after the fourth indent:‘—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;(e)the following two sections shall be added:‘4.The information included in the declarations covered by this Annex shall be kept for a period of at least 15 years from the date of manufacture of the last product.5.For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’; | (a) | Section 2.1 shall be amended as follows:(i)the first indent shall be replaced by the following two indents:‘—the name and address of the manufacturer,—the information necessary for the identification of the product in question,’;(ii)in the third indent, the word ‘doctor’ shall be replaced by the words ‘duly qualified medical practitioner’;(iii)the fourth indent shall be replaced by the following:‘—the specific characteristics of the product revealed by the prescription,’; | (i) | the first indent shall be replaced by the following two indents:‘—the name and address of the manufacturer,—the information necessary for the identification of the product in question,’; | ‘— | the name and address of the manufacturer, | — | the information necessary for the identification of the product in question,’; | (ii) | in the third indent, the word ‘doctor’ shall be replaced by the words ‘duly qualified medical practitioner’; | (iii) | the fourth indent shall be replaced by the following:‘—the specific characteristics of the product revealed by the prescription,’; | ‘— | the specific characteristics of the product revealed by the prescription,’; | (b) | Section 2.2 shall be replaced by the following:‘2.2.For devices intended for clinical investigations covered in Annex 7:—data allowing the devices in question to be identified,—the clinical investigation plan,—the investigator’s brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,—the opinion of the ethics committee concerned and details of the aspects covered by its opinion,—the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,—the place, date of commencement and duration scheduled for the investigations,—a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’; | ‘2.2. | For devices intended for clinical investigations covered in Annex 7:—data allowing the devices in question to be identified,—the clinical investigation plan,—the investigator’s brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,—the opinion of the ethics committee concerned and details of the aspects covered by its opinion,—the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,—the place, date of commencement and duration scheduled for the investigations,—a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’; | — | data allowing the devices in question to be identified, | — | the clinical investigation plan, | — | the investigator’s brochure, | — | the confirmation of insurance of subjects, | — | the documents used to obtain informed consent, | — | a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, | — | the opinion of the ethics committee concerned and details of the aspects covered by its opinion, | — | the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations, | — | the place, date of commencement and duration scheduled for the investigations, | — | a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’; | (c) | in Section 3.1, the first paragraph shall be replaced by the following:‘For custom-made devices, documentation, indicating manufacturing site(s) and enabling the design, manufacture and performances of the product, including the expected performances, to be understood, so as to allow conformity with the requirements of this Directive to be assessed.’; | (d) | in Section 3.2, the first paragraph shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the product and its intended use,’;(ii)in the fourth indent, the words ‘a list of the standards’ shall be replaced by the words ‘the results of the risk analysis and a list of the standards’;(iii)the following indent shall be inserted after the fourth indent:‘—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’; | (i) | the first indent shall be replaced by the following:‘—a general description of the product and its intended use,’; | ‘— | a general description of the product and its intended use,’; | (ii) | in the fourth indent, the words ‘a list of the standards’ shall be replaced by the words ‘the results of the risk analysis and a list of the standards’; | (iii) | the following indent shall be inserted after the fourth indent:‘—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’; | ‘— | if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’; | (e) | the following two sections shall be added:‘4.The information included in the declarations covered by this Annex shall be kept for a period of at least 15 years from the date of manufacture of the last product.5.For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’; | ‘4. | The information included in the declarations covered by this Annex shall be kept for a period of at least 15 years from the date of manufacture of the last product. | 5. | For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’; | (i) | any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health; | (ii) | any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;

(a) | Section 2.1 shall be amended as follows:(i)the first indent shall be replaced by the following two indents:‘—the name and address of the manufacturer,—the information necessary for the identification of the product in question,’;(ii)in the third indent, the word ‘doctor’ shall be replaced by the words ‘duly qualified medical practitioner’;(iii)the fourth indent shall be replaced by the following:‘—the specific characteristics of the product revealed by the prescription,’; | (i) | the first indent shall be replaced by the following two indents:‘—the name and address of the manufacturer,—the information necessary for the identification of the product in question,’; | ‘— | the name and address of the manufacturer, | — | the information necessary for the identification of the product in question,’; | (ii) | in the third indent, the word ‘doctor’ shall be replaced by the words ‘duly qualified medical practitioner’; | (iii) | the fourth indent shall be replaced by the following:‘—the specific characteristics of the product revealed by the prescription,’; | ‘— | the specific characteristics of the product revealed by the prescription,’;

(i) | the first indent shall be replaced by the following two indents:‘—the name and address of the manufacturer,—the information necessary for the identification of the product in question,’; | ‘— | the name and address of the manufacturer, | — | the information necessary for the identification of the product in question,’;

‘— | the name and address of the manufacturer,

— | the information necessary for the identification of the product in question,’;

(ii) | in the third indent, the word ‘doctor’ shall be replaced by the words ‘duly qualified medical practitioner’;

(iii) | the fourth indent shall be replaced by the following:‘—the specific characteristics of the product revealed by the prescription,’; | ‘— | the specific characteristics of the product revealed by the prescription,’;

‘— | the specific characteristics of the product revealed by the prescription,’;

(b) | Section 2.2 shall be replaced by the following:‘2.2.For devices intended for clinical investigations covered in Annex 7:—data allowing the devices in question to be identified,—the clinical investigation plan,—the investigator’s brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,—the opinion of the ethics committee concerned and details of the aspects covered by its opinion,—the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,—the place, date of commencement and duration scheduled for the investigations,—a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’; | ‘2.2. | For devices intended for clinical investigations covered in Annex 7:—data allowing the devices in question to be identified,—the clinical investigation plan,—the investigator’s brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,—the opinion of the ethics committee concerned and details of the aspects covered by its opinion,—the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,—the place, date of commencement and duration scheduled for the investigations,—a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’; | — | data allowing the devices in question to be identified, | — | the clinical investigation plan, | — | the investigator’s brochure, | — | the confirmation of insurance of subjects, | — | the documents used to obtain informed consent, | — | a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, | — | the opinion of the ethics committee concerned and details of the aspects covered by its opinion, | — | the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations, | — | the place, date of commencement and duration scheduled for the investigations, | — | a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;

‘2.2. | For devices intended for clinical investigations covered in Annex 7:—data allowing the devices in question to be identified,—the clinical investigation plan,—the investigator’s brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,—the opinion of the ethics committee concerned and details of the aspects covered by its opinion,—the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,—the place, date of commencement and duration scheduled for the investigations,—a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’; | — | data allowing the devices in question to be identified, | — | the clinical investigation plan, | — | the investigator’s brochure, | — | the confirmation of insurance of subjects, | — | the documents used to obtain informed consent, | — | a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, | — | the opinion of the ethics committee concerned and details of the aspects covered by its opinion, | — | the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations, | — | the place, date of commencement and duration scheduled for the investigations, | — | a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;

— | data allowing the devices in question to be identified,

— | the clinical investigation plan,

— | the investigator’s brochure,

— | the confirmation of insurance of subjects,

— | the documents used to obtain informed consent,

— | a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,

— | the opinion of the ethics committee concerned and details of the aspects covered by its opinion,

— | the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,

— | the place, date of commencement and duration scheduled for the investigations,

— | a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;

(c) | in Section 3.1, the first paragraph shall be replaced by the following:‘For custom-made devices, documentation, indicating manufacturing site(s) and enabling the design, manufacture and performances of the product, including the expected performances, to be understood, so as to allow conformity with the requirements of this Directive to be assessed.’;

(d) | in Section 3.2, the first paragraph shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the product and its intended use,’;(ii)in the fourth indent, the words ‘a list of the standards’ shall be replaced by the words ‘the results of the risk analysis and a list of the standards’;(iii)the following indent shall be inserted after the fourth indent:‘—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’; | (i) | the first indent shall be replaced by the following:‘—a general description of the product and its intended use,’; | ‘— | a general description of the product and its intended use,’; | (ii) | in the fourth indent, the words ‘a list of the standards’ shall be replaced by the words ‘the results of the risk analysis and a list of the standards’; | (iii) | the following indent shall be inserted after the fourth indent:‘—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’; | ‘— | if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;

(i) | the first indent shall be replaced by the following:‘—a general description of the product and its intended use,’; | ‘— | a general description of the product and its intended use,’;

‘— | a general description of the product and its intended use,’;

(ii) | in the fourth indent, the words ‘a list of the standards’ shall be replaced by the words ‘the results of the risk analysis and a list of the standards’;

(iii) | the following indent shall be inserted after the fourth indent:‘—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’; | ‘— | if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;

‘— | if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,’;

(e) | the following two sections shall be added:‘4.The information included in the declarations covered by this Annex shall be kept for a period of at least 15 years from the date of manufacture of the last product.5.For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’; | ‘4. | The information included in the declarations covered by this Annex shall be kept for a period of at least 15 years from the date of manufacture of the last product. | 5. | For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’; | (i) | any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health; | (ii) | any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;

‘4. | The information included in the declarations covered by this Annex shall be kept for a period of at least 15 years from the date of manufacture of the last product.

5. | For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’; | (i) | any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health; | (ii) | any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;

(i) | any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;

(ii) | any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.’;

7. | Annex 7 shall be amended as follows:(a)Section 1 shall be replaced by the following:‘1.   General provisions1.1.As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 2 of Annex 1 under the normal conditions of use of the device and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 5 of Annex 1, must be based on clinical data. The evaluation of this data (hereinafter referred to as clinical evaluation), where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:1.1.1.Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where:—there is demonstration of equivalence of the device to the device to which the data relates and,—the data adequately demonstrate compliance with the relevant essential requirements;1.1.2.Or a critical evaluation of the results of all the clinical investigations made,1.1.3.Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.1.2.Clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.1.3.The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.1.4.The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.1.5.Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.1.6.All data must remain confidential unless it is deemed essential that they be divulged.’(b)Section 2.3.5 shall be replaced by the following:‘2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’(c)In Section 2.3.6, the words ‘appropriately qualified medical specialist’ shall be replaced by the words ‘duly qualified medical practitioner or authorised person’. | (a) | Section 1 shall be replaced by the following:‘1.   General provisions1.1.As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 2 of Annex 1 under the normal conditions of use of the device and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 5 of Annex 1, must be based on clinical data. The evaluation of this data (hereinafter referred to as clinical evaluation), where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:1.1.1.Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where:—there is demonstration of equivalence of the device to the device to which the data relates and,—the data adequately demonstrate compliance with the relevant essential requirements;1.1.2.Or a critical evaluation of the results of all the clinical investigations made,1.1.3.Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.1.2.Clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.1.3.The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.1.4.The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.1.5.Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.1.6.All data must remain confidential unless it is deemed essential that they be divulged.’ |  | 1.1. | As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 2 of Annex 1 under the normal conditions of use of the device and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 5 of Annex 1, must be based on clinical data. The evaluation of this data (hereinafter referred to as clinical evaluation), where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on: |  | 1.1.1. | Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where:—there is demonstration of equivalence of the device to the device to which the data relates and,—the data adequately demonstrate compliance with the relevant essential requirements; | — | there is demonstration of equivalence of the device to the device to which the data relates and, | — | the data adequately demonstrate compliance with the relevant essential requirements; |  | 1.1.2. | Or a critical evaluation of the results of all the clinical investigations made, |  | 1.1.3. | Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2. |  | 1.2. | Clinical investigations shall be performed unless it is duly justified to rely on existing clinical data. |  | 1.3. | The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device. |  | 1.4. | The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented. |  | 1.5. | Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated. |  | 1.6. | All data must remain confidential unless it is deemed essential that they be divulged.’ | (b) | Section 2.3.5 shall be replaced by the following:‘2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’ | ‘2.3.5. | All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’ | (c) | In Section 2.3.6, the words ‘appropriately qualified medical specialist’ shall be replaced by the words ‘duly qualified medical practitioner or authorised person’.

(a) | Section 1 shall be replaced by the following:‘1.   General provisions1.1.As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 2 of Annex 1 under the normal conditions of use of the device and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 5 of Annex 1, must be based on clinical data. The evaluation of this data (hereinafter referred to as clinical evaluation), where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:1.1.1.Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where:—there is demonstration of equivalence of the device to the device to which the data relates and,—the data adequately demonstrate compliance with the relevant essential requirements;1.1.2.Or a critical evaluation of the results of all the clinical investigations made,1.1.3.Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.1.2.Clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.1.3.The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.1.4.The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.1.5.Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.1.6.All data must remain confidential unless it is deemed essential that they be divulged.’ |  | 1.1. | As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 2 of Annex 1 under the normal conditions of use of the device and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 5 of Annex 1, must be based on clinical data. The evaluation of this data (hereinafter referred to as clinical evaluation), where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on: |  | 1.1.1. | Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where:—there is demonstration of equivalence of the device to the device to which the data relates and,—the data adequately demonstrate compliance with the relevant essential requirements; | — | there is demonstration of equivalence of the device to the device to which the data relates and, | — | the data adequately demonstrate compliance with the relevant essential requirements; |  | 1.1.2. | Or a critical evaluation of the results of all the clinical investigations made, |  | 1.1.3. | Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2. |  | 1.2. | Clinical investigations shall be performed unless it is duly justified to rely on existing clinical data. |  | 1.3. | The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device. |  | 1.4. | The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented. |  | 1.5. | Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated. |  | 1.6. | All data must remain confidential unless it is deemed essential that they be divulged.’

 | 1.1. | As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 2 of Annex 1 under the normal conditions of use of the device and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 5 of Annex 1, must be based on clinical data. The evaluation of this data (hereinafter referred to as clinical evaluation), where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:

 | 1.1.1. | Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where:—there is demonstration of equivalence of the device to the device to which the data relates and,—the data adequately demonstrate compliance with the relevant essential requirements; | — | there is demonstration of equivalence of the device to the device to which the data relates and, | — | the data adequately demonstrate compliance with the relevant essential requirements;

— | there is demonstration of equivalence of the device to the device to which the data relates and,

— | the data adequately demonstrate compliance with the relevant essential requirements;

 | 1.1.2. | Or a critical evaluation of the results of all the clinical investigations made,

 | 1.1.3. | Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.

 | 1.2. | Clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.

 | 1.3. | The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.

 | 1.4. | The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.

 | 1.5. | Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.

 | 1.6. | All data must remain confidential unless it is deemed essential that they be divulged.’

(b) | Section 2.3.5 shall be replaced by the following:‘2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’ | ‘2.3.5. | All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’

‘2.3.5. | All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’

(c) | In Section 2.3.6, the words ‘appropriately qualified medical specialist’ shall be replaced by the words ‘duly qualified medical practitioner or authorised person’.

(*1)  

            OJ L 159, 29.6.1996, p. 1.

(*2)  

            OJ L 180, 9.7.1997, p. 22.’;

(*3)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as last amended by Regulation (EC) No 1901/2006.’;’
ANNEX IIAnnexes I to X to Directive 93/42/EEC shall be amended as follows:
1. | Annex I shall be amended as follows:(a)Section 1 shall be replaced by the following:‘1.The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.This shall include:—reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and—consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;(b)the following Section shall be inserted:‘6a.Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.’;(c)in Section 7.1, the following indent shall be added:‘—where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.’;(d)Section 7.4. shall be replaced by the following:‘7.4.Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*1)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.(*1)Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as last amended by Regulation (EC) No 1901/2006.’

                                          “(e)Section 7.5 shall be replaced by the following:‘7.5.The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(*2).If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.(*2)OJ 196, 16.8.1967, p. 1. Directive as last amended by Directive 2006/121/EC of the European Parliament and of the Council (OJ L 396, 30.12.2006, p. 850).’

                                          “(f)in Section 8.2, the word ‘transferable’ shall be replaced by the word ‘transmissible’;(g)the following Section shall be inserted:‘12.1aFor devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;(h)in Section 13.1, the first paragraph shall be replaced by the following:‘13.1.Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.’;(i)Section 13.3 shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’(ii)point (b) shall be replaced by the following:‘(b)the details strictly necessary to identify the device and the contents of the packaging especially for the users;’(iii)point (f) shall be replaced by the following:‘(f)where appropriate, an indication that the device is for single use. A manufacturer’s indication of single use must be consistent across the Community;’(j)Section 13.6 shall be amended as follows:(i)the following subparagraph shall be added to point (h):‘If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;’(ii)point (o) shall be replaced by the following:‘(o)medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’(iii)the following point shall be added:‘(q)date of issue or the latest revision of the instructions for use.’;(k)Section 14 shall be deleted. | (a) | Section 1 shall be replaced by the following:‘1.The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.This shall include:—reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and—consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’; | ‘1. | The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.This shall include:—reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and—consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’; | — | reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and | — | consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’; | (b) | the following Section shall be inserted:‘6a.Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.’; | ‘6a. | Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.’; | (c) | in Section 7.1, the following indent shall be added:‘—where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.’; | ‘— | where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.’; | (d) | Section 7.4. shall be replaced by the following:‘7.4.Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*1)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.(*1)Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as last amended by Regulation (EC) No 1901/2006.’

                                          ” | ‘7.4. | Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*1)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure. | (e) | Section 7.5 shall be replaced by the following:‘7.5.The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(*2).If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.(*2)OJ 196, 16.8.1967, p. 1. Directive as last amended by Directive 2006/121/EC of the European Parliament and of the Council (OJ L 396, 30.12.2006, p. 850).’

                                          ” | ‘7.5. | The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(*2).If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures. | (f) | in Section 8.2, the word ‘transferable’ shall be replaced by the word ‘transmissible’; | (g) | the following Section shall be inserted:‘12.1aFor devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’; | ‘12.1a | For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’; | (h) | in Section 13.1, the first paragraph shall be replaced by the following:‘13.1.Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.’; | ‘13.1. | Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.’; | (i) | Section 13.3 shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’(ii)point (b) shall be replaced by the following:‘(b)the details strictly necessary to identify the device and the contents of the packaging especially for the users;’(iii)point (f) shall be replaced by the following:‘(f)where appropriate, an indication that the device is for single use. A manufacturer’s indication of single use must be consistent across the Community;’ | (i) | point (a) shall be replaced by the following:‘(a)the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’ | ‘(a) | the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’ | (ii) | point (b) shall be replaced by the following:‘(b)the details strictly necessary to identify the device and the contents of the packaging especially for the users;’ | ‘(b) | the details strictly necessary to identify the device and the contents of the packaging especially for the users;’ | (iii) | point (f) shall be replaced by the following:‘(f)where appropriate, an indication that the device is for single use. A manufacturer’s indication of single use must be consistent across the Community;’ | ‘(f) | where appropriate, an indication that the device is for single use. A manufacturer’s indication of single use must be consistent across the Community;’ | (j) | Section 13.6 shall be amended as follows:(i)the following subparagraph shall be added to point (h):‘If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;’(ii)point (o) shall be replaced by the following:‘(o)medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’(iii)the following point shall be added:‘(q)date of issue or the latest revision of the instructions for use.’; | (i) | the following subparagraph shall be added to point (h):‘If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;’ | (ii) | point (o) shall be replaced by the following:‘(o)medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’ | ‘(o) | medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’ | (iii) | the following point shall be added:‘(q)date of issue or the latest revision of the instructions for use.’; | ‘(q) | date of issue or the latest revision of the instructions for use.’; | (k) | Section 14 shall be deleted.

(a) | Section 1 shall be replaced by the following:‘1.The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.This shall include:—reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and—consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’; | ‘1. | The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.This shall include:—reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and—consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’; | — | reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and | — | consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;

‘1. | The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.This shall include:—reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and—consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’; | — | reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and | — | consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;

— | reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and

— | consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;

(b) | the following Section shall be inserted:‘6a.Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.’; | ‘6a. | Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.’;

‘6a. | Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.’;

(c) | in Section 7.1, the following indent shall be added:‘—where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.’; | ‘— | where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.’;

‘— | where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.’;

(d) | Section 7.4. shall be replaced by the following:‘7.4.Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*1)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.(*1)Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as last amended by Regulation (EC) No 1901/2006.’

                                          ” | ‘7.4. | Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*1)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.

‘7.4. | Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004(*1)on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.

(e) | Section 7.5 shall be replaced by the following:‘7.5.The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(*2).If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.(*2)OJ 196, 16.8.1967, p. 1. Directive as last amended by Directive 2006/121/EC of the European Parliament and of the Council (OJ L 396, 30.12.2006, p. 850).’

                                          ” | ‘7.5. | The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(*2).If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.

‘7.5. | The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(*2).If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.

(f) | in Section 8.2, the word ‘transferable’ shall be replaced by the word ‘transmissible’;

(g) | the following Section shall be inserted:‘12.1aFor devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’; | ‘12.1a | For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;

‘12.1a | For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;

(h) | in Section 13.1, the first paragraph shall be replaced by the following:‘13.1.Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.’; | ‘13.1. | Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.’;

‘13.1. | Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.’;

(i) | Section 13.3 shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’(ii)point (b) shall be replaced by the following:‘(b)the details strictly necessary to identify the device and the contents of the packaging especially for the users;’(iii)point (f) shall be replaced by the following:‘(f)where appropriate, an indication that the device is for single use. A manufacturer’s indication of single use must be consistent across the Community;’ | (i) | point (a) shall be replaced by the following:‘(a)the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’ | ‘(a) | the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’ | (ii) | point (b) shall be replaced by the following:‘(b)the details strictly necessary to identify the device and the contents of the packaging especially for the users;’ | ‘(b) | the details strictly necessary to identify the device and the contents of the packaging especially for the users;’ | (iii) | point (f) shall be replaced by the following:‘(f)where appropriate, an indication that the device is for single use. A manufacturer’s indication of single use must be consistent across the Community;’ | ‘(f) | where appropriate, an indication that the device is for single use. A manufacturer’s indication of single use must be consistent across the Community;’

(i) | point (a) shall be replaced by the following:‘(a)the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’ | ‘(a) | the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’

‘(a) | the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’

(ii) | point (b) shall be replaced by the following:‘(b)the details strictly necessary to identify the device and the contents of the packaging especially for the users;’ | ‘(b) | the details strictly necessary to identify the device and the contents of the packaging especially for the users;’

‘(b) | the details strictly necessary to identify the device and the contents of the packaging especially for the users;’

(iii) | point (f) shall be replaced by the following:‘(f)where appropriate, an indication that the device is for single use. A manufacturer’s indication of single use must be consistent across the Community;’ | ‘(f) | where appropriate, an indication that the device is for single use. A manufacturer’s indication of single use must be consistent across the Community;’

‘(f) | where appropriate, an indication that the device is for single use. A manufacturer’s indication of single use must be consistent across the Community;’

(j) | Section 13.6 shall be amended as follows:(i)the following subparagraph shall be added to point (h):‘If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;’(ii)point (o) shall be replaced by the following:‘(o)medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’(iii)the following point shall be added:‘(q)date of issue or the latest revision of the instructions for use.’; | (i) | the following subparagraph shall be added to point (h):‘If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;’ | (ii) | point (o) shall be replaced by the following:‘(o)medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’ | ‘(o) | medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’ | (iii) | the following point shall be added:‘(q)date of issue or the latest revision of the instructions for use.’; | ‘(q) | date of issue or the latest revision of the instructions for use.’;

(i) | the following subparagraph shall be added to point (h):‘If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;’

(ii) | point (o) shall be replaced by the following:‘(o)medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’ | ‘(o) | medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’

‘(o) | medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’

(iii) | the following point shall be added:‘(q)date of issue or the latest revision of the instructions for use.’; | ‘(q) | date of issue or the latest revision of the instructions for use.’;

‘(q) | date of issue or the latest revision of the instructions for use.’;

(k) | Section 14 shall be deleted.

2. | Annex II shall be amended as follows:(a)Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;(b)in Section 3.1, second paragraph, the introductory part of the seventh indent shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;(c)Section 3.2 shall be amended as follows:(i)the following paragraph shall be inserted after the first paragraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;(ii)in point (b), the following indent shall be added:‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’(iii)point (c) shall be replaced by the following:‘(c)the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.(*3)Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).’

                                                                     “(d)the second paragraph of Section 3.3 shall be replaced by the following:‘The assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an assessment, on a representative basis, of the documentation of the design of the product(s) concerned, an inspection on the manufacturer’s premises and, in duly substantiated cases, on the premises of the manufacturer’s suppliers and/or subcontractors to inspect the manufacturing processes.’;(e)in Section 4.3, the second and third paragraphs shall be replaced by the following:‘In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA’s scientific opinion is unfavourable. It will convey its final decision to the EMEA.In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the notified body must follow the procedures referred to in that Directive.’;(f)in Section 5.2, the second indent shall be replaced by the following:‘—the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,’;(g)Section 6.1 shall be amended as follows:(i)the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities:’;(ii)the following phrase shall be added to the second indent:‘and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,’;(h)Section 6.3 shall be deleted;(i)Section 7 shall be replaced by the following:‘7.Application to devices in Classes IIa and IIb.7.1.In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb. Section 4, however, does not apply.7.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.7.3.For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive.7.4.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.7.5.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 5.’;(j)in Section 8, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’; | (a) | Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’; | ‘2. | The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’; | (b) | in Section 3.1, second paragraph, the introductory part of the seventh indent shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’; | ‘— | an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’; | (c) | Section 3.2 shall be amended as follows:(i)the following paragraph shall be inserted after the first paragraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;(ii)in point (b), the following indent shall be added:‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’(iii)point (c) shall be replaced by the following:‘(c)the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.(*3)Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).’

                                                                     ” | (i) | the following paragraph shall be inserted after the first paragraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’; | (ii) | in point (b), the following indent shall be added:‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’ | ‘— | where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’ | (iii) | point (c) shall be replaced by the following:‘(c)the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.(*3)Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).’

                                                                     ” | ‘(c) | the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use. | — | a general description of the product, including any variants planned, and its intended use(s), | — | the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full, | — | the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed, | — | if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer, | — | a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device, | — | a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3), | — | the solutions adopted as referred to in Annex I, Chapter I, Section 2, | — | the pre-clinical evaluation, | — | the clinical evaluation referred to in Annex X, | — | the draft label and, where appropriate, instructions for use. | (d) | the second paragraph of Section 3.3 shall be replaced by the following:‘The assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an assessment, on a representative basis, of the documentation of the design of the product(s) concerned, an inspection on the manufacturer’s premises and, in duly substantiated cases, on the premises of the manufacturer’s suppliers and/or subcontractors to inspect the manufacturing processes.’; | (e) | in Section 4.3, the second and third paragraphs shall be replaced by the following:‘In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA’s scientific opinion is unfavourable. It will convey its final decision to the EMEA.In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the notified body must follow the procedures referred to in that Directive.’; | (f) | in Section 5.2, the second indent shall be replaced by the following:‘—the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,’; | ‘— | the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,’; | (g) | Section 6.1 shall be amended as follows:(i)the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities:’;(ii)the following phrase shall be added to the second indent:‘and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,’; | (i) | the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities:’; | (ii) | the following phrase shall be added to the second indent:‘and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,’; | (h) | Section 6.3 shall be deleted; | (i) | Section 7 shall be replaced by the following:‘7.Application to devices in Classes IIa and IIb.7.1.In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb. Section 4, however, does not apply.7.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.7.3.For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive.7.4.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.7.5.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 5.’; | ‘7. | Application to devices in Classes IIa and IIb. | 7.1. | In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb. Section 4, however, does not apply. | 7.2. | For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each device subcategory for compliance with the provisions of this Directive. | 7.3. | For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive. | 7.4. | In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken. | 7.5. | Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 5.’; | (j) | in Section 8, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;

(a) | Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’; | ‘2. | The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;

‘2. | The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;

(b) | in Section 3.1, second paragraph, the introductory part of the seventh indent shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’; | ‘— | an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;

‘— | an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;

(c) | Section 3.2 shall be amended as follows:(i)the following paragraph shall be inserted after the first paragraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;(ii)in point (b), the following indent shall be added:‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’(iii)point (c) shall be replaced by the following:‘(c)the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.(*3)Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).’

                                                                     ” | (i) | the following paragraph shall be inserted after the first paragraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’; | (ii) | in point (b), the following indent shall be added:‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’ | ‘— | where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’ | (iii) | point (c) shall be replaced by the following:‘(c)the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.(*3)Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).’

                                                                     ” | ‘(c) | the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use. | — | a general description of the product, including any variants planned, and its intended use(s), | — | the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full, | — | the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed, | — | if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer, | — | a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device, | — | a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3), | — | the solutions adopted as referred to in Annex I, Chapter I, Section 2, | — | the pre-clinical evaluation, | — | the clinical evaluation referred to in Annex X, | — | the draft label and, where appropriate, instructions for use.

(i) | the following paragraph shall be inserted after the first paragraph:‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;

(ii) | in point (b), the following indent shall be added:‘—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’ | ‘— | where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’

‘— | where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’

(iii) | point (c) shall be replaced by the following:‘(c)the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.(*3)Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).’

                                                                     ” | ‘(c) | the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use. | — | a general description of the product, including any variants planned, and its intended use(s), | — | the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full, | — | the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed, | — | if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer, | — | a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device, | — | a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3), | — | the solutions adopted as referred to in Annex I, Chapter I, Section 2, | — | the pre-clinical evaluation, | — | the clinical evaluation referred to in Annex X, | — | the draft label and, where appropriate, instructions for use.

‘(c) | the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:—a general description of the product, including any variants planned, and its intended use(s),—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,—the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,—if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use. | — | a general description of the product, including any variants planned, and its intended use(s), | — | the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full, | — | the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed, | — | if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer, | — | a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device, | — | a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3), | — | the solutions adopted as referred to in Annex I, Chapter I, Section 2, | — | the pre-clinical evaluation, | — | the clinical evaluation referred to in Annex X, | — | the draft label and, where appropriate, instructions for use.

— | a general description of the product, including any variants planned, and its intended use(s),

— | the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,

— | the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,

— | if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,

— | a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

— | a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC(*3),

— | the solutions adopted as referred to in Annex I, Chapter I, Section 2,

— | the pre-clinical evaluation,

— | the clinical evaluation referred to in Annex X,

— | the draft label and, where appropriate, instructions for use.

(d) | the second paragraph of Section 3.3 shall be replaced by the following:‘The assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an assessment, on a representative basis, of the documentation of the design of the product(s) concerned, an inspection on the manufacturer’s premises and, in duly substantiated cases, on the premises of the manufacturer’s suppliers and/or subcontractors to inspect the manufacturing processes.’;

(e) | in Section 4.3, the second and third paragraphs shall be replaced by the following:‘In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA’s scientific opinion is unfavourable. It will convey its final decision to the EMEA.In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the notified body must follow the procedures referred to in that Directive.’;

(f) | in Section 5.2, the second indent shall be replaced by the following:‘—the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,’; | ‘— | the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,’;

‘— | the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,’;

(g) | Section 6.1 shall be amended as follows:(i)the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities:’;(ii)the following phrase shall be added to the second indent:‘and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,’; | (i) | the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities:’; | (ii) | the following phrase shall be added to the second indent:‘and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,’;

(i) | the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities:’;

(ii) | the following phrase shall be added to the second indent:‘and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,’;

(h) | Section 6.3 shall be deleted;

(i) | Section 7 shall be replaced by the following:‘7.Application to devices in Classes IIa and IIb.7.1.In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb. Section 4, however, does not apply.7.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.7.3.For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive.7.4.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.7.5.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 5.’; | ‘7. | Application to devices in Classes IIa and IIb. | 7.1. | In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb. Section 4, however, does not apply. | 7.2. | For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each device subcategory for compliance with the provisions of this Directive. | 7.3. | For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive. | 7.4. | In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken. | 7.5. | Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 5.’;

‘7. | Application to devices in Classes IIa and IIb.

7.1. | In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb. Section 4, however, does not apply.

7.2. | For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.

7.3. | For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive.

7.4. | In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.

7.5. | Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 5.’;

(j) | in Section 8, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;

3. | Annex III shall be amended as follows:(a)Section 3 shall be replaced by the following:‘3.The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular:—a general description of the type, including any variants planned, and its intended use(s),—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,—the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,—a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.’;(b)in Section 5, the second and third paragraphs shall be replaced by the following:‘In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA’s scientific opinion is unfavourable. It will convey its final decision to the EMEA.In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the notified body must follow the procedures referred to in that Directive.’;(c)Section 7.3 shall be replaced by the following:‘7.3.The manufacturer or his authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least five years after the last device has been manufactured. In the case of implantable devices, the period shall be at least 15 years after the last product has been manufactured.’;(d)Section 7.4 shall be deleted; | (a) | Section 3 shall be replaced by the following:‘3.The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular:—a general description of the type, including any variants planned, and its intended use(s),—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,—the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,—a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.’; | ‘3. | The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular:—a general description of the type, including any variants planned, and its intended use(s),—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,—the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,—a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.’; | — | a general description of the type, including any variants planned, and its intended use(s), | — | design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc., | — | the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product, | — | a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full, | — | the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out, | — | a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device, | — | a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, | — | the solutions adopted as referred to in Annex I, Chapter I, Section 2, | — | the pre-clinical evaluation, | — | the clinical evaluation referred to in Annex X, | — | the draft label and, where appropriate, instructions for use.’; | (b) | in Section 5, the second and third paragraphs shall be replaced by the following:‘In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA’s scientific opinion is unfavourable. It will convey its final decision to the EMEA.In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the notified body must follow the procedures referred to in that Directive.’; | (c) | Section 7.3 shall be replaced by the following:‘7.3.The manufacturer or his authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least five years after the last device has been manufactured. In the case of implantable devices, the period shall be at least 15 years after the last product has been manufactured.’; | ‘7.3. | The manufacturer or his authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least five years after the last device has been manufactured. In the case of implantable devices, the period shall be at least 15 years after the last product has been manufactured.’; | (d) | Section 7.4 shall be deleted;

(a) | Section 3 shall be replaced by the following:‘3.The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular:—a general description of the type, including any variants planned, and its intended use(s),—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,—the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,—a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.’; | ‘3. | The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular:—a general description of the type, including any variants planned, and its intended use(s),—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,—the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,—a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.’; | — | a general description of the type, including any variants planned, and its intended use(s), | — | design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc., | — | the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product, | — | a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full, | — | the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out, | — | a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device, | — | a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, | — | the solutions adopted as referred to in Annex I, Chapter I, Section 2, | — | the pre-clinical evaluation, | — | the clinical evaluation referred to in Annex X, | — | the draft label and, where appropriate, instructions for use.’;

‘3. | The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular:—a general description of the type, including any variants planned, and its intended use(s),—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,—the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,—a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,—the clinical evaluation referred to in Annex X,—the draft label and, where appropriate, instructions for use.’; | — | a general description of the type, including any variants planned, and its intended use(s), | — | design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc., | — | the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product, | — | a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full, | — | the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out, | — | a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device, | — | a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, | — | the solutions adopted as referred to in Annex I, Chapter I, Section 2, | — | the pre-clinical evaluation, | — | the clinical evaluation referred to in Annex X, | — | the draft label and, where appropriate, instructions for use.’;

— | a general description of the type, including any variants planned, and its intended use(s),

— | design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,

— | the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,

— | a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,

— | the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,

— | a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,

— | a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,

— | the solutions adopted as referred to in Annex I, Chapter I, Section 2,

— | the pre-clinical evaluation,

— | the clinical evaluation referred to in Annex X,

— | the draft label and, where appropriate, instructions for use.’;

(b) | in Section 5, the second and third paragraphs shall be replaced by the following:‘In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA’s scientific opinion is unfavourable. It will convey its final decision to the EMEA.In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the notified body must follow the procedures referred to in that Directive.’;

(c) | Section 7.3 shall be replaced by the following:‘7.3.The manufacturer or his authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least five years after the last device has been manufactured. In the case of implantable devices, the period shall be at least 15 years after the last product has been manufactured.’; | ‘7.3. | The manufacturer or his authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least five years after the last device has been manufactured. In the case of implantable devices, the period shall be at least 15 years after the last product has been manufactured.’;

‘7.3. | The manufacturer or his authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least five years after the last device has been manufactured. In the case of implantable devices, the period shall be at least 15 years after the last product has been manufactured.’;

(d) | Section 7.4 shall be deleted;

4. | Annex IV shall be amended as follows:(a)in Section 1, the words ‘established in the Community’ shall be deleted;(b)in Section 3, the first paragraph shall be replaced by the following:‘3.The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;(c)Section 6.3 shall be replaced by the following:‘6.3.Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;(d)in Section 7, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’;(e)in the introductory part of Section 8 the word ‘exemptions’ shall be deleted;(f)in Section 9, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’; | (a) | in Section 1, the words ‘established in the Community’ shall be deleted; | (b) | in Section 3, the first paragraph shall be replaced by the following:‘3.The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’; | ‘3. | The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’; | (c) | Section 6.3 shall be replaced by the following:‘6.3.Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’; | ‘6.3. | Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’; | (d) | in Section 7, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’; | (e) | in the introductory part of Section 8 the word ‘exemptions’ shall be deleted; | (f) | in Section 9, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;

(a) | in Section 1, the words ‘established in the Community’ shall be deleted;

(b) | in Section 3, the first paragraph shall be replaced by the following:‘3.The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’; | ‘3. | The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;

‘3. | The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;

(c) | Section 6.3 shall be replaced by the following:‘6.3.Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’; | ‘6.3. | Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;

‘6.3. | Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;

(d) | in Section 7, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’;

(e) | in the introductory part of Section 8 the word ‘exemptions’ shall be deleted;

(f) | in Section 9, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;

5. | Annex V shall be amended as follows:(a)Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and must be kept by the manufacturer.’;(b)in the eighth indent of the second paragraph of Section 3.1, the introductory part shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them;’;(c)in point (b) of the third paragraph of Section 3.2, the following indent shall be added:‘—where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’(d)in Section 4.2, the following indent shall be inserted after the first indent:‘—the technical documentation,’;(e)in Section 5.1, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’;(f)Section 6 shall be replaced by the following:‘6.   Application to devices in Class IIaIn line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:6.1.By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.6.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.6.3.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.6.4.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;(g)in Section 7, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’; | (a) | Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and must be kept by the manufacturer.’; | ‘2. | The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and must be kept by the manufacturer.’; | (b) | in the eighth indent of the second paragraph of Section 3.1, the introductory part shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them;’; | ‘— | an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them;’; | (c) | in point (b) of the third paragraph of Section 3.2, the following indent shall be added:‘—where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’ | ‘— | where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’ | (d) | in Section 4.2, the following indent shall be inserted after the first indent:‘—the technical documentation,’; | ‘— | the technical documentation,’; | (e) | in Section 5.1, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’; | (f) | Section 6 shall be replaced by the following:‘6.   Application to devices in Class IIaIn line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:6.1.By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.6.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.6.3.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.6.4.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’; | 6.1. | By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them. | 6.2. | For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive. | 6.3. | In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken. | 6.4. | Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’; | (g) | in Section 7, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;

(a) | Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and must be kept by the manufacturer.’; | ‘2. | The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and must be kept by the manufacturer.’;

‘2. | The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and must be kept by the manufacturer.’;

(b) | in the eighth indent of the second paragraph of Section 3.1, the introductory part shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them;’; | ‘— | an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them;’;

‘— | an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them;’;

(c) | in point (b) of the third paragraph of Section 3.2, the following indent shall be added:‘—where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’ | ‘— | where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’

‘— | where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’

(d) | in Section 4.2, the following indent shall be inserted after the first indent:‘—the technical documentation,’; | ‘— | the technical documentation,’;

‘— | the technical documentation,’;

(e) | in Section 5.1, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’;

(f) | Section 6 shall be replaced by the following:‘6.   Application to devices in Class IIaIn line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:6.1.By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.6.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.6.3.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.6.4.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’; | 6.1. | By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them. | 6.2. | For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive. | 6.3. | In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken. | 6.4. | Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;

6.1. | By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.

6.2. | For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.

6.3. | In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.

6.4. | Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;

(g) | in Section 7, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;

6. | Annex VI shall be amended as follows:(a)Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and be kept by the manufacturer. The CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Annex.’;(b)in the eighth indent of the second paragraph of Section 3.1, the introductory part shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;(c)in Section 3.2, the following indent shall be added:‘—where the final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’(d)in Section 5.1, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’;(e)Section 6 shall be replaced by the following:‘6.   Application to devices in Class IIaIn line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:6.1.By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.6.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.6.3.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.6.4.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’; | (a) | Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and be kept by the manufacturer. The CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Annex.’; | ‘2. | The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and be kept by the manufacturer. The CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Annex.’; | (b) | in the eighth indent of the second paragraph of Section 3.1, the introductory part shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’; | ‘— | an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’; | (c) | in Section 3.2, the following indent shall be added:‘—where the final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’ | ‘— | where the final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’ | (d) | in Section 5.1, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’; | (e) | Section 6 shall be replaced by the following:‘6.   Application to devices in Class IIaIn line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:6.1.By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.6.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.6.3.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.6.4.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’; | 6.1. | By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them. | 6.2. | For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive. | 6.3. | In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken. | 6.4. | Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;

(a) | Section 2 shall be replaced by the following:‘2.The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and be kept by the manufacturer. The CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Annex.’; | ‘2. | The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and be kept by the manufacturer. The CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Annex.’;

‘2. | The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and be kept by the manufacturer. The CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Annex.’;

(b) | in the eighth indent of the second paragraph of Section 3.1, the introductory part shall be replaced by the following:‘—an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’; | ‘— | an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;

‘— | an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;

(c) | in Section 3.2, the following indent shall be added:‘—where the final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’ | ‘— | where the final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’

‘— | where the final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’

(d) | in Section 5.1, the introductory part shall be replaced by the following:‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’;

(e) | Section 6 shall be replaced by the following:‘6.   Application to devices in Class IIaIn line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:6.1.By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.6.2.For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.6.3.In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.6.4.Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’; | 6.1. | By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them. | 6.2. | For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive. | 6.3. | In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken. | 6.4. | Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;

6.1. | By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.

6.2. | For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.

6.3. | In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.

6.4. | Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;

7. | Annex VII shall be amended as follows:(a)Sections 1 and 2 shall be replaced by the following:‘1.The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.2.The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.’;(b)Section 3 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the product, including any variants planned and its intended use(s),’;(ii)the fifth indent shall be replaced by the following:‘—in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;(iii)the seventh indent shall be replaced by the following indents:‘—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,’;(iv)the following indent shall be inserted after the seventh indent:‘—the clinical evaluation in accordance with Annex X,’;(c)in Section 4, the introductory part shall be replaced by the following:‘4.The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. He shall notify the competent authorities of the following incidents immediately on learning of them:’;(d)in Section 5, the words ‘Annex IV, V or VI’ shall be replaced by the words ‘Annex II, IV, V or VI’; | (a) | Sections 1 and 2 shall be replaced by the following:‘1.The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.2.The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.’; | ‘1. | The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them. | 2. | The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.’; | (b) | Section 3 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the product, including any variants planned and its intended use(s),’;(ii)the fifth indent shall be replaced by the following:‘—in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;(iii)the seventh indent shall be replaced by the following indents:‘—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,’;(iv)the following indent shall be inserted after the seventh indent:‘—the clinical evaluation in accordance with Annex X,’; | (i) | the first indent shall be replaced by the following:‘—a general description of the product, including any variants planned and its intended use(s),’; | ‘— | a general description of the product, including any variants planned and its intended use(s),’; | (ii) | the fifth indent shall be replaced by the following:‘—in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’; | ‘— | in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’; | (iii) | the seventh indent shall be replaced by the following indents:‘—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,’; | ‘— | the solutions adopted as referred to in Annex I, Chapter I, Section 2, | — | the pre-clinical evaluation,’; | (iv) | the following indent shall be inserted after the seventh indent:‘—the clinical evaluation in accordance with Annex X,’; | ‘— | the clinical evaluation in accordance with Annex X,’; | (c) | in Section 4, the introductory part shall be replaced by the following:‘4.The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. He shall notify the competent authorities of the following incidents immediately on learning of them:’; | ‘4. | The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. He shall notify the competent authorities of the following incidents immediately on learning of them:’; | (d) | in Section 5, the words ‘Annex IV, V or VI’ shall be replaced by the words ‘Annex II, IV, V or VI’;

(a) | Sections 1 and 2 shall be replaced by the following:‘1.The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.2.The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.’; | ‘1. | The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them. | 2. | The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.’;

‘1. | The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.

2. | The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.’;

(b) | Section 3 shall be amended as follows:(i)the first indent shall be replaced by the following:‘—a general description of the product, including any variants planned and its intended use(s),’;(ii)the fifth indent shall be replaced by the following:‘—in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;(iii)the seventh indent shall be replaced by the following indents:‘—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,’;(iv)the following indent shall be inserted after the seventh indent:‘—the clinical evaluation in accordance with Annex X,’; | (i) | the first indent shall be replaced by the following:‘—a general description of the product, including any variants planned and its intended use(s),’; | ‘— | a general description of the product, including any variants planned and its intended use(s),’; | (ii) | the fifth indent shall be replaced by the following:‘—in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’; | ‘— | in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’; | (iii) | the seventh indent shall be replaced by the following indents:‘—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,’; | ‘— | the solutions adopted as referred to in Annex I, Chapter I, Section 2, | — | the pre-clinical evaluation,’; | (iv) | the following indent shall be inserted after the seventh indent:‘—the clinical evaluation in accordance with Annex X,’; | ‘— | the clinical evaluation in accordance with Annex X,’;

(i) | the first indent shall be replaced by the following:‘—a general description of the product, including any variants planned and its intended use(s),’; | ‘— | a general description of the product, including any variants planned and its intended use(s),’;

‘— | a general description of the product, including any variants planned and its intended use(s),’;

(ii) | the fifth indent shall be replaced by the following:‘—in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’; | ‘— | in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;

‘— | in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;

(iii) | the seventh indent shall be replaced by the following indents:‘—the solutions adopted as referred to in Annex I, Chapter I, Section 2,—the pre-clinical evaluation,’; | ‘— | the solutions adopted as referred to in Annex I, Chapter I, Section 2, | — | the pre-clinical evaluation,’;

‘— | the solutions adopted as referred to in Annex I, Chapter I, Section 2,

— | the pre-clinical evaluation,’;

(iv) | the following indent shall be inserted after the seventh indent:‘—the clinical evaluation in accordance with Annex X,’; | ‘— | the clinical evaluation in accordance with Annex X,’;

‘— | the clinical evaluation in accordance with Annex X,’;

(c) | in Section 4, the introductory part shall be replaced by the following:‘4.The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. He shall notify the competent authorities of the following incidents immediately on learning of them:’; | ‘4. | The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. He shall notify the competent authorities of the following incidents immediately on learning of them:’;

‘4. | The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. He shall notify the competent authorities of the following incidents immediately on learning of them:’;

(d) | in Section 5, the words ‘Annex IV, V or VI’ shall be replaced by the words ‘Annex II, IV, V or VI’;

8. | Annex VIII shall be amended as follows:(a)in Section 1, the words ‘established in the Community’ shall be deleted;(b)Section 2.1 shall be amended as follows:(i)the following indent shall be inserted after the introductory phrase:‘—the name and address of the manufacturer,’;(ii)the fourth indent shall be replaced by the following:‘—the specific characteristics of the product as indicated by the prescription,’;(c)Section 2.2 shall be amended as follows:(i)the second indent shall be replaced by the following:‘—the clinical investigation plan,’;(ii)the following indents shall be inserted after the second indent:‘—the investigator’s brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;(d)in Section 3.1, the first paragraph shall be replaced by the following:‘3.1.For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.’;(e)Section 3.2 shall be replaced by the following:‘3.2.For devices intended for clinical investigations, the documentation must contain:—a general description of the product and its intended use,—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,—the results of the design calculations, and of the inspections and technical tests carried out, etc.The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation referred to in the first paragraph of this Section.The manufacturer must authorise the assessment, or audit where necessary, of the effectiveness of these measures.’;(f)Section 4 shall be replaced by the following:‘4.The information contained in the declarations concerned by this Annex shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years.’;(g)the following section shall be added:‘5.For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’; | (a) | in Section 1, the words ‘established in the Community’ shall be deleted; | (b) | Section 2.1 shall be amended as follows:(i)the following indent shall be inserted after the introductory phrase:‘—the name and address of the manufacturer,’;(ii)the fourth indent shall be replaced by the following:‘—the specific characteristics of the product as indicated by the prescription,’; | (i) | the following indent shall be inserted after the introductory phrase:‘—the name and address of the manufacturer,’; | ‘— | the name and address of the manufacturer,’; | (ii) | the fourth indent shall be replaced by the following:‘—the specific characteristics of the product as indicated by the prescription,’; | ‘— | the specific characteristics of the product as indicated by the prescription,’; | (c) | Section 2.2 shall be amended as follows:(i)the second indent shall be replaced by the following:‘—the clinical investigation plan,’;(ii)the following indents shall be inserted after the second indent:‘—the investigator’s brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’; | (i) | the second indent shall be replaced by the following:‘—the clinical investigation plan,’; | ‘— | the clinical investigation plan,’; | (ii) | the following indents shall be inserted after the second indent:‘—the investigator’s brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’; | ‘— | the investigator’s brochure, | — | the confirmation of insurance of subjects, | — | the documents used to obtain informed consent, | — | a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, | — | a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’; | (d) | in Section 3.1, the first paragraph shall be replaced by the following:‘3.1.For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.’; | ‘3.1. | For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.’; | (e) | Section 3.2 shall be replaced by the following:‘3.2.For devices intended for clinical investigations, the documentation must contain:—a general description of the product and its intended use,—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,—the results of the design calculations, and of the inspections and technical tests carried out, etc.The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation referred to in the first paragraph of this Section.The manufacturer must authorise the assessment, or audit where necessary, of the effectiveness of these measures.’; | ‘3.2. | For devices intended for clinical investigations, the documentation must contain:—a general description of the product and its intended use,—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,—the results of the design calculations, and of the inspections and technical tests carried out, etc. | — | a general description of the product and its intended use, | — | design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc., | — | the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product, | — | the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied, | — | if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device, | — | if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection, | — | the results of the design calculations, and of the inspections and technical tests carried out, etc. | (f) | Section 4 shall be replaced by the following:‘4.The information contained in the declarations concerned by this Annex shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years.’; | ‘4. | The information contained in the declarations concerned by this Annex shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years.’; | (g) | the following section shall be added:‘5.For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’; | ‘5. | For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’; | (i) | any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health; | (ii) | any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;

(a) | in Section 1, the words ‘established in the Community’ shall be deleted;

(b) | Section 2.1 shall be amended as follows:(i)the following indent shall be inserted after the introductory phrase:‘—the name and address of the manufacturer,’;(ii)the fourth indent shall be replaced by the following:‘—the specific characteristics of the product as indicated by the prescription,’; | (i) | the following indent shall be inserted after the introductory phrase:‘—the name and address of the manufacturer,’; | ‘— | the name and address of the manufacturer,’; | (ii) | the fourth indent shall be replaced by the following:‘—the specific characteristics of the product as indicated by the prescription,’; | ‘— | the specific characteristics of the product as indicated by the prescription,’;

(i) | the following indent shall be inserted after the introductory phrase:‘—the name and address of the manufacturer,’; | ‘— | the name and address of the manufacturer,’;

‘— | the name and address of the manufacturer,’;

(ii) | the fourth indent shall be replaced by the following:‘—the specific characteristics of the product as indicated by the prescription,’; | ‘— | the specific characteristics of the product as indicated by the prescription,’;

‘— | the specific characteristics of the product as indicated by the prescription,’;

(c) | Section 2.2 shall be amended as follows:(i)the second indent shall be replaced by the following:‘—the clinical investigation plan,’;(ii)the following indents shall be inserted after the second indent:‘—the investigator’s brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’; | (i) | the second indent shall be replaced by the following:‘—the clinical investigation plan,’; | ‘— | the clinical investigation plan,’; | (ii) | the following indents shall be inserted after the second indent:‘—the investigator’s brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’; | ‘— | the investigator’s brochure, | — | the confirmation of insurance of subjects, | — | the documents used to obtain informed consent, | — | a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, | — | a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;

(i) | the second indent shall be replaced by the following:‘—the clinical investigation plan,’; | ‘— | the clinical investigation plan,’;

‘— | the clinical investigation plan,’;

(ii) | the following indents shall be inserted after the second indent:‘—the investigator’s brochure,—the confirmation of insurance of subjects,—the documents used to obtain informed consent,—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’; | ‘— | the investigator’s brochure, | — | the confirmation of insurance of subjects, | — | the documents used to obtain informed consent, | — | a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, | — | a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;

‘— | the investigator’s brochure,

— | the confirmation of insurance of subjects,

— | the documents used to obtain informed consent,

— | a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,

— | a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;

(d) | in Section 3.1, the first paragraph shall be replaced by the following:‘3.1.For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.’; | ‘3.1. | For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.’;

‘3.1. | For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.’;

(e) | Section 3.2 shall be replaced by the following:‘3.2.For devices intended for clinical investigations, the documentation must contain:—a general description of the product and its intended use,—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,—the results of the design calculations, and of the inspections and technical tests carried out, etc.The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation referred to in the first paragraph of this Section.The manufacturer must authorise the assessment, or audit where necessary, of the effectiveness of these measures.’; | ‘3.2. | For devices intended for clinical investigations, the documentation must contain:—a general description of the product and its intended use,—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,—the results of the design calculations, and of the inspections and technical tests carried out, etc. | — | a general description of the product and its intended use, | — | design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc., | — | the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product, | — | the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied, | — | if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device, | — | if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection, | — | the results of the design calculations, and of the inspections and technical tests carried out, etc.

‘3.2. | For devices intended for clinical investigations, the documentation must contain:—a general description of the product and its intended use,—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,—the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,—if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,—the results of the design calculations, and of the inspections and technical tests carried out, etc. | — | a general description of the product and its intended use, | — | design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc., | — | the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product, | — | the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied, | — | if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device, | — | if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection, | — | the results of the design calculations, and of the inspections and technical tests carried out, etc.

— | a general description of the product and its intended use,

— | design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,

— | the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,

— | the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,

— | if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

— | if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,

— | the results of the design calculations, and of the inspections and technical tests carried out, etc.

(f) | Section 4 shall be replaced by the following:‘4.The information contained in the declarations concerned by this Annex shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years.’; | ‘4. | The information contained in the declarations concerned by this Annex shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years.’;

‘4. | The information contained in the declarations concerned by this Annex shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years.’;

(g) | the following section shall be added:‘5.For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’; | ‘5. | For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’; | (i) | any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health; | (ii) | any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;

‘5. | For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(ii)any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’; | (i) | any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health; | (ii) | any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;

(i) | any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;

(ii) | any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;

9. | Annex IX shall be amended as follows:(a)Chapter I shall be amended as follows:(i)in Section 1.4, the following sentence shall be added:‘Stand alone software is considered to be an active medical device.’;(ii)Section 1.7 shall be replaced by the following:‘1.7.   Central circulatory systemFor the purposes of this Directive, “central circulatory system” means the following vessels:arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.’;(b)in Chapter II, Section 2, the following section shall be added:‘2.6.In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means “an uninterrupted actual use of the device for the intended purpose”. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.’;(c)Chapter III shall be amended as follows:(i)the introductory phrase of the first paragraph of Section 2.1 shall be replaced by the following:‘All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:’;(ii)Section 2.2 shall be replaced by the following:‘2.2.   Rule 6All surgically invasive devices intended for transient use are in Class IIa unless they are:—intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,—reusable surgical instruments, in which case they are in Class I,—intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,—intended to supply energy in the form of ionising radiation in which case they are in Class IIb,—intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,—intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;(iii)in Section 2.3, the first indent shall be replaced by the following:‘—either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;(iv)in Section 4.1, first paragraph, the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;(v)in Section 4.1, the second paragraph shall be replaced by the following:‘All devices incorporating, as an integral part, a human blood derivative are in Class III.’;(vi)in Section 4.3, second paragraph, the following phrase shall be added:‘unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.’;(vii)in Section 4.4, the words ‘Non-active devices’ shall be replaced by the word ‘Devices’; | (a) | Chapter I shall be amended as follows:(i)in Section 1.4, the following sentence shall be added:‘Stand alone software is considered to be an active medical device.’;(ii)Section 1.7 shall be replaced by the following:‘1.7.   Central circulatory systemFor the purposes of this Directive, “central circulatory system” means the following vessels:arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.’; | (i) | in Section 1.4, the following sentence shall be added:‘Stand alone software is considered to be an active medical device.’; | (ii) | Section 1.7 shall be replaced by the following:‘1.7.   Central circulatory systemFor the purposes of this Directive, “central circulatory system” means the following vessels:arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.’; | (b) | in Chapter II, Section 2, the following section shall be added:‘2.6.In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means “an uninterrupted actual use of the device for the intended purpose”. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.’; | ‘2.6. | In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means “an uninterrupted actual use of the device for the intended purpose”. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.’; | (c) | Chapter III shall be amended as follows:(i)the introductory phrase of the first paragraph of Section 2.1 shall be replaced by the following:‘All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:’;(ii)Section 2.2 shall be replaced by the following:‘2.2.   Rule 6All surgically invasive devices intended for transient use are in Class IIa unless they are:—intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,—reusable surgical instruments, in which case they are in Class I,—intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,—intended to supply energy in the form of ionising radiation in which case they are in Class IIb,—intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,—intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;(iii)in Section 2.3, the first indent shall be replaced by the following:‘—either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;(iv)in Section 4.1, first paragraph, the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;(v)in Section 4.1, the second paragraph shall be replaced by the following:‘All devices incorporating, as an integral part, a human blood derivative are in Class III.’;(vi)in Section 4.3, second paragraph, the following phrase shall be added:‘unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.’;(vii)in Section 4.4, the words ‘Non-active devices’ shall be replaced by the word ‘Devices’; | (i) | the introductory phrase of the first paragraph of Section 2.1 shall be replaced by the following:‘All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:’; | (ii) | Section 2.2 shall be replaced by the following:‘2.2.   Rule 6All surgically invasive devices intended for transient use are in Class IIa unless they are:—intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,—reusable surgical instruments, in which case they are in Class I,—intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,—intended to supply energy in the form of ionising radiation in which case they are in Class IIb,—intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,—intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’; | — | intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III, | — | reusable surgical instruments, in which case they are in Class I, | — | intended specifically for use in direct contact with the central nervous system, in which case they are in Class III, | — | intended to supply energy in the form of ionising radiation in which case they are in Class IIb, | — | intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb, | — | intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’; | (iii) | in Section 2.3, the first indent shall be replaced by the following:‘—either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’; | ‘— | either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’; | (iv) | in Section 4.1, first paragraph, the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’; | (v) | in Section 4.1, the second paragraph shall be replaced by the following:‘All devices incorporating, as an integral part, a human blood derivative are in Class III.’; | (vi) | in Section 4.3, second paragraph, the following phrase shall be added:‘unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.’; | (vii) | in Section 4.4, the words ‘Non-active devices’ shall be replaced by the word ‘Devices’;

(a) | Chapter I shall be amended as follows:(i)in Section 1.4, the following sentence shall be added:‘Stand alone software is considered to be an active medical device.’;(ii)Section 1.7 shall be replaced by the following:‘1.7.   Central circulatory systemFor the purposes of this Directive, “central circulatory system” means the following vessels:arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.’; | (i) | in Section 1.4, the following sentence shall be added:‘Stand alone software is considered to be an active medical device.’; | (ii) | Section 1.7 shall be replaced by the following:‘1.7.   Central circulatory systemFor the purposes of this Directive, “central circulatory system” means the following vessels:arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.’;

(i) | in Section 1.4, the following sentence shall be added:‘Stand alone software is considered to be an active medical device.’;

(ii) | Section 1.7 shall be replaced by the following:‘1.7.   Central circulatory systemFor the purposes of this Directive, “central circulatory system” means the following vessels:arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.’;

(b) | in Chapter II, Section 2, the following section shall be added:‘2.6.In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means “an uninterrupted actual use of the device for the intended purpose”. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.’; | ‘2.6. | In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means “an uninterrupted actual use of the device for the intended purpose”. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.’;

‘2.6. | In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means “an uninterrupted actual use of the device for the intended purpose”. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.’;

(c) | Chapter III shall be amended as follows:(i)the introductory phrase of the first paragraph of Section 2.1 shall be replaced by the following:‘All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:’;(ii)Section 2.2 shall be replaced by the following:‘2.2.   Rule 6All surgically invasive devices intended for transient use are in Class IIa unless they are:—intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,—reusable surgical instruments, in which case they are in Class I,—intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,—intended to supply energy in the form of ionising radiation in which case they are in Class IIb,—intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,—intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;(iii)in Section 2.3, the first indent shall be replaced by the following:‘—either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;(iv)in Section 4.1, first paragraph, the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;(v)in Section 4.1, the second paragraph shall be replaced by the following:‘All devices incorporating, as an integral part, a human blood derivative are in Class III.’;(vi)in Section 4.3, second paragraph, the following phrase shall be added:‘unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.’;(vii)in Section 4.4, the words ‘Non-active devices’ shall be replaced by the word ‘Devices’; | (i) | the introductory phrase of the first paragraph of Section 2.1 shall be replaced by the following:‘All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:’; | (ii) | Section 2.2 shall be replaced by the following:‘2.2.   Rule 6All surgically invasive devices intended for transient use are in Class IIa unless they are:—intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,—reusable surgical instruments, in which case they are in Class I,—intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,—intended to supply energy in the form of ionising radiation in which case they are in Class IIb,—intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,—intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’; | — | intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III, | — | reusable surgical instruments, in which case they are in Class I, | — | intended specifically for use in direct contact with the central nervous system, in which case they are in Class III, | — | intended to supply energy in the form of ionising radiation in which case they are in Class IIb, | — | intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb, | — | intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’; | (iii) | in Section 2.3, the first indent shall be replaced by the following:‘—either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’; | ‘— | either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’; | (iv) | in Section 4.1, first paragraph, the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’; | (v) | in Section 4.1, the second paragraph shall be replaced by the following:‘All devices incorporating, as an integral part, a human blood derivative are in Class III.’; | (vi) | in Section 4.3, second paragraph, the following phrase shall be added:‘unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.’; | (vii) | in Section 4.4, the words ‘Non-active devices’ shall be replaced by the word ‘Devices’;

(i) | the introductory phrase of the first paragraph of Section 2.1 shall be replaced by the following:‘All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:’;

(ii) | Section 2.2 shall be replaced by the following:‘2.2.   Rule 6All surgically invasive devices intended for transient use are in Class IIa unless they are:—intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,—reusable surgical instruments, in which case they are in Class I,—intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,—intended to supply energy in the form of ionising radiation in which case they are in Class IIb,—intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,—intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’; | — | intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III, | — | reusable surgical instruments, in which case they are in Class I, | — | intended specifically for use in direct contact with the central nervous system, in which case they are in Class III, | — | intended to supply energy in the form of ionising radiation in which case they are in Class IIb, | — | intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb, | — | intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;

— | intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,

— | reusable surgical instruments, in which case they are in Class I,

— | intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,

— | intended to supply energy in the form of ionising radiation in which case they are in Class IIb,

— | intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,

— | intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.’;

(iii) | in Section 2.3, the first indent shall be replaced by the following:‘—either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’; | ‘— | either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;

‘— | either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,’;

(iv) | in Section 4.1, first paragraph, the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;

(v) | in Section 4.1, the second paragraph shall be replaced by the following:‘All devices incorporating, as an integral part, a human blood derivative are in Class III.’;

(vi) | in Section 4.3, second paragraph, the following phrase shall be added:‘unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.’;

(vii) | in Section 4.4, the words ‘Non-active devices’ shall be replaced by the word ‘Devices’;

10. | Annex X shall be amended as follows:(a)Section 1.1 shall be replaced by the following:‘1.1.As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referred to as “clinical evaluation”, where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:1.1.1.Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:—there is demonstration of equivalence of the device to the device to which the data relates, and—the data adequately demonstrate compliance with the relevant essential requirements.1.1.2.Or a critical evaluation of the results of all clinical investigations made.1.1.3.Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.’(b)The following Sections shall be inserted:‘1.1aIn the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.1.1bThe clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.1.1cThe clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.1.1dWhere demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.’;(c)in Section 2.2, the first sentence shall be replaced by the following:‘Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, as last amended by the World Medical Assembly.’;(d)Section 2.3.5 shall be replaced by the following:‘2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’. | (a) | Section 1.1 shall be replaced by the following:‘1.1.As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referred to as “clinical evaluation”, where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:1.1.1.Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:—there is demonstration of equivalence of the device to the device to which the data relates, and—the data adequately demonstrate compliance with the relevant essential requirements.1.1.2.Or a critical evaluation of the results of all clinical investigations made.1.1.3.Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.’ | ‘1.1. | As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referred to as “clinical evaluation”, where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on: | 1.1.1. | Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:—there is demonstration of equivalence of the device to the device to which the data relates, and—the data adequately demonstrate compliance with the relevant essential requirements. | — | there is demonstration of equivalence of the device to the device to which the data relates, and | — | the data adequately demonstrate compliance with the relevant essential requirements. | 1.1.2. | Or a critical evaluation of the results of all clinical investigations made. | 1.1.3. | Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.’ | (b) | The following Sections shall be inserted:‘1.1aIn the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.1.1bThe clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.1.1cThe clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.1.1dWhere demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.’; | ‘1.1a | In the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data. | 1.1b | The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device. | 1.1c | The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented. | 1.1d | Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.’; | (c) | in Section 2.2, the first sentence shall be replaced by the following:‘Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, as last amended by the World Medical Assembly.’; | (d) | Section 2.3.5 shall be replaced by the following:‘2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’. | ‘2.3.5. | All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’.

(a) | Section 1.1 shall be replaced by the following:‘1.1.As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referred to as “clinical evaluation”, where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:1.1.1.Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:—there is demonstration of equivalence of the device to the device to which the data relates, and—the data adequately demonstrate compliance with the relevant essential requirements.1.1.2.Or a critical evaluation of the results of all clinical investigations made.1.1.3.Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.’ | ‘1.1. | As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referred to as “clinical evaluation”, where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on: | 1.1.1. | Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:—there is demonstration of equivalence of the device to the device to which the data relates, and—the data adequately demonstrate compliance with the relevant essential requirements. | — | there is demonstration of equivalence of the device to the device to which the data relates, and | — | the data adequately demonstrate compliance with the relevant essential requirements. | 1.1.2. | Or a critical evaluation of the results of all clinical investigations made. | 1.1.3. | Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.’

‘1.1. | As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referred to as “clinical evaluation”, where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:

1.1.1. | Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:—there is demonstration of equivalence of the device to the device to which the data relates, and—the data adequately demonstrate compliance with the relevant essential requirements. | — | there is demonstration of equivalence of the device to the device to which the data relates, and | — | the data adequately demonstrate compliance with the relevant essential requirements.

— | there is demonstration of equivalence of the device to the device to which the data relates, and

— | the data adequately demonstrate compliance with the relevant essential requirements.

1.1.2. | Or a critical evaluation of the results of all clinical investigations made.

1.1.3. | Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.’

(b) | The following Sections shall be inserted:‘1.1aIn the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.1.1bThe clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.1.1cThe clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.1.1dWhere demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.’; | ‘1.1a | In the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data. | 1.1b | The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device. | 1.1c | The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented. | 1.1d | Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.’;

‘1.1a | In the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.

1.1b | The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.

1.1c | The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.

1.1d | Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.’;

(c) | in Section 2.2, the first sentence shall be replaced by the following:‘Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, as last amended by the World Medical Assembly.’;

(d) | Section 2.3.5 shall be replaced by the following:‘2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’. | ‘2.3.5. | All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’.

‘2.3.5. | All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’.

(*1)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as last amended by Regulation (EC) No 1901/2006.’
(*2)  

            OJ 196, 16.8.1967, p. 1. Directive as last amended by Directive 2006/121/EC of the European Parliament and of the Council (OJ L 396, 30.12.2006, p. 850).’
(*3)  Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).’

         ’
			

Pending: 32007L0033

                                January 16, 2026                            

16.6.2007
EN
Official Journal of the European Union
L 156/12

(1)
Since the adoption of Council Directive 69/465/EEC of 8 December 1969 on control of Potato Cyst Eelworm(1), there have been significant developments in the nomenclature, biology and epidemiology of potato cyst nematode species and populations and their distribution pattern.

(2)
Potato cyst nematodes (Globodera pallida(Stone) Behrens (European populations) andGlobodera rostochiensis(Wollenweber) Behrens (European populations)) are recognised as harmful organisms of potatoes.

(3)
The provisions of Directive 69/465/EEC have been re-examined and, as a result of this re-examination, have been found insufficient. Therefore, the adoption of more comprehensive provisions is necessary.

(4)
The provisions should take into account that official investigations are necessary to ensure that no potato cyst nematodes are found in fields in which seed potatoes intended for the production of seed potatoes, and certain plants intended for the production of plants for planting, are planted or stored.

(5)
Official surveys should be carried out on fields used for the production of potatoes other than those used for the production of seed potatoes in order to determine the distribution of the potato cyst nematodes.

(6)
Sampling and testing procedures should be set out for conducting such official investigations and surveys.

(7)
Account should be taken of the means of spread of the pathogen.

(8)
The provisions should take into account that the control of potato cyst nematodes is traditionally by crop rotation as it is recognised that several years in the absence of potato cultivation will reduce the population of nematodes by a significant degree. More recently crop rotation has been supplemented by the use of resistant potato varieties.

(9)
Furthermore, Member States should be able to take additional or stricter measures where necessary, provided that there is no hindrance to the movement of potatoes within the Community, except insofar as laid down in Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(2). Such measures should be notified to the Commission and to the other Member States.

(10)
Directive 69/465/EEC should therefore be repealed.

(11)
Since the objectives of this Directive, namely to determine the distribution of potato cyst nematodes to prevent their spread and to control them, cannot be sufficiently achieved by the Member States and can therefore by reason of the scale and effects of this Directive be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.

(12)
The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(3),

(a)
‘official’ or ‘officially’ means established, authorised or performed by the responsible official bodies of a Member State as defined in Article 2(1)(g) of Directive 2000/29/EC;

(b)
‘resistant potato variety’ means a variety that when grown significantly inhibits the development of a particular population of potato cyst nematodes;

(c)
‘investigation’ means a methodical procedure to determine the presence of potato cyst nematodes in a field;

(d)
‘survey means’ a methodical procedure conducted over a defined period of time to determine the distribution of potato cyst nematodes in the territory of a Member State.

(a)
the planting of plants listed in Annex I, intended for the production of plants for planting to be used within the same place of production situated in an officially defined area;

(b)
the planting of seed potatoes, intended for the production of seed potatoes to be used within the same place of production situated in an officially defined area;

(c)
the planting of plants listed in point 2 of Annex I, intended for the production of plants for planting where the harvested plants are to be subject to the officially approved measures referred to in Section III(A) of Annex III.

(a)
no potatoes intended for the production of seed potatoes shall be planted; and

(b)
no plants listed in Annex I, intended for replanting, shall be planted or stored. However, plants listed in point 2 of Annex I may be planted in that field provided that these plants are to be subject to the officially approved measures referred to in Section III(A) of Annex III, such that there is no identifiable risk of spreading potato cyst nematodes.

(a)
in the case of seed potatoes and the host plants listed in point 1 of Annex I, they shall not be planted unless they have been decontaminated under the supervision of the responsible official bodies of a Member State using an appropriate method adopted under paragraph 2 of this Article, based on scientific evidence that there is no risk of spreading potato cyst nematodes;

(b)
in the case of potatoes intended for industrial processing or grading, they shall be subject to officially approved measures in accordance with Section III(B) of Annex III;

(c)
in the case of plants listed in point 2 of Annex I, they shall not be planted unless they have been subject to the officially approved measures as referred to in Section III(A) of Annex III, such that they are no longer contaminated.

1.
Host plants with roots:Capsicumspp.,Lycopersicon lycopersicum(L.) Karsten ex Farw.,Solanum melongenaL.

Capsicumspp.,

Lycopersicon lycopersicum(L.) Karsten ex Farw.,

Solanum melongenaL.

Capsicumspp.,

Lycopersicon lycopersicum(L.) Karsten ex Farw.,

Solanum melongenaL.

Capsicumspp.,

Lycopersicon lycopersicum(L.) Karsten ex Farw.,

Solanum melongenaL.

2.
(a)Other plants with roots:Allium porrumL.,Beta vulgarisL.,Brassicaspp.,FragariaL.,Asparagus officinalisL.(b)Bulbs, tubers and rhizomes, not subjected to the officially approved measures as referred to in Section III(A) of Annex III, grown in soil and intended for planting, other than those for which there shall be evidence by their packaging or by other means that they are intended for sale to final consumers not involved in professional plant or cut flower production, of:Allium ascalonicumL.,Allium cepaL.,Dahliaspp.,GladiolusTourn. Ex L.,Hyacinthusspp.,Irisspp.,Liliumspp.,NarcissusL.,TulipaL.
(a)
Other plants with roots:Allium porrumL.,Beta vulgarisL.,Brassicaspp.,FragariaL.,Asparagus officinalisL.

Allium porrumL.,

Beta vulgarisL.,

Brassicaspp.,

FragariaL.,

Asparagus officinalisL.
(b)
Bulbs, tubers and rhizomes, not subjected to the officially approved measures as referred to in Section III(A) of Annex III, grown in soil and intended for planting, other than those for which there shall be evidence by their packaging or by other means that they are intended for sale to final consumers not involved in professional plant or cut flower production, of:Allium ascalonicumL.,Allium cepaL.,Dahliaspp.,GladiolusTourn. Ex L.,Hyacinthusspp.,Irisspp.,Liliumspp.,NarcissusL.,TulipaL.

Allium ascalonicumL.,

Allium cepaL.,

Dahliaspp.,

GladiolusTourn. Ex L.,

Hyacinthusspp.,

Irisspp.,

Liliumspp.,

NarcissusL.,

TulipaL.

(a)
Other plants with roots:Allium porrumL.,Beta vulgarisL.,Brassicaspp.,FragariaL.,Asparagus officinalisL.

Allium porrumL.,

Beta vulgarisL.,

Brassicaspp.,

FragariaL.,

Asparagus officinalisL.

Allium porrumL.,

Beta vulgarisL.,

Brassicaspp.,

FragariaL.,

Asparagus officinalisL.

(b)
Bulbs, tubers and rhizomes, not subjected to the officially approved measures as referred to in Section III(A) of Annex III, grown in soil and intended for planting, other than those for which there shall be evidence by their packaging or by other means that they are intended for sale to final consumers not involved in professional plant or cut flower production, of:Allium ascalonicumL.,Allium cepaL.,Dahliaspp.,GladiolusTourn. Ex L.,Hyacinthusspp.,Irisspp.,Liliumspp.,NarcissusL.,TulipaL.

Allium ascalonicumL.,

Allium cepaL.,

Dahliaspp.,

GladiolusTourn. Ex L.,

Hyacinthusspp.,

Irisspp.,

Liliumspp.,

NarcissusL.,

TulipaL.

Allium ascalonicumL.,

Allium cepaL.,

Dahliaspp.,

GladiolusTourn. Ex L.,

Hyacinthusspp.,

Irisspp.,

Liliumspp.,

NarcissusL.,

TulipaL.

(a)
Other plants with roots:Allium porrumL.,Beta vulgarisL.,Brassicaspp.,FragariaL.,Asparagus officinalisL.

Allium porrumL.,

Beta vulgarisL.,

Brassicaspp.,

FragariaL.,

Asparagus officinalisL.

Allium porrumL.,

Beta vulgarisL.,

Brassicaspp.,

FragariaL.,

Asparagus officinalisL.

Allium porrumL.,

Beta vulgarisL.,

Brassicaspp.,

FragariaL.,

Asparagus officinalisL.

(b)
Bulbs, tubers and rhizomes, not subjected to the officially approved measures as referred to in Section III(A) of Annex III, grown in soil and intended for planting, other than those for which there shall be evidence by their packaging or by other means that they are intended for sale to final consumers not involved in professional plant or cut flower production, of:Allium ascalonicumL.,Allium cepaL.,Dahliaspp.,GladiolusTourn. Ex L.,Hyacinthusspp.,Irisspp.,Liliumspp.,NarcissusL.,TulipaL.

Allium ascalonicumL.,

Allium cepaL.,

Dahliaspp.,

GladiolusTourn. Ex L.,

Hyacinthusspp.,

Irisspp.,

Liliumspp.,

NarcissusL.,

TulipaL.

Allium ascalonicumL.,

Allium cepaL.,

Dahliaspp.,

GladiolusTourn. Ex L.,

Hyacinthusspp.,

Irisspp.,

Liliumspp.,

NarcissusL.,

TulipaL.

Allium ascalonicumL.,

Allium cepaL.,

Dahliaspp.,

GladiolusTourn. Ex L.,

Hyacinthusspp.,

Irisspp.,

Liliumspp.,

NarcissusL.,

TulipaL.

(a)
sampling shall involve a soil sample with a standard rate of at least 1 500 ml soil/ha collected from at least 100 cores/ha preferably in a rectangular grid of not less than 5 metres in width and not more than 20 metres in length between sampling points covering the entire field. The whole sample shall be used for further examination, i.e. extraction of cysts, species identification and, if applicable, pathotype/virulence group determination;

(b)
testing shall involve methods for the extraction of potato cyst nematodes described in the relevant Phytosanitary Procedures or Diagnostic Protocols forGlobodera pallidaandGlobodera rostochiensis: EPPO standards.

(a)
sampling shall be:—the sampling described in paragraph 1 with a minimum sampling rate of soil of at least 400 ml/ha,or—targeted sampling of at least 400 ml of soil after visual examination of roots where there are visual symptoms,or—sampling of at least 400 ml of soil associated with the potatoes after harvesting provided that the field where the potatoes were grown is traceable;
—
the sampling described in paragraph 1 with a minimum sampling rate of soil of at least 400 ml/ha,
—
targeted sampling of at least 400 ml of soil after visual examination of roots where there are visual symptoms,
—
sampling of at least 400 ml of soil associated with the potatoes after harvesting provided that the field where the potatoes were grown is traceable;

—
the sampling described in paragraph 1 with a minimum sampling rate of soil of at least 400 ml/ha,

—
targeted sampling of at least 400 ml of soil after visual examination of roots where there are visual symptoms,

—
sampling of at least 400 ml of soil associated with the potatoes after harvesting provided that the field where the potatoes were grown is traceable;

—
the sampling described in paragraph 1 with a minimum sampling rate of soil of at least 400 ml/ha,

—
targeted sampling of at least 400 ml of soil after visual examination of roots where there are visual symptoms,

—
sampling of at least 400 ml of soil associated with the potatoes after harvesting provided that the field where the potatoes were grown is traceable;

(b)
testing shall be the testing referred to in paragraph 1.

(a)
there is documentary evidence that no potatoes or other host plants listed in point 1 of Annex I have been grown and were present in the field in the six years prior to the official investigation;

(b)
no potato cyst nematodes have been found during the last two successive official investigations in samples of 1 500 ml soil/ha and no potatoes or other host plants listed in point 1 of Annex I, other than those for which an official investigation is required according to Article 4(1), have been grown after the first official investigation;

(c)
no potato cyst nematodes or potato cyst nematode cysts without live content have been found in the last official investigation which must have consisted of a sample size of at least 1 500 ml soil/ha and no potatoes or other host plants listed in point 1 of Annex I, other than those for which an official investigation is required according to Article 4(1), have been grown in the field since the last official investigation.

(a)
in the case of the standard rate referred to in paragraph 1, the first 8 ha shall be sampled at the rate specified therein, but may be reduced for each additional hectare to a minimum of 400 ml of soil/ha;

(b)
in the case of the reduced rate referred to in paragraph 3, the first 4 ha shall be sampled at the rate specified therein, but may be further reduced for each additional hectare to a minimum of 200 ml of soil/ha.

—
no history of potato cyst nematodes in the field during the last 12 years, based on the results of appropriate officially approved testing,

—
a known cropping history in which no potatoes or other hosts plants listed in point 1 of Annex I have been grown in the field in the past 12 years.

(A)
The officially approved measures referred to in Article 4(4)(c), 9(1)(b) Article 10(1)(c) and in paragraph 2b of Annex I are:1.disinfestation by appropriate methods such that there is no identifiable risk of the potato cyst nematodes spreading;2.removal of soil by washing or brushing until practically free of soil such that there is no identifiable risk of the potato cyst nematodes spreading.
1.
disinfestation by appropriate methods such that there is no identifiable risk of the potato cyst nematodes spreading;
2.
removal of soil by washing or brushing until practically free of soil such that there is no identifiable risk of the potato cyst nematodes spreading.

1.
disinfestation by appropriate methods such that there is no identifiable risk of the potato cyst nematodes spreading;

2.
removal of soil by washing or brushing until practically free of soil such that there is no identifiable risk of the potato cyst nematodes spreading.

1.
disinfestation by appropriate methods such that there is no identifiable risk of the potato cyst nematodes spreading;

2.
removal of soil by washing or brushing until practically free of soil such that there is no identifiable risk of the potato cyst nematodes spreading.

(B)
The officially approved measures referred to in Article 10(1)(b) are delivery to a processing or grading plant with appropriate and officially approved waste disposal procedures for which it has been established that there is no risk of the potato cyst nematodes spreading.

(C)
The officially approved measures referred to in Article 13 are an official re-sampling of the field officially recorded as infested as referred to in Article 8(1) or 8(2), and testing using one of the methods specified in Annex II, after a minimum period of six years counting from the positive confirmation of potato cyst nematodes, or counting from the growing of the last potato crop. This period may be reduced to a minimum of three years if appropriate officially approved control measures have been taken.

Relative susceptibility (%)
Score

< 1
9

1,1-3
8

3,1-5
7

5,1-10
6

10,1-15
5

15,1-25
4

25,1-50
3

50,1-100
2

> 100
1

1.
The test shall be performed in a quarantine facility either outside, in glasshouses, or in climate chambers.

2.
The test shall be performed in pots each containing at least one litre of soil (or suitable substrate).

3.
The soil temperature during the course of the test shall not exceed 25 °C and adequate watering shall be provided.

4.
When planting the test or control variety one potato eye plug of each test or control variety shall be used. Removal of all stems except one is recommended.

5.
The potato variety ‘Désirée’ shall be used as a standard susceptible control variety in every test. Additional fully susceptible control varieties of local relevance may be added as internal checks. The standard susceptible control variety may be changed if research indicates that other varieties are either more suitable or more accessible.

6.
The following standard populations of potato cyst nematodes shall be used against pathotypes Ro1, Ro5, Pa1 and Pa3:Ro1: population EcosseRo5: population HarmerzPa1: population ScottishPa3: population ChavornayOther potato cyst nematode populations of local relevance may be added.

Ro1: population Ecosse

Ro5: population Harmerz

Pa1: population Scottish

Pa3: population Chavornay

Ro1: population Ecosse

Ro5: population Harmerz

Pa1: population Scottish

Pa3: population Chavornay

Ro1: population Ecosse

Ro5: population Harmerz

Pa1: population Scottish

Pa3: population Chavornay

7.
The identity of the standard population used shall be checked using appropriate methods. It is recommended that at least two resistant varieties or two differential standard clones of known resistance capacity are used in the test experiments.

8.
The potato cyst nematode inoculum (Pi) shall consist in total of five infective eggs and juveniles per ml of soil. It is recommended that the number of potato cyst nematodes to be inoculated per ml of soil is determined in hatching experiments. The potato cyst nematodes may be inoculated as cysts, or combined as eggs and juveniles in a suspension.

9.
The viability of the potato cyst nematode cyst content used as the inoculum source shall be at least 70 %. It is recommended that the cysts are 6-24 months old and are kept for at least four months at 4 °C immediately prior to use.

10.
There shall be at least four replicates (pots) per combination of potato cyst nematode population and potato variety tested. It is recommended to use at least 10 replicates for the standard susceptible control variety.

11.
The duration of the test shall be at least three months and the maturity of developing females shall be checked before breaking up the experiment.

12.
Potato cyst nematode cysts from the four replicates shall be extracted and counted separately for each pot.

13.
The final population (Pf) on the standard susceptible control variety at the end of the resistance test shall be determined by counting all cysts from all replicates and the eggs and juveniles from at least four replicates.

14.
A multiplication rate of at least 20 × (Pf/Pi) on the standard susceptible control variety shall be achieved.

15.
The coefficient of variation (CV) on the standard susceptible control variety shall not exceed 35 %.

16.
The relative susceptibility of the tested potato variety to the standard susceptible control variety shall be determined and expressed as a percentage according to the formula:Pftest variety/Pfstandard susceptible control variety× 100 %.

17.
If a tested potato variety has a relative susceptibility of more than 3 %, cyst counts will suffice. In cases where the relative susceptibility is less than 3 %, eggs and juveniles shall be counted in addition to cyst counts.

18.
Where the results of tests in the first year indicate that a variety is fully susceptible to a pathotype, there is no requirement to repeat these tests in a second year.

19.
The results of the tests shall be confirmed by at least one other trial performed in another year. The arithmetic mean of the relative susceptibility in the two years shall be used to derive the score according to the standard scoring notation.

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Parliament,

(1) Since the adoption of Council Directive 69/465/EEC of 8 December 1969 on control of Potato Cyst Eelworm(1), there have been significant developments in the nomenclature, biology and epidemiology of potato cyst nematode species and populations and their distribution pattern.

(2) Potato cyst nematodes (Globodera pallida(Stone) Behrens (European populations) andGlobodera rostochiensis(Wollenweber) Behrens (European populations)) are recognised as harmful organisms of potatoes.

(3) The provisions of Directive 69/465/EEC have been re-examined and, as a result of this re-examination, have been found insufficient. Therefore, the adoption of more comprehensive provisions is necessary.

(4) The provisions should take into account that official investigations are necessary to ensure that no potato cyst nematodes are found in fields in which seed potatoes intended for the production of seed potatoes, and certain plants intended for the production of plants for planting, are planted or stored.

(5) Official surveys should be carried out on fields used for the production of potatoes other than those used for the production of seed potatoes in order to determine the distribution of the potato cyst nematodes.

(6) Sampling and testing procedures should be set out for conducting such official investigations and surveys.

(7) Account should be taken of the means of spread of the pathogen.

(8) The provisions should take into account that the control of potato cyst nematodes is traditionally by crop rotation as it is recognised that several years in the absence of potato cultivation will reduce the population of nematodes by a significant degree. More recently crop rotation has been supplemented by the use of resistant potato varieties.

(9) Furthermore, Member States should be able to take additional or stricter measures where necessary, provided that there is no hindrance to the movement of potatoes within the Community, except insofar as laid down in Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(2). Such measures should be notified to the Commission and to the other Member States.

(10) Directive 69/465/EEC should therefore be repealed.

(11) Since the objectives of this Directive, namely to determine the distribution of potato cyst nematodes to prevent their spread and to control them, cannot be sufficiently achieved by the Member States and can therefore by reason of the scale and effects of this Directive be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.

(12) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(3),

HAS ADOPTED THIS DIRECTIVE:
Article 1

This Directive establishes the measures to be taken by the Member States againstGlobodera pallida(Stone) Behrens (European populations) andGlobodera rostochiensis(Wollenweber) Behrens (European populations), hereinafter referred to as ‘potato cyst nematodes’, in order to determine their distribution, to prevent their spread and to control them.
Article 2

For the purpose of this Directive, the following definitions shall apply:

(a)

‘official’ or ‘officially’ means established, authorised or performed by the responsible official bodies of a Member State as defined in Article 2(1)(g) of Directive 2000/29/EC;

(b)

‘resistant potato variety’ means a variety that when grown significantly inhibits the development of a particular population of potato cyst nematodes;

(c)

‘investigation’ means a methodical procedure to determine the presence of potato cyst nematodes in a field;

(d)

‘survey means’ a methodical procedure conducted over a defined period of time to determine the distribution of potato cyst nematodes in the territory of a Member State.
Article 3

1.   The responsible official bodies of the Member State shall define what constitutes a field for the purposes of this Directive in order to ensure that phytosanitary conditions within a field are homogeneous as regards the risk of potato cyst nematodes. In doing so, they shall take into account sound scientific and statistical principles, the biology of the potato cyst nematode, the cultivation of the field and the particular production systems of the host plants of potato cyst nematodes in that Member State. The detailed criteria for the definition of a field shall be officially notified to the Commission and to the other Member States.

2.   Further provisions related to the criteria for the definition of a field may be adopted in accordance with the procedure referred to in Article 17(2).
Article 4

1.   Member States shall prescribe that an official investigation for the presence of potato cyst nematodes shall be carried out on the field in which the plants listed in Annex I, intended for the production of plants for planting, or seed potatoes intended for the production of seed potatoes, are to be planted or stored.

2.   The official investigation provided for in paragraph 1 shall be carried out in the period between the harvesting of the last crop in the field and the planting of the plants or seed potatoes mentioned in paragraph 1. It may be carried out earlier, in which case documentary evidence shall be available of the results of that investigation confirming that potato cyst nematodes have not been found and that potatoes and other host plants listed in point 1 of Annex I were not present at the time of the investigation and have not been grown since the investigation.

3.   Results of official investigations other than those referred to in paragraph 1 and carried out before 1 July 2010 may be considered as evidence as referred to in paragraph 2.

4.   If the responsible official bodies of a Member State have established that there is no risk of spreading potato cyst nematodes, the official investigation referred to in paragraph 1 shall not be required for:

(a)

the planting of plants listed in Annex I, intended for the production of plants for planting to be used within the same place of production situated in an officially defined area;

(b)

the planting of seed potatoes, intended for the production of seed potatoes to be used within the same place of production situated in an officially defined area;

(c)

the planting of plants listed in point 2 of Annex I, intended for the production of plants for planting where the harvested plants are to be subject to the officially approved measures referred to in Section III(A) of Annex III.

5.   Member States shall ensure that the results of the investigations referred to in paragraphs 1 and 3 are officially recorded and are accessible to the Commission.
Article 5

1.   In the case of fields in which seed potatoes or plants listed in point 1 of Annex I intended for the production of plants for planting, are to be planted or stored, the official investigation referred to in Article 4(1) shall involve sampling and testing for the presence of potato cyst nematodes in accordance with Annex II.

2.   In the case of fields in which the plants listed in point 2 of Annex I, intended for the production of plants for planting, are to be planted or stored, the official investigation referred to in Article 4(1) shall involve sampling and testing for the presence of potato cyst nematodes in accordance with Annex II or verification as set out in Section I of Annex III.
Article 6

1.   Member States shall provide that official surveys are carried out on fields used for the production of potatoes, other than those intended for the production of seed potatoes, in order to determine the distribution of potato cyst nematodes.

2.   The official surveys shall involve sampling and testing for the presence of potato cyst nematodes in accordance with paragraph 2 of Annex II and shall be carried out in accordance with Section II of Annex III.

3.   The results of the official surveys shall be notified in writing to the Commission in accordance with Section II of Annex III.
Article 7

If, as a result of the official investigation referred to in Article 4(1) and the other official investigations referred to in Article 4(3), no potato cyst nematodes are found, the responsible official bodies of a Member State shall ensure that this information is officially recorded.
Article 8

1.   When a field is found infested with potato cyst nematodes during the official investigation referred to in Article 4(1), the responsible official bodies of a Member State shall ensure that this information is officially recorded.

2.   When a field is found infested with potato cyst nematodes during the official survey referred to in Article 6(1), the responsible official bodies of a Member State shall ensure that this information is officially recorded.

3.   Potatoes or plants listed in Annex I which come from a field officially recorded as infested with potato cyst nematodes as referred to in paragraph 1 or paragraph 2 of this Article, or have been in contact with soil in which potato cyst nematodes have been found, shall be officially designated as contaminated.
Article 9

1.   Member States shall prescribe that in a field which has been officially recorded as infested as referred to in Article 8(1) or 8(2):

(a)

no potatoes intended for the production of seed potatoes shall be planted; and

(b)

no plants listed in Annex I, intended for replanting, shall be planted or stored. However, plants listed in point 2 of Annex I may be planted in that field provided that these plants are to be subject to the officially approved measures referred to in Section III(A) of Annex III, such that there is no identifiable risk of spreading potato cyst nematodes.

2.   In the case of fields to be used for planting potatoes, other than those intended for the production of seed potatoes, officially recorded as infested as referred to in Article 8(1) or 8(2), the responsible official bodies of the Member States shall prescribe that these fields shall be subject to an official control programme aiming at least at the suppression of potato cyst nematodes.

The programme referred to in paragraph 2 of this Article shall take into account the particular production and marketing systems for host plants of potato cyst nematodes in the relevant Member State, the characteristics of the population of potato cyst nematodes present, the use of resistant potato varieties of the highest levels of resistance available as specified in Section I of Annex IV and, where appropriate, other measures. This programme shall be notified in writing to the Commission and to the other Member States with a view to ensuring comparable levels of assurance between the Member States.

The degree of resistance of potato varieties, other than those already notified under Article 10(1) of Directive 69/465/EEC shall be quantified according to the standard scoring notation table set out in Section I of Annex IV of this Directive. Testing for resistance shall be carried out according to the protocol set out in Section II of Annex IV of this Directive.
Article 10

1.   Member States shall prescribe that for potatoes or plants listed in Annex I, which have been designated as contaminated under Article 8(3):

(a)

in the case of seed potatoes and the host plants listed in point 1 of Annex I, they shall not be planted unless they have been decontaminated under the supervision of the responsible official bodies of a Member State using an appropriate method adopted under paragraph 2 of this Article, based on scientific evidence that there is no risk of spreading potato cyst nematodes;

(b)

in the case of potatoes intended for industrial processing or grading, they shall be subject to officially approved measures in accordance with Section III(B) of Annex III;

(c)

in the case of plants listed in point 2 of Annex I, they shall not be planted unless they have been subject to the officially approved measures as referred to in Section III(A) of Annex III, such that they are no longer contaminated.

2.   Specifications of the methods referred to in paragraph 1(a) of this Article shall be adopted in accordance with the procedure referred to in Article 17(2).
Article 11

1.   Without prejudice to Article 16(1) of Directive 2000/29/EC, Member States shall prescribe that the suspected occurrence or confirmed presence of potato cyst nematodes in their territory resulting from a breakdown or change in the effectiveness of a resistant potato variety which relates to an exceptional change in the composition of nematode species, pathotype or virulence group shall be reported to their own responsible official bodies.

2.   For all cases reported under paragraph 1, Member States shall provide that the potato cyst nematode species and, where applicable, the pathotype or virulence group involved, are investigated and confirmed by appropriate methods.

3.   The details of the confirmations referred to in paragraph 2 shall be sent in writing each year by 31 December at the latest to the Commission and to the other Member States.

4.   The appropriate methods referred to in paragraph 2 of this Article may be adopted in accordance with the procedure referred to in Article 17(2).
Article 12

Member States shall notify in writing to the Commission and to the other Member States each year by 31 January at the latest, a list of all new varieties of potatoes which they have found by official testing to be resistant to potato cyst nematodes. They shall state the species, pathotypes, virulence groups or populations to which the varieties are resistant, the degree of resistance and the year of its determination.
Article 13

If, after the officially approved measures referred to in Section III(C) of Annex III have been taken, the presence of potato cyst nematodes is not confirmed, the responsible official bodies of the Member State shall ensure that the official record referred to in Article 4(5), Article 8(1) and Article 8(2) is updated and any restrictions imposed on the field are revoked.
Article 14

Without prejudice to Articles 3 and 5 of Directive 2000/29/EC, Member States may authorise derogations from the measures referred to in Articles 9 and 10 of this Directive in accordance with the provisions laid down in Commission Directive 95/44/EC of 26 July 1995 establishing the conditions under which certain harmful organisms, plants, plant products and other objects listed in Annexes I to V to Council Directive 77/93/EEC may be introduced into or moved within the Community or certain protected zones thereof, for trial or scientific purposes and for work on varietal selections(4).
Article 15

Member States may adopt in relation to their own production such additional or stricter measures as may be required to control potato cyst nematodes or to prevent them spreading in so far as they are in compliance with Directive 2000/29/EC.

Those measures shall be notified in writing to the Commission and to the other Member States.
Article 16

Amendments to the Annexes, to be made in the light of developments in scientific or technical knowledge, shall be adopted in accordance with the procedure referred to in Article 17(2).
Article 17

1.   The Commission shall be assisted by the Standing Committee on Plant Health, hereinafter referred to as ‘the Committee’.

2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
Article 18

1.   Member States shall adopt and publish by 30 June 2010 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from 1 July 2010.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2.   Member States shall communicate to the Commission the text of the main provisions of national law, which they adopt in the field governed by this Directive.
Article 19

Directive 69/465/EEC is repealed with effect from 1 July 2010.
Article 20

This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.

This Directive is addressed to the Member States.
THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Parliament,

(1) Since the adoption of Council Directive 69/465/EEC of 8 December 1969 on control of Potato Cyst Eelworm(1), there have been significant developments in the nomenclature, biology and epidemiology of potato cyst nematode species and populations and their distribution pattern.

(2) Potato cyst nematodes (Globodera pallida(Stone) Behrens (European populations) andGlobodera rostochiensis(Wollenweber) Behrens (European populations)) are recognised as harmful organisms of potatoes.

(3) The provisions of Directive 69/465/EEC have been re-examined and, as a result of this re-examination, have been found insufficient. Therefore, the adoption of more comprehensive provisions is necessary.

(4) The provisions should take into account that official investigations are necessary to ensure that no potato cyst nematodes are found in fields in which seed potatoes intended for the production of seed potatoes, and certain plants intended for the production of plants for planting, are planted or stored.

(5) Official surveys should be carried out on fields used for the production of potatoes other than those used for the production of seed potatoes in order to determine the distribution of the potato cyst nematodes.

(6) Sampling and testing procedures should be set out for conducting such official investigations and surveys.

(7) Account should be taken of the means of spread of the pathogen.

(8) The provisions should take into account that the control of potato cyst nematodes is traditionally by crop rotation as it is recognised that several years in the absence of potato cultivation will reduce the population of nematodes by a significant degree. More recently crop rotation has been supplemented by the use of resistant potato varieties.

(9) Furthermore, Member States should be able to take additional or stricter measures where necessary, provided that there is no hindrance to the movement of potatoes within the Community, except insofar as laid down in Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(2). Such measures should be notified to the Commission and to the other Member States.

(10) Directive 69/465/EEC should therefore be repealed.

(11) Since the objectives of this Directive, namely to determine the distribution of potato cyst nematodes to prevent their spread and to control them, cannot be sufficiently achieved by the Member States and can therefore by reason of the scale and effects of this Directive be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.

(12) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(3),

HAS ADOPTED THIS DIRECTIVE:
This Directive establishes the measures to be taken by the Member States againstGlobodera pallida(Stone) Behrens (European populations) andGlobodera rostochiensis(Wollenweber) Behrens (European populations), hereinafter referred to as ‘potato cyst nematodes’, in order to determine their distribution, to prevent their spread and to control them.
For the purpose of this Directive, the following definitions shall apply:

(a)

‘official’ or ‘officially’ means established, authorised or performed by the responsible official bodies of a Member State as defined in Article 2(1)(g) of Directive 2000/29/EC;

(b)

‘resistant potato variety’ means a variety that when grown significantly inhibits the development of a particular population of potato cyst nematodes;

(c)

‘investigation’ means a methodical procedure to determine the presence of potato cyst nematodes in a field;

(d)

‘survey means’ a methodical procedure conducted over a defined period of time to determine the distribution of potato cyst nematodes in the territory of a Member State.
1.   The responsible official bodies of the Member State shall define what constitutes a field for the purposes of this Directive in order to ensure that phytosanitary conditions within a field are homogeneous as regards the risk of potato cyst nematodes. In doing so, they shall take into account sound scientific and statistical principles, the biology of the potato cyst nematode, the cultivation of the field and the particular production systems of the host plants of potato cyst nematodes in that Member State. The detailed criteria for the definition of a field shall be officially notified to the Commission and to the other Member States.

2.   Further provisions related to the criteria for the definition of a field may be adopted in accordance with the procedure referred to in Article 17(2).
1.   Member States shall prescribe that an official investigation for the presence of potato cyst nematodes shall be carried out on the field in which the plants listed in Annex I, intended for the production of plants for planting, or seed potatoes intended for the production of seed potatoes, are to be planted or stored.

2.   The official investigation provided for in paragraph 1 shall be carried out in the period between the harvesting of the last crop in the field and the planting of the plants or seed potatoes mentioned in paragraph 1. It may be carried out earlier, in which case documentary evidence shall be available of the results of that investigation confirming that potato cyst nematodes have not been found and that potatoes and other host plants listed in point 1 of Annex I were not present at the time of the investigation and have not been grown since the investigation.

3.   Results of official investigations other than those referred to in paragraph 1 and carried out before 1 July 2010 may be considered as evidence as referred to in paragraph 2.

4.   If the responsible official bodies of a Member State have established that there is no risk of spreading potato cyst nematodes, the official investigation referred to in paragraph 1 shall not be required for:

(a)

the planting of plants listed in Annex I, intended for the production of plants for planting to be used within the same place of production situated in an officially defined area;

(b)

the planting of seed potatoes, intended for the production of seed potatoes to be used within the same place of production situated in an officially defined area;

(c)

the planting of plants listed in point 2 of Annex I, intended for the production of plants for planting where the harvested plants are to be subject to the officially approved measures referred to in Section III(A) of Annex III.

5.   Member States shall ensure that the results of the investigations referred to in paragraphs 1 and 3 are officially recorded and are accessible to the Commission.
1.   In the case of fields in which seed potatoes or plants listed in point 1 of Annex I intended for the production of plants for planting, are to be planted or stored, the official investigation referred to in Article 4(1) shall involve sampling and testing for the presence of potato cyst nematodes in accordance with Annex II.

2.   In the case of fields in which the plants listed in point 2 of Annex I, intended for the production of plants for planting, are to be planted or stored, the official investigation referred to in Article 4(1) shall involve sampling and testing for the presence of potato cyst nematodes in accordance with Annex II or verification as set out in Section I of Annex III.
1.   Member States shall provide that official surveys are carried out on fields used for the production of potatoes, other than those intended for the production of seed potatoes, in order to determine the distribution of potato cyst nematodes.

2.   The official surveys shall involve sampling and testing for the presence of potato cyst nematodes in accordance with paragraph 2 of Annex II and shall be carried out in accordance with Section II of Annex III.

3.   The results of the official surveys shall be notified in writing to the Commission in accordance with Section II of Annex III.
If, as a result of the official investigation referred to in Article 4(1) and the other official investigations referred to in Article 4(3), no potato cyst nematodes are found, the responsible official bodies of a Member State shall ensure that this information is officially recorded.
1.   When a field is found infested with potato cyst nematodes during the official investigation referred to in Article 4(1), the responsible official bodies of a Member State shall ensure that this information is officially recorded.

2.   When a field is found infested with potato cyst nematodes during the official survey referred to in Article 6(1), the responsible official bodies of a Member State shall ensure that this information is officially recorded.

3.   Potatoes or plants listed in Annex I which come from a field officially recorded as infested with potato cyst nematodes as referred to in paragraph 1 or paragraph 2 of this Article, or have been in contact with soil in which potato cyst nematodes have been found, shall be officially designated as contaminated.
1.   Member States shall prescribe that in a field which has been officially recorded as infested as referred to in Article 8(1) or 8(2):

(a)

no potatoes intended for the production of seed potatoes shall be planted; and

(b)

no plants listed in Annex I, intended for replanting, shall be planted or stored. However, plants listed in point 2 of Annex I may be planted in that field provided that these plants are to be subject to the officially approved measures referred to in Section III(A) of Annex III, such that there is no identifiable risk of spreading potato cyst nematodes.

2.   In the case of fields to be used for planting potatoes, other than those intended for the production of seed potatoes, officially recorded as infested as referred to in Article 8(1) or 8(2), the responsible official bodies of the Member States shall prescribe that these fields shall be subject to an official control programme aiming at least at the suppression of potato cyst nematodes.

The programme referred to in paragraph 2 of this Article shall take into account the particular production and marketing systems for host plants of potato cyst nematodes in the relevant Member State, the characteristics of the population of potato cyst nematodes present, the use of resistant potato varieties of the highest levels of resistance available as specified in Section I of Annex IV and, where appropriate, other measures. This programme shall be notified in writing to the Commission and to the other Member States with a view to ensuring comparable levels of assurance between the Member States.

The degree of resistance of potato varieties, other than those already notified under Article 10(1) of Directive 69/465/EEC shall be quantified according to the standard scoring notation table set out in Section I of Annex IV of this Directive. Testing for resistance shall be carried out according to the protocol set out in Section II of Annex IV of this Directive.
1.   Member States shall prescribe that for potatoes or plants listed in Annex I, which have been designated as contaminated under Article 8(3):

(a)

in the case of seed potatoes and the host plants listed in point 1 of Annex I, they shall not be planted unless they have been decontaminated under the supervision of the responsible official bodies of a Member State using an appropriate method adopted under paragraph 2 of this Article, based on scientific evidence that there is no risk of spreading potato cyst nematodes;

(b)

in the case of potatoes intended for industrial processing or grading, they shall be subject to officially approved measures in accordance with Section III(B) of Annex III;

(c)

in the case of plants listed in point 2 of Annex I, they shall not be planted unless they have been subject to the officially approved measures as referred to in Section III(A) of Annex III, such that they are no longer contaminated.

2.   Specifications of the methods referred to in paragraph 1(a) of this Article shall be adopted in accordance with the procedure referred to in Article 17(2).
1.   Without prejudice to Article 16(1) of Directive 2000/29/EC, Member States shall prescribe that the suspected occurrence or confirmed presence of potato cyst nematodes in their territory resulting from a breakdown or change in the effectiveness of a resistant potato variety which relates to an exceptional change in the composition of nematode species, pathotype or virulence group shall be reported to their own responsible official bodies.

2.   For all cases reported under paragraph 1, Member States shall provide that the potato cyst nematode species and, where applicable, the pathotype or virulence group involved, are investigated and confirmed by appropriate methods.

3.   The details of the confirmations referred to in paragraph 2 shall be sent in writing each year by 31 December at the latest to the Commission and to the other Member States.

4.   The appropriate methods referred to in paragraph 2 of this Article may be adopted in accordance with the procedure referred to in Article 17(2).
Member States shall notify in writing to the Commission and to the other Member States each year by 31 January at the latest, a list of all new varieties of potatoes which they have found by official testing to be resistant to potato cyst nematodes. They shall state the species, pathotypes, virulence groups or populations to which the varieties are resistant, the degree of resistance and the year of its determination.
If, after the officially approved measures referred to in Section III(C) of Annex III have been taken, the presence of potato cyst nematodes is not confirmed, the responsible official bodies of the Member State shall ensure that the official record referred to in Article 4(5), Article 8(1) and Article 8(2) is updated and any restrictions imposed on the field are revoked.
Without prejudice to Articles 3 and 5 of Directive 2000/29/EC, Member States may authorise derogations from the measures referred to in Articles 9 and 10 of this Directive in accordance with the provisions laid down in Commission Directive 95/44/EC of 26 July 1995 establishing the conditions under which certain harmful organisms, plants, plant products and other objects listed in Annexes I to V to Council Directive 77/93/EEC may be introduced into or moved within the Community or certain protected zones thereof, for trial or scientific purposes and for work on varietal selections(4).
Member States may adopt in relation to their own production such additional or stricter measures as may be required to control potato cyst nematodes or to prevent them spreading in so far as they are in compliance with Directive 2000/29/EC.

Those measures shall be notified in writing to the Commission and to the other Member States.
Amendments to the Annexes, to be made in the light of developments in scientific or technical knowledge, shall be adopted in accordance with the procedure referred to in Article 17(2).
1.   The Commission shall be assisted by the Standing Committee on Plant Health, hereinafter referred to as ‘the Committee’.

2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
1.   Member States shall adopt and publish by 30 June 2010 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from 1 July 2010.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2.   Member States shall communicate to the Commission the text of the main provisions of national law, which they adopt in the field governed by this Directive.
Directive 69/465/EEC is repealed with effect from 1 July 2010.
This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.

This Directive is addressed to the Member States.
ANNEX IList of plants referred to in Articles 4(1), 4(2), 4(4), 5(1), 5(2), 8(3), 9(1)(b), and 10(1)
1. | Host plants with roots:Capsicumspp.,Lycopersicon lycopersicum(L.) Karsten ex Farw.,Solanum melongenaL. |  | Capsicumspp., |  | Lycopersicon lycopersicum(L.) Karsten ex Farw., |  | Solanum melongenaL.

 | Capsicumspp.,

 | Lycopersicon lycopersicum(L.) Karsten ex Farw.,

 | Solanum melongenaL.

2. | (a)Other plants with roots:Allium porrumL.,Beta vulgarisL.,Brassicaspp.,FragariaL.,Asparagus officinalisL.(b)Bulbs, tubers and rhizomes, not subjected to the officially approved measures as referred to in Section III(A) of Annex III, grown in soil and intended for planting, other than those for which there shall be evidence by their packaging or by other means that they are intended for sale to final consumers not involved in professional plant or cut flower production, of:Allium ascalonicumL.,Allium cepaL.,Dahliaspp.,GladiolusTourn. Ex L.,Hyacinthusspp.,Irisspp.,Liliumspp.,NarcissusL.,TulipaL. | (a) | Other plants with roots:Allium porrumL.,Beta vulgarisL.,Brassicaspp.,FragariaL.,Asparagus officinalisL. |  | Allium porrumL., |  | Beta vulgarisL., |  | Brassicaspp., |  | FragariaL., |  | Asparagus officinalisL. | (b) | Bulbs, tubers and rhizomes, not subjected to the officially approved measures as referred to in Section III(A) of Annex III, grown in soil and intended for planting, other than those for which there shall be evidence by their packaging or by other means that they are intended for sale to final consumers not involved in professional plant or cut flower production, of:Allium ascalonicumL.,Allium cepaL.,Dahliaspp.,GladiolusTourn. Ex L.,Hyacinthusspp.,Irisspp.,Liliumspp.,NarcissusL.,TulipaL. |  | Allium ascalonicumL., |  | Allium cepaL., |  | Dahliaspp., |  | GladiolusTourn. Ex L., |  | Hyacinthusspp., |  | Irisspp., |  | Liliumspp., |  | NarcissusL., |  | TulipaL.

(a) | Other plants with roots:Allium porrumL.,Beta vulgarisL.,Brassicaspp.,FragariaL.,Asparagus officinalisL. |  | Allium porrumL., |  | Beta vulgarisL., |  | Brassicaspp., |  | FragariaL., |  | Asparagus officinalisL.

 | Allium porrumL.,

 | Beta vulgarisL.,

 | Brassicaspp.,

 | FragariaL.,

 | Asparagus officinalisL.

(b) | Bulbs, tubers and rhizomes, not subjected to the officially approved measures as referred to in Section III(A) of Annex III, grown in soil and intended for planting, other than those for which there shall be evidence by their packaging or by other means that they are intended for sale to final consumers not involved in professional plant or cut flower production, of:Allium ascalonicumL.,Allium cepaL.,Dahliaspp.,GladiolusTourn. Ex L.,Hyacinthusspp.,Irisspp.,Liliumspp.,NarcissusL.,TulipaL. |  | Allium ascalonicumL., |  | Allium cepaL., |  | Dahliaspp., |  | GladiolusTourn. Ex L., |  | Hyacinthusspp., |  | Irisspp., |  | Liliumspp., |  | NarcissusL., |  | TulipaL.

 | Allium ascalonicumL.,

 | Allium cepaL.,

 | Dahliaspp.,

 | GladiolusTourn. Ex L.,

 | Hyacinthusspp.,

 | Irisspp.,

 | Liliumspp.,

 | NarcissusL.,

 | TulipaL.
ANNEX II 1.   

With reference to the sampling and testing for the official investigation referred to in Article 5(1) and 5(2):

(a) sampling shall involve a soil sample with a standard rate of at least 1 500 ml soil/ha collected from at least 100 cores/ha preferably in a rectangular grid of not less than 5 metres in width and not more than 20 metres in length between sampling points covering the entire field. The whole sample shall be used for further examination, i.e. extraction of cysts, species identification and, if applicable, pathotype/virulence group determination;

(b) testing shall involve methods for the extraction of potato cyst nematodes described in the relevant Phytosanitary Procedures or Diagnostic Protocols for Globodera pallida and Globodera rostochiensis: EPPO standards.

 2.   

With reference to the sampling and testing for the official survey referred to in Article 6(2):

(a) sampling shall be:

—

the sampling described in paragraph 1 with a minimum sampling rate of soil of at least 400 ml/ha,

or

—

targeted sampling of at least 400 ml of soil after visual examination of roots where there are visual symptoms,

or

—

sampling of at least 400 ml of soil associated with the potatoes after harvesting provided that the field where the potatoes were grown is traceable;

(b) testing shall be the testing referred to in paragraph 1.  3.   

By way of derogation the standard sampling rate referred to in paragraph 1 may be reduced to a minimum of 400 ml of soil/ha provided that:

(a) there is documentary evidence that no potatoes or other host plants listed in point 1 of Annex I have been grown and were present in the field in the six years prior to the official investigation;

or

(b) no potato cyst nematodes have been found during the last two successive official investigations in samples of 1 500 ml soil/ha and no potatoes or other host plants listed in point 1 of Annex I, other than those for which an official investigation is required according to Article 4(1), have been grown after the first official investigation;

or

(c) no potato cyst nematodes or potato cyst nematode cysts without live content have been found in the last official investigation which must have consisted of a sample size of at least 1 500 ml soil/ha and no potatoes or other host plants listed in point 1 of Annex I, other than those for which an official investigation is required according to Article 4(1), have been grown in the field since the last official investigation.

Results of other official investigations carried out before 1 July 2010 may be considered as official investigations as referred to in subparagraphs (b) and (c).

 4.   

By way of derogation the sampling rate referred to at paragraphs 1 and 3 may be reduced for fields larger than 8 ha and 4 ha respectively:

(a) in the case of the standard rate referred to in paragraph 1, the first 8 ha shall be sampled at the rate specified therein, but may be reduced for each additional hectare to a minimum of 400 ml of soil/ha;

(b) in the case of the reduced rate referred to in paragraph 3, the first 4 ha shall be sampled at the rate specified therein, but may be further reduced for each additional hectare to a minimum of 200 ml of soil/ha.

 5.   

The use of the reduced sample size as referred to at paragraphs 3 and 4 may be continued in the subsequent official investigations referred to in Article 4(1) until potato cyst nematodes have been found in the field concerned.

 6.   

By way of derogation the standard size of the soil sample referred to in paragraph 1 may be reduced to a minimum of 200 ml of soil/ha provided that the field is situated in an area declared free from potato cyst nematodes, and designated, maintained and surveyed in accordance with the relevant International Standards for Phytosanitary Measures. Details of such areas shall be officially notified in writing to the Commission and the other Member States.

 7.   

The minimum size of the soil sample in all cases shall be 100 ml of soil per field.
SECTION IANNEX IIIVERIFICATIONWith reference to Article 5(2), the official investigation referred to in Article 4(1) shall establish that at the time of verification one of the following criteria are met:
— | no history of potato cyst nematodes in the field during the last 12 years, based on the results of appropriate officially approved testing,or
— | a known cropping history in which no potatoes or other hosts plants listed in point 1 of Annex I have been grown in the field in the past 12 years.SECTION IISURVEYSThe official surveys referred to in Article 6(1), shall be conducted on at least 0,5 % of the acreage used in the relevant year for the production of potatoes, other than that intended for the production of seed potatoes. The results of the surveys shall be notified to the Commission by 1 April for the previous 12 month period.

SECTION IIIOFFICIAL MEASURES

 | (A) | The officially approved measures referred to in Article 4(4)(c), 9(1)(b) Article 10(1)(c) and in paragraph 2b of Annex I are:1.disinfestation by appropriate methods such that there is no identifiable risk of the potato cyst nematodes spreading;2.removal of soil by washing or brushing until practically free of soil such that there is no identifiable risk of the potato cyst nematodes spreading. | 1. | disinfestation by appropriate methods such that there is no identifiable risk of the potato cyst nematodes spreading; | 2. | removal of soil by washing or brushing until practically free of soil such that there is no identifiable risk of the potato cyst nematodes spreading.

1. | disinfestation by appropriate methods such that there is no identifiable risk of the potato cyst nematodes spreading;

2. | removal of soil by washing or brushing until practically free of soil such that there is no identifiable risk of the potato cyst nematodes spreading.

 | (B) | The officially approved measures referred to in Article 10(1)(b) are delivery to a processing or grading plant with appropriate and officially approved waste disposal procedures for which it has been established that there is no risk of the potato cyst nematodes spreading.

 | (C) | The officially approved measures referred to in Article 13 are an official re-sampling of the field officially recorded as infested as referred to in Article 8(1) or 8(2), and testing using one of the methods specified in Annex II, after a minimum period of six years counting from the positive confirmation of potato cyst nematodes, or counting from the growing of the last potato crop. This period may be reduced to a minimum of three years if appropriate officially approved control measures have been taken.
SECTION IANNEX IVDEGREE OF RESISTANCEThe degree of susceptibility of potatoes to potato cyst nematodes shall be quantified according to the following standard scoring notation as referred to in Article 9(2).

The score 9 indicates the highest level of resistance.
Relative susceptibility (%) | Score

< 1 | 9

1,1-3 | 8

3,1-5 | 7

5,1-10 | 6

10,1-15 | 5

15,1-25 | 4

25,1-50 | 3

50,1-100 | 2

> 100 | 1SECTION IIPROTOCOL FOR RESISTANCE TESTING

 | 1. | The test shall be performed in a quarantine facility either outside, in glasshouses, or in climate chambers.

 | 2. | The test shall be performed in pots each containing at least one litre of soil (or suitable substrate).

 | 3. | The soil temperature during the course of the test shall not exceed 25 °C and adequate watering shall be provided.

 | 4. | When planting the test or control variety one potato eye plug of each test or control variety shall be used. Removal of all stems except one is recommended.

 | 5. | The potato variety ‘Désirée’ shall be used as a standard susceptible control variety in every test. Additional fully susceptible control varieties of local relevance may be added as internal checks. The standard susceptible control variety may be changed if research indicates that other varieties are either more suitable or more accessible.

 | 6. | The following standard populations of potato cyst nematodes shall be used against pathotypes Ro1, Ro5, Pa1 and Pa3:Ro1: population EcosseRo5: population HarmerzPa1: population ScottishPa3: population ChavornayOther potato cyst nematode populations of local relevance may be added. |  | Ro1: population Ecosse |  | Ro5: population Harmerz |  | Pa1: population Scottish |  | Pa3: population Chavornay

 | Ro1: population Ecosse

 | Ro5: population Harmerz

 | Pa1: population Scottish

 | Pa3: population Chavornay

 | 7. | The identity of the standard population used shall be checked using appropriate methods. It is recommended that at least two resistant varieties or two differential standard clones of known resistance capacity are used in the test experiments.

 | 8. | The potato cyst nematode inoculum (Pi) shall consist in total of five infective eggs and juveniles per ml of soil. It is recommended that the number of potato cyst nematodes to be inoculated per ml of soil is determined in hatching experiments. The potato cyst nematodes may be inoculated as cysts, or combined as eggs and juveniles in a suspension.

 | 9. | The viability of the potato cyst nematode cyst content used as the inoculum source shall be at least 70 %. It is recommended that the cysts are 6-24 months old and are kept for at least four months at 4 °C immediately prior to use.

 | 10. | There shall be at least four replicates (pots) per combination of potato cyst nematode population and potato variety tested. It is recommended to use at least 10 replicates for the standard susceptible control variety.

 | 11. | The duration of the test shall be at least three months and the maturity of developing females shall be checked before breaking up the experiment.

 | 12. | Potato cyst nematode cysts from the four replicates shall be extracted and counted separately for each pot.

 | 13. | The final population (Pf) on the standard susceptible control variety at the end of the resistance test shall be determined by counting all cysts from all replicates and the eggs and juveniles from at least four replicates.

 | 14. | A multiplication rate of at least 20 × (Pf/Pi) on the standard susceptible control variety shall be achieved.

 | 15. | The coefficient of variation (CV) on the standard susceptible control variety shall not exceed 35 %.

 | 16. | The relative susceptibility of the tested potato variety to the standard susceptible control variety shall be determined and expressed as a percentage according to the formula:Pftest variety/Pfstandard susceptible control variety× 100 %.

 | 17. | If a tested potato variety has a relative susceptibility of more than 3 %, cyst counts will suffice. In cases where the relative susceptibility is less than 3 %, eggs and juveniles shall be counted in addition to cyst counts.

 | 18. | Where the results of tests in the first year indicate that a variety is fully susceptible to a pathotype, there is no requirement to repeat these tests in a second year.

 | 19. | The results of the tests shall be confirmed by at least one other trial performed in another year. The arithmetic mean of the relative susceptibility in the two years shall be used to derive the score according to the standard scoring notation.

Pending: 32007L0005

                                January 16, 2026                            

8.2.2007
EN
Official Journal of the European Union
L 35/11

(1)
Commission Regulations (EC) No 451/2000(2)and (EC) No 703/2001(3)lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes captan, folpet, formetanate and methiocarb.

(2)
For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 703/2001 for a range of uses proposed by the notifier. Moreover, those Regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 8(1) of Regulation (EC) No 451/2000. For captan, folpet and formetanate, the rapporteur Member State was Italy and all relevant information was submitted on 20 October 2003 for captan and folpet and on 13 July 2004 for formetanate. For methiocarb the rapporteur Member State was United Kingdom and all relevant information was submitted on 4 March 2004.

(3)
The assessment reports have been peer reviewed by the Member States and the EFSA and presented to the Commission on 24 April 2006 for captan, folpet and formetanate and on 12 May 2006 for methiocarb in the format of the EFSA Scientific Reports(4). These reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 29 September 2006 in the format of the Commission review reports for captan, folpet, formetanate and methiocarb.

(4)
It has appeared from the various examinations made that plant protection products containing captan, folpet, formetanate and methiocarb may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive.

(5)
Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points concerning captan, folpet, formetanate and methiocarb. Article 6(1) of Directive 91/414/EC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore it is appropriate to require that captan, folpet, formetanate and methiocarb should be subjected to further testing for confirmation of the risk assessment for some issues and that such studies should be presented by the notifiers.

(6)
A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

(7)
Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing captan, folpet, formetanate and methiocarb to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By way of derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

(8)
The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.

(9)
It is therefore appropriate to amend Directive 91/414/EEC accordingly.

(10)
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(a)
in the case of a product containing captan, folpet, formetanate and methiocarb as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2011 at the latest; or

(b)
in the case of a product containing captan, folpet, formetanate and methiocarb as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2011 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

No
Common name, identification numbers
IUPAC name
Purity(1)
Entry into force
Expiration of inclusion
Specific provisions

‘151
CaptanCAS No 133-06-02CIPAC No 40
N-(trichloromethylthio)cyclohex-4-ene-1,2-dicarboximide
≥ 910 g/kgImpurities:Perchloromethylmercaptan (R005406): not more than 5 g/kgFolpet: not more than 10 g/kgCarbon tetrachloride not more than 0,01 g/kg

Perchloromethylmercaptan (R005406): not more than 5 g/kg

Folpet: not more than 10 g/kg

Carbon tetrachloride not more than 0,01 g/kg
1 October 2007
30 September 2017
PART AOnly uses as fungicide can be authorised.PART BIn assessing applications to authorise plant protection products containing captan for uses other than tomatoes Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on captan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.In this overall assessment Member States must pay particular attention to:—the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure;—the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;—the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate;—the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures.The Member States concerned shall request the submission of further studies to confirm the long term risk assessment for birds and mammals, as well as the toxicological assessment on metabolites potentially present in groundwater under vulnerable conditions. They shall ensure that the notifiers at whose request captan has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.
—
the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure;
—
the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;
—
the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate;
—
the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures.

Perchloromethylmercaptan (R005406): not more than 5 g/kg

Folpet: not more than 10 g/kg

Carbon tetrachloride not more than 0,01 g/kg

—
the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure;

—
the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;

—
the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate;

—
the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures.

152
FolpetCAS No 133-07-3CIPAC No 75
N-(trichloromethylthio)phthalimide
≥ 940 g/kgImpurities:Perchloromethylmercaptan (R005406): not more than 3,5 g/kgCarbon tetrachloride not more than 4 g/kg

Perchloromethylmercaptan (R005406): not more than 3,5 g/kg

Carbon tetrachloride not more than 4 g/kg
1 October 2007
30 September 2017
PART AOnly uses as fungicide can be authorised.PART BIn assessing applications to authorise plant protection products containing folpet for uses other than winter wheat Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on folpet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.In this overall assessment Member States must pay particular attention to:—operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment;—the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;—the protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should include risk mitigation measures.The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and earthworms. They shall ensure that the notifiers at whose request folpet has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.
—
operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment;
—
the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;
—
the protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should include risk mitigation measures.

Perchloromethylmercaptan (R005406): not more than 3,5 g/kg

Carbon tetrachloride not more than 4 g/kg

—
operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment;

—
the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;

—
the protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should include risk mitigation measures.

153
FormetanateCAS No 23422-53-9CIPAC No 697
3-dimethylaminomethyleneaminophenyl methylcarbamate
≥ 910 g/kg
1 October 2007
30 September 2017
PART AOnly uses as insecticide and acaricide may be authorised.PART BIn assessing applications to authorise plant protection products containing formetanate for uses other than in field tomatoes and ornamental shrubs Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on formetanate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.In this overall assessment Member States:—must pay particular attention to the protection of birds, mammals, non-target arthropods and bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;—must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;—must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods. They shall ensure that the notifier at whose request formetanate has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.
—
must pay particular attention to the protection of birds, mammals, non-target arthropods and bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;
—
must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;
—
must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

—
must pay particular attention to the protection of birds, mammals, non-target arthropods and bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;

—
must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

—
must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

154
MethiocarbCAS No 2032-65-7CIPAC No 165
4-methylthio-3,5-xylyl methylcarbamate
≥ 980 g/kg
1 October 2007
30 September 2017
PART AOnly uses as repellent in seed treatment, insecticide and molluscicide may be authorised.PART BIn assessing applications to authorise plant protection products containing methiocarb for uses other than seed treatment in maize Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on methiocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.In this overall assessment Member States:—must pay particular attention to the protection of birds, mammals and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;—must pay particular attention to the operator and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;—must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods, as well as to confirm the toxicological assessment on metabolites potentially present in crops. They shall ensure that the notifier at whose request methiocarb has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.’
—
must pay particular attention to the protection of birds, mammals and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;
—
must pay particular attention to the operator and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;
—
must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

—
must pay particular attention to the protection of birds, mammals and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;

—
must pay particular attention to the operator and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

—
must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

Perchloromethylmercaptan (R005406): not more than 5 g/kg

Folpet: not more than 10 g/kg

Carbon tetrachloride not more than 0,01 g/kg

—
the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure;

—
the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;

—
the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate;

—
the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures.

Perchloromethylmercaptan (R005406): not more than 3,5 g/kg

Carbon tetrachloride not more than 4 g/kg

—
operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment;

—
the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;

—
the protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should include risk mitigation measures.

—
must pay particular attention to the protection of birds, mammals, non-target arthropods and bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;

—
must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

—
must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

—
must pay particular attention to the protection of birds, mammals and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;

—
must pay particular attention to the operator and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

—
must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), and in particular Article 6(1) thereof,

(1) Commission Regulations (EC) No 451/2000(2)and (EC) No 703/2001(3)lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes captan, folpet, formetanate and methiocarb.

(2) For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 703/2001 for a range of uses proposed by the notifier. Moreover, those Regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 8(1) of Regulation (EC) No 451/2000. For captan, folpet and formetanate, the rapporteur Member State was Italy and all relevant information was submitted on 20 October 2003 for captan and folpet and on 13 July 2004 for formetanate. For methiocarb the rapporteur Member State was United Kingdom and all relevant information was submitted on 4 March 2004.

(3) The assessment reports have been peer reviewed by the Member States and the EFSA and presented to the Commission on 24 April 2006 for captan, folpet and formetanate and on 12 May 2006 for methiocarb in the format of the EFSA Scientific Reports(4). These reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 29 September 2006 in the format of the Commission review reports for captan, folpet, formetanate and methiocarb.

(4) It has appeared from the various examinations made that plant protection products containing captan, folpet, formetanate and methiocarb may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive.

(5) Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points concerning captan, folpet, formetanate and methiocarb. Article 6(1) of Directive 91/414/EC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore it is appropriate to require that captan, folpet, formetanate and methiocarb should be subjected to further testing for confirmation of the risk assessment for some issues and that such studies should be presented by the notifiers.

(6) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

(7) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing captan, folpet, formetanate and methiocarb to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By way of derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

(8) The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.

(9) It is therefore appropriate to amend Directive 91/414/EEC accordingly.

(10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DIRECTIVE:
Article 1

Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
Article 2

Member States shall adopt and publish by 31 March 2008 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from 1 April 2008.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 3

1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing captan, folpet, formetanate and methiocarb as active substances by 31 March 2008.

By that date they shall in particular verify that the conditions in Annex I to that Directive relating to captan, folpet, formetanate and methiocarb are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.

2.   By way of derogation from paragraph 1, for each authorised plant protection product containing captan, folpet, formetanate and methiocarb as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 September 2007 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning captan, folpet, formetanate and methiocarb respectively. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.

Following that determination Member States shall:

(a)

in the case of a product containing captan, folpet, formetanate and methiocarb as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2011 at the latest; or

(b)

in the case of a product containing captan, folpet, formetanate and methiocarb as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2011 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.
Article 4

This Directive shall enter into force on 1 October 2007.
Article 5

This Directive is addressed to the Member States.
THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), and in particular Article 6(1) thereof,

(1) Commission Regulations (EC) No 451/2000(2)and (EC) No 703/2001(3)lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes captan, folpet, formetanate and methiocarb.

(2) For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 703/2001 for a range of uses proposed by the notifier. Moreover, those Regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 8(1) of Regulation (EC) No 451/2000. For captan, folpet and formetanate, the rapporteur Member State was Italy and all relevant information was submitted on 20 October 2003 for captan and folpet and on 13 July 2004 for formetanate. For methiocarb the rapporteur Member State was United Kingdom and all relevant information was submitted on 4 March 2004.

(3) The assessment reports have been peer reviewed by the Member States and the EFSA and presented to the Commission on 24 April 2006 for captan, folpet and formetanate and on 12 May 2006 for methiocarb in the format of the EFSA Scientific Reports(4). These reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 29 September 2006 in the format of the Commission review reports for captan, folpet, formetanate and methiocarb.

(4) It has appeared from the various examinations made that plant protection products containing captan, folpet, formetanate and methiocarb may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive.

(5) Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points concerning captan, folpet, formetanate and methiocarb. Article 6(1) of Directive 91/414/EC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore it is appropriate to require that captan, folpet, formetanate and methiocarb should be subjected to further testing for confirmation of the risk assessment for some issues and that such studies should be presented by the notifiers.

(6) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

(7) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing captan, folpet, formetanate and methiocarb to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By way of derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

(8) The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.

(9) It is therefore appropriate to amend Directive 91/414/EEC accordingly.

(10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DIRECTIVE:
Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
Member States shall adopt and publish by 31 March 2008 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from 1 April 2008.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing captan, folpet, formetanate and methiocarb as active substances by 31 March 2008.

By that date they shall in particular verify that the conditions in Annex I to that Directive relating to captan, folpet, formetanate and methiocarb are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.

2.   By way of derogation from paragraph 1, for each authorised plant protection product containing captan, folpet, formetanate and methiocarb as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 September 2007 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning captan, folpet, formetanate and methiocarb respectively. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.

Following that determination Member States shall:

(a)

in the case of a product containing captan, folpet, formetanate and methiocarb as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2011 at the latest; or

(b)

in the case of a product containing captan, folpet, formetanate and methiocarb as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2011 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.
This Directive shall enter into force on 1 October 2007.
This Directive is addressed to the Member States.
ANNEXThe following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:
No

Common name, identification numbers

IUPAC name

Purity (1) Entry into force

Expiration of inclusion

Specific provisions

‘151

Captan

CAS No 133-06-02

CIPAC No 40

N-(trichloromethylthio)cyclohex-4-ene-1,2-dicarboximide

≥ 910 g/kg

Impurities:
Perchloromethylmercaptan (R005406): not more than 5 g/kg
Folpet: not more than 10 g/kg
Carbon tetrachloride not more than 0,01 g/kg

1 October 2007

30 September 2017

PART A

Only uses as fungicide can be authorised.

PART B

In assessing applications to authorise plant protection products containing captan for uses other than tomatoes Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on captan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

—

the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure;

—

the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;

—

the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate;

—

the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures.

The Member States concerned shall request the submission of further studies to confirm the long term risk assessment for birds and mammals, as well as the toxicological assessment on metabolites potentially present in groundwater under vulnerable conditions. They shall ensure that the notifiers at whose request captan has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.

152

Folpet

CAS No 133-07-3

CIPAC No 75

N-(trichloromethylthio)phthalimide

≥ 940 g/kg

Impurities:
Perchloromethylmercaptan (R005406): not more than 3,5 g/kg
Carbon tetrachloride not more than 4 g/kg

1 October 2007

30 September 2017

PART A

Only uses as fungicide can be authorised.

PART B

In assessing applications to authorise plant protection products containing folpet for uses other than winter wheat Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on folpet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

—

operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment;

—

the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;

—

the protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should include risk mitigation measures.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and earthworms. They shall ensure that the notifiers at whose request folpet has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.

153

Formetanate

CAS No 23422-53-9

CIPAC No 697

3-dimethylaminomethyleneaminophenyl methylcarbamate

≥ 910 g/kg

1 October 2007

30 September 2017

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

In assessing applications to authorise plant protection products containing formetanate for uses other than in field tomatoes and ornamental shrubs Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on formetanate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.

In this overall assessment Member States:

—

must pay particular attention to the protection of birds, mammals, non-target arthropods and bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;

—

must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

—

must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods. They shall ensure that the notifier at whose request formetanate has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.

154

Methiocarb

CAS No 2032-65-7

CIPAC No 165

4-methylthio-3,5-xylyl methylcarbamate

≥ 980 g/kg

1 October 2007

30 September 2017

PART A

Only uses as repellent in seed treatment, insecticide and molluscicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing methiocarb for uses other than seed treatment in maize Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on methiocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.

In this overall assessment Member States:

—

must pay particular attention to the protection of birds, mammals and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;

—

must pay particular attention to the operator and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

—

must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods, as well as to confirm the toxicological assessment on metabolites potentially present in crops. They shall ensure that the notifier at whose request methiocarb has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.’
(1)  Further details on identity and specification of active substance are provided in the review report.

Pending: 32006L0137

                                January 16, 2026                            

30.12.2006
EN
Official Journal of the European Union
L 389/261

(1)
Directive 2006/87/EC(2)establishes harmonised conditions for issuing technical certificates for inland waterway vessels throughout the Community's inland waterway network.

(2)
The technical requirements set out in the Annexes to Directive 2006/87/EC for the most part incorporate the provisions laid down in the Regulation on Inspection of Shipping on the Rhine, in the version approved in 2004 by the member states of the Central Commission for Navigation on the Rhine (CCNR). The conditions and technical requirements for issuing inland navigation certificates under Article 22 of the Revised Convention for Rhine Navigation are updated regularly and are recognised as reflecting current technological developments.

(3)
In order to prevent distortions of competition and varying levels of safety, it is desirable, specifically in the interests of promoting harmonisation at European level, to adopt equivalent technical requirements for the whole of the Community's inland waterway network and, subsequently, to update them at regular intervals in order to maintain that equivalence.

(4)
Directive 2006/87/EC authorises the Commission to adapt those technical requirements in the light of technical progress and of developments arising from the work of other international organisations, in particular that of the CCNR.

(5)
Those amendments need to be made rapidly in order to ensure that the technical requirements necessary for the issuing of the Community inland navigation certificate give a level of safety equivalent to that required for the issuing of the certificate referred to in Article 22 of the Revised Convention for Rhine Navigation.

(6)
The measures necessary for the implementation of Directive 2006/87/EC should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission5(3).

(7)
In particular the Commission should be empowered to establish the conditions under which the technical requirements and administrative procedures set out in the Annexes to Directive 2006/87/EC may be amended. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2006/87/EC, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(8)
On grounds of efficiency, the normal time-limits for the regulatory procedure with scrutiny should be curtailed for the adoption of such measures amending the Annexes to Directive 2006/87/EC.

(9)
On grounds of urgency, it is necessary to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of any amendment of the Annexes to Directive 2006/87/EC to take account of technical developments or related developments arising from the work of other international organisations, in particular the CCNR, as well as for the adoption of temporary requirements.

(10)
Directive 2006/87/ECshould therefore be amended accordingly,

1)
The following paragraphs shall be added to Article 19:‘3.   Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The time limits provided for in Article 5a(3)(c), (4)(b) and (4)(e) of Decision 1999/468/EC shall be set at twenty-one days, fifteen days and one month respectively.4.   Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’

2)
Article 20 shall be replaced by the following:‘Article 20Adaptation of the Annexes and recommendations on provisional certificates1.   Any amendments which are necessary to adapt the Annexes to this Directive to technical progress or to developments in this area arising from the work of other international organisations, in particular that of the Central Commission for Navigation on the Rhine (CCNR), to ensure that the two certificates referred to in Article 3(1)(a) are issued on the basis of technical requirements which guarantee an equivalent level of safety, or to take account of the cases referred to in Article 5, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3). On imperative grounds of urgency, the Commission may follow the urgency procedure referred to in Article 19(4).Those amendments shall be made rapidly in order to ensure that the technical requirements for the issuing of the Community inland navigation certificate recognised for navigation on the Rhine give a level of safety equivalent to that required for the issuing of the certificate referred to in Article 22 of the Revised Convention for Rhine Navigation.2.   Notwithstanding paragraph 1, the Commission shall adopt the approvals referred to in Article 5(2) in accordance with the procedure referred to in Article 19(2).3.   The Commission shall decide on recommendations from the Committee on the issue of provisional Community inland navigation certificates in accordance with Article 2.19 of Annex II.’

3)
Annex II shall be amended as follows:1)Article 1.06 shall be replaced by the following:‘1.06Temporary requirementsTemporary requirements designed to amend non-essential elements of this Directive, by supplementing it, may be adopted, in accordance with the regulatory procedure with scrutiny referred to in Article 19(4) of this Directive, where it is found urgently necessary, for the purposes of adaptation to technical progress of inland waterway transport, to allow derogations from the provisions of this Directive or to allow tests. The requirements shall be published and shall be valid for a maximum of three years. They shall enter into force at the same time and shall be annulled under the same conditions in all Member States.’2)Article 10.03a(5) shall be replaced by the following:‘5.   Systems spraying smaller quantities of water shall have a type-approval pursuant to IMO Resolution A 800(19) or another recognised standard. Such recognitions, when designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3) of this Directive. Type-approval shall be carried out by an approved classification society or an accredited testing institution. The accredited testing institution shall comply with the European standard for general requirements for the competence of testing and calibrating laboratories (EN ISO/IEC 17025: 2000).’3)Article 10.03b(1) shall be replaced by the following:‘1.   Extinguishing agentsFor protecting engine rooms, boiler rooms and pump rooms, the following extinguishing agents may be used in permanently installed fire-fighting systems:(a)CO2(carbon dioxide);(b)HFC 227 ea (heptafluoropropane);(c)IG-541 (52 % nitrogen, 40 % argon, 8 % carbon dioxide).Permission to use other extinguishing agents, when such permission is designed to amend non-essential elements of this Directive, shall be given in accordance with the regulatory procedure with scrutiny referred to in Article 19(3) of this Directive.’
1)
Article 1.06 shall be replaced by the following:‘1.06Temporary requirementsTemporary requirements designed to amend non-essential elements of this Directive, by supplementing it, may be adopted, in accordance with the regulatory procedure with scrutiny referred to in Article 19(4) of this Directive, where it is found urgently necessary, for the purposes of adaptation to technical progress of inland waterway transport, to allow derogations from the provisions of this Directive or to allow tests. The requirements shall be published and shall be valid for a maximum of three years. They shall enter into force at the same time and shall be annulled under the same conditions in all Member States.’
2)
Article 10.03a(5) shall be replaced by the following:‘5.   Systems spraying smaller quantities of water shall have a type-approval pursuant to IMO Resolution A 800(19) or another recognised standard. Such recognitions, when designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3) of this Directive. Type-approval shall be carried out by an approved classification society or an accredited testing institution. The accredited testing institution shall comply with the European standard for general requirements for the competence of testing and calibrating laboratories (EN ISO/IEC 17025: 2000).’
3)
Article 10.03b(1) shall be replaced by the following:‘1.   Extinguishing agentsFor protecting engine rooms, boiler rooms and pump rooms, the following extinguishing agents may be used in permanently installed fire-fighting systems:(a)CO2(carbon dioxide);(b)HFC 227 ea (heptafluoropropane);(c)IG-541 (52 % nitrogen, 40 % argon, 8 % carbon dioxide).Permission to use other extinguishing agents, when such permission is designed to amend non-essential elements of this Directive, shall be given in accordance with the regulatory procedure with scrutiny referred to in Article 19(3) of this Directive.’
(a)
CO2(carbon dioxide);
(b)
HFC 227 ea (heptafluoropropane);
(c)
IG-541 (52 % nitrogen, 40 % argon, 8 % carbon dioxide).

1)
Article 1.06 shall be replaced by the following:‘1.06Temporary requirementsTemporary requirements designed to amend non-essential elements of this Directive, by supplementing it, may be adopted, in accordance with the regulatory procedure with scrutiny referred to in Article 19(4) of this Directive, where it is found urgently necessary, for the purposes of adaptation to technical progress of inland waterway transport, to allow derogations from the provisions of this Directive or to allow tests. The requirements shall be published and shall be valid for a maximum of three years. They shall enter into force at the same time and shall be annulled under the same conditions in all Member States.’

2)
Article 10.03a(5) shall be replaced by the following:‘5.   Systems spraying smaller quantities of water shall have a type-approval pursuant to IMO Resolution A 800(19) or another recognised standard. Such recognitions, when designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3) of this Directive. Type-approval shall be carried out by an approved classification society or an accredited testing institution. The accredited testing institution shall comply with the European standard for general requirements for the competence of testing and calibrating laboratories (EN ISO/IEC 17025: 2000).’

3)
Article 10.03b(1) shall be replaced by the following:‘1.   Extinguishing agentsFor protecting engine rooms, boiler rooms and pump rooms, the following extinguishing agents may be used in permanently installed fire-fighting systems:(a)CO2(carbon dioxide);(b)HFC 227 ea (heptafluoropropane);(c)IG-541 (52 % nitrogen, 40 % argon, 8 % carbon dioxide).Permission to use other extinguishing agents, when such permission is designed to amend non-essential elements of this Directive, shall be given in accordance with the regulatory procedure with scrutiny referred to in Article 19(3) of this Directive.’
(a)
CO2(carbon dioxide);
(b)
HFC 227 ea (heptafluoropropane);
(c)
IG-541 (52 % nitrogen, 40 % argon, 8 % carbon dioxide).

(a)
CO2(carbon dioxide);

(b)
HFC 227 ea (heptafluoropropane);

(c)
IG-541 (52 % nitrogen, 40 % argon, 8 % carbon dioxide).

1)
Article 1.06 shall be replaced by the following:‘1.06Temporary requirementsTemporary requirements designed to amend non-essential elements of this Directive, by supplementing it, may be adopted, in accordance with the regulatory procedure with scrutiny referred to in Article 19(4) of this Directive, where it is found urgently necessary, for the purposes of adaptation to technical progress of inland waterway transport, to allow derogations from the provisions of this Directive or to allow tests. The requirements shall be published and shall be valid for a maximum of three years. They shall enter into force at the same time and shall be annulled under the same conditions in all Member States.’

2)
Article 10.03a(5) shall be replaced by the following:‘5.   Systems spraying smaller quantities of water shall have a type-approval pursuant to IMO Resolution A 800(19) or another recognised standard. Such recognitions, when designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3) of this Directive. Type-approval shall be carried out by an approved classification society or an accredited testing institution. The accredited testing institution shall comply with the European standard for general requirements for the competence of testing and calibrating laboratories (EN ISO/IEC 17025: 2000).’

3)
Article 10.03b(1) shall be replaced by the following:‘1.   Extinguishing agentsFor protecting engine rooms, boiler rooms and pump rooms, the following extinguishing agents may be used in permanently installed fire-fighting systems:(a)CO2(carbon dioxide);(b)HFC 227 ea (heptafluoropropane);(c)IG-541 (52 % nitrogen, 40 % argon, 8 % carbon dioxide).Permission to use other extinguishing agents, when such permission is designed to amend non-essential elements of this Directive, shall be given in accordance with the regulatory procedure with scrutiny referred to in Article 19(3) of this Directive.’
(a)
CO2(carbon dioxide);
(b)
HFC 227 ea (heptafluoropropane);
(c)
IG-541 (52 % nitrogen, 40 % argon, 8 % carbon dioxide).

(a)
CO2(carbon dioxide);

(b)
HFC 227 ea (heptafluoropropane);

(c)
IG-541 (52 % nitrogen, 40 % argon, 8 % carbon dioxide).

(a)
CO2(carbon dioxide);

(b)
HFC 227 ea (heptafluoropropane);

(c)
IG-541 (52 % nitrogen, 40 % argon, 8 % carbon dioxide).

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 71(1) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee,

After consulting the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty(1),

(1) Directive 2006/87/EC(2)establishes harmonised conditions for issuing technical certificates for inland waterway vessels throughout the Community’s inland waterway network.

(2) The technical requirements set out in the Annexes to Directive 2006/87/EC for the most part incorporate the provisions laid down in the Regulation on Inspection of Shipping on the Rhine, in the version approved in 2004 by the member states of the Central Commission for Navigation on the Rhine (CCNR). The conditions and technical requirements for issuing inland navigation certificates under Article 22 of the Revised Convention for Rhine Navigation are updated regularly and are recognised as reflecting current technological developments.

(3) In order to prevent distortions of competition and varying levels of safety, it is desirable, specifically in the interests of promoting harmonisation at European level, to adopt equivalent technical requirements for the whole of the Community’s inland waterway network and, subsequently, to update them at regular intervals in order to maintain that equivalence.

(4) Directive 2006/87/EC authorises the Commission to adapt those technical requirements in the light of technical progress and of developments arising from the work of other international organisations, in particular that of the CCNR.

(5) Those amendments need to be made rapidly in order to ensure that the technical requirements necessary for the issuing of the Community inland navigation certificate give a level of safety equivalent to that required for the issuing of the certificate referred to in Article 22 of the Revised Convention for Rhine Navigation.

(6) The measures necessary for the implementation of Directive 2006/87/EC should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission5(3).

(7) In particular the Commission should be empowered to establish the conditions under which the technical requirements and administrative procedures set out in the Annexes to Directive 2006/87/EC may be amended. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2006/87/EC, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(8) On grounds of efficiency, the normal time-limits for the regulatory procedure with scrutiny should be curtailed for the adoption of such measures amending the Annexes to Directive 2006/87/EC.

(9) On grounds of urgency, it is necessary to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of any amendment of the Annexes to Directive 2006/87/EC to take account of technical developments or related developments arising from the work of other international organisations, in particular the CCNR, as well as for the adoption of temporary requirements.

(10) Directive 2006/87/ECshould therefore be amended accordingly,

HAVE ADOPTED THIS DIRECTIVE:
Article 1

Directive 2006/87/EC is hereby amended as follows:

1)

The following paragraphs shall be added to Article 19:

‘3.   Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The time limits provided for in Article 5a(3)(c), (4)(b) and (4)(e) of Decision 1999/468/EC shall be set at twenty-one days, fifteen days and one month respectively.

4.   Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’

2)

Article 20 shall be replaced by the following:

1.   Any amendments which are necessary to adapt the Annexes to this Directive to technical progress or to developments in this area arising from the work of other international organisations, in particular that of the Central Commission for Navigation on the Rhine (CCNR), to ensure that the two certificates referred to in Article 3(1)(a) are issued on the basis of technical requirements which guarantee an equivalent level of safety, or to take account of the cases referred to in Article 5, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3). On imperative grounds of urgency, the Commission may follow the urgency procedure referred to in Article 19(4).

Those amendments shall be made rapidly in order to ensure that the technical requirements for the issuing of the Community inland navigation certificate recognised for navigation on the Rhine give a level of safety equivalent to that required for the issuing of the certificate referred to in Article 22 of the Revised Convention for Rhine Navigation.

2.   Notwithstanding paragraph 1, the Commission shall adopt the approvals referred to in Article 5(2) in accordance with the procedure referred to in Article 19(2).

3.   The Commission shall decide on recommendations from the Committee on the issue of provisional Community inland navigation certificates in accordance with Article 2.19 of Annex II.’

3)

Annex II shall be amended as follows:

1)

Article 1.06 shall be replaced by the following:

Temporary requirements designed to amend non-essential elements of this Directive, by supplementing it, may be adopted, in accordance with the regulatory procedure with scrutiny referred to in Article 19(4) of this Directive, where it is found urgently necessary, for the purposes of adaptation to technical progress of inland waterway transport, to allow derogations from the provisions of this Directive or to allow tests. The requirements shall be published and shall be valid for a maximum of three years. They shall enter into force at the same time and shall be annulled under the same conditions in all Member States.’

2)

Article 10.03a(5) shall be replaced by the following:

‘5.   Systems spraying smaller quantities of water shall have a type-approval pursuant to IMO Resolution A 800(19) or another recognised standard. Such recognitions, when designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3) of this Directive. Type-approval shall be carried out by an approved classification society or an accredited testing institution. The accredited testing institution shall comply with the European standard for general requirements for the competence of testing and calibrating laboratories (EN ISO/IEC 17025: 2000).’

3)

Article 10.03b(1) shall be replaced by the following:

‘1.   Extinguishing agents

For protecting engine rooms, boiler rooms and pump rooms, the following extinguishing agents may be used in permanently installed fire-fighting systems:

(a)

CO2(carbon dioxide);

(b)

HFC 227 ea (heptafluoropropane);

(c)

IG-541 (52 % nitrogen, 40 % argon, 8 % carbon dioxide).

Permission to use other extinguishing agents, when such permission is designed to amend non-essential elements of this Directive, shall be given in accordance with the regulatory procedure with scrutiny referred to in Article 19(3) of this Directive.’
Article 2

1.   Member States which have inland waterways as referred to in Article 1(1) of Directive 2006/87/EC shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 30 December 2008. They shall forthwith inform the Commission thereof.

When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof.
Article 3

This Directive shall enter into force on the day of its publication in theOfficial Journal of the European Union.
Article 4

This Directive is addressed to the Member States which have inland waterways as referred to in Article 1(1) of Directive 2006/87/EC.
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 71(1) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee,

After consulting the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty(1),

(1) Directive 2006/87/EC(2)establishes harmonised conditions for issuing technical certificates for inland waterway vessels throughout the Community’s inland waterway network.

(2) The technical requirements set out in the Annexes to Directive 2006/87/EC for the most part incorporate the provisions laid down in the Regulation on Inspection of Shipping on the Rhine, in the version approved in 2004 by the member states of the Central Commission for Navigation on the Rhine (CCNR). The conditions and technical requirements for issuing inland navigation certificates under Article 22 of the Revised Convention for Rhine Navigation are updated regularly and are recognised as reflecting current technological developments.

(3) In order to prevent distortions of competition and varying levels of safety, it is desirable, specifically in the interests of promoting harmonisation at European level, to adopt equivalent technical requirements for the whole of the Community’s inland waterway network and, subsequently, to update them at regular intervals in order to maintain that equivalence.

(4) Directive 2006/87/EC authorises the Commission to adapt those technical requirements in the light of technical progress and of developments arising from the work of other international organisations, in particular that of the CCNR.

(5) Those amendments need to be made rapidly in order to ensure that the technical requirements necessary for the issuing of the Community inland navigation certificate give a level of safety equivalent to that required for the issuing of the certificate referred to in Article 22 of the Revised Convention for Rhine Navigation.

(6) The measures necessary for the implementation of Directive 2006/87/EC should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission5(3).

(7) In particular the Commission should be empowered to establish the conditions under which the technical requirements and administrative procedures set out in the Annexes to Directive 2006/87/EC may be amended. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2006/87/EC, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(8) On grounds of efficiency, the normal time-limits for the regulatory procedure with scrutiny should be curtailed for the adoption of such measures amending the Annexes to Directive 2006/87/EC.

(9) On grounds of urgency, it is necessary to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of any amendment of the Annexes to Directive 2006/87/EC to take account of technical developments or related developments arising from the work of other international organisations, in particular the CCNR, as well as for the adoption of temporary requirements.

(10) Directive 2006/87/ECshould therefore be amended accordingly,

HAVE ADOPTED THIS DIRECTIVE:
Directive 2006/87/EC is hereby amended as follows:

1)

The following paragraphs shall be added to Article 19:

‘3.   Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The time limits provided for in Article 5a(3)(c), (4)(b) and (4)(e) of Decision 1999/468/EC shall be set at twenty-one days, fifteen days and one month respectively.

4.   Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’

2)

Article 20 shall be replaced by the following:

1.   Any amendments which are necessary to adapt the Annexes to this Directive to technical progress or to developments in this area arising from the work of other international organisations, in particular that of the Central Commission for Navigation on the Rhine (CCNR), to ensure that the two certificates referred to in Article 3(1)(a) are issued on the basis of technical requirements which guarantee an equivalent level of safety, or to take account of the cases referred to in Article 5, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3). On imperative grounds of urgency, the Commission may follow the urgency procedure referred to in Article 19(4).

Those amendments shall be made rapidly in order to ensure that the technical requirements for the issuing of the Community inland navigation certificate recognised for navigation on the Rhine give a level of safety equivalent to that required for the issuing of the certificate referred to in Article 22 of the Revised Convention for Rhine Navigation.

2.   Notwithstanding paragraph 1, the Commission shall adopt the approvals referred to in Article 5(2) in accordance with the procedure referred to in Article 19(2).

3.   The Commission shall decide on recommendations from the Committee on the issue of provisional Community inland navigation certificates in accordance with Article 2.19 of Annex II.’

3)

Annex II shall be amended as follows:

1)

Article 1.06 shall be replaced by the following:

Temporary requirements designed to amend non-essential elements of this Directive, by supplementing it, may be adopted, in accordance with the regulatory procedure with scrutiny referred to in Article 19(4) of this Directive, where it is found urgently necessary, for the purposes of adaptation to technical progress of inland waterway transport, to allow derogations from the provisions of this Directive or to allow tests. The requirements shall be published and shall be valid for a maximum of three years. They shall enter into force at the same time and shall be annulled under the same conditions in all Member States.’

2)

Article 10.03a(5) shall be replaced by the following:

‘5.   Systems spraying smaller quantities of water shall have a type-approval pursuant to IMO Resolution A 800(19) or another recognised standard. Such recognitions, when designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3) of this Directive. Type-approval shall be carried out by an approved classification society or an accredited testing institution. The accredited testing institution shall comply with the European standard for general requirements for the competence of testing and calibrating laboratories (EN ISO/IEC 17025: 2000).’

3)

Article 10.03b(1) shall be replaced by the following:

‘1.   Extinguishing agents

For protecting engine rooms, boiler rooms and pump rooms, the following extinguishing agents may be used in permanently installed fire-fighting systems:

(a)

CO2(carbon dioxide);

(b)

HFC 227 ea (heptafluoropropane);

(c)

IG-541 (52 % nitrogen, 40 % argon, 8 % carbon dioxide).

Permission to use other extinguishing agents, when such permission is designed to amend non-essential elements of this Directive, shall be given in accordance with the regulatory procedure with scrutiny referred to in Article 19(3) of this Directive.’
1.   Member States which have inland waterways as referred to in Article 1(1) of Directive 2006/87/EC shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 30 December 2008. They shall forthwith inform the Commission thereof.

When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof.
This Directive shall enter into force on the day of its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States which have inland waterways as referred to in Article 1(1) of Directive 2006/87/EC.

Pending: 32006L0113

                                January 16, 2026                            

27.12.2006
EN
Official Journal of the European Union
L 376/14

(1)
Council Directive 79/923/EEC of 30 October 1979 on the quality required of shellfish waters(2)has been substantially amended(3). In the interests of clarity and rationality the said Directive should be codified.

(2)
The protection and improvement of the environment necessitate concrete measures to protect waters, including shellfish waters, against pollution.

(3)
It is necessary to safeguard certain shellfish populations from various harmful consequences, resulting from the discharge of pollutant substances into the sea.

(4)
Decision No 1600/2002/EC of the European Parliament and of the Council of 22 July 2002 laying down the Sixth Community Environment Action Programme(4)provides that quality objectives are to be jointly drawn up fixing the various requirements which an environment must meet,inter aliathe definition of parameters for water, including shellfish waters.

(5)
Differences between the provisions in force in the various Member States as regards the quality required of shellfish waters may create unequal conditions of competition and thus directly affect the functioning of the internal market.

(6)
In order to attain the objectives of this Directive, the Member States must designate the waters to which it will apply and set limit values corresponding to certain parameters. The waters so designated will have to conform to these values within six years of designation.

(7)
For the purpose of checking the quality required of shellfish waters, a minimum number of samples should be taken and the measurements relating to parameters set out in Annex I should be carried out. Such sampling may be reduced or discontinued in the light of the results of the measurements.

(8)
Certain natural circumstances are beyond the control of the Member States and it is therefore necessary to provide for the possibility of derogating from this Directive in certain cases.

(9)
Technical and scientific progress may make necessary the rapid adaptation of some of the requirements laid down in Annex I. In order to facilitate the introduction of the measures required for this purpose, a procedure should be laid down establishing close cooperation between the Member States and the Commission. Such cooperation should take place in the Committee on Adaptation to Technical and Scientific Progress set up by Article 13(1) of Directive 2006/44/EC of the European Parliament and of the Council of 6 September 2006 on the quality of fresh waters needing protection or improvement in order to support fish life(5).

(10)
This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives, as set out in Part B of Annex II,

(a)
100 % of the samples for the parameters ‘organohalogenated substances’ and ‘metals’;

(b)
95 % of the samples for the parameters ‘salinity’ and ‘dissolved oxygen’;

(c)
75 % of the samples for the other parameters listed in Annex I.

(a)
the waters designated in accordance with Article 4(1), in summary form;

(b)
the revision of the designation of certain waters in accordance with Article 4(2);

(c)
the provisions laid down in order to establish new parameters in accordance with Article 9.

Parameter
G
I
Reference methods of analysis
Minimum sampling and measuring frequency

1.
pHpH unit

7 — 9
—ElectrometryMeasuredin situat the time of sampling
—
ElectrometryMeasuredin situat the time of sampling
Quarterly

—
ElectrometryMeasuredin situat the time of sampling

2.
Temperature °C
A discharge affecting shellfish waters must not cause the temperature of the waters to exceed by more than 2 °C the temperature of waters not so affected

—ThermometryMeasuredin situat the time of sampling
—
ThermometryMeasuredin situat the time of sampling
Quarterly

—
ThermometryMeasuredin situat the time of sampling

3.
Coloration (after filtration) mg Pt/l

A discharge affecting shellfish waters must not cause the colour of the waters after filtration to deviate by more than 10 mg Pt/l from the colour of waters not so affected
—Filter through a 0·45 µm membranePhotometric method, using the platinum/cobalt scale
—
Filter through a 0·45 µm membranePhotometric method, using the platinum/cobalt scale
Quarterly

—
Filter through a 0·45 µm membranePhotometric method, using the platinum/cobalt scale

4.
Suspended solids mg/l

A discharge affecting shellfish waters must not cause the suspended solid content of the waters to exceed by more than 30 % the content of waters not so affected
—Filtration through a 0·45 µm membrane, drying at 105 °C and weighing—Centrifuging (for at least five minutes, with mean acceleration 2 800 to 3 200  g), drying at 105 °C and weighing
—
Filtration through a 0·45 µm membrane, drying at 105 °C and weighing
—
Centrifuging (for at least five minutes, with mean acceleration 2 800 to 3 200  g), drying at 105 °C and weighing
Quarterly

—
Filtration through a 0·45 µm membrane, drying at 105 °C and weighing

—
Centrifuging (for at least five minutes, with mean acceleration 2 800 to 3 200  g), drying at 105 °C and weighing

5.
Salinity ‰
12 to 38 ‰
≤ 40 ‰Discharge affecting shellfish waters must not cause their salinity to exceed by more than 10 % the salinity of waters not so affected
Conductimetry
Monthly

6.
Dissolved oxygen(Saturation %)
≥ 80 %
≥ 70 % (average value)Should an individual measurement indicate a value lower than 70 %, measurements shall be repeatedAn individual measurement may not indicate a value of less than 60 % unless there are no harmful consequences for the development of shellfish colonies
Winkler's methodElectrochemical method
Monthly, with a minimum of one sample representative of low oxygen conditions on the day of sampling. However, where major daily variations are suspected, a minimum of two samples in one day shall be taken

7.
Petroleum hydrocarbons

Hydrocarbons must not be present in the shellfish water in such quantities as to:—produce a visible film on the surface of the water and/or a deposit on the shellfish,—have harmful effects on the shellfish
—
produce a visible film on the surface of the water and/or a deposit on the shellfish,
—
have harmful effects on the shellfish
Visual examination
Quarterly

—
produce a visible film on the surface of the water and/or a deposit on the shellfish,

—
have harmful effects on the shellfish

8.
Organohalogenated substances
The concentration of each substance in shellfish flesh must be so limited that it contributes, in accordance with Article 1, to the high quality of shellfish products
The concentration of each substance in the shellfish water or in shellfish flesh must not reach or exceed a level which has harmful effects on the shellfish and larvae
Gas chromatography after extraction with suitable solvents and purification
Half-yearly

9.
Metals
The concentration of each substance in shellfish flesh must be so limited that it contributes in accordance with Article 1, to the high quality of shellfish products
The concentration of each substance in the shellfish water or in the shellfish flesh must not exceed a level which gives rise to harmful effects on the shellfish and their larvaeThe synergic effects of these metals must be taken into consideration
Spectrometry of atomic absorption preceded, where appropriate, by concentration and/or extraction
Half-yearly

Silver
Ag

Arsenic
As

Cadmium
Cd

Chromium
Cr

Copper
Cu

Mercury
Hg

Nickel
Ni

Lead
Pb

Zinc
Zn

mg/l

10.
Faecal coliforms/100 ml
≤ 300 in the shellfish flesh and intervalvular liquid

Method of dilution with fermentation in liquid substrates in at least three tubes in three dilutions. Subculturing of the positive tubes on a confirmation medium. Count according to MPN (most probable number). Incubation temperature 44 °C ± 0,5 °C
Quarterly

11.
Substances affecting the taste of the shellfish

Concentration lower than that liable to impair the taste of the shellfish
Examination of the shellfish by tasting where the presence of one of these substances is presumed

12.
Saxitoxin (produced by dinoflagellates)

Abbreviations:G=guideI=mandatory
G
=
guide
I
=
mandatory

G
=
guide

I
=
mandatory

—
ElectrometryMeasuredin situat the time of sampling

—
ThermometryMeasuredin situat the time of sampling

—
Filter through a 0·45 µm membranePhotometric method, using the platinum/cobalt scale

—
Filtration through a 0·45 µm membrane, drying at 105 °C and weighing

—
Centrifuging (for at least five minutes, with mean acceleration 2 800 to 3 200  g), drying at 105 °C and weighing

—
produce a visible film on the surface of the water and/or a deposit on the shellfish,

—
have harmful effects on the shellfish

G
=
guide

I
=
mandatory

Council Directive 79/923/EEC(OJ L 281, 10.11.1979, p. 47)

Council Directive 91/692/EEC(OJ L 377, 31.12.1991, p. 48)
Only Annex I, point (e)

Directive
Time-limit for transposition

79/923/EEC
6 November 1981

91/692/EEC
1 January 1993

Directive 79/923/EEC
This Directive

Article 1
Article 1

Article 2
Article 2

Article 3
Article 3

Article 4(1) and (2)
Article 4(1)

Article 4(3)
Article 4(2)

Article 5
Article 5

Article 6(1), first subparagraph, introductory sentence
Article 6(1), first subparagraph, introductory sentence

Article 6(1), first subparagraph, first indent
Article 6(1), first subparagraph, point (a)

Article 6(1), first subparagraph, second indent
Article 6(1), first subparagraph, point (b)

Article 6(1), first subparagraph, third indent
Article 6(1), first subparagraph, point (c)

Article 6(1), second subparagraph
Article 6(1), second subparagraph

Article 6(2)
Article 6(2)

Article 7
Article 7

Article 8
Article 8

Article 9
Article 9

Article 10
Article 10

Article 11
Article 11

Article 12
Article 12

Article 13, first paragraph, introductory sentence
Article 13(1), introductory sentence

Article 13, first paragraph, first indent
Article 13(1), point (a)

Article 13, first paragraph, second indent
Article 13(1), point (b)

Article 13, first paragraph, third indent
Article 13(1), point (c)

Article 13, second paragraph
Article 13(2)

Article 13, third paragraph
Article 13(3)

Article 14
Article 14

Article 15(1)
—

Article 15(2)
Article 15

—
Article 16

—
Article 17

Article 16
Article 18

Annex
Annex I

—
Annex II

—
Annex III

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Economic and Social Committee,

After consulting the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty(1),

(1) Council Directive 79/923/EEC of 30 October 1979 on the quality required of shellfish waters(2)has been substantially amended(3). In the interests of clarity and rationality the said Directive should be codified.

(2) The protection and improvement of the environment necessitate concrete measures to protect waters, including shellfish waters, against pollution.

(3) It is necessary to safeguard certain shellfish populations from various harmful consequences, resulting from the discharge of pollutant substances into the sea.

(4) Decision No 1600/2002/EC of the European Parliament and of the Council of 22 July 2002 laying down the Sixth Community Environment Action Programme(4)provides that quality objectives are to be jointly drawn up fixing the various requirements which an environment must meet,inter aliathe definition of parameters for water, including shellfish waters.

(5) Differences between the provisions in force in the various Member States as regards the quality required of shellfish waters may create unequal conditions of competition and thus directly affect the functioning of the internal market.

(6) In order to attain the objectives of this Directive, the Member States must designate the waters to which it will apply and set limit values corresponding to certain parameters. The waters so designated will have to conform to these values within six years of designation.

(7) For the purpose of checking the quality required of shellfish waters, a minimum number of samples should be taken and the measurements relating to parameters set out in Annex I should be carried out. Such sampling may be reduced or discontinued in the light of the results of the measurements.

(8) Certain natural circumstances are beyond the control of the Member States and it is therefore necessary to provide for the possibility of derogating from this Directive in certain cases.

(9) Technical and scientific progress may make necessary the rapid adaptation of some of the requirements laid down in Annex I. In order to facilitate the introduction of the measures required for this purpose, a procedure should be laid down establishing close cooperation between the Member States and the Commission. Such cooperation should take place in the Committee on Adaptation to Technical and Scientific Progress set up by Article 13(1) of Directive 2006/44/EC of the European Parliament and of the Council of 6 September 2006 on the quality of fresh waters needing protection or improvement in order to support fish life(5).

(10) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives, as set out in Part B of Annex II,

HAVE ADOPTED THIS DIRECTIVE:
Article 1

This Directive concerns the quality of shellfish waters and applies to those coastal and brackish waters designated by the Member States as needing protection or improvement in order to support shellfish (bivalve and gasteropod molluscs) life and growth and thus to contribute to the high quality of shellfish products directly edible by man.
Article 2

The parameters applicable to the waters designated by the Member States are listed in Annex I.
Article 3

1.   Member States shall, for the designated waters, set values for the parameters listed in Annex I, in so far as values are given in column G or I. They shall comply with the comments contained in both columns.

2.   Member States shall not set values less stringent than those given in column I of Annex I and shall endeavour to observe the values in column G, while taking into account the principle set out in Article 8.

3.   For discharges of effluents falling within parameters ‘organohalogenated substances’ and ‘metals’, the emission standards laid down by the Member States pursuant to Directive 2006/11/EC of the European Parliament and of the Council of 15 February 2006 on pollution caused by certain dangerous substances discharged into the aquatic environment of the Community(6)shall be applied at the same time as the quality objectives and the other obligations arising from this Directive, in particular those relating to sampling.
Article 4

1.   Member States shall designate shellfish waters and may subsequently make additional designations.

2.   Member States may revise the designation of certain waters owing in particular to factors unforeseen at the time of designation, taking into account the principle set out in Article 8.
Article 5

Member States shall establish programmes in order to reduce pollution and to ensure that designated waters conform, within six years following designation in accordance with Article 4, to both the values set by the Member States in accordance with Article 3 and the comments contained in columns G and I of Annex I.
Article 6

1.   For the purposes of implementing Article 5, the designated waters shall be deemed to conform to the provisions of this Directive if samples of such waters, taken at the minimum frequency specified in Annex I, at the same sampling point and over a period of 12 months, show that they conform to both the values set by the Member States in accordance with Article 3 and the comments contained in columns G and I of Annex I, as regards:

(a)

100 % of the samples for the parameters ‘organohalogenated substances’ and ‘metals’;

(b)

95 % of the samples for the parameters ‘salinity’ and ‘dissolved oxygen’;

(c)

75 % of the samples for the other parameters listed in Annex I.

If, in accordance with Article 7(2), the sampling frequency for all the parameters in Annex I except ‘organohalogenated substances’ and ‘metals’ is lower than that indicated in Annex I, the values and comments referred to in the first subparagraph of this paragraph shall be complied with in the case of all the samples.

2.   Instances in which the values set by Member States in accordance with Article 3 or the comments contained in columns G and I of Annex I are not respected shall not be taken into consideration in the calculation of the percentages provided for in paragraph 1 when such instances are the result of a disaster.
Article 7

1.   The competent authorities in the Member States shall carry out sampling operations, the minimum frequency of which is laid down in Annex I.

2.   Where the competent authority records that the quality of designated waters is appreciably higher than that which would result from the application of the values set in accordance with Article 3 and the comments contained in columns G and I of Annex I, the frequency of the sampling may be reduced. Where there is no pollution and no risk of deterioration in the quality of the waters, the competent authority concerned may decide that no sampling is necessary.

3.   If sampling shows that a value set in accordance with Article 3 or a comment contained in columns G or I of Annex I is not respected, the competent authority shall establish whether this is the result of chance, a natural phenomenon or pollution and shall adopt appropriate measures.

4.   The exact sampling point, the distance from this point to the nearest point where pollutants are discharged and the depth at which the samples are to be taken shall be fixed by the competent authority of each Member State on the basis of local environmental conditions in particular.

5.   The reference methods of analysis to be used for calculating the value of the parameters concerned are set out in Annex I. Laboratories which employ other methods shall ensure that the results obtained are equivalent or comparable to those specified in Annex I.
Article 8

Implementation of the measures taken pursuant to this Directive may on no account lead, either directly or indirectly, to increased pollution of coastal and brackish waters.
Article 9

Member States may at any time set more stringent values for designated waters than those laid down in this Directive. They may also lay down provisions relating to parameters other than those provided for in this Directive.
Article 10

Where a Member State considers designating shellfish waters in the immediate vicinity of a frontier with another Member State, these States shall consult each other in order to determine the stretches of such waters to which this Directive might apply and the consequences to be drawn from the common quality objectives; these consequences shall be determined, after formal consultations, by each Member State concerned. The Commission may participate in these deliberations.
Article 11

The Member States may derogate from this Directive in the event of exceptional weather or geographical conditions.
Article 12

Such amendments as are necessary for adapting to technical and scientific progress the G values for the parameters and the methods of analysis contained in Annex I shall be adopted by the Committee set up by Article 13(1) of Directive 2006/44/EC in accordance with the procedure referred to in Article 13(2) thereof.
Article 13

1.   For the purpose of applying this Directive, Member States shall provide the Commission with information concerning:

(a)

the waters designated in accordance with Article 4(1), in summary form;

(b)

the revision of the designation of certain waters in accordance with Article 4(2);

(c)

the provisions laid down in order to establish new parameters in accordance with Article 9.

2.   Where a Member State applies the provisions of Article 11, it shall forthwith notify the Commission thereof, stating its reasons and the periods anticipated.

3.   More generally, Member States shall provide the Commission, on a reasoned request from the latter, with any information necessary for the application of this Directive.
Article 14

At intervals of three years, and for the first time for the period from 1993 to 1995 inclusive, the Member States shall send information to the Commission on the implementation of this Directive, in the form of a sectoral report which shall also cover other pertinent Community Directives. This report shall be drawn up on the basis of a questionnaire or outline drafted by the Commission in accordance with the procedure referred to in Article 6(2) of Council Directive 91/692/EEC of 23 December 1991 standardising and rationalising reports on the implementation of certain Directives relating to the environment(7). The questionnaire or outline shall be sent to the Member States six months before the start of the period covered by the report. The report shall be sent to the Commission within nine months of the end of the three-year period covered by it.

The Commission shall publish a Community report on the implementation of this Directive within nine months of receiving the reports from the Member States.
Article 15

Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.
Article 16

Directive 79/923/EEC is hereby repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives, as set out in Part B of Annex II.

References made to the repealed Directive shall be construed as being made to this Directive and should be read in accordance with the correlation table in Annex III.
Article 17

This Directive shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.
Article 18

This Directive is addressed to the Member States.
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Economic and Social Committee,

After consulting the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty(1),

(1) Council Directive 79/923/EEC of 30 October 1979 on the quality required of shellfish waters(2)has been substantially amended(3). In the interests of clarity and rationality the said Directive should be codified.

(2) The protection and improvement of the environment necessitate concrete measures to protect waters, including shellfish waters, against pollution.

(3) It is necessary to safeguard certain shellfish populations from various harmful consequences, resulting from the discharge of pollutant substances into the sea.

(4) Decision No 1600/2002/EC of the European Parliament and of the Council of 22 July 2002 laying down the Sixth Community Environment Action Programme(4)provides that quality objectives are to be jointly drawn up fixing the various requirements which an environment must meet,inter aliathe definition of parameters for water, including shellfish waters.

(5) Differences between the provisions in force in the various Member States as regards the quality required of shellfish waters may create unequal conditions of competition and thus directly affect the functioning of the internal market.

(6) In order to attain the objectives of this Directive, the Member States must designate the waters to which it will apply and set limit values corresponding to certain parameters. The waters so designated will have to conform to these values within six years of designation.

(7) For the purpose of checking the quality required of shellfish waters, a minimum number of samples should be taken and the measurements relating to parameters set out in Annex I should be carried out. Such sampling may be reduced or discontinued in the light of the results of the measurements.

(8) Certain natural circumstances are beyond the control of the Member States and it is therefore necessary to provide for the possibility of derogating from this Directive in certain cases.

(9) Technical and scientific progress may make necessary the rapid adaptation of some of the requirements laid down in Annex I. In order to facilitate the introduction of the measures required for this purpose, a procedure should be laid down establishing close cooperation between the Member States and the Commission. Such cooperation should take place in the Committee on Adaptation to Technical and Scientific Progress set up by Article 13(1) of Directive 2006/44/EC of the European Parliament and of the Council of 6 September 2006 on the quality of fresh waters needing protection or improvement in order to support fish life(5).

(10) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives, as set out in Part B of Annex II,

HAVE ADOPTED THIS DIRECTIVE:
This Directive concerns the quality of shellfish waters and applies to those coastal and brackish waters designated by the Member States as needing protection or improvement in order to support shellfish (bivalve and gasteropod molluscs) life and growth and thus to contribute to the high quality of shellfish products directly edible by man.
The parameters applicable to the waters designated by the Member States are listed in Annex I.
1.   Member States shall, for the designated waters, set values for the parameters listed in Annex I, in so far as values are given in column G or I. They shall comply with the comments contained in both columns.

2.   Member States shall not set values less stringent than those given in column I of Annex I and shall endeavour to observe the values in column G, while taking into account the principle set out in Article 8.

3.   For discharges of effluents falling within parameters ‘organohalogenated substances’ and ‘metals’, the emission standards laid down by the Member States pursuant to Directive 2006/11/EC of the European Parliament and of the Council of 15 February 2006 on pollution caused by certain dangerous substances discharged into the aquatic environment of the Community(6)shall be applied at the same time as the quality objectives and the other obligations arising from this Directive, in particular those relating to sampling.
1.   Member States shall designate shellfish waters and may subsequently make additional designations.

2.   Member States may revise the designation of certain waters owing in particular to factors unforeseen at the time of designation, taking into account the principle set out in Article 8.
Member States shall establish programmes in order to reduce pollution and to ensure that designated waters conform, within six years following designation in accordance with Article 4, to both the values set by the Member States in accordance with Article 3 and the comments contained in columns G and I of Annex I.
1.   For the purposes of implementing Article 5, the designated waters shall be deemed to conform to the provisions of this Directive if samples of such waters, taken at the minimum frequency specified in Annex I, at the same sampling point and over a period of 12 months, show that they conform to both the values set by the Member States in accordance with Article 3 and the comments contained in columns G and I of Annex I, as regards:

(a)

100 % of the samples for the parameters ‘organohalogenated substances’ and ‘metals’;

(b)

95 % of the samples for the parameters ‘salinity’ and ‘dissolved oxygen’;

(c)

75 % of the samples for the other parameters listed in Annex I.

If, in accordance with Article 7(2), the sampling frequency for all the parameters in Annex I except ‘organohalogenated substances’ and ‘metals’ is lower than that indicated in Annex I, the values and comments referred to in the first subparagraph of this paragraph shall be complied with in the case of all the samples.

2.   Instances in which the values set by Member States in accordance with Article 3 or the comments contained in columns G and I of Annex I are not respected shall not be taken into consideration in the calculation of the percentages provided for in paragraph 1 when such instances are the result of a disaster.
1.   The competent authorities in the Member States shall carry out sampling operations, the minimum frequency of which is laid down in Annex I.

2.   Where the competent authority records that the quality of designated waters is appreciably higher than that which would result from the application of the values set in accordance with Article 3 and the comments contained in columns G and I of Annex I, the frequency of the sampling may be reduced. Where there is no pollution and no risk of deterioration in the quality of the waters, the competent authority concerned may decide that no sampling is necessary.

3.   If sampling shows that a value set in accordance with Article 3 or a comment contained in columns G or I of Annex I is not respected, the competent authority shall establish whether this is the result of chance, a natural phenomenon or pollution and shall adopt appropriate measures.

4.   The exact sampling point, the distance from this point to the nearest point where pollutants are discharged and the depth at which the samples are to be taken shall be fixed by the competent authority of each Member State on the basis of local environmental conditions in particular.

5.   The reference methods of analysis to be used for calculating the value of the parameters concerned are set out in Annex I. Laboratories which employ other methods shall ensure that the results obtained are equivalent or comparable to those specified in Annex I.
Implementation of the measures taken pursuant to this Directive may on no account lead, either directly or indirectly, to increased pollution of coastal and brackish waters.
Member States may at any time set more stringent values for designated waters than those laid down in this Directive. They may also lay down provisions relating to parameters other than those provided for in this Directive.
Where a Member State considers designating shellfish waters in the immediate vicinity of a frontier with another Member State, these States shall consult each other in order to determine the stretches of such waters to which this Directive might apply and the consequences to be drawn from the common quality objectives; these consequences shall be determined, after formal consultations, by each Member State concerned. The Commission may participate in these deliberations.
The Member States may derogate from this Directive in the event of exceptional weather or geographical conditions.
Such amendments as are necessary for adapting to technical and scientific progress the G values for the parameters and the methods of analysis contained in Annex I shall be adopted by the Committee set up by Article 13(1) of Directive 2006/44/EC in accordance with the procedure referred to in Article 13(2) thereof.
1.   For the purpose of applying this Directive, Member States shall provide the Commission with information concerning:

(a)

the waters designated in accordance with Article 4(1), in summary form;

(b)

the revision of the designation of certain waters in accordance with Article 4(2);

(c)

the provisions laid down in order to establish new parameters in accordance with Article 9.

2.   Where a Member State applies the provisions of Article 11, it shall forthwith notify the Commission thereof, stating its reasons and the periods anticipated.

3.   More generally, Member States shall provide the Commission, on a reasoned request from the latter, with any information necessary for the application of this Directive.
At intervals of three years, and for the first time for the period from 1993 to 1995 inclusive, the Member States shall send information to the Commission on the implementation of this Directive, in the form of a sectoral report which shall also cover other pertinent Community Directives. This report shall be drawn up on the basis of a questionnaire or outline drafted by the Commission in accordance with the procedure referred to in Article 6(2) of Council Directive 91/692/EEC of 23 December 1991 standardising and rationalising reports on the implementation of certain Directives relating to the environment(7). The questionnaire or outline shall be sent to the Member States six months before the start of the period covered by the report. The report shall be sent to the Commission within nine months of the end of the three-year period covered by it.

The Commission shall publish a Community report on the implementation of this Directive within nine months of receiving the reports from the Member States.
Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.
Directive 79/923/EEC is hereby repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives, as set out in Part B of Annex II.

References made to the repealed Directive shall be construed as being made to this Directive and should be read in accordance with the correlation table in Annex III.
This Directive shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States.
ANNEX IQUALITY OF SHELLFISH WATERS

 | Parameter | G | I | Reference methods of analysis | Minimum sampling and measuring frequency

1. | pHpH unit |  | 7 — 9 | —ElectrometryMeasuredin situat the time of sampling | — | ElectrometryMeasuredin situat the time of sampling | Quarterly

— | ElectrometryMeasuredin situat the time of sampling

2. | Temperature °C | A discharge affecting shellfish waters must not cause the temperature of the waters to exceed by more than 2 °C the temperature of waters not so affected |  | —ThermometryMeasuredin situat the time of sampling | — | ThermometryMeasuredin situat the time of sampling | Quarterly

— | ThermometryMeasuredin situat the time of sampling

3. | Coloration (after filtration) mg Pt/l |  | A discharge affecting shellfish waters must not cause the colour of the waters after filtration to deviate by more than 10 mg Pt/l from the colour of waters not so affected | —Filter through a 0·45 µm membranePhotometric method, using the platinum/cobalt scale | — | Filter through a 0·45 µm membranePhotometric method, using the platinum/cobalt scale | Quarterly

— | Filter through a 0·45 µm membranePhotometric method, using the platinum/cobalt scale

4. | Suspended solids mg/l |  | A discharge affecting shellfish waters must not cause the suspended solid content of the waters to exceed by more than 30 % the content of waters not so affected | —Filtration through a 0·45 µm membrane, drying at 105 °C and weighing—Centrifuging (for at least five minutes, with mean acceleration 2 800  to 3 200  g), drying at 105 °C and weighing | — | Filtration through a 0·45 µm membrane, drying at 105 °C and weighing | — | Centrifuging (for at least five minutes, with mean acceleration 2 800  to 3 200  g), drying at 105 °C and weighing | Quarterly

— | Filtration through a 0·45 µm membrane, drying at 105 °C and weighing

— | Centrifuging (for at least five minutes, with mean acceleration 2 800  to 3 200  g), drying at 105 °C and weighing

5. | Salinity ‰ | 12 to 38 ‰ | ≤ 40 ‰Discharge affecting shellfish waters must not cause their salinity to exceed by more than 10 % the salinity of waters not so affected | Conductimetry | Monthly

6. | Dissolved oxygen(Saturation %) | ≥ 80 % | ≥ 70 % (average value)Should an individual measurement indicate a value lower than 70 %, measurements shall be repeatedAn individual measurement may not indicate a value of less than 60 % unless there are no harmful consequences for the development of shellfish colonies | Winkler’s methodElectrochemical method | Monthly, with a minimum of one sample representative of low oxygen conditions on the day of sampling. However, where major daily variations are suspected, a minimum of two samples in one day shall be taken

7. | Petroleum hydrocarbons |  | Hydrocarbons must not be present in the shellfish water in such quantities as to:—produce a visible film on the surface of the water and/or a deposit on the shellfish,—have harmful effects on the shellfish | — | produce a visible film on the surface of the water and/or a deposit on the shellfish, | — | have harmful effects on the shellfish | Visual examination | Quarterly

— | produce a visible film on the surface of the water and/or a deposit on the shellfish,

— | have harmful effects on the shellfish

8. | Organohalogenated substances | The concentration of each substance in shellfish flesh must be so limited that it contributes, in accordance with Article 1, to the high quality of shellfish products | The concentration of each substance in the shellfish water or in shellfish flesh must not reach or exceed a level which has harmful effects on the shellfish and larvae | Gas chromatography after extraction with suitable solvents and purification | Half-yearly

9. | Metals | The concentration of each substance in shellfish flesh must be so limited that it contributes in accordance with Article 1, to the high quality of shellfish products | The concentration of each substance in the shellfish water or in the shellfish flesh must not exceed a level which gives rise to harmful effects on the shellfish and their larvaeThe synergic effects of these metals must be taken into consideration | Spectrometry of atomic absorption preceded, where appropriate, by concentration and/or extraction | Half-yearly

Silver | Ag

Arsenic | As

Cadmium | Cd

Chromium | Cr

Copper | Cu

Mercury | Hg

Nickel | Ni

Lead | Pb

Zinc | Zn

mg/l | 

10. | Faecal coliforms/100 ml | ≤ 300 in the shellfish flesh and intervalvular liquid |  | Method of dilution with fermentation in liquid substrates in at least three tubes in three dilutions. Subculturing of the positive tubes on a confirmation medium. Count according to MPN (most probable number). Incubation temperature 44 °C ± 0,5 °C | Quarterly

11. | Substances affecting the taste of the shellfish |  | Concentration lower than that liable to impair the taste of the shellfish | Examination of the shellfish by tasting where the presence of one of these substances is presumed | 

12. | Saxitoxin (produced by dinoflagellates) |  |  |  | 

Abbreviations:G=guideI=mandatory | G | = | guide | I | = | mandatory

G | = | guide

I | = | mandatory
PART AANNEX IIRepealed Directive with its amendment

Council Directive 79/923/EEC(OJ L 281, 10.11.1979, p. 47) | 

Council Directive 91/692/EEC(OJ L 377, 31.12.1991, p. 48) | Only Annex I, point (e)PART BList of time-limits for transposition into national law

(referred to in Article 16)
Directive | Time-limit for transposition

79/923/EEC | 6 November 1981

91/692/EEC | 1 January 1993
ANNEX IIICORRELATION TABLE

Directive 79/923/EEC | This Directive

Article 1 | Article 1

Article 2 | Article 2

Article 3 | Article 3

Article 4(1) and (2) | Article 4(1)

Article 4(3) | Article 4(2)

Article 5 | Article 5

Article 6(1), first subparagraph, introductory sentence | Article 6(1), first subparagraph, introductory sentence

Article 6(1), first subparagraph, first indent | Article 6(1), first subparagraph, point (a)

Article 6(1), first subparagraph, second indent | Article 6(1), first subparagraph, point (b)

Article 6(1), first subparagraph, third indent | Article 6(1), first subparagraph, point (c)

Article 6(1), second subparagraph | Article 6(1), second subparagraph

Article 6(2) | Article 6(2)

Article 7 | Article 7

Article 8 | Article 8

Article 9 | Article 9

Article 10 | Article 10

Article 11 | Article 11

Article 12 | Article 12

Article 13, first paragraph, introductory sentence | Article 13(1), introductory sentence

Article 13, first paragraph, first indent | Article 13(1), point (a)

Article 13, first paragraph, second indent | Article 13(1), point (b)

Article 13, first paragraph, third indent | Article 13(1), point (c)

Article 13, second paragraph | Article 13(2)

Article 13, third paragraph | Article 13(3)

Article 14 | Article 14

Article 15(1) | —

Article 15(2) | Article 15

— | Article 16

— | Article 17

Article 16 | Article 18

Annex | Annex I

— | Annex II

— | Annex III

Pending: 32006L0102

                                January 16, 2026                            

20.12.2006
EN
Official Journal of the European Union
L 363/241



(1)
Pursuant to Article 56 of the Act of Accession, where acts of the institutions remain valid beyond 1 January 2007, and require adaptation by reason of accession, and the necessary adaptations have not been provided for in the Act of Accession or its Annexes, the necessary acts are to be adopted by the Council unless the Commission adopted the original act.



(2)
The Final Act of the Conference which drew up the Treaty of Accession indicated that the High Contracting Parties had reached political agreement on a set of adaptations to acts adopted by the institutions required by reason of accession and invited the Council and the Commission to adopt these adaptations before accession, completed and updated where necessary to take account of the evolution of the law of the Union.



(3)
Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(2)should therefore be amended accordingly,



—
31969 L 0081: Council Directive 69/81/CEE of 13.3.1969 (OJ L 68, 19.3.1969, p. 1),



—
31970 L 0189: Council Directive 70/189/EEC of 6.3.1970 (OJ L 59, 14.3.1970, p. 33),



—
31971 L 0144: Council Directive 71/144/EEC of 22.3.1971 (OJ L 74, 29.3.1971, p. 15),



—
31973 L 0146: Council Directive 73/146/EEC of 21.5.1973 (OJ L 167, 25.6.1973, p. 1),



—
31975 L 0409: Council Directive 75/409/EEC of 24.6.1975 (OJ L 183, 14.7.1975, p. 22),



—
31976 L 0907: Commission Directive 76/907/EEC of 14.7.1976 (OJ L 360, 30.12.1976, p. 1),



—
11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),



—
31979 L 0370: Commission Directive 79/370/EEC of 30.1.1979 (OJ L 88, 7.4.1979, p. 1),



—
31979 L 0831: Council Directive 79/831/EEC of 18.9.1979 (OJ L 259, 15.10.1979, p. 10),



—
31980 L 1189: Council Directive 80/1189/EEC of 4.12.1980 (OJ L 366, 31.12.1980, p. 1),



—
31981 L 0957: Commission Directive 81/957/EEC of 23.10.1981 (OJ L 351, 7.12.1981, p. 5),



—
31982 L 0232: Commission Directive 82/232/EEC of 25.3.1982 (OJ L 106, 21.4.1982, p. 18),



—
31983 L 0467: Commission Directive 83/467/EEC of 29.7.1983 (OJ L 257, 16.9.1983, p. 1),



—
31984 L 0449: Commission Directive 84/449/EEC of 25.4.1984 (OJ L 251, 19.9.1984, p. 1),



—
11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),



—
31986 L 0431: Commission Directive 86/431/EEC of 24.6.1986 (OJ L 247, 1.9.1986, p. 1),



—
31987 L 0432: Council Directive 87/432/EEC of 3.8.1987 (OJ L 239, 21.8.1987, p. 1),



—
31988 L 0302: Commission Directive 88/302/EEC of 18.11.1987 (OJ L 133, 30.5.1988, p. 1),



—
31988 L 0490: Commission Directive 88/490/EEC of 22.7.1988 (OJ L 259, 19.9.1988, p. 1),



—
31990 L 0517: Council Directive 90/517/EEC of 9.10.1990 (OJ L 287, 19.10.1990, p. 37),



—
31991 L 0325: Commission Directive 91/325/EEC of 1.3.1991 (OJ L 180, 8.7.1991, p. 1),



—
31991 L 0326: Commission Directive 91/326/EEC of 5.3.1991 (OJ L 180, 8.7.1991, p. 79),



—
31991 L 0410: Commission Directive 91/410/EEC of 22.7.1991 (OJ L 228, 17.8.1991, p. 67),



—
31991 L 0632: Commission Directive 91/632/EEC of 28.10.1991 (OJ L 338, 10.12.1991, p. 23),



—
31992 L 0032: Council Directive 92/32/EEC of 30.4.1992 (OJ L 154, 5.6.1992, p. 1),



—
31992 L 0037: Commission Directive 92/37/EEC of 30.4.1992 (OJ L 154, 5.6.1992, p. 30),



—
31993 L 0021: Commission Directive 93/21/EEC of 27.4.1993 (OJ L 110, 4.5.1993, p. 20),



—
31993 L 0072: Commission Directive 93/72/EEC of 1.9.1993 (OJ L 258, 16.10.1993, p. 29),



—
31993 L 0101: Commission Directive 93/101/EC of 11.11.1993 (OJ L 13, 15.1.1994, p. 1),



—
31993 L 0105: Commission Directive 93/105/EC of 25.11.1993 (OJ L 294, 30.11.1993, p. 21),



—
11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),



—
31994 L 0069: Commission Directive 94/69/EC of 19.12.1994 (OJ L 381, 31.12.1994, p. 1),



—
31996 L 0054: Commission Directive 96/54/EC of 30.7.1996 (OJ L 248, 30.9.1996, p. 1),



—
31996 L 0056: Directive 96/56/EC of the European Parliament and the Council of 3.9.1996 (OJ L 236, 18.9.1996, p. 35),



—
31997 L 0069: Commission Directive 97/69/EC of 5.12.1997 (OJ L 343, 13.12.1997, p. 19),



—
31998 L 0073: Commission Directive 98/73/EC of 18.9.1998 (OJ L 305, 16.11.1998, p. 1),



—
31998 L 0098: Commission Directive 98/98/EC of 15.12.1998(OJ L 355, 30.12.1998, p. 1),



—
31999 L 0033: Directive 1999/33/EC of the European Parliament and of the Council of 10.5.1999 (OJ L 199, 30.7.1999, p. 57),



—
32000 L 0032: Commission Directive 2000/32/EC of 19.5.2000 (OJ L 136, 8.6.2000, p. 1),



—
32000 L 0033: Commission Directive 2000/33/EC of 25.4.2000 (OJ L 136, 8.6.2000, p. 90),



—
32001 L 0059: Commission Directive 2001/59/EC of 6.8.2001 (OJ L 225, 21.8.2001, p. 1),



—
12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),



—
32003 R 0807: Council Regulation (EC) No 807/2003 of 14.4.2003 (OJ L 122, 16.5.2003, p. 36),



—
32004 L 0073: Commission Directive 2004/73/EC of 29.4.2004 (OJ L 152, 30.4.2004, p. 1).



(a)
Table A in the foreword to Annex I is replaced by the following:‘ТАБЛИЦА А — TABLA A — TABULKA A — TABEL A — TABELLE A — TABEL A — ΠΙΝΑΚΑΣ A — TABLE A — TABLEAU A — TABELLA A — A TABULA — A LENTELĖ — A. TÁBLÁZAT — TABELLA A — TABEL A — TABELA A — TABELA A — TABEL A — TABUĽKA A — TABELA A — TAULUKKO A — TABELL AСписък на химичните елементи, подредени по техния атомен номер (Z)Lista de los elementos químicos clasificados por su número atómico (Z)Seznam chemických prvků seřazených podle jejich atomového čísla (Z)Liste over grundstoffer, ordnet efter deres atomvægt (Z)Liste der chemischen Elemente, geordnet nach der Ordnungszahl (Z)Keemiliste elementide nimekiri aatomnumbri (Z) järgiΚατάλογος χημικών στοιχείων ταξινομημένων σύμφωνα με τον ατομικό τους αριθμό (Ζ)List of chemical elements listed according to their atomic number (Z)Liste des éléments chimiques classés selon leur numéro atomique (Z)Elenco degli elementi chimici ordinati secondo il loro numero atomico (Z)Ķīmisko elementu saraksts — sakārtojums pēc atomnumuriem (Z)Cheminių elementų, išdėstytų pagal atominį skaičių (Z), sąrašasKémiai elemek listája, rendszámuk sorrendjében (Z)Lista ta' elementi kimiċi elenkati skond in-numru atomiku tagħhom (Z)Lijst van chemische elementen, gerangschikt naar atoomgewicht (Z)Lista pierwiastków chemicznych ułożona według wzrastającej liczby atomowej (Z)Lista dos elementos químicos ordenados segundo o seu número atómico (Z)Lista elementelor chimice, în ordinea numerelor atomice (Z)Zoznam chemických prvkov zoradených podľa atómových čísiel (Z)Seznam kemijskih elementov, razvrščenih po vrstnem številu (Z)Alkuaineiden luettelo, järjestysluvun mukaan (Z)Lista över grundämnen, ordnade efter deras atomnummer (Z)ZSymbolBGESCSDADEETELENFRITLV1HВодородHidrógenoVodíkHydrogenWasserstoffVesinikΥδρογόνοHydrogenHydrogèneIdrogenoŪdeņradis2HeХелийHelioHeliumHeliumHeliumHeeliumΉλιοHeliumHéliumElioHēlijs3LiЛитийLitioLithiumLithiumLithiumLiitiumΛίθιοLithiumLithiumLitioLitijs4BeБерилийBerilioBerylliumBerylliumBerylliumBerülliumΒηρύλλιοBerylliumBéryllium(Glucinium)BerillioBerilijs5BБорBoroBorBorBorBoorΒόριοBoronBoreBoroBors6CВъглеродCarbonoUhlíkCarbon (kulstof)KohlenstoffSüsinikΆνθρακαςCarbonCarboneCarbonioOgleklis7NАзотNitrógenoDusíkNitrogenStickstoffLämmastikΆζωτοNitrogenAzoteAzotoSlāpeklis8OКислородOxígenoKyslíkOxygen (ilt)SauerstoffHapnikΟξυγόνοOxygenOxygèneOssigenoSkābeklis9FФлуорFlúorFluorFluorFluorFluorΦθόριοFluorineFluorFluoroFluors10NeНеонNeónNeonNeonNeonNeoonΝέονNeonNéonNeonNeons11NaНатрийSodioSodíkNatriumNatriumNaatriumΝάτριοSodiumSodiumSodioNātrijs12MgМагнезийMagnesioHořčíkMagnesiumMagnesiumMagneesiumΜαγνήσιοMagnesiumMagnésiumMagnesioMagnijs13AlАлуминийAluminioHliníkAluminiumAluminiumAlumiiniumΑργίλλιοAluminiumAluminiumAlluminioAlumīnijs14SiСилицийSilicioKřemíkSiliciumSiliciumRäniΠυρίτιοSiliconSiliciumSilicioSilīcijs15PФосфорFósforoFosforPhosphorPhosphorFosforΦωσφόροςPhosphorusPhosphoreFosforoFosfors16SСяраAzufreSíraSvovlSchwefelVäävelΘείονSulphurSoufreZolfoSērs17ClХлорCloroChlorChlorChlorKloorΧλώριοChlorineChloreCloroHlors18ArАргонArgónArgonArgonArgonArgoonArgόArgonArgonArgonArgons19KКалийPotasioDraslíkKaliumKaliumKaaliumΚάλιοPotassiumPotassiumPotassioKālijs20CaКалцийCalcioVápníkCalciumCalciumKaltsiumΑσβέστιοCalciumCalciumCalcioKalcijs21ScСкандийEscandioSkandiumScandiumScandiumSkandiumΣκάνδιοScandiumScandiumScandioSkandijs22TiТитанTitanioTitanTitanTitanTitaanΤιτάνιοTitaniumTitaneTitanioTitāns23VВанадийVanadioVanadVanadiumVanadiumVanaadiumΒανάδιοVanadiumVanadiumVanadioVanādijs24CrХромCromoChromChromChromKroomΧρώμιοChromiumChromeCromoHroms25MnМанганManganesoManganManganManganMangaanΜαγγάνιοManganeseManganèseManganeseMangāns26FeЖелязоHierroŽelezoJernEisenRaudΣίδηροςIronFerFerroDzelzs27CoКобалтCobaltoKobaltCobaltKobaltKoobaltΚοβάλτιοCobaltCobaltCobaltoKobalts28NiНикелNíquelNiklNikkelNickelNikkelΝικέλιοNickelNickelNichelNiķelis29CuМедCobreMěďKobberKupferVaskΧαλκόςCopperCuivreRameVarš30ZnЦинкZincZinekZinkZinkTsinkΨευδάργυροςZincZincZincoCinks31GaГалийGalioGalliumGalliumGalliumGalliumΓάλλιοGalliumGalliumGallioGallijs32GeГерманийGermanioGermaniumGermaniumGermaniumGermaaniumΓερμάνιοGermaniumGermaniumGermanioGermānijs33AsАрсенArsénicoArsenArsenArsenArseenΑρσενικόArsenicArsenicArsenicoArsēns34SeСеленSelenioSelenSelenSelenSeleenΣελήνιοSeleniumSéléniumSelenioSelēns35BrБромBromoBromBromBromBroomΒρώμιοBromineBromeBromoBroms36KrКриптонCriptónKryptonKryptonKryptonKrüptoonΚρυπτόKryptonKryptonKryptonKriptons37RbРубидийRubidioRubidiumRubidiumRubidiumRubiidiumΡουβήδιοRubidiumRubidiumRubidioRubīdijs38SrСтронцийEstroncioStronciumStrontiumStrontiumStrontsiumΣτρόντιοStrontiumStrontiumStronzioStroncijs39YИтрийItrioYttriumYttriumYttriumÜtriumΎττριοYttriumYttriumIttrioItrijs40ZrЦирконийCirconioZirkoniumZirconiumZirkonTsirkooniumΖιρκόνιοZirconiumZirconiumZirconioCirkonijs41NbНиобийNiobioNiobNiobiumNiobNioobiumΝιόβιοNiobiumNiobiumNiobioNiobijs42MoМолибденMolibdenoMolybdenMolybdenMolybdänMolübdeenΜολυβδένιοMolybdenumMolybdèneMolibdenoMolibdēns43TcТехнецийTecnecioTechneciumTechnetiumTechnetiumTehneetsiumΤεχνήτιοTechnetiumTechnetiumTecnezioTehnēcijs44RuРутенийRutenioRutheniumRutheniumRutheniumRuteeniumΡουθήνιοRutheniumRuthéniumRutenioRutēnijs45RhРодийRodioRhodiumRhodiumRhodiumRoodiumΡόδιοRhodiumRhodiumRodioRodijs46PdПаладийPaladioPalladiumPalladiumPalladiumPallaadiumΠαλλάδιοPalladiumPalladiumPalladioPallādijs47AgСреброPlataStříbroSølvSilberHõbeΆργυροςSilverArgentArgentoSudrabs48CdКадмийCadmioKadmiumCadmiumCadmiumKaadiumΚάδμιοCadmiumCadmiumCadmioKadmijs49InИндийIndioIndiumIndiumIndiumIndiumΊνδιοIndiumIndiumIndioIndijs50SnКалайEstañoCínTinZinnTinaΚασσίτεροςTinÉtainStagnoAlva51SbАнтимонAntimonioAntimonAntimonAntimonAntimonΑντιμόνιοAntimonyAntimoineAntimonioAntimons52TeТелурTelurioTellurTelurTellurTelluurΤελλούριοTelluriumTellureTellurioTelūrs53IЙодYodoJodJodJodJoodΙώδιοIodineIodeIodioJods54XeКсенонXenónXenonXenonXenonKsenoonΞένοXenonXénonXenonKsenons55CsЦезийCesioCesiumCæsiumCaesiumTseesiumΚαίσιοCaesiumCésiumCesioCēzijs56BaБарийBarioBaryumBariumBariumBaariumΒάριοBariumBaryumBarioBārijs57LaЛантанLantanoLanthanLanthanLanthanLantaanΛανδάνιοLanthanumLanthaneLantanioLantāns58CeЦерийCerioCerCeriumCerTseeriumΔημήτριοCeriumCériumCerioCērijs59PrПразеодимPraseodimioPraseodymPraseodymPraseodymPraseodüümΠρασεοδύμιοPraseodymiumPraséodymePraseodimioPrazeodīms60NdНеодимNiodimioNeodymNeodymNeodymNeodüümΝεοδύμιοNeodymiumNéodymeNeodimioNeodīms61PmПрометийPrometioPromethiumPromethiumPromethiumPromeetiumΠρομήθειοPromethiumProméthiumPromezioPrometijs62SmСамарийSamarioSamariumSamariumSamariumSamaariumΣαμάριοSamariumSamariumSamarioSamārijs63EuЕвропийEuropioEuropiumEuropiumEuropiumEuroopiumΕυρώπιοEuropiumEuropiumEuropioEiropijs64GdГадолинийGadolinioGadoliniumGadoliniumGadoliniumGadoliiniumΓαδολίνιοGadoliniumGadoliniumGadolinioGadolīnijs65TbТербийTerbioTerbiumTerbiumTerbiumTerbiumΤέρβιοTerbiumTerbiumTerbioTerbijs66DyДиспросийDisprosioDysprosiumDysprosiumDysprosiumDüsproosiumΔυσπρόσιοDysprosiumDysprosiumDisprosioDisprozijs67HoХолмийHolmioHolmiumHolmiumHolmiumHolmiumΌλμιοHolmiumHolmiumOlmioHolmijs68ErЕрбийErbioErbiumErbiumErbiumErbiumΈρβιοErbiumErbiumErbioErbijs69TmТулийTulioThuliumThuliumThuliumTuuliumΘούλιοThuliumThuliumTulioTūlijs70YbИтербийIterbioYtterbiumYtterbiumYtterbiumÜterbiumΥττέρβιοYtterbiumYtterbiumItterbioIterbijs71LuЛютецийLutecioLuteciumLutetiumLvtéciumLuteetsiumΛουτήτιοLutetiumLutéciumLutezioLutēcijs72HfХафнийHafnioHafniumHafniumHafniumHafniumΆφνιοHafniumHafniumAfnioHafnijs73TaТанталTántaloTantalTantalTantalTantaalΤαντάλιοTantalumTantaleTantalioTantāls74WВолфрамVolframioWolframWolframWolframVolframΒολφράμιο(Τουγκοτένιο)TungstenTungstèneTungstenoVolframs75ReРенийRenioRheniumRheniumRheniumReeniumΡήνιοRheniumRhéniumRenioRēnijs76OsОсмийOsmioOsmiumOsmiumOsmiumOsmiumΌσμιοOsmiumOsmiumOsmioOsmijs77IrИридийIridioIridiumIridiumIridiumIriidiumΙρίδιοIridiumIridiumIridioIrīdijs78PtПлатинаPlatinoPlatinaPlatinPlatinPlaatinaΛευκόχρυσοςPlatinumPlatinePlatinoPlatīns79AuЗлатоOroZlatoGuldGoldKuldΧρυσόςGoldOrOroZelts80HgЖивакMercurioRtuťKviksølvQuecksilberElavhõbeΥδράργυροςMercuryMercureMercurioDzīvsudrabs81TlТалийTalioThalliumThaliumThalliumTalliumΘάλλιοThalliumThalliumTallioTallijs82PbОловоPlomoOlovoBlyBleiPliiΜόλυβδοςLeadPlombPiomboSvins83BiБисмутBismutoBismutBismuthWismuthVismutΒισμούθιοBismuthBismuthBismutoBismuts84PoПолонийPolonioPoloniumPloniumPoloniumPolooniumΠολώνιοPoloniumPoloniumPolonioPolonijs85AtАстатAstatoAstatAstatAstatAstaatΑστάτιοAstatineAstateAstatoAstats86RnРадонRadónRadonRadonRadonRadoonΡαδόνιοRadonRadonRadonRadons87FrФранцийFrancioFranciumFranciumFranciumFrantsiumΦράγκιοFranciumFranciumFrancioFrancijs88RaРадийRadioRadiumRadiumRadiumRaadiumΡάδιοRadiumRadiumRadioRādijs89AcАктинийActinioAktiniumActiniumActiniumAktiiniumΑκτίνιοActiniumActiniumAttinioAktīnijs90ThТорийTorioThoriumThoriumThoriumTooriumΘόριοThoriumThoriumTorioTorijs91PaПротактинийProtactinioProtaktiniumProtactiniumProtactiniumProtaktiiniumΠρωτακτίνιοProtactiniumProtactiniumProtoattinioProtaktīnijs92UУранUranioUranUranUranUraanΟυράνιοUraniumUraniumUranioUrāns93NpНептунийNeptunioNeptuniumNeptuniumNeptuniumNeptuuniumΝεπτούνιο(Ποσειδώνιο)NeptuniumNeptuniumNettunioNeptūnijs94PuПлутонийPlutonioPlutoniumPlutoniumPlutoniumPlutooniumΠλουτώνιοPlutoniumPlutoniumPlutonioPlutonijs95AmАмерицийAmericioAmericiumAmericiumAmericiumAmeriitsiumΑμερίκιοAmericiumAmériciumAmericioAmerīcijs96CmКюрийCurioCuriumCuriumCuriumKuuriumΚιούριοCuriumCuriumCurioKirijs97BkБерклийBerkelioBerkeliumBerkeliumBerkeliumBerkeeliumΜπερκέλιοBerkeliumBerkéliumBerkelioBerklijs98CfКалифорнийCalifornioKaliforniumCaliforniumCaliforniumKaliforniumΚαλιφόρνιοCaliforniumCaliforniumCalifornioKalifornijs99EsАйнщайнийEinstenioEinsteiniumEinsteiniumEinsteiniumEinsteiniumΑϊνστάνιονEinsteiniumEinsteiniumEinstenioEinšteinijs100FmФермийFermioFermiumFermiumFermiumFermiumΦέρμιοFermiumFermiumFermioFermijs101MdМенделеевийMendelevioMendeleviumMendeleviumMendeleviumMendeleeviumΜεντελέβιοMendeleviumMendéléviumMendelevioMendeļejevijs102NoНобелийNobelioNobeliumNobeliumNobeliumNobeeliumΝομπέλιοNobeliumNobéliumNobelioNobēlijs103LwЛоуренсийLaurencioLawrenciumLawrentiumLawrentiumLavrentsiumΛαυρένσιοLawrenciumLawrenciumLawrencioLourensijsZSymbolLTHUMTNLPLPTROSKSLFISV1HVandenilisHidrogénIdroġenuWaterstofWodórHidrogénioHidrogenVodíkVodikVetyVäte2HeHelisHéliumEljuHeliumHelHélioHeliuHéliumHelijHeliumHelium3LiLitisLítiumLitjuLithiumLitLítioLitiuLítiumLitijLitiumLitium4BeBerilisBerilliumBerilljuBerylliumBerylBerílioBeriliuBerýliumBerilijBerylliumBeryllium5BBorasBórBoronBoorBorBoroBorBórBorBooriBor6CAnglisSzénKarbonjuKoolstofWęgielCarbonoCarbonUhlíkOgljikHiiliKol7NAzotasNitrogénAzotuStikstofAzotAzotoAzotDusíkDušikTyppiKväve8ODeguonisOxigénOssiġenuZuurstofTlenOxigénioOxigenKyslíkKisikHappiSyre9FFluorasFluorFluworinFluorFluorFlúorFluorFluórFluorFluoriFluor10NeNeonasNeonNeonNeonNeonNéonNeonNeónNeonNeonNeon11NaNatrisNátriumSodjuNatriumSódSódioSodiuSodíkNatrijNatriumNatrium12MgMagnisMagnéziumManjesjuMagnesiumMagnezMagnésioMagneziuHorčíkMagnezijMagnesiumMagnesium13AlAliuminisAlumíniumAluminjuAluminiumGlinAlumínioAluminiuHliníkAluminijAlumiiniAluminium14SiSilicisSziliciumSilikonSiliciumKrzemSilícioSiliciuKremíkSilicijPiiKisel15PFosforasFoszforFosfruFosforFosforFósforoFosforFosforFosforFosforiFosfor16SSieraKénKubritZwavelSiarkaEnxofreSulfSíraŽveploRikkiSvavel17ClChlorasKlórKloruChloorChlorCloroClorChlórKlorKlooriKlor18ArArgonasArgonArgonArgonArgonÁrgonArgonArgónArgonArgonArgon19KKalisKáliumPotassjuKaliumPotasPotássioPotasiuDraslíkKalijKaliumKalium20CaKalcisKalciumKalċjuCalciumWapńCálcioCalciuVápnikKalcijKalsiumKalcium21ScSkandisSzkandiumSkandjuScandiumSkandEscândioScandiuSkandiumSkandijSkandiumSkandium22TiTitanasTitánTitanjuTitaanTytanTitânioTitanTitánTitanTitaaniTitan23VVanadisVanádiumVanadjuVanadiumWanadVanádioVanadiuVanádVanadijVanadiiniVanadin24CrChromasKrómKromjuChroomChromCrómioCromChrómKromKromiKrom25MnManganasMangánManganiżMangaanManganManganêsManganMangánManganMangaaniMangan26FeGeležisVasĦadidIjzerŻelazoFerroFierŽelezoŽelezoRautaJärn27CoKobaltasKobaltKobaltKobaltKobaltCobaltoCobaltKobaltKobaltKobolttiKobolt28NiNikelisNikkelNikilNikkelNikielNíquelNichelNikelNikeljNikkeliNickel29CuVarisRézRamKoperMiedźCobreCupruMeďBakerKupariKoppar30ZnCinkasCinkŻinguZìnkCynkZincoZincZinokCinkSinkkiZink31GaGalisGalliumGalljuGalliumGalGálioGaliuGáliumGalijGalliumGallium32GeGermanisGermániumĠermanjuGermaniumGermanGermânioGermaniuGermániumGermanijGermaniumGermanium33AsArsenasArzénArsenikuArseenArsenArsénioArsenArzénArzenArseeniArsenik34SeSelenasSzelénSelenjuSeleniumSelenSelénioSeleniuSelénSelenSeleeniSelen35BrBromasBrómBromuBroomBromBromoBromBrómBromBromiBrom36KrKriptonasKriptonKriptonKryptonKryptonKríptonKriptonKryptónKriptonKryptonKrypton37RbRubidisRubídiumRubidjuRubidiumRubidRubídioRubidiuRubídiumRubidijRubidiumRubidium38SrStroncisStronciumStronzjuStrontiumStrontEstrôncioStronţiuStronciumStroncijStrontiumStrontium39YItrisIttriumIttrijuYttriumItrÍtrioYtriuYtriumItrijYttriumYttrium40ZrCirkonisCirkóniumŻirkonjuZirkoniumCyrkonZircónioZirconiuZirkóniumCirkonijZirkoniumZirkonium41NbNiobisNióbiumNijobjuNiobiumNiobNióbioNiobiuNióbNiobijNiobiumNiob42MoMolibdenasMolibdénMolibdenuMolybdeenMolibdenMolibdénioMolibdenMolybdénMolibdenMolybdeeniMolybden43TcTechnecisTechnéciumTeknezjuTechnetiumTechnetTecnécioTehneţiuTechnéciumTehnecijTeknetiumTeknetium44RuRutenisRuténiumRutenjuRutherniumRutenRuténioRuteniuRuténiumRutenijRuteniumRutenium45RhRodisRódiumRodjuRodiumRodRódioRodiuRódiumRodijRodiumRodium46PdPaladisPalládiumPalladjuPalladiumPalladPaládioPaladiuPaládiumPaladijPalladiumPalladium47AgSidabrasEzüstFiddaZilverSrebroPrataArgintStriebroSrebroHopeaSilver48CdKadmisKadmiumKadmjuCadmiumKadmCádmioCadmiuKadmiumKadmijKadmiumKadmium49InIndisIndiumIndjuIndiumIndÍndioIndiuIndiumIndijIndiumIndium50SnAlavasÓnLandaTinCynaEstanhoStaniuCínKositerTinaTenn51SbStibisAntimonAntimonjuAntimoonAntymonAntimónioStibiuAntimónAntimonAntimoniAntimon52TeTelūrasTellúrTellurjuTelluurTellurTelúrioTelurTelúrTelurTelluuriTellur53IJodasJódJodjuJoodJodIodoIodJódJodJodiJod54XeKsenonasXenonKsenoXenonKsenonXénonXenonXenónKsenonKsenonXenon55CsCezisCéziumĊesjuCesiumCezCésioCesiuCésiumCezijCesiumCesium56BaBarisBáriumBarjuBariumBarBárioBariuBáriumBarijBariumBarium57LaLantanasLantánLantanuLanthaanLantanLantânioLantanLantánLantanLantaaniLantan58CeCerisCériumĊerjuCeriumCerCérioCeriuCérCerijCeriumCerium59PrPrazeodimisPrazeodímiumPrasedimjuPraseodymiumPrazeodymPraseodímioPraseodimPrazeodýmPrazeodimPraseodyymiPraseodym60NdNeodimisNeodímiumNeodimjuNeodymiumNeodymNeodímioNeodimNeodýmNeodimNeodyymiNeodym61PmPrometisPrométiumPrometjuPromethiumPrometPromécioPromeţiuPrométiumPrometijPrometiumPrometium62SmSamarisSzamáriumSamarjuSamariumSamarSamárioSamariuSamáriumSamarijSamariumSamarium63EuEuropisEurópiumEwropjuEuropiumEuropEurópioEuropiuEurópiumEvropijEuropiumEuropium64GdGadolinisGadolíniumGadolinjuGadoliniumGadolinGadolínioGadoliniuGadolíniumGadolinijGadoliniumGadolinium65TbTerbisTerbiumTerbjuTerbiumTerbTérbioTerbiuTerbiumTerbijTerbiumTerbium66DyDisprozisDiszpróziumDisprosjuDysprosiumDysprozDisprósioDysprosiuDyspróziumDisprozijDysprosiumDysprosium67HoHolmisHolmiumOlmjuHolmiumHolmHólmioHolmiuHolmiumHolmijHolmiumHolmium68ErErbisErbiumErbjuErbiumErbÉrbioErbiuErbiumErbijErbiumErbium69TmTulisTúliumTuljuThuliumTulTúlioTuliuTúliumTulijTuliumTulium70YbIterbisItterbiumItterbjuYtterbiumIterbItérbioYterbiuYterbiumIterbijYtterbiumYtterbium71LuLiutecisLutéciumLutezjuLutetiumLutetLutécioLuteţiuLutéciumLutecijLutetiumLutetium72HfHafnisHafniumĦafnjuHafniumHafnHáfnioHafniuHafniumHafnijHafniumHafnium73TaTantalasTantálTantaluTantaalTantalTântaloTantalTantalTantalTantaaliTantal74WVolframasVolfrámTungstenuWolframWolframTungsténioWolframVolfrámVolframVolframiWolfram75ReRenisRéniumRênjuReniumRenRénioReniuRéniumRenijReniumRhenium76OsOsmisOzmiumOsmjuOsmiumOsmÓsmioOsmiuOsmiumOsmijOsmiumOsmium77IrIridisIrídiumIridjuIridiumIrydIrídioIridiuIrídiumIridijIridiumIridium78PtPlatinaPlatinaPlatinuPlatinumPlatynaPlatinaPlatinaPlatinaPlatinaPlatinaPlatina79AuAuksasAranyDehebGoudZłotoOuroAurZlatoZlatoKultaGuld80HgGyvsidabrisHiganyMerkurjuKwikRtęćMercúrioMercurOrtuťŽivo srebroElohopeaKvicksilver81TlTalisTalliumTalljuThalliumTalTálioTaliuTáliumTalijTalliumTallium82PbŠvinasÓlomĊombLoodOłówChumboPlumbOlovoSvinecLyijyBly83BiBismutasBizmutBismùtBismuthBizmutBismutoBismutBizmutBizmutVismuttiVismut84PoPolonisPolóniumPolonjuPoloniumPolonPolónioPoloniuPolóniumPolonijPoloniumPolonium85AtAstatinasAsztáciumAstatinaAstaatAstatAstatoAstatiniuAstátAstatAstatiiniAstat86RnRadonasRadonRadonRadonRadonRádonRadonRadónRadonRadonRadon87FrFrancisFranciumFranċjuFranciumFransFrâncioFranciuFranciumFrancijFrankiumFrancium88RaRadisRádiumRadjuRadiumRadRádioRadiuRádiumRadijRadiumRadium89AcAktinisAktíniumAktinjuActiniumAktynActínioActiniuAktíniumAktinijAktiniumAktinium90ThTorisTóriumTorjuThoriumTorTórioToriuTóriumTorijToriumTorium91PaProtaktinisProtaktíniumProtaktinjuProtactiniumProtaktynProtactínioProactiniuProtaktíniumProtaktinijProtaktiniumProtaktinium92UUranasUránUranjuUraniumUranUrânioUraniuUránUranUraaniUran93NpNeptūnisNeptúniumNettunjuNeptuniumNeptunNeptúnioNeptuniuNeptúniumNeptunijNeptuniumNeptunium94PuPlutonisPlutóniumPlutonjuPlutoniumPlutonPlutónioPlutoniuPlutóniumPlutonijPlutoniumPlutonium95AmAmericisAmeríciumAmeriċjuAmericiumAmerykAmerícioAmericiuAmeríciumAmericijAmerikiumAmericium96CmKiurisKűriumKurjuCuriumKiurCúrioCuriuCuriumKirijCuriumCurium97BkBerklisBerkéliumBerkeljuBerkeliumBerkelBerquélioBerkeliuBerkeliumBerkelijBerkeliumBerkelium98CfKalifornisKaliforniumKalifornjuCaliforniumKalifornCalifórnioCaliforniuKaliforniumKalifornijKaliforniumCalifornium99EsEinšteinisEinsteiniumEnstejnjuEinsteiniumEinsteinEinsteinioEinsteiniuEinsteiniumAjnštajnijEinsteiniumEinsteinium100FmFermisFermiumFermjuFermiumFermFérmioFermiuFermiumFermijFermiumFermium101MdMendelevisMendeléviumMendelevjuMendeleviumMendelewMendelévioMendeleeviuMendeleviumMendelevijMendeleviumMendelevium102NoNobelisNobéliumNobeljuNobeliumNobelNobélioNobeliuNobeliumNobelijNobeliumNobelium103LwLorensisLaurenciumLawrenċjuLaurentiumLorensLaurêncioLaurenţiuLaurenciumLavrencijLawrensiumLawrentium’
Z
Symbol
BG
ES
CS
DA
DE
ET
EL
EN
FR
IT
LV
1
H
Водород
Hidrógeno
Vodík
Hydrogen
Wasserstoff
Vesinik
Υδρογόνο
Hydrogen
Hydrogène
Idrogeno
Ūdeņradis
2
He
Хелий
Helio
Helium
Helium
Helium
Heelium
Ήλιο
Helium
Hélium
Elio
Hēlijs
3
Li
Литий
Litio
Lithium
Lithium
Lithium
Liitium
Λίθιο
Lithium
Lithium
Litio
Litijs
4
Be
Берилий
Berilio
Beryllium
Beryllium
Beryllium
Berüllium
Βηρύλλιο
Beryllium
Béryllium(Glucinium)
Berillio
Berilijs
5
B
Бор
Boro
Bor
Bor
Bor
Boor
Βόριο
Boron
Bore
Boro
Bors
6
C
Въглерод
Carbono
Uhlík
Carbon (kulstof)
Kohlenstoff
Süsinik
Άνθρακας
Carbon
Carbone
Carbonio
Ogleklis
7
N
Азот
Nitrógeno
Dusík
Nitrogen
Stickstoff
Lämmastik
Άζωτο
Nitrogen
Azote
Azoto
Slāpeklis
8
O
Кислород
Oxígeno
Kyslík
Oxygen (ilt)
Sauerstoff
Hapnik
Οξυγόνο
Oxygen
Oxygène
Ossigeno
Skābeklis
9
F
Флуор
Flúor
Fluor
Fluor
Fluor
Fluor
Φθόριο
Fluorine
Fluor
Fluoro
Fluors
10
Ne
Неон
Neón
Neon
Neon
Neon
Neoon
Νέον
Neon
Néon
Neon
Neons
11
Na
Натрий
Sodio
Sodík
Natrium
Natrium
Naatrium
Νάτριο
Sodium
Sodium
Sodio
Nātrijs
12
Mg
Магнезий
Magnesio
Hořčík
Magnesium
Magnesium
Magneesium
Μαγνήσιο
Magnesium
Magnésium
Magnesio
Magnijs
13
Al
Алуминий
Aluminio
Hliník
Aluminium
Aluminium
Alumiinium
Αργίλλιο
Aluminium
Aluminium
Alluminio
Alumīnijs
14
Si
Силиций
Silicio
Křemík
Silicium
Silicium
Räni
Πυρίτιο
Silicon
Silicium
Silicio
Silīcijs
15
P
Фосфор
Fósforo
Fosfor
Phosphor
Phosphor
Fosfor
Φωσφόρος
Phosphorus
Phosphore
Fosforo
Fosfors
16
S
Сяра
Azufre
Síra
Svovl
Schwefel
Väävel
Θείον
Sulphur
Soufre
Zolfo
Sērs
17
Cl
Хлор
Cloro
Chlor
Chlor
Chlor
Kloor
Χλώριο
Chlorine
Chlore
Cloro
Hlors
18
Ar
Аргон
Argón
Argon
Argon
Argon
Argoon
Argό
Argon
Argon
Argon
Argons
19
K
Калий
Potasio
Draslík
Kalium
Kalium
Kaalium
Κάλιο
Potassium
Potassium
Potassio
Kālijs
20
Ca
Калций
Calcio
Vápník
Calcium
Calcium
Kaltsium
Ασβέστιο
Calcium
Calcium
Calcio
Kalcijs
21
Sc
Скандий
Escandio
Skandium
Scandium
Scandium
Skandium
Σκάνδιο
Scandium
Scandium
Scandio
Skandijs
22
Ti
Титан
Titanio
Titan
Titan
Titan
Titaan
Τιτάνιο
Titanium
Titane
Titanio
Titāns
23
V
Ванадий
Vanadio
Vanad
Vanadium
Vanadium
Vanaadium
Βανάδιο
Vanadium
Vanadium
Vanadio
Vanādijs
24
Cr
Хром
Cromo
Chrom
Chrom
Chrom
Kroom
Χρώμιο
Chromium
Chrome
Cromo
Hroms
25
Mn
Манган
Manganeso
Mangan
Mangan
Mangan
Mangaan
Μαγγάνιο
Manganese
Manganèse
Manganese
Mangāns
26
Fe
Желязо
Hierro
Železo
Jern
Eisen
Raud
Σίδηρος
Iron
Fer
Ferro
Dzelzs
27
Co
Кобалт
Cobalto
Kobalt
Cobalt
Kobalt
Koobalt
Κοβάλτιο
Cobalt
Cobalt
Cobalto
Kobalts
28
Ni
Никел
Níquel
Nikl
Nikkel
Nickel
Nikkel
Νικέλιο
Nickel
Nickel
Nichel
Niķelis
29
Cu
Мед
Cobre
Měď
Kobber
Kupfer
Vask
Χαλκός
Copper
Cuivre
Rame
Varš
30
Zn
Цинк
Zinc
Zinek
Zink
Zink
Tsink
Ψευδάργυρος
Zinc
Zinc
Zinco
Cinks
31
Ga
Галий
Galio
Gallium
Gallium
Gallium
Gallium
Γάλλιο
Gallium
Gallium
Gallio
Gallijs
32
Ge
Германий
Germanio
Germanium
Germanium
Germanium
Germaanium
Γερμάνιο
Germanium
Germanium
Germanio
Germānijs
33
As
Арсен
Arsénico
Arsen
Arsen
Arsen
Arseen
Αρσενικό
Arsenic
Arsenic
Arsenico
Arsēns
34
Se
Селен
Selenio
Selen
Selen
Selen
Seleen
Σελήνιο
Selenium
Sélénium
Selenio
Selēns
35
Br
Бром
Bromo
Brom
Brom
Brom
Broom
Βρώμιο
Bromine
Brome
Bromo
Broms
36
Kr
Криптон
Criptón
Krypton
Krypton
Krypton
Krüptoon
Κρυπτό
Krypton
Krypton
Krypton
Kriptons
37
Rb
Рубидий
Rubidio
Rubidium
Rubidium
Rubidium
Rubiidium
Ρουβήδιο
Rubidium
Rubidium
Rubidio
Rubīdijs
38
Sr
Стронций
Estroncio
Stroncium
Strontium
Strontium
Strontsium
Στρόντιο
Strontium
Strontium
Stronzio
Stroncijs
39
Y
Итрий
Itrio
Yttrium
Yttrium
Yttrium
Ütrium
Ύττριο
Yttrium
Yttrium
Ittrio
Itrijs
40
Zr
Цирконий
Circonio
Zirkonium
Zirconium
Zirkon
Tsirkoonium
Ζιρκόνιο
Zirconium
Zirconium
Zirconio
Cirkonijs
41
Nb
Ниобий
Niobio
Niob
Niobium
Niob
Nioobium
Νιόβιο
Niobium
Niobium
Niobio
Niobijs
42
Mo
Молибден
Molibdeno
Molybden
Molybden
Molybdän
Molübdeen
Μολυβδένιο
Molybdenum
Molybdène
Molibdeno
Molibdēns
43
Tc
Технеций
Tecnecio
Technecium
Technetium
Technetium
Tehneetsium
Τεχνήτιο
Technetium
Technetium
Tecnezio
Tehnēcijs
44
Ru
Рутений
Rutenio
Ruthenium
Ruthenium
Ruthenium
Ruteenium
Ρουθήνιο
Ruthenium
Ruthénium
Rutenio
Rutēnijs
45
Rh
Родий
Rodio
Rhodium
Rhodium
Rhodium
Roodium
Ρόδιο
Rhodium
Rhodium
Rodio
Rodijs
46
Pd
Паладий
Paladio
Palladium
Palladium
Palladium
Pallaadium
Παλλάδιο
Palladium
Palladium
Palladio
Pallādijs
47
Ag
Сребро
Plata
Stříbro
Sølv
Silber
Hõbe
Άργυρος
Silver
Argent
Argento
Sudrabs
48
Cd
Кадмий
Cadmio
Kadmium
Cadmium
Cadmium
Kaadium
Κάδμιο
Cadmium
Cadmium
Cadmio
Kadmijs
49
In
Индий
Indio
Indium
Indium
Indium
Indium
Ίνδιο
Indium
Indium
Indio
Indijs
50
Sn
Калай
Estaño
Cín
Tin
Zinn
Tina
Κασσίτερος
Tin
Étain
Stagno
Alva
51
Sb
Антимон
Antimonio
Antimon
Antimon
Antimon
Antimon
Αντιμόνιο
Antimony
Antimoine
Antimonio
Antimons
52
Te
Телур
Telurio
Tellur
Telur
Tellur
Telluur
Τελλούριο
Tellurium
Tellure
Tellurio
Telūrs
53
I
Йод
Yodo
Jod
Jod
Jod
Jood
Ιώδιο
Iodine
Iode
Iodio
Jods
54
Xe
Ксенон
Xenón
Xenon
Xenon
Xenon
Ksenoon
Ξένο
Xenon
Xénon
Xenon
Ksenons
55
Cs
Цезий
Cesio
Cesium
Cæsium
Caesium
Tseesium
Καίσιο
Caesium
Césium
Cesio
Cēzijs
56
Ba
Барий
Bario
Baryum
Barium
Barium
Baarium
Βάριο
Barium
Baryum
Bario
Bārijs
57
La
Лантан
Lantano
Lanthan
Lanthan
Lanthan
Lantaan
Λανδάνιο
Lanthanum
Lanthane
Lantanio
Lantāns
58
Ce
Церий
Cerio
Cer
Cerium
Cer
Tseerium
Δημήτριο
Cerium
Cérium
Cerio
Cērijs
59
Pr
Празеодим
Praseodimio
Praseodym
Praseodym
Praseodym
Praseodüüm
Πρασεοδύμιο
Praseodymium
Praséodyme
Praseodimio
Prazeodīms
60
Nd
Неодим
Niodimio
Neodym
Neodym
Neodym
Neodüüm
Νεοδύμιο
Neodymium
Néodyme
Neodimio
Neodīms
61
Pm
Прометий
Prometio
Promethium
Promethium
Promethium
Promeetium
Προμήθειο
Promethium
Prométhium
Promezio
Prometijs
62
Sm
Самарий
Samario
Samarium
Samarium
Samarium
Samaarium
Σαμάριο
Samarium
Samarium
Samario
Samārijs
63
Eu
Европий
Europio
Europium
Europium
Europium
Euroopium
Ευρώπιο
Europium
Europium
Europio
Eiropijs
64
Gd
Гадолиний
Gadolinio
Gadolinium
Gadolinium
Gadolinium
Gadoliinium
Γαδολίνιο
Gadolinium
Gadolinium
Gadolinio
Gadolīnijs
65
Tb
Тербий
Terbio
Terbium
Terbium
Terbium
Terbium
Τέρβιο
Terbium
Terbium
Terbio
Terbijs
66
Dy
Диспросий
Disprosio
Dysprosium
Dysprosium
Dysprosium
Düsproosium
Δυσπρόσιο
Dysprosium
Dysprosium
Disprosio
Disprozijs
67
Ho
Холмий
Holmio
Holmium
Holmium
Holmium
Holmium
Όλμιο
Holmium
Holmium
Olmio
Holmijs
68
Er
Ербий
Erbio
Erbium
Erbium
Erbium
Erbium
Έρβιο
Erbium
Erbium
Erbio
Erbijs
69
Tm
Тулий
Tulio
Thulium
Thulium
Thulium
Tuulium
Θούλιο
Thulium
Thulium
Tulio
Tūlijs
70
Yb
Итербий
Iterbio
Ytterbium
Ytterbium
Ytterbium
Üterbium
Υττέρβιο
Ytterbium
Ytterbium
Itterbio
Iterbijs
71
Lu
Лютеций
Lutecio
Lutecium
Lutetium
Lvtécium
Luteetsium
Λουτήτιο
Lutetium
Lutécium
Lutezio
Lutēcijs
72
Hf
Хафний
Hafnio
Hafnium
Hafnium
Hafnium
Hafnium
Άφνιο
Hafnium
Hafnium
Afnio
Hafnijs
73
Ta
Тантал
Tántalo
Tantal
Tantal
Tantal
Tantaal
Ταντάλιο
Tantalum
Tantale
Tantalio
Tantāls
74
W
Волфрам
Volframio
Wolfram
Wolfram
Wolfram
Volfram
Βολφράμιο(Τουγκοτένιο)
Tungsten
Tungstène
Tungsteno
Volframs
75
Re
Рений
Renio
Rhenium
Rhenium
Rhenium
Reenium
Ρήνιο
Rhenium
Rhénium
Renio
Rēnijs
76
Os
Осмий
Osmio
Osmium
Osmium
Osmium
Osmium
Όσμιο
Osmium
Osmium
Osmio
Osmijs
77
Ir
Иридий
Iridio
Iridium
Iridium
Iridium
Iriidium
Ιρίδιο
Iridium
Iridium
Iridio
Irīdijs
78
Pt
Платина
Platino
Platina
Platin
Platin
Plaatina
Λευκόχρυσος
Platinum
Platine
Platino
Platīns
79
Au
Злато
Oro
Zlato
Guld
Gold
Kuld
Χρυσός
Gold
Or
Oro
Zelts
80
Hg
Живак
Mercurio
Rtuť
Kviksølv
Quecksilber
Elavhõbe
Υδράργυρος
Mercury
Mercure
Mercurio
Dzīvsudrabs
81
Tl
Талий
Talio
Thallium
Thalium
Thallium
Tallium
Θάλλιο
Thallium
Thallium
Tallio
Tallijs
82
Pb
Олово
Plomo
Olovo
Bly
Blei
Plii
Μόλυβδος
Lead
Plomb
Piombo
Svins
83
Bi
Бисмут
Bismuto
Bismut
Bismuth
Wismuth
Vismut
Βισμούθιο
Bismuth
Bismuth
Bismuto
Bismuts
84
Po
Полоний
Polonio
Polonium
Plonium
Polonium
Poloonium
Πολώνιο
Polonium
Polonium
Polonio
Polonijs
85
At
Астат
Astato
Astat
Astat
Astat
Astaat
Αστάτιο
Astatine
Astate
Astato
Astats
86
Rn
Радон
Radón
Radon
Radon
Radon
Radoon
Ραδόνιο
Radon
Radon
Radon
Radons
87
Fr
Франций
Francio
Francium
Francium
Francium
Frantsium
Φράγκιο
Francium
Francium
Francio
Francijs
88
Ra
Радий
Radio
Radium
Radium
Radium
Raadium
Ράδιο
Radium
Radium
Radio
Rādijs
89
Ac
Актиний
Actinio
Aktinium
Actinium
Actinium
Aktiinium
Ακτίνιο
Actinium
Actinium
Attinio
Aktīnijs
90
Th
Торий
Torio
Thorium
Thorium
Thorium
Toorium
Θόριο
Thorium
Thorium
Torio
Torijs
91
Pa
Протактиний
Protactinio
Protaktinium
Protactinium
Protactinium
Protaktiinium
Πρωτακτίνιο
Protactinium
Protactinium
Protoattinio
Protaktīnijs
92
U
Уран
Uranio
Uran
Uran
Uran
Uraan
Ουράνιο
Uranium
Uranium
Uranio
Urāns
93
Np
Нептуний
Neptunio
Neptunium
Neptunium
Neptunium
Neptuunium
Νεπτούνιο(Ποσειδώνιο)
Neptunium
Neptunium
Nettunio
Neptūnijs
94
Pu
Плутоний
Plutonio
Plutonium
Plutonium
Plutonium
Plutoonium
Πλουτώνιο
Plutonium
Plutonium
Plutonio
Plutonijs
95
Am
Америций
Americio
Americium
Americium
Americium
Ameriitsium
Αμερίκιο
Americium
Américium
Americio
Amerīcijs
96
Cm
Кюрий
Curio
Curium
Curium
Curium
Kuurium
Κιούριο
Curium
Curium
Curio
Kirijs
97
Bk
Берклий
Berkelio
Berkelium
Berkelium
Berkelium
Berkeelium
Μπερκέλιο
Berkelium
Berkélium
Berkelio
Berklijs
98
Cf
Калифорний
Californio
Kalifornium
Californium
Californium
Kalifornium
Καλιφόρνιο
Californium
Californium
Californio
Kalifornijs
99
Es
Айнщайний
Einstenio
Einsteinium
Einsteinium
Einsteinium
Einsteinium
Αϊνστάνιον
Einsteinium
Einsteinium
Einstenio
Einšteinijs
100
Fm
Фермий
Fermio
Fermium
Fermium
Fermium
Fermium
Φέρμιο
Fermium
Fermium
Fermio
Fermijs
101
Md
Менделеевий
Mendelevio
Mendelevium
Mendelevium
Mendelevium
Mendeleevium
Μεντελέβιο
Mendelevium
Mendélévium
Mendelevio
Mendeļejevijs
102
No
Нобелий
Nobelio
Nobelium
Nobelium
Nobelium
Nobeelium
Νομπέλιο
Nobelium
Nobélium
Nobelio
Nobēlijs
103
Lw
Лоуренсий
Laurencio
Lawrencium
Lawrentium
Lawrentium
Lavrentsium
Λαυρένσιο
Lawrencium
Lawrencium
Lawrencio
Lourensijs
Z
Symbol
LT
HU
MT
NL
PL
PT
RO
SK
SL
FI
SV
1
H
Vandenilis
Hidrogén
Idroġenu
Waterstof
Wodór
Hidrogénio
Hidrogen
Vodík
Vodik
Vety
Väte
2
He
Helis
Hélium
Elju
Helium
Hel
Hélio
Heliu
Hélium
Helij
Helium
Helium
3
Li
Litis
Lítium
Litju
Lithium
Lit
Lítio
Litiu
Lítium
Litij
Litium
Litium
4
Be
Berilis
Berillium
Berillju
Beryllium
Beryl
Berílio
Beriliu
Berýlium
Berilij
Beryllium
Beryllium
5
B
Boras
Bór
Boron
Boor
Bor
Boro
Bor
Bór
Bor
Boori
Bor
6
C
Anglis
Szén
Karbonju
Koolstof
Węgiel
Carbono
Carbon
Uhlík
Ogljik
Hiili
Kol
7
N
Azotas
Nitrogén
Azotu
Stikstof
Azot
Azoto
Azot
Dusík
Dušik
Typpi
Kväve
8
O
Deguonis
Oxigén
Ossiġenu
Zuurstof
Tlen
Oxigénio
Oxigen
Kyslík
Kisik
Happi
Syre
9
F
Fluoras
Fluor
Fluworin
Fluor
Fluor
Flúor
Fluor
Fluór
Fluor
Fluori
Fluor
10
Ne
Neonas
Neon
Neon
Neon
Neon
Néon
Neon
Neón
Neon
Neon
Neon
11
Na
Natris
Nátrium
Sodju
Natrium
Sód
Sódio
Sodiu
Sodík
Natrij
Natrium
Natrium
12
Mg
Magnis
Magnézium
Manjesju
Magnesium
Magnez
Magnésio
Magneziu
Horčík
Magnezij
Magnesium
Magnesium
13
Al
Aliuminis
Alumínium
Aluminju
Aluminium
Glin
Alumínio
Aluminiu
Hliník
Aluminij
Alumiini
Aluminium
14
Si
Silicis
Szilicium
Silikon
Silicium
Krzem
Silício
Siliciu
Kremík
Silicij
Pii
Kisel
15
P
Fosforas
Foszfor
Fosfru
Fosfor
Fosfor
Fósforo
Fosfor
Fosfor
Fosfor
Fosfori
Fosfor
16
S
Siera
Kén
Kubrit
Zwavel
Siarka
Enxofre
Sulf
Síra
Žveplo
Rikki
Svavel
17
Cl
Chloras
Klór
Kloru
Chloor
Chlor
Cloro
Clor
Chlór
Klor
Kloori
Klor
18
Ar
Argonas
Argon
Argon
Argon
Argon
Árgon
Argon
Argón
Argon
Argon
Argon
19
K
Kalis
Kálium
Potassju
Kalium
Potas
Potássio
Potasiu
Draslík
Kalij
Kalium
Kalium
20
Ca
Kalcis
Kalcium
Kalċju
Calcium
Wapń
Cálcio
Calciu
Vápnik
Kalcij
Kalsium
Kalcium
21
Sc
Skandis
Szkandium
Skandju
Scandium
Skand
Escândio
Scandiu
Skandium
Skandij
Skandium
Skandium
22
Ti
Titanas
Titán
Titanju
Titaan
Tytan
Titânio
Titan
Titán
Titan
Titaani
Titan
23
V
Vanadis
Vanádium
Vanadju
Vanadium
Wanad
Vanádio
Vanadiu
Vanád
Vanadij
Vanadiini
Vanadin
24
Cr
Chromas
Króm
Kromju
Chroom
Chrom
Crómio
Crom
Chróm
Krom
Kromi
Krom
25
Mn
Manganas
Mangán
Manganiż
Mangaan
Mangan
Manganês
Mangan
Mangán
Mangan
Mangaani
Mangan
26
Fe
Geležis
Vas
Ħadid
Ijzer
Żelazo
Ferro
Fier
Železo
Železo
Rauta
Järn
27
Co
Kobaltas
Kobalt
Kobalt
Kobalt
Kobalt
Cobalto
Cobalt
Kobalt
Kobalt
Koboltti
Kobolt
28
Ni
Nikelis
Nikkel
Nikil
Nikkel
Nikiel
Níquel
Nichel
Nikel
Nikelj
Nikkeli
Nickel
29
Cu
Varis
Réz
Ram
Koper
Miedź
Cobre
Cupru
Meď
Baker
Kupari
Koppar
30
Zn
Cinkas
Cink
Żingu
Zìnk
Cynk
Zinco
Zinc
Zinok
Cink
Sinkki
Zink
31
Ga
Galis
Gallium
Gallju
Gallium
Gal
Gálio
Galiu
Gálium
Galij
Gallium
Gallium
32
Ge
Germanis
Germánium
Ġermanju
Germanium
German
Germânio
Germaniu
Germánium
Germanij
Germanium
Germanium
33
As
Arsenas
Arzén
Arseniku
Arseen
Arsen
Arsénio
Arsen
Arzén
Arzen
Arseeni
Arsenik
34
Se
Selenas
Szelén
Selenju
Selenium
Selen
Selénio
Seleniu
Selén
Selen
Seleeni
Selen
35
Br
Bromas
Bróm
Bromu
Broom
Brom
Bromo
Brom
Bróm
Brom
Bromi
Brom
36
Kr
Kriptonas
Kripton
Kripton
Krypton
Krypton
Krípton
Kripton
Kryptón
Kripton
Krypton
Krypton
37
Rb
Rubidis
Rubídium
Rubidju
Rubidium
Rubid
Rubídio
Rubidiu
Rubídium
Rubidij
Rubidium
Rubidium
38
Sr
Stroncis
Stroncium
Stronzju
Strontium
Stront
Estrôncio
Stronţiu
Stroncium
Stroncij
Strontium
Strontium
39
Y
Itris
Ittrium
Ittriju
Yttrium
Itr
Ítrio
Ytriu
Ytrium
Itrij
Yttrium
Yttrium
40
Zr
Cirkonis
Cirkónium
Żirkonju
Zirkonium
Cyrkon
Zircónio
Zirconiu
Zirkónium
Cirkonij
Zirkonium
Zirkonium
41
Nb
Niobis
Nióbium
Nijobju
Niobium
Niob
Nióbio
Niobiu
Niób
Niobij
Niobium
Niob
42
Mo
Molibdenas
Molibdén
Molibdenu
Molybdeen
Molibden
Molibdénio
Molibden
Molybdén
Molibden
Molybdeeni
Molybden
43
Tc
Technecis
Technécium
Teknezju
Technetium
Technet
Tecnécio
Tehneţiu
Technécium
Tehnecij
Teknetium
Teknetium
44
Ru
Rutenis
Ruténium
Rutenju
Ruthernium
Ruten
Ruténio
Ruteniu
Ruténium
Rutenij
Rutenium
Rutenium
45
Rh
Rodis
Ródium
Rodju
Rodium
Rod
Ródio
Rodiu
Ródium
Rodij
Rodium
Rodium
46
Pd
Paladis
Palládium
Palladju
Palladium
Pallad
Paládio
Paladiu
Paládium
Paladij
Palladium
Palladium
47
Ag
Sidabras
Ezüst
Fidda
Zilver
Srebro
Prata
Argint
Striebro
Srebro
Hopea
Silver
48
Cd
Kadmis
Kadmium
Kadmju
Cadmium
Kadm
Cádmio
Cadmiu
Kadmium
Kadmij
Kadmium
Kadmium
49
In
Indis
Indium
Indju
Indium
Ind
Índio
Indiu
Indium
Indij
Indium
Indium
50
Sn
Alavas
Ón
Landa
Tin
Cyna
Estanho
Staniu
Cín
Kositer
Tina
Tenn
51
Sb
Stibis
Antimon
Antimonju
Antimoon
Antymon
Antimónio
Stibiu
Antimón
Antimon
Antimoni
Antimon
52
Te
Telūras
Tellúr
Tellurju
Telluur
Tellur
Telúrio
Telur
Telúr
Telur
Telluuri
Tellur
53
I
Jodas
Jód
Jodju
Jood
Jod
Iodo
Iod
Jód
Jod
Jodi
Jod
54
Xe
Ksenonas
Xenon
Kseno
Xenon
Ksenon
Xénon
Xenon
Xenón
Ksenon
Ksenon
Xenon
55
Cs
Cezis
Cézium
Ċesju
Cesium
Cez
Césio
Cesiu
Césium
Cezij
Cesium
Cesium
56
Ba
Baris
Bárium
Barju
Barium
Bar
Bário
Bariu
Bárium
Barij
Barium
Barium
57
La
Lantanas
Lantán
Lantanu
Lanthaan
Lantan
Lantânio
Lantan
Lantán
Lantan
Lantaani
Lantan
58
Ce
Ceris
Cérium
Ċerju
Cerium
Cer
Cério
Ceriu
Cér
Cerij
Cerium
Cerium
59
Pr
Prazeodimis
Prazeodímium
Prasedimju
Praseodymium
Prazeodym
Praseodímio
Praseodim
Prazeodým
Prazeodim
Praseodyymi
Praseodym
60
Nd
Neodimis
Neodímium
Neodimju
Neodymium
Neodym
Neodímio
Neodim
Neodým
Neodim
Neodyymi
Neodym
61
Pm
Prometis
Prométium
Prometju
Promethium
Promet
Promécio
Promeţiu
Prométium
Prometij
Prometium
Prometium
62
Sm
Samaris
Szamárium
Samarju
Samarium
Samar
Samário
Samariu
Samárium
Samarij
Samarium
Samarium
63
Eu
Europis
Európium
Ewropju
Europium
Europ
Európio
Europiu
Európium
Evropij
Europium
Europium
64
Gd
Gadolinis
Gadolínium
Gadolinju
Gadolinium
Gadolin
Gadolínio
Gadoliniu
Gadolínium
Gadolinij
Gadolinium
Gadolinium
65
Tb
Terbis
Terbium
Terbju
Terbium
Terb
Térbio
Terbiu
Terbium
Terbij
Terbium
Terbium
66
Dy
Disprozis
Diszprózium
Disprosju
Dysprosium
Dysproz
Disprósio
Dysprosiu
Dysprózium
Disprozij
Dysprosium
Dysprosium
67
Ho
Holmis
Holmium
Olmju
Holmium
Holm
Hólmio
Holmiu
Holmium
Holmij
Holmium
Holmium
68
Er
Erbis
Erbium
Erbju
Erbium
Erb
Érbio
Erbiu
Erbium
Erbij
Erbium
Erbium
69
Tm
Tulis
Túlium
Tulju
Thulium
Tul
Túlio
Tuliu
Túlium
Tulij
Tulium
Tulium
70
Yb
Iterbis
Itterbium
Itterbju
Ytterbium
Iterb
Itérbio
Yterbiu
Yterbium
Iterbij
Ytterbium
Ytterbium
71
Lu
Liutecis
Lutécium
Lutezju
Lutetium
Lutet
Lutécio
Luteţiu
Lutécium
Lutecij
Lutetium
Lutetium
72
Hf
Hafnis
Hafnium
Ħafnju
Hafnium
Hafn
Háfnio
Hafniu
Hafnium
Hafnij
Hafnium
Hafnium
73
Ta
Tantalas
Tantál
Tantalu
Tantaal
Tantal
Tântalo
Tantal
Tantal
Tantal
Tantaali
Tantal
74
W
Volframas
Volfrám
Tungstenu
Wolfram
Wolfram
Tungsténio
Wolfram
Volfrám
Volfram
Volframi
Wolfram
75
Re
Renis
Rénium
Rênju
Renium
Ren
Rénio
Reniu
Rénium
Renij
Renium
Rhenium
76
Os
Osmis
Ozmium
Osmju
Osmium
Osm
Ósmio
Osmiu
Osmium
Osmij
Osmium
Osmium
77
Ir
Iridis
Irídium
Iridju
Iridium
Iryd
Irídio
Iridiu
Irídium
Iridij
Iridium
Iridium
78
Pt
Platina
Platina
Platinu
Platinum
Platyna
Platina
Platina
Platina
Platina
Platina
Platina
79
Au
Auksas
Arany
Deheb
Goud
Złoto
Ouro
Aur
Zlato
Zlato
Kulta
Guld
80
Hg
Gyvsidabris
Higany
Merkurju
Kwik
Rtęć
Mercúrio
Mercur
Ortuť
Živo srebro
Elohopea
Kvicksilver
81
Tl
Talis
Tallium
Tallju
Thallium
Tal
Tálio
Taliu
Tálium
Talij
Tallium
Tallium
82
Pb
Švinas
Ólom
Ċomb
Lood
Ołów
Chumbo
Plumb
Olovo
Svinec
Lyijy
Bly
83
Bi
Bismutas
Bizmut
Bismùt
Bismuth
Bizmut
Bismuto
Bismut
Bizmut
Bizmut
Vismutti
Vismut
84
Po
Polonis
Polónium
Polonju
Polonium
Polon
Polónio
Poloniu
Polónium
Polonij
Polonium
Polonium
85
At
Astatinas
Asztácium
Astatina
Astaat
Astat
Astato
Astatiniu
Astát
Astat
Astatiini
Astat
86
Rn
Radonas
Radon
Radon
Radon
Radon
Rádon
Radon
Radón
Radon
Radon
Radon
87
Fr
Francis
Francium
Franċju
Francium
Frans
Frâncio
Franciu
Francium
Francij
Frankium
Francium
88
Ra
Radis
Rádium
Radju
Radium
Rad
Rádio
Radiu
Rádium
Radij
Radium
Radium
89
Ac
Aktinis
Aktínium
Aktinju
Actinium
Aktyn
Actínio
Actiniu
Aktínium
Aktinij
Aktinium
Aktinium
90
Th
Toris
Tórium
Torju
Thorium
Tor
Tório
Toriu
Tórium
Torij
Torium
Torium
91
Pa
Protaktinis
Protaktínium
Protaktinju
Protactinium
Protaktyn
Protactínio
Proactiniu
Protaktínium
Protaktinij
Protaktinium
Protaktinium
92
U
Uranas
Urán
Uranju
Uranium
Uran
Urânio
Uraniu
Urán
Uran
Uraani
Uran
93
Np
Neptūnis
Neptúnium
Nettunju
Neptunium
Neptun
Neptúnio
Neptuniu
Neptúnium
Neptunij
Neptunium
Neptunium
94
Pu
Plutonis
Plutónium
Plutonju
Plutonium
Pluton
Plutónio
Plutoniu
Plutónium
Plutonij
Plutonium
Plutonium
95
Am
Americis
Amerícium
Ameriċju
Americium
Ameryk
Amerício
Americiu
Amerícium
Americij
Amerikium
Americium
96
Cm
Kiuris
Kűrium
Kurju
Curium
Kiur
Cúrio
Curiu
Curium
Kirij
Curium
Curium
97
Bk
Berklis
Berkélium
Berkelju
Berkelium
Berkel
Berquélio
Berkeliu
Berkelium
Berkelij
Berkelium
Berkelium
98
Cf
Kalifornis
Kalifornium
Kalifornju
Californium
Kaliforn
Califórnio
Californiu
Kalifornium
Kalifornij
Kalifornium
Californium
99
Es
Einšteinis
Einsteinium
Enstejnju
Einsteinium
Einstein
Einsteinio
Einsteiniu
Einsteinium
Ajnštajnij
Einsteinium
Einsteinium
100
Fm
Fermis
Fermium
Fermju
Fermium
Ferm
Férmio
Fermiu
Fermium
Fermij
Fermium
Fermium
101
Md
Mendelevis
Mendelévium
Mendelevju
Mendelevium
Mendelew
Mendelévio
Mendeleeviu
Mendelevium
Mendelevij
Mendelevium
Mendelevium
102
No
Nobelis
Nobélium
Nobelju
Nobelium
Nobel
Nobélio
Nobeliu
Nobelium
Nobelij
Nobelium
Nobelium
103
Lw
Lorensis
Laurencium
Lawrenċju
Laurentium
Lorens
Laurêncio
Laurenţiu
Laurencium
Lavrencij
Lawrensium
Lawrentium’

Z
Symbol
BG
ES
CS
DA
DE
ET
EL
EN
FR
IT
LV

1
H
Водород
Hidrógeno
Vodík
Hydrogen
Wasserstoff
Vesinik
Υδρογόνο
Hydrogen
Hydrogène
Idrogeno
Ūdeņradis

2
He
Хелий
Helio
Helium
Helium
Helium
Heelium
Ήλιο
Helium
Hélium
Elio
Hēlijs

3
Li
Литий
Litio
Lithium
Lithium
Lithium
Liitium
Λίθιο
Lithium
Lithium
Litio
Litijs

4
Be
Берилий
Berilio
Beryllium
Beryllium
Beryllium
Berüllium
Βηρύλλιο
Beryllium
Béryllium(Glucinium)
Berillio
Berilijs

5
B
Бор
Boro
Bor
Bor
Bor
Boor
Βόριο
Boron
Bore
Boro
Bors

6
C
Въглерод
Carbono
Uhlík
Carbon (kulstof)
Kohlenstoff
Süsinik
Άνθρακας
Carbon
Carbone
Carbonio
Ogleklis

7
N
Азот
Nitrógeno
Dusík
Nitrogen
Stickstoff
Lämmastik
Άζωτο
Nitrogen
Azote
Azoto
Slāpeklis

8
O
Кислород
Oxígeno
Kyslík
Oxygen (ilt)
Sauerstoff
Hapnik
Οξυγόνο
Oxygen
Oxygène
Ossigeno
Skābeklis

9
F
Флуор
Flúor
Fluor
Fluor
Fluor
Fluor
Φθόριο
Fluorine
Fluor
Fluoro
Fluors

10
Ne
Неон
Neón
Neon
Neon
Neon
Neoon
Νέον
Neon
Néon
Neon
Neons

11
Na
Натрий
Sodio
Sodík
Natrium
Natrium
Naatrium
Νάτριο
Sodium
Sodium
Sodio
Nātrijs

12
Mg
Магнезий
Magnesio
Hořčík
Magnesium
Magnesium
Magneesium
Μαγνήσιο
Magnesium
Magnésium
Magnesio
Magnijs

13
Al
Алуминий
Aluminio
Hliník
Aluminium
Aluminium
Alumiinium
Αργίλλιο
Aluminium
Aluminium
Alluminio
Alumīnijs

14
Si
Силиций
Silicio
Křemík
Silicium
Silicium
Räni
Πυρίτιο
Silicon
Silicium
Silicio
Silīcijs

15
P
Фосфор
Fósforo
Fosfor
Phosphor
Phosphor
Fosfor
Φωσφόρος
Phosphorus
Phosphore
Fosforo
Fosfors

16
S
Сяра
Azufre
Síra
Svovl
Schwefel
Väävel
Θείον
Sulphur
Soufre
Zolfo
Sērs

17
Cl
Хлор
Cloro
Chlor
Chlor
Chlor
Kloor
Χλώριο
Chlorine
Chlore
Cloro
Hlors

18
Ar
Аргон
Argón
Argon
Argon
Argon
Argoon
Argό
Argon
Argon
Argon
Argons

19
K
Калий
Potasio
Draslík
Kalium
Kalium
Kaalium
Κάλιο
Potassium
Potassium
Potassio
Kālijs

20
Ca
Калций
Calcio
Vápník
Calcium
Calcium
Kaltsium
Ασβέστιο
Calcium
Calcium
Calcio
Kalcijs

21
Sc
Скандий
Escandio
Skandium
Scandium
Scandium
Skandium
Σκάνδιο
Scandium
Scandium
Scandio
Skandijs

22
Ti
Титан
Titanio
Titan
Titan
Titan
Titaan
Τιτάνιο
Titanium
Titane
Titanio
Titāns

23
V
Ванадий
Vanadio
Vanad
Vanadium
Vanadium
Vanaadium
Βανάδιο
Vanadium
Vanadium
Vanadio
Vanādijs

24
Cr
Хром
Cromo
Chrom
Chrom
Chrom
Kroom
Χρώμιο
Chromium
Chrome
Cromo
Hroms

25
Mn
Манган
Manganeso
Mangan
Mangan
Mangan
Mangaan
Μαγγάνιο
Manganese
Manganèse
Manganese
Mangāns

26
Fe
Желязо
Hierro
Železo
Jern
Eisen
Raud
Σίδηρος
Iron
Fer
Ferro
Dzelzs

27
Co
Кобалт
Cobalto
Kobalt
Cobalt
Kobalt
Koobalt
Κοβάλτιο
Cobalt
Cobalt
Cobalto
Kobalts

28
Ni
Никел
Níquel
Nikl
Nikkel
Nickel
Nikkel
Νικέλιο
Nickel
Nickel
Nichel
Niķelis

29
Cu
Мед
Cobre
Měď
Kobber
Kupfer
Vask
Χαλκός
Copper
Cuivre
Rame
Varš

30
Zn
Цинк
Zinc
Zinek
Zink
Zink
Tsink
Ψευδάργυρος
Zinc
Zinc
Zinco
Cinks

31
Ga
Галий
Galio
Gallium
Gallium
Gallium
Gallium
Γάλλιο
Gallium
Gallium
Gallio
Gallijs

32
Ge
Германий
Germanio
Germanium
Germanium
Germanium
Germaanium
Γερμάνιο
Germanium
Germanium
Germanio
Germānijs

33
As
Арсен
Arsénico
Arsen
Arsen
Arsen
Arseen
Αρσενικό
Arsenic
Arsenic
Arsenico
Arsēns

34
Se
Селен
Selenio
Selen
Selen
Selen
Seleen
Σελήνιο
Selenium
Sélénium
Selenio
Selēns

35
Br
Бром
Bromo
Brom
Brom
Brom
Broom
Βρώμιο
Bromine
Brome
Bromo
Broms

36
Kr
Криптон
Criptón
Krypton
Krypton
Krypton
Krüptoon
Κρυπτό
Krypton
Krypton
Krypton
Kriptons

37
Rb
Рубидий
Rubidio
Rubidium
Rubidium
Rubidium
Rubiidium
Ρουβήδιο
Rubidium
Rubidium
Rubidio
Rubīdijs

38
Sr
Стронций
Estroncio
Stroncium
Strontium
Strontium
Strontsium
Στρόντιο
Strontium
Strontium
Stronzio
Stroncijs

39
Y
Итрий
Itrio
Yttrium
Yttrium
Yttrium
Ütrium
Ύττριο
Yttrium
Yttrium
Ittrio
Itrijs

40
Zr
Цирконий
Circonio
Zirkonium
Zirconium
Zirkon
Tsirkoonium
Ζιρκόνιο
Zirconium
Zirconium
Zirconio
Cirkonijs

41
Nb
Ниобий
Niobio
Niob
Niobium
Niob
Nioobium
Νιόβιο
Niobium
Niobium
Niobio
Niobijs

42
Mo
Молибден
Molibdeno
Molybden
Molybden
Molybdän
Molübdeen
Μολυβδένιο
Molybdenum
Molybdène
Molibdeno
Molibdēns

43
Tc
Технеций
Tecnecio
Technecium
Technetium
Technetium
Tehneetsium
Τεχνήτιο
Technetium
Technetium
Tecnezio
Tehnēcijs

44
Ru
Рутений
Rutenio
Ruthenium
Ruthenium
Ruthenium
Ruteenium
Ρουθήνιο
Ruthenium
Ruthénium
Rutenio
Rutēnijs

45
Rh
Родий
Rodio
Rhodium
Rhodium
Rhodium
Roodium
Ρόδιο
Rhodium
Rhodium
Rodio
Rodijs

46
Pd
Паладий
Paladio
Palladium
Palladium
Palladium
Pallaadium
Παλλάδιο
Palladium
Palladium
Palladio
Pallādijs

47
Ag
Сребро
Plata
Stříbro
Sølv
Silber
Hõbe
Άργυρος
Silver
Argent
Argento
Sudrabs

48
Cd
Кадмий
Cadmio
Kadmium
Cadmium
Cadmium
Kaadium
Κάδμιο
Cadmium
Cadmium
Cadmio
Kadmijs

49
In
Индий
Indio
Indium
Indium
Indium
Indium
Ίνδιο
Indium
Indium
Indio
Indijs

50
Sn
Калай
Estaño
Cín
Tin
Zinn
Tina
Κασσίτερος
Tin
Étain
Stagno
Alva

51
Sb
Антимон
Antimonio
Antimon
Antimon
Antimon
Antimon
Αντιμόνιο
Antimony
Antimoine
Antimonio
Antimons

52
Te
Телур
Telurio
Tellur
Telur
Tellur
Telluur
Τελλούριο
Tellurium
Tellure
Tellurio
Telūrs

53
I
Йод
Yodo
Jod
Jod
Jod
Jood
Ιώδιο
Iodine
Iode
Iodio
Jods

54
Xe
Ксенон
Xenón
Xenon
Xenon
Xenon
Ksenoon
Ξένο
Xenon
Xénon
Xenon
Ksenons

55
Cs
Цезий
Cesio
Cesium
Cæsium
Caesium
Tseesium
Καίσιο
Caesium
Césium
Cesio
Cēzijs

56
Ba
Барий
Bario
Baryum
Barium
Barium
Baarium
Βάριο
Barium
Baryum
Bario
Bārijs

57
La
Лантан
Lantano
Lanthan
Lanthan
Lanthan
Lantaan
Λανδάνιο
Lanthanum
Lanthane
Lantanio
Lantāns

58
Ce
Церий
Cerio
Cer
Cerium
Cer
Tseerium
Δημήτριο
Cerium
Cérium
Cerio
Cērijs

59
Pr
Празеодим
Praseodimio
Praseodym
Praseodym
Praseodym
Praseodüüm
Πρασεοδύμιο
Praseodymium
Praséodyme
Praseodimio
Prazeodīms

60
Nd
Неодим
Niodimio
Neodym
Neodym
Neodym
Neodüüm
Νεοδύμιο
Neodymium
Néodyme
Neodimio
Neodīms

61
Pm
Прометий
Prometio
Promethium
Promethium
Promethium
Promeetium
Προμήθειο
Promethium
Prométhium
Promezio
Prometijs

62
Sm
Самарий
Samario
Samarium
Samarium
Samarium
Samaarium
Σαμάριο
Samarium
Samarium
Samario
Samārijs

63
Eu
Европий
Europio
Europium
Europium
Europium
Euroopium
Ευρώπιο
Europium
Europium
Europio
Eiropijs

64
Gd
Гадолиний
Gadolinio
Gadolinium
Gadolinium
Gadolinium
Gadoliinium
Γαδολίνιο
Gadolinium
Gadolinium
Gadolinio
Gadolīnijs

65
Tb
Тербий
Terbio
Terbium
Terbium
Terbium
Terbium
Τέρβιο
Terbium
Terbium
Terbio
Terbijs

66
Dy
Диспросий
Disprosio
Dysprosium
Dysprosium
Dysprosium
Düsproosium
Δυσπρόσιο
Dysprosium
Dysprosium
Disprosio
Disprozijs

67
Ho
Холмий
Holmio
Holmium
Holmium
Holmium
Holmium
Όλμιο
Holmium
Holmium
Olmio
Holmijs

68
Er
Ербий
Erbio
Erbium
Erbium
Erbium
Erbium
Έρβιο
Erbium
Erbium
Erbio
Erbijs

69
Tm
Тулий
Tulio
Thulium
Thulium
Thulium
Tuulium
Θούλιο
Thulium
Thulium
Tulio
Tūlijs

70
Yb
Итербий
Iterbio
Ytterbium
Ytterbium
Ytterbium
Üterbium
Υττέρβιο
Ytterbium
Ytterbium
Itterbio
Iterbijs

71
Lu
Лютеций
Lutecio
Lutecium
Lutetium
Lvtécium
Luteetsium
Λουτήτιο
Lutetium
Lutécium
Lutezio
Lutēcijs

72
Hf
Хафний
Hafnio
Hafnium
Hafnium
Hafnium
Hafnium
Άφνιο
Hafnium
Hafnium
Afnio
Hafnijs

73
Ta
Тантал
Tántalo
Tantal
Tantal
Tantal
Tantaal
Ταντάλιο
Tantalum
Tantale
Tantalio
Tantāls

74
W
Волфрам
Volframio
Wolfram
Wolfram
Wolfram
Volfram
Βολφράμιο(Τουγκοτένιο)
Tungsten
Tungstène
Tungsteno
Volframs

75
Re
Рений
Renio
Rhenium
Rhenium
Rhenium
Reenium
Ρήνιο
Rhenium
Rhénium
Renio
Rēnijs

76
Os
Осмий
Osmio
Osmium
Osmium
Osmium
Osmium
Όσμιο
Osmium
Osmium
Osmio
Osmijs

77
Ir
Иридий
Iridio
Iridium
Iridium
Iridium
Iriidium
Ιρίδιο
Iridium
Iridium
Iridio
Irīdijs

78
Pt
Платина
Platino
Platina
Platin
Platin
Plaatina
Λευκόχρυσος
Platinum
Platine
Platino
Platīns

79
Au
Злато
Oro
Zlato
Guld
Gold
Kuld
Χρυσός
Gold
Or
Oro
Zelts

80
Hg
Живак
Mercurio
Rtuť
Kviksølv
Quecksilber
Elavhõbe
Υδράργυρος
Mercury
Mercure
Mercurio
Dzīvsudrabs

81
Tl
Талий
Talio
Thallium
Thalium
Thallium
Tallium
Θάλλιο
Thallium
Thallium
Tallio
Tallijs

82
Pb
Олово
Plomo
Olovo
Bly
Blei
Plii
Μόλυβδος
Lead
Plomb
Piombo
Svins

83
Bi
Бисмут
Bismuto
Bismut
Bismuth
Wismuth
Vismut
Βισμούθιο
Bismuth
Bismuth
Bismuto
Bismuts

84
Po
Полоний
Polonio
Polonium
Plonium
Polonium
Poloonium
Πολώνιο
Polonium
Polonium
Polonio
Polonijs

85
At
Астат
Astato
Astat
Astat
Astat
Astaat
Αστάτιο
Astatine
Astate
Astato
Astats

86
Rn
Радон
Radón
Radon
Radon
Radon
Radoon
Ραδόνιο
Radon
Radon
Radon
Radons

87
Fr
Франций
Francio
Francium
Francium
Francium
Frantsium
Φράγκιο
Francium
Francium
Francio
Francijs

88
Ra
Радий
Radio
Radium
Radium
Radium
Raadium
Ράδιο
Radium
Radium
Radio
Rādijs

89
Ac
Актиний
Actinio
Aktinium
Actinium
Actinium
Aktiinium
Ακτίνιο
Actinium
Actinium
Attinio
Aktīnijs

90
Th
Торий
Torio
Thorium
Thorium
Thorium
Toorium
Θόριο
Thorium
Thorium
Torio
Torijs

91
Pa
Протактиний
Protactinio
Protaktinium
Protactinium
Protactinium
Protaktiinium
Πρωτακτίνιο
Protactinium
Protactinium
Protoattinio
Protaktīnijs

92
U
Уран
Uranio
Uran
Uran
Uran
Uraan
Ουράνιο
Uranium
Uranium
Uranio
Urāns

93
Np
Нептуний
Neptunio
Neptunium
Neptunium
Neptunium
Neptuunium
Νεπτούνιο(Ποσειδώνιο)
Neptunium
Neptunium
Nettunio
Neptūnijs

94
Pu
Плутоний
Plutonio
Plutonium
Plutonium
Plutonium
Plutoonium
Πλουτώνιο
Plutonium
Plutonium
Plutonio
Plutonijs

95
Am
Америций
Americio
Americium
Americium
Americium
Ameriitsium
Αμερίκιο
Americium
Américium
Americio
Amerīcijs

96
Cm
Кюрий
Curio
Curium
Curium
Curium
Kuurium
Κιούριο
Curium
Curium
Curio
Kirijs

97
Bk
Берклий
Berkelio
Berkelium
Berkelium
Berkelium
Berkeelium
Μπερκέλιο
Berkelium
Berkélium
Berkelio
Berklijs

98
Cf
Калифорний
Californio
Kalifornium
Californium
Californium
Kalifornium
Καλιφόρνιο
Californium
Californium
Californio
Kalifornijs

99
Es
Айнщайний
Einstenio
Einsteinium
Einsteinium
Einsteinium
Einsteinium
Αϊνστάνιον
Einsteinium
Einsteinium
Einstenio
Einšteinijs

100
Fm
Фермий
Fermio
Fermium
Fermium
Fermium
Fermium
Φέρμιο
Fermium
Fermium
Fermio
Fermijs

101
Md
Менделеевий
Mendelevio
Mendelevium
Mendelevium
Mendelevium
Mendeleevium
Μεντελέβιο
Mendelevium
Mendélévium
Mendelevio
Mendeļejevijs

102
No
Нобелий
Nobelio
Nobelium
Nobelium
Nobelium
Nobeelium
Νομπέλιο
Nobelium
Nobélium
Nobelio
Nobēlijs

103
Lw
Лоуренсий
Laurencio
Lawrencium
Lawrentium
Lawrentium
Lavrentsium
Λαυρένσιο
Lawrencium
Lawrencium
Lawrencio
Lourensijs

Z
Symbol
LT
HU
MT
NL
PL
PT
RO
SK
SL
FI
SV

1
H
Vandenilis
Hidrogén
Idroġenu
Waterstof
Wodór
Hidrogénio
Hidrogen
Vodík
Vodik
Vety
Väte

2
He
Helis
Hélium
Elju
Helium
Hel
Hélio
Heliu
Hélium
Helij
Helium
Helium

3
Li
Litis
Lítium
Litju
Lithium
Lit
Lítio
Litiu
Lítium
Litij
Litium
Litium

4
Be
Berilis
Berillium
Berillju
Beryllium
Beryl
Berílio
Beriliu
Berýlium
Berilij
Beryllium
Beryllium

5
B
Boras
Bór
Boron
Boor
Bor
Boro
Bor
Bór
Bor
Boori
Bor

6
C
Anglis
Szén
Karbonju
Koolstof
Węgiel
Carbono
Carbon
Uhlík
Ogljik
Hiili
Kol

7
N
Azotas
Nitrogén
Azotu
Stikstof
Azot
Azoto
Azot
Dusík
Dušik
Typpi
Kväve

8
O
Deguonis
Oxigén
Ossiġenu
Zuurstof
Tlen
Oxigénio
Oxigen
Kyslík
Kisik
Happi
Syre

9
F
Fluoras
Fluor
Fluworin
Fluor
Fluor
Flúor
Fluor
Fluór
Fluor
Fluori
Fluor

10
Ne
Neonas
Neon
Neon
Neon
Neon
Néon
Neon
Neón
Neon
Neon
Neon

11
Na
Natris
Nátrium
Sodju
Natrium
Sód
Sódio
Sodiu
Sodík
Natrij
Natrium
Natrium

12
Mg
Magnis
Magnézium
Manjesju
Magnesium
Magnez
Magnésio
Magneziu
Horčík
Magnezij
Magnesium
Magnesium

13
Al
Aliuminis
Alumínium
Aluminju
Aluminium
Glin
Alumínio
Aluminiu
Hliník
Aluminij
Alumiini
Aluminium

14
Si
Silicis
Szilicium
Silikon
Silicium
Krzem
Silício
Siliciu
Kremík
Silicij
Pii
Kisel

15
P
Fosforas
Foszfor
Fosfru
Fosfor
Fosfor
Fósforo
Fosfor
Fosfor
Fosfor
Fosfori
Fosfor

16
S
Siera
Kén
Kubrit
Zwavel
Siarka
Enxofre
Sulf
Síra
Žveplo
Rikki
Svavel

17
Cl
Chloras
Klór
Kloru
Chloor
Chlor
Cloro
Clor
Chlór
Klor
Kloori
Klor

18
Ar
Argonas
Argon
Argon
Argon
Argon
Árgon
Argon
Argón
Argon
Argon
Argon

19
K
Kalis
Kálium
Potassju
Kalium
Potas
Potássio
Potasiu
Draslík
Kalij
Kalium
Kalium

20
Ca
Kalcis
Kalcium
Kalċju
Calcium
Wapń
Cálcio
Calciu
Vápnik
Kalcij
Kalsium
Kalcium

21
Sc
Skandis
Szkandium
Skandju
Scandium
Skand
Escândio
Scandiu
Skandium
Skandij
Skandium
Skandium

22
Ti
Titanas
Titán
Titanju
Titaan
Tytan
Titânio
Titan
Titán
Titan
Titaani
Titan

23
V
Vanadis
Vanádium
Vanadju
Vanadium
Wanad
Vanádio
Vanadiu
Vanád
Vanadij
Vanadiini
Vanadin

24
Cr
Chromas
Króm
Kromju
Chroom
Chrom
Crómio
Crom
Chróm
Krom
Kromi
Krom

25
Mn
Manganas
Mangán
Manganiż
Mangaan
Mangan
Manganês
Mangan
Mangán
Mangan
Mangaani
Mangan

26
Fe
Geležis
Vas
Ħadid
Ijzer
Żelazo
Ferro
Fier
Železo
Železo
Rauta
Järn

27
Co
Kobaltas
Kobalt
Kobalt
Kobalt
Kobalt
Cobalto
Cobalt
Kobalt
Kobalt
Koboltti
Kobolt

28
Ni
Nikelis
Nikkel
Nikil
Nikkel
Nikiel
Níquel
Nichel
Nikel
Nikelj
Nikkeli
Nickel

29
Cu
Varis
Réz
Ram
Koper
Miedź
Cobre
Cupru
Meď
Baker
Kupari
Koppar

30
Zn
Cinkas
Cink
Żingu
Zìnk
Cynk
Zinco
Zinc
Zinok
Cink
Sinkki
Zink

31
Ga
Galis
Gallium
Gallju
Gallium
Gal
Gálio
Galiu
Gálium
Galij
Gallium
Gallium

32
Ge
Germanis
Germánium
Ġermanju
Germanium
German
Germânio
Germaniu
Germánium
Germanij
Germanium
Germanium

33
As
Arsenas
Arzén
Arseniku
Arseen
Arsen
Arsénio
Arsen
Arzén
Arzen
Arseeni
Arsenik

34
Se
Selenas
Szelén
Selenju
Selenium
Selen
Selénio
Seleniu
Selén
Selen
Seleeni
Selen

35
Br
Bromas
Bróm
Bromu
Broom
Brom
Bromo
Brom
Bróm
Brom
Bromi
Brom

36
Kr
Kriptonas
Kripton
Kripton
Krypton
Krypton
Krípton
Kripton
Kryptón
Kripton
Krypton
Krypton

37
Rb
Rubidis
Rubídium
Rubidju
Rubidium
Rubid
Rubídio
Rubidiu
Rubídium
Rubidij
Rubidium
Rubidium

38
Sr
Stroncis
Stroncium
Stronzju
Strontium
Stront
Estrôncio
Stronţiu
Stroncium
Stroncij
Strontium
Strontium

39
Y
Itris
Ittrium
Ittriju
Yttrium
Itr
Ítrio
Ytriu
Ytrium
Itrij
Yttrium
Yttrium

40
Zr
Cirkonis
Cirkónium
Żirkonju
Zirkonium
Cyrkon
Zircónio
Zirconiu
Zirkónium
Cirkonij
Zirkonium
Zirkonium

41
Nb
Niobis
Nióbium
Nijobju
Niobium
Niob
Nióbio
Niobiu
Niób
Niobij
Niobium
Niob

42
Mo
Molibdenas
Molibdén
Molibdenu
Molybdeen
Molibden
Molibdénio
Molibden
Molybdén
Molibden
Molybdeeni
Molybden

43
Tc
Technecis
Technécium
Teknezju
Technetium
Technet
Tecnécio
Tehneţiu
Technécium
Tehnecij
Teknetium
Teknetium

44
Ru
Rutenis
Ruténium
Rutenju
Ruthernium
Ruten
Ruténio
Ruteniu
Ruténium
Rutenij
Rutenium
Rutenium

45
Rh
Rodis
Ródium
Rodju
Rodium
Rod
Ródio
Rodiu
Ródium
Rodij
Rodium
Rodium

46
Pd
Paladis
Palládium
Palladju
Palladium
Pallad
Paládio
Paladiu
Paládium
Paladij
Palladium
Palladium

47
Ag
Sidabras
Ezüst
Fidda
Zilver
Srebro
Prata
Argint
Striebro
Srebro
Hopea
Silver

48
Cd
Kadmis
Kadmium
Kadmju
Cadmium
Kadm
Cádmio
Cadmiu
Kadmium
Kadmij
Kadmium
Kadmium

49
In
Indis
Indium
Indju
Indium
Ind
Índio
Indiu
Indium
Indij
Indium
Indium

50
Sn
Alavas
Ón
Landa
Tin
Cyna
Estanho
Staniu
Cín
Kositer
Tina
Tenn

51
Sb
Stibis
Antimon
Antimonju
Antimoon
Antymon
Antimónio
Stibiu
Antimón
Antimon
Antimoni
Antimon

52
Te
Telūras
Tellúr
Tellurju
Telluur
Tellur
Telúrio
Telur
Telúr
Telur
Telluuri
Tellur

53
I
Jodas
Jód
Jodju
Jood
Jod
Iodo
Iod
Jód
Jod
Jodi
Jod

54
Xe
Ksenonas
Xenon
Kseno
Xenon
Ksenon
Xénon
Xenon
Xenón
Ksenon
Ksenon
Xenon

55
Cs
Cezis
Cézium
Ċesju
Cesium
Cez
Césio
Cesiu
Césium
Cezij
Cesium
Cesium

56
Ba
Baris
Bárium
Barju
Barium
Bar
Bário
Bariu
Bárium
Barij
Barium
Barium

57
La
Lantanas
Lantán
Lantanu
Lanthaan
Lantan
Lantânio
Lantan
Lantán
Lantan
Lantaani
Lantan

58
Ce
Ceris
Cérium
Ċerju
Cerium
Cer
Cério
Ceriu
Cér
Cerij
Cerium
Cerium

59
Pr
Prazeodimis
Prazeodímium
Prasedimju
Praseodymium
Prazeodym
Praseodímio
Praseodim
Prazeodým
Prazeodim
Praseodyymi
Praseodym

60
Nd
Neodimis
Neodímium
Neodimju
Neodymium
Neodym
Neodímio
Neodim
Neodým
Neodim
Neodyymi
Neodym

61
Pm
Prometis
Prométium
Prometju
Promethium
Promet
Promécio
Promeţiu
Prométium
Prometij
Prometium
Prometium

62
Sm
Samaris
Szamárium
Samarju
Samarium
Samar
Samário
Samariu
Samárium
Samarij
Samarium
Samarium

63
Eu
Europis
Európium
Ewropju
Europium
Europ
Európio
Europiu
Európium
Evropij
Europium
Europium

64
Gd
Gadolinis
Gadolínium
Gadolinju
Gadolinium
Gadolin
Gadolínio
Gadoliniu
Gadolínium
Gadolinij
Gadolinium
Gadolinium

65
Tb
Terbis
Terbium
Terbju
Terbium
Terb
Térbio
Terbiu
Terbium
Terbij
Terbium
Terbium

66
Dy
Disprozis
Diszprózium
Disprosju
Dysprosium
Dysproz
Disprósio
Dysprosiu
Dysprózium
Disprozij
Dysprosium
Dysprosium

67
Ho
Holmis
Holmium
Olmju
Holmium
Holm
Hólmio
Holmiu
Holmium
Holmij
Holmium
Holmium

68
Er
Erbis
Erbium
Erbju
Erbium
Erb
Érbio
Erbiu
Erbium
Erbij
Erbium
Erbium

69
Tm
Tulis
Túlium
Tulju
Thulium
Tul
Túlio
Tuliu
Túlium
Tulij
Tulium
Tulium

70
Yb
Iterbis
Itterbium
Itterbju
Ytterbium
Iterb
Itérbio
Yterbiu
Yterbium
Iterbij
Ytterbium
Ytterbium

71
Lu
Liutecis
Lutécium
Lutezju
Lutetium
Lutet
Lutécio
Luteţiu
Lutécium
Lutecij
Lutetium
Lutetium

72
Hf
Hafnis
Hafnium
Ħafnju
Hafnium
Hafn
Háfnio
Hafniu
Hafnium
Hafnij
Hafnium
Hafnium

73
Ta
Tantalas
Tantál
Tantalu
Tantaal
Tantal
Tântalo
Tantal
Tantal
Tantal
Tantaali
Tantal

74
W
Volframas
Volfrám
Tungstenu
Wolfram
Wolfram
Tungsténio
Wolfram
Volfrám
Volfram
Volframi
Wolfram

75
Re
Renis
Rénium
Rênju
Renium
Ren
Rénio
Reniu
Rénium
Renij
Renium
Rhenium

76
Os
Osmis
Ozmium
Osmju
Osmium
Osm
Ósmio
Osmiu
Osmium
Osmij
Osmium
Osmium

77
Ir
Iridis
Irídium
Iridju
Iridium
Iryd
Irídio
Iridiu
Irídium
Iridij
Iridium
Iridium

78
Pt
Platina
Platina
Platinu
Platinum
Platyna
Platina
Platina
Platina
Platina
Platina
Platina

79
Au
Auksas
Arany
Deheb
Goud
Złoto
Ouro
Aur
Zlato
Zlato
Kulta
Guld

80
Hg
Gyvsidabris
Higany
Merkurju
Kwik
Rtęć
Mercúrio
Mercur
Ortuť
Živo srebro
Elohopea
Kvicksilver

81
Tl
Talis
Tallium
Tallju
Thallium
Tal
Tálio
Taliu
Tálium
Talij
Tallium
Tallium

82
Pb
Švinas
Ólom
Ċomb
Lood
Ołów
Chumbo
Plumb
Olovo
Svinec
Lyijy
Bly

83
Bi
Bismutas
Bizmut
Bismùt
Bismuth
Bizmut
Bismuto
Bismut
Bizmut
Bizmut
Vismutti
Vismut

84
Po
Polonis
Polónium
Polonju
Polonium
Polon
Polónio
Poloniu
Polónium
Polonij
Polonium
Polonium

85
At
Astatinas
Asztácium
Astatina
Astaat
Astat
Astato
Astatiniu
Astát
Astat
Astatiini
Astat

86
Rn
Radonas
Radon
Radon
Radon
Radon
Rádon
Radon
Radón
Radon
Radon
Radon

87
Fr
Francis
Francium
Franċju
Francium
Frans
Frâncio
Franciu
Francium
Francij
Frankium
Francium

88
Ra
Radis
Rádium
Radju
Radium
Rad
Rádio
Radiu
Rádium
Radij
Radium
Radium

89
Ac
Aktinis
Aktínium
Aktinju
Actinium
Aktyn
Actínio
Actiniu
Aktínium
Aktinij
Aktinium
Aktinium

90
Th
Toris
Tórium
Torju
Thorium
Tor
Tório
Toriu
Tórium
Torij
Torium
Torium

91
Pa
Protaktinis
Protaktínium
Protaktinju
Protactinium
Protaktyn
Protactínio
Proactiniu
Protaktínium
Protaktinij
Protaktinium
Protaktinium

92
U
Uranas
Urán
Uranju
Uranium
Uran
Urânio
Uraniu
Urán
Uran
Uraani
Uran

93
Np
Neptūnis
Neptúnium
Nettunju
Neptunium
Neptun
Neptúnio
Neptuniu
Neptúnium
Neptunij
Neptunium
Neptunium

94
Pu
Plutonis
Plutónium
Plutonju
Plutonium
Pluton
Plutónio
Plutoniu
Plutónium
Plutonij
Plutonium
Plutonium

95
Am
Americis
Amerícium
Ameriċju
Americium
Ameryk
Amerício
Americiu
Amerícium
Americij
Amerikium
Americium

96
Cm
Kiuris
Kűrium
Kurju
Curium
Kiur
Cúrio
Curiu
Curium
Kirij
Curium
Curium

97
Bk
Berklis
Berkélium
Berkelju
Berkelium
Berkel
Berquélio
Berkeliu
Berkelium
Berkelij
Berkelium
Berkelium

98
Cf
Kalifornis
Kalifornium
Kalifornju
Californium
Kaliforn
Califórnio
Californiu
Kalifornium
Kalifornij
Kalifornium
Californium

99
Es
Einšteinis
Einsteinium
Enstejnju
Einsteinium
Einstein
Einsteinio
Einsteiniu
Einsteinium
Ajnštajnij
Einsteinium
Einsteinium

100
Fm
Fermis
Fermium
Fermju
Fermium
Ferm
Férmio
Fermiu
Fermium
Fermij
Fermium
Fermium

101
Md
Mendelevis
Mendelévium
Mendelevju
Mendelevium
Mendelew
Mendelévio
Mendeleeviu
Mendelevium
Mendelevij
Mendelevium
Mendelevium

102
No
Nobelis
Nobélium
Nobelju
Nobelium
Nobel
Nobélio
Nobeliu
Nobelium
Nobelij
Nobelium
Nobelium

103
Lw
Lorensis
Laurencium
Lawrenċju
Laurentium
Lorens
Laurêncio
Laurenţiu
Laurencium
Lavrencij
Lawrensium
Lawrentium’



Z
Symbol
BG
ES
CS
DA
DE
ET
EL
EN
FR
IT
LV

1
H
Водород
Hidrógeno
Vodík
Hydrogen
Wasserstoff
Vesinik
Υδρογόνο
Hydrogen
Hydrogène
Idrogeno
Ūdeņradis

2
He
Хелий
Helio
Helium
Helium
Helium
Heelium
Ήλιο
Helium
Hélium
Elio
Hēlijs

3
Li
Литий
Litio
Lithium
Lithium
Lithium
Liitium
Λίθιο
Lithium
Lithium
Litio
Litijs

4
Be
Берилий
Berilio
Beryllium
Beryllium
Beryllium
Berüllium
Βηρύλλιο
Beryllium
Béryllium(Glucinium)
Berillio
Berilijs

5
B
Бор
Boro
Bor
Bor
Bor
Boor
Βόριο
Boron
Bore
Boro
Bors

6
C
Въглерод
Carbono
Uhlík
Carbon (kulstof)
Kohlenstoff
Süsinik
Άνθρακας
Carbon
Carbone
Carbonio
Ogleklis

7
N
Азот
Nitrógeno
Dusík
Nitrogen
Stickstoff
Lämmastik
Άζωτο
Nitrogen
Azote
Azoto
Slāpeklis

8
O
Кислород
Oxígeno
Kyslík
Oxygen (ilt)
Sauerstoff
Hapnik
Οξυγόνο
Oxygen
Oxygène
Ossigeno
Skābeklis

9
F
Флуор
Flúor
Fluor
Fluor
Fluor
Fluor
Φθόριο
Fluorine
Fluor
Fluoro
Fluors

10
Ne
Неон
Neón
Neon
Neon
Neon
Neoon
Νέον
Neon
Néon
Neon
Neons

11
Na
Натрий
Sodio
Sodík
Natrium
Natrium
Naatrium
Νάτριο
Sodium
Sodium
Sodio
Nātrijs

12
Mg
Магнезий
Magnesio
Hořčík
Magnesium
Magnesium
Magneesium
Μαγνήσιο
Magnesium
Magnésium
Magnesio
Magnijs

13
Al
Алуминий
Aluminio
Hliník
Aluminium
Aluminium
Alumiinium
Αργίλλιο
Aluminium
Aluminium
Alluminio
Alumīnijs

14
Si
Силиций
Silicio
Křemík
Silicium
Silicium
Räni
Πυρίτιο
Silicon
Silicium
Silicio
Silīcijs

15
P
Фосфор
Fósforo
Fosfor
Phosphor
Phosphor
Fosfor
Φωσφόρος
Phosphorus
Phosphore
Fosforo
Fosfors

16
S
Сяра
Azufre
Síra
Svovl
Schwefel
Väävel
Θείον
Sulphur
Soufre
Zolfo
Sērs

17
Cl
Хлор
Cloro
Chlor
Chlor
Chlor
Kloor
Χλώριο
Chlorine
Chlore
Cloro
Hlors

18
Ar
Аргон
Argón
Argon
Argon
Argon
Argoon
Argό
Argon
Argon
Argon
Argons

19
K
Калий
Potasio
Draslík
Kalium
Kalium
Kaalium
Κάλιο
Potassium
Potassium
Potassio
Kālijs

20
Ca
Калций
Calcio
Vápník
Calcium
Calcium
Kaltsium
Ασβέστιο
Calcium
Calcium
Calcio
Kalcijs

21
Sc
Скандий
Escandio
Skandium
Scandium
Scandium
Skandium
Σκάνδιο
Scandium
Scandium
Scandio
Skandijs

22
Ti
Титан
Titanio
Titan
Titan
Titan
Titaan
Τιτάνιο
Titanium
Titane
Titanio
Titāns

23
V
Ванадий
Vanadio
Vanad
Vanadium
Vanadium
Vanaadium
Βανάδιο
Vanadium
Vanadium
Vanadio
Vanādijs

24
Cr
Хром
Cromo
Chrom
Chrom
Chrom
Kroom
Χρώμιο
Chromium
Chrome
Cromo
Hroms

25
Mn
Манган
Manganeso
Mangan
Mangan
Mangan
Mangaan
Μαγγάνιο
Manganese
Manganèse
Manganese
Mangāns

26
Fe
Желязо
Hierro
Železo
Jern
Eisen
Raud
Σίδηρος
Iron
Fer
Ferro
Dzelzs

27
Co
Кобалт
Cobalto
Kobalt
Cobalt
Kobalt
Koobalt
Κοβάλτιο
Cobalt
Cobalt
Cobalto
Kobalts

28
Ni
Никел
Níquel
Nikl
Nikkel
Nickel
Nikkel
Νικέλιο
Nickel
Nickel
Nichel
Niķelis

29
Cu
Мед
Cobre
Měď
Kobber
Kupfer
Vask
Χαλκός
Copper
Cuivre
Rame
Varš

30
Zn
Цинк
Zinc
Zinek
Zink
Zink
Tsink
Ψευδάργυρος
Zinc
Zinc
Zinco
Cinks

31
Ga
Галий
Galio
Gallium
Gallium
Gallium
Gallium
Γάλλιο
Gallium
Gallium
Gallio
Gallijs

32
Ge
Германий
Germanio
Germanium
Germanium
Germanium
Germaanium
Γερμάνιο
Germanium
Germanium
Germanio
Germānijs

33
As
Арсен
Arsénico
Arsen
Arsen
Arsen
Arseen
Αρσενικό
Arsenic
Arsenic
Arsenico
Arsēns

34
Se
Селен
Selenio
Selen
Selen
Selen
Seleen
Σελήνιο
Selenium
Sélénium
Selenio
Selēns

35
Br
Бром
Bromo
Brom
Brom
Brom
Broom
Βρώμιο
Bromine
Brome
Bromo
Broms

36
Kr
Криптон
Criptón
Krypton
Krypton
Krypton
Krüptoon
Κρυπτό
Krypton
Krypton
Krypton
Kriptons

37
Rb
Рубидий
Rubidio
Rubidium
Rubidium
Rubidium
Rubiidium
Ρουβήδιο
Rubidium
Rubidium
Rubidio
Rubīdijs

38
Sr
Стронций
Estroncio
Stroncium
Strontium
Strontium
Strontsium
Στρόντιο
Strontium
Strontium
Stronzio
Stroncijs

39
Y
Итрий
Itrio
Yttrium
Yttrium
Yttrium
Ütrium
Ύττριο
Yttrium
Yttrium
Ittrio
Itrijs

40
Zr
Цирконий
Circonio
Zirkonium
Zirconium
Zirkon
Tsirkoonium
Ζιρκόνιο
Zirconium
Zirconium
Zirconio
Cirkonijs

41
Nb
Ниобий
Niobio
Niob
Niobium
Niob
Nioobium
Νιόβιο
Niobium
Niobium
Niobio
Niobijs

42
Mo
Молибден
Molibdeno
Molybden
Molybden
Molybdän
Molübdeen
Μολυβδένιο
Molybdenum
Molybdène
Molibdeno
Molibdēns

43
Tc
Технеций
Tecnecio
Technecium
Technetium
Technetium
Tehneetsium
Τεχνήτιο
Technetium
Technetium
Tecnezio
Tehnēcijs

44
Ru
Рутений
Rutenio
Ruthenium
Ruthenium
Ruthenium
Ruteenium
Ρουθήνιο
Ruthenium
Ruthénium
Rutenio
Rutēnijs

45
Rh
Родий
Rodio
Rhodium
Rhodium
Rhodium
Roodium
Ρόδιο
Rhodium
Rhodium
Rodio
Rodijs

46
Pd
Паладий
Paladio
Palladium
Palladium
Palladium
Pallaadium
Παλλάδιο
Palladium
Palladium
Palladio
Pallādijs

47
Ag
Сребро
Plata
Stříbro
Sølv
Silber
Hõbe
Άργυρος
Silver
Argent
Argento
Sudrabs

48
Cd
Кадмий
Cadmio
Kadmium
Cadmium
Cadmium
Kaadium
Κάδμιο
Cadmium
Cadmium
Cadmio
Kadmijs

49
In
Индий
Indio
Indium
Indium
Indium
Indium
Ίνδιο
Indium
Indium
Indio
Indijs

50
Sn
Калай
Estaño
Cín
Tin
Zinn
Tina
Κασσίτερος
Tin
Étain
Stagno
Alva

51
Sb
Антимон
Antimonio
Antimon
Antimon
Antimon
Antimon
Αντιμόνιο
Antimony
Antimoine
Antimonio
Antimons

52
Te
Телур
Telurio
Tellur
Telur
Tellur
Telluur
Τελλούριο
Tellurium
Tellure
Tellurio
Telūrs

53
I
Йод
Yodo
Jod
Jod
Jod
Jood
Ιώδιο
Iodine
Iode
Iodio
Jods

54
Xe
Ксенон
Xenón
Xenon
Xenon
Xenon
Ksenoon
Ξένο
Xenon
Xénon
Xenon
Ksenons

55
Cs
Цезий
Cesio
Cesium
Cæsium
Caesium
Tseesium
Καίσιο
Caesium
Césium
Cesio
Cēzijs

56
Ba
Барий
Bario
Baryum
Barium
Barium
Baarium
Βάριο
Barium
Baryum
Bario
Bārijs

57
La
Лантан
Lantano
Lanthan
Lanthan
Lanthan
Lantaan
Λανδάνιο
Lanthanum
Lanthane
Lantanio
Lantāns

58
Ce
Церий
Cerio
Cer
Cerium
Cer
Tseerium
Δημήτριο
Cerium
Cérium
Cerio
Cērijs

59
Pr
Празеодим
Praseodimio
Praseodym
Praseodym
Praseodym
Praseodüüm
Πρασεοδύμιο
Praseodymium
Praséodyme
Praseodimio
Prazeodīms

60
Nd
Неодим
Niodimio
Neodym
Neodym
Neodym
Neodüüm
Νεοδύμιο
Neodymium
Néodyme
Neodimio
Neodīms

61
Pm
Прометий
Prometio
Promethium
Promethium
Promethium
Promeetium
Προμήθειο
Promethium
Prométhium
Promezio
Prometijs

62
Sm
Самарий
Samario
Samarium
Samarium
Samarium
Samaarium
Σαμάριο
Samarium
Samarium
Samario
Samārijs

63
Eu
Европий
Europio
Europium
Europium
Europium
Euroopium
Ευρώπιο
Europium
Europium
Europio
Eiropijs

64
Gd
Гадолиний
Gadolinio
Gadolinium
Gadolinium
Gadolinium
Gadoliinium
Γαδολίνιο
Gadolinium
Gadolinium
Gadolinio
Gadolīnijs

65
Tb
Тербий
Terbio
Terbium
Terbium
Terbium
Terbium
Τέρβιο
Terbium
Terbium
Terbio
Terbijs

66
Dy
Диспросий
Disprosio
Dysprosium
Dysprosium
Dysprosium
Düsproosium
Δυσπρόσιο
Dysprosium
Dysprosium
Disprosio
Disprozijs

67
Ho
Холмий
Holmio
Holmium
Holmium
Holmium
Holmium
Όλμιο
Holmium
Holmium
Olmio
Holmijs

68
Er
Ербий
Erbio
Erbium
Erbium
Erbium
Erbium
Έρβιο
Erbium
Erbium
Erbio
Erbijs

69
Tm
Тулий
Tulio
Thulium
Thulium
Thulium
Tuulium
Θούλιο
Thulium
Thulium
Tulio
Tūlijs

70
Yb
Итербий
Iterbio
Ytterbium
Ytterbium
Ytterbium
Üterbium
Υττέρβιο
Ytterbium
Ytterbium
Itterbio
Iterbijs

71
Lu
Лютеций
Lutecio
Lutecium
Lutetium
Lvtécium
Luteetsium
Λουτήτιο
Lutetium
Lutécium
Lutezio
Lutēcijs

72
Hf
Хафний
Hafnio
Hafnium
Hafnium
Hafnium
Hafnium
Άφνιο
Hafnium
Hafnium
Afnio
Hafnijs

73
Ta
Тантал
Tántalo
Tantal
Tantal
Tantal
Tantaal
Ταντάλιο
Tantalum
Tantale
Tantalio
Tantāls

74
W
Волфрам
Volframio
Wolfram
Wolfram
Wolfram
Volfram
Βολφράμιο(Τουγκοτένιο)
Tungsten
Tungstène
Tungsteno
Volframs

75
Re
Рений
Renio
Rhenium
Rhenium
Rhenium
Reenium
Ρήνιο
Rhenium
Rhénium
Renio
Rēnijs

76
Os
Осмий
Osmio
Osmium
Osmium
Osmium
Osmium
Όσμιο
Osmium
Osmium
Osmio
Osmijs

77
Ir
Иридий
Iridio
Iridium
Iridium
Iridium
Iriidium
Ιρίδιο
Iridium
Iridium
Iridio
Irīdijs

78
Pt
Платина
Platino
Platina
Platin
Platin
Plaatina
Λευκόχρυσος
Platinum
Platine
Platino
Platīns

79
Au
Злато
Oro
Zlato
Guld
Gold
Kuld
Χρυσός
Gold
Or
Oro
Zelts

80
Hg
Живак
Mercurio
Rtuť
Kviksølv
Quecksilber
Elavhõbe
Υδράργυρος
Mercury
Mercure
Mercurio
Dzīvsudrabs

81
Tl
Талий
Talio
Thallium
Thalium
Thallium
Tallium
Θάλλιο
Thallium
Thallium
Tallio
Tallijs

82
Pb
Олово
Plomo
Olovo
Bly
Blei
Plii
Μόλυβδος
Lead
Plomb
Piombo
Svins

83
Bi
Бисмут
Bismuto
Bismut
Bismuth
Wismuth
Vismut
Βισμούθιο
Bismuth
Bismuth
Bismuto
Bismuts

84
Po
Полоний
Polonio
Polonium
Plonium
Polonium
Poloonium
Πολώνιο
Polonium
Polonium
Polonio
Polonijs

85
At
Астат
Astato
Astat
Astat
Astat
Astaat
Αστάτιο
Astatine
Astate
Astato
Astats

86
Rn
Радон
Radón
Radon
Radon
Radon
Radoon
Ραδόνιο
Radon
Radon
Radon
Radons

87
Fr
Франций
Francio
Francium
Francium
Francium
Frantsium
Φράγκιο
Francium
Francium
Francio
Francijs

88
Ra
Радий
Radio
Radium
Radium
Radium
Raadium
Ράδιο
Radium
Radium
Radio
Rādijs

89
Ac
Актиний
Actinio
Aktinium
Actinium
Actinium
Aktiinium
Ακτίνιο
Actinium
Actinium
Attinio
Aktīnijs

90
Th
Торий
Torio
Thorium
Thorium
Thorium
Toorium
Θόριο
Thorium
Thorium
Torio
Torijs

91
Pa
Протактиний
Protactinio
Protaktinium
Protactinium
Protactinium
Protaktiinium
Πρωτακτίνιο
Protactinium
Protactinium
Protoattinio
Protaktīnijs

92
U
Уран
Uranio
Uran
Uran
Uran
Uraan
Ουράνιο
Uranium
Uranium
Uranio
Urāns

93
Np
Нептуний
Neptunio
Neptunium
Neptunium
Neptunium
Neptuunium
Νεπτούνιο(Ποσειδώνιο)
Neptunium
Neptunium
Nettunio
Neptūnijs

94
Pu
Плутоний
Plutonio
Plutonium
Plutonium
Plutonium
Plutoonium
Πλουτώνιο
Plutonium
Plutonium
Plutonio
Plutonijs

95
Am
Америций
Americio
Americium
Americium
Americium
Ameriitsium
Αμερίκιο
Americium
Américium
Americio
Amerīcijs

96
Cm
Кюрий
Curio
Curium
Curium
Curium
Kuurium
Κιούριο
Curium
Curium
Curio
Kirijs

97
Bk
Берклий
Berkelio
Berkelium
Berkelium
Berkelium
Berkeelium
Μπερκέλιο
Berkelium
Berkélium
Berkelio
Berklijs

98
Cf
Калифорний
Californio
Kalifornium
Californium
Californium
Kalifornium
Καλιφόρνιο
Californium
Californium
Californio
Kalifornijs

99
Es
Айнщайний
Einstenio
Einsteinium
Einsteinium
Einsteinium
Einsteinium
Αϊνστάνιον
Einsteinium
Einsteinium
Einstenio
Einšteinijs

100
Fm
Фермий
Fermio
Fermium
Fermium
Fermium
Fermium
Φέρμιο
Fermium
Fermium
Fermio
Fermijs

101
Md
Менделеевий
Mendelevio
Mendelevium
Mendelevium
Mendelevium
Mendeleevium
Μεντελέβιο
Mendelevium
Mendélévium
Mendelevio
Mendeļejevijs

102
No
Нобелий
Nobelio
Nobelium
Nobelium
Nobelium
Nobeelium
Νομπέλιο
Nobelium
Nobélium
Nobelio
Nobēlijs

103
Lw
Лоуренсий
Laurencio
Lawrencium
Lawrentium
Lawrentium
Lavrentsium
Λαυρένσιο
Lawrencium
Lawrencium
Lawrencio
Lourensijs



Z
Symbol
LT
HU
MT
NL
PL
PT
RO
SK
SL
FI
SV

1
H
Vandenilis
Hidrogén
Idroġenu
Waterstof
Wodór
Hidrogénio
Hidrogen
Vodík
Vodik
Vety
Väte

2
He
Helis
Hélium
Elju
Helium
Hel
Hélio
Heliu
Hélium
Helij
Helium
Helium

3
Li
Litis
Lítium
Litju
Lithium
Lit
Lítio
Litiu
Lítium
Litij
Litium
Litium

4
Be
Berilis
Berillium
Berillju
Beryllium
Beryl
Berílio
Beriliu
Berýlium
Berilij
Beryllium
Beryllium

5
B
Boras
Bór
Boron
Boor
Bor
Boro
Bor
Bór
Bor
Boori
Bor

6
C
Anglis
Szén
Karbonju
Koolstof
Węgiel
Carbono
Carbon
Uhlík
Ogljik
Hiili
Kol

7
N
Azotas
Nitrogén
Azotu
Stikstof
Azot
Azoto
Azot
Dusík
Dušik
Typpi
Kväve

8
O
Deguonis
Oxigén
Ossiġenu
Zuurstof
Tlen
Oxigénio
Oxigen
Kyslík
Kisik
Happi
Syre

9
F
Fluoras
Fluor
Fluworin
Fluor
Fluor
Flúor
Fluor
Fluór
Fluor
Fluori
Fluor

10
Ne
Neonas
Neon
Neon
Neon
Neon
Néon
Neon
Neón
Neon
Neon
Neon

11
Na
Natris
Nátrium
Sodju
Natrium
Sód
Sódio
Sodiu
Sodík
Natrij
Natrium
Natrium

12
Mg
Magnis
Magnézium
Manjesju
Magnesium
Magnez
Magnésio
Magneziu
Horčík
Magnezij
Magnesium
Magnesium

13
Al
Aliuminis
Alumínium
Aluminju
Aluminium
Glin
Alumínio
Aluminiu
Hliník
Aluminij
Alumiini
Aluminium

14
Si
Silicis
Szilicium
Silikon
Silicium
Krzem
Silício
Siliciu
Kremík
Silicij
Pii
Kisel

15
P
Fosforas
Foszfor
Fosfru
Fosfor
Fosfor
Fósforo
Fosfor
Fosfor
Fosfor
Fosfori
Fosfor

16
S
Siera
Kén
Kubrit
Zwavel
Siarka
Enxofre
Sulf
Síra
Žveplo
Rikki
Svavel

17
Cl
Chloras
Klór
Kloru
Chloor
Chlor
Cloro
Clor
Chlór
Klor
Kloori
Klor

18
Ar
Argonas
Argon
Argon
Argon
Argon
Árgon
Argon
Argón
Argon
Argon
Argon

19
K
Kalis
Kálium
Potassju
Kalium
Potas
Potássio
Potasiu
Draslík
Kalij
Kalium
Kalium

20
Ca
Kalcis
Kalcium
Kalċju
Calcium
Wapń
Cálcio
Calciu
Vápnik
Kalcij
Kalsium
Kalcium

21
Sc
Skandis
Szkandium
Skandju
Scandium
Skand
Escândio
Scandiu
Skandium
Skandij
Skandium
Skandium

22
Ti
Titanas
Titán
Titanju
Titaan
Tytan
Titânio
Titan
Titán
Titan
Titaani
Titan

23
V
Vanadis
Vanádium
Vanadju
Vanadium
Wanad
Vanádio
Vanadiu
Vanád
Vanadij
Vanadiini
Vanadin

24
Cr
Chromas
Króm
Kromju
Chroom
Chrom
Crómio
Crom
Chróm
Krom
Kromi
Krom

25
Mn
Manganas
Mangán
Manganiż
Mangaan
Mangan
Manganês
Mangan
Mangán
Mangan
Mangaani
Mangan

26
Fe
Geležis
Vas
Ħadid
Ijzer
Żelazo
Ferro
Fier
Železo
Železo
Rauta
Järn

27
Co
Kobaltas
Kobalt
Kobalt
Kobalt
Kobalt
Cobalto
Cobalt
Kobalt
Kobalt
Koboltti
Kobolt

28
Ni
Nikelis
Nikkel
Nikil
Nikkel
Nikiel
Níquel
Nichel
Nikel
Nikelj
Nikkeli
Nickel

29
Cu
Varis
Réz
Ram
Koper
Miedź
Cobre
Cupru
Meď
Baker
Kupari
Koppar

30
Zn
Cinkas
Cink
Żingu
Zìnk
Cynk
Zinco
Zinc
Zinok
Cink
Sinkki
Zink

31
Ga
Galis
Gallium
Gallju
Gallium
Gal
Gálio
Galiu
Gálium
Galij
Gallium
Gallium

32
Ge
Germanis
Germánium
Ġermanju
Germanium
German
Germânio
Germaniu
Germánium
Germanij
Germanium
Germanium

33
As
Arsenas
Arzén
Arseniku
Arseen
Arsen
Arsénio
Arsen
Arzén
Arzen
Arseeni
Arsenik

34
Se
Selenas
Szelén
Selenju
Selenium
Selen
Selénio
Seleniu
Selén
Selen
Seleeni
Selen

35
Br
Bromas
Bróm
Bromu
Broom
Brom
Bromo
Brom
Bróm
Brom
Bromi
Brom

36
Kr
Kriptonas
Kripton
Kripton
Krypton
Krypton
Krípton
Kripton
Kryptón
Kripton
Krypton
Krypton

37
Rb
Rubidis
Rubídium
Rubidju
Rubidium
Rubid
Rubídio
Rubidiu
Rubídium
Rubidij
Rubidium
Rubidium

38
Sr
Stroncis
Stroncium
Stronzju
Strontium
Stront
Estrôncio
Stronţiu
Stroncium
Stroncij
Strontium
Strontium

39
Y
Itris
Ittrium
Ittriju
Yttrium
Itr
Ítrio
Ytriu
Ytrium
Itrij
Yttrium
Yttrium

40
Zr
Cirkonis
Cirkónium
Żirkonju
Zirkonium
Cyrkon
Zircónio
Zirconiu
Zirkónium
Cirkonij
Zirkonium
Zirkonium

41
Nb
Niobis
Nióbium
Nijobju
Niobium
Niob
Nióbio
Niobiu
Niób
Niobij
Niobium
Niob

42
Mo
Molibdenas
Molibdén
Molibdenu
Molybdeen
Molibden
Molibdénio
Molibden
Molybdén
Molibden
Molybdeeni
Molybden

43
Tc
Technecis
Technécium
Teknezju
Technetium
Technet
Tecnécio
Tehneţiu
Technécium
Tehnecij
Teknetium
Teknetium

44
Ru
Rutenis
Ruténium
Rutenju
Ruthernium
Ruten
Ruténio
Ruteniu
Ruténium
Rutenij
Rutenium
Rutenium

45
Rh
Rodis
Ródium
Rodju
Rodium
Rod
Ródio
Rodiu
Ródium
Rodij
Rodium
Rodium

46
Pd
Paladis
Palládium
Palladju
Palladium
Pallad
Paládio
Paladiu
Paládium
Paladij
Palladium
Palladium

47
Ag
Sidabras
Ezüst
Fidda
Zilver
Srebro
Prata
Argint
Striebro
Srebro
Hopea
Silver

48
Cd
Kadmis
Kadmium
Kadmju
Cadmium
Kadm
Cádmio
Cadmiu
Kadmium
Kadmij
Kadmium
Kadmium

49
In
Indis
Indium
Indju
Indium
Ind
Índio
Indiu
Indium
Indij
Indium
Indium

50
Sn
Alavas
Ón
Landa
Tin
Cyna
Estanho
Staniu
Cín
Kositer
Tina
Tenn

51
Sb
Stibis
Antimon
Antimonju
Antimoon
Antymon
Antimónio
Stibiu
Antimón
Antimon
Antimoni
Antimon

52
Te
Telūras
Tellúr
Tellurju
Telluur
Tellur
Telúrio
Telur
Telúr
Telur
Telluuri
Tellur

53
I
Jodas
Jód
Jodju
Jood
Jod
Iodo
Iod
Jód
Jod
Jodi
Jod

54
Xe
Ksenonas
Xenon
Kseno
Xenon
Ksenon
Xénon
Xenon
Xenón
Ksenon
Ksenon
Xenon

55
Cs
Cezis
Cézium
Ċesju
Cesium
Cez
Césio
Cesiu
Césium
Cezij
Cesium
Cesium

56
Ba
Baris
Bárium
Barju
Barium
Bar
Bário
Bariu
Bárium
Barij
Barium
Barium

57
La
Lantanas
Lantán
Lantanu
Lanthaan
Lantan
Lantânio
Lantan
Lantán
Lantan
Lantaani
Lantan

58
Ce
Ceris
Cérium
Ċerju
Cerium
Cer
Cério
Ceriu
Cér
Cerij
Cerium
Cerium

59
Pr
Prazeodimis
Prazeodímium
Prasedimju
Praseodymium
Prazeodym
Praseodímio
Praseodim
Prazeodým
Prazeodim
Praseodyymi
Praseodym

60
Nd
Neodimis
Neodímium
Neodimju
Neodymium
Neodym
Neodímio
Neodim
Neodým
Neodim
Neodyymi
Neodym

61
Pm
Prometis
Prométium
Prometju
Promethium
Promet
Promécio
Promeţiu
Prométium
Prometij
Prometium
Prometium

62
Sm
Samaris
Szamárium
Samarju
Samarium
Samar
Samário
Samariu
Samárium
Samarij
Samarium
Samarium

63
Eu
Europis
Európium
Ewropju
Europium
Europ
Európio
Europiu
Európium
Evropij
Europium
Europium

64
Gd
Gadolinis
Gadolínium
Gadolinju
Gadolinium
Gadolin
Gadolínio
Gadoliniu
Gadolínium
Gadolinij
Gadolinium
Gadolinium

65
Tb
Terbis
Terbium
Terbju
Terbium
Terb
Térbio
Terbiu
Terbium
Terbij
Terbium
Terbium

66
Dy
Disprozis
Diszprózium
Disprosju
Dysprosium
Dysproz
Disprósio
Dysprosiu
Dysprózium
Disprozij
Dysprosium
Dysprosium

67
Ho
Holmis
Holmium
Olmju
Holmium
Holm
Hólmio
Holmiu
Holmium
Holmij
Holmium
Holmium

68
Er
Erbis
Erbium
Erbju
Erbium
Erb
Érbio
Erbiu
Erbium
Erbij
Erbium
Erbium

69
Tm
Tulis
Túlium
Tulju
Thulium
Tul
Túlio
Tuliu
Túlium
Tulij
Tulium
Tulium

70
Yb
Iterbis
Itterbium
Itterbju
Ytterbium
Iterb
Itérbio
Yterbiu
Yterbium
Iterbij
Ytterbium
Ytterbium

71
Lu
Liutecis
Lutécium
Lutezju
Lutetium
Lutet
Lutécio
Luteţiu
Lutécium
Lutecij
Lutetium
Lutetium

72
Hf
Hafnis
Hafnium
Ħafnju
Hafnium
Hafn
Háfnio
Hafniu
Hafnium
Hafnij
Hafnium
Hafnium

73
Ta
Tantalas
Tantál
Tantalu
Tantaal
Tantal
Tântalo
Tantal
Tantal
Tantal
Tantaali
Tantal

74
W
Volframas
Volfrám
Tungstenu
Wolfram
Wolfram
Tungsténio
Wolfram
Volfrám
Volfram
Volframi
Wolfram

75
Re
Renis
Rénium
Rênju
Renium
Ren
Rénio
Reniu
Rénium
Renij
Renium
Rhenium

76
Os
Osmis
Ozmium
Osmju
Osmium
Osm
Ósmio
Osmiu
Osmium
Osmij
Osmium
Osmium

77
Ir
Iridis
Irídium
Iridju
Iridium
Iryd
Irídio
Iridiu
Irídium
Iridij
Iridium
Iridium

78
Pt
Platina
Platina
Platinu
Platinum
Platyna
Platina
Platina
Platina
Platina
Platina
Platina

79
Au
Auksas
Arany
Deheb
Goud
Złoto
Ouro
Aur
Zlato
Zlato
Kulta
Guld

80
Hg
Gyvsidabris
Higany
Merkurju
Kwik
Rtęć
Mercúrio
Mercur
Ortuť
Živo srebro
Elohopea
Kvicksilver

81
Tl
Talis
Tallium
Tallju
Thallium
Tal
Tálio
Taliu
Tálium
Talij
Tallium
Tallium

82
Pb
Švinas
Ólom
Ċomb
Lood
Ołów
Chumbo
Plumb
Olovo
Svinec
Lyijy
Bly

83
Bi
Bismutas
Bizmut
Bismùt
Bismuth
Bizmut
Bismuto
Bismut
Bizmut
Bizmut
Vismutti
Vismut

84
Po
Polonis
Polónium
Polonju
Polonium
Polon
Polónio
Poloniu
Polónium
Polonij
Polonium
Polonium

85
At
Astatinas
Asztácium
Astatina
Astaat
Astat
Astato
Astatiniu
Astát
Astat
Astatiini
Astat

86
Rn
Radonas
Radon
Radon
Radon
Radon
Rádon
Radon
Radón
Radon
Radon
Radon

87
Fr
Francis
Francium
Franċju
Francium
Frans
Frâncio
Franciu
Francium
Francij
Frankium
Francium

88
Ra
Radis
Rádium
Radju
Radium
Rad
Rádio
Radiu
Rádium
Radij
Radium
Radium

89
Ac
Aktinis
Aktínium
Aktinju
Actinium
Aktyn
Actínio
Actiniu
Aktínium
Aktinij
Aktinium
Aktinium

90
Th
Toris
Tórium
Torju
Thorium
Tor
Tório
Toriu
Tórium
Torij
Torium
Torium

91
Pa
Protaktinis
Protaktínium
Protaktinju
Protactinium
Protaktyn
Protactínio
Proactiniu
Protaktínium
Protaktinij
Protaktinium
Protaktinium

92
U
Uranas
Urán
Uranju
Uranium
Uran
Urânio
Uraniu
Urán
Uran
Uraani
Uran

93
Np
Neptūnis
Neptúnium
Nettunju
Neptunium
Neptun
Neptúnio
Neptuniu
Neptúnium
Neptunij
Neptunium
Neptunium

94
Pu
Plutonis
Plutónium
Plutonju
Plutonium
Pluton
Plutónio
Plutoniu
Plutónium
Plutonij
Plutonium
Plutonium

95
Am
Americis
Amerícium
Ameriċju
Americium
Ameryk
Amerício
Americiu
Amerícium
Americij
Amerikium
Americium

96
Cm
Kiuris
Kűrium
Kurju
Curium
Kiur
Cúrio
Curiu
Curium
Kirij
Curium
Curium

97
Bk
Berklis
Berkélium
Berkelju
Berkelium
Berkel
Berquélio
Berkeliu
Berkelium
Berkelij
Berkelium
Berkelium

98
Cf
Kalifornis
Kalifornium
Kalifornju
Californium
Kaliforn
Califórnio
Californiu
Kalifornium
Kalifornij
Kalifornium
Californium

99
Es
Einšteinis
Einsteinium
Enstejnju
Einsteinium
Einstein
Einsteinio
Einsteiniu
Einsteinium
Ajnštajnij
Einsteinium
Einsteinium

100
Fm
Fermis
Fermium
Fermju
Fermium
Ferm
Férmio
Fermiu
Fermium
Fermij
Fermium
Fermium

101
Md
Mendelevis
Mendelévium
Mendelevju
Mendelevium
Mendelew
Mendelévio
Mendeleeviu
Mendelevium
Mendelevij
Mendelevium
Mendelevium

102
No
Nobelis
Nobélium
Nobelju
Nobelium
Nobel
Nobélio
Nobeliu
Nobelium
Nobelij
Nobelium
Nobelium

103
Lw
Lorensis
Laurencium
Lawrenċju
Laurentium
Lorens
Laurêncio
Laurenţiu
Laurencium
Lavrencij
Lawrensium
Lawrentium’



(b)
Table B in the foreword to Annex I is replaced by the following:‘ТАБЛИЦА Б — TABLA B — TABULKA B — TABEL B — TABELLE B — TABEL B — ΠΙΝΑΚΑΣ B — TABLE B — TABLEAU B — TABELLA B — B TABULA — B LENTELĖ — B. TÁBLÁZAT — TABELLA B — TABEL B — TABELA B — TABELA B — TABEL B — TABUĽKA B — TABELA B — TAULUKKO B — TABELL BСпециална класификация на органичните веществаClasificación especial para las sustancias orgánicasSpeciální třídy organických látekSærlig inddeling af organiske stofferSpezielle Anordnung für die organischen StoffeSpetsiaalne orgaaniliste ainete klassifikatsioon'Ειδική ταξινόμηση των οργανικών ουσιώνSpecial classification for organic substancesClassification particulière aux substances organiquesClassificazione speciale per le sostanze organicheOrganisko ķīmisko vielu grupasSpeciali organinių medžiagų klasifikacijaSzerves anyagok speciális osztályozásaKlassifikazzjoni speċjali għal sustanzi organiċiSpeciale indeling voor de organische stoffenNumery klas substancji organicznychClassificação especial para as substâncias orgânicasClasificare specifică pentru substanţele organicePrehľadná klasifikácia organických látokPosebna razvrstitev organskih spojinErityisryhmät orgaanisille aineilleSärskild indelning av organiska ämnen601ВъглеводородиHidrocarburosUhlovodíkyCarbonhydrider (kulbrinter)KohlenwasserstoffeSüsivesinikudΥδρογονάνθρακεςHydrocarbonsHydrocarburesIdrocarburiOgļūdeņražiAngliavandeniliaiSzénhidrogénekIdrokarburiKoolwaterstoffenWęglowodoryHidrocarbonetosHidrocarburiUhľovodíkyOgljikovodikiHiilivedytKolväten602Халогенирани въглеводородиHidrocarburos halogenadosHalogenované uhlovodíkyHalogensubstituerede carbonhydriderHalogen-KohlenwasserstoffeHalogeenitud süsivesinikudΑλογονοπαράγωγα υδρογονανθράκωνHalogenated hydrocarbonsDérivés halogénés des hydrocarburesDerivati idrocarburi alogenatiHalogenētie ogļūdeņražiHalogeninti angliavandeniliaiHalogénezett szénhidrogénekIdrokarburi aloġenatiGehalogeneerde koolwaterstoffenHalogenowe pochodne węglowodorówHidrocarbonetos halogenadosDerivaţi halogenaţi ai hidrocarburilorHalogénované uhľovodíkyHalogenirani ogljikovodikiHalogenoidut hiilivedytHalogenerade kolväten603Алкохоли и техните производниAlcoholes y derivadosAlkoholy a jejich derivátyAlkoholer og deres derivaterAlkohole und ihre DerivateAlkoholid ja nende derivaadidΑλκοόλες και παράγωγά τουςAlcohols and their derivativesAlcools et dérivésAlcoli e derivatiSpirti un to atvasinājumiAlkoholiai ir jų dariniaiAlkoholok és származékaikAlkoħoliċi u derivatiAlcoholen en derivatenAlkohole i ich pochodneÁlcoois e derivadosAlcooli şi derivaţii lorAlkoholy a ich derivátyAlkoholi in njihovi derivatiAlkoholit ja niiden johdannaisetAlkoholer och deras derivat604Феноли и техните производниFenoles y derivadosFenoly a jejich derivátyPhenoler og deres derivaterPhenole und ihre DerivateFenoolid ja nende derivaadidΦαινόλες και παράγωγά τουςPhenols and their derivativesPhénols et dérivésFenoli e derivatiFenoli un to atvasinājumiFenoliai ir jų dariniaiFenolok és származékaikFenoli u derivatiFenolen en derivatenFenole i ich pochodneFenóis e derivadosFenoli şi derivaţii lorFenoly a ich derivátyFenoli in njihovi derivatiFenolit ja niiden johdannaisetFenoler och deras derivat605Алдехиди и техните производниAldehídos y derivadosAldehydy a jejich derivátyAldehyder og deres derivaterAldehyde und ihre DerivateAldehüüdid ja nende derivaadidΑλδεΰδες και παράγωγά τουςAldehydes and their derivativesAldéhydes et dérivésAldeidi e derivatiAldehīdi un to atvasinājumiAldehidai ir jų dariniaiAldehidek és származékaikAldeidi u derivatiAldehyden en derivatenAldehydy i ich pochodneAldeidos e derivadosAldehide şi derivaţii lorAldehydy a ich derivátyAldehidi in njihovi derivatiAldehydit ja niiden johdannaisetAldehyder och deras derivat606Кетони и техните производниCetonas y derivadosKetony a jejich derivátyKetoner og deres derivaterKetone und ihre DerivateKetoonid ja nende derivaadidΚετόνες και παράγωγά τουςKetones and their derivativesCétones et dérivésChetoni e derivatiKetoni un to atvasinājumiKetonai ir jų dariniaiKetonok és származékaikKeton u derivatiKetonen en derivatenKetony i ich pochodneCetonas e derivadosCetone şi derivaţii lorKetóny a ich derivátyKetoni in njihovi derivatiKetonit ja niiden johdannaisetKetoner och deras derivat607Органични киселини и техните производниÁcidos orgánicos y derivadosOrganické kyseliny a jejich derivátyOrganiske syrer og deres derivaterOrganische Säuren und ihre DerivateOrgaanilised happed ja nende derivaadidΟργανικά οξέα και παράγωγά τουςOrganic acids and their derivativesAcides organiques et dérivésAcidi organici e derivatiOrganiskās skābes un to atvasinājumiOrganinės rūgštys ir jų dariniaiSzerves savak és származékaikAċidi organiċi u derivatiOrganische zuren en derivatenKwasy organiczne i ich pochodneÁcidos orgânicos e derivadosAcizi organici şi derivaţii lorOrganické kyseliny a ich derivátyOrganske kisline in njihovi derivatiOrgaaniset hapot ja niiden johdannaisetOrganiska syror och deras derivat608НитрилиNitrilosNitrilyNitrilerNitrileNitriilidΝιτρίλιαNitrilesNitrilesNitriliNitrilsavienojumi un to atvasinājumiNitrilaiNitrilekNitriliNitrillenNitryleNitrilosNitriliNitrilyNitriliNitriilitNitriler609НитросъединенияDerivados nitradosNitrosloučeninyNitroforbindelserNitroverbindungenNitroühendidΝιτροενώσειςNitro compoundsDérivés nitrésNitroderivatiNitrosavienojumiNitrojunginiaiNitrovegyületekKomposti tan-nitruNitroverbindingenNitrozwiązkiDerivados nitradosNitro-derivaţiNitrozlúčeninyNitro spojineNitroyhdisteetKväveföreningar610ХлоронитросъединенияDerivados cloronitradosChlorované nitrosloučeninyChlornitroforbindelserChlornitroverbindungenKloronitroühendidΧλωρονιτροενώσειςChloronitro compoundsDérivés chloronitrésCloronitro derivatiHlornitrosavienojumiChlornitrojunginiaiKlór-nitrovegyületekKomposti tal-kloronitruChloornitroverbindingenChloronitrozwiązkiDerivados cloronitradosClor- nitro-derivaţiChlórované nitrozlúčeninyKloro-nitro spojineKloorinitroyhdisteetKlornitroföreningar611Азокси- и азосъединенияDerivados azoicos y azoxiAzoxysloučeniny a azosloučeninyAzoxy- og azoforbindelserAzoxy- und AzoverbindungenAsoksü- ja asoühendidΆζωξυ- και άζω-ενώσειςAzoxy- and azo compoundsDérivés azoxy et azoïquesAzossi- e azoderivatiAzoksisavienojumi un azosavienojumiAzoksijunginiai ir azojunginiaiAzoxi és azo-vegyületekKomposti ta' l-azossi u ta' l-azoAzoxy- en azoverbindingenAzoksy- i azozwiązkiDerivados azoxi e azóicosAzoxi- şi azo-derivaţiAzoxyzlúčeniny a azozlúčeninyAzoksi in azo spojineAtsoksi- ja atsoyhdisteetAzoxi- och azoföreningar612АминосъединенияDerivados aminadosAminosloučeninyAminerAminoverbindungenAmiinühendidΑμινοενώσειςAmine compoundsDérivés aminésAminoderivatiAminosavienojumiAminojunginiaiAmin vegyületekKomposti ta' l-aminoAminoverbindingenAminozwiązkiDerivados aminadosAmino-derivaţiAminozlúčeninyAmino spojineAmiiniyhdisteetAminer613Хетероциклени основи и техните производниBases heterocíclicas y derivadosHeterocyklické báze a jejich derivátyHeterocykliske baser og deres derivaterHeterocyclische Basen und ihre DerivateHeterotsüklilised alused ja nende derivaadidΕτεροκυκλικές βάσεις και παράγωγά τουςHeterocyclic bases and their derivativesBases hétérocycliques et dérivésBasi eterocicliche e derivatiHeterocikliskie savienojumi un to atvasinājumiHeterociklinės bazės ir jų dariniaiHeterociklusos bázisok és származékaikBażijiet eteroċikliċi u derivatiHeterocyclische basen en hun derivatenZasady heterocykliczne i ich pochodneBases heterocíclicas e derivadosBaze heterociclice şi derivaţii lorHeterocyklické bázy a ich derivátyHeterociklične baze in njihovi derivatiHeterosykliset emäkset ja niiden johdannaisetHeterocykliska baser och deras derivat614Глюкозиди и алкалоидиGlucósidos y alcaloidesGlykosidy a alkaloidyGlycosider og alkaloiderGlycoside und AlkaloideGlükosiidid ja alkaloididΓλυκοζίτες και αλκαλοειδήGlycosides and alkaloidsGlucosides et alcaloïdesGlucosidi e alcaloidiGlikozīdi un alkaloīdiGlikozidai ir alkaloidaiGlikozidok és alkaloidokGlukosidi u alkalojdiGlycosiden en alkaloïdenGlikozydy i alkaloidyGlicósidos e alcalóidesGlicozide şi alcaloiziGlykozidy a alkaloidyGlikozidi in alkaloidiGlykosidit ja alkaloiditGlykosider och alkaloider615Цианати и изоцианатиCianatos e isocianatosKyanáty a isokyanátyCyanater og isocyanaterCyanate und IsocyanateTsüanaadid ja isotsüanaadidΚυανικές και ισοκυανικές ενώσειςCyanates and isocyanatesCyanates et isocyanatesCianati e isocianatiCianāti un izocianātiCianatai ir izocianataiCianátok és izocianátokĊjanati u isoċjanatiCyanaten en isocyanatenCyjaniany i izocyjanianyCianatos e isocianatosCianaţi şi izocianaţiKyanáty a izokyanátyCianati in izocianatiSyanaatit ja isosyanaatitCyanater och isocyanater616Амиди и техните производниAmidas y derivadosAmidy a jejich derivátyAmider og deres derivaterAmide und ihre DerivateAmiidid ja nende derivaadidΑμίδια και παράγωγά τουςAmides and their derivativesAmides et dérivésAmmidi e derivatiAmīdi un to atvasinājumiAmidai ir jų dariniaiAmidok és származékaikAmidi u derivatiAmiden en derivatenAmidy i ich pochodneAmidas e derivadosAmide şi derivaţii lorAmidy a ich derivátyAmidi in njihovi derivatiAmidit ja niiden johdannaisetAmider och deras derivat617Органични пероксидиPeróxidos orgánicosOrganické peroxidyOrganiske peroxiderOrganische PeroxideOrgaanilised peroksiididΟργανικά υπεροξείδιαOrganic peroxidesPeroxydes organiquesPerossidi organiciOrganiskie peroksīdiOrganiniai peroksidaiSzerves peroxidokPerossidi organiċiOrganische peroxidenNadtlenki organicznePeróxidos orgânicosPeroxizi organiciOrganické peroxidyOrganski peroksidiOrgaaniset peroksiditOrganiska peroxider647ЕнзимиEnzimasEnzymyEnzymerEnzymeEnsüümidΈνζυμαEnzymesEnzymesEnzimiEnzīmiEnzimaiEnzimekEnzīmiEnzymenEnzymyEnzimasEnzimeEnzýmyEncimiEntsyymitEnzymer648Комплексни съединения, получени при преработка на въглищаSustancias complejas derivadas del carbónDehtochemické produktyKomplekse kulderivaterAus Kohle abgeleitete komplexe StoffeKivisöest saadud kompleksühendidΣύμπλοκες ουσίες παραγόμενες από άνθρακαComplex substances derived from coalSubstances complexes dérivées du charbonSostanze complesse derivate dal carboneKompleksa sastāva akmeņogļu pārstrādes produktiIš akmens anglių pagamintos sudėtingos medžiagosKomplex kőszénszármazékokSustanzi kumplessi derivati mill-faħamComplexe steenkoolderivatenZłożone związki wytworzone z węgla kamiennegoSubstâncias complexas derivadas do carvãoSubstanţe complexe derivate din cărbuneDechtochemické produktyKompleksne snovi, pridobljene iz premogaMonimutkaiset hiilijohdannaisetKomplexa kolderivat649Комплексни съединения, получени при преработка на нефтSustancias complejas derivadas del petróleoRopné produktyKomplekse oliederivaterAus Erdöl abgeleitete komplexe StoffePetrooleumist saadud kompleksühendidΣύμπλοκες ουσίες παραγόμενες από πετρέλαιοComplex substances derived from petroleumSubstances complexes dérivées du pétroleSostanze complesse derivate dal petrolioKompleksa sastāva naftas pārstrādes produktiIš naftos pagamintos sudėtingos medžiagosKomplex olajszármazékokSustanzi kumplessi derivati mill-pitroljuComplexe aardoliederivatenZłożone związki wytworzone z ropy naftowejSubstâncias complexas derivadas do petróleoSubstanţe complexe derivate din petrolRopné produktyKompleksne snovi pridobljene iz nafteMonimutkaiset öljyjohdannaisetKomplexa oljederivat650Други веществаSustancias diversasRůzné látkyDiverse stofferVerschiedene StoffeSegaainedΔιάφορες ουσίεςMiscellaneous substancesSubstances diversesSostanze diverseDažādas vielasĮvairios medžiagosKülönböző anyagokSustanzi mixxellanjiDiversenRóżne substancjeSubstâncias diversasSubstanţe diverseRôzne chemické látkyOstale snoviMuut aineetDiverse ämnen’
601
ВъглеводородиHidrocarburosUhlovodíkyCarbonhydrider (kulbrinter)KohlenwasserstoffeSüsivesinikudΥδρογονάνθρακεςHydrocarbonsHydrocarburesIdrocarburiOgļūdeņražiAngliavandeniliaiSzénhidrogénekIdrokarburiKoolwaterstoffenWęglowodoryHidrocarbonetosHidrocarburiUhľovodíkyOgljikovodikiHiilivedytKolväten
602
Халогенирани въглеводородиHidrocarburos halogenadosHalogenované uhlovodíkyHalogensubstituerede carbonhydriderHalogen-KohlenwasserstoffeHalogeenitud süsivesinikudΑλογονοπαράγωγα υδρογονανθράκωνHalogenated hydrocarbonsDérivés halogénés des hydrocarburesDerivati idrocarburi alogenatiHalogenētie ogļūdeņražiHalogeninti angliavandeniliaiHalogénezett szénhidrogénekIdrokarburi aloġenatiGehalogeneerde koolwaterstoffenHalogenowe pochodne węglowodorówHidrocarbonetos halogenadosDerivaţi halogenaţi ai hidrocarburilorHalogénované uhľovodíkyHalogenirani ogljikovodikiHalogenoidut hiilivedytHalogenerade kolväten
603
Алкохоли и техните производниAlcoholes y derivadosAlkoholy a jejich derivátyAlkoholer og deres derivaterAlkohole und ihre DerivateAlkoholid ja nende derivaadidΑλκοόλες και παράγωγά τουςAlcohols and their derivativesAlcools et dérivésAlcoli e derivatiSpirti un to atvasinājumiAlkoholiai ir jų dariniaiAlkoholok és származékaikAlkoħoliċi u derivatiAlcoholen en derivatenAlkohole i ich pochodneÁlcoois e derivadosAlcooli şi derivaţii lorAlkoholy a ich derivátyAlkoholi in njihovi derivatiAlkoholit ja niiden johdannaisetAlkoholer och deras derivat
604
Феноли и техните производниFenoles y derivadosFenoly a jejich derivátyPhenoler og deres derivaterPhenole und ihre DerivateFenoolid ja nende derivaadidΦαινόλες και παράγωγά τουςPhenols and their derivativesPhénols et dérivésFenoli e derivatiFenoli un to atvasinājumiFenoliai ir jų dariniaiFenolok és származékaikFenoli u derivatiFenolen en derivatenFenole i ich pochodneFenóis e derivadosFenoli şi derivaţii lorFenoly a ich derivátyFenoli in njihovi derivatiFenolit ja niiden johdannaisetFenoler och deras derivat
605
Алдехиди и техните производниAldehídos y derivadosAldehydy a jejich derivátyAldehyder og deres derivaterAldehyde und ihre DerivateAldehüüdid ja nende derivaadidΑλδεΰδες και παράγωγά τουςAldehydes and their derivativesAldéhydes et dérivésAldeidi e derivatiAldehīdi un to atvasinājumiAldehidai ir jų dariniaiAldehidek és származékaikAldeidi u derivatiAldehyden en derivatenAldehydy i ich pochodneAldeidos e derivadosAldehide şi derivaţii lorAldehydy a ich derivátyAldehidi in njihovi derivatiAldehydit ja niiden johdannaisetAldehyder och deras derivat
606
Кетони и техните производниCetonas y derivadosKetony a jejich derivátyKetoner og deres derivaterKetone und ihre DerivateKetoonid ja nende derivaadidΚετόνες και παράγωγά τουςKetones and their derivativesCétones et dérivésChetoni e derivatiKetoni un to atvasinājumiKetonai ir jų dariniaiKetonok és származékaikKeton u derivatiKetonen en derivatenKetony i ich pochodneCetonas e derivadosCetone şi derivaţii lorKetóny a ich derivátyKetoni in njihovi derivatiKetonit ja niiden johdannaisetKetoner och deras derivat
607
Органични киселини и техните производниÁcidos orgánicos y derivadosOrganické kyseliny a jejich derivátyOrganiske syrer og deres derivaterOrganische Säuren und ihre DerivateOrgaanilised happed ja nende derivaadidΟργανικά οξέα και παράγωγά τουςOrganic acids and their derivativesAcides organiques et dérivésAcidi organici e derivatiOrganiskās skābes un to atvasinājumiOrganinės rūgštys ir jų dariniaiSzerves savak és származékaikAċidi organiċi u derivatiOrganische zuren en derivatenKwasy organiczne i ich pochodneÁcidos orgânicos e derivadosAcizi organici şi derivaţii lorOrganické kyseliny a ich derivátyOrganske kisline in njihovi derivatiOrgaaniset hapot ja niiden johdannaisetOrganiska syror och deras derivat
608
НитрилиNitrilosNitrilyNitrilerNitrileNitriilidΝιτρίλιαNitrilesNitrilesNitriliNitrilsavienojumi un to atvasinājumiNitrilaiNitrilekNitriliNitrillenNitryleNitrilosNitriliNitrilyNitriliNitriilitNitriler
609
НитросъединенияDerivados nitradosNitrosloučeninyNitroforbindelserNitroverbindungenNitroühendidΝιτροενώσειςNitro compoundsDérivés nitrésNitroderivatiNitrosavienojumiNitrojunginiaiNitrovegyületekKomposti tan-nitruNitroverbindingenNitrozwiązkiDerivados nitradosNitro-derivaţiNitrozlúčeninyNitro spojineNitroyhdisteetKväveföreningar
610
ХлоронитросъединенияDerivados cloronitradosChlorované nitrosloučeninyChlornitroforbindelserChlornitroverbindungenKloronitroühendidΧλωρονιτροενώσειςChloronitro compoundsDérivés chloronitrésCloronitro derivatiHlornitrosavienojumiChlornitrojunginiaiKlór-nitrovegyületekKomposti tal-kloronitruChloornitroverbindingenChloronitrozwiązkiDerivados cloronitradosClor- nitro-derivaţiChlórované nitrozlúčeninyKloro-nitro spojineKloorinitroyhdisteetKlornitroföreningar
611
Азокси- и азосъединенияDerivados azoicos y azoxiAzoxysloučeniny a azosloučeninyAzoxy- og azoforbindelserAzoxy- und AzoverbindungenAsoksü- ja asoühendidΆζωξυ- και άζω-ενώσειςAzoxy- and azo compoundsDérivés azoxy et azoïquesAzossi- e azoderivatiAzoksisavienojumi un azosavienojumiAzoksijunginiai ir azojunginiaiAzoxi és azo-vegyületekKomposti ta' l-azossi u ta' l-azoAzoxy- en azoverbindingenAzoksy- i azozwiązkiDerivados azoxi e azóicosAzoxi- şi azo-derivaţiAzoxyzlúčeniny a azozlúčeninyAzoksi in azo spojineAtsoksi- ja atsoyhdisteetAzoxi- och azoföreningar
612
АминосъединенияDerivados aminadosAminosloučeninyAminerAminoverbindungenAmiinühendidΑμινοενώσειςAmine compoundsDérivés aminésAminoderivatiAminosavienojumiAminojunginiaiAmin vegyületekKomposti ta' l-aminoAminoverbindingenAminozwiązkiDerivados aminadosAmino-derivaţiAminozlúčeninyAmino spojineAmiiniyhdisteetAminer
613
Хетероциклени основи и техните производниBases heterocíclicas y derivadosHeterocyklické báze a jejich derivátyHeterocykliske baser og deres derivaterHeterocyclische Basen und ihre DerivateHeterotsüklilised alused ja nende derivaadidΕτεροκυκλικές βάσεις και παράγωγά τουςHeterocyclic bases and their derivativesBases hétérocycliques et dérivésBasi eterocicliche e derivatiHeterocikliskie savienojumi un to atvasinājumiHeterociklinės bazės ir jų dariniaiHeterociklusos bázisok és származékaikBażijiet eteroċikliċi u derivatiHeterocyclische basen en hun derivatenZasady heterocykliczne i ich pochodneBases heterocíclicas e derivadosBaze heterociclice şi derivaţii lorHeterocyklické bázy a ich derivátyHeterociklične baze in njihovi derivatiHeterosykliset emäkset ja niiden johdannaisetHeterocykliska baser och deras derivat
614
Глюкозиди и алкалоидиGlucósidos y alcaloidesGlykosidy a alkaloidyGlycosider og alkaloiderGlycoside und AlkaloideGlükosiidid ja alkaloididΓλυκοζίτες και αλκαλοειδήGlycosides and alkaloidsGlucosides et alcaloïdesGlucosidi e alcaloidiGlikozīdi un alkaloīdiGlikozidai ir alkaloidaiGlikozidok és alkaloidokGlukosidi u alkalojdiGlycosiden en alkaloïdenGlikozydy i alkaloidyGlicósidos e alcalóidesGlicozide şi alcaloiziGlykozidy a alkaloidyGlikozidi in alkaloidiGlykosidit ja alkaloiditGlykosider och alkaloider
615
Цианати и изоцианатиCianatos e isocianatosKyanáty a isokyanátyCyanater og isocyanaterCyanate und IsocyanateTsüanaadid ja isotsüanaadidΚυανικές και ισοκυανικές ενώσειςCyanates and isocyanatesCyanates et isocyanatesCianati e isocianatiCianāti un izocianātiCianatai ir izocianataiCianátok és izocianátokĊjanati u isoċjanatiCyanaten en isocyanatenCyjaniany i izocyjanianyCianatos e isocianatosCianaţi şi izocianaţiKyanáty a izokyanátyCianati in izocianatiSyanaatit ja isosyanaatitCyanater och isocyanater
616
Амиди и техните производниAmidas y derivadosAmidy a jejich derivátyAmider og deres derivaterAmide und ihre DerivateAmiidid ja nende derivaadidΑμίδια και παράγωγά τουςAmides and their derivativesAmides et dérivésAmmidi e derivatiAmīdi un to atvasinājumiAmidai ir jų dariniaiAmidok és származékaikAmidi u derivatiAmiden en derivatenAmidy i ich pochodneAmidas e derivadosAmide şi derivaţii lorAmidy a ich derivátyAmidi in njihovi derivatiAmidit ja niiden johdannaisetAmider och deras derivat
617
Органични пероксидиPeróxidos orgánicosOrganické peroxidyOrganiske peroxiderOrganische PeroxideOrgaanilised peroksiididΟργανικά υπεροξείδιαOrganic peroxidesPeroxydes organiquesPerossidi organiciOrganiskie peroksīdiOrganiniai peroksidaiSzerves peroxidokPerossidi organiċiOrganische peroxidenNadtlenki organicznePeróxidos orgânicosPeroxizi organiciOrganické peroxidyOrganski peroksidiOrgaaniset peroksiditOrganiska peroxider
647
ЕнзимиEnzimasEnzymyEnzymerEnzymeEnsüümidΈνζυμαEnzymesEnzymesEnzimiEnzīmiEnzimaiEnzimekEnzīmiEnzymenEnzymyEnzimasEnzimeEnzýmyEncimiEntsyymitEnzymer
648
Комплексни съединения, получени при преработка на въглищаSustancias complejas derivadas del carbónDehtochemické produktyKomplekse kulderivaterAus Kohle abgeleitete komplexe StoffeKivisöest saadud kompleksühendidΣύμπλοκες ουσίες παραγόμενες από άνθρακαComplex substances derived from coalSubstances complexes dérivées du charbonSostanze complesse derivate dal carboneKompleksa sastāva akmeņogļu pārstrādes produktiIš akmens anglių pagamintos sudėtingos medžiagosKomplex kőszénszármazékokSustanzi kumplessi derivati mill-faħamComplexe steenkoolderivatenZłożone związki wytworzone z węgla kamiennegoSubstâncias complexas derivadas do carvãoSubstanţe complexe derivate din cărbuneDechtochemické produktyKompleksne snovi, pridobljene iz premogaMonimutkaiset hiilijohdannaisetKomplexa kolderivat
649
Комплексни съединения, получени при преработка на нефтSustancias complejas derivadas del petróleoRopné produktyKomplekse oliederivaterAus Erdöl abgeleitete komplexe StoffePetrooleumist saadud kompleksühendidΣύμπλοκες ουσίες παραγόμενες από πετρέλαιοComplex substances derived from petroleumSubstances complexes dérivées du pétroleSostanze complesse derivate dal petrolioKompleksa sastāva naftas pārstrādes produktiIš naftos pagamintos sudėtingos medžiagosKomplex olajszármazékokSustanzi kumplessi derivati mill-pitroljuComplexe aardoliederivatenZłożone związki wytworzone z ropy naftowejSubstâncias complexas derivadas do petróleoSubstanţe complexe derivate din petrolRopné produktyKompleksne snovi pridobljene iz nafteMonimutkaiset öljyjohdannaisetKomplexa oljederivat
650
Други веществаSustancias diversasRůzné látkyDiverse stofferVerschiedene StoffeSegaainedΔιάφορες ουσίεςMiscellaneous substancesSubstances diversesSostanze diverseDažādas vielasĮvairios medžiagosKülönböző anyagokSustanzi mixxellanjiDiversenRóżne substancjeSubstâncias diversasSubstanţe diverseRôzne chemické látkyOstale snoviMuut aineetDiverse ämnen’

601
ВъглеводородиHidrocarburosUhlovodíkyCarbonhydrider (kulbrinter)KohlenwasserstoffeSüsivesinikudΥδρογονάνθρακεςHydrocarbonsHydrocarburesIdrocarburiOgļūdeņražiAngliavandeniliaiSzénhidrogénekIdrokarburiKoolwaterstoffenWęglowodoryHidrocarbonetosHidrocarburiUhľovodíkyOgljikovodikiHiilivedytKolväten

602
Халогенирани въглеводородиHidrocarburos halogenadosHalogenované uhlovodíkyHalogensubstituerede carbonhydriderHalogen-KohlenwasserstoffeHalogeenitud süsivesinikudΑλογονοπαράγωγα υδρογονανθράκωνHalogenated hydrocarbonsDérivés halogénés des hydrocarburesDerivati idrocarburi alogenatiHalogenētie ogļūdeņražiHalogeninti angliavandeniliaiHalogénezett szénhidrogénekIdrokarburi aloġenatiGehalogeneerde koolwaterstoffenHalogenowe pochodne węglowodorówHidrocarbonetos halogenadosDerivaţi halogenaţi ai hidrocarburilorHalogénované uhľovodíkyHalogenirani ogljikovodikiHalogenoidut hiilivedytHalogenerade kolväten

603
Алкохоли и техните производниAlcoholes y derivadosAlkoholy a jejich derivátyAlkoholer og deres derivaterAlkohole und ihre DerivateAlkoholid ja nende derivaadidΑλκοόλες και παράγωγά τουςAlcohols and their derivativesAlcools et dérivésAlcoli e derivatiSpirti un to atvasinājumiAlkoholiai ir jų dariniaiAlkoholok és származékaikAlkoħoliċi u derivatiAlcoholen en derivatenAlkohole i ich pochodneÁlcoois e derivadosAlcooli şi derivaţii lorAlkoholy a ich derivátyAlkoholi in njihovi derivatiAlkoholit ja niiden johdannaisetAlkoholer och deras derivat

604
Феноли и техните производниFenoles y derivadosFenoly a jejich derivátyPhenoler og deres derivaterPhenole und ihre DerivateFenoolid ja nende derivaadidΦαινόλες και παράγωγά τουςPhenols and their derivativesPhénols et dérivésFenoli e derivatiFenoli un to atvasinājumiFenoliai ir jų dariniaiFenolok és származékaikFenoli u derivatiFenolen en derivatenFenole i ich pochodneFenóis e derivadosFenoli şi derivaţii lorFenoly a ich derivátyFenoli in njihovi derivatiFenolit ja niiden johdannaisetFenoler och deras derivat

605
Алдехиди и техните производниAldehídos y derivadosAldehydy a jejich derivátyAldehyder og deres derivaterAldehyde und ihre DerivateAldehüüdid ja nende derivaadidΑλδεΰδες και παράγωγά τουςAldehydes and their derivativesAldéhydes et dérivésAldeidi e derivatiAldehīdi un to atvasinājumiAldehidai ir jų dariniaiAldehidek és származékaikAldeidi u derivatiAldehyden en derivatenAldehydy i ich pochodneAldeidos e derivadosAldehide şi derivaţii lorAldehydy a ich derivátyAldehidi in njihovi derivatiAldehydit ja niiden johdannaisetAldehyder och deras derivat

606
Кетони и техните производниCetonas y derivadosKetony a jejich derivátyKetoner og deres derivaterKetone und ihre DerivateKetoonid ja nende derivaadidΚετόνες και παράγωγά τουςKetones and their derivativesCétones et dérivésChetoni e derivatiKetoni un to atvasinājumiKetonai ir jų dariniaiKetonok és származékaikKeton u derivatiKetonen en derivatenKetony i ich pochodneCetonas e derivadosCetone şi derivaţii lorKetóny a ich derivátyKetoni in njihovi derivatiKetonit ja niiden johdannaisetKetoner och deras derivat

607
Органични киселини и техните производниÁcidos orgánicos y derivadosOrganické kyseliny a jejich derivátyOrganiske syrer og deres derivaterOrganische Säuren und ihre DerivateOrgaanilised happed ja nende derivaadidΟργανικά οξέα και παράγωγά τουςOrganic acids and their derivativesAcides organiques et dérivésAcidi organici e derivatiOrganiskās skābes un to atvasinājumiOrganinės rūgštys ir jų dariniaiSzerves savak és származékaikAċidi organiċi u derivatiOrganische zuren en derivatenKwasy organiczne i ich pochodneÁcidos orgânicos e derivadosAcizi organici şi derivaţii lorOrganické kyseliny a ich derivátyOrganske kisline in njihovi derivatiOrgaaniset hapot ja niiden johdannaisetOrganiska syror och deras derivat

608
НитрилиNitrilosNitrilyNitrilerNitrileNitriilidΝιτρίλιαNitrilesNitrilesNitriliNitrilsavienojumi un to atvasinājumiNitrilaiNitrilekNitriliNitrillenNitryleNitrilosNitriliNitrilyNitriliNitriilitNitriler

609
НитросъединенияDerivados nitradosNitrosloučeninyNitroforbindelserNitroverbindungenNitroühendidΝιτροενώσειςNitro compoundsDérivés nitrésNitroderivatiNitrosavienojumiNitrojunginiaiNitrovegyületekKomposti tan-nitruNitroverbindingenNitrozwiązkiDerivados nitradosNitro-derivaţiNitrozlúčeninyNitro spojineNitroyhdisteetKväveföreningar

610
ХлоронитросъединенияDerivados cloronitradosChlorované nitrosloučeninyChlornitroforbindelserChlornitroverbindungenKloronitroühendidΧλωρονιτροενώσειςChloronitro compoundsDérivés chloronitrésCloronitro derivatiHlornitrosavienojumiChlornitrojunginiaiKlór-nitrovegyületekKomposti tal-kloronitruChloornitroverbindingenChloronitrozwiązkiDerivados cloronitradosClor- nitro-derivaţiChlórované nitrozlúčeninyKloro-nitro spojineKloorinitroyhdisteetKlornitroföreningar

611
Азокси- и азосъединенияDerivados azoicos y azoxiAzoxysloučeniny a azosloučeninyAzoxy- og azoforbindelserAzoxy- und AzoverbindungenAsoksü- ja asoühendidΆζωξυ- και άζω-ενώσειςAzoxy- and azo compoundsDérivés azoxy et azoïquesAzossi- e azoderivatiAzoksisavienojumi un azosavienojumiAzoksijunginiai ir azojunginiaiAzoxi és azo-vegyületekKomposti ta' l-azossi u ta' l-azoAzoxy- en azoverbindingenAzoksy- i azozwiązkiDerivados azoxi e azóicosAzoxi- şi azo-derivaţiAzoxyzlúčeniny a azozlúčeninyAzoksi in azo spojineAtsoksi- ja atsoyhdisteetAzoxi- och azoföreningar

612
АминосъединенияDerivados aminadosAminosloučeninyAminerAminoverbindungenAmiinühendidΑμινοενώσειςAmine compoundsDérivés aminésAminoderivatiAminosavienojumiAminojunginiaiAmin vegyületekKomposti ta' l-aminoAminoverbindingenAminozwiązkiDerivados aminadosAmino-derivaţiAminozlúčeninyAmino spojineAmiiniyhdisteetAminer

613
Хетероциклени основи и техните производниBases heterocíclicas y derivadosHeterocyklické báze a jejich derivátyHeterocykliske baser og deres derivaterHeterocyclische Basen und ihre DerivateHeterotsüklilised alused ja nende derivaadidΕτεροκυκλικές βάσεις και παράγωγά τουςHeterocyclic bases and their derivativesBases hétérocycliques et dérivésBasi eterocicliche e derivatiHeterocikliskie savienojumi un to atvasinājumiHeterociklinės bazės ir jų dariniaiHeterociklusos bázisok és származékaikBażijiet eteroċikliċi u derivatiHeterocyclische basen en hun derivatenZasady heterocykliczne i ich pochodneBases heterocíclicas e derivadosBaze heterociclice şi derivaţii lorHeterocyklické bázy a ich derivátyHeterociklične baze in njihovi derivatiHeterosykliset emäkset ja niiden johdannaisetHeterocykliska baser och deras derivat

614
Глюкозиди и алкалоидиGlucósidos y alcaloidesGlykosidy a alkaloidyGlycosider og alkaloiderGlycoside und AlkaloideGlükosiidid ja alkaloididΓλυκοζίτες και αλκαλοειδήGlycosides and alkaloidsGlucosides et alcaloïdesGlucosidi e alcaloidiGlikozīdi un alkaloīdiGlikozidai ir alkaloidaiGlikozidok és alkaloidokGlukosidi u alkalojdiGlycosiden en alkaloïdenGlikozydy i alkaloidyGlicósidos e alcalóidesGlicozide şi alcaloiziGlykozidy a alkaloidyGlikozidi in alkaloidiGlykosidit ja alkaloiditGlykosider och alkaloider

615
Цианати и изоцианатиCianatos e isocianatosKyanáty a isokyanátyCyanater og isocyanaterCyanate und IsocyanateTsüanaadid ja isotsüanaadidΚυανικές και ισοκυανικές ενώσειςCyanates and isocyanatesCyanates et isocyanatesCianati e isocianatiCianāti un izocianātiCianatai ir izocianataiCianátok és izocianátokĊjanati u isoċjanatiCyanaten en isocyanatenCyjaniany i izocyjanianyCianatos e isocianatosCianaţi şi izocianaţiKyanáty a izokyanátyCianati in izocianatiSyanaatit ja isosyanaatitCyanater och isocyanater

616
Амиди и техните производниAmidas y derivadosAmidy a jejich derivátyAmider og deres derivaterAmide und ihre DerivateAmiidid ja nende derivaadidΑμίδια και παράγωγά τουςAmides and their derivativesAmides et dérivésAmmidi e derivatiAmīdi un to atvasinājumiAmidai ir jų dariniaiAmidok és származékaikAmidi u derivatiAmiden en derivatenAmidy i ich pochodneAmidas e derivadosAmide şi derivaţii lorAmidy a ich derivátyAmidi in njihovi derivatiAmidit ja niiden johdannaisetAmider och deras derivat

617
Органични пероксидиPeróxidos orgánicosOrganické peroxidyOrganiske peroxiderOrganische PeroxideOrgaanilised peroksiididΟργανικά υπεροξείδιαOrganic peroxidesPeroxydes organiquesPerossidi organiciOrganiskie peroksīdiOrganiniai peroksidaiSzerves peroxidokPerossidi organiċiOrganische peroxidenNadtlenki organicznePeróxidos orgânicosPeroxizi organiciOrganické peroxidyOrganski peroksidiOrgaaniset peroksiditOrganiska peroxider

647
ЕнзимиEnzimasEnzymyEnzymerEnzymeEnsüümidΈνζυμαEnzymesEnzymesEnzimiEnzīmiEnzimaiEnzimekEnzīmiEnzymenEnzymyEnzimasEnzimeEnzýmyEncimiEntsyymitEnzymer

648
Комплексни съединения, получени при преработка на въглищаSustancias complejas derivadas del carbónDehtochemické produktyKomplekse kulderivaterAus Kohle abgeleitete komplexe StoffeKivisöest saadud kompleksühendidΣύμπλοκες ουσίες παραγόμενες από άνθρακαComplex substances derived from coalSubstances complexes dérivées du charbonSostanze complesse derivate dal carboneKompleksa sastāva akmeņogļu pārstrādes produktiIš akmens anglių pagamintos sudėtingos medžiagosKomplex kőszénszármazékokSustanzi kumplessi derivati mill-faħamComplexe steenkoolderivatenZłożone związki wytworzone z węgla kamiennegoSubstâncias complexas derivadas do carvãoSubstanţe complexe derivate din cărbuneDechtochemické produktyKompleksne snovi, pridobljene iz premogaMonimutkaiset hiilijohdannaisetKomplexa kolderivat

649
Комплексни съединения, получени при преработка на нефтSustancias complejas derivadas del petróleoRopné produktyKomplekse oliederivaterAus Erdöl abgeleitete komplexe StoffePetrooleumist saadud kompleksühendidΣύμπλοκες ουσίες παραγόμενες από πετρέλαιοComplex substances derived from petroleumSubstances complexes dérivées du pétroleSostanze complesse derivate dal petrolioKompleksa sastāva naftas pārstrādes produktiIš naftos pagamintos sudėtingos medžiagosKomplex olajszármazékokSustanzi kumplessi derivati mill-pitroljuComplexe aardoliederivatenZłożone związki wytworzone z ropy naftowejSubstâncias complexas derivadas do petróleoSubstanţe complexe derivate din petrolRopné produktyKompleksne snovi pridobljene iz nafteMonimutkaiset öljyjohdannaisetKomplexa oljederivat

650
Други веществаSustancias diversasRůzné látkyDiverse stofferVerschiedene StoffeSegaainedΔιάφορες ουσίεςMiscellaneous substancesSubstances diversesSostanze diverseDažādas vielasĮvairios medžiagosKülönböző anyagokSustanzi mixxellanjiDiversenRóżne substancjeSubstâncias diversasSubstanţe diverseRôzne chemické látkyOstale snoviMuut aineetDiverse ämnen’



601
ВъглеводородиHidrocarburosUhlovodíkyCarbonhydrider (kulbrinter)KohlenwasserstoffeSüsivesinikudΥδρογονάνθρακεςHydrocarbonsHydrocarburesIdrocarburiOgļūdeņražiAngliavandeniliaiSzénhidrogénekIdrokarburiKoolwaterstoffenWęglowodoryHidrocarbonetosHidrocarburiUhľovodíkyOgljikovodikiHiilivedytKolväten

602
Халогенирани въглеводородиHidrocarburos halogenadosHalogenované uhlovodíkyHalogensubstituerede carbonhydriderHalogen-KohlenwasserstoffeHalogeenitud süsivesinikudΑλογονοπαράγωγα υδρογονανθράκωνHalogenated hydrocarbonsDérivés halogénés des hydrocarburesDerivati idrocarburi alogenatiHalogenētie ogļūdeņražiHalogeninti angliavandeniliaiHalogénezett szénhidrogénekIdrokarburi aloġenatiGehalogeneerde koolwaterstoffenHalogenowe pochodne węglowodorówHidrocarbonetos halogenadosDerivaţi halogenaţi ai hidrocarburilorHalogénované uhľovodíkyHalogenirani ogljikovodikiHalogenoidut hiilivedytHalogenerade kolväten

603
Алкохоли и техните производниAlcoholes y derivadosAlkoholy a jejich derivátyAlkoholer og deres derivaterAlkohole und ihre DerivateAlkoholid ja nende derivaadidΑλκοόλες και παράγωγά τουςAlcohols and their derivativesAlcools et dérivésAlcoli e derivatiSpirti un to atvasinājumiAlkoholiai ir jų dariniaiAlkoholok és származékaikAlkoħoliċi u derivatiAlcoholen en derivatenAlkohole i ich pochodneÁlcoois e derivadosAlcooli şi derivaţii lorAlkoholy a ich derivátyAlkoholi in njihovi derivatiAlkoholit ja niiden johdannaisetAlkoholer och deras derivat

604
Феноли и техните производниFenoles y derivadosFenoly a jejich derivátyPhenoler og deres derivaterPhenole und ihre DerivateFenoolid ja nende derivaadidΦαινόλες και παράγωγά τουςPhenols and their derivativesPhénols et dérivésFenoli e derivatiFenoli un to atvasinājumiFenoliai ir jų dariniaiFenolok és származékaikFenoli u derivatiFenolen en derivatenFenole i ich pochodneFenóis e derivadosFenoli şi derivaţii lorFenoly a ich derivátyFenoli in njihovi derivatiFenolit ja niiden johdannaisetFenoler och deras derivat

605
Алдехиди и техните производниAldehídos y derivadosAldehydy a jejich derivátyAldehyder og deres derivaterAldehyde und ihre DerivateAldehüüdid ja nende derivaadidΑλδεΰδες και παράγωγά τουςAldehydes and their derivativesAldéhydes et dérivésAldeidi e derivatiAldehīdi un to atvasinājumiAldehidai ir jų dariniaiAldehidek és származékaikAldeidi u derivatiAldehyden en derivatenAldehydy i ich pochodneAldeidos e derivadosAldehide şi derivaţii lorAldehydy a ich derivátyAldehidi in njihovi derivatiAldehydit ja niiden johdannaisetAldehyder och deras derivat

606
Кетони и техните производниCetonas y derivadosKetony a jejich derivátyKetoner og deres derivaterKetone und ihre DerivateKetoonid ja nende derivaadidΚετόνες και παράγωγά τουςKetones and their derivativesCétones et dérivésChetoni e derivatiKetoni un to atvasinājumiKetonai ir jų dariniaiKetonok és származékaikKeton u derivatiKetonen en derivatenKetony i ich pochodneCetonas e derivadosCetone şi derivaţii lorKetóny a ich derivátyKetoni in njihovi derivatiKetonit ja niiden johdannaisetKetoner och deras derivat

607
Органични киселини и техните производниÁcidos orgánicos y derivadosOrganické kyseliny a jejich derivátyOrganiske syrer og deres derivaterOrganische Säuren und ihre DerivateOrgaanilised happed ja nende derivaadidΟργανικά οξέα και παράγωγά τουςOrganic acids and their derivativesAcides organiques et dérivésAcidi organici e derivatiOrganiskās skābes un to atvasinājumiOrganinės rūgštys ir jų dariniaiSzerves savak és származékaikAċidi organiċi u derivatiOrganische zuren en derivatenKwasy organiczne i ich pochodneÁcidos orgânicos e derivadosAcizi organici şi derivaţii lorOrganické kyseliny a ich derivátyOrganske kisline in njihovi derivatiOrgaaniset hapot ja niiden johdannaisetOrganiska syror och deras derivat

608
НитрилиNitrilosNitrilyNitrilerNitrileNitriilidΝιτρίλιαNitrilesNitrilesNitriliNitrilsavienojumi un to atvasinājumiNitrilaiNitrilekNitriliNitrillenNitryleNitrilosNitriliNitrilyNitriliNitriilitNitriler

609
НитросъединенияDerivados nitradosNitrosloučeninyNitroforbindelserNitroverbindungenNitroühendidΝιτροενώσειςNitro compoundsDérivés nitrésNitroderivatiNitrosavienojumiNitrojunginiaiNitrovegyületekKomposti tan-nitruNitroverbindingenNitrozwiązkiDerivados nitradosNitro-derivaţiNitrozlúčeninyNitro spojineNitroyhdisteetKväveföreningar

610
ХлоронитросъединенияDerivados cloronitradosChlorované nitrosloučeninyChlornitroforbindelserChlornitroverbindungenKloronitroühendidΧλωρονιτροενώσειςChloronitro compoundsDérivés chloronitrésCloronitro derivatiHlornitrosavienojumiChlornitrojunginiaiKlór-nitrovegyületekKomposti tal-kloronitruChloornitroverbindingenChloronitrozwiązkiDerivados cloronitradosClor- nitro-derivaţiChlórované nitrozlúčeninyKloro-nitro spojineKloorinitroyhdisteetKlornitroföreningar

611
Азокси- и азосъединенияDerivados azoicos y azoxiAzoxysloučeniny a azosloučeninyAzoxy- og azoforbindelserAzoxy- und AzoverbindungenAsoksü- ja asoühendidΆζωξυ- και άζω-ενώσειςAzoxy- and azo compoundsDérivés azoxy et azoïquesAzossi- e azoderivatiAzoksisavienojumi un azosavienojumiAzoksijunginiai ir azojunginiaiAzoxi és azo-vegyületekKomposti ta' l-azossi u ta' l-azoAzoxy- en azoverbindingenAzoksy- i azozwiązkiDerivados azoxi e azóicosAzoxi- şi azo-derivaţiAzoxyzlúčeniny a azozlúčeninyAzoksi in azo spojineAtsoksi- ja atsoyhdisteetAzoxi- och azoföreningar

612
АминосъединенияDerivados aminadosAminosloučeninyAminerAminoverbindungenAmiinühendidΑμινοενώσειςAmine compoundsDérivés aminésAminoderivatiAminosavienojumiAminojunginiaiAmin vegyületekKomposti ta' l-aminoAminoverbindingenAminozwiązkiDerivados aminadosAmino-derivaţiAminozlúčeninyAmino spojineAmiiniyhdisteetAminer

613
Хетероциклени основи и техните производниBases heterocíclicas y derivadosHeterocyklické báze a jejich derivátyHeterocykliske baser og deres derivaterHeterocyclische Basen und ihre DerivateHeterotsüklilised alused ja nende derivaadidΕτεροκυκλικές βάσεις και παράγωγά τουςHeterocyclic bases and their derivativesBases hétérocycliques et dérivésBasi eterocicliche e derivatiHeterocikliskie savienojumi un to atvasinājumiHeterociklinės bazės ir jų dariniaiHeterociklusos bázisok és származékaikBażijiet eteroċikliċi u derivatiHeterocyclische basen en hun derivatenZasady heterocykliczne i ich pochodneBases heterocíclicas e derivadosBaze heterociclice şi derivaţii lorHeterocyklické bázy a ich derivátyHeterociklične baze in njihovi derivatiHeterosykliset emäkset ja niiden johdannaisetHeterocykliska baser och deras derivat

614
Глюкозиди и алкалоидиGlucósidos y alcaloidesGlykosidy a alkaloidyGlycosider og alkaloiderGlycoside und AlkaloideGlükosiidid ja alkaloididΓλυκοζίτες και αλκαλοειδήGlycosides and alkaloidsGlucosides et alcaloïdesGlucosidi e alcaloidiGlikozīdi un alkaloīdiGlikozidai ir alkaloidaiGlikozidok és alkaloidokGlukosidi u alkalojdiGlycosiden en alkaloïdenGlikozydy i alkaloidyGlicósidos e alcalóidesGlicozide şi alcaloiziGlykozidy a alkaloidyGlikozidi in alkaloidiGlykosidit ja alkaloiditGlykosider och alkaloider

615
Цианати и изоцианатиCianatos e isocianatosKyanáty a isokyanátyCyanater og isocyanaterCyanate und IsocyanateTsüanaadid ja isotsüanaadidΚυανικές και ισοκυανικές ενώσειςCyanates and isocyanatesCyanates et isocyanatesCianati e isocianatiCianāti un izocianātiCianatai ir izocianataiCianátok és izocianátokĊjanati u isoċjanatiCyanaten en isocyanatenCyjaniany i izocyjanianyCianatos e isocianatosCianaţi şi izocianaţiKyanáty a izokyanátyCianati in izocianatiSyanaatit ja isosyanaatitCyanater och isocyanater

616
Амиди и техните производниAmidas y derivadosAmidy a jejich derivátyAmider og deres derivaterAmide und ihre DerivateAmiidid ja nende derivaadidΑμίδια και παράγωγά τουςAmides and their derivativesAmides et dérivésAmmidi e derivatiAmīdi un to atvasinājumiAmidai ir jų dariniaiAmidok és származékaikAmidi u derivatiAmiden en derivatenAmidy i ich pochodneAmidas e derivadosAmide şi derivaţii lorAmidy a ich derivátyAmidi in njihovi derivatiAmidit ja niiden johdannaisetAmider och deras derivat

617
Органични пероксидиPeróxidos orgánicosOrganické peroxidyOrganiske peroxiderOrganische PeroxideOrgaanilised peroksiididΟργανικά υπεροξείδιαOrganic peroxidesPeroxydes organiquesPerossidi organiciOrganiskie peroksīdiOrganiniai peroksidaiSzerves peroxidokPerossidi organiċiOrganische peroxidenNadtlenki organicznePeróxidos orgânicosPeroxizi organiciOrganické peroxidyOrganski peroksidiOrgaaniset peroksiditOrganiska peroxider

647
ЕнзимиEnzimasEnzymyEnzymerEnzymeEnsüümidΈνζυμαEnzymesEnzymesEnzimiEnzīmiEnzimaiEnzimekEnzīmiEnzymenEnzymyEnzimasEnzimeEnzýmyEncimiEntsyymitEnzymer

648
Комплексни съединения, получени при преработка на въглищаSustancias complejas derivadas del carbónDehtochemické produktyKomplekse kulderivaterAus Kohle abgeleitete komplexe StoffeKivisöest saadud kompleksühendidΣύμπλοκες ουσίες παραγόμενες από άνθρακαComplex substances derived from coalSubstances complexes dérivées du charbonSostanze complesse derivate dal carboneKompleksa sastāva akmeņogļu pārstrādes produktiIš akmens anglių pagamintos sudėtingos medžiagosKomplex kőszénszármazékokSustanzi kumplessi derivati mill-faħamComplexe steenkoolderivatenZłożone związki wytworzone z węgla kamiennegoSubstâncias complexas derivadas do carvãoSubstanţe complexe derivate din cărbuneDechtochemické produktyKompleksne snovi, pridobljene iz premogaMonimutkaiset hiilijohdannaisetKomplexa kolderivat

649
Комплексни съединения, получени при преработка на нефтSustancias complejas derivadas del petróleoRopné produktyKomplekse oliederivaterAus Erdöl abgeleitete komplexe StoffePetrooleumist saadud kompleksühendidΣύμπλοκες ουσίες παραγόμενες από πετρέλαιοComplex substances derived from petroleumSubstances complexes dérivées du pétroleSostanze complesse derivate dal petrolioKompleksa sastāva naftas pārstrādes produktiIš naftos pagamintos sudėtingos medžiagosKomplex olajszármazékokSustanzi kumplessi derivati mill-pitroljuComplexe aardoliederivatenZłożone związki wytworzone z ropy naftowejSubstâncias complexas derivadas do petróleoSubstanţe complexe derivate din petrolRopné produktyKompleksne snovi pridobljene iz nafteMonimutkaiset öljyjohdannaisetKomplexa oljederivat

650
Други веществаSustancias diversasRůzné látkyDiverse stofferVerschiedene StoffeSegaainedΔιάφορες ουσίεςMiscellaneous substancesSubstances diversesSostanze diverseDažādas vielasĮvairios medžiagosKülönböző anyagokSustanzi mixxellanjiDiversenRóżne substancjeSubstâncias diversasSubstanţe diverseRôzne chemické látkyOstale snoviMuut aineetDiverse ämnen’



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Annex II is replaced by the following:‘ПРИЛОЖЕНИЕ II — ANEXO II — PŘÍLOHA II — BILAG II — ANHANG II — II LISA — ΠΑΡΑΡΤΗΜΑ ΙΙ — ANNEX II — ANNEXE II — ALLEGATO II — II PIELIKUMS — II PRIEDAS — II. MELLÉKLET — ANNESS II — BIJLAGE II — ZAŁĄCZNIK II — ANEXO II — ANEXA II — PRÍLOHA II — PRILOGA II — LIITE II — BILAGA IIПРИЛОЖЕНИЕ IIСимволи и индикации за опасност на опасните вещества и препаратиANEXO IISímbolos e indicaciones de peligro de las sustancias y preparados peligrososPŘÍLOHA IISymboly a označení nebezpečnosti pro nebezpečné látky a přípravkyBILAG IIFaresymboler og farebetegnelser for farlige stoffer og præparaterANHANG IIGefahrensymbole und -bezeichnungen für gefährliche Stoffe und ZubereitungenII LISAOhtlike ainete ja valmististe ohtlikkuse sümbolid ning indikaatoridΠΑΡΑΡΤΗΜΑ ΙΙΣύμβολα και ενδείξεις κινδύνου για επικίνδυνες ουσίες και παρασκευάσματαANNEX IISymbols and indications of danger for dangerous substances and preparationsANNEXE IISymboles et indications de danger des substances et préparations dangereusesALLEGATO IISimboli e indicazioni di pericolo delle sostanze e preparati pericolosiII PIELIKUMSBīstamo vielu un preparātu simboli un bīstamības paskaidrojumiII PRIEDASPavojingų medžiagų ir preparatų pavojingumo simboliai ir nuorodosII. MELLÉKLETVeszélyes anyagok és készítmények veszélyszimbólumai és jeleiANNESS IISimboli u indikazzjonijiet ta' periklu minn sustanzi u preparazzjonijiet perikolużiBIJLAGE IIGevaarsymbolen en -aanduidingen van gevaarlijke stoffen en preparatenZAŁĄCZNIK IIWzory znaków ostrzegawczych oraz napisy określające ich znaczenieANEXO IISímbolos e indicações de perigo das substâncias e preparações perigosasANEXA IISimboluri şi indicaţii de pericol pentru substanţele şi preparatele periculoasePRÍLOHA IIVýstražné symboly a označenia nebezpečenstva pre nebezpečné látky a prípravkyPRILOGA IIGrafični znaki in napisi za opozarjanje na nevarnost za nevarne snovi in pripravkeLIITE IIvaroitusmerkit ja niiden nimet vaarallisille aineille ja valmisteilleBILAGA IIFarosymboler och farobeteckningar för farliga ämnen och beredningarЗабележка: Буквите E, O, F, F+, T, T+, C, Xn, Xi u N не са част от символа.Nota:Las letras E, O, F, F+, T, T+, C, Xn, Xi y N no forman parte del símbolo.Poznámka:Písmenná vyjádření E, O, F, F+, T, T+, C, Xn, Xi a N nejsou součástí symbolu.Bemærkning:Bogstaverne E, O, F, F+, T, T+, C, Xn, Xi og N udgør ikke en del af symbolet.Anmerkung:Die Buchstaben E, O, F, F+, T, T+, C, Xn, Xi und N sind nicht Bestandteil des Gefahrensymbols.Tähelepanu:tähed E, O, F, F+, T, T+, C, Xn, Xi ja N ei ole ohusümboli osa.Σημείωση:Τα γράμματα E, O, F, F+, T, T+, C, Xn, Xi και N δεν αποτελούν μέρος του συμβόλου.Note:The letters E, O, F, F+, T, T+, C, Xn, Xi and N do not form part of the symbol.Remarque:Les lettres E, O, F, F+, T, T+, C, Xn, Xi et N ne font pas partie du symbole.Nota:Le lettere E, O, F, F+, T, T+, C, Xn, Xi e N non fanno parte del simbolo.Piezīme:Bīstamības apzīmējums ar burtu (burtiem E, O, F, F+, T, T+, C, Xn, Xi un N) nav marķējuma sastāvdaļa.Pastaba:Raidės E, O, F, F+, T, T+, C, Xn, Xi ir N nėra simbolio dalis.Megjegyzés:Az E, O, F, F+, T, T+, C, Xn, Xi és N betűk nem részei a szimbólumnak.Nota:L-ittri E, O, F, F+, T, T+, C, Xn, Xi u N m'humiex parti mis-simbolu.Opmerking:De letters E, O, F, F+, T, T+, C, Xn, Xi en N maken geen deel uit van het gevaarsymbool.Uwaga:litery E, O, F, F+, T, T+, C, Xn, Xi oraz N nie stanowią części znaku ostrzegawczego.Nota:As letras E, O, F, F+, T, T+, C, Xn, Xi e N não fazem parte do símbolo.Notă:Literele E, O, F, F+, T, T+, C, Xn, Xi, şi N nu fac parte din simbol.Poznámka:Písmená E, O, F, F+, T, T+, C, Xn, Xi, a N nie sú súčasťou symbolu.Opomba:črke E, O, F, F+, T, T+, C, Xn, Xi, in N niso del grafičnega znaka.Huomautus:Varoitusmerkkien kirjaintunnukset E, O, F, F+, T, T+, C, Xn, Xi ja N eivät ole osa varoitusmerkkiä.Anmärkning:Bokstäverna E, O, F, F+, T, T+, C, Xn, Xi och N utgör inte en del av symbolen.EBG: ЕксплозивенES: ExplosivoCS: VýbušnýDA: EksplosivDE: ExplosionsgefährlichET: PlahvatusohtlikEL: ΕκρηκτικόEN: ExplosiveFR: ExplosifIT: EsplosivoLV: SprādzienbīstamsLT: SprogstamojiHU: RobbanásveszélyesMT: SplussivNL: OntplofbaarPL: Produkt wybuchowyPT: ExplosivoRO: ExplozivSK: VýbušnýSL: EksplozivnoFI: RäjähtäväSV: ExplosivtOBG: ОксидиращES: ComburenteCS: OxidujícíDA: BrandnærendeDE: BrandförderndET: OksüdeerivEL: ΟξειδωτικόEN: OxidizingFR: ComburantIT: ComburenteLV: Spēcīgs oksidētājsLT: OksiduojantiHU: Égést tápláló, oxidálóMT: IqabbadNL: OxyderendPL: Produkt utleniającyPT: ComburenteRO: OxidantSK: OxidujúciSL: OksidativnoFI: HapettavaSV: OxiderandeFBG: Лесно запалимES: Fácilmente inflamableCS: Vysoce hořlavýDA: Meget brandfarligDE: LeichtentzündlichET: Väga tuleohtlikEL: Πολύ εύφλεκτοEN: Highly flammableFR: Facilement inflammableIT: Facilmente infiammabileLV: Viegli uzliesmojošsLT: Labai degiHU: TűzveszélyesMT: Jaqbad malajrNL: Licht ontvlambaarPL: Produkt wysoce łatwopalnyPT: Facilmente inflamávelRO: Foarte inflamabilSK: Veľmi horľavýSL: Lahko vnetljivoFI: Helposti syttyväSV: Mycket brandfarligtF+BG: Изключително запалимES: Extremadamente inflamableCS: Extrémně hořlavýDA: Yderst brandfarligDE: HochentzündlichET: Eriti tuleohtlikEL: Εξαιρετικά εύφλεκτοEN: Extremely flammableFR: Extrêmement inflammableIT: Estremamente infiammabileLV: Īpaši viegli uzliesmojošsLT: Ypač degiHU: Fokozottan tűzveszélyesMT: Jaqbad malajr ħafnaNL: Zeer licht ontvlambaarPL: Produkt skrajnie łatwopalnyPT: Extremamente inflamávelRO: Extrem de inflamabilSK: Mimoriadne horľavýSL: Zelo lahko vnetljivoFI: Erittäin helposti syttyväSV: Extremt brandfarligtTBG: ТоксиченES: TóxicoCS: ToxickýDA: GiftigDE: GiftigET: MürgineEL: ΤοξικόEN: ToxicFR: ToxiqueIT: TossicoLV: ToksisksLT: ToksiškaHU: MérgezőMT: TossikuNL: VergiftigPL: Produkt toksycznyPT: TóxicoRO: ToxicSK: JedovatýSL: StrupenoFI: MyrkyllinenSV: GiftigT +BG: Силно токсиченES: Muy tóxicoCS: Vysoce toxickýDA: Meget giftigDE: Sehr giftigET: Väga mürgineEL: Πολύ τοξικόEN: Very toxicFR: Très toxiqueIT: Molto tossicoLV: Ļoti toksisksLT: Labai toksiškaHU: Nagyon mérgezőMT: Tossiku ħafnaNL: Zeer vergiftigPL: Produkt bardzo toksycznyPT: Muito tóxicoRO: Foarte toxicSK: Veľmi jedovatýSL: Zelo strupenoFI: Erittäin myrkyllinenSV: Mycket giftigCBG: КорозивенES: CorrosivoCS: ŽíravýDA: ÆtsendeDE: ÄtzendET: SööbivEL: ΔιαβρωτικόEN: CorrosiveFR: CorrosifIT: CorrosivoLV: KodīgsLT: Ardanti (ėsdinanti)HU: MaróMT: KorrużivNL: BijtendPL: Produkt żrącyPT: CorrosivoRO: CorozivSK: ŽieravýSL: JedkoFI: SyövyttäväSV: FrätandeXnBG: ВреденES: NocivoCS: Zdraví škodlivýDA: SundhedsskadeligDE: GesundheitsschädlichET: KahjulikEL: ΕπιβλαβέςEN: HarmfulFR: NocifIT: NocivoLV: KaitīgsLT: KenksmingaHU: ÁrtalmasMT: Jagħmel il-ħsaraNL: SchadelijkPL: Produkt szkodliwyPT: NocivoRO: NocivSK: ŠkodlivýSL: Zdravju škodljivoFI: HaitallinenSV: HälsoskadligXiBG: ДразнещES: IrritanteCS: DráždivýDA: LokalirriterendeDE: ReizendET: ÄrritavEL: ΕρεθιστικόEN: IrritantFR: IrritantIT: IrritanteLV: KairinošsLT: DirginantiHU: IrritatívMT: IrritantiNL: IrriterendPL: Produkt drażniącyPT: IrritanteRO: IritantSK: DráždivýSL: DražilnoFI: ÄrsyttäväSV: IrriterandeNBG: Опасен за околната средаES: Peligroso para el medio ambienteCS: Nebezpečný pro životní prostředíDA: MiljøfarligDE: UmweltgefährlichET: KeskkonnaohtlikEL: Επικίνδυνο για το περιβάλλονEN: Dangerous for the environmentFR: Dangereux pour l'environnementIT: Pericoloso per l'ambienteLV: Bīstams videiLT: Aplinkai pavojingaHU: Környezetre veszélyesMT: Perikoluż għall-ambjentNL: MilieugevaarlijkPL: Produkt niebezpieczny dla środowiskaPT: Perigoso para o ambienteRO: Periculos pentru mediuSK: Nebezpečný pre životné prostredieSL: Okolju nevarnoFI: Ympäristölle vaarallinenSV: Miljöfarlig’



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Annex III is replaced by the following:‘ПРИЛОЖЕНИЕ III — ANEXO III — PŘÍLOHA III — BILAG III — ANHANG III — III LISA — ΠΑΡΑΡΤΗΜΑ ΙΙI — ANNEX III — ANNEXE III — ALLEGATO III — III PIELIKUMS — III PRIEDAS — III. MELLÉKLET — ANNESS III — BIJLAGE III — ZAŁĄCZNIK III — ANEXO III — ANEXA III — PRÍLOHA III — PRILOGA III — LIITE III — BILAGA IIIПРИЛОЖЕНИЕ IIIХарактер на специфичните рискове, свързани с опасните вещества и препаратиANEXO IIINaturaleza de los riesgos específicos atribuidos a las sustancias y preparados peligrososPŘÍLOHA IIIPovaha specifických rizik spojených s nebezpečnými látkami a přípravkyBILAG IIIArten af de saerlige risici, der er forbundet med de farlige stoffer og præparaterANHANG IIIBezeichnungen der besonderen Gefahren bei gefährlichen Stoffen und ZubereitungenIII LISAOhtlike ainete ja valmististe riskilausedΠΑΡΑΡΤΗΜΑ ΙΙΙΦύση των ειδικών κινδύνων που αφορούν επικίνδυνες ουσίες και παρασκευάσματαANNEX IIINature of special risks attributed to dangerous substances and preparationsANNEXE IIINature des risques particuliers attribués aux substances et préparations dangereusesALLEGATO IIINatura dei rischi specifici attribuiti alle sostanze e preparati pericolosiIII PIELIKUMSĶīmisko vielu iedarbības raksturojumi un apvienotie raksturojumiIII PRIEDASPavojingoms medžiagoms ir preparatams priskiriamų ypatingųjų rizikos veiksnių pobūdisIII. MELLÉKLETA veszélyes anyagok és készítmények veszélyeinek/kockázatainak jellege (R-mondatok)ANNESS IIIIn-natura ta' riskji speċjali attribwiti lil sustanzi u preparazzjonijiet perikolużiBIJLAGE IIIAard der bijzondere gevaren toegeschreven aan gevaarlijke stoffen en preparatenZAŁĄCZNIK IIIZwroty wskazujące rodzaj zagrożenia stwarzanego przez substancję niebezpieczną lub preparat niebezpiecznyANEXO IIINatureza dos riscos específicos atribuídos às substâncias e preparações perigosasANEXA IIINatura riscurilor specifice atribuite substanţelor şi preparatelor periculoasePRÍLOHA IIIZoznam označení špecifického rizika upozorňujúcich na nebezpečné vlastnosti chemickej látky a prípravkuPRILOGA IIIStandardna opozorila za označevanje nevarnih snovi in pripravkovLIITE IIIErityisten vaarojen luonne liittyen vaarallisiin aineisiin ja valmisteisiinBILAGA IIIRiskfraser som tilldelas farliga ämnen och beredningarR1BG: Експлозивен в сухо състояние.ES: Explosivo en estado seco.CS: Výbušný v suchém stavu.DA: Eksplosiv i tør tilstand.DE: In trockenem Zustand explosionsgefährlich.ET: Plahvatusohtlik kuivana.EL: Εκρηκτικό σε ξηρή κατάσταση.EN: Explosive when dry.FR: Explosif à l'état sec.IT: Esplosivo allo stato secco.LV: Sprādzienbīstams sausā veidā.LT: Sausa gali sprogti.HU: Száraz állapotban robbanásveszélyes.MT: Jisplodi meta jinxef.NL: In droge toestand ontplofbaar.PL: Produkt wybuchowy w stanie suchym.PT: Explosivo no estado seco.RO: Exploziv în stare uscată.SK: V suchom stave výbušný.SL: Eksplozivno v suhem stanju.FI: Räjähtävää kuivana.SV: Explosivt i torrt tillstånd.R2BG: Риск от експлозия при удар, триене, огън или други източници на запалване.ES: Riesgo de explosión por choque, fricción, fuego u otras fuentes de ignición.CS: Nebezpečí výbuchu při úderu, tření, ohni nebo působením jiných zdrojů zapálení.DA: Eksplosionsfarlig ved stød, gnidning, ild eller andre antændelseskilder.DE: Durch Schlag, Reibung, Feuer oder andere Zündquellen explosionsgefährlich.ET: Plahvatusohtlik löögi, hõõrdumise, tule või muu süttimisallika toimel.EL: Κίνδυνος εκρήξεως από κρούση, τριβή, φωτιά ή άλλες πηγές αναφλέξεως.EN: Risk of explosion by shock, friction, fire or other sources of ignition.FR: Risque d'explosion par le choc, la friction, le feu ou d'autres sources d'ignition.IT: Rischio di esplosione per urto, sfregamento, fuoco o altre sorgenti d'ignizione.LV: Sprādziena risks trieciena, berzes, liesmas vai cita aizdedzināšanas avota iedarbībā.LT: Sprogimo rizika nuo smūgio, trinties, ugnies ar kitų uždegimo šaltinių.HU: Ütés, súrlódás, tűz vagy más gyújtóforrás robbanást okozhat.MT: Riskju ta' splużjoni minn xokk, frizzjoni, nar jew għejun oħra ta' qbid tan-nar.NL: Ontploffingsgevaar door schok, wrijving, vuur of andere ontstekingsoorzaken.PL: Zagrożenie wybuchem wskutek uderzenia, tarcia, kontaktu z ogniem lub innymi źródłami zapłonu.PT: Risco de explosão por choque, fricção, fogo ou outras fontes de ignição.RO: Risc de explozie la şoc, frecare, foc sau alte surse de aprindere.SK: Riziko výbuchu nárazom, trením, horením alebo inými zdrojmi zapálenia.SL: Nevarnost eksplozije ob udarcu, trenju, požaru ali drugih virih vžiga.FI: Räjähtävää iskun, hankauksen, avotulen tai muun sytytyslähteen vaikutuksesta.SV: Explosivt vid stöt, friktion, eld eller annan antändningsorsak.R3BG: Повишен риск от експлозия при удар, триене, огън или други източници на запалване.ES: Alto riesgo de explosión por choque, fricción, fuego u otras fuentes de ignición.CS: Velké nebezpečí výbuchu při úderu, tření, ohni nebo působením jiných zdrojů zapálení.DA: Meget eksplosionsfarlig ved stød, gnidning, ild eller andre antændelseskilder.DE: Durch Schlag, Reibung, Feuer oder andere Zündquellen besonders explosionsgefährlich.ET: Eriti plahvatusohtlik löögi, hõõrdumise, tule või muu süttimisallika toimel.EL: Πολύ μεγάλος κίνδυνος εκρήξεως από κρούση, τριβή, φωτιά ή άλλες πηγές αναφλέξεως.EN: Extreme risk of explosion by shock, friction, fire or other sources of ignition.FR: Grand risque d'explosion par le choc, la friction, le feu ou d'autres sources d'ignition.IT: Elevato rischio di esplosione per urto, sfregamento, fuoco o altre sorgenti d'ignizione.LV: Augsts sprādziena risks trieciena, berzes, liesmas vai cita aizdedzināšanas avota iedarbībā.LT: Ypač didelė sprogimo rizika nuo smūgio, trinties, ugnies ar kitų uždegimo šaltinių.HU: Ütés, súrlódás, tűz vagy egyéb gyújtóforrás rendkívüli mértékben növeli a robbanásveszélyt.MT: Riskju kbir ħafna ta' splużjoni minn xokk, frizzjoni, nar jew għejun oħra ta' qbid.NL: Ernstig ontploffingsgevaar door schok, wrijving, vuur of andere ontstekingsoorzaken.PL: Skrajne zagrożenie wybuchem wskutek uderzenia, tarcia, kontaktu z ogniem lub innymi źródłami zapłonu.PT: Grande risco de explosão por choque, fricção, fogo ou outras fontes de ignição.RO: Risc mare de explozie la şoc, frecare, foc sau alte surse de aprindere.SK: Mimoriadne riziko výbuchu nárazom, trením, horením alebo inými zdrojmi zapálenia.SL: Velika nevarnost eksplozije ob udarcu, trenju, požaru ali drugih virih vžiga.FI: Erittäin helposti räjähtävää iskun, hankauksen, avotulen tai muun sytytyslähteen vaikutuksesta.SV: Mycket explosivt vid stöt, friktion, eld eller annan antändningsorsak.R4BG: Образува силно чувствителни експлозивни метални съединения.ES: Forma compuestos metálicos explosivos muy sensibles.CS: Vytváří vysoce výbušné kovové sloučeniny.DA: Danner meget følsomme eksplosive metalforbindelser.DE: Bildet hochempfindliche explosionsgefährliche Metallverbindungen.ET: Moodustab väga plahvatusohtlikke metalliühendeid.EL: Σχηματίζει πολύ ευαίσθητες εκρηκτικές μεταλλικές ενώσεις.EN: Forms very sensitive explosive metallic compounds.FR: Forme des composés métalliques explosifs très sensibles.IT: Forma composti metallici esplosivi molto sensibili.LV: Veido sprādzienbīstamus savienojumus ar metāliem.LT: Sudaro labai jautrius sprogstamuosius metalo junginius.HU: Nagyon érzékeny, robbanásveszélyes fémvegyületeket képez.MT: Jifforma komposti metalliċi esplussivi sensittivi ħafna.NL: Vormt met metalen zeer gemakkelijk ontplofbare verbindingen.PL: Tworzy łatwo wybuchające związki metaliczne.PT: Forma compostos metálicos explosivos muito sensíveis.RO: Formează compuşi metalici explozivi foarte sensibili.SK: Vytvára veľmi citlivé výbušné zlúčeniny kovov.SL: Tvori zelo občutljive eksplozivne kovinske spojine.FI: Muodostaa erittäin herkästi räjähtäviä metalliyhdisteitä.SV: Bildar mycket känsliga explosiva metallföreningar.R5BG: Може да предизвика експлозия при нагряване.ES: Peligro de explosión en caso de calentamiento.CS: Zahřívání může způsobit výbuch.DA: Eksplosionsfarlig ved opvarmning.DE: Beim Erwärmen explosionsfähig.ET: Kuumenemine võib põhjustada plahvatuse.EL: Θέρμανση μπορεί να προκαλέσει έκρηξη.EN: Heating may cause an explosion.FR: Danger d'explosion sous l'action de la chaleur.IT: Pericolo di esplosione per riscaldamento.LV: Karsēšana var izraisīt eksploziju.LT: Kaitinama gali sprogti.HU: Hő hatására robbanhat.MT: Jista' jisplodi bis-sħana.NL: Ontploffingsgevaar door verwarming.PL: Ogrzanie grozi wybuchem.PT: Perigo de explosão sob a acção do calor.RO: Pericol de explozie sub acţiunea căldurii.SK: Zahriatie môže spôsobiť výbuch.SL: Segrevanje lahko povzroči eksplozijo.FI: Räjähdysvaarallinen kuumennettaessa.SV: Explosivt vid uppvärmning.R6BG: Експлозивен в или без присъствие на въздух.ES: Peligro de explosión, en contacto o sin contacto con el aire.CS: Výbušný za přístupu i bez přístupu vzduchu.DA: Eksplosiv ved og uden kontakt med luft.DE: Mit und ohne Luft explosionsfähig.ET: Plahvatusohtlik õhuga kokkupuutel või kokkupuuteta.EL: Εκρηκτικό σε επαφή ή χωρίς επαφή με τον αέρα.EN: Explosive with or without contact with air.FR: Danger d'explosion en contact ou sans contact avec l'air.IT: Esplosivo a contatto o senza contatto con l'aria.LV: Sprādzienbīstams gaisa un bezgaisa vidē.LT: Gali sprogti ore arba beorėje aplinkoje.HU: Levegővel érintkezve vagy anélkül is robbanásveszélyes.MT: Jista' jisplodi b'kuntatt jew bla kuntatt ma' l-arja.NL: Ontplofbaar met en zonder lucht.PL: Produkt wybuchowy z dostępem i bez dostępu powietrza.PT: Perigo de explosão em contacto ou sem contacto com o ar.RO: Pericol de explozie în contact sau fără contact cu aerul.SK: Výbušný pri kontakte alebo bez kontaktu so vzduchom.SL: Eksplozivno na zraku ali brez zraka.FI: Räjähtävää sellaisenaan tai ilman kanssa.SV: Explosivt vid kontakt och utan kontakt med luft.R7BG: Може да предизвика пожар.ES: Puede provocar incendios.CS: Může způsobit požár.DA: Kan forårsage brand.DE: Kann Brand verursachen.ET: Võib põhjustada tulekahju.EL: Μπορεί να προκαλέσει πυρκαγιά.EN: May cause fire.FR: Peut provoquer un incendie.IT: Può provocare un incendio.LV: Var izraisīt ugunsgrēku.LT: Pavojinga gaisro atžvilgiu.HU: Tüzet okozhat.MT: Jista' jqabbad nar.NL: Kan brand veroorzaken.PL: Może spowodować pożar.PT: Pode provocar incêndio.RO: Poate provoca un incendiu.SK: Môže spôsobiť požiar.SL: Lahko povzroči požar.FI: Aiheuttaa tulipalon vaaran.SV: Kan orsaka brand.R8BG: Пожароопасен при контакт с горими материали.ES: Peligro de fuego en contacto con materias combustibles.CS: Dotek s hořlavým materiálem může způsobit požár.DA: Brandfarlig ved kontakt med brandbare stoffer.DE: Feuergefahr bei Berührung mit brennbaren Stoffen.ET: Kokkupuutel süttiva ainega võib põhjustada tulekahju.EL: Η επαφή με καύσιμο υλικό μπορεί να προκαλέσει πυρκαγιά.EN: Contact with combustible material may cause fire.FR: Favorise l'inflammation des matières combustibles.IT: Può provocare l'accensione di materie combustibili.LV: Saskaroties ar degošu materiālu, var izraisīt ugunsgrēku.LT: Gali užsidegti dėl sąveikos su galinčiomis degti medžiagomis.HU: Éghető anyaggal érintkezve tüzet okozhat.MT: Kuntatt ma' materjal li jaqbad jista' jqabbad nar.NL: Bevordert de ontbranding van brandbare stoffen.PL: Kontakt z materiałami zapalnymi może spowodować pożar.PT: Favorece a inflamação de matérias combustíveis.RO: Contactul cu materiale combustibile poate provoca incendiu.SK: Pri kontakte s horľavým materiálom môže spôsobiť požiar.SL: V stiku z vnetljivim materialom lahko povzroči požar.FI: Aiheuttaa tulipalon vaaran palavien aineiden kanssa.SV: Kontakt med brännbart material kan orsaka brand.R9BG: Експлозивен при смесване с горими материали.ES: Peligro de explosión al mezclar con materias combustibles.CS: Výbušný při smíchání s hořlavým materiálem.DA: Eksplosionsfarlig ved blanding med brandbare stoffer.DE: Explosionsgefahr bei Mischung mit brennbaren Stoffen.ET: Plahvatusohtlik segatult süttiva ainega.EL: Εκρηκτικό όταν αναμιχθεί με καύσιμα υλικά.EN: Explosive when mixed with combustible material.FR: Peut exploser en mélange avec des matières combustibles.IT: Esplosivo in miscela con materie combustibili.LV: Sprādzienbīstams, sajaucot ar degošu materiālu.LT: Gali sprogti sumaišyta su galinčiomis degti medžiagomis.HU: Éghető anyaggal keveredve robbanásveszélyes.MT: Jisplodi meta jitħallat ma' materjal li jaqbad.NL: Ontploffingsgevaar bij menging met brandbare stoffen.PL: Grozi wybuchem po zmieszaniu z materiałem zapalnym.PT: Pode explodir quando misturado com matérias combustíveis.RO: Exploziv în amestec cu materiale combustibile.SK: Výbušný po zmiešaní s horľavým materiálom.SL: Eksplozivno v mešanici z vnetljivim materialom.FI: Räjähtävää sekoitettaessa palavien aineiden kanssa.SV: Explosivt vid blandning med brännbart material.R10BG: Запалим.ES: Inflamable.CS: Hořlavý.DA: Brandfarlig.DE: Entzündlich.ET: Tuleohtlik.EL: Εύφλεκτο.EN: Flammable.FR: Inflammable.IT: Infiammabile.LV: Uzliesmojošs.LT: Degi.HU: Kis mértékben tűzveszélyesMT: Jieħu n-nar.NL: Ontvlambaar.PL: Produkt łatwopalny.PT: Inflamável.RO: Inflamabil.SK: Horľavý.SL: Vnetljivo.FI: Syttyvää.SV: Brandfarligt.R11BG: Лесно запалим.ES: Fácilmente inflamable.CS: Vysoce hořlavý.DA: Meget brandfarlig.DE: Leichtentzündlich.ET: Väga tuleohtlik.EL: Πολύ εύφλεκτο.EN: Highly flammable.FR: Facilement inflammable.IT: Facilmente infiammabile.LV: Viegli uzliesmojošs.LT: Labai degi.HU: Tűzveszélyes.MT: Jieħu n-nar malajr.NL: Licht ontvlambaar.PL: Produkt wysoce łatwopalny.PT: Facilmente inflamável.RO: Foarte inflamabil.SK: Veľmi horľavý.SL: Lahko vnetljivo.FI: Helposti syttyvää.SV: Mycket brandfarligt.R12BG: Изключително запалим.ES: Extremadamente inflamable.CS: Extrémně hořlavý.DA: Yderst brandfarlig.DE: Hochentzündlich.ET: Eriti tuleohtlik.EL: Εξαιρετικά εύφλεκτο.EN: Extremely flammable.FR: Extrêmement inflammable.IT: Estremamente infiammabile.LV: Īpaši viegli uzliesmojošs.LT: Ypač degi.HU: Fokozottan tűzveszélyes.MT: Jieħu n-nar malajr ħafna.NL: Zeer licht ontvlambaar.PL: Produkt skrajnie łatwopalny.PT: Extremamente inflamável.RO: Extrem de inflamabil.SK: Mimoriadne horľavý.SL: Zelo lahko vnetljivo.FI: Erittäin helposti syttyvää.SV: Extremt brandfarligt.R14BG: Реагира бурно с вода.ES: Reacciona violentamente con el agua.CS: Prudce reaguje s vodou.DA: Reagerer voldsomt med vand.DE: Reagiert heftig mit Wasser.ET: Reageerib ägedalt veega.EL: Αντιδρά βίαια με νερό.EN: Reacts violently with water.FR: Réagit violemment au contact de l'eau.IT: Reagisce violentemente con l'acqua.LV: Aktīvi reaģē ar ūdeni.LT: Smarkiai reaguoja su vandeniu.HU: Vízzel hevesen reagál.MT: Jirreaġixxi bil-qawwa meta jmiss l-ilma.NL: Reageert heftig met water.PL: Reaguje gwałtownie z wodą.PT: Reage violentamente em contacto com a água.RO: Reacţionează violent la contactul cu apa.SK: Prudko reaguje s vodou.SL: Burno reagira z vodo.FI: Reagoi voimakkaasti veden kanssa.SV: Reagerar häftigt med vatten.R15BG: При контакт с вода се отделят изключително запалими газове.ES: Reacciona con el agua liberando gases extremadamente inflamables.CS: Při styku s vodou uvolňuje extrémně hořlavé plyny.DA: Reagerer med vand under dannelse af yderst brandfarlige gasser.DE: Reagiert mit Wasser unter Bildung hochentzündlicher Gase.ET: Kokkupuutel veega eraldub väga tuleohtlik gaas.EL: Σε επαφή με το νερό εκλύει εξαιρετικά εύφλεκτα αέρια.EN: Contact with water liberates extremely flammable gases.FR: Au contact de l'eau, dégage des gaz extrêmement inflammables.IT: A contatto con l'acqua libera gas estremamente infiammabili.LV: Saskaroties ar ūdeni, izdala īpaši viegli uzliesmojošas gāzes.LT: Reaguoja su vandeniu, išskirdama ypač degias dujas.HU: Vízzel érintkezve fokozottan tűzveszélyes gázok képződnek.MT: B'kuntatt ma' l-ilma joħroġ gassijiet li jieħdu n-nar malajr ħafna.NL: Vormt zeer licht ontvlambaar gas in contact met water.PL: W kontakcie z wodą uwalnia skrajnie łatwopalne gazy.PT: Em contacto com a água liberta gases extremamente inflamáveis.RO: La contactul cu apa degajă gaze extrem de inflamabile.SK: Pri kontakte s vodou sa uvoľňujú mimoriadne horľavé plyny.SL: V stiku z vodo se sproščajo zelo lahko vnetljivi plini.FI: Vapauttaa erittäin helposti syttyviä kaasuja veden kanssa.SV: Vid kontakt med vatten bildas extremt brandfarliga gaser.R16BG: Експлозивен при смесване с оксидиращи вещества.ES: Puede explosionar en mezcla con substancias comburentes.CS: Výbušný při smíchání s oxidačními látkami.DA: Eksplosionsfarlig ved blanding med oxiderende stoffer.DE: Explosionsgefährlich in Mischung mit brandfördernden Stoffen.ET: Plahvatusohtlik segatult oksüdeerivate ainetega.EL: Εκρηκτικό όταν αναμιχθεί με οξειδωτικές ουσίες.EN: Explosive when mixed with oxidizing substances.FR: Peut exploser en mélange avec des substances comburantes.IT: Pericolo di esplosione se mescolato con sostanze comburenti.LV: Sprāgst, saskaroties ar oksidētājiem.LT: Gali sprogti sumaišyta su oksiduojančiomis medžiagomis.HU: Oxidáló anyaggal keveredve robbanásveszélyes.MT: Jista' jisplodi meta jitħallat ma' sustanzi li jsaddu.NL: Ontploffingsgevaar bij menging met oxyderende stoffen.PL: Produkt wybuchowy po zmieszaniu z substancjami utleniającymi.PT: Explosivo quando misturado com substâncias comburentes.RO: Exploziv în amestec cu substanţe oxidante.SK: Výbušný po zmiešaní s oxidujúcimi látkami.SL: Eksplozivno v mešanici z oksidativnimi snovmi.FI: Räjähtävää hapettavien aineiden kanssa.SV: Explosivt vid blandning med oxiderande ämnen.R17BG: Самозапалва се в присъствие на въздух.ES: Se inflama espontáneamente en contacto con el aire.CS: Samovznětlivý na vzduchu.DA: Selvantændelig i luft.DE: Selbstentzündlich an der Luft.ET: Isesüttiv õhu käes.EL: Αυτοαναφλέγεται στον αέρα.EN: Spontaneously flammable in air.FR: Spontanément inflammable à l'air.IT: Spontaneamente infiammabile all'aria.LV: Spontāni uzliesmo gaisā.LT: Savaime užsideganti ore.HU: Levegőn öngyulladó.MT: Jaqbad waħdu fl-arja.NL: Spontaan ontvlambaar in lucht.PL: Samorzutnie zapala się w powietrzu.PT: Espontaneamente inflamável ao ar.RO: Inflamabil spontan în aer.SK: Vznietivý na vzduchu.SL: Samovnetljivo na zraku.FI: Itsestään syttyvää ilmassa.SV: Självantänder i luft.R18BG: При употреба може да образува запалима или експлозивна паровъздушнa смес.ES: Al usarlo pueden formarse mezclas aire-vapor explosivas/inflamables.CS: Při používání může vytvářet hořlavé nebo výbušné směsi par se vzduchem.DA: Ved brug kan brandbare dampe/eksplosive damp-luftblandinger dannes.DE: Bei Gebrauch Bildung explosionsfähiger/leichtentzündlicher Dampf/Luft-Gemische möglich.ET: Kasutamisel võib moodustuda tule-/plahvatusohtlik auru-õhu segu.EL: Κατά τη χρήση μπορεί να σχηματίσει εύφλεκτα/εκρηκτικά μείγματα ατμού-αέρος.EN: In use, may form flammable/explosive vapour-air mixture.FR: Lors de l'utilisation, formation possible de mélange vapeur-air inflammable/explosif.IT: Durante l'uso può formare con aria miscele esplosive/infiammabili.LV: Izmantojot var veidot uzliesmojošu vai sprādzienbīstamu tvaiku un gaisa maisījumu.LT: Naudojama gali sudaryti degius (sprogius) garų (oro) mišinius.HU: A használat során robbanásveszélyes/tűzveszélyes gáz-levegő elegy keletkezhet.MT: Meta jintuża jista' jifforma taħlitiet esplussivi jew li jaqbdu jekk jitħallat ma' l-arja.NL: Kan bij gebruik een ontvlambaar/ontplofbaar damp-luchtmengsel vormen.PL: Podczas stosowania mogą powstawać łatwopalne lub wybuchowe mieszaniny par z powietrzem.PT: Pode formar mistura vapor-ar explosiva/inflamável durante a utilização.RO: La utilizare, vaporii pot forma cu aerul amestecuri explozive/inflamabile.SK: Pri použití môže vytvárať horľavé/výbušné zmesi pár so vzduchom.SL: Pri uporabi lahko tvori vnetljivo/eksplozivno zmes hlapi-zrak.FI: Käytössä voi muodostua syttyvä/räjähtävä höyry-ilma-seos.SV: Vid användning kan brännbara/explosiva ång-luftblandningar bildas.R19BG: Може да образува експлозивни пероксиди.ES: Puede formar peróxidos explosivos.CS: Může vytvářet výbušné peroxidy.DA: Kan danne eksplosive peroxider.DE: Kann explosionsfähige Peroxide bilden.ET: Võib moodustada plahvatusohtlikke peroksiide.EL: Μπορεί να σχηματίσει εκρηκτικά υπεροξείδια.EN: May form explosive peroxides.FR: Peut former des peroxydes explosifs.IT: Può formare perossidi esplosivi.LV: Var veidot sprādzienbīstamus peroksīdus.LT: Gali sudaryti sprogstamuosius peroksidus.HU: Robbanásveszélyes peroxidokat képezhet.MT: Jista' jifforma perossidi esplussivi.NL: Kan ontplofbare peroxiden vormen.PL: Może tworzyć wybuchowe nadtlenki.PT: Pode formar peróxidos explosivos.RO: Poate forma peroxizi explozivi.SK: Môže vytvárať výbušné peroxidy.SL: Lahko tvori eksplozivne perokside.FI: Saattaa muodostua räjähtäviä peroksideja.SV: Kan bilda explosiva peroxider.R20BG: Вреден при вдишване.ES: Nocivo por inhalación.CS: Zdraví škodlivý při vdechování.DA: Farlig ved indånding.DE: Gesundheitsschädlich beim Einatmen.ET: Kahjulik sissehingamisel.EL: Επιβλαβές όταν εισπνέεται.EN: Harmful by inhalation.FR: Nocif par inhalation.IT: Nocivo per inalazione.LV: Kaitīgs ieelpojot.LT: Kenksminga įkvėpus.HU: Belélegezve ártalmas.MT: Jagħmel ħsara meta jinxtamm.NL: Schadelijk bij inademing.PL: Działa szkodliwie przez drogi oddechowe.PT: Nocivo por inalação.RO: Nociv prin inhalare.SK: Škodlivý pri vdýchnutí.SL: Zdravju škodljivo pri vdihavanju.FI: Terveydelle haitallista hengitettynä.SV: Farligt vid inandning.R21BG: Вреден при контакт с кожата.ES: Nocivo en contacto con la piel.CS: Zdraví škodlivý při styku s kůží.DA: Farlig ved hudkontakt.DE: Gesundheitsschädlich bei Berührung mit der Haut.ET: Kahjulik kokkupuutel nahaga.EL: Επιβλαβές σε επαφή με το δέρμα.EN: Harmful in contact with skin.FR: Nocif par contact avec la peau.IT: Nocivo a contatto con la pelle.LV: Kaitīgs, nonākot saskarē ar ādu.LT: Kenksminga susilietus su oda.HU: Bőrrel érintkezve ártalmas.MT: Jagħmel ħsara meta jmiss il-ġilda.NL: Schadelijk bij aanraking met de huid.PL: Działa szkodliwie w kontakcie ze skórą.PT: Nocivo em contacto com a pele.RO: Nociv în contact cu pielea.SK: Škodlivý pri kontakte s pokožkou.SL: Zdravju škodljivo v stiku s kožo.FI: Terveydelle haitallista joutuessaan iholle.SV: Farligt vid hudkontakt.R22BG: Вреден при поглъщане.ES: Nocivo por ingestión.CS: Zdraví škodlivý při požití.DA: Farlig ved indtagelse.DE: Gesundheitsschädlich beim Verschlucken.ET: Kahjulik allaneelamisel.EL: Επιβλαβές σε περίπτωση καταπόσεως.EN: Harmful if swallowed.FR: Nocif en cas d'ingestion.IT: Nocivo per ingestione.LV: Kaitīgs norijot.LT: Kenksminga prarijus.HU: Lenyelve ártalmas.MT: Jagħmel ħsara meta jinbela'.NL: Schadelijk bij opname door de mond.PL: Działa szkodliwie po połknięciu.PT: Nocivo por ingestão.RO: Nociv în caz de înghiţire.SK: Škodlivý po požití.SL: Zdravju škodljivo pri zaužitju.FI: Terveydelle haitallista nieltynä.SV: Farligt vid förtäring.R23BG: Токсичен при вдишване.ES: Tóxico por inhalación.CS: Toxický při vdechování.DA: Giftig ved indånding.DE: Giftig beim Einatmen.ET: Mürgine sissehingamisel.EL: Τοξικό όταν εισπνέεται.EN: Toxic by inhalation.FR: Toxique par inhalation.IT: Tossico per inalazione.LV: Toksisks ieelpojot.LT: Toksiška įkvėpus.HU: Belélegezve mérgező (toxikus).MT: Tossiku meta jinxtamm.NL: Vergiftig bij inademing.PL: Działa toksycznie przez drogi oddechowe.PT: Tóxico por inalação.RO: Toxic prin inhalare.SK: Jedovatý pri vdýchnutí.SL: Strupeno pri vdihavanju.FI: Myrkyllistä hengitettynä.SV: Giftigt vid inandning.R24BG: Токсичен при контакт с кожата.ES: Tóxico en contacto con la piel.CS: Toxický při styku s kůží.DA: Giftig ved hudkontakt.DE: Giftig bei Berührung mit der Haut.ET: Mürgine kokkupuutel nahaga.EL: Τοξικό σε επαφή με το δέρμα.EN: Toxic in contact with skin.FR: Toxique par contact avec la peau.IT: Tossico a contatto con la pelle.LV: Toksisks, nonākot saskarē ar ādu.LT: Toksiška susilietus su oda.HU: Bőrrel érintkezve mérgező (toxikus).MT: Tossiku meta jmiss il-ġilda.NL: Vergiftig bij aanraking met de huid.PL: Działa toksycznie w kontakcie ze skórą.PT: Tóxico em contacto com a pele.RO: Toxic în contact cu pielea.SK: Jedovatý pri kontakte s pokožkou.SL: Strupeno v stiku s kožo.FI: Myrkyllistä joutuessaan iholle.SV: Giftigt vid hudkontakt.R25BG: Токсичен при поглъщане.ES: Tóxico por ingestión.CS: Toxický při požití.DA: Giftig ved indtagelse.DE: Giftig beim Verschlucken.ET: Mürgine allaneelamisel.EL: Τοξικό σε περίπτωση καταπόσεως.EN: Toxic if swallowed.FR: Toxique en cas d'ingestion.IT: Tossico per ingestione.LV: Toksisks norijot.LT: Toksiška prarijus.HU: Lenyelve mérgező (toxikus).MT: Tossiku jekk jinbela'.NL: Vergiftig bij opname door de mond.PL: Działa toksycznie po połknięciu.PT: Tóxico por ingestão.RO: Toxic în caz de înghiţire.SK: Jedovatý po požití.SL: Strupeno pri zaužitju.FI: Myrkyllistä nieltynä.SV: Giftigt vid förtäring.R26BG: Силно токсичен при вдишване.ES: Muy tóxico por inhalación.CS: Vysoce toxický při vdechování.DA: Meget giftig ved indånding.DE: Sehr giftig beim Einatmen.ET: Väga mürgine sissehingamisel.EL: Πολύ τοξικό όταν εισπνέεται.EN: Very toxic by inhalation.FR: Très toxique par inhalation.IT: Molto tossico per inalazione.LV: Ļoti toksisks ieelpojot.LT: Labai toksiška įkvėpus.HU: Belélegezve nagyon mérgező (toxikus).MT: Tossiku ħafna meta jinxtamm.NL: Zeer vergiftig bij inademing.PL: Działa bardzo toksycznie przez drogi oddechowe.PT: Muito tóxico por inalação.RO: Foarte toxic prin inhalare.SK: Veľmi jedovatý pri vdýchnutí.SL: Zelo strupeno pri vdihavanju.FI: Erittäin myrkyllistä hengitettynä.SV: Mycket giftigt vid inandning.R27BG: Силно токсичен при контакт с кожата.ES: Muy tóxico en contacto con la piel.CS: Vysoce toxický při styku s kůží.DA: Meget giftig ved hudkontakt.DE: Sehr giftig bei Berührung mit der Haut.ET: Väga mürgine kokkupuutel nahaga.EL: Πολύ τοξικό σε επαφή με το δέρμα.EN: Very toxic in contact with skin.FR: Très toxique par contact avec la peau.IT: Molto tossico a contatto con la pelle.LV: Ļoti toksisks, nonākot saskarē ar ādu.LT: Labai toksiška susilietus su oda.HU: Bőrrel érintkezve nagyon mérgező (toxikus).MT: Tossiku ħafna meta jmiss il-ġilda.NL: Zeer vergiftig bij aanraking met de huid.PL: Działa bardzo toksycznie w kontakcie ze skórą.PT: Muito tóxico em contacto com a pele.RO: Foarte toxic în contact cu pielea.SK: Veľmi jedovatý pri kontakte s pokožkou.SL: Zelo strupeno v stiku s kožo.FI: Erittäin myrkyllistä joutuessaan iholle.SV: Mycket giftigt vid hudkontakt.R28BG: Силно токсичен при поглъщане.ES: Muy tóxico por ingestión.CS: Vysoce toxický při požití.DA: Meget giftig ved indtagelse.DE: Sehr giftig beim Verschlucken.ET: Väga mürgine allaneelamisel.EL: Πολύ τοξικό σε περίπτωση καταπόσεως.EN: Very toxic if swallowed.FR: Très toxique en cas d'ingestion.IT: Molto tossico per ingestione.LV: Ļoti toksisks norijot.LT: Labai toksiška prarijus.HU: Lenyelve nagyon mérgező (toxikus).MT: Tossiku ħafna jekk jinbela'.NL: Zeer vergiftig bij opname door de mond.PL: Działa bardzo toksycznie po połknięciu.PT: Muito tóxico por ingestão.RO: Foarte toxic în caz de înghiţire.SK: Veľmi jedovatý po požití.SL: Zelo strupeno pri zaužitju.FI: Erittäin myrkyllistä nieltynä.SV: Mycket giftigt vid förtäring.R29BG: При контакт с вода се отделя токсичен газ.ES: En contacto con agua libera gases tóxicos.CS: Uvolňuje toxický plyn při styku s vodou.DA: Udvikler giftig gas ved kontakt med vand.DE: Entwickelt bei Berührung mit Wasser giftige Gase.ET: Kokkupuutel veega eraldub mürgine gaas.EL: Σε επαφή με το νερό ελευθερώνονται τοξικά αέρια.EN: Contact with water liberates toxic gas.FR: Au contact de l'eau, dégage des gaz toxiques.IT: A contatto con l'acqua libera gas tossici.LV: Saskaroties ar ūdeni, izdala toksiskas gāzes.LT: Reaguodama su vandeniu, išskiria toksiškas dujas.HU: Vízzel érintkezve mérgező gázok képződnek.MT: Jitfa' gass tossiku meta jmiss l-ilma.NL: Vormt vergiftig gas in contact met water.PL: W kontakcie z wodą uwalnia toksyczne gazy.PT: Em contacto com a água liberta gases tóxicos.RO: La contactul cu apa se degajă gaze toxice.SK: Pri kontakte s vodou uvoľňuje jedovatý plyn.SL: V stiku z vodo se sprošča strupen plin.FI: Kehittää myrkyllistä kaasua veden kanssa.SV: Utvecklar giftig gas vid kontakt med vatten.R30BG: Може да стане лесно запалим при употреба.ES: Puede inflamarse fácilmente al usarlo.CS: Při používání se může stát vysoce hořlavým.DA: Kan blive meget brandfarlig under brug.DE: Kann bei Gebrauch leicht entzündlich werden.ET: Kasutamisel võib muutuda väga tuleohtlikuks.EL: Κατά τη χρήση γίνεται πολύ εύφλεκτο.EN: Can become highly flammable in use.FR: Peut devenir facilement inflammable pendant l'utilisation.IT: Può divenire facilmente infiammabile durante l'uso.LV: Var viegli uzliesmot lietošanas laikā.LT: Naudojama gali tapti labai degi.HU: A használat során tűzveszélyessé válik.MT: Jista' jaqbad malajr waqt li jintuża.NL: Kan bij gebruik licht ontvlambaar worden.PL: Podczas stosowania może stać się wysoce łatwopalny.PT: Pode-se tornar facilmente inflamável durante o uso.RO: Poate deveni foarte inflamabil în timpul utilizării.SK: Pri použití sa môže stať veľmi horľavým.SL: Med uporabo utegne postati 'lahko vnetljivo'.FI: Käytettäessä voi muuttua helposti syttyväksi.SV: Kan bli mycket brandfarligt vid användning.R31BG: При контакт с киселини се отделя токсичен газ.ES: En contacto con ácidos libera gases tóxicos.CS: Uvolňuje toxický plyn při styku s kyselinami.DA: Udvikler giftig gas ved kontakt med syre.DE: Entwickelt bei Berührung mit Säure giftige Gase.ET: Kokkupuutel hapetega eraldub mürgine gaas.EL: Σε επαφή με οξέα ελευθερώνονται τοξικά αέρια.EN: Contact with acids liberates toxic gas.FR: Au contact d'un acide, dégage un gaz toxique.IT: A contatto con acidi libera gas tossico.LV: Saskaroties ar skābēm, izdala toksiskas gāzes.LT: Reaguodama su rūgštimis, išskiria toksiškas dujas.HU: Savval érintkezve mérgező gázok képződnek.MT: Jitfa' gass tossiku meta jmiss l-aċidi.NL: Vormt vergiftige gassen in contact met zuren.PL: W kontakcie z kwasami uwalnia toksyczne gazy.PT: Em contacto com ácidos liberta gases tóxicos.RO: La contactul cu acizii se degajă gaze toxice.SK: Pri kontakte s kyselinami uvoľňuje jedovatý plyn.SL: V stiku s kislinami se sprošča strupen plin.FI: Kehittää myrkyllistä kaasua hapon kanssa.SV: Utvecklar giftig gas vid kontakt med syra.R32BG: При контакт с киселини се отделя силно токсичен газ.ES: En contacto con ácidos libera gases muy tóxicos.CS: Uvolňuje vysoce toxický plyn při styku s kyselinami.DA: Udvikler meget giftig gas ved kontakt med syre.DE: Entwickelt bei Berührung mit Säure sehr giftige Gase.ET: Kokkupuutel hapetega eraldub väga mürgine gaas.EL: Σε επαφή με οξέα ελευθερώνονται πολύ τοξικά αέρια.EN: Contact with acids liberates very toxic gas.FR: Au contact d'un acide, dégage un gaz très toxique.IT: A contatto con acidi libera gas molto tossico.LV: Saskaroties ar skābēm, izdala ļoti toksiskas gāzes.LT: Reaguodama su rūgštimis, išskiria labai toksiškas dujas.HU: Savval érintkezve nagyon mérgező gázok képződnek.MT: Jitfa' gass tossiku ħafna meta jmiss l-aċidi.NL: Vormt zeer vergiftige gassen in contact met zuren.PL: W kontakcie z kwasami uwalnia bardzo toksyczne gazy.PT: Em contacto com ácidos liberta gases muito tóxicos.RO: La contactul cu acizii se degajă gaze foarte toxice.SK: Pri kontakte s kyselinami uvoľňuje veľmi jedovatý plyn.SL: V stiku s kislinami se sprošča zelo strupen plin.FI: Kehittää erittäin myrkyllistä kaasua hapon kanssa.SV: Utvecklar mycket giftig gas vid kontakt med syra.R33BG: Опасност от кумулативни ефекти.ES: Peligro de efectos acumulativos.CS: Nebezpečí kumulativních účinků.DA: Kan ophobes i kroppen efter gentagen brug.DE: Gefahr kumulativer Wirkungen.ET: Kumulatiivse toime oht.EL: Κίνδυνος αθροιστικών επιδράσεων.EN: Danger of cumulative effects.FR: Danger d'effets cumulatifs.IT: Pericolo di effetti cumulativi.LV: Kaitīgas kumulatīvas ietekmes draudi.LT: Pavojinga — kaupiasi organizme.HU: A halmozódó (kumulatív) hatások miatt veszélyes.MT: Periklu ta' effetti kumulattivi.NL: Gevaar voor cumulatieve effecten.PL: Niebezpieczeństwo kumulacji w organizmie.PT: Perigo de efeitos cumulativos.RO: Pericol de efecte cumulative.SK: Nebezpečenstvo kumulatívnych účinkov.SL: Nevarnost za zdravje zaradi kopičenja v organizmu.FI: Terveydellisten haittojen vaara pitkäaikaisessa altistuksessa.SV: Kan ansamlas i kroppen och ge skador.R34BG: Предизвиква изгаряния.ES: Provoca quemaduras.CS: Způsobuje poleptání.DA: Ætsningsfare.DE: Verursacht Verätzungen.ET: Põhjustab söövitust.EL: Προκαλεί εγκαύματα.EN: Causes burns.FR: Provoque des brûlures.IT: Provoca ustioni.LV: Rada apdegumus.LT: Nudegina.HU: Égési sérülést okoz.MT: Jikkaġuna l-ħruq (fil-ġisem).NL: Veroorzaakt brandwonden.PL: Powoduje oparzenia.PT: Provoca queimaduras.RO: Provoacă arsuri.SK: Spôsobuje popáleniny/poleptanie.SL: Povzroča opekline.FI: Syövyttävää.SV: Frätande.R35BG: Предизвиква тежки изгаряния.ES: Provoca quemaduras graves.CS: Způsobuje těžké poleptání.DA: Alvorlig ætsningsfare.DE: Verursacht schwere Verätzungen.ET: Põhjustab tugevat söövitust.EL: Προκαλεί σοβαρά εγκαύματα.EN: Causes severe burns.FR: Provoque de graves brûlures.IT: Provoca gravi ustioni.LV: Rada smagus apdegumus.LT: Stipriai nudegina.HU: Súlyos égési sérülést okoz.MT: Jikkaġuna ħruq serju (fil-ġisem).NL: Veroorzaakt ernstige brandwonden.PL: Powoduje poważne oparzenia.PT: Provoca queimaduras graves.RO: Provoacă arsuri grave.SK: Spôsobuje silné popáleniny/poleptanie.SL: Povzroča hude opekline.FI: Voimakkaasti syövyttävää.SV: Starkt frätande.R36BG: Дразни очите.ES: Irrita los ojos.CS: Dráždí oči.DA: Irriterer øjnene.DE: Reizt die Augen.ET: Ärritab silmi.EL: Ερεθίζει τα μάτια.EN: Irritating to eyes.FR: Irritant pour les yeux.IT: Irritante per gli occhi.LV: Kairina acis.LT: Dirgina akis.HU: Szemizgató hatású.MT: Jirrita l-għajnejn.NL: Irriterend voor de ogen.PL: Działa drażniąco na oczy.PT: Irritante para os olhos.RO: Iritant pentru ochi.SK: Dráždi oči.SL: Draži oči.FI: Ärsyttää silmiä.SV: Irriterar ögonen.R37BG: Дразни дихателните пътища.ES: Irrita las vías respiratorias.CS: Dráždí dýchací orgány.DA: Irriterer åndedrætsorganerne.DE: Reizt die Atmungsorgane.ET: Ärritab hingamiselundeid.EL: Ερεθίζει το αναπνευστικό σύστημα.EN: Irritating to respiratory system.FR: Irritant pour les voies respiratoires.IT: Irritante per le vie respiratorie.LV: Kairina elpošanas sistēmu.LT: Dirgina kvėpavimo takus.HU: Izgatja a légutakat.MT: Jirrita s-sistema respiratorja.NL: Irriterend voor de ademhalingswegen.PL: Działa drażniąco na drogi oddechowe.PT: Irritante para as vias respiratórias.RO: Iritant pentru sistemul respirator.SK: Dráždi dýchacie cesty.SL: Draži dihala.FI: Ärsyttää hengityselimiä.SV: Irriterar andningsorganen.R38BG: Дразни кожата.ES: Irrita la piel.CS: Dráždí kůži.DA: Irriterer huden.DE: Reizt die Haut.ET: Ärritab nahka.EL: Ερεθίζει το δέρμα.EN: Irritating to skin.FR: Irritant pour la peau.IT: Irritante per la pelle.LV: Kairina ādu.LT: Dirgina odą.HU: Bőrizgató hatású.MT: Jirrita l-ġilda.NL: Irriterend voor de huid.PL: Działa drażniąco na skórę.PT: Irritante para a pele.RO: Iritant pentru piele.SK: Dráždi pokožku.SL: Draži kožo.FI: Ärsyttää ihoa.SV: Irriterar huden.R39BG: Опасност от много тежки необратими ефекти.ES: Peligro de efectos irreversibles muy graves.CS: Nebezpečí velmi vážných nevratných účinků.DA: Fare for varig alvorlig skade på helbred.DE: Ernste Gefahr irreversiblen Schadens.ET: Väga tõsiste pöördumatute tervisekahjustuste oht.EL: Κίνδυνος πολύ σοβαρών μονίμων επιδράσεων.EN: Danger of very serious irreversible effects.FR: Danger d'effets irréversibles très graves.IT: Pericolo di effetti irreversibili molto gravi.LV: Būtiski neatgriezeniskas iedarbības draudi.LT: Sukelia labai sunkius negrįžtamus sveikatos pakenkimus.HU: Nagyon súlyos és maradandó egészségkárosodást okozhat.MT: Periklu ta' effetti serji irreversibbli.NL: Gevaar voor ernstige onherstelbare effecten.PL: Zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Perigo de efeitos irreversíveis muito graves.RO: Pericol de efecte ireversibile foarte grave.SK: Nebezpečenstvo veľmi vážnych ireverzibilných účinkov.SL: Nevarnost zelo hudih trajnih okvar zdravja.FI: Erittäin vakavien pysyvien vaurioiden vaara.SV: Risk för mycket allvarliga bestående hälsoskador.R40BG: Съществуващи, но недостатъчни данни за канцерогенен ефект.ES: Posibles efectos cancerígenos.CS: Podezření na karcinogenní účinky.DA: Mulighed for kræftfremkaldende effekt.DE: Verdacht auf krebserzeugende Wirkung.ET: Võimalik vähktõve põhjustaja.EL: Ύποπτο καρκινογένεσης.EN: Limited evidence of a carcinogenic effect.FR: Effet cancérogène suspecté — preuves insuffisantes.IT: Possibilità di effetti cancerogeni — prove insufficienti.LV: Kancerogenitāte ir daļēji pierādīta.LT: Įtariama, kad gali sukelti vėžį.HU: A rákkeltő hatás korlátozott mértékben bizonyított.MT: Possibilità, mhix għal kollox ippruvata, ta’ effetti kanċeroġeni.NL: Carcinogene effecten zijn niet uitgesloten.PL: Ograniczone dowody działania rakotwórczego.PT: Possibilidade de efeitos cancerígenos.RO: Posibil efect cancerigen — dovezi insuficiente.SK: Možnosť karcinogénneho účinku.SL: Možen rakotvoren učinek.FI: Epäillään aiheuttavan syöpäsairauden vaaraa.SV: Misstänks kunna ge cancer.R41BG: Риск от тежко увреждане на очите.ES: Riesgo de lesiones oculares graves.CS: Nebezpečí vážného poškození očí.DA: Risiko for alvorlig øjenskade.DE: Gefahr ernster Augenschäden.ET: Silmade kahjustamise tõsine oht.EL: Κίνδυνος σοβαρών οφθαλμικών βλαβών.EN: Risk of serious damage to eyes.FR: Risque de lésions oculaires graves.IT: Rischio di gravi lesioni oculari.LV: Nopietnu bojājumu draudi acīm.LT: Gali smarkiai pažeisti akis.HU: Súlyos szemkárosodást okozhat.MT: Riskju ta' ħsara serja lill-għajnejn.NL: Gevaar voor ernstig oogletsel.PL: Ryzyko poważnego uszkodzenia oczu.PT: Risco de lesões oculares graves.RO: Risc de leziuni oculare grave.SK: Riziko vážneho poškodenia očí.SL: Nevarnost hudih poškodb oči.FI: Vakavan silmävaurion vaara.SV: Risk för allvarliga ögonskador.R42BG: Възможна е сенсибилизация при вдишване.ES: Posibilidad de sensibilización por inhalación.CS: Může vyvolat senzibilizaci při vdechování.DA: Kan give overfølsomhed ved indånding.DE: Sensibilisierung durch Einatmen möglich.ET: Sissehingamisel võib põhjustada ülitundlikkust.EL: Μπορεί να προκαλέσει ευαισθητοποίηση όταν εισπνέεται.EN: May cause sensitization by inhalation.FR: Peut entraîner une sensibilisation par inhalation.IT: Può provocare sensibilizzazione per inalazione.LV: Ieelpojot var izraisīt paaugstinātu jutīgumu.LT: Gali sukelti alergiją įkvėpus.HU: Belélegezve túlérzékenységet okozhat (szenzibilizáló hatású lehet).MT: Jista' jġib sensitizzazzjoni meta jinxtamm.NL: Kan overgevoeligheid veroorzaken bij inademing.PL: Może powodować uczulenie w następstwie narażenia drogą oddechową.PT: Pode causar sensibilização por inalação.RO: Poate provoca o sensibilizare prin inhalare.SK: Môže spôsobiť senzibilizáciu pri vdýchnutí.SL: Vdihavanje lahko povzroči preobčutljivost.FI: Altistuminen hengitysteitse voi aiheuttaa herkistymistä.SV: Kan ge allergi vid inandning.R43BG: Възможна е сенсибилизация при контакт с кожата.ES: Posibilidad de sensibilización en contacto con la piel.CS: Může vyvolat senzibilizaci při styku s kůží.DA: Kan give overfølsomhed ved kontakt med huden.DE: Sensibilisierung durch Hautkontakt möglich.ET: Kokkupuutel nahaga võib põhjustada ülitundlikkust.EL: Μπορεί να προκαλέσει ευαισθητοποίηση σε επαφή με το δέρμα.EN: May cause sensitisation by skin contact.FR: Peut entraîner une sensibilisation par contact avec la peau.IT: Può provocare sensibilizzazione per contatto con la pelle.LV: Saskaroties ar ādu, var izraisīt paaugstinātu jutīgumu.LT: Gali sukelti alergiją susilietus su oda.HU: Bőrrel érintkezve túlérzékenységet okozhat (szenzibilizáló hatású lehet).MT: Jista' jikkaġuna sensitizzazzjoni meta jmiss il-ġilda.NL: Kan overgevoeligheid veroorzaken bij contact met de huid.PL: Może powodować uczulenie w kontakcie ze skórą.PT: Pode causar sensibilização em contacto com a pele.RO: Poate provoca o sensibilizare în contact cu pielea.SK: Môže spôsobiť senzibilizáciu pri kontakte s pokožkou.SL: Stik s kožo lahko povzroči preobčutljivost.FI: Ihokosketus voi aiheuttaa herkistymistä.SV: Kan ge allergi vid hudkontakt.R44BG: Риск от експлозия при нагряване в затворено пространство.ES: Riesgo de explosión al calentarlo en ambiente confinado.CS: Nebezpečí výbuchu při zahřátí v uzavřeném obalu.DA: Eksplosionsfarlig ved opvarmning under indeslutning.DE: Explosionsgefahr bei Erhitzen unter Einschluss.ET: Plahvatusohtlik kuumutamisel kinnises mahutis.EL: Κίνδυνος εκρήξεως εάν θερμανθεί υπό περιορισμό.EN: Risk of explosion if heated under confinement.FR: Risque d'explosion si chauffé en ambiance confinée.IT: Rischio di esplosione per riscaldamento in ambiente confinato.LV: Sprādziena draudi, karsējot slēgtā vidē.LT: Gali sprogti, jei kaitinama sandariai uždaryta.HU: Zárt térben hő hatására robbanhat.MT: Riskju ta' splużjoni jekk jissaħħan fil-magħluq.NL: Ontploffingsgevaar bij verwarming in afgesloten toestand.PL: Zagrożenie wybuchem po ogrzaniu w zamkniętym pojemniku.PT: Risco de explosão se aquecido em ambiente fechado.RO: Risc de explozie dacă este încălzit în spaţiu închis.SK: Riziko výbuchu pri zahrievaní v uzavretom priestore.SL: Nevarnost eksplozije ob segrevanju v zaprtem prostoru.FI: Räjähdysvaara kuumennettaessa suljetussa astiassa.SV: Explosionsrisk vid uppvärmning i sluten behållare.R45BG: Може да причини рак.ES: Puede causar cáncer.CS: Může vyvolat rakovinu.DA: Kan fremkalde kræft.DE: Kann Krebs erzeugen.ET: Võib põhjustada vähktõbe.EL: Μπορεί να προκαλέσει καρκίνο.EN: May cause cancer.FR: Peut provoquer le cancer.IT: Può provocare il cancro.LV: Kancerogēna viela.LT: Gali sukelti vėžį.HU: Rákot okozhat (karcinogén hatású lehet).MT: Jista' jġib il-kanċer.NL: Kan kanker veroorzaken.PL: Może powodować raka.PT: Pode causar cancro.RO: Poate cauza cancer.SK: Môže spôsobiť rakovinu.SL: Lahko povzroči raka.FI: Aiheuttaa syöpäsairauden vaaraa.SV: Kan ge cancer.R46BG: Може да причини наследствено генетично увреждане.ES: Puede causar alteraciones genéticas hereditarias.CS: Může vyvolat poškození dědičných vlastností.DA: Kan forårsage arvelige genetiske skader.DE: Kann vererbbare Schäden verursachen.ET: Võib põhjustada pärilikke kahjustusi.EL: Μπορεί να προκαλέσει κληρονομικές γενετικές βλάβες.EN: May cause heritable genetic damage.FR: Peut provoquer des altérations génétiques héréditaires.IT: Può provocare alterazioni genetiche ereditarie.LV: Var radīt pārmantojamus ģenētiskus defektus.LT: Gali sukelti paveldimus genetinius pakenkimus.HU: Öröklődő genetikai károsodást okozhat (mutagén hatású lehet).MT: Jista' jikkaġuna ħsara ġenetika li tintiret.NL: Kan erfelijke genetische schade veroorzaken.PL: Może powodować dziedziczne wady genetyczne.PT: Pode causar alterações genéticas hereditárias.RO: Poate provoca modificări genetice ereditare.SK: Môže spôsobiť dedičné genetické poškodenie.SL: Lahko povzroči dedne genetske okvare.FI: Saattaa aiheuttaa periytyviä perimävaurioita.SV: Kan ge ärftliga genetiska skador.R48BG: Опасност от тежко увреждане на здравето при продължителна експозиция.ES: Riesgo de efectos graves para la salud en caso de exposición prolongada.CS: Při dlouhodobé expozici nebezpečí vážného poškození zdraví.DA: Alvorlig sundhedsfare ved længere tids påvirkning.DE: Gefahr ernster Gesundheitsschäden bei längerer Exposition.ET: Pikaajalisel toimel tõsise tervisekahjustuse oht.EL: Κίνδυνος σοβαρής βλάβης της υγείας ύστερα απο παρατεταμένη έκθεση.EN: Danger of serious damage to health by prolonged exposure.FR: Risque d'effets graves pour la santé en cas d'exposition prolongée.IT: Pericolo di gravi danni per la salute in caso di esposizione prolungata.LV: Iespējams nopietns kaitējums veselībai pēc ilgstošas saskares.LT: Veikiant ilgą laiką sukelia sunkius sveikatos sutrikimus.HU: Hosszú időn át hatva súlyos egészségkárosodást okozhat.MT: Periklu ta' ħsara serja lis-saħħa jekk wieħed ikun espost għalih fit-tul.NL: Gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling.PL: Stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Risco de efeitos graves para a saúde em caso de exposição prolongada.RO: Pericol de efecte grave asupra sănătăţii în caz de expunere prelungită.SK: Nebezpečenstvo vážneho poškodenia zdravia pri dlhodobej expozícii.SL: Nevarnost hudih okvar zdravja pri dolgotrajnejši izpostavljenosti.FI: Pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle.SV: Risk för allvarliga hälsoskador vid långvarig exponering.R49BG: Може да причини рак при вдишване.ES: Puede causar cáncer por inhalación.CS: Může vyvolat rakovinu při vdechování.DA: Kan fremkalde kræft ved indånding.DE: Kann Krebs erzeugen beim Einatmen.ET: Sissehingamisel võib põhjustada vähktõbe.EL: Μπορεί να προκαλέσει καρκίνο όταν εισπνέεται.EN: May cause cancer by inhalation.FR: Peut provoquer le cancer par inhalation.IT: Può provocare il cancro per inalazione.LV: Ieelpojot var izraisīt ļaundabīgus audzējus.LT: Gali sukelti vėžį įkvėpus.HU: Belélegezve rákot okozhat (karcinogén hatású lehet).MT: Jista' jikkaġuna l-kanċer meta jinxtamm.NL: Kan kanker veroorzaken bij inademing.PL: Może powodować raka w następstwie narażenia drogą oddechową.PT: Pode causar cancro por inalação.RO: Poate cauza cancer prin inhalare.SK: Môže spôsobiť rakovinu pri vdýchnutí.SL: Pri vdihavanju lahko povzroči raka.FI: Aiheuttaa syöpäsairauden vaaraa hengitettynä.SV: Kan ge cancer vid inandning.R50BG: Силно токсичен за водни организми.ES: Muy tóxico para los organismos acuáticos.CS: Vysoce toxický pro vodní organismy.DA: Meget giftig for organismer, der lever i vand.DE: Sehr giftig für Wasserorganismen.ET: Väga mürgine veeorganismidele.EL: Πολύ τοξικό για τους υδρόβιους οργανισμούς.EN: Very toxic to aquatic organisms.FR: Très toxique pour les organismes aquatiques.IT: Altamente tossico per gli organismi acquatici.LV: Ļoti toksisks ūdens organismiem.LT: Labai toksiška vandens organizmams.HU: Nagyon mérgező a vízi szervezetekre.MT: Tossiku ħafna għal organiżmi akwatiċi.NL: Zeer vergiftig voor in het water levende organismen.PL: Działa bardzo toksycznie na organizmy wodne.PT: Muito tóxico para os organismos aquáticos.RO: Foarte toxic pentru organismele acvatice.SK: Veľmi jedovatý pre vodné organizmy.SL: Zelo strupeno za vodne organizme.FI: Erittäin myrkyllistä vesieliöille.SV: Mycket giftigt för vattenlevande organismer.R51BG: Токсичен за водни организми.ES: Tóxico para los organismos acuáticos.CS: Toxický pro vodní organismy.DA: Giftig for organismer, der lever i vand.DE: Giftig für Wasserorganismen.ET: Mürgine veeorganismidele.EL: Τοξικό για τους υδρόβιους οργανισμούς.EN: Toxic to aquatic organisms.FR: Toxique pour les organismes aquatiques.IT: Tossico per gli organismi acquatici.LV: Toksisks ūdens organismiem.LT: Toksiška vandens organizmams.HU: Mérgező a vízi szervezetekre.MT: Tossiku għal organiżmi akwatiċi.NL: Vergiftig voor in het water levende organismen.PL: Działa toksycznie na organizmy wodne.PT: Tóxico para os organismos aquáticos.RO: Toxic pentru organismele acvatice.SK: Jedovatý pre vodné organizmy.SL: Strupeno za vodne organizme.FI: Myrkyllistä vesieliöille.SV: Giftigt för vattenlevande organismer.R52BG: Вреден за водни организми.ES: Nocivo para los organismos acuáticos.CS: Škodlivý pro vodní organismy.DA: Skadelig for organismer, der lever i vand.DE: Schädlich für Wasserorganismen.ET: Kahjulik veeorganismidele.EL: Επιβλαβές για τους υδρόβιους οργανισμούς.EN: Harmful to aquatic organisms.FR: Nocif pour les organismes aquatiques.IT: Nocivo per gli organismi acquatici.LV: Kaitīgs ūdens organismiem.LT: Kenksminga vandens organizmams.HU: Ártalmas a vízi szervezetekre.MT: Jaħmel ħsara lil organiżmi akwatiċi.NL: Schadelijk voor in het water levende organismen.PL: Działa szkodliwie na organizmy wodne.PT: Nocivo para os organismos aquáticos.RO: Nociv pentru organismele acvatice.SK: Škodlivý pre vodné organizmy.SL: Škodljivo za vodne organizme.FI: Haitallista vesieliöille.SV: Skadligt för vattenlevande organismer.R53BG: Може да причини дълготрайни неблагоприятни ефекти във водната среда.ES: Puede provocar a largo plazo efectos negativos en el medio ambiente acuático.CS: Může vyvolat dlouhodobé nepříznivé účinky ve vodním prostředí.DA: Kan forårsage uønskede langtidsvirkninger i vandmiljøet.DE: Kann in Gewässern längerfristig schädliche Wirkungen haben.ET: Võib avaldada pikaajalist veekeskkonda kahjustavat toimet.EL: Μπορεί να προκαλέσει μακροχρόνιες δυσμενείς επιπτώσεις στο υδάτινο περιβάλλον.EN: May cause long-term adverse effects in the aquatic environment.FR: Peut entraîner des effets néfastes à long terme pour l'environnement aquatique.IT: Può provocare a lungo termine effetti negativi per l'ambiente acquatico.LV: Var radīt ilglaicīgu negatīvu ietekmi ūdens vidē.LT: Gali sukelti ilgalaikius nepalankius vandens ekosistemų pakitimus.HU: A vízi környezetben hosszan tartó károsodást okozhat.MT: Jista' jikkaġuna effetti ħżiena fit-tul lill-ambjent akwatiku.NL: Kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.PL: Może powodować długo utrzymujące się niekorzystne zmiany w środowisku wodnym.PT: Pode causar efeitos nefastos a longo prazo no ambiente aquático.RO: Poate provoca efecte adverse pe termen lung asupra mediului acvatic.SK: Môže spôsobiť dlhodobé škodlivé účinky vo vodnej zložke životného prostredia.SL: Lahko povzroči dolgotrajne škodljive učinke na vodno okolje.FI: Voi aiheuttaa pitkäaikaisia haittavaikutuksia vesiympäristössä.SV: Kan orsaka skadliga långtidseffekter i vattenmiljön.R54BG: Токсичен за флората.ES: Tóxico para la flora.CS: Toxický pro rostliny.DA: Giftig for planter.DE: Giftig für Pflanzen.ET: Mürgine taimedele.EL: Τοξικό για τη χλωρίδα.EN: Toxic to flora.FR: Toxique pour la flore.IT: Tossico per la flora.LV: Toksisks augiem.LT: Toksiška augmenijai.HU: Mérgező a növényekre.MT: Tossiku għall-flora.NL: Vergiftig voor planten.PL: Działa toksycznie na rośliny.PT: Tóxico para a flora.RO: Toxic pentru floră.SK: Jedovatý pre flóru.SL: Strupeno za rastline.FI: Myrkyllistä kasveille.SV: Giftigt för växter.R55BG: Токсичен за фауната.ES: Tóxico para la fauna.CS: Toxický pro živočichy.DA: Giftig for dyr.DE: Giftig für Tiere.ET: Mürgine loomadele.EL: Τοξικό για την πανίδα.EN: Toxic to fauna.FR: Toxique pour la faune.IT: Tossico per la fauna.LV: Toksisks dzīvniekiem.LT: Toksiška gyvūnijai.HU: Mérgező az állatokra.MT: Tossiku għall-fawna.NL: Vergiftig voor dieren.PL: Działa toksycznie na zwierzęta.PT: Tóxico para a fauna.RO: Toxic pentru faună.SK: Jedovatý pre faunu.SL: Strupeno za živali.FI: Myrkyllistä eläimille.SV: Giftigt för djur.R56BG: Токсичен за почвените организми.ES: Tóxico para los organismos del suelo.CS: Toxický pro půdní organismy.DA: Giftig for organismer i jordbunden.DE: Giftig für Bodenorganismen.ET: Mürgine mullaorganismidele.EL: Τοξικό για τους οργανισμούς του εδάφους.EN: Toxic to soil organisms.FR: Toxique pour les organismes du sol.IT: Tossico per gli organismi del terreno.LV: Toksisks augsnes organismiem.LT: Toksiška dirvožemio organizmams.HU: Mérgező a talaj szervezeteire.MT: Tossiku għal organiżmi tal-ħamrija.NL: Vergiftig voor bodemorganismen.PL: Działa toksycznie na organizmy glebowe.RO: Toxic pentru organismele din sol.PT: Tóxico para os organismos do solo.SK: Jedovatý pre pôdne organizmy.SL: Strupeno za organizme v zemlji.FI: Myrkyllistä maaperäeliöille.SV: Giftigt för marklevande organismer.R57BG: Токсичен за пчелите.ES: Tóxico para las abejas.CS: Toxický pro včely.DA: Giftig for bier.DE: Giftig für Bienen.ET: Mürgine mesilastele.EL: Τοξικό για τις μέλισσες.EN: Toxic to bees.FR: Toxique pour les abeilles.IT: Tossico per le api.LV: Toksisks bitēm.LT: Toksiška bitėms.HU: Mérgező a méhekre.MT: Tossiku għan-naħal.NL: Vergiftig voor bijen.PL: Działa toksycznie na pszczoły.PT: Tóxico para as abelhas.RO: Toxic pentru albine.SK: Jedovatý pre včely.SL: Strupeno za čebele.FI: Myrkyllistä mehiläisille.SV: Giftigt för bin.R58BG: Може да причини дълготрайни неблагоприятни ефекти върху околната среда.ES: Puede provocar a largo plazo efectos negativos en el medio ambiente.CS: Může vyvolat dlouhodobé nepříznivé účinky v životním prostředí.DA: Kan forårsage uønskede langtidsvirkninger i miljøet.DE: Kann längerfristig schädliche Wirkungen auf die Umwelt haben.ET: Võib avaldada pikaajalist keskkonda kahjustavat toimet.EL: Μπορεί να προκαλέσει μακροχρόνιες δυσμενείς επιπτώσεις στο περιβάλλον.EN: May cause long-term adverse effects in the environment.FR: Peut entraîner des effets néfastes à long terme pour l'environnement.IT: Può provocare a lungo termine effetti negativi per l'ambiente.LV: Var izraisīt ilglaicīgu negatīvu ietekmi vidē.LT: Gali sukelti ilgalaikius nepalankius aplinkos pakitimus.HU: A környezetben hosszan tartó károsodást okozhat.MT: Jista' jikkaġuna effetti ħżiena fit-tul lill-ambjent.NL: Kan in het milieu op lange termijn schadelijke effecten veroorzaken.PL: Może powodować długo utrzymujące się niekorzystne zmiany w środowisku.PT: Pode causar efeitos nefastos a longo prazo no ambiente.RO: Poate provoca efecte adverse pe termen lung asupra mediului înconjurător.SK: Môže mať dlhodobé nepriaznivé účinky na životné prostredie.SL: Lahko povzroči dolgotrajne škodljive učinke na okolje.FI: Voi aiheuttaa pitkäaikaisia haittavaikutuksia ympäristössä.SV: Kan orsaka skadliga långtidseffekter i miljön.R59BG: Опасен за озоновия слой.ES: Peligroso para la capa de ozono.CS: Nebezpečný pro ozonovou vrstvu.DA: Farlig for ozonlaget.DE: Gefährlich für die Ozonschicht.ET: Ohtlik osoonikihile.EL: Επικίνδυνο για τη στοιβάδα του όζοντος.EN: Dangerous for the ozone layer.FR: Dangereux pour la couche d'ozone.IT: Pericoloso per lo strato di ozono.LV: Bīstams ozona slānim.LT: Pavojinga ozono sluoksniui.HU: Veszélyes az ózonrétegre.MT: Perikoluż għas-saff ta' l-ożonu.NL: Gevaarlijk voor de ozonlaag.PL: Stwarza zagrożenie dla warstwy ozonowej.PT: Perigoso para a camada de ozono.RO: Periculos pentru stratul de ozon.SK: Nebezpečný pre ozónovú vrstvu.SL: Nevarno za ozonski plašč.FI: Vaarallista otsonikerrokselle.SV: Farligt för ozonskiktet.R60BG: Може да увреди възпроизводителната функция.ES: Puede perjudicar la fertilidad.CS: Může poškodit reprodukční schopnost.DA: Kan skade forplantningsevnen.DE: Kann die Fortpflanzungsfähigkeit beeinträchtigen.ET: Võib kahjustada sigivust.EL: Μπορεί να εξασθενίσει τη γονιμότητα.EN: May impair fertility.FR: Peut altérer la fertilité.IT: Può ridurre la fertilità.LV: Var kaitēt reproduktīvajām spējām.LT: Kenkia vaisingumui.HU: A fogamzóképességet vagy nemzőképességet (fertilitást) károsíthatja.MT: Jista' jdgħajjef il-fertilità.NL: Kan de vruchtbaarheid schaden.PL: Może upośledzać płodność.PT: Pode comprometer a fertilidade.RO: Poate afecta fertilitatea.SK: Môže poškodiť plodnosť.SL: Lahko škoduje plodnosti.FI: Voi heikentää hedelmällisyyttä.SV: Kan ge nedsatt fortplantningsförmåga.R61BG: Може да увреди плода при бременност.ES: Riesgo durante el embarazo de efectos adversos para el feto.CS: Může poškodit plod v těle matky.DA: Kan skade barnet under graviditeten.DE: Kann das Kind im Mutterleib schädigen.ET: Võib kahjustada loodet.EL: Μπορεί να βλάψει το έμβρυο κατά τη διάρκεια της κύησης.EN: May cause harm to the unborn child.FR: Risque pendant la grossesse d'effets néfastes pour l'enfant.IT: Può danneggiare i bambini non ancora nati.LV: Var kaitēt augļa attīstībai.LT: Kenkia negimusiam vaikui.HU: A születendő gyermekre ártalmas lehet.MT: Jista' jagħmel ħsara lit-tarbija fil-ġuf.NL: Kan het ongeboren kind schaden.PL: Może działać szkodliwie na dziecko w łonie matki.PT: Risco durante a gravidez com efeitos adversos na descendência.RO: Poate provoca efecte adverse asupra copilului în timpul sarcinii.SK: Môže spôsobiť poškodenie nenarodeného dieťaťa.SL: Lahko škoduje nerojenemu otroku.FI: Vaarallista sikiölle.SV: Kan ge fosterskador.R62BG: Възможен риск от увреждане на възпроизводителната функция.ES: Posible riesgo de perjudicar la fertilidad.CS: Možné nebezpečí poškození reprodukční schopnosti.DA: Mulighed for skade på forplantningsevnen.DE: Kann möglicherweise die Fortpflanzungsfähigkeit beeinträchtigen.ET: Võimalik sigivuse kahjustamise oht.EL: Πιθανός κίνδυνος για εξασθένηση της γονιμότητας.EN: Possible risk of impaired fertility.FR: Risque possible d'altération de la fertilité.IT: Possibile rischio di ridotta fertilità.LV: Iespējams kaitējuma risks reproduktīvajām spējām.LT: Gali pakenkti vaisingumui.HU: A fogamzóképességre vagy nemzőképességre (fertilitásra) ártalmas lehet.MT: Possibiltà ta' riskju ta' fertilità mdgħajjfa.NL: Mogelijk gevaar voor verminderde vruchtbaarheid.PL: Możliwe ryzyko upośledzenia płodności.PT: Possíveis riscos de comprometer a fertilidade.RO: Risc posibil de afectare a fertilităţii.SK: Možné riziko poškodenia plodnosti.SL: Možna nevarnost oslabitve plodnosti.FI: Voi mahdollisesti heikentää hedelmällisyyttä.SV: Möjlig risk för nedsatt fortplantningsförmåga.R63BG: Възможен риск от увреждане на плода при бременност.ES: Posible riesgo durante el embarazo de efectos adversos para el feto.CS: Možné nebezpečí poškození plodu v těle matky.DA: Mulighed for skade på barnet under graviditeten.DE: Kann das Kind im Mutterleib möglicherweise schädigen.ET: Võimalik loote kahjustamise oht.EL: Πιθανός κίνδυνος δυσμενών επιδράσεων στο έμβρυο κατά τη διάρκεια της κύησης.EN: Possible risk of harm to the unborn child.FR: Risque possible pendant la grossesse d'effets néfastes pour l'enfant.IT: Possibile rischio di danni ai bambini non ancora nati.LV: Iespējams kaitējuma risks augļa attīstībai.LT: Gali pakenkti negimusiam vaikui.HU: A születendő gyermeket károsíthatja.MT: Possibiltà ta' riskju lit-tarbija fil-ġuf.NL: Mogelijk gevaar voor beschadiging van het ongeboren kind.PL: Możliwe ryzyko szkodliwego działania na dziecko w łonie matki.PT: Possíveis riscos durante a gravidez com efeitos adversos na descendência.RO: Risc posibil de a dăuna copilului în timpul sarcinii.SK: Možné riziko poškodenia nenarodeného dieťaťa.SL: Možna nevarnost škodovanja nerojenemu otroku.FI: Voi olla vaarallista sikiölle.SV: Möjlig risk för fosterskador.R64BG: Може да причини увреждане на здравето на кърмачета.ES: Puede perjudicar a los niños alimentados con leche materna.CS: Může poškodit kojené dítě.DA: Kan skade børn i ammeperioden.DE: Kann Säuglinge über die Muttermilch schädigen.ET: Võib olla ohtlik imikule rinnapiima kaudu.EL: Μπορεί να βλάψει τα βρέφη που τρέφονται με μητρικό γάλα.EN: May cause harm to breastfed babies.FR: Risque possible pour les bébés nourris au lait maternel.IT: Possibile rischio per i bambini allattati al seno.LV: Var kaitēt zīdāmam bērnam.LT: Kenkia žindomam vaikui.HU: A szoptatott újszülöttet és csecsemőt károsíthatja.MT: Jista' jikkaġuna ħsara lil trabi qed jitreddgħu.NL: Kan schadelijk zijn via de borstvoeding.PL: Może oddziaływać szkodliwie na dzieci karmione piersią.PT: Pode causar danos às crianças alimentadas com leite materno.RO: Risc posibil pentru sugarii hrăniţi cu lapte matern.SK: Môže spôsobiť poškodenie dojčiat.SL: Lahko škoduje zdravju dojenčka preko materinega mleka.FI: Saattaa aiheuttaa haittaa rintaruokinnassa oleville lapsille.SV: Kan skada spädbarn under amningsperioden.R65BG: Вреден: може да причини увреждане на белите дробове при поглъщане.ES: Nocivo: si se ingiere puede causar daño pulmonar.CS: Zdraví škodlivý: při požití může vyvolat poškození plic.DA: Farlig: kan give lungeskade ved indtagelse.DE: Gesundheitsschädlich: kann beim Verschlucken Lungenschäden verursachen.ET: Kahjulik: allaneelamisel võib põhjustada kopsukahjustusi.EL: Επιβλαβές: μπορεί να προκαλέσει βλάβη στους πνεύμονες σε περίπτωση κατάποσης.EN: Harmful: may cause lung damage if swallowed.FR: Nocif: peut provoquer une atteinte des poumons en cas d'ingestion.IT: Nocivo: può causare danni ai polmoni in caso di ingestione.LV: Kaitīgs – norijot var izraisīt plaušu bojājumu.LT: Kenksminga — prarijus, gali pakenkti plaučiams.HU: Lenyelve ártalmas, aspiráció (idegen anyagnak a légutakba beszívása) esetén tüdőkárosodást okozhat.MT: Jagħmel ħsara: jista' jikkaġuna ħsara lill-pulmuni jekk jinbela'.NL: Schadelijk: kan longschade veroorzaken na verslikken.PL: Działa szkodliwie; może powodować uszkodzenie płuc w przypadku połknięcia.PT: Nocivo: pode causar danos nos pulmões se ingerido.RO: Nociv: poate provoca afecţiuni pulmonare în caz de înghiţire.SK: Škodlivý, po požití môže spôsobiť poškodenie pľúc.SL: Zdravju škodljivo: pri zaužitju lahko povzroči poškodbo pljuč.FI: Haitallista: voi aiheuttaa keuhkovaurion nieltäessä.SV: Farligt: kan ge lungskador vid förtäring.R66BG: Повтарящата се експозиция може да предизвика сухота или напукване на кожата.ES: La exposición repetida puede provocar sequedad o formación de grietas en la piel.CS: Opakovaná expozice může způsobit vysušení nebo popraskání kůže.DA: Gentagen udsættelse kan give tør eller revnet hud.DE: Wiederholter Kontakt kann zu spröder oder rissiger Haut führen.ET: Korduv toime võib põhjustada naha kuivust või lõhenemist.EL: Παρατεταμένη έκθεση μπορεί να προκαλέσει ξηρότητα δέρματος ή σκάσιμο.EN: Repeated exposure may cause skin dryness or cracking.FR: L'exposition répétée peut provoquer dessèchement ou gerçures de la peau.IT: L'esposizione ripetuta può provocare secchezza e screpolature della pelle.LV: Atkārtota iedarbība var radīt sausu ādu vai izraisīt tās sprēgāšanu.LT: Pakartotinas poveikis gali sukelti odos džiūvimą arba skilinėjimą.HU: Ismételt expozíció a bőr kiszáradását vagy megrepedezését okozhatja.MT: Espożizzjoni ripetuta tista' tikkaġuna nxif jew qsim tal-ġilda.NL: Herhaalde blootstelling kan een droge of een gebarsten huid veroorzaken.PL: Powtarzające się narażenie może powodować wysuszanie lub pękanie skóry.PT: Pode provocar secura da pele ou fissuras, por exposição repetida.RO: Expunerea repetată poate provoca uscarea sau crăparea pielii.SK: Opakovaná expozícia môže spôsobiť vysušenie alebo popraskanie pokožky.SL: Ponavljajoča izpostavljenost lahko povzroči nastanek suhe ali razpokane kože.FI: Toistuva altistus voi aiheuttaa ihon kuivumista tai halkeilua.SV: Upprepad kontakt kan ge torr hud eller hudsprickor.R67BG: Парите могат да предизвикат сънливост и световъртеж.ES: La inhalación de vapores puede provocar somnolencia y vértigo.CS: Vdechování par může způsobit ospalost a závratě.DA: Dampe kan give sløvhed og svimmelhed.DE: Dämpfe können Schläfrigkeit und Benommenheit verursachen.ET: Aurud võivad põhjustada uimasust ja peapööritust.EL: H εισπνοή ατμών μπορεί να προκαλέσει υπνηλία και ζάλη.EN: Vapours may cause drowsiness and dizziness.FR: L'inhalation de vapeurs peut provoquer somnolence et vertiges.IT: L'inalazione dei vapori può provocare sonnolenza e vertigini.LV: Tvaiki var radīt miegainību un reiboni.LT: Garai gali sukelti mieguistumą ir galvos svaigimą.HU: A gőzök belégzése álmosságot vagy szédülést okozhat.MT: Ix-xamm tal-fwar jista' jikkaġuna ħedla ta' ngħas u sturdamenti.NL: Dampen kunnen slaperigheid en duizeligheid veroorzaken.PL: Pary mogą wywoływać uczucie senności i zawroty głowy.PT: Pode provocar sonolência e vertigens, por inalação dos vapores.RO: Inhalarea vaporilor poate provoca somnolenţă şi ameţeală.SK: Pary môžu spôsobiť ospalosť a závrat.SL: Hlapi lahko povzročijo zaspanost in omotico.FI: Höyryt voivat aiheuttaa uneliaisuutta ja huimausta.SV: Ångor kan göra att man blir dåsig och omtöcknad.R68BG: Възможен риск от необратими ефекти.ES: Posibilidad de efectos irreversibles.CS: Možné nebezpečí nevratných účinků.DA: Mulighed for varig skade på helbred.DE: Irreversibler Schaden möglich.ET: Pöördumatute kahjustuste oht.EL: Πιθανοί κίνδυνοι μονίμων επιδράσεων.EN: Possible risk of irreversible effects.FR: Possibilité d'effets irréversibles.IT: Possibilità di effetti irreversibili.LV: Iespējams neatgriezeniskas iedarbības risks.LT: Gali sukelti negrįžtamus sveikatos pakenkimus.HU: Maradandó egészségkárosodást okozhat.MT: Riskju possibbli ta' effetti irreversibbli.NL: Onherstelbare effecten zijn niet uitgesloten.PL: Możliwe ryzyko powstania nieodwracalnych zmian w stanie zdrowia.PT: Possibilidade de efeitos irreversíveis.RO: Risc posibil de efecte ireversibile.SK: Možné riziká ireverzibilných účinkov.SL: Možna nevarnost trajnih okvar zdravja.FI: Pysyvien vaurioiden vaara.SV: Möjlig risk för bestående hälsoskador.Комбинирани R-фразиCombinación de frases-RKombinace R-větKombination af R-sætningerKombination der R-SätzeR ühendlausedΣυνδυασμός των R-φράσεωνCombination of R-phrasesCombinaison des phrases RCombinazioni delle frasi RR frāžu kombinācijaR frazių derinysÖsszetett R-mondatokKombinazzjoni ta' Frażi RCombinatie van R-zinnenŁączone zwroty RCombinação das frases RCombinaţii de fraze RKombinácie R-vietSestavljeni stavki RYhdistetyt R-lausekkeetSammansatta R-fraserR14/15BG: Реагира бурно с вода и се отделят изключително запалими газове.ES: Reacciona violentamente con el agua, liberando gases extremadamente inflamables.CS: Prudce reaguje s vodou za uvolňování extrémně hořlavých plynů.DA: Reagerer voldsomt med vand under dannelse af yderst brandfarlige gasser.DE: Reagiert heftig mit Wasser unter Bildung hochentzündlicher Gase.ET: Reageerib ägedalt veega, eraldades väga tuleohtlikku gaasi.EL: Αντιδρά βίαια σε επαφή με νερό εκλύοντας αέρια εξόχως εύφλεκτα.EN: Reacts violently with water, liberating extremely flammable gases.FR: Réagit violemment au contact de l'eau en dégageant des gaz extrêmement inflammables.IT: Reagisce violentemente con l'acqua liberando gas estremamente infiammabili.LV: Aktīvi reaģē ar ūdeni, izdalot īpaši viegli uzliesmojošas gāzes.LT: Smarkiai reaguoja su vandeniu, išskirdama ypač degias dujas.HU: Vízzel hevesen reagál és közben fokozottan tűzveszélyes gázok képződnek.MT: Jirreaġixxi b'mod vjolenti meta jmiss l-ilma billi jitfa' gassijiet li jieħdu n-nar malajr ħafna.NL: Reageert heftig met water en vormt daarbij zeer ontvlambaar gas.PL: Reaguje gwałtownie z wodą uwalniając skrajnie łatwopalne gazy.PT: Reage violentamente com a água libertando gases extremamente inflamáveis.RO: Reacţionează violent cu apa, cu degajare de gaze extrem de inflamabile.SK: Prudko reaguje s vodou, pričom uvoľňuje mimoriadne horľavé plyny.SL: Burno reagira z vodo, pri čemer se sprošča zelo lahko vnetljiv plin.FI: Reagoi voimakkaasti veden kanssa vapauttaen helposti syttyviä kaasuja.SV: Reagerar häftigt med vatten varvid extremt brandfarliga gaser bildas.R15/29BG: При контакт с вода се отделят токсични и изключително запалими газове.ES: En contacto con el agua, libera gases tóxicos y extremadamente inflamables.CS: Při styku s vodou uvolňuje toxický, extrémně hořlavý plyn.DA: Reagerer med vand under dannelse af giftige og yderst brandfarlige gasser.DE: Reagiert mit Wasser unter Bildung giftiger und hochentzündlicher Gase.ET: Kokkupuutel veega eraldub mürgine, väga tuleohtlik gaas.EL: Σε επαφή με νερό ελευθερώνονται τοξικά, εξόχως εύφλεκτα αέρια.EN: Contact with water liberates toxic, extremely flammable gas.FR: Au contact de l'eau, dégage des gaz toxiques et extrêmement inflammables.IT: A contatto con acqua libera gas tossici e estremamente infiammabili.LV: Saskaroties ar ūdeni, izdala īpaši viegli uzliesmojošas toksiskas gāzes.LT: Reaguoja su vandeniu, išskirdama toksiškas ir ypač degias dujas.HU: Vízzel érintkezve fokozottan tűzveszélyes és mérgező gázok képződnek.MT: Meta jmiss l-ilma jitfa' gassijiet tossiċi u li jieħdu n-nar malajr ħafna.NL: Vormt vergiftig en zeer ontvlambaar gas in contact met water.PL: W kontakcie z wodą uwalnia skrajnie łatwopalne, toksyczne gazy.PT: Em contacto com a água liberta gases tóxicos e extremamente inflamáveis.RO: În contact cu apa se degajă gaze toxice şi extrem de inflamabile.SK: Pri kontakte s vodou sa uvoľňuje jedovatý, mimoriadne horľavý plyn.SL: V stiku z vodo se sprošča strupen, zelo lahko vnetljiv plin.FI: Vapauttaa myrkyllisiä, helposti syttyviä kaasuja veden kanssa.SV: Utvecklar giftig och extremt brandfarlig gas vid kontakt med vatten.R20/21BG: Вреден при вдишване и при контакт с кожата.ES: Nocivo por inhalación y en contacto con la piel.CS: Zdraví škodlivý při vdechování a při styku s kůží.DA: Farlig ved indånding og ved hudkontakt.DE: Gesundheitsschädlich beim Einatmen und bei Berührung mit der Haut.ET: Kahjulik sissehingamisel ja kokkupuutel nahaga.EL: Επιβλαβές όταν εισπνέεται και σε επαφή με το δέρμα.EN: Harmful by inhalation and in contact with skin.FR: Nocif par inhalation et par contact avec la peau.IT: Nocivo per inalazione e contatto con la pelle.LV: Kaitīgs ieelpojot un nonākot saskarē ar ādu.LT: Kenksminga įkvėpus ir susilietus su oda.HU: Belélegezve és bőrrel érintkezve ártalmas.MT: Jagħmel ħsara meta jinxtamm u meta jmiss il-ġilda.NL: Schadelijk bij inademing en bij aanraking met de huid.PL: Działa szkodliwie przez drogi oddechowe i w kontakcie ze skórą.PT: Nocivo por inalação e em contacto com a pele.RO: Nociv prin inhalare şi în contact cu pielea.SK: Škodlivý pri vdýchnutí a pri kontakte s pokožkou.SL: Zdravju škodljivo pri vdihavanju in v stiku s kožo.FI: Terveydelle haitallista hengitettynä ja joutuessaan iholle.SV: Farligt vid inandning och hudkontakt.R20/22BG: Вреден при вдишване и при поглъщане.ES: Nocivo por inhalación y por ingestión.CS: Zdraví škodlivý při vdechování a při požití.DA: Farlig ved indånding og ved indtagelse.DE: Gesundheitsschädlich beim Einatmen und Verschlucken.ET: Kahjulik sissehingamisel ja allaneelamisel.EL: Επιβλαβές όταν εισπνέεται και σε περίπτωση καταπόσεως.EN: Harmful by inhalation and if swallowed.FR: Nocif par inhalation et par ingestion.IT: Nocivo per inalazione e ingestione.LV: Kaitīgs ieelpojot un norijot.LT: Kenksminga įkvėpus ir prarijus.HU: Belélegezve és lenyelve ártalmas.MT: Jagħmel ħsara meta jinxtamm jew jinbela'.NL: Schadelijk bij inademing en opname door de mond.PL: Działa szkodliwie przez drogi oddechowe i po połknięciu.PT: Nocivo por inalação e ingestão.RO: Nociv prin inhalare şi prin înghiţire.SK: Škodlivý pri vdýchnutí a po požití.SL: Zdravju škodljivo pri vdihavanju in pri zaužitju.FI: Terveydelle haitallista hengitettynä ja nieltynä.SV: Farligt vid inandning och förtäring.R20/21/22BG: Вреден при вдишване, при контакт с кожата и при поглъщане.ES: Nocivo por inhalación, por ingestión y en contacto con la piel.CS: Zdraví škodlivý při vdechování, styku s kůží a při požití.DA: Farlig ved indånding, ved hudkontakt og ved indtagelse.DE: Gesundheitsschädlich beim Einatmen, Verschlucken und Berührung mit der Haut.ET: Kahjulik sissehingamisel, kokkupuutel nahaga ja allaneelamisel.EL: Επιβλαβές όταν εισπνέεται, σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Harmful by inhalation, in contact with skin and if swallowed.FR: Nocif par inhalation, par contact avec la peau et par ingestion.IT: Nocivo per inalazione, contatto con la pelle e per ingestione.LV: Kaitīgs ieelpojot, nonākot saskarē ar ādu un norijot.LT: Kenksminga įkvėpus, susilietus su oda ir prarijus.HU: Belélegezve, bőrrel érintkezve és lenyelve ártalmas.MT: Jagħmel ħsara meta jinxtamm, imiss il-ġilda jew jinbela'.NL: Schadelijk bij inademing, opname door de mond en aanraking met de huid.PL: Działa szkodliwie przez drogi oddechowe, w kontakcie ze skórą i po połknięciu.PT: Nocivo por inalação, em contacto com a pele e por ingestão.RO: Nociv prin inhalare, în contact cu pielea şi prin înghiţire.SK: Škodlivý pri vdýchnutí, pri kontakte s pokožkou a po požití.SL: Zdravju škodljivo pri vdihavanju, v stiku s kožo in pri zaužitju.FI: Terveydelle haitallista hengitettynä, joutuessaan iholle ja nieltynä.SV: Farligt vid inandning, hudkontakt och förtäring.R21/22BG: Вреден при контакт с кожата и при поглъщане.ES: Nocivo en contacto con la piel y por ingestión.CS: Zdraví škodlivý při styku s kůží a při požití.DA: Farlig ved hudkontakt og ved indtagelse.DE: Gesundheitsschädlich bei Berührung mit der Haut und beim Verschlucken.ET: Kahjulik kokkupuutel nahaga ja allaneelamisel.EL: Επιβλαβές σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Harmful in contact with skin and if swallowed.FR: Nocif par contact avec la peau et par ingestion.IT: Nocivo a contatto con la pelle e per ingestione.LV: Kaitīgs, nonākot saskarē ar ādu un norijot.LT: Kenksminga susilietus su oda ir prarijus.HU: Bőrrel érintkezve és lenyelve ártalmas.MT: Jagħmel ħsara meta jmiss il-ġilda jew jinbela'.NL: Schadelijk bij aanraking met de huid en bij opname door de mond.PL: Działa szkodliwie w kontakcie ze skórą i po połknięciu.PT: Nocivo em contacto com a pele e por ingestão.RO: Nociv în contact cu pielea şi prin înghiţire.SK: Škodlivý pri kontakte s pokožkou a po požití.SL: Zdravju škodljivo v stiku s kožo in pri zaužitju.FI: Terveydelle haitallista joutuessaan iholle ja nieltynä.SV: Farligt vid hudkontakt och förtäring.R23/24BG: Токсичен при вдишване и при контакт с кожата.ES: Tóxico por inhalación y en contacto con la piel.CS: Toxický při vdechování a při styku s kůží.DA: Giftig ved indånding og ved hudkontakt.DE: Giftig beim Einatmen und bei Berührung mit der Haut.ET: Mürgine sissehingamisel ja kokkupuutel nahaga.EL: Τοξικό όταν εισπνέεται και σε επαφή με το δέρμα.EN: Toxic by inhalation and in contact with skin.FR: Toxique par inhalation et par contact avec la peau.IT: Tossico per inalazione e contatto con la pelle.LV: Toksisks ieelpojot un nonākot saskarē ar ādu.LT: Toksiška įkvėpus ir susilietus su oda.HU: Belélegezve és bőrrel érintkezve mérgező.MT: Tossiku meta jinxtamm u meta jmiss il-ġilda.NL: Vergiftig bij inademing en bij aanraking met de huid.PL: Działa toksycznie przez drogi oddechowe i w kontakcie ze skórą.PT: Tóxico por inalação e em contacto com a pele.RO: Toxic prin inhalare şi în contact cu pielea.SK: Jedovatý pri vdýchnutí a pri kontakte s pokožkou.SL: Strupeno pri vdihavanju in v stiku s kožo.FI: Myrkyllistä hengitettynä ja joutuessaan iholle.SV: Giftigt vid inandning och hudkontakt.R23/25BG: Токсичен при вдишване и при поглъщане.ES: Tóxico por inhalación y por ingestión.CS: Toxický při vdechování a při požití.DA: Giftig ved indånding og ved indtagelse.DE: Giftig beim Einatmen und Verschlucken.ET: Mürgine sissehingamisel ja allaneelamisel.EL: Τοξικό όταν εισπνέεται και σε περίπτωση καταπόσεως.EN: Toxic by inhalation and if swallowed.FR: Toxique par inhalation et par ingestion.IT: Tossico per inalazione e ingestione.LV: Toksisks ieelpojot un norijot.LT: Toksiška įkvėpus ir prarijus.HU: Belélegezve és lenyelve mérgező.MT: Tossiku meta jinxtamm jew meta jinbela'.NL: Vergiftig bij inademing en opname door de mond.PL: Działa toksycznie przez drogi oddechowe i po połknięciu.PT: Tóxico por inalação e ingestão.RO: Toxic prin inhalare şi prin înghiţire.SK: Jedovatý pri vdýchnutí a po požití.SL: Strupeno pri vdihavanju in pri zaužitju.FI: Myrkyllistä hengitettynä ja nieltynä.SV: Giftigt vid inandning och förtäring.R23/24/25BG: Токсичен при вдишване, при контакт с кожата и при поглъщане.ES: Tóxico por inhalación, por ingestión y en contacto con la piel.CS: Toxický při vdechování, styku s kůží a při požití.DA: Giftig ved indånding, ved hudkontakt og ved indtagelse.DE: Giftig beim Einatmen, Verschlucken und Berührung mit der Haut.ET: Mürgine sissehingamisel, kokkupuutel nahaga ja allaneelamisel.EL: Τοξικό όταν εισπνέεται, σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Toxic by inhalation, in contact with skin and if swallowed.FR: Toxique par inhalation, par contact avec la peau et par ingestion.IT: Tossico per inalazione, contatto con la pelle e per ingestione.LV: Toksisks ieelpojot, nonākot saskarē ar ādu un norijot.LT: Toksiška įkvėpus, susilietus su oda ir prarijus.HU: Belélegezve, bőrrel érintkezve és lenyelve mérgező.MT: Tossiku meta jinxtamm, imiss il-ġilda jew jinbela'.NL: Vergiftig bij inademing, opname door de mond en aanraking met de huid.PL: Działa toksycznie przez drogi oddechowe, w kontakcie ze skórą i po połknięciu.PT: Tóxico por inalação, em contacto com a pele e por ingestão.RO: Toxic prin inhalare, în contact cu pielea şi prin înghiţire.SK: Jedovatý pri vdýchnutí, pri kontakte s pokožkou a po požití.SL: Strupeno pri vdihavanju, v stiku s kožo in pri zaužitju.FI: Myrkyllistä hengitettynä, joutuessaan iholle ja nieltynä.SV: Giftigt vid inandning, hudkontakt och förtäring.R24/25BG: Токсичен при контакт с кожата и при поглъщане.ES: Tóxico en contacto con la piel y por ingestión.CS: Toxický při styku s kůží a při požití.DA: Giftig ved hudkontakt og ved indtagelse.DE: Giftig bei Berührung mit der Haut und beim Verschlucken.ET: Mürgine kokkupuutel nahaga ja allaneelamisel.EL: Τοξικό σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Toxic in contact with skin and if swallowed.FR: Toxique par contact avec la peau et par ingestion.IT: Tossico a contatto con la pelle e per ingestione.LV: Toksisks, nonākot saskarē ar ādu un norijot.LT: Toksiška susilietus su oda ir prarijus.HU: Bőrrel érintkezve és lenyelve mérgező.MT: Tossiku meta jmiss il-ġilda jew meta jinbela'.NL: Vergiftig bij aanraking met de huid en bij opname door de mond.PL: Działa toksycznie w kontakcie ze skórą i po połknięciu.PT: Tóxico em contacto com a pele e por ingestão.RO: Toxic în contact cu pielea şi prin înghiţire.SK: Jedovatý pri kontakte s pokožkou a po požití.SL: Strupeno v stiku s kožo in pri zaužitju.FI: Myrkyllistä joutuessaan iholle ja nieltynä.SV: Giftigt vid hudkontakt och förtäring.R26/27BG: Силно токсичен при вдишване и при контакт с кожата.ES: Muy tóxico por inhalación y en contacto con la piel.CS: Vysoce toxický při vdechování a při styku s kůží.DA: Meget giftig ved indånding og ved hudkontakt.DE: Sehr giftig beim Einatmen und bei Berührung mit der Haut.ET: Väga mürgine sissehingamisel ja kokkupuutel nahaga.EL: Πολύ τοξικό όταν εισπνέεται και σε επαφή με το δέρμα.EN: Very toxic by inhalation and in contact with skin.FR: Très toxique par inhalation et par contact avec la peau.IT: Molto tossico per inalazione e contatto con la pelle.LV: Ļoti toksisks ieelpojot un nonākot saskarē ar ādu.LT: Labai toksiška įkvėpus ir susilietus su oda.HU: Belélegezve és bőrrel érintkezve nagyon mérgező.MT: Tossiku ħafna meta jinxtamm u meta jmiss il-ġilda.NL: Zeer vergiftig bij inademing en bij aanraking met de huid.PL: Działa bardzo toksycznie przez drogi oddechowe i w kontakcie ze skórą.PT: Muito tóxico por inalação e em contacto com a pele.RO: Foarte toxic prin inhalare şi în contact cu pielea.SK: Veľmi jedovatý pri vdýchnutí a pri kontakte s pokožkou.SL: Zelo strupeno pri vdihavanju in v stiku s kožo.FI: Erittäin myrkyllistä hengitettynä ja joutuessaan iholle.SV: Mycket giftigt vid inandning och hudkontakt.R26/28BG: Силно токсичен при вдишване и при поглъщане.ES: Muy tóxico por inhalación y por ingestión.CS: Vysoce toxický při vdechování a při požití.DA: Meget giftig ved indånding og ved indtagelse.DE: Sehr giftig beim Einatmen und Verschlucken.ET: Väga mürgine sissehingamisel ja allaneelamisel.EL: Πολύ τοξικό όταν εισπνέεται και σε περίπτωση καταπόσεως.EN: Very toxic by inhalation and if swallowed.FR: Très toxique par inhalation et par ingestion.IT: Molto tossico per inalazione e per ingestione.LV: Ļoti toksisks ieelpojot un norijot.LT: Labai toksiška įkvėpus ir prarijus.HU: Belélegezve és lenyelve nagyon mérgező.MT: Tossiku ħafna meta jinxtamm jew meta jinbela'.NL: Zeer vergiftig bij inademing en opname door de mond.PL: Działa bardzo toksycznie przez drogi oddechowe i po połknięciu.PT: Muito tóxico por inalação e ingestão.RO: Foarte toxic prin inhalare şi prin înghiţire.SK: Veľmi jedovatý pri vdýchnutí a po požití.SL: Zelo strupeno pri vdihavanju in pri zaužitju.FI: Erittäin myrkyllistä hengitettynä ja nieltynä.SV: Mycket giftigt vid inandning och förtäring.R26/27/28BG: Силно токсичен при вдишване, при контакт с кожата и при поглъщане.ES: Muy tóxico por inhalación, por ingestión y en contacto con la piel.CS: Vysoce toxický při vdechování, styku s kůží a při požití.DA: Meget giftig ved indånding, ved hudkontakt og ved indtagelse.DE: Sehr giftig beim Einatmen, Verschlucken und Berührung mit der Haut.ET: Väga mürgine sissehingamisel, kokkupuutel nahaga ja allaneelamisel.EL: Πολύ τοξικό όταν εισπνέεται, σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Very toxic by inhalation, in contact with skin and if swallowed.FR: Très toxique par inhalation, par contact avec la peau et par ingestion.IT: Molto tossico per inalazione, contatto con la pelle e per ingestione.LV: Ļoti toksisks ieelpojot, nonākot saskarē ar ādu un norijot.LT: Labai toksiška įkvėpus, susilietus su oda ir prarijus.HU: Belélegezve, bőrrel érintkezve és lenyelve nagyon mérgező.MT: Tossiku ħafna meta jinxtamm, imiss il-ġilda jew meta jinbela'.NL: Zeer vergiftig bij inademing, opname door de mond en aanraking met de huid.PL: Działa bardzo toksycznie przez drogi oddechowe, w kontakcie ze skórą i po połknięciu.PT: Muito tóxico por inalação, em contacto com a pele e por ingestão.RO: Foarte toxic prin inhalare, în contact cu pielea şi prin înghiţire.SK: Veľmi jedovatý pri vdýchnutí, pri kontakte s pokožkou a po požití.SL: Zelo strupeno pri vdihavanju, v stiku s kožo in pri zaužitju.FI: Erittäin myrkyllistä hengitettynä, joutuessaan iholle ja nieltynä.SV: Mycket giftigt vid inandning, hudkontakt och förtäring.R27/28BG: Силно токсичен при контакт с кожата и при поглъщане.ES: Muy tóxico en contacto con la piel y por ingestión.CS: Vysoce toxický při styku s kůží a při požití.DA: Meget giftig ved hudkontakt og ved indtagelse.DE: Sehr giftig bei Berührung mit der Haut und beim Verschlucken.ET: Väga mürgine kokkupuutel nahaga ja allaneelamisel.EL: Πολύ τοξικό σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Very toxic in contact with skin and if swallowed.FR: Très toxique par contact avec la peau et par ingestion.IT: Molto tossico a contatto con la pelle e per ingestione.LV: Ļoti toksisks, nonākot saskarē ar ādu un norijot.LT: Labai toksiška susilietus su oda ir prarijus.HU: Bőrrel érintkezve és lenyelve nagyon mérgező.MT: Tossiku ħafna meta jmiss il-ġilda jew meta jinbela'.NL: Zeer vergiftig bij aanraking met de huid en bij opname door de mond.PL: Działa bardzo toksycznie w kontakcie ze skórą i po połknięciu.PT: Muito tóxico em contacto com a pele e por ingestão.RO: Foarte toxic în contact cu pielea şi prin înghiţire.SK: Veľmi jedovatý pri kontakte s pokožkou a po požití.SL: Zelo strupeno v stiku s kožo in pri zaužitju.FI: Erittäin myrkyllistä joutuessaan iholle ja nieltynä.SV: Mycket giftigt vid hudkontakt och förtäring.R36/37BG: Дразни очите и дихателните пътища.ES: Irrita los ojos y las vías respiratorias.CS: Dráždí oči a dýchací orgány.DA: Irriterer øjnene og åndedrætsorganerne.DE: Reizt die Augen und die Atmungsorgane.ET: Ärritab silmi ja hingamiselundeid.EL: Ερεθίζει τα μάτια και το αναπνευστικό σύστημα.EN: Irritating to eyes and respiratory system.FR: Irritant pour les yeux et les voies respiratoires.IT: Irritante per gli occhi e le vie respiratorie.LV: Kairina acis un elpošanas sistēmu.LT: Dirgina akis ir kvėpavimo takus.HU: Szemizgató hatású, izgatja a légutakat.MT: Jirrita l-għajnejn u s-sistema respiratorja.NL: Irriterend voor de ogen en de ademhalingswegen.PL: Działa drażniąco na oczy i drogi oddechowe.PT: Irritante para os olhos e vias respiratórias.RO: Iritant pentru ochi şi sistemul respirator.SK: Dráždi oči a dýchacie cesty.SL: Draži oči in dihala.FI: Ärsyttää silmiä ja hengityselimiä.SV: Irriterar ögonen och andningsorganen.R36/38BG: Дразни очите и кожата.ES: Irrita los ojos y la piel.CS: Dráždí oči a kůži.DA: Irriterer øjnene og huden.DE: Reizt die Augen und die Haut.ET: Ärritab silmi ja nahka.EL: Ερεθίζει τα μάτια και το δέρμα.EN: Irritating to eyes and skin.FR: Irritant pour les yeux et la peau.IT: Irritante per gli occhi e la pelle.LV: Kairina acis un ādu.LT: Dirgina akis ir odą.HU: Szem- és bőrizgató hatású.MT: Jirrita l-għajnejn u l-ġilda.NL: Irriterend voor de ogen en de huid.PL: Działa drażniąco na oczy i skórę.PT: Irritante para os olhos e pele.RO: Iritant pentru ochi şi pentru piele.SK: Dráždi oči a pokožku.SL: Draži oči in kožo.FI: Ärsyttää silmiä ja ihoa.SV: Irriterar ögonen och huden.R36/37/38BG: Дразни очите, дихателните пътища и кожата.ES: Irrita los ojos, la piel y las vías respiratorias.CS: Dráždí oči, dýchací orgány a kůži.DA: Irriterer øjnene, åndedrætsorganerne og huden.DE: Reizt die Augen, Atmungsorgane und die Haut.ET: Ärritab silmi, hingamiselundeid ja nahka.EL: Ερεθίζει τα μάτια, το αναπνευστικό σύστημα και το δέρμα.EN: Irritating to eyes, respiratory system and skin.FR: Irritant pour les yeux, les voies respiratoires et la peau.IT: Irritante per gli occhi, le vie respiratorie e la pelle.LV: Kairina acis, ādu un elpošanas sistēmu.LT: Dirgina akis, kvėpavimo takus ir odą.HU: Szem- és bőrizgató hatású, izgatja a légutakat.MT: Jirrita l-għajnejn, is-sistema respiratorja u l-ġilda.NL: Irriterend voor de ogen, de ademhalingswegen en de huid.PL: Działa drażniąco na oczy, drogi oddechowe i skórę.PT: Irritante para os olhos, vias respiratórias e pele.RO: Iritant pentru ochi, sistemul respirator şi pentru piele.SK: Dráždi oči, dýchacie cesty a pokožku.SL: Draži oči, dihala in kožo.FI: Ärsyttää silmiä, hengityselimiä ja ihoa.SV: Irriterar ögonen, andningsorganen och huden.R37/38BG: Дразни дихателните пътища и кожата.ES: Irrita las vías respiratorias y la piel.CS: Dráždí dýchací orgány a kůži.DA: Irriterer åndedrætsorganerne og huden.DE: Reizt die Atmungsorgane und die Haut.ET: Ärritab hingamiselundeid ja nahka.EL: Ερεθίζει το αναπνευστικό σύστημα και το δέρμα.EN: Irritating to respiratory system and skin.FR: Irritant pour les voies respiratoires et la peau.IT: Irritante per le vie respiratorie e la pelle.LV: Kairina elpošanas sistēmu un ādu.LT: Dirgina kvėpavimo takus ir odą.HU: Bőrizgató hatású, izgatja a légutakat.MT: Jirrita s-sistema respiratorja u l-ġilda.NL: Irriterend voor de ademhalingswegen en de huid.PL: Działa drażniąco na drogi oddechowe i skórę.PT: Irritante para as vias respiratórias e pele.RO: Iritant pentru sistemul respirator şi pentru piele.SK: Dráždi dýchacie cesty a pokožku.SL: Draži dihala in kožo.FI: Ärsyttää hengityselimiä ja ihoa.SV: Irriterar andningsorganen och huden.R39/23BG: Токсичен: опасност от много тежки необратими ефекти при вдишване.ES: Tóxico: peligro de efectos irreversibles muy graves por inhalación.CS: Toxický: nebezpečí velmi vážných nevratných účinků při vdechování.DA: Giftig: fare for varig alvorlig skade på helbred ved indånding.DE: Giftig: ernste Gefahr irreversiblen Schadens durch Einatmen.ET: Mürgine: väga tõsiste pöördumatute kahjustuste oht sissehingamisel.EL: Τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων όταν εισπνέεται.EN: Toxic: danger of very serious irreversible effects through inhalation.FR: Toxique: danger d'effets irréversibles très graves par inhalation.IT: Tossico: pericolo di effetti irreversibili molto gravi per inalazione.LV: Toksisks – būtiski neatgriezeniskas iedarbības draudi ieelpojot.LT: Toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus įkvėpus.HU: Belélegezve mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku: periklu ta' effetti irriversibbli serji ħafna meta jinxtamm.NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing.PL: Działa toksycznie przez drogi oddechowe; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Tóxico: perigo de efeitos irreversíveis muito graves por inalação.RO: Toxic: pericol de efecte ireversibile foarte grave prin inhalare.SK: Jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov vdýchnutím.SL: Strupeno: nevarnost zelo hudih trajnih okvar zdravja pri vdihavanju.FI: Myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara hengitettynä.SV: Giftigt: risk för mycket allvarliga bestående hälsoskador vid inandning.R39/24BG: Токсичен: опасност от много тежки необратими ефекти при контакт с кожата.ES: Tóxico: peligro de efectos irreversibles muy graves por contacto con la piel.CS: Toxický: nebezpečí velmi vážných nevratných účinků při styku s kůží.DA: Giftig: fare for varig alvorlig skade på helbred ved hudkontakt.DE: Giftig: ernste Gefahr irreversiblen Schadens bei Berührung mit der Haut.ET: Mürgine: väga tõsiste pöördumatute kahjustuste oht nahale sattumisel.EL: Τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων σε επαφή με το δέρμα.EN: Toxic: danger of very serious irreversible effects in contact with skin.FR: Toxique: danger d'effets irréversibles très graves par contact avec la peau.IT: Tossico: pericolo di effetti irreversibili molto gravi a contatto con la pelle.LV: Toksisks – būtiski neatgriezeniskas iedarbības draudi, nonākot saskarē ar ādu.LT: Toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus susilietus su oda.HU: Bőrrel érintkezve mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku: periklu ta' effetti irriversibbli serji ħafna meta jmiss il-ġilda.NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij aanraking met de huid.PL: Działa toksycznie w kontakcie ze skórą; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Tóxico: perigo de efeitos irreversíveis muito graves em contacto com a pele.RO: Toxic: pericol de efecte ireversibile foarte grave în contact cu pielea.SK: Jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov pri kontakte s pokožkou.SL: Strupeno: nevarnost zelo hudih trajnih okvar zdravja v stiku s kožo.FI: Myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara joutuessaan iholle.SV: Giftigt: risk för mycket allvarliga bestående hälsoskador vid hudkontakt.R39/25BG: Токсичен: опасност от много тежки необратими ефекти при поглъщане.ES: Tóxico: peligro de efectos irreversibles muy graves por ingestión.CS: Toxický: nebezpečí velmi vážných nevratných účinků při požití.DA: Giftig: fare for varig alvorlig skade på helbred ved indtagelse.DE: Giftig: ernste Gefahr irreversiblen Schadens durch Verschlucken.ET: Mürgine: väga tõsiste pöördumatute kahjustuste oht allaneelamisel.EL: Τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων σε περίπτωση καταπόσεως.EN: Toxic: danger of very serious irreversible effects if swallowed.FR: Toxique: danger d'effets irréversibles très graves par ingestion.IT: Tossico: pericolo di effetti irreversibili molto gravi per ingestione.LV: Toksisks – būtiski neatgriezeniskas iedarbības draudi norijot.LT: Toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus prarijus.HU: Lenyelve mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku: periklu ta' effetti irriversibbli serji ħafna jekk jinxtamm.NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij opname door de mond.PL: Działa toksycznie po połknięciu; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Tóxico: perigo de efeitos irreversíveis muito graves por ingestão.RO: Toxic: pericol de efecte ireversibile foarte grave prin înghiţire.SK: Jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov po požití.SL: Strupeno: nevarnost zelo hudih trajnih okvar zdravja pri zaužitju.FI: Myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara nieltynä.SV: Giftigt: risk för mycket allvarliga bestående hälsoskador vid förtäring.R39/23/24BG: Токсичен: опасност от много тежки необратими ефекти при вдишване и при контакт с кожата.ES: Tóxico: peligro de efectos irreversibles muy graves por inhalación y contacto con la piel.CS: Toxický: nebezpečí velmi vážných nevratných účinků při vdechování a při styku s kůží.DA: Giftig: fare for varig alvorlig skade på helbred ved indånding og hudkontakt.DE: Giftig: ernste Gefahr irreversiblen Schadens durch Einatmen und bei Berührung mit der Haut.ET: Mürgine: väga tõsiste pöördumatute kahjustuste oht sissehingamisel ja kokkupuutel nahaga.EL: Τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων όταν εισπνέεται και σε επαφή με το δέρμα.EN: Toxic: danger of very serious irreversible effects through inhalation and in contact with skin.FR: Toxique: danger d'effets irréversibles très graves par inhalation et par contact avec la peau.IT: Tossico: pericolo di effetti irreversibili molto gravi per inalazione e a contatto con la pelle.LV: Toksisks – būtiski neatgriezeniskas iedarbības draudi ieelpojot un nonākot saskarē ar ādu.LT: Toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus įkvėpus ir susilietus su oda.HU: Belélegezve és bőrrel érintkezve mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku: periklu ta' effetti irriversibbli serji ħafna meta jinxtamm u meta jmiss il-ġilda.NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing en aanraking met de huid.PL: Działa toksycznie przez drogi oddechowe i w kontakcie ze skórą; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Tóxico: perigo de efeitos irreversíveis muito graves por inalação e em contacto com a pele.RO: Toxic: pericol de efecte ireversibile foarte grave prin inhalare şi în contact cu pielea.SK: Jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov vdýchnutím a pri kontakte s pokožkou.SL: Strupeno: nevarnost zelo hudih trajnih okvar zdravja pri vdihavanju in v stiku s kožo.FI: Myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara hengitettynä ja joutuessaan iholle.SV: Giftigt: risk för mycket allvarliga bestående hälsoskador vid inandning och hudkontakt.R39/23/25BG: Токсичен: опасност от много тежки необратими ефекти при вдишване и при поглъщане.ES: Tóxico: peligro de efectos irreversibles muy graves por inhalación e ingestión.CS: Toxický: nebezpečí velmi vážných nevratných účinků při vdechování a při požití.DA: Giftig: fare for varig alvorlig skade på helbred ved indånding og indtagelse.DE: Giftig: ernste Gefahr irreversiblen Schadens durch Einatmen und durch Verschlucken.ET: Mürgine: väga tõsiste pöördumatute kahjustuste oht sissehingamisel ja allaneelamisel.EL: Τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων όταν εισπνέεται και σε περίπτωση καταπόσεως.EN: Toxic: danger of very serious irreversible effects through inhalation and if swallowed.FR: Toxique: danger d'effets irréversibles très graves par inhalation et par ingestion.IT: Tossico: pericolo di effetti irreversibili molto gravi per inalazione ed ingestione.LV: Toksisks: būtiski neatgriezeniskas iedarbības draudi ieelpojot un norijot.LT: Toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus įkvėpus ir prarijus.HU: Belélegezve és lenyelve mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku: periklu ta' effetti irriversibbli serji ħafna meta jinxtamm jew meta jinbela'.NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing en opname door de mond.PL: Działa toksycznie przez drogi oddechowe i po połknięciu; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Tóxico: perigo de efeitos irreversíveis muito graves por inalação e ingestão.RO: Toxic: pericol de efecte ireversibile foarte grave prin inhalare şi prin înghiţire.SK: Jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov vdýchnutím a po požití.SL: Strupeno: nevarnost zelo hudih trajnih okvar zdravja pri vdihavanju in pri zaužitju.FI: Myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara hengitettynä ja nieltynä.SV: Giftigt: risk för mycket allvarliga bestående hälsoskador vid inandning och förtäring.R39/24/25BG: Токсичен: опасност от много тежки необратими ефекти при контакт с кожата и при поглъщане.ES: Tóxico: peligro de efectos irreversibles muy graves por contacto con la piel e ingestión.CS: Toxický: nebezpečí velmi vážných nevratných účinků při styku s kůží a při požití.DA: Giftig: fare for varig alvorlig skade på helbred ved hudkontakt og indtagelse.DE: Giftig: ernste Gefahr irreversiblen Schadens bei Berührung mit der Haut und durch Verschlucken.ET: Mürgine: väga tõsiste pöördumatute kahjustuste oht kokkupuutel nahaga ja allaneelamisel.EL: Τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Toxic: danger of very serious irreversible effects in contact with skin and if swallowed.FR: Toxique: danger d'effets irréversibles très graves par contact avec la peau et par ingestion.IT: Tossico: pericolo di effetti irreversibili molto gravi a contatto con la pelle e per ingestione.LV: Toksisks – būtiski neatgriezeniskas iedarbības draudi, nonākot saskarē ar ādu un norijot.LT: Toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus susilietus su oda ir prarijus.HU: Bőrrel érintkezve és lenyelve mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku: periklu ta' effetti irriversibbli serji ħafna meta jmiss il-ġilda jew meta jinbela'.NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij aanraking met de huid en opname door de mond.PL: Działa toksycznie w kontakcie ze skórą i po połknięciu; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Tóxico: perigo de efeitos irreversíveis muito graves em contacto com a pele e por ingestão.RO: Toxic: pericol de efecte ireversibile foarte grave în contact cu pielea şi prin înghiţire.SK: Jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov pri kontakte s pokožkou a po požití.SL: Strupeno: nevarnost zelo hudih trajnih okvar zdravja v stiku s kožo in pri zaužitju.FI: Myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara joutuessaan iholle ja nieltynä.SV: Giftigt: risk för mycket allvarliga bestående hälsoskador vid hudkontakt och förtäring.R39/23/24/25BG: Токсичен: опасност от много тежки необратими ефекти при вдишване, при контакт с кожата и при поглъщане.ES: Tóxico: peligro de efectos irreversibles muy graves por inhalación, contacto con la piel e ingestión.CS: Toxický: nebezpečí velmi vážných nevratných účinků při vdechování, styku s kůží a při požití.DA: Giftig: fare for varig alvorlig skade på helbred ved indånding, hudkontakt og indtagelse.DE: Giftig: ernste Gefahr irreversiblen Schadens durch Einatmen, Berührung mit der Haut und durch Verschlucken.ET: Mürgine: väga tõsiste pöördumatute kahjustuste oht sissehingamisel, kokkupuutel nahaga ja allaneelamisel.EL: Τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων όταν εισπνέεται, σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed.FR: Toxique: danger d'effets irréversibles très graves par inhalation, par contact avec la peau et par ingestion.IT: Tossico: pericolo di effetti irreversibili molto gravi per inalazione, a contatto con la pelle e per ingestione.LV: Toksisks – būtiski neatgriezeniskas iedarbības draudi ieelpojot, nonākot saskarē ar ādu un norijot.LT: Toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus įkvėpus, susilietus su oda ir prarijus.HU: Belélegezve, bőrrel érintkezve és lenyelve mérgező: nagyon súlyos, maradandó egészségkárosodást okozhatMT: Tossiku: periklu ta' effetti irriversibbli serji ħafna meta jinxtamm, imiss il-ġilda jew meta jinbela'.NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing, aanraking met de huid en opname door de mond.PL: Działa toksycznie przez drogi oddechowe, w kontakcie ze skórą i po połknięciu; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Tóxico: perigo de efeitos irreversíveis muito graves por inalação, em contacto com a pele e por ingestão.RO: Toxic: pericol de efecte ireversibile foarte grave prin inhalare, în contact cu pielea şi prin înghiţire.SK: Jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov vdýchnutím, pri kontakte s pokožkou a po požití.SL: Strupeno: nevarnost zelo hudih trajnih okvar zdravja pri vdihavanju, v stiku s kožo in pri zaužitju.FI: Myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara hengitettynä, joutuessaan iholle ja nieltynä.SV: Giftigt: risk för mycket allvarliga bestående hälsoskador vid inandning, hudkontakt och förtäring.R39/26BG: Силно токсичен: опасност от много тежки необратими ефекти при вдишване.ES: Muy tóxico: peligro de efectos irreversibles muy graves por inhalación.CS: Vysoce toxický: nebezpečí velmi vážných nevratných účinků při vdechování.DA: Meget giftig: fare for varig alvorlig skade på helbred ved indånding.DE: Sehr giftig: ernste Gefahr irreversiblen Schadens durch Einatmen.ET: Väga mürgine: väga tõsiste pöördumatute kahjustuste oht sissehingamisel.EL: Πολύ τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων όταν εισπνέεται.EN: Very toxic: danger of very serious irreversible effects through inhalation.FR: Très toxique: danger d'effets irréversibles très graves par inhalation.IT: Molto tossico: pericolo di effetti irreversibili molto gravi per inalazione.LV: Ļoti toksisks – būtiski neatgriezeniskas iedarbības draudi ieelpojot.LT: Labai toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus įkvėpus.HU: Belélegezve nagyon mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku ħafna: periklu ta' effetti irriversibbli serji ħafna meta jinxtamm.NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing.PL: Działa bardzo toksycznie przez drogi oddechowe; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Muito tóxico: perigo de efeitos irreversíveis muito graves por inalação.RO: Foarte toxic: pericol de efecte ireversibile foarte grave prin inhalare.SK: Veľmi jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov vdýchnutím.SL: Zelo strupeno: nevarnost zelo hudih trajnih okvar zdravja pri vdihavanju.FI: Erittäin myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara hengitettynä.SV: Mycket giftigt: risk för mycket allvarliga bestående hälsoskador vid inandning.R39/27BG: Силно токсичен: опасност от много тежки необратими ефекти при контакт с кожата.ES: Muy tóxico: peligro de efectos irreversibles muy graves por contacto con la piel.CS: Vysoce toxický: nebezpečí velmi vážných nevratných účinků při styku s kůží.DA: Meget giftig: fare for varig alvorlig skade på helbred ved hudkontakt.DE: Sehr giftig: ernste Gefahr irreversiblen Schadens bei Berührung mit der Haut.ET: Väga mürgine: väga tõsiste pöördumatute kahjustuste oht kokkupuutel nahaga.EL: Πολύ τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων σε επαφή με το δέρμα.EN: Very toxic: danger of very serious irreversible effects in contact with skin.FR: Très toxique: danger d'effets irréversibles très graves par contact avec la peau.IT: Molto tossico: pericolo di effetti irreversibili molto gravi a contatto con la pelle.LV: Ļoti toksisks – būtiski neatgriezeniskas iedarbības draudi, nonākot saskarē ar ādu.LT: Labai toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus susilietus su oda.HU: Bőrrel érintkezve nagyon mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku ħafna: periklu ta' effetti irriversibbli serji ħafna meta jmiss il-ġilda.NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij aanraking met de huid.PL: Działa bardzo toksycznie w kontakcie ze skórą; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Muito tóxico: perigo de efeitos irreversíveis muito graves em contacto com a pele.RO: Foarte toxic: pericol de efecte ireversibile foarte grave în contact cu pielea.SK: Veľmi jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov pri kontakte s pokožkou.SL: Zelo strupeno: nevarnost zelo hudih trajnih okvar zdravja v stiku s kožo.FI: Erittäin myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara joutuessaan iholle.SV: Mycket giftigt: risk för mycket allvarliga bestående hälsoskador vid hudkontakt.R39/28BG: Силно токсичен: опасност от много тежки необратими ефекти при поглъщане.ES: Muy tóxico: peligro de efectos irreversibles muy graves por ingestión.CS: Vysoce toxický: nebezpečí velmi vážných nevratných účinků při požití.DA: Meget giftig: fare for varig alvorlig skade på helbred ved indtagelse.DE: Sehr giftig: ernste Gefahr irreversiblen Schadens durch Verschlucken.ET: Väga mürgine: väga tõsiste pöördumatute kahjustuste oht allaneelamisel.EL: Πολύ τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων σε περίπτωση καταπόσεως.EN: Very toxic: danger of very serious irreversible effects if swallowed.FR: Très toxique: danger d'effets irréversibles très graves par ingestion.IT: Molto tossico: pericolo di effetti irreversibili molto gravi per ingestione.LV: Ļoti toksisks – būtiski neatgriezeniskas iedarbības draudi norijot.LT: Labai toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus prarijus.HU: Lenyelve nagyon mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku ħafna: periklu ta' effetti irriversibbli serji ħafna jekk jinbela'.NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij opname door de mond.PL: Działa bardzo toksycznie po połknięciu; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Muito tóxico: perigo de efeitos irreversíveis muito graves por ingestão.RO: Foarte toxic: pericol de efecte ireversibile foarte grave prin înghiţire.SK: Veľmi jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov po požití.SL: Zelo strupeno: nevarnost zelo hudih trajnih okvar zdravja pri zaužitju.FI: Erittäin myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara nieltynä.SV: Mycket giftigt: risk för mycket allvarliga bestående hälsoskador vid förtäring.R39/26/27BG: Силно токсичен: опасност от много тежки необратими ефекти при вдишване и при контакт с кожата.ES: Muy tóxico: peligro de efectos irreversibles muy graves por inhalación y contacto con la piel.CS: Vysoce toxický: nebezpečí velmi vážných nevratných účinků při vdechování a při styku s kůží.DA: Meget giftig: fare for varig alvorlig skade på helbred ved indånding og hudkontakt.DE: Sehr giftig: ernste Gefahr irreversiblen Schadens durch Einatmen und bei Berührung mit der Haut.ET: Väga mürgine: väga tõsiste pöördumatute kahjustuste oht sissehingamisel ja kokkupuutel nahaga.EL: Πολύ τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων όταν εισπνέεται και σε επαφή με το δέρμα.EN: Very toxic: danger of very serious irreversible effects through inhalation and in contact with skin.FR: Très toxique: danger d'effets irréversibles très graves par inhalation et par contact avec la peau.IT: Molto tossico: pericolo di effetti irreversibili molto gravi per inalazione e a contatto con la pelle.LV: Ļoti toksisks – būtiski neatgriezeniskas iedarbības draudi ieelpojot un nonākot saskarē ar ādu.LT: Labai toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus įkvėpus ir susilietus su oda.HU: Belélegezve és bőrrel érintkezve nagyon mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku ħafna: periklu ta' effetti irriversibbli serji ħafna meta jinxtamm u jmiss il-ġilda.NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing en aanraking met de huid.PL: Działa bardzo toksycznie przez drogi oddechowe i w kontakcie ze skórą; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Muito tóxico: perigo de efeitos irreversíveis muito graves por inalação e em contacto com a pele.RO: Foarte toxic: pericol de efecte ireversibile foarte grave prin inhalare şi în contact cu pielea.SK: Veľmi jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov vdýchnutím a pri kontakte s pokožkou.SL: Zelo strupeno: nevarnost zelo hudih trajnih okvar zdravja pri vdihavanju in v stiku s kožo.FI: Erittäin myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara hengitettynä ja joutuessaan iholle.SV: Mycket giftigt: risk för mycket allvarliga bestående hälsoskador vid inandning och hudkontakt.R39/26/28BG: Силно токсичен: опасност от много тежки необратими ефекти при вдишване и при поглъщане.ES: Muy tóxico: peligro de efectos irreversibles muy graves por inhalación e ingestión.CS: Vysoce toxický: nebezpečí velmi vážných nevratných účinků při vdechování a při požití.DA: Meget giftig: fare for varig alvorlig skade på helbred ved indånding og indtagelse.DE: Sehr giftig: ernste Gefahr irreversiblen Schadens durch Einatmen und durch Verschlucken.ET: Väga mürgine: väga tõsiste pöördumatute kahjustuste oht sissehingamisel ja allaneelamisel.EL: Πολύ τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων όταν εισπνέεται και σε περίπτωση καταπόσεως.EN: Very toxic: danger of very serious irreversible effects through inhalation and if swallowed.FR: Très toxique: danger d'effets irréversibles très graves par inhalation et par ingestion.IT: Molto tossico: pericolo di effetti irreversibili molto gravi per inalazione ed ingestione.LV: Ļoti toksisks – būtiski neatgriezeniskas iedarbības draudi ieelpojot un norijot.LT: Labai toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus įkvėpus ir prarijus.HU: Belélegezve és lenyelve nagyon mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku ħafna: periklu ta' effetti irriversibbli serji ħafna meta jinxtamm u jekk jinbela'.NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing en opname door de mond.PL: Działa bardzo toksycznie przez drogi oddechowe i po połknięciu; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Muito tóxico: perigo de efeitos irreversíveis muito graves por inalação e ingestão.RO: Foarte toxic: pericol de efecte ireversibile foarte grave prin inhalare şi prin înghiţire.SK: Veľmi jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov vdýchnutím a po požití.SL: Zelo strupeno: nevarnost zelo hudih trajnih okvar zdravja pri vdihavanju in pri zaužitju.FI: Erittäin myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara hengitettynä ja nieltynä.SV: Mycket giftigt: risk för mycket allvarliga bestående hälsoskador vid inandning och förtäring.R39/27/28BG: Силно токсичен: опасност от много тежки необратими ефекти при контакт с кожата и при поглъщане.ES: Muy tóxico: peligro de efectos irreversibles muy graves por contacto con la piel e ingestión.CS: Vysoce toxický: nebezpečí velmi vážných nevratných účinků při styku s kůží a při požití.DA: Meget giftig: fare for varig alvorlig skade på helbred ved hudkontakt og indtagelse.DE: Sehr giftig: ernste Gefahr irreversiblen Schadens bei Berührung mit der Haut und durch Verschlucken.ET: Väga mürgine: väga tõsiste pöördumatute kahjustuste oht kokkupuutel nahaga ja allaneelamisel.EL: Πολύ τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Very toxic: danger of very serious irreversible effects in contact with skin and if swallowed.FR: Très toxique: danger d'effets irréversibles très graves par contact avec la peau et par ingestion.IT: Molto tossico: pericolo di effetti irreversibili molto gravi a contatto con la pelle e per ingestione.LV: Ļoti toksisks – būtiski neatgriezeniskas iedarbības draudi, nonākot saskarē ar ādu un norijot.LT: Labai toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus susilietus su oda ir prarijus.HU: Bőrrel érintkezve és lenyelve nagyon mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku ħafna: periklu ta' effetti irriversibbli serji ħafna meta jmiss il-ġilda u jekk jinbela'.NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij aanraking met de huid en opname door de mond.PL: Działa bardzo toksycznie w kontakcie ze skórą i po połknięciu; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Muito tóxico: perigo de efeitos irreversíveis muito graves em contacto com a pele e por ingestão.RO: Foarte toxic: pericol de efecte ireversibile foarte grave în contact cu pielea şi prin înghiţire.SK: Veľmi jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov pri kontakte s pokožkou a po požití.SL: Zelo strupeno: nevarnost zelo hudih trajnih okvar zdravja v stiku s kožo in pri zaužitju.FI: Erittäin myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara joutuessaan iholle ja nieltynä.SV: Mycket giftigt: risk för mycket allvarliga bestående hälsoskador vid hudkontakt och förtäring.R39/26/27/28BG: Силно токсичен: опасност от много тежки необратими ефекти при вдишване, при контакт с кожата и при поглъщане.ES: Muy tóxico: peligro de efectos irreversibles muy graves por inhalación, contacto con la piel e ingestión.CS: Vysoce toxický: nebezpečí velmi vážných nevratných účinků při vdechování, styku s kůží a při požití.DA: Meget giftig: fare for varig alvorlig skade på helbred ved indånding, hudkontakt og indtagelse.DE: Sehr giftig: ernste Gefahr irreversiblen Schadens durch Einatmen, Berührung mit der Haut und durch Verschlucken.ET: Väga mürgine: väga tõsiste pöördumatute kahjustuste oht sissehingamisel, kokkupuutel nahaga ja allaneelamisel.EL: Πολύ τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων όταν εισπνέεται, σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Very toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed.FR: Très toxique: danger d'effets irréversibles très graves par inhalation, par contact avec la peau et par ingestion.IT: Molto tossico: pericolo di effetti irreversibili molto gravi per inalazione, a contatto con la pelle e per ingestione.LV: Ļoti toksisks – būtiski neatgriezeniskas iedarbības draudi ieelpojot, nonākot saskarē ar ādu vai norijot.LT: Labai toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus įkvėpus, susilietus su oda ir prarijus.HU: Belélegezve, bőrrel érintkezve, lenyelve nagyon mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku ħafna: periklu ta' effetti irriversibbli serji ħafna meta jinxtamm, imiss il-ġilda u jekk jinbela'.NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing, aanraking met de huid en opname door de mond.PL: Działa bardzo toksycznie przez drogi oddechowe, w kontakcie ze skórą i po połknięciu; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Muito tóxico: perigo de efeitos irreversíveis muito graves por inalação, em contacto com a pele e por ingestão.RO: Foarte toxic: pericol de efecte ireversibile foarte grave prin inhalare, în contact cu pielea şi prin înghiţire.SK: Veľmi jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov vdýchnutím, pri kontakte s pokožkou a po požití.SL: Zelo strupeno: nevarnost zelo hudih trajnih okvar zdravja pri vdihavanju, v stiku s kožo in pri zaužitju.FI: Erittäin myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara hengitettynä, joutuessaan iholle ja nieltynä.SV: Mycket giftigt: risk för mycket allvarliga bestående hälsoskador vid inandning, hudkontakt och förtäring.R42/43BG: Възможна е сенсибилизация при вдишване и при контакт с кожата.ES: Posibilidad de sensibilización por inhalación y por contacto con la piel.CS: Může vyvolat senzibilizaci při vdechování a při styku s kůží.DA: Kan give overfølsomhed ved indånding og ved kontakt med huden.DE: Sensibilisierung durch Einatmen und Hautkontakt möglich.ET: Võib põhjustada ülitundlikkust sissehingamisel ja kokkupuutel nahaga.EL: Μπορεί να προκαλέσει ευαισθητοποίηση όταν εισπνέεται και σε επαφή με το δέρμα.EN: May cause sensitization by inhalation and skin contact.FR: Peut entraîner une sensibilisation par inhalation et par contact avec la peau.IT: Può provocare sensibilizzazione per inalazione e contatto con la pelle.LV: Saskaroties ar ādu vai ieelpojot, var izraisīt paaugstinātu jutīgumu.LT: Gali sukelti alergiją įkvėpus ir susilietus su oda.HU: Belélegezve és bőrrel érintkezve túlérzékenységet okozhat (szenzibilizáló hatású lehet).MT: Jista' jikkaġuna sensitizzazzjoni meta jinxtamm u meta jmiss il-ġilda.NL: Kan overgevoeligheid veroorzaken bij inademing of contact met de huid.PL: Może powodować uczulenie w następstwie narażenia drogą oddechową i w kontakcie ze skórą.PT: Pode causar sensibilização por inalação e em contacto com a pele.RO: Poate provoca sensibilizare prin inhalare şi în contact cu pielea.SK: Môže spôsobiť senzibilizáciu po vdýchnutí a po kontakte s pokožkou.SL: Lahko povzroči preobčutljivost pri vdihavanju in v stiku s kožo.FI: Altistuminen hengitysteitse ja ihokosketus voi aiheuttaa herkistymistä.SV: Kan ge allergi vid inandning och hudkontakt.R48/20BG: Вреден: опасност от тежко увреждане на здравето при продължителна експозиция чрез вдишване.ES: Nocivo: riesgo de efectos graves para la salud en caso de exposición prolongada por inhalación.CS: Zdraví škodlivý: nebezpečí vážného poškození zdraví při dlouhodobé expozici vdechováním.DA: Farlig: alvorlig sundhedsfare ved længere tids påvirkning ved indånding.DE: Gesundheitsschädlich: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Einatmen.ET: Kahjulik: tõsise tervisekahjustuse oht pikaajalisel sissehingamisel.EL: Επιβλαβές: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση όταν εισπνέεται.EN: Harmful: danger of serious damage to health by prolonged exposure through inhalation.FR: Nocif: risque d'effets graves pour la santé en cas d'exposition prolongée par inhalation.IT: Nocivo: pericolo di gravi danni per la salute in caso di esposizione prolungata per inalazione.LV: Kaitīgs – ieelpojot iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības.LT: Kenksminga: ilgą laiką pakartotinai įkvepiant sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át belélegezve ártalmas: súlyos egészségkárosodást okozhat.MT: Jagħmel ħsara: periklu ta' ħsara serja lis-saħħa minn espożizzjoni għat-tul minħabba xamm.NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing.PL: Działa szkodliwie przez drogi oddechowe; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Nocivo: risco de efeitos graves para a saúde em caso de exposição prolongada por inalação.RO: Nociv: pericol de efecte grave asupra sănătăţii la expunere prelungită prin inhalare.SK: Škodlivý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou vdýchnutím.SL: Zdravju škodljivo: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega vdihavanja.FI: Terveydelle haitallista: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettynä.SV: Farligt: risk för allvarliga hälsoskador vid långvarig exponering genom inandning.R48/21BG: Вреден: опасност от тежко увреждане на здравето при продължителна експозиция при контакт с кожата.ES: Nocivo: riesgo de efectos graves para la salud en caso de exposición prolongada por contacto con la piel.CS: Zdraví škodlivý: nebezpečí vážného poškození zdraví při dlouhodobé expozici stykem s kůží.DA: Farlig: alvorlig sundhedsfare ved længere tids påvirkning ved hudkontakt.DE: Gesundheitsschädlich: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Berührung mit der Haut.ET: Kahjulik: tõsise tervisekahjustuse oht pikaajalisel kokkupuutel nahaga.EL: Επιβλαβές: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση σε επαφή με το δέρμα.EN: Harmful: danger of serious damage to health by prolonged exposure in contact with skin.FR: Nocif: risque d'effets graves pour la santé en cas d'exposition prolongée par contact avec la peau.IT: Nocivo: pericolo di gravi danni alla salute in caso di esposizione prolungata a contatto con la pelle.LV: Kaitīgs – iespējams nopietns kaitējums veselībai pēc ilgstošas saskares ar ādu.LT: Kenksminga: ilgą laiką pakartotinai veikiant per odą sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át bőrrel érintkezve ártalmas: súlyos egészségkárosodást okozhat.MT: Jagħmel ħsara: periklu ta' ħsara serja lis-saħħa minn espożizzjoni għat-tul waqt li jmiss il-ġilda.NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij aanraking met de huid.PL: Działa szkodliwie w kontakcie ze skórą; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Nocivo: risco de efeitos graves para a saúde em caso de exposição prolongada em contacto com a pele.RO: Nociv: pericol de efecte grave asupra sănătăţii la expunere prelungită în contact cu pielea.SK: Škodlivý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou pri kontakte s pokožkou.SL: Zdravju škodljivo: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega stika s kožo.FI: Terveydelle haitallista: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle joutuessaan iholle.SV: Farligt: risk för allvarliga hälsoskador vid långvarig exponering genom hudkontakt.R48/22BG: Вреден: опасност от тежко увреждане на здравето при продължителна експозиция при поглъщане.ES: Nocivo: riesgo de efectos graves para la salud en caso de exposición prolongada por ingestión.CS: Zdraví škodlivý: nebezpečí vážného poškození zdraví při dlouhodobé expozici požíváním.DA: Farlig: alvorlig sundhedsfare ved længere tids påvirkning ved indtagelse.DE: Gesundheitsschädlich: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Verschlucken.ET: Kahjulik: tõsise tervisekahjustuse oht pikaajalisel allaneelamisel.EL: Επιβλαβές: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση σε περίπτωση καταπόσεως.EN: Harmful: danger of serious damage to health by prolonged exposure if swallowed.FR: Nocif: risque d'effets graves pour la santé en cas d'exposition prolongée par ingestion.IT: Nocivo: pericolo di gravi danni alla salute in caso di esposizione prolungata per ingestione.LV: Kaitīgs – norijot iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības.LT: Kenksminga: ilgą laiką pakartotinai praryjant sukelia sunkius sveikatos sutrikimus.HU: Szájon keresztül hosszabb időn át a szervezetbe jutva ártalmas: súlyos egészségkárosodást okozhat.MT: Jagħmel ħsara: periklu ta' ħsara serja lis-saħħa minn espożizzjoni għat-tul jekk jinbela'.NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij opname door de mond.PL: Działa szkodliwie po połknięciu; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Nocivo: risco de efeitos graves para a saúde em caso de exposição prolongada por ingestão.RO: Nociv: pericol de efecte grave asupra sănătăţii la expunere prelungită prin înghiţire.SK: Škodlivý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou po požití.SL: Zdravju škodljivo: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega zauživanja.FI: Terveydelle haitallista: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle nieltynä.SV: Farligt: risk för allvarliga hälsoskador vid långvarig exponering genom förtäring.R48/20/21BG: Вреден: опасност от тежко увреждане на здравето при продължителна експозиция чрез вдишване и при контакт с кожата.ES: Nocivo: riesgo de efectos graves para la salud en caso de exposición prolongada por inhalación y contacto con la piel.CS: Zdraví škodlivý: nebezpečí vážného poškození zdraví při dlouhodobé expozici vdechováním a stykem s kůží.DA: Farlig: alvorlig sundhedsfare ved længere tids påvirkning ved indånding og hudkontakt.DE: Gesundheitsschädlich: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Einatmen und durch Berührung mit der Haut.ET: Kahjulik: tõsise tervisekahjustuse oht pikaajalisel sissehingamisel ja kokkupuutel nahaga.EL: Επιβλαβές: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση όταν εισπνέεται και σε επαφή με το δέρμα.EN: Harmful: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin.FR: Nocif: risque d'effets graves pour la santé en cas d'exposition prolongée par inhalation et par contact avec la peau.IT: Nocivo: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione e a contatto con la pelle.LV: Kaitīgs – ieelpojot un nonākot saskarē ar ādu, iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības.LT: Kenksminga: ilgą laiką pakartotinai įkvepiant ir veikiant per odą sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át belélegezve és bőrrel érintkezve ártalmas: súlyos egészségkárosodást okozhat.MT: Jagħmel ħsara: periklu ta' ħsara serja lis-saħħa minn espożizzjoni għat-tul minħabba xamm u mess mal-ġilda.NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing en aanraking met de huid.PL: Działa szkodliwie przez drogi oddechowe i w kontakcie ze skórą; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Nocivo: risco de efeitos graves para a saúde em caso de exposição prolongada por inalação e em contacto com a pele.RO: Nociv: pericol de efecte grave asupra sănătăţii la expunere prelungită prin inhalare şi în contact cu pielea.SK: Škodlivý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou vdýchnutím a pri kontakte s pokožkou.SL: Zdravju škodljivo: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega vdihavanja in stika s kožo.FI: Terveydelle haitallista: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettynä ja joutuessaan iholle.SV: Farligt: risk för allvarliga hälsoskador vid långvarig exponering genom inandning och hudkontakt.R48/20/22BG: Вреден: опасност от тежко увреждане на здравето при продължителна експозиция чрез вдишване и при поглъщане.ES: Nocivo: riesgo de efectos graves para la salud en caso de exposición prolongada por inhalación e ingestión.CS: Zdraví škodlivý: nebezpečí vážného poškození zdraví při dlouhodobé expozici vdechováním a požíváním.DA: Farlig: alvorlig sundhedsfare ved længere tids påvirkning ved indånding og indtagelse.DE: Gesundheitsschädlich: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Einatmen und durch Verschlucken.ET: Kahjulik: tõsise tervisekahjustuse oht pikaajalisel sissehingamisel ja allaneelamisel.EL: Επιβλαβές: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση όταν εισπνέεται και σε περίπτωση καταπόσεως.EN: Harmful: danger of serious damage to health by prolonged exposure through inhalation and if swallowed.FR: Nocif: risque d'effets graves pour la santé en cas d'exposition prolongée par inhalation et par ingestion.IT: Nocivo: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione e ingestione.LV: Kaitīgs – ieelpojot un norijot iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības.LT: Kenksminga: ilgą laiką pakartotinai įkvepiant ir praryjant sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át belélegezve és szájon át a szervezetbe jutva ártalmas: súlyos egészségkárosodást okozhat.MT: Jagħmel ħsara: periklu ta' ħsara serja lis-saħħa minn espożizzjoni għat-tul minħabba xamm u jekk jinbela'.NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing en opname door de mond.PL: Działa szkodliwie przez drogi oddechowe i po połknięciu; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Nocivo: risco de efeitos graves para a saúde em caso de exposição prolongada por inalação e ingestão.RO: Nociv: pericol de efecte grave asupra sănătăţii la expunere prelungită prin inhalare şi prin înghiţire.SK: Škodlivý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou vdýchnutím a po požití.SL: Zdravju škodljivo: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega vdihavanja in zauživanja.FI: Terveydelle haitallista: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettynä ja nieltynä.SV: Farligt: risk för allvarliga hälsoskador vid långvarig exponering genom inandning och förtäring.R48/21/22BG: Вреден: опасност от тежко увреждане на здравето при продължителна експозиция при контакт с кожата и при поглъщане.ES: Nocivo: riesgo de efectos graves para la salud en caso de exposición prolongada por contacto con la piel e ingestión.CS: Zdraví škodlivý: nebezpečí vážného poškození zdraví při dlouhodobé expozici stykem s kůží a požíváním.DA: Farlig: alvorlig sundhedsfare ved længere tids påvirkning ved hudkontakt og indtagelse.DE: Gesundheitsschädlich: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Berührung mit der Haut und durch Verschlucken.ET: Kahjulik: tõsise tervisekahjustuse oht pikaajalisel kokkupuutel nahaga ja allaneelamisel.EL: Επιβλαβές: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Harmful: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed.FR: Nocif: risque d'effets graves pour la santé en cas d'exposition prolongée par contact avec la peau et par ingestion.IT: Nocivo: pericolo di gravi danni alla salute in caso di esposizione prolungata a contatto con la pelle e per ingestione.LV: Kaitīgs – iespējams nopietns kaitējums veselībai pēc ilgstošas saskares ar ādu un norijot.LT: Kenksminga: ilgą laiką pakartotinai veikiant per odą ir praryjant sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át bőrrel érintkezve és szájon át a szervezetbe jutva ártalmas: súlyos egészségkárosodást okozhat.MT: Jagħmel ħsara: periklu ta' ħsara serja lis-saħħa minn espożizzjoni għat-tul meta jmiss il-ġilda u jekk jinbela'.NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij aanraking met de huid en opname door de mond.PL: Działa szkodliwie w kontakcie ze skórą i po połknięciu; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Nocivo: risco de efeitos graves para a saúde em caso de exposição prolongada em contacto com a pele e por ingestão.RO: Nociv: pericol de efecte grave asupra sănătăţii la expunere prelungită în contact cu pielea şi prin înghiţire.SK: Škodlivý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou pri kontakte s pokožkou a po požití.SL: Zdravju škodljivo: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega stika s kožo in zauživanja.FI: Terveydelle haitallista: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle joutuessaan iholle ja nieltynä.SV: Farligt: risk för allvarliga hälsoskador vid långvarig exponering genom hudkontakt och förtäring.R48/20/21/22BG: Вреден: опасност от тежко увреждане на здравето при продължителна експозиция чрез вдишване, при контакт с кожата и при поглъщане.ES: Nocivo: riesgo de efectos graves para la salud en caso de exposición prolongada por inhalación, contacto con la piel e ingestión.CS: Zdraví škodlivý: nebezpečí vážného poškození zdraví při dlouhodobé expozici vdechováním, stykem s kůží a požíváním.DA: Farlig: alvorlig sundhedsfare ved længere tids påvirkning ved indånding, hudkontakt og indtagelse.DE: Gesundheitsschädlich: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Einatmen, Berührung mit der Haut und durch Verschlucken.ET: Kahjulik: tõsise tervisekahjustuse oht pikaajalisel sissehingamisel, kokkupuutel nahaga ja allaneelamisel.EL: Επιβλαβές: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση όταν εισπνέεται, σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Harmful: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed.FR: Nocif: risque d'effets graves pour la santé en cas d'exposition prolongée par inhalation, par contact avec la peau et par ingestion.IT: Nocivo: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione, a contatto con la pelle e per ingestione.LV: Kaitīgs – iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības ieelpojot, norijot un nonākot saskarē ar ādu.LT: Kenksminga: ilgą laiką pakartotinai įkvepiant, veikiant per odą ir praryjant sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át belélegezve, bőrrel érintkezve és szájon keresztül a szervezetbe jutva ártalmas: súlyos egészségkárosodást okozhat.MT: Jagħmel ħsara: periklu ta' ħsara serja lis-saħħa minn espożizzjoni għat-tul minħabba xamm, mess mal-ġilda jew jekk jinbela'.NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing, aanraking met de huid en opname door de mond.PL: Działa szkodliwie przez drogi oddechowe, w kontakcie ze skórą i po połknięciu; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Nocivo: risco de efeitos graves para a saúde em caso de exposição prolongada por inalação, em contacto com a pele e por ingestão.RO: Nociv: pericol de efecte grave asupra sănătăţii la expunere prelungită prin inhalare, în contact cu pielea şi prin înghiţire.SK: Škodlivý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou vdýchnutím, pri kontakte s pokožkou a po požití.SL: Zdravju škodljivo: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega vdihavanja, stika s kožo in zauživanja.FI: Terveydelle haitallista: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettynä, joutuessaan iholle ja nieltynä.SV: Farligt: risk för allvarliga hälsoskador vid långvarig exponering genom inandning, hudkontakt och förtäring.R48/23BG: Токсичен: опасност от тежко увреждане на здравето при продължителна експозиция чрез вдишване.ES: Tóxico: riesgo de efectos graves para la salud en caso de exposición prolongada por inhalación.CS: Toxický: nebezpečí vážného poškození zdraví při dlouhodobé expozici vdechováním.DA: Giftig: alvorlig sundhedsfare ved længere tids påvirkning ved indånding.DE: Giftig: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Einatmen.ET: Mürgine: tõsise tervisekahjustuse oht pikaajalisel sissehingamisel.EL: Τοξικό: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση όταν εισπνέεται.EN: Toxic: danger of serious damage to health by prolonged exposure through inhalation.FR: Toxique: risque d'effets graves pour la santé en cas d'exposition prolongée par inhalation.IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione.LV: Toksisks – iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības ieelpojot.LT: Toksiška: ilgą laiką pakartotinai įkvepiant sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át belélegezve mérgező: súlyos egészségkárosodást okozhat.MT: Tossiku: periklu ta' ħsara serja lis-saħħa minn espożizzjoni għat-tul minħabba xamm.NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing.PL: Działa toksycznie przez drogi oddechowe; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Tóxico: risco de efeitos graves para a saúde em caso de exposição prolongada por inalação.RO: Toxic: pericol de efecte grave asupra sănătăţii la expunere prelungită prin inhalare.SK: Jedovatý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou vdýchnutím.SL: Strupeno: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega vdihavanja.FI: Myrkyllistä: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettynä.SV: Giftigt: risk för allvarliga hälsoskador vid långvarig exponering genom inandning.R48/24BG: Токсичен: опасност от тежко увреждане на здравето при продължителна експозиция при контакт с кожата.ES: Tóxico: riesgo de efectos graves para la salud en caso de exposición prolongada por contacto con la piel.CS: Toxický: nebezpečí vážného poškození zdraví při dlouhodobé expozici stykem s kůží.DA: Giftig: alvorlig sundhedsfare ved længere tids påvirkning ved hudkontakt.DE: Giftig: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Berührung mit der Haut.ET: Mürgine: tõsise tervisekahjustuse oht pikaajalisel kokkupuutel nahaga.EL: Τοξικό: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση σε επαφή με το δέρμα.EN: Toxic: danger of serious damage to health by prolonged exposure in contact with skin.FR: Toxique: risque d'effets graves pour la santé en cas d'exposition prolongée par contact avec la peau.IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata a contatto con la pelle.LV: Toksisks – iespējams nopietns kaitējums veselībai pēc ilgstošas saskares ar ādu.LT: Toksiška: ilgą laiką pakartotinai veikiant per odą sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át bőrrel érintkezve mérgező: súlyos egészségkárosodást okozhat.MT: Tossiku: periklu ta' ħsara serja lis-saħħa minn espożizzjoni għat-tul għal mess mal-ġilda.NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij aanraking met de huid.PL: Działa toksycznie w kontakcie ze skórą; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Tóxico: risco de efeitos graves para a saúde em caso de exposição prolongada em contacto com a pele.RO: Toxic: pericol de efecte grave asupra sănătăţii la expunere prelungită în contact cu pielea.SK: Jedovatý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou pri kontakte s pokožkou.SL: Strupeno: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega stika s kožo.FI: Myrkyllistä: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle joutuessaan iholle.SV: Giftigt: risk för allvarliga hälsoskador vid långvarig exponering genom hudkontakt.R48/25BG: Токсичен: опасност от тежко увреждане на здравето при продължителна експозиция при поглъщане.ES: Tóxico: riesgo de efectos graves para la salud en caso de exposición prolongada por ingestión.CS: Toxický: nebezpečí vážného poškození zdraví při dlouhodobé expozici požíváním.DA: Giftig: alvorlig sundhedsfare ved længere tids påvirkning ved indtagelse.DE: Giftig: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Verschlucken.ET: Mürgine: tõsise tervisekahjustuse oht pikaajalisel allaneelamisel.EL: Τοξικό: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση σε περίπτωση καταπόσεως.EN: Toxic: danger of serious damage to health by prolonged exposure if swallowed.FR: Toxique: risque d'effets graves pour la santé en cas d'exposition prolongée par ingestion.IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata per ingestione.LV: Toksisks – iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības norijot.LT: Toksiška: ilgą laiką pakartotinai praryjant sukelia sunkius sveikatos sutrikimus.HU: Szájon keresztül hosszabb időn át a szervezetbe jutva mérgező: súlyos egészségkárosodást okozhat.MT: Tossiku: periklu ta' ħsara serja lis-saħħa minn espożizzjoni għat-tul jekk jinbela'.NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij opname door de mond.PL: Działa toksycznie po połknięciu; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Tóxico: risco de efeitos graves para a saúde em caso de exposição prolongada por ingestão.RO: Toxic: pericol de efecte grave asupra sănătăţii la expunere prelungită prin înghiţire.SK: Jedovatý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou po požití.SL: Strupeno: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega zauživanja.FI: Myrkyllistä: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle nieltynä.SV: Giftigt: risk för allvarliga hälsoskador vid långvarig exponering genom förtäring.R48/23/24BG: Токсичен: опасност от тежко увреждане на здравето при продължителна експозиция чрез вдишване и при контакт с кожата.ES: Tóxico: riesgo de efectos graves para la salud en caso de exposición prolongada por inhalación y contacto con la piel.CS: Toxický: nebezpečí vážného poškození zdraví při dlouhodobé expozici vdechováním a stykem s kůží.DA: Giftig: alvorlig sundhedsfare ved længere tids påvirkning ved indånding og hudkontakt.DE: Giftig: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Einatmen und durch Berührung mit der Haut.ET: Mürgine: tõsise tervisekahjustuse oht pikaajalisel sissehingamisel ja kokkupuutel nahaga.EL: Τοξικό: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση όταν εισπνέεται και σε επαφή με το δέρμα.EN: Toxic: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin.FR: Toxique: risque d'effets graves pour la santé en cas d'exposition prolongée par inhalation et par contact avec la peau.IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione e a contatto con la pelle.LV: Toksisks – iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības ieelpojot un nonākot saskarē ar ādu.LT: Toksiška: ilgą laiką pakartotinai įkvepiant ir veikiant per odą sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át belélegezve és bőrrel érintkezve mérgező: súlyos egészségkárosodást okozhat.MT: Tossiku: periklu ta' ħsara serja lis-saħħa minn espożizzjoni għat-tul minħabba xamm u mess mal-ġilda.NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing en aanraking met de huid.PL: Działa toksycznie przez drogi oddechowe i w kontakcie ze skórą; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Tóxico: risco de efeitos graves para a saúde em caso de exposição prolongada por inalação e em contacto com a pele.RO: Toxic: pericol de efecte grave asupra sănătăţii la expunere prelungită prin inhalare şi în contact cu pielea.SK: Jedovatý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou vdýchnutím a pri kontakte s pokožkou.SL: Strupeno: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega vdihavanja in stika s kožo.FI: Myrkyllistä: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettynä ja joutuessaan iholle.SV: Giftigt: risk för allvarliga hälsoskador vid långvarig exponering genom inandning och hudkontakt.R48/23/25BG: Токсичен: опасност от тежко увреждане на здравето при продължителна експозиция чрез вдишване и при поглъщане.ES: Tóxico: riesgo de efectos graves para la salud en caso de exposición prolongada por inhalación e ingestión.CS: Toxický: nebezpečí vážného poškození zdraví při dlouhodobé expozici vdechováním a požíváním.DA: Giftig: alvorlig sundhedsfare ved længere tids påvirkning ved indånding og indtagelse.DE: Giftig: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Einatmen und durch Verschlucken.ET: Mürgine: tõsise tervisekahjustuse oht pikaajalisel sissehingamisel ja allaneelamisel.EL: Τοξικό: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση όταν εισπνέεται και σε περίπτωση καταπόσεως.EN: Toxic: danger of serious damage to health by prolonged exposure through inhalation and if swallowed.FR: Toxique: risque d'effets graves pour la santé en cas d'exposition prolongée par inhalation et par ingestion.IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione ed ingestione.LV: Toksisks – iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības ieelpojot un norijot.LT: Toksiška: ilgą laiką pakartotinai įkvepiant ir praryjant sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át belélegezve és szájon keresztül a szervezetbe jutva mérgező: súlyos egészségkárosodást okozhat.MT: Tossiku: periklu ta' ħsara serja lis-saħħa minn espożizzjoni għat-tul minħabba xamm u jekk jinbela'.NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing en opname door de mond.PL: Działa toksycznie przez drogi oddechowe i po połknięciu; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Tóxico: risco de efeitos graves para a saúde em caso de exposição prolongada por inalação e ingestão.RO: Toxic: pericol de efecte grave asupra sănătăţii la expunere prelungită prin inhalare şi prin înghiţire.SK: Jedovatý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou vdýchnutím a po požití.SL: Strupeno: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega vdihavanja in zauživanja.FI: Myrkyllistä: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettynä ja nieltynä.SV: Giftigt: risk för allvarliga hälsoskador vid långvarig exponering genom inandning och förtäring.R48/24/25BG: Токсичен: опасност от тежко увреждане на здравето при продължителна експозиция при контакт с кожата и при поглъщане.ES: Tóxico: riesgo de efectos graves para la salud en caso de exposición prolongada por contacto con la piel e ingestión.CS: Toxický: nebezpečí vážného poškození zdraví při dlouhodobé expozici stykem s kůží a požíváním.DA: Giftig: alvorlig sundhedsfare ved længere tids påvirkning ved hudkontakt og indtagelse.DE: Giftig: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Berührung mit der Haut und durch Verschlucken.ET: Mürgine: tõsise tervisekahjustuse oht pikaajalisel kokkupuutel nahaga ja allaneelamisel.EL: Τοξικό: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Toxic: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed.FR: Toxique: risque d'effets graves pour la santé en cas d'exposition prolongée par contact avec la peau et par ingestion.IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata a contatto con la pelle e per ingestione.LV: Toksisks – iespējams nopietns kaitējums veselībai pēc ilgstošas saskares ar ādu un norijot.LT: Toksiška: ilgą laiką pakartotinai veikiant per odą ir praryjant sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át bőrrel érintkezve és szájon keresztül a szervezetbe jutva mérgező: súlyos egészségkárosodást okozhat.MT: Tossiku: periklu ta' ħsara serja lis-saħħa minn espożizzjoni għat-tul għal mess mal-ġilda u jekk jinbela'.NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij aanraking met de huid en opname door de mond.PL: Działa toksycznie w kontakcie ze skórą i po połknięciu; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Tóxico: risco de efeitos graves para a saúde em caso de exposição prolongada em contacto com a pele e por ingestão.RO: Toxic: pericol de efecte grave asupra sănătăţii la expunere prelungită în contact cu pielea şi prin înghiţire.SK: Jedovatý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou pri kontakte s pokožkou a po požití.SL: Strupeno: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega stika s kožo in zauživanja.FI: Myrkyllistä: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle joutuessaan iholle ja nieltynä.SV: Giftigt: risk för allvarliga hälsoskador vid långvarig exponering genom hudkontakt och förtäring.R48/23/24/25BG: Токсичен: опасност от тежко увреждане на здравето при продължителна експозиция чрез вдишване, при контакт с кожата и при поглъщане.ES: Tóxico: riesgo de efectos graves para la salud en caso de exposición prolongada por inhalación, contacto con la piel e ingestión.CS: Toxický: nebezpečí vážného poškození zdraví při dlouhodobé expozici vdechováním, stykem s kůží a požíváním.DA: Giftig: alvorlig sundhedsfare ved længere tids påvirkning ved indånding, hudkontakt og indtagelse.DE: Giftig: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Einatmen, Berührung mit der Haut und durch Verschlucken.ET: Mürgine: tõsise tervisekahjustuse oht pikaajalisel sissehingamisel, kokkupuutel nahaga ja allaneelamisel.EL: Τοξικό: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση όταν εισπνέεται, σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed.FR: Toxique: risque d'effets graves pour la santé en cas d'exposition prolongée par inhalation, par contact avec la peau et par ingestion.IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione, a contatto con la pelle e per ingestione.LV: Toksisks – iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības ieelpojot, nonākot saskarē ar ādu un norijot.LT: Toksiška: ilgą laiką pakartotinai įkvepiant, veikiant per odą ir praryjant sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át belélegezve, bőrrel érintkezve és szájon keresztül a szervezetbe jutva mérgező: súlyos egészségkárosodást okozhat.MT: Tossiku: periklu ta' ħsara serja lis-saħħa minn espożizzjoni għat-tul minħabba xamm, mess mal-ġilda jew jekk jinbela'.NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing, aanraking met de huid en opname door de mond.PL: Działa toksycznie przez drogi oddechowe, w kontakcie ze skórą i po połknięciu; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Tóxico: risco de efeitos graves para a saúde em caso de exposição prolongada por inalação, em contacto com a pele e por ingestão.RO: Toxic: pericol de efecte grave asupra sănătăţii la expunere prelungită prin inhalare, în contact cu pielea şi prin înghiţire.SK: Jedovatý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou vdýchnutím, pri kontakte s pokožkou a po požití.SL: Strupeno: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega vdihavanja, stika s kožo in zauživanja.FI: Myrkyllistä: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettynä, joutuessaan iholle ja nieltynä.SV: Giftigt: risk för allvarliga hälsoskador vid långvarig exponering genom inandning, hudkontakt och förtäring.R50/53BG: Силно токсичен за водни организми, може да причини дълготрайни неблагоприятни ефекти във водната среда.ES: Muy tóxico para los organismos acuáticos, puede provocar a largo plazo efectos negativos en el medio ambiente acuático.CS: Vysoce toxický pro vodní organismy, může vyvolat dlouhodobé nepříznivé účinky ve vodním prostředí.DA: Meget giftig for organismer, der lever i vand; kan forårsage uønskede langtidsvirkninger i vandmiljøet.DE: Sehr giftig für Wasserorganismen, kann in Gewässern längerfristig schädliche Wirkungen haben.ET: Väga mürgine veeorganismidele, võib põhjustada pikaajalist veekeskkonda kahjustavat toimet.EL: Πολύ τοξικό για τους υδρόβιους οργανισμούς, μπορεί να προκαλέσει μακροχρόνιες δυσμενείς επιπτώσεις στο υδάτινο περιβάλλον.EN: Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.FR: Très toxique pour les organismes aquatiques, peut entraîner des effets néfastes à long terme pour l'environnement aquatique.IT: Altamente tossico per gli organismi acquatici, può provocare a lungo termine effetti negativi per l'ambiente acquatico.LV: Ļoti toksisks ūdens organismiem, var radīt ilgtermiņa nevēlamu ietekmi ūdens vidē.LT: Labai toksiška vandens organizmams, gali sukelti ilgalaikius nepalankius vandens ekosistemų pakitimus.HU: Nagyon mérgező a vízi szervezetekre, a vízi környezetben hosszan tartó károsodást okozhat.MT: Tossiku ħafna għal organiżmi akwatiċi, jista' jikkaġuna effetti ħżiena għat-tul fl-ambjent akwatiku.NL: Zeer vergiftig voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.PL: Działa bardzo toksycznie na organizmy wodne; może powodować długo utrzymujące się niekorzystne zmiany w środowisku wodnym.PT: Muito tóxico para os organismos aquáticos, podendo causar efeitos nefastos a longo prazo no ambiente aquático.RO: Foarte toxic pentru organismele acvatice, poate provoca efecte adverse pe termen lung asupra mediului acvatic.SK: Veľmi jedovatý pre vodné organizmy, môže spôsobiť dlhodobé nepriaznivé účinky vo vodnej zložke životného prostredia.SL: Zelo strupeno za vodne organizme: lahko povzroči dolgotrajne škodljive učinke na vodno okolje.FI: Erittäin myrkyllistä vesieliöille, voi aiheuttaa pitkäaikaisia haittavaikutuksia vesiympäristössä.SV: Mycket giftigt för vattenlevande organismer, kan orsaka skadliga långtidseffekter i vattenmiljön.R51/53BG: Токсичен за водни организми, може да причини дълготрайни неблагоприятни ефекти във водната среда.ES: Tóxico para los organismos acuáticos, puede provocar a largo plazo efectos negativos en el medio ambiente acuático.CS: Toxický pro vodní organismy, může vyvolat dlouhodobé nepříznivé účinky ve vodním prostředí.DA: Giftig for organismer, der lever i vand; kan forårsage uønskede langtidsvirkninger i vandmiljøet.DE: Giftig für Wasserorganismen, kann in Gewässern längerfristig schädliche Wirkungen haben.ET: Mürgine veeorganismidele, võib põhjustada pikaajalist veekeskkonda kahjustavat toimet.EL: Τοξικό για τους υδρόβιους οργανισμούς, μπορεί να προκαλέσει μακροχρόνιες δυσμενείς επιπτώσεις στο υδάτινο περιβάλλον.EN: Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.FR: Toxique pour les organismes aquatiques, peut entraîner des effets néfastes à long terme pour l'environnement aquatique.IT: Tossico per gli organismi acquatici, può provocare a lungo termine effetti negativi per l'ambiente acquatico.LV: Toksisks ūdens organismiem, var radīt ilglaicīgu negatīvu ietekmi ūdens vidē.LT: Toksiška vandens organizmams, gali sukelti ilgalaikius nepalankius vandens ekosistemų pakitimus.HU: Mérgező a vízi szervezetekre, a vízi környezetben hosszan tartó károsodást okozhat.MT: Tossiku għal organiżmi akwatiċi; jista' jikkaġuna effetti ħżiena għat-tul fl-ambjent akwatiku.NL: Vergiftig voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.PL: Działa toksycznie na organizmy wodne; może powodować długo utrzymujące się niekorzystne zmiany w środowisku wodnym.PT: Tóxico para os organismos aquáticos, podendo causar efeitos nefastos a longo prazo no ambiente aquático.RO: Toxic pentru organismele acvatice, poate provoca efecte adverse pe termen lung asupra mediului acvatic.SK: Jedovatý pre vodné organizmy, môže spôsobiť dlhodobé nepriaznivé účinky vo vodnej zložke životného prostredia.SL: Strupeno za vodne organizme: lahko povzroči dolgotrajne škodljive učinke na vodno okolje.FI: Myrkyllistä vesieliöille, voi aiheuttaa pitkäaikaisia haittavaikutuksia vesiympäristössä.SV: Giftigt för vattenlevande organismer, kan orsaka skadliga långtidseffekter i vattenmiljön.R52/53BG: Вреден за водни организми, може да причини дълготрайни неблагоприятни ефекти във водната среда.ES: Nocivo para los organismos acuáticos, puede provocar a largo plazo efectos negativos en el medio ambiente acuático.CS: Škodlivý pro vodní organismy, může vyvolat dlouhodobé nepříznivé účinky ve vodním prostředí.DA: Skadelig for organismer, der lever i vand; kan forårsage uønskede langtidsvirkninger i vandmiljøet.DE: Schädlich für Wasserorganismen, kann in Gewässern längerfristig schädliche Wirkungen haben.ET: Kahjulik veeorganismidele, võib põhjustada pikaajalist veekeskkonda kahjustavat toimet.EL: Επιβλαβές για τους υδρόβιους οργανισμούς, μπορεί να προκαλέσει μακροχρόνιες δυσμενείς επιπτώσεις στο υδάτινο περιβάλλον.EN: Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.FR: Nocif pour les organismes aquatiques, peut entraîner des effets néfastes à long terme pour l'environnement aquatique.IT: Nocivo per gli organismi acquatici, può provocare a lungo termine effetti negativi per l'ambiente acquatico.LV: Bīstams ūdens organismiem, var radīt ilglaicīgu negatīvu ietekmi ūdens vidē.LT: Kenksminga vandens organizmams, gali sukelti ilgalaikius nepalankius vandens ekosistemų pakitimus.HU: Ártalmas a vízi szervezetekre, a vízi környezetben hosszan tartó károsodást okozhat.MT: Jagħmel ħsara lil organiżmi akwatiċi, jista' jikkaġuna effetti ħżiena għat-tul fl-ambjent akwatiku.NL: Schadelijk voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.PL: Działa szkodliwie na organizmy wodne; może powodować długo utrzymujące się niekorzystne zmiany w środowisku wodnym.PT: Nocivo para os organismos aquáticos, podendo causar efeitos nefastos a longo prazo no ambiente aquático.RO: Nociv pentru organismele acvatice, poate provoca efecte adverse pe termen lung asupra mediului acvatic.SK: Škodlivý pre vodné organizmy, môže spôsobiť dlhodobé nepriaznivé účinky vo vodnej zložke životného prostredia.SL: Škodljivo za vodne organizme: lahko povzroči dolgotrajne škodljive učinke na vodno okolje.FI: Haitallista vesieliöille, voi aiheuttaa pitkäaikaisia haittavaikutuksia vesiympäristössä.SV: Skadligt för vattenlevande organismer, kan orsaka skadliga långtidseffekter i vattenmiljön.R68/20BG: Вреден: възможен риск от необратими ефекти при вдишване.ES: Nocivo: posibilidad de efectos irreversibles por inhalación.CS: Zdraví škodlivý: Možné nebezpečí nevratných účinků při vdechování.DA: Farlig: mulighed for varig skade på helbred ved indånding.DE: Gesundheitsschädlich: Möglichkeit irreversiblen Schadens durch Einatmen.ET: Kahjulik: võimalik pöördumatute kahjustuste oht sissehingamisel.EL: Επιβλαβές: πιθανοί κίνδυνοι μονίμων επιδράσεων όταν εισπνέεται.EN: Harmful: possible risk of irreversible effects through inhalation.FR: Nocif: possibilité d'effets irréversibles par inhalation.IT: Nocivo: possibilità di effetti irreversibili per inalazione.LV: Kaitīgs – iespējams neatgriezeniskas iedarbības risks ieelpojot.LT: Kenksminga: gali sukelti negrįžtamus sveikatos pakenkimus įkvėpus.HU: Belélegezve ártalmas: maradandó egészségkárosodást okozhat.MT: Jagħmel ħsara: riskju possibbli ta' effetti irreversibbli minħabba xamm.NL: Schadelijk: bij inademing zijn onherstelbare effecten niet uitgesloten.PL: Działa szkodliwie przez drogi oddechowe; możliwe ryzyko powstania nieodwracalnych zmian w stanie zdrowia.PT: Nocivo: possibilidade de efeitos irreversíveis por inalação.RO: Nociv: risc posibil de efecte ireversibile prin inhalare.SK: Škodlivý, možné riziko ireverzibilných účinkov vdýchnutím.SL: Zdravju škodljivo: možna nevarnost trajnih okvar zdravja pri vdihavanju.FI: Terveydelle haitallista: pysyvien vaurioiden vaara hengitettynä.SV: Farligt: möjlig risk för bestående hälsoskador vid inandning.R68/21BG: Вреден: възможен риск от необратими ефекти при контакт с кожата.ES: Nocivo: posibilidad de efectos irreversibles por contacto con la piel.CS: Zdraví škodlivý: Možné nebezpečí nevratných účinků při styku s kůží.DA: Farlig: mulighed for varig skade på helbred ved hudkontakt.DE: Gesundheitsschädlich: Möglichkeit irreversiblen Schadens bei Berührung mit der Haut.ET: Kahjulik: võimalik pöördumatute kahjustuste oht kokkupuutel nahaga.EL: Επιβλαβές: πιθανοί κίνδυνοι μονίμων επιδράσεων σε επαφή με το δέρμα.EN: Harmful: possible risk of irreversible effects in contact with skin.FR: Nocif: possibilité d'effets irréversibles par contact avec la peau.IT: Nocivo: possibilità di effetti irreversibili a contatto con la pelle.LV: Kaitīgs – iespējams neatgriezeniskas iedarbības risks, nonākot saskarē ar ādu.LT: Kenksminga: gali sukelti negrįžtamus sveikatos pakenkimus susilietus su oda.HU: Bőrrel érintkezve ártalmas: maradandó egészségkárosodást okozhat.MT: Jagħmel ħsara: riskju possibbli ta' effetti irreversibbli meta jmiss il-ġilda.NL: Schadelijk: bij aanraking met de huid zijn onherstelbare effecten niet uitgesloten.PL: Działa szkodliwie w kontakcie ze skórą; możliwe ryzyko powstania nieodwracalnych zmian w stanie zdrowia.PT: Nocivo: possibilidade de efeitos irreversíveis em contacto com a pele.RO: Nociv: risc posibil de efecte ireversibile în contact cu pielea.SK: Škodlivý, možné riziko ireverzibilných účinkov pri kontakte s pokožkou.SL: Zdravju škodljivo: možna nevarnost trajnih okvar zdravja v stiku s kožo.FI: Terveydelle haitallista: pysyvien vaurioiden vaara joutuessaan iholle.SV: Farligt: möjlig risk för bestående hälsoskador vid hudkontakt.R68/22BG: Вреден: възможен риск от необратими ефекти при поглъщане.ES: Nocivo: posibilidad de efectos irreversibles por ingestión.CS: Zdraví škodlivý: Možné nebezpečí nevratných účinků při požití.DA: Farlig: mulighed for varig skade på helbred ved indtagelse.DE: Gesundheitsschädlich: Möglichkeit irreversiblen Schadens durch Verschlucken.ET: Kahjulik: võimalik pöördumatute kahjustuste oht allaneelamisel.EL: Επιβλαβές: πιθανοί κίνδυνοι μονίμων επιδράσεων σε περίπτωση καταπόσεως.EN: Harmful: possible risk of irreversible effects if swallowed.FR: Nocif: possibilité d'effets irréversibles par ingestion.IT: Nocivo: possibilità di effetti irreversibili per ingestione.LV: Kaitīgs – iespējams neatgriezeniskas iedarbības risks norijot.LT: Kenksminga: gali sukelti negrįžtamus sveikatos pakenkimus prarijus.HU: Lenyelve ártalmas: maradandó egészségkárosodást okozhat.MT: Jagħmel ħsara: riskju possibbli ta' effetti irreversibbli jekk jinbela'.NL: Schadelijk: bij opname door de mond zijn onherstelbare effecten niet uitgesloten.PL: Działa szkodliwie po połknięciu; możliwe ryzyko powstania nieodwracalnych zmian w stanie zdrowia.PT: Nocivo: possibilidade de efeitos irreversíveis por ingestão.RO: Nociv: risc posibil de efecte ireversibile prin înghiţire.SK: Škodlivý, možné riziko ireverzibilných účinkov po požití.SL: Zdravju škodljivo: možna nevarnost trajnih okvar zdravja pri zaužitju.FI: Terveydelle haitallista: pysyvien vaurioiden vaara nieltynä.SV: Farligt: möjlig risk för bestående hälsoskador vid förtäring.R68/20/21BG: Вреден: възможен риск от необратими ефекти при вдишване и при контакт с кожата.ES: Nocivo: posibilidad de efectos irreversibles por inhalación y contacto con la piel.CS: Zdraví škodlivý: Možné nebezpečí nevratných účinků při vdechování a při styku s kůží.DA: Farlig: mulighed for varig skade på helbred ved indånding og hudkontakt.DE: Gesundheitsschädlich: Möglichkeit irreversiblen Schadens durch Einatmen und bei Berührung mit der Haut.ET: Kahjulik: võimalik pöördumatute kahjustuste oht sissehingamisel ja kokkupuutel nahaga.EL: Επιβλαβές: πιθανοί κίνδυνοι μονίμων επιδράσεων όταν εισπνέεται και σε επαφή με το δέρμα.EN: Harmful: possible risk of irreversible effects through inhalation and in contact with skin.FR: Nocif: possibilité d'effets irréversibles par inhalation et par contact avec la peau.IT: Nocivo: possibilità di effetti irreversibili per inalazione e a contatto con la pelle.LV: Kaitīgs – iespējams neatgriezeniskas iedarbības risks ieelpojot un nonākot saskarē ar ādu.LT: Kenksminga: gali sukelti negrįžtamus sveikatos pakenkimus įkvėpus ir susilietus su oda.HU: Belélegezve és bőrrel érintkezve ártalmas: maradandó egészségkárosodást okozhat.MT: Jagħmel ħsara: riskju possibbli ta' effetti irriversibbli minħabba xamm u meta jmiss il-ġilda.NL: Schadelijk: bij inademing en aanraking met de huid zijn onherstelbare effecten niet uitgesloten.PL: Działa szkodliwie przez drogi oddechowe i w kontakcie ze skórą; możliwe ryzyko powstania nieodwracalnych zmian w stanie zdrowia.PT: Nocivo: possibilidade de efeitos irreversíveis por inalação e em contacto com a pele.RO: Nociv: risc posibil de efecte ireversibile prin inhalare şi în contact cu pielea.SK: Škodlivý, možné riziko ireverzibilných účinkov vdýchnutím a pri kontakte s pokožkou.SL: Zdravju škodljivo: možna nevarnost trajnih okvar zdravja pri vdihavanju in v stiku s kožo.FI: Terveydelle haitallista: pysyvien vaurioiden vaara hengitettynä ja joutuessaan iholle.SV: Farligt: möjlig risk för bestående hälsoskador vid inandning och hudkontakt.R68/20/22BG: Вреден: възможен риск от необратими ефекти при вдишване и при поглъщане.ES: Nocivo: Posibilidad de efectos irreversibles por inhalación e ingestión.CS: Zdraví škodlivý: Možné nebezpečí nevratných účinků při vdechování a při požití.DA: Farlig: mulighed for varig skade på helbred ved indånding og indtagelse.DE: Gesundheitsschädlich: Möglichkeit irreversiblen Schadens durch Einatmen und durch Verschlucken.ET: Kahjulik: võimalik pöördumatute kahjustuste oht sissehingamisel ja allaneelamisel.EL: Επιβλαβές: πιθανοί κίνδυνοι μονίμων επιδράσεων όταν εισπνέεται και σε περίπτωση καταπόσεως.EN: Harmful: possible risk of irreversible effects through inhalation and if swallowed.FR: Nocif: possibilité d'effets irréversibles par inhalation et par ingestion.IT: Nocivo: possibilità di effetti irreversibili per inalazione ed ingestione.LV: Kaitīgs – iespējams neatgriezeniskas iedarbības risks ieelpojot un norijot.LT: Kenksminga: gali sukelti negrįžtamus sveikatos pakenkimus įkvėpus ir prarijus.HU: Belélegezve és lenyelve ártalmas: maradandó egészségkárosodást okozhat.MT: Jagħmel ħsara: riskju possibbli ta' effetti irreversibbli minħabba xamm u jekk jinbela'.NL: Schadelijk: bij inademing en opname door de mond zijn onherstelbare effecten niet uitgesloten.PL: Działa szkodliwie przez drogi oddechowe i po połknięciu; możliwe ryzyko powstania nieodwracalnych zmian w stanie zdrowia.PT: Nocivo: possibilidade de efeitos irreversíveis por inalação e ingestão.RO: Nociv: risc posibil de efecte ireversibile prin inhalare şi prin înghiţire.SK: Škodlivý, možné riziko ireverzibilných účinkov vdýchnutím a po požití.SL: Zdravju škodljivo: možna nevarnost trajnih okvar zdravja pri vdihavanju in pri zaužitju.FI: Terveydelle haitallista: pysyvien vaurioiden vaara hengitettynä ja nieltynä.SV: Farligt: möjlig risk för bestående hälsoskador vid inandning och förtäring.R68/21/22BG: Вреден: възможен риск от необратими ефекти при контакт с кожата и при поглъщане.ES: Nocivo: posibilidad de efectos irreversibles por contacto con la piel e ingestión.CS: Zdraví škodlivý: Možné nebezpečí nevratných účinků při styku s kůží a při požití.DA: Farlig: mulighed for varig skade på helbred ved hudkontakt og indtagelse.DE: Gesundheitsschädlich: Möglichkeit irreversiblen Schadens bei Berührung mit der Haut und durch Verschlucken.ET: Kahjulik: võimalik pöördumatute kahjustuste oht kokkupuutel nahaga ja allaneelamisel.EL: Επιβλαβές: πιθανοί κίνδυνοι μονίμων επιδράσεων σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Harmful: possible risk of irreversible effects in contact with skin and if swallowed.FR: Nocif: possibilité d'effets irréversibles par contact avec la peau et par ingestion.IT: Nocivo: possibilità di effetti irreversibili a contatto con la pelle e per ingestione.LV: Kaitīgs – iespējams neatgriezeniskas iedarbības risks, nonākot saskarē ar ādu un norijot.LT: Kenksminga: gali sukelti negrįžtamus sveikatos pakenkimus susilietus su oda ir prarijus.HU: Bőrrel érintkezve és lenyelve ártalmas: maradandó egészségkárosodást okozhat.MT: Jagħmel ħsara: riskju possibbli ta' effetti irreversibbli meta jmiss il-ġilda u jekk jinbela'.NL: Schadelijk: bij aanraking met de huid en opname door de mond zijn onherstelbare effecten niet uitgesloten.PL: Działa szkodliwie w kontakcie ze skórą i po połknięciu; możliwe ryzyko powstania nieodwracalnych zmian w stanie zdrowia.PT: Nocivo: possibilidade de efeitos irreversíveis em contacto com a pele e por ingestão.RO: Nociv: risc posibil de efecte ireversibile în contact cu pielea şi prin înghiţire.SK: Škodlivý, možné riziko ireverzibilných účinkov pri kontakte s pokožkou a po požití.SL: Zdravju škodljivo: možna nevarnost trajnih okvar zdravja v stiku s kožo in pri zaužitju.FI: Terveydelle haitallista: pysyvien vaurioiden vaara joutuessaan iholle ja nieltynä.SV: Farligt: möjlig risk för bestående hälsoskador vid hudkontakt och förtäring.R68/20/21/22BG: Вреден: възможен риск от необратими ефекти при вдишване, при контакт с кожата и при поглъщане.ES: Nocivo: posibilidad de efectos irreversibles por inhalación, contacto con la piel e ingestión.CS: Zdraví škodlivý: Možné nebezpečí nevratných účinků při vdechování, při styku s kůží a při požití.DA: Farlig: mulighed for varig skade på helbred ved indånding, hudkontakt og indtagelse.DE: Gesundheitsschädlich: Möglichkeit irreversiblen Schadens durch Einatmen, Berührung mit der Haut und durch Verschlucken.ET: Kahjulik: võimalik pöördumatute kahjustuste oht sissehingamisel, kokkupuutel nahaga ja allaneelamisel.EL: Επιβλαβές: πιθανοί κίνδυνοι μονίμων επιδράσεων όταν εισπνέεται, σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Harmful: possible risk of irreversible effects through inhalation, in contact with skin and if swallowed.FR: Nocif: possibilité d'effets irréversibles par inhalation, par contact avec la peau et par ingestion.IT: Nocivo: possibilità di effetti irreversibili per inalazione, a contatto con la pelle e per ingestione.LV: Kaitīgs – iespējams neatgriezeniskas iedarbības risks ieelpojot, nonākot saskarē ar ādu un norijot.LT: Kenksminga: gali sukelti negrįžtamus sveikatos pakenkimus įkvėpus, susilietus su oda ir prarijus.HU: Belélegezve, bőrrel érintkezve és lenyelve ártalmas: maradandó egészségkárosodást okozhat.MT: Jagħmel ħsara: riskju possibbli ta' effetti irriversibbli minħabba xamm, meta jmiss il-ġilda u jekk jinbela'.NL: Schadelijk: bij inademing, aanraking met de huid en opname door de mond zijn onherstelbare effecten niet uitgesloten.PL: Działa szkodliwie przez drogi oddechowe, w kontakcie ze skórą i po połknięciu; możliwe ryzyko powstania nieodwracalnych zmian w stanie zdrowia.PT: Nocivo: possibilidade de efeitos irreversíveis por inalação, em contacto com a pele e por ingestão.RO: Nociv: risc posibil de efecte ireversibile prin inhalare, în contact cu pielea şi prin înghiţire.SK: Škodlivý, možné riziko ireverzibilných účinkov vdýchnutím, pri kontakte s pokožkou a po požití.SL: Zdravju škodljivo: možna nevarnost trajnih okvar zdravja pri vdihavanju, v stiku s kožo in pri zaužitju.FI: Terveydelle haitallista: pysyvien vaurioiden vaara hengitettynä, joutuessaan iholle ja nieltynä.SV: Farligt: möjlig risk för bestående hälsoskador vid inandning, hudkontakt och förtäring.’



(e)
Annex IV is replaced by the following:‘ПРИЛОЖЕНИЕ IV — ANEXO IV — PŘÍLOHA IV — BILAG IV — IV ANHANG — IV LISA — ΠΑΡΑΡΤΗΜΑ IV — ANNEX IV — ANNEXE IV — ALLEGATO IV — IV PIELIKUMS — IV PRIEDAS — IV. MELLÉKLET — ANNESS IV — BIJLAGE IV — ZAŁĄCZNIK IV — ANEXO IV — ANEXA IV — PRÍLOHA IV — PRILOGA IV — LIITE IV — BILAGA IVПРИЛОЖЕНИЕ IVСъвети за безопасност, свързани с опасните вещества и препаратиANEXO IVConsejos de prudencia relativos a las sustancias y preparados peligrososPŘÍLOHA IVStandardní pokyny pro bezpečné zacházení týkající se nebezpečných látek a přípravkůBILAG IVForsigtighedsregler for farlige stoffer og præparaterANHANG IVSicherheitsratschläge für gefährliche Stoffe und ZubereitungenIV LISAOhtlike ainete ja valmististe ohutuslausedΠΑΡΑΡΤΗΜΑ IVΟδηγίες ασφαλούς χρήσης που αφορούν επικίνδυνες χημικές ουσίες και παρασκευάσματαANNEX IVSafety advice concerning dangerous substances and preparationsANNEXE IVConseils de prudence concernant les substances et préparations dangereusesALLEGATO IVConsigli di prudenza riguardanti le sostanze e preparati pericolosiIV PIELIKUMSDrošības prasību apzīmējumi un apvienotie apzīmējumiIV PRIEDASSaugos patarimai dėl pavojingų medžiagų ir preparatųIV. MELLÉKLETA veszélyes anyagok és készítmények biztonságos használatára vonatkozó útmutatásokANNESS IVPariri ta' sigurtà dwar sustanzi u preparazzjonijiet perikolużiBIJLAGE IVVeiligheidsaanbevelingen met betrekking tot gevaarlijke stoffen en preparatenZAŁĄCZNIK IVZwroty określające warunki bezpiecznego stosowania substancji niebezpiecznej lub preparatu niebezpiecznegoANEXO IVConselhos de prudência relativos a substâncias e preparações perigosasANEXA IVRecomandări de prudenţă privind substanţele şi preparatele periculoasePRÍLOHA IVZoznam označení na bezpečné používanie chemickej látky a chemického prípravkuPRILOGA IVStandardna obvestila za označevanje nevarnih snovi in pripravkovLIITE IVVaarallisten aineiden ja valmisteiden turvallisuusohjeetBILAGA IVSkyddsfraser för farliga ämnen och beredningarS1BG: Да се съхранява под ключ.ES: Consérvese bajo llave.CS: Uchovávejte uzamčené.DA: Opbevares under lås.DE: Unter Verschluss aufbewahren.ET: Hoida lukustatult.EL: Να φυλάσσεται κλειδωμένο.EN: Keep locked up.FR: Conserver sous clé.IT: Conservare sotto chiave.LV: Turēt noslēgtu.LT: Laikyti užrakintą.HU: Elzárva tartandó.MT: Żomm maqful.NL: Achter slot bewaren.PL: Przechowywać pod zamknięciem.PT: Guardar fechado à chave.RO: A se păstra sub cheie.SK: Uchovávajte uzamknuté.SL: Hraniti zaklenjeno.FI: Säilytettävä lukitussa tilassa.SV: Förvaras i låst utrymme.S2BG: Да се пази далече от достъп на деца.ES: Manténgase fuera del alcance de los niños.CS: Uchovávejte mimo dosah dětí.DA: Opbevares utilgængeligt for børn.DE: Darf nicht in die Hände von Kindern gelangen.ET: Hoida lastele kättesaamatus kohas.EL: Μακριά από παιδιά.EN: Keep out of the reach of children.FR: Conserver hors de la portée des enfants.IT: Conservare fuori della portata dei bambini.LV: Sargāt no bērniem.LT: Saugoti nuo vaikų.HU: Gyermekek kezébe nem kerülhet.MT: Żomm fejn ma jintlaħaqx mit-tfal.NL: Buiten bereik van kinderen bewaren.PL: Chronić przed dziećmi.PT: Manter fora do alcance das crianças.RO: A nu se lăsa la îndemâna copiilor.SK: Uchovávajte mimo dosahu detí.SL: Hraniti izven dosega otrok.FI: Säilytettävä lasten ulottumattomissa.SV: Förvaras oåtkomligt för barn.S3BG: Да се съхранява на хладно място.ES: Consérvese en lugar fresco.CS: Uchovávejte na chladném místě.DA: Opbevares køligt.DE: Kühl aufbewahren.ET: Hoida jahedas.EL: Να φυλάσσεται σε δροσερό μέρος.EN: Keep in a cool place.FR: Conserver dans un endroit frais.IT: Conservare in luogo fresco.LV: Uzglabāt vēsā vietā.LT: Laikyti vėsioje vietoje.HU: Hűvös helyen tartandó.MT: Żomm f'post frisk.NL: Op een koele plaats bewaren.PL: Przechowywać w chłodnym miejscu.PT: Guardar em lugar fresco.RO: A se păstra într-un loc răcoros.SK: Uchovávajte na chladnom mieste.SL: Hraniti na hladnem.FI: Säilytettävä viileässä.SV: Förvaras svalt.S4BG: Да се съхранява далече от жилищни помещения.ES: Manténgase lejos de locales habitados.CS: Uchovávejte mimo obytné objekty.DA: Må ikke opbevares i nærheden af bebølse.DE: Von Wohnplätzen fernhalten.ET: Mitte hoida eluruumides.EL: Μακριά από κατοικημένους χώρους.EN: Keep away from living quarters.FR: Conserver à l'écart de tout local d'habitation.IT: Conservare lontano da locali di abitazione.LV: Neuzglabāt dzīvojamās telpās.LT: Nelaikyti gyvenamosiose patalpose.HU: Lakóterülettől távol tartandó.MT: Żomm 'il bogħod minn postijiet ta' abitazzjoni.NL: Verwijderd van woonruimten opbergen.PL: Nie przechowywać w pomieszczeniach mieszkalnych.PT: Manter fora de qualquer zona de habitação.RO: A se păstra departe de zonele locuite.SK: Uchovávajte mimo obývaných priestorov.SL: Hraniti izven bivališč.FI: Ei saa säilyttää asuintiloissa.SV: Förvaras avskilt från bostadsutrymmen.S5BG: Да се съхранява под … (подходяща течност, указана от производителя).ES: Consérvese en … (líquido apropiado a especificar por el fabricante).CS: Uchovávejte pod … (příslušnou kapalinu specifikuje výrobce).DA: Opbevares under … (en egnet væske, som angives af fabikanten).DE: Unter … aufbewahren (geeignete Flüssigkeit vom Hersteller anzugeben).ET: Hoida sisu … all (sobiva vedeliku määrab valmistaja).EL: Να διατηρείται το περιεχόμενο μέσα σε … (το είδος του κατάλληλου υγρού καθορίζεται από τον παραγωγό).EN: Keep contents under … (appropriate liquid to be specified by the manufacturer).FR: Conserver sous … (liquide approprié à spécifier par le fabricant).IT: Conservare sotto … (liquido appropriato da indicarsi da parte del fabbricante).LV: Uzglabāt … (ražotājs norāda šķidrumu, kurā viela vai produkts uzglabājams).LT: Laikyti užpiltą … (tinkamą skystį nurodo gamintojas).HU: … alatt tartandó (a folyadékot a gyártó határozza meg).MT: Żomm taħt… (il-likwidu adatt li jkun indikat mill-manifattur).NL: Onder … houden. (geschikte vloeistof aan te geven door fabrikant).PL: Przechowywać w … (cieczy wskazanej przez producenta).PT: Manter sob … (líquido apropriado a especificar pelo produtor).RO: A se păstra sub… (lichidul adecvat va fi indicat de fabricant).SK: Obsah uchovávajte pod … (vhodnou kvapalinou, ktorú špecifikuje výrobca).SL: Hraniti pod/v … (ustrezno tekočino, v kateri je treba snov ali pripravek hraniti, določi proizvajalec).FI: Sisältö säilytettävä … (tarkoitukseen soveltuvan nesteen ilmoittaa valmistaja/maahantuoja).SV: Förvara innehållet i … (lämplig vätska anges av tillverkaren).S6BG: Да се съхранява под … (инертен газ, указан от производителя).ES: Consérvese en … (gas inerte a especificar por el fabricante).CS: Uchovávejte pod … (inertní plyn specifikuje výrobce).DA: Opbevares under … (en inaktiv gas, som angives af fabrikanten).DE: Unter … aufbewahren (inertes Gas vom Hersteller anzugeben).ET: Hoida … all (inertgaasi määrab valmistaja).EL: Να διατηρείται σε ατμόσφαιρα … (το είδος του αδρανούς αερίου καθορίζεται από τον παραγωγό).EN: Keep under … (inert gas to be specified by the manufacturer).FR: Conserver sous … (gaz inerte à spécifier par le fabricant).IT: Conservare sotto … (gas inerte da indicarsi da parte del fabbricante).LV: Uzglabāt … (ražotājs norāda gāzi, kurā viela vai produkts uzglabājams).LT: Laikyti …. (inertines dujas nurodo gamintojas) aplinkoje.HU: … alatt tartandó (az inert gázt a gyártó határozza meg).MT: Żomm taħt… (gass inerti li jkun speċifikat mill-manifattur).NL: Onder … houden. (inert gas aan te geven door fabrikant).PL: Przechowywać w atmosferze … (obojętnego gazu wskazanego przez producenta).PT: Manter sob … (gás inerte a especificar pelo produtor).RO: A se păstra sub… (gazul inert va fi indicat de fabricant).SK: Uchovávajte pod … (inertným plynom, ktorý špecifikuje výrobca).SL: Hraniti v … (ustrezen inertni plin, v katerem je treba snov ali pripravek hraniti, določi proizvajalec).FI: Säilytettävä … (inertin kaasun ilmoittaa valmistaja/maahantuoja).SV: Förvaras i … (inert gas anges av tillverkaren).S7BG: Съдът да се държи плътно затворен.ES: Manténgase el recipiente bien cerrado.CS: Uchovávejte obal těsně uzavřený.DA: Emballagen skal holdes tæt lukket.DE: Behälter dicht geschlossen halten.ET: Hoida pakend tihedalt suletuna.EL: Το δοχείο να διατηρείται ερμητικά κλεισμένο.EN: Keep container tightly closed.FR: Conserver le récipient bien fermé.IT: Conservare il recipiente ben chiuso.LV: Uzglabāt cieši noslēgtu.LT: Pakuotę laikyti sandariai uždarytą.HU: Az edényzet légmentesen lezárva tartandó.MT: Żomm il-kontenitur magħluq sewwa.NL: In goed gesloten verpakking bewaren.PL: Przechowywać pojemnik szczelnie zamknięty.PT: Manter o recipiente bem fechado.RO: A se păstra ambalajul închis ermetic.SK: Uchovávajte nádobu tesne uzavretú.SL: Hraniti v tesno zaprti posodi.FI: Säilytettävä tiiviisti suljettuna.SV: Förpackningen förvaras väl tillsluten.S8BG: Съдът да се съхранява на сухо място.ES: Manténgase el recipiente en lugar seco.CS: Uchovávejte obal suchý.DA: Emballagen skal opbevares tørt.DE: Behälter trocken halten.ET: Hoida pakend kuivana.EL: Το δοχείο να προστατεύεται από την υγρασία.EN: Keep container dry.FR: Conserver le récipient à l'abri de l'humidité.IT: Conservare al riparo dall'umidità.LV: Uzglabāt sausu.LT: Pakuotę laikyti sausoje vietoje.HU: Az edényzet szárazon tartandó.MT: Żomm il-kontenitur niexef.NL: Verpakking droog houden.PL: Przechowywać pojemnik w suchym pomieszczeniu.PT: Manter o recipiente ao abrigo da humidade.RO: A se păstra ambalajul într-un loc uscat, ferit de umiditate.SK: Uchovávajte nádobu suchú.SL: Posodo hraniti na suhem.FI: Säilytettävä kuivana.SV: Förpackningen förvaras torrt.S9BG: Съдът да се съхранява на добре проветриво място.ES: Consérvese el recipiente en lugar bien ventilado.CS: Uchovávejte obal na dobře větraném místě.DA: Emballagen skal opbevares på et godt ventileret sted.DE: Behälter an einem gut gelüfteten Ort aufbewahren.ET: Hoida pakend hästi ventileeritavas kohas.EL: Το δοχείο να διατηρείται σε καλά αεριζόμενο μέρος.EN: Keep container in a well-ventilated place.FR: Conserver le récipient dans un endroit bien ventilé.IT: Conservare il recipiente in luogo ben ventilato.LV: Uzglabāt labi vēdināmā vietā.LT: Pakuotę laikyti gerai vėdinamoje vietoje.HU: Az edényzet jól szellőztetett helyen tartandó.MT: Żomm il-kontenitur f'post ivventilat sewwa.NL: Op een goed geventileerde plaats bewaren.PL: Przechowywać pojemnik w miejscu dobrze wentylowanym.PT: Manter o recipiente num local bem ventilado.RO: A se păstra ambalajul într-un loc bine ventilat.SK: Uchovávajte nádobu na dobre vetranom mieste.SL: Posodo hraniti na dobro prezračevanem mestu.FI: Säilytettävä paikassa, jossa on hyvä ilmanvaihto.SV: Förpackningen förvaras på väl ventilerad plats.S12BG: Съдът да не се затваря херметично.ES: No cerrar el recipiente herméticamente.CS: Neuchovávejte obal těsně uzavřený.DA: Emballagen må ikke lukkes tæt.DE: Behälter nicht gasdicht verschließen.ET: Mitte hoida hermeetiliselt suletud pakendis.EL: Μη διατηρείτε το δοχείο ερμητικά κλεισμένο.EN: Do not keep the container sealed.FR: Ne pas fermer hermétiquement le récipient.IT: Non chiudere ermeticamente il recipiente.LV: Neuzglabāt slēgtā veidā.LT: Nelaikyti sandariai uždarytos pakuotės.HU: Az edényzetet nem szabad légmentesen lezárni.MT: Tħallix il-kontenitur magħluq.NL: De verpakking niet hermetisch sluiten.PL: Nie przechowywać pojemnika szczelnie zamkniętego.PT: Não fechar o recipiente hermeticamente.RO: A nu se închide ermetic ambalajul.SK: Neuchovávajte nádobu hermeticky uzatvorenú.SL: Posoda ne sme biti tesno zaprta.FI: Pakkausta ei saa sulkea ilmatiiviisti.SV: Förpackningen får inte tillslutas lufttätt.S13BG: Да се съхранява далече от напитки и храни за хора и животни.ES: Manténgase lejos de alimentos, bebidas y piensos.CS: Uchovávejte odděleně od potravin, nápojů a krmiv.DA: Må ikke opbevares sammen med fødevarer, drikkevarer og foderstoffer.DE: Von Nahrungsmitteln, Getränken und Futtermitteln fernhalten.ET: Hoida eemal toiduainest, joogist ja loomasöödast.EL: Μακριά από τρόφιμα, ποτά και ζωοτροφές.EN: Keep away from food, drink and animal feedingstuffs.FR: Conserver à l'écart des aliments et boissons, y compris ceux pour animaux.IT: Conservare lontano da alimenti o mangimi e da bevande.LV: Neuzglabāt kopā ar pārtiku vai dzīvnieku barību.LT: Laikyti atokiau nuo maisto, gėrimų ir gyvulių pašaro.HU: Élelmiszertől, italtól és takarmánytól távol tartandó.MT: Żomm 'il bogħod minn ikel, xorb u minn għalf ta' l-annimali.NL: Verwijderd houden van eet- en drinkwaren en van diervoeder.PL: Nie przechowywać razem z żywnością, napojami i paszami dla zwierząt.PT: Manter afastado de alimentos e bebidas incluindo os dos animais.RO: A se păstra departe de hrană, băuturi şi hrană pentru animale.SK: Uchovávajte mimo dosahu potravín, nápojov a krmív pre zvieratá.SL: Hraniti ločeno od hrane, pijače in krmil.FI: Ei saa säilyttää yhdessä elintarvikkeiden eikä eläinravinnon kanssa.SV: Förvaras åtskilt från livsmedel och djurfoder.S14BG: Да се съхранява далече от … (несъвместимите материали се посочват от производителя).ES: Consérvese lejos de … (materiales incompatibles a especificar por el fabricante).CS: Uchovávejte odděleně od … (vzájemně se vylučující látky uvede výrobce).DA: Opbevares adskilt fra … (uforligelige stoffer, som angives af fabrikanten).DE: Von … fernhalten (inkompatible Substanzen sind vom Hersteller anzugeben).ET: Hoida eraldi … (kokkusobimatud kemikaalid määrab valmistaja).EL: Μακριά από … (ασύμβατες ουσίες καθορίζονται από τον παραγωγό).EN: Keep away from … (incompatible materials to be indicated by the manufacturer).FR: Conserver à l'écart des … (matières incompatibles à indiquer par le fabricant).IT: Conservare lontano da … (sostanze incompatibili da precisare da parte del produttore).LV: Neuzglabāt kopā ar … (ražotājs norāda nesavietojamās vielas).LT: Laikyti atokiau nuo…( nesuderinamas medžiagas nurodo gamintojas).HU: …-tól/-től távol tartandó (az összeférhetetlen anyago(ka)t a gyártó határozza meg).MT: Żomm 'il bogħod minn … (materjal inkompatibbli li jkun indikat mill-manifattur).NL: Verwijderd houden van … (stoffen waarmee contact vermeden dient te worden aan te geven door de fabrikant).PL: Nie przechowywać razem z … (materiałami określonymi przez producenta).PT: Manter afastado de … (matérias incompatíveis a indicar pelo produtor).RO: A se păstra departe de … (materialele incompatibile vor fi indicate de fabricant).SK: Uchovávajte mimo dosahu … (neznášanlivého materiálu, ktorý určí výrobca).SL: Hraniti ločeno od … (nezdružljive snovi določi proizvajalec).FI: Säilytettävä erillään … (yhteensopimattomat aineet ilmoittaa valmistaja/maahantuoja).SV: Förvaras åtskilt från … (oförenliga ämnen anges av tillverkaren).S15BG: Да се съхранява далече от топлина.ES: Conservar alejado del calor.CS: Chraňte před teplem.DA: Må ikke udsættes for varme.DE: Vor Hitze schützen.ET: Hoida eemal soojusallikast.EL: Μακριά από θερμότητα.EN: Keep away from heat.FR: Conserver à l'écart de la chaleur.IT: Conservare lontano dal calore.LV: Sargāt no sasilšanas.LT: Laikyti atokiau nuo šilumos šaltinių.HU: Hőhatástól távol tartandó.MT: Żomm 'il bogħod mis-sħana.NL: Verwijderd houden van warmte.PL: Przechowywać z dala od źródeł ciepła.PT: Manter afastado do calor.RO: A se păstra departe de căldură.SK: Uchovávajte mimo dosahu tepla.SL: Varovati pred toploto.FI: Suojattava lämmöltä.SV: Får inte utsättas för värme.S16BG: Да се съхранява далече от източници на запалване. Да не се пуши.ES: Conservar alejado de toda llama o fuente de chispas — No fumar.CS: Uchovávejte mimo dosah zdrojů zapálení — Zákaz kouření.DA: Holdes væk fra antændelseskilder — Rygning forbudt.DE: Von Zündquellen fernhalten — Nicht rauchen.ET: Hoida eemal süttimisallikast — Mitte suitsetada!.EL: Μακριά από πηγές ανάφλεξης — Απαγορεύεται το κάπνισμα.EN: Keep away from sources of ignition — No smoking.FR: Conserver à l'écart de toute flamme ou source d'étincelles — Ne pas fumer.IT: Conservare lontano da fiamme e scintille — Non fumare.LV: Sargāt no uguns – nesmēķēt.LT: Laikyti atokiau nuo uždegimo šaltinių. Nerūkyti.HU: Gyújtóforrástól távol tartandó — Tilos a dohányzás.MT: Żomm 'il bogħod minn fjammi u qbid tan-nar — Tpejjipx.NL: Verwijderd houden van ontstekingsbronnen — Niet roken.PL: Nie przechowywać w pobliżu źródeł zapłonu — nie palić tytoniu.PT: Manter afastado de qualquer chama ou fonte de ignição — Não fumar.RO: A se păstra departe de orice flacără sau sursă de scântei — Fumatul interzis.SK: Uchovávajte mimo dosahu zdrojov zapálenia — Zákaz fajčenia.SL: Hraniti ločeno od virov vžiga — ne kaditi.FI: Eristettävä sytytyslähteistä — Tupakointi kielletty.SV: Förvaras åtskilt från antändningskällor — Rökning förbjuden.S17BG: Да се съхранява далече от горими материали.ES: Manténgase lejos de materias combustibles.CS: Uchovávejte mimo dosah hořlavých materiálů.DA: Holdes væk fra brandbare stoffer.DE: Von brennbaren Stoffen fernhalten.ET: Hoida eemal süttivatest ainetest.EL: Μακριά από καύσιμα υλικά.EN: Keep away from combustible material.FR: Tenir à l'écart des matières combustibles.IT: Tenere lontano da sostanze combustibili.LV: Sargāt no degoša materiāla.LT: Laikyti atokiau nuo galinčių degti medžiagų.HU: Éghető anyagoktól távol tartandó.MT: Żomm 'il bogħod minn materjal li jieħu n-nar.NL: Verwijderd houden van brandbare stoffen.PL: Nie przechowywać razem z materiałami zapalnymi.PT: Manter afastado de matérias combustíveis.RO: A se păstra departe de materiale combustibile.SK: Uchovávajte mimo dosahu horľavého materiálu.SL: Hraniti ločeno od gorljivih snovi.FI: Säilytettävä erillään syttyvistä kemikaaleista.SV: Förvaras åtskilt från brandfarliga ämnen.S18BG: Съдът да се манипулира и отваря внимателно.ES: Manipúlese y ábrase el recipiente con prudencia.CS: Zacházejte s obalem opatrně a opatrně jej otevírejte.DA: Emballagen skal behandles og åbnes med forsigtighed.DE: Behälter mit Vorsicht öffnen und handhaben.ET: Käidelda ja avada pakend ettevaatlikult.EL: Χειριστείτε και ανοίξτε το δοχείο προσεκτικά.EN: Handle and open container with care.FR: Manipuler et ouvrir le récipient avec prudence.IT: Manipolare ed aprire il recipiente con cautela.LV: Ievērot īpašu piesardzību, darbojoties ar konteineru un atverot to.LT: Pakuotę naudoti ir atidaryti atsargiai.HU: Az edényzetet óvatosan kell kezelni és kinyitni.MT: Attent kif tħarrek u tiftaħ il-kontenitur.NL: Verpakking voorzichtig behandelen en openen.PL: Zachować ostrożność w trakcie otwierania i manipulacji z pojemnikiem.PT: Manipular e abrir o recipiente com prudência.RO: A se manipula şi a se deschide ambalajul cu prudenţă.SK: S nádobou zaobchádzajte a otvárajte opatrne.SL: Previdno ravnati s posodo in jo previdno odpirati.FI: Pakkauksen käsittelyssä ja avaamisessa on noudatettava varovaisuutta.SV: Förpackningen hanteras och öppnas försiktigt.S20BG: Да не се яде и пие по време на работа.ES: No comer ni beber durante su utilización.CS: Nejezte a nepijte při používání.DA: Der må ikke spises eller drikkes under brugen.DE: Bei der Arbeit nicht essen und trinken.ET: Käitlemisel söömine ja joomine keelatud.EL: Μη τρώτε ή πίνετε όταν το χρησιμοποιείτε.EN: When using do not eat or drink.FR: Ne pas manger et ne pas boire pendant l'utilisation.IT: Non mangiare né bere durante l'impiego.LV: Nedzert un neēst, darbojoties ar vielu.LT: Naudojant nevalgyti ir negerti.HU: Használat közben enni, inni nem szabad.MT: Tikolx u tixrobx waqt li qed tużah.NL: Niet eten of drinken tijdens gebruik.PL: Nie jeść i nie pić podczas stosowania produktu.PT: Não comer nem beber durante a utilização.RO: A nu mânca sau bea în timpul utilizării.SK: Pri používaní nejedzte ani nepite.SL: Med uporabo ne jesti in ne piti.FI: Syöminen ja juominen kielletty kemikaalia käsiteltäessä.SV: Ät inte eller drick inte under hanteringen.S21BG: Да не се пуши по време на работа.ES: No fumar durante su utilización.CS: Nekuřte při používání.DA: Der må ikke ryges under brugen.DE: Bei der Arbeit nicht rauchen.ET: Käitlemisel suitsetamine keelatud.EL: Μη καπνίζετε όταν το χρησιμοποιείτε.EN: When using do not smoke.FR: Ne pas fumer pendant l'utilisation.IT: Non fumare durante l'impiego.LV: Nesmēķēt, darbojoties ar vielu.LT: Naudojant nerūkyti.HU: Használat közben tilos a dohányzás.MT: Tpejjipx waqt li qed tużah.NL: Niet roken tijdens gebruik.PL: Nie palić tytoniu podczas stosowania produktu.PT: Não fumar durante a utilização.RO: Fumatul interzis în timpul utilizării.SK: Pri používaní nefajčite.SL: Med uporabo ne kaditi.FI: Tupakointi kielletty kemikaalia käytettäessä.SV: Rök inte under hanteringen.S22BG: Да не се вдишва праха.ES: No respirar el polvo.CS: Nevdechujte prach.DA: Undgå indånding af støv.DE: Staub nicht einatmen.ET: Vältida tolmu sissehingamist.EL: Μη αναπνέετε την σκόνη.EN: Do not breathe dust.FR: Ne pas respirer les poussières.IT: Non respirare le polveri.LV: Izvairīties no putekļu ieelpošanas.LT: Neįkvėpti dulkių.HU: Az anyag porát nem szabad belélegezni.MT: Tiġbidx it-trab 'il ġewwa b'imnifsejk.NL: Stof niet inademen.PL: Nie wdychać pyłu.PT: Não respirar as poeiras.RO: A nu se inspira praful.SK: Nevdychujte prach.SL: Ne vdihavati prahu.FI: Vältettävä pölyn hengittämistä.SV: Undvik inandning av damm.S23BG: Да не се вдишва газа/дима/парите/аерозола (подходящата дума/подходящите думи се посочва/посочват от производителя).ES: No respirar los gases/humos/vapores/aerosoles (denominación(es) adecuada(s) a especificar por el fabricante).CS: Nevdechujte plyny/dýmy/páry/aerosoly (příslušný výraz specifikuje výrobce).DA: Undgå indånding af gas/røg/dampe/aerosol-tåger (den eller de pågældende betegnelser angives af fabrikanten).DE: Gas/Rauch/Dampf/Aerosol nicht einatmen (geeignete Bezeichnung(en) vom Hersteller anzugeben).ET: Vältida gaasi/suitsu/auru/udu (sobiva mõiste määrab valmistaja) sissehingamist.EL: Μην αναπνέετε αέρια/αναθυμιάσεις/ατμούς/εκνεφώματα (η κατάλληλη διατύπωση καθορίζεται από τον παραγωγό).EN: Do not breathe gas/fumes/vapour/spray (appropriate wording to be specified by the manufacturer).FR: Ne pas respirer les gaz/fumées/vapeurs/aérosols (terme(s) approprié(s) à indiquer par le fabricant).IT: Non respirare i gas/fumi/vapori/aerosoli (termine(i) appropriato(i) da precisare da parte del produttore).LV: Izvairīties no gāzes vai dūmu, vai tvaiku, vai aerosolu ieelpošanas (formulējumu nosaka ražotājs).LT: Neįkvėpti dujų, dūmų, garų, aerozolių (konkrečiai nurodo gamintojas).HU: A keletkező gázt/füstöt/gőzt/permetet nem szabad belélegezni (a megfelelő szöveget a gyártó határozza meg).MT: Tiġbidx gass/dħaħen/fwar/sprej 'il ġewwa b'imnifsejk (it-terminu jew termini adatti jridu jkunu speċifikati mill-manifattur).NL: Gas/rook/damp/spuitnevel niet inademen. (toepasselijke term(en) aan te geven door de fabrikant).PL: Nie wdychać gazu/dymu/pary/rozpylonej cieczy (rodzaj określi producent).PT: Não respirar os gases/vapores/fumos/aerossóis (termo(s) apropriado(s) a indicar pelo produtor).RO: A nu se inspira gazul/fumul/vaporii/aerosolii (fabricantul va indica termenul(ii) corespunzător(i)).SK: Nevdychujte plyn/dym/pary/aerosóly (Vhodné slovo špecifikuje výrobca).SL: Ne vdihavati plina/dima/hlapov/meglice (ustrezno besedilo določi proizvajalec).FI: Vältettävä kaasun/huurun/höyryn/sumun hengittämistä (oikean sanamuodon valitsee valmistaja/maahantuoja).SV: Undvik inandning av gas/rök/ånga/dimma (lämplig formulering anges av tillverkaren).S24BG: Да се избягва контакт с кожата.ES: Evítese el contacto con la piel.CS: Zamezte styku s kůží.DA: Undgå kontakt med huden.DE: Berührung mit der Haut vermeiden.ET: Vältida kokkupuudet nahaga.EL: Αποφεύγετε την επαφή με το δέρμα.EN: Avoid contact with skin.FR: Éviter le contact avec la peau.IT: Evitare il contatto con la pelle.LV: Nepieļaut nokļūšanu uz ādas.LT: Vengti patekimo ant odos.HU: A bőrrel való érintkezés kerülendő.MT: Evita l-kuntatt mal-ġilda.NL: Aanraking met de huid vermijden.PL: Unikać zanieczyszczenia skóry.PT: Evitar o contacto com a pele.RO: A se evita contactul cu pielea.SK: Zabráňte kontaktu s pokožkou.SL: Preprečiti stik s kožo.FI: Varottava kemikaalin joutumista iholle.SV: Undvik kontakt med huden.S25BG: Да се избягва контакт с очите.ES: Evítese el contacto con los ojos.CS: Zamezte styku s očima.DA: Undgå kontakt med øjnene.DE: Berührung mit den Augen vermeiden.ET: Vältida silma sattumist.EL: Αποφεύγετε την επαφή με τα μάτια.EN: Avoid contact with eyes.FR: Éviter le contact avec les yeux.IT: Evitare il contatto con gli occhi.LV: Nepieļaut nokļūšanu acīs.LT: Vengti patekimo į akis.HU: Kerülni kell a szembe jutást.MT: Evita l-kuntatt ma' l-għajnejn.NL: Aanraking met de ogen vermijden.PL: Unikać zanieczyszczenia oczu.PT: Evitar o contacto com os olhos.RO: A se evita contactul cu ochii.SK: Zabráňte kontaktu s očami.SL: Preprečiti stik z očmi.FI: Varottava kemikaalin joutumista silmiin.SV: Undvik kontakt med ögonen.S26BG: При контакт с очите, веднага да се изплакнат обилно с вода и да се потърси медицинска помощ.ES: En caso de contacto con los ojos, lávense inmediata y abundantemente con agua y acúdase a un médico.CS: Při zasažení očí okamžitě důkladně vypláchněte vodou a vyhledejte lékařskou pomoc.DA: Kommer stoffet i øjnene, skylles straks grundigt med vand og læge kontaktes.DE: Bei Berührung mit den Augen sofort gründlich mit Wasser abspülen und Arzt konsultieren.ET: Silma sattumisel loputada koheselt rohke veega ja pöörduda arsti poole.EL: Σε περίπτωση επαφής με τα μάτια πλύνετέ τα αμέσως με άφθονο νερό και ζητήστε ιατρική συμβουλή.EN: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.FR: En cas de contact avec les yeux, laver immédiatement et abondamment avec de l'eau et consulter un spécialiste.IT: In caso di contatto con gli occhi, lavare immediatamente e abbondantemente con acqua e consultare un medico.LV: Ja nokļūst acīs, nekavējoties tās skalot ar lielu daudzumu ūdens un meklēt medicīnisku palīdzību.LT: Patekus į akis, nedelsiant gerai praplauti vandeniu ir kreiptis į gydytoją.HU: Ha szembe jut, bő vízzel azonnal ki kell mosni és orvoshoz kell fordulni.MT: F'każ ta' kuntatt ma' l-għajnejn, aħsel immedjatament b'ħafna ilma u ara tabib.NL: Bij aanraking met de ogen onmiddellijk met overvloedig water afspoelen en deskundig medisch advies inwinnen.PL: Zanieczyszczone oczy przemyć natychmiast dużą ilością wody i zasięgnąć porady lekarza.PT: Em caso de contacto com os olhos, lavar imediata e abundantemente com água e consultar um especialista.RO: În cazul contactului cu ochii, spălaţi imediat cu multă apă şi consultaţi medicul.SK: V prípade kontaktu s očami je potrebné ihneď ich vymyť s veľkým množstvom vody a vyhľadať lekársku pomoc.SL: Če pride v oči, takoj izpirati z obilo vode in poiskati zdravniško pomoč.FI: Roiskeet silmistä huuhdeltava välittömästi runsaalla vedellä ja mentävä lääkäriin.SV: Vid kontakt med ögonen, spola genast med mycket vatten och kontakta läkare.S27BG: Незабавно да се съблече цялото замърсено облекло.ES: Quítese inmediatamente la ropa manchada o salpicada.CS: Okamžitě odložte veškeré kontaminované oblečení.DA: Tilsmudset tøj tages straks af.DE: Beschmutzte, getränkte Kleidung sofort ausziehen.ET: Võtta koheselt seljast saastunud riietus.EL: Αφαιρέστε αμέσως όλα τα ενδύματα που έχουν μολυνθεί.EN: Take off immediately all contaminated clothing.FR: Enlever immédiatement tout vêtement souillé ou éclaboussé.IT: Togliersi di dosso immediatamente gli indumenti contaminati.LV: Nekavējoties novilkt notraipīto apģērbu.LT: Nedelsiant nusivilkti visus užterštus drabužius.HU: A szennyezett ruhát azonnal le kell vetni.MT: Inża' mill-ewwel kull ilbies imniġġes.NL: Verontreinigde kleding onmiddellijk uittrekken.PL: Natychmiast zdjąć całą zanieczyszczoną odzież.PT: Retirar imediatamente todo o vestuário contaminado.RO: Scoateţi imediat toată îmbrăcămintea contaminată.SK: Okamžite si vyzlečte kontaminovaný odev.SL: Takoj sleči vso onesnaženo obleko.FI: Riisuttava välittömästi saastunut vaatetus.SV: Tag genast av alla nedstänkta kläder.S28BG: След контакт с кожата, веднага да се измие обилно с … (посочва се от производителя).ES: En caso de contacto con la piel, lávese inmediata y abundantemente con … (productos a especificar por el fabricante).CS: Při styku s kůží okamžitě omyjte velkým množstvím … (vhodnou kapalinu specifikuje výrobce).DA: Kommer stof på huden vaskes straks med store mængder … (angives af fabrikanten).DE: Bei Berührung mit der Haut sofort abwaschen mit viel … (vom Hersteller anzugeben).ET: Nahale sattumisel pesta koheselt rohke … (määrab valmistaja).EL: Σε περίπτωση επαφής με το δέρμα, πλυθείτε αμέσως με άφθονο … (το είδος του υγρού καθορίζεται από τον παραγωγό).EN: After contact with skin, wash immediately with plenty of … (to be specified by the manufacturer).FR: Après contact avec la peau, se laver immédiatement et abondamment avec … (produits appropriés à indiquer par le fabricant).IT: In caso di contatto con la pelle lavarsi immediatamente ed abbondantemente con … (prodotti idonei da indicarsi da parte del fabbricante).LV: Ja nokļūst uz ādas, nekavējoties skalot ar lielu daudzumu … (norāda ražotājs).LT: Patekus ant odos, nedelsiant gerai nuplauti … (kuo — nurodo gamintojas).HU: Ha az anyag a bőrre kerül, …-val/vel bőven azonnal le kell mosni (az anyagot a gyártó határozza meg).MT: F'każ ta' kuntatt mal-ġilda, aħsel mill-ewwel b'ħafna … (ikun speċifikat mill-manifattur).NL: Na aanraking met de huid onmiddellijk wassen met veel … (aan te geven door de fabrikant).PL: Zanieczyszczoną skórę natychmiast przemyć dużą ilością … (cieczy określonej przez producenta).PT: Após contacto com a pele, lavar imediata e abundantemente com … (produtos adequados a indicar pelo produtor).RO: După contactul cu pielea, spălaţi imediat cu mult … (produsul corespunzător va fi indicat de fabricant).SK: Po kontakte s pokožkou je potrebné ju umyť veľkým množstvom … (bude špecifikované výrobcom).SL: Ob stiku s kožo takoj izprati z obilo … (sredstvo določi proizvajalec).FI: Roiskeet iholta huuhdeltava välittömästi runsaalla määrällä … (aineen ilmoittaa valmistaja/maahantuoja).SV: Vid kontakt med huden tvätta genast med mycket … (anges av tillverkaren).S29BG: Да не се изпуска в канализацията.ES: No tirar los residuos por el desagüe.CS: Nevylévejte do kanalizace.DA: Må ikke tømmes i kloakafløb.DE: Nicht in die Kanalisation gelangen lassen.ET: Mitte valada kanalisatsiooni.EL: Μην αδειάζετε το υπόλοιπο του περιεχομένου στην αποχέτευση.EN: Do not empty into drains.FR: Ne pas jeter les résidus à l'égout.IT: Non gettare i residui nelle fognature.LV: Aizliegts izliet kanalizācijā.LT: Neišleisti į kanalizaciją.HU: Csatornába engedni nem szabad.MT: Titfax il-fdal fid- drenaġġ.NL: Afval niet in de gootsteen werpen.PL: Nie wprowadzać do kanalizacji.PT: Não deitar os resíduos no esgoto.RO: A nu se arunca la canalizare.SK: Nevypúšťať do kanalizačnej siete.SL: Ne izprazniti v kanalizacijo.FI: Ei saa tyhjentää viemäriin.SV: Töm ej i avloppet.S30BG: Никога да не се добавя вода в този продукт.ES: No echar jamás agua a este producto.CS: K tomuto výrobku nikdy nepřidávejte vodu.DA: Hæld aldrig vand på eller i produktet.DE: Niemals Wasser hinzugießen.ET: Kemikaalile vett mitte lisada.EL: Ποτέ μην προσθέτετε νερό στο προϊόν αυτό.EN: Never add water to this product.FR: Ne jamais verser de l'eau dans ce produit.IT: Non versare acqua sul prodotto.LV: Stingri aizliegts pievienot ūdeni.LT: Niekada nemaišyti šios medžiagos su vandeniu.HU: Soha nem szabad vizet hozzáadni.MT: Qatt titfa' ilma fuq dan il-prodott.NL: Nooit water op deze stof gieten.PL: Nigdy nie dodawać wody do tego produktu.PT: Nunca adicionar água a este produto.RO: A nu se turna niciodată apă peste acest produs.SK: Nikdy nepridávajte vodu k tomuto prípravku.SL: Nikoli dolivati vode.FI: Tuotteeseen ei saa lisätä vettä.SV: Häll aldrig vatten på eller i produkten.S33BG: Да се вземат предпазни мерки срещу статично електричество.ES: Evítese la acumulación de cargas electroestáticas.CS: Proveďte preventivní opatření proti výbojům statické elektřiny.DA: Træf foranstaltninger mod statisk elektricitet.DE: Maßnahmen gegen elektrostatische Aufladungen treffen.ET: Vältida staatilise elektri teket.EL: Λάβετε προστατευτικά μέτρα έναντι ηλεκτροστατικών εκκενώσεων.EN: Take precautionary measures against static discharges.FR: Éviter l'accumulation de charges électrostatiques.IT: Evitare l'accumulo di cariche elettrostatiche.LV: Veikt drošības pasākumus, lai pasargātu no statiskās elektrības iedarbības.LT: Imtis atsargumo priemonių elektrostatinėms iškrovoms išvengti.HU: A sztatikus feltöltődés ellen védekezni kell.MT: Evita l-akkumulazzjoni ta' kargi elettrostatiċi.NL: Maatregelen treffen tegen ontladingen van statische elektriciteit.PL: Zastosować środki ostrożności zapobiegające wyładowaniom elektrostatycznym.PT: Evitar acumulação de cargas electrostáticas.RO: A se lua măsuri de precauţie pentru evitarea descărcărilor electrostatice.SK: Vykonajte predbežné opatrenia proti statickým výbojom.SL: Preprečiti statično naelektrenje.FI: Estettävä staattisen sähkön aiheuttama kipinöinti.SV: Vidtag åtgärder mot statisk elektricitet.S35BG: Този материал и неговата опаковка да се третират по безопасен начин.ES: Elimínense los residuos del producto y sus recipientes con todas las precauciones posibles.CS: Tento materiál a jeho obal musí být zneškodněny bezpečným způsobem.DA: Materialet og dets beholder skal bortskaffes på en sikker måde.DE: Abfälle und Behälter müssen in gesicherter Weise beseitigt werden.ET: Kemikaal ja pakend tuleb jäätmetena hävitada ohutult.EL: Το υλικό και ο περιέκτης του πρέπει να διατεθεί με ασφαλή τρόπο.EN: This material and its container must be disposed of in a safe way.FR: Ne se débarrasser de ce produit et de son récipient qu'en prenant toutes précautions d'usage.IT: Non disfarsi del prodotto e del recipiente se non con le dovute precauzioni.LV: Šo vielu vai produktu un iepakojumu likvidēt drošā veidā.LT: Atliekos ir pakuotė turi būti saugiai pašalintos.HU: Az anyagot és az edényzetét megfelelő módon ártalmatlanítani kell.MT: Dan il-materjal u l-kontenitur tiegħu għandhom jintremew bil-prekawzjonijiet meħtieġa.NL: Deze stof en de verpakking op veilige wijze afvoeren.PL: Usuwać produkt i jego opakowanie w sposób bezpieczny.PT: Não se desfazer deste produto e do seu recipiente sem tomar as precauções de segurança devidas.RO: A nu se arunca acest produs şi ambalajul său decât după ce sau luat toate precauţiile.SK: Tento materiál a jeho obal uložte na bezpečnom mieste.SL: Vsebina in embalaža morata biti varno odstranjeni.FI: Tämä aine ja sen pakkaus on hävitettävä turvallisesti.SV: Produkt och förpackning skall oskadliggöras på säkert sätt.S36BG: Да се носи подходящо защитно облекло.ES: Úsese indumentaria protectora adecuada.CS: Používejte vhodný ochranný oděv.DA: Brug særligt arbejdstøj.DE: Bei der Arbeit geeignete Schutzkleidung tragen.ET: Kanda sobivat kaitseriietust.EL: Να φοράτε κατάλληλη προστατευτική ενδυμασία.EN: Wear suitable protective clothing.FR: Porter un vêtement de protection approprié.IT: Usare indumenti protettivi adatti.LV: Izmantot piemērotu aizsargapģērbu.LT: Dėvėti tinkamus apsauginius drabužius.HU: Megfelelő védőruházatot kell viselni.MT: Ilbes ilbies protettiv adatt.NL: Draag geschikte beschermende kleding.PL: Nosić odpowiednią odzież ochronną.PT: Usar vestuário de protecção adequado.RO: A se purta echipamentul de protecţie corespunzător.SK: Noste vhodný ochranný odev.SL: Nositi primerno zaščitno obleko.FI: Käytettävä sopivaa suojavaatetusta.SV: Använd lämpliga skyddskläder.S37BG: Да се носят подходящи ръкавици.ES: Úsense guantes adecuados.CS: Používejte vhodné ochranné rukavice.DA: Brug egnede beskyttelseshandsker under arbejdet.DE: Geeignete Schutzhandschuhe tragen.ET: Kanda sobivaid kaitsekindaid.EL: Να φοράτε κατάλληλα γάντια.EN: Wear suitable gloves.FR: Porter des gants appropriés.IT: Usare guanti adatti.LV: Strādāt aizsargcimdos.LT: Mūvėti tinkamas pirštines.HU: Megfelelő védőkesztyűt kell viselni.MT: Ilbes ingwanti adatt.NL: Draag geschikte handschoenen.PL: Nosić odpowiednie rękawice ochronne.PT: Usar luvas adequadas.RO: A se purta mănuşi corespunzătoare.SK: Noste vhodné rukavice.SL: Nositi primerne zaščitne rokavice.FI: Käytettävä sopivia suojakäsineitä.SV: Använd lämpliga skyddshandskar.S38BG: При недостатъчна вентилация, да се използват подходящи средства за дихателна защита.ES: En caso de ventilación insuficiente, úsese equipo respiratorio adecuado.CS: V případě nedostatečného větrání používejte vhodné vybavení pro ochranu dýchacích orgánů.DA: Brug egnet åndedrætsværn, hvis effektiv ventilation ikke er mulig.DE: Bei unzureichender Belüftung Atemschutzgerät anlegen.ET: Ebapiisava ventilatsiooni korral kanda sobivat hingamisteede kaitsevahendit.EL: Σε περίπτωση ανεπαρκούς αερισμού, χρησιμοποιείτε κατάλληλη αναπνευστική συσκευή.EN: In case of insufficient ventilation, wear suitable respiratory equipment.FR: En cas de ventilation insuffisante, porter un appareil respiratoire approprié.IT: In caso di ventilazione insufficiente, usare un apparecchio respiratorio adatto.LV: Nepietiekamas ventilācijas apstākļos aizsargāt elpošanas orgānus.LT: Esant nepakankamam vėdinimui, naudoti tinkamas kvėpavimo takų apsaugos priemones.HU: Ha a szellőzés elégtelen, megfelelő légzőkészüléket kell használni.MT: F'każ ta' nuqqas ta' ventilazzjoni biżżejjed, ilbes apparat respiratorju adatt.NL: Bij ontoereikende ventilatie een geschikte adembescherming dragen.PL: W przypadku niedostatecznej wentylacji stosować odpowiednie indywidualne środki ochrony dróg oddechowych.PT: Em caso de ventilação insuficiente, usar equipamento respiratório adequado.RO: În cazul unei ventilaţii insuficiente, a se purta un echipament de respiraţie corespunzător.SK: V prípade nedostatočného vetrania použite vhodný respirátor.SL: Ob nezadostnem prezračevanju nositi primerno dihalno opremo.FI: Kemikaalin käyttö edellyttää tehokasta ilmanvaihtoa tai sopivaa hengityksensuojainta.SV: Använd lämpligt andningsskydd vid otillräcklig ventilation.S39BG: Да се носят предпазни средства за очите/лицето.ES: Úsese protección para los ojos/la cara.CS: Používejte osobní ochranné prostředky pro oči a obličej.DA: Brug beskyttelsesbriller/ansigtsskærm under arbejdet.DE: Schutzbrille/Gesichtsschutz tragen.ET: Kanda silmade/näokaitset.EL: Χρησιμοποιείτε συσκευή προστασίας ματιών/προσώπου.EN: Wear eye/face protection.FR: Porter un appareil de protection des yeux/du visage.IT: Proteggersi gli occhi/la faccia.LV: Valkāt acu vai sejas aizsargu.LT: Naudoti akių (veido) apsaugos priemones.HU: Szem-/arcvédőt kell viselni.MT: Ipproteġi 'l għajnejk/wiċċek.NL: Een bescherming voor de ogen/voor het gezicht dragen.PL: Nosić okulary lub ochronę twarzy.PT: Usar um equipamento protector para os olhos /face.RO: A se purta mască de protecţie a ochilor/feţei.SK: Použite ochranu očí a tváre.SL: Nositi zaščito za oči/obraz.FI: Käytettävä silmiem-tai kasvonsuojainta.SV: Använd skyddsglasögon eller ansiktsskydd.S40BG: За почистване на пода и всички предмети, замърсени с този продукт, да се използва … (посочва се от производителя).ES: Para limpiar el suelo y los objetos contaminados por este producto, úsese … (a especificar por el fabricante).CS: Podlahy a předměty znečistěné tímto materiálem čistěte … (specifikuje výrobce).DA: Gulvet og tilsmudsede genstande renses med … (midlerne angives af fabrikanten).DE: Fußboden und verunreinigte Gegenstände mit … reinigen (Material vom Hersteller anzugeben).ET: Kemikaaliga saastunud pindade ja esemete puhastamiseks kasuta … (määrab valmistaja)EL: Για τον καθαρισμό του δαπέδου και όλων των αντικειμένων που έχουν μολυνθεί από το υλικό αυτό χρησιμοποιείτε … (το είδος καθορίζεται από τον παραγωγό).EN: To clean the floor and all objects contaminated by this material, use … (to be specified by the manufacturer).FR: Pour nettoyer le sol ou les objets souillés par ce produit, utiliser … (à préciser par le fabricant).IT: Per pulire il pavimento e gli oggetti contaminati da questo prodotto, usare … (da precisare da parte del produttore).LV: Tīrot grīdu un piesārņotos objektus, izmantot … (norāda ražotājs).LT: Šia medžiaga užterštus daiktus ir grindis valyti su … (kuo — nurodo gamintojas).HU: A padlót és a beszennyeződött tárgyakat …-val/-vel kell tisztítani (az anyagot a gyártó határozza meg).MT: Biex taħsel l-art u l-oġġetti kollha mniġġsin b'dan il-materjal, uża … (ikun speċifikat mill-manifattur).NL: Voor de reiniging van de vloer en alle voorwerpen verontreinigd met dit materiaal, … gebruiken. (aan te geven door de fabrikant).PL: Czyścić podłogę i wszystkie inne obiekty zanieczyszczone tym produktem … (środkiem wskazanym przez producenta).PT: Para limpeza do chão e objectos contaminados por este produto, utilizar … (a especificar pelo produtor).RO: Pentru curăţirea pardoselei sau a obiectelor murdărite de acest produs, folosiţi … (va fi indicat de către fabricant).SK: Na vyčistenie podlahy a všetkých predmetov kontaminovaných týmto materiálom použite … (špecifikuje výrobca).SL: Tla in predmete, onesnažene s to snovjo/pripravkom, očistiti s/z … (čistilo določi proizvajalec).FI: Kemikaali puhdistettava pinnoilta käyttäen … (kemikaalin ilmoittaa valmistaja/maahantuoja).SV: Golv och förorenade föremål tvättas med … (anges av tillverkaren).S41BG: В случай на пожар и/или експлозия да не се вдишва дима.ES: En caso de incendio y/o de explosión no respire los humos.CS: V případě požáru nebo výbuchu nevdechujte dýmy.DA: Undgå at indånde røgen ved brand eller eksplosion.DE: Explosions- und Brandgase nicht einatmen.ET: Tulekahju ja/või plahvatuse korral vältida suitsu sissehingamist.EL: Σε περίπτωση πυρκαγιάς και/ή εκρήξεως μην αναπνέετε τους καπνούς.EN: In case of fire and/or explosion do not breathe fumes.FR: En cas d'incendie et/ou d'explosion, ne pas respirer les fumées.IT: In caso di incendio e/o esplosione non respirare i fumi.LV: Ugunsgrēka vai eksplozijas gadījumā neieelpot dūmus.LT: Gaisro arba sprogimo atveju neįkvėpti dūmų.HU: Robbanás és/vagy tűz esetén a keletkező gázokat nem szabad belélegezni.MT: F'każ ta' nar jew/u splużjoni tiblax id-dħaħen.NL: In geval van brand en/of explosie inademen van rook vermijden.PL: Nie wdychać dymów powstających w wyniku pożaru lub wybuchu.PT: Em caso de incêndio e/ou explosão não respirar os fumos.RO: A nu se inspira fumul în caz de incendiu şi/sau explozie.SK: V prípade požiaru alebo výbuchu nevdychujte výpary.SL: Ne vdihavati plinov, ki nastanejo ob požaru in/ali eksploziji.FI: Vältettävä palamisessa tai räjähdyksessä muodostuvan savun hengittämistä.SV: Undvik inandning av rök vid brand eller explosion.S42BG: При опушване/пръскане да се използват подходящи средства за дихателна защита. (подходящата дума/подходящите думи се посочва/посочват от производителя).ES: Durante las fumigaciones/pulverizaciones, úsese equipo respiratorio adecuado (denominación(es) adecuada(s) a especificar por el fabricante).CS: Při fumigaci nebo rozprašování používejte vhodný ochranný prostředek k ochraně dýchacích orgánů (specifikaci uvede výrobce).DA: Brug egnet åndedrætsværn ved rygning/sprøjtning (den eller de pågældende betegnelser angives af fabrikanten).DE: Beim Räuchern/Versprühen geeignetes Atemschutzgerät anlegen (geeignete Bezeichnung(en) vom Hersteller anzugeben).ET: Suitsutamisel/piserdamisel kanda sobivat hingamiselundite kaitsevahendit (sõnastuse täpsustab valmistaja).EL: Κατά τη διάρκεια υποκαπνισμού/ψεκάσματος χρησιμοποιείτε κατάλληλη αναπνευστική συσκευή (η κατάλληλη διατύπωση καθορίζεται από τον παραγωγό).EN: During fumigation/spraying wear suitable respiratory equipment (appropriate wording to be specified by the manufacturer).FR: Pendant les fumigations/pulvérisations, porter un appareil respiratoire approprié (terme(s) approprié(s) à indiquer par le fabricant).IT: Durante le fumigazioni/polimerizzazioni usare un apparecchio respiratorio adatto (termine(i) appropriato(i) da precisare da parte del produttore).LV: Izsmidzināšanas laikā izmantot šādus elpošanas ceļu aizsardzības līdzekļus … (norāda ražotājs).LT: Purškiant (fumiguojant) naudoti tinkamas kvėpavimo takų apsaugos priemones (konkrečiai nurodo gamintojas).HU: Füst-/permetképződés esetén megfelelő légzőkészüléket kell viselni (a megfelelő szöveget a gyártó határozza meg).MT: Waqt il-fumigazzjoni/l-isprejjar ilbes apparat respiratorju adatt (it-terminu adattat irid ikun speċifikat mill-manifattur).NL: Tijdens de ontsmetting/bespuiting een geschikte adembescherming dragen. (geschikte term(en) door de fabrikant aan te geven).PL: Podczas fumigacji/rozpylania/natryskiwania stosować odpowiednie środki ochrony dróg oddechowych (rodzaj określi producent).PT: Durante as fumigações/pulverizações usar equipamento respiratório adequado (termo(s) adequado(s) a indicar pelo produtor).RO: În timpul fumigaţiilor/pulverizărilor, a se purta un echipament de respiraţie corespunzător (fabricantul va indica termenul(ii) corespunzător(i)).SK: Počas zadymovania/rozprašovania použite vhodný respirátor (špecifikuje výrobca).SL: Med zaplinjanjem/razprševanjem nositi primerno dihalno opremo (natančnejše pogoje določi proizvajalec).FI: Kaasutuksen/ruiskutuksen aikana käytettävä sopivaa hengityksensuojainta (oikean sanamuodon valitsee valmistaja/maahantuoja).SV: Använd lämpligt andningsskydd vid gasning/sprutning (specificeras av tillverkaren).S43BG: При пожар да се използва … (да се посочи точният тип на пожарогасителното устройство. Ако водата увеличава риска, да се добави: “Никога да не се използва вода!”).ES: En caso de incendio, utilizar … (los medios de extinción los debe especificar el fabricante). (Si el agua aumenta el riesgo, se deberá añadir: “No usar nunca agua”).CS: V případě požáru použijte … (uveďte zde konkrétní typ hasicího zařízení. Pokud zvyšuje riziko voda, připojte “Nikdy nepoužívat vodu”).DA: Brug … ved brandslukning (den nøjagtige type brandslukningsudstyr angives af fabrikanten. Såfremt vand ikke må bruges tilføjes: “Brug ikke vand”).DE: Zum Löschen … (vom Hersteller anzugeben) verwenden (wenn Wasser die Gefahr erhöht, anfügen: “Kein Wasser verwenden”).ET: Tulekahju korral kasutada … (näidata täpne kustutusvahendi tüüp. Kui vesi suurendab ohtu, lisada: Vett mitte kasutada).EL: Σε περίπτωση πυρκαγιάς χρησιμοποιείτε … (Αναφέρεται το ακριβές είδος μέσων πυρόσβεσης. Εάν το νερό αυξάνει τον κίνδυνο, προστίθεται: “Μη χρησιμοποιείτε ποτέ νερό”).EN: In case of fire, use … (indicate in the space the precise type of fire-fighting equipment. If water increases risk, add — “Never use water”).FR: En cas d'incendie, utiliser … (moyens d'extinction à préciser par le fabricant. Si l'eau augmente les risques, ajouter: “Ne jamais utiliser d'eau”).IT: In caso di incendio usare … (mezzi estinguenti idonei da indicarsi da parte del fabbricante. Se l'acqua aumenta il rischio precisare “Non usare acqua”).LV: Ugunsgrēka gadījumā izmantot … (precīzi norādīt nepieciešamo ugunsdzēsības līdzekli. Ja ūdens palielina risku, papildināt ar norādi “Aizliegts izmantot ūdeni”).LT: Gaisrui gesinti naudoti … (tiksliai nurodyti gesinimo priemonę. Jeigu vanduo didina riziką, papildomai nurodyti “Nenaudoti vandens”).HU: Tűz esetén …-val/-vel oltandó (az anyagot a gyártó határozza meg). Ha a víz használata fokozza a veszélyt, a “Víz használata tilos.” mondattal is ki kell egészíteni.MT: F'każ ta' nar uża … (indika fl-ispazju t-tip preċiż ta' apparat tat-tifi tan-nar. Jekk l-ilma jkabbar ir-riskju, żid “Qatt tuża l-ilma”).NL: In geval van brand … gebruiken. (blusmiddelen aan te duiden door de fabrikant. Indien water het risico vergroot toevoegen: “Nooit water gebruiken”).PL: W przypadku pożaru używać … (podać rodzaj sprzętu przeciwpożarowego. Jeżeli woda zwiększa zagrożenie, dodać “Nigdy nie używać wody”).PT: Em caso de incêndio, utilizar … (meios de extinção a especificar pelo produtor. Se a água aumentar os riscos, acrescentar “Nunca utilizar água”).RO: În caz de incendiu se va utiliza… (Mijloacele de stingere a incendiului vor fi indicate de fabricant. Dacă apa măreşte riscurile, se va adăuga “Niciodată nu folosiţi apă”).SK: V prípade požiaru použite … (uveďte presný typ hasiaceho prístroja. Ak voda zvyšuje riziko, dodajte — “Nikdy nehaste vodou”).SL: Za gašenje uporabiti … (natančno navesti vrsto gasila in opreme za gašenje. Če voda povečuje nevarnost, dodati: “Ne uporabljati vode!”).FI: Sammutukseen käytettävä … (ilmoitettava sopiva sammutusmenetelmä. Jos vesi lisää vaaraa, lisättävä sanat: “Sammutukseen ei saa käyttää vettä”).SV: Vid brandsläckning använd … (ange lämplig metod. Om vatten ökar riskerna, lägg till: “Använd aldrig vatten”).S45BG: При злополука или неразположение да се потърси незабавно медицинска помощ и когато е възможно да се покаже етикета.ES: En caso de accidente o malestar, acúdase inmediatamente al médico (si es posible, muéstresele la etiqueta).CS: V případě nehody, nebo necítíte-li se dobře, okamžitě vyhledejte lékařskou pomoc (je-li možno, ukažte toto označení).DA: Ved ulykkestilfælde eller ved ildebefindende er omgåænde lægebehandling nødvendig; vis etiketten, hvis det er muligt.DE: Bei Unfall oder Unwohlsein sofort Arzt zuziehen (wenn möglich, dieses Etikett vorzeigen).ET: Õnnetusjuhtumi või halva enesetunde korral pöörduda arsti poole (võimaluse korral näidata talle etiketti).EL: Σε περίπτωση ατυχήματος ή αν αισθανθείτε αδιαθεσία ζητήστε αμέσως ιατρική συμβουλή (δείξτε την ετικέτα αν είναι δυνατό).EN: In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible).FR: En cas d'accident ou de malaise, consulter immédiatement un médecin (si possible lui montrer l'étiquette).IT: In caso di incidente o di malessere consultare immediatamente il medico (se possibile, mostrargli l'etichetta).LV: Ja noticis nelaimes gadījums vai jūtami veselības traucējumi, nekavējoties meklēt medicīnisku palīdzību (ja iespējams, uzrādīt marķējumu).LT: Nelaimingo atsitikimo atveju arba pasijutus blogai, nedelsiant kreiptis į gydytoją (jeigu įmanoma, parodyti šią etiketę).HU: Baleset vagy rosszullét esetén azonnal orvoshoz kell fordulni. Ha lehetséges, a címkét meg kell mutatni.MT: F'każ ta' inċident jew jekk tħossok ma tiflaħx, ara tabib mill-ewwel (jekk hu possibbli, urih it-tikketta).NL: Bij een ongeval of indien men zich onwel voelt, onmiddellijk een arts raadplegen (indien mogelijk hem dit etiket tonen).PL: W przypadku awarii lub jeżeli źle się poczujesz, niezwłocznie zasięgnij porady lekarza –jeżeli to możliwe, pokaż etykietę.PT: Em caso de acidente ou de indisposição, consultar imediatamente o médico (se possível mostrar-lhe o rótulo).RO: În caz de accident sau simptome de boală, consultaţi imediat medicul (Dacă este posibil, i se va arăta eticheta).SK: V prípade nehody alebo ak sa necítite dobre, okamžite vyhľadajte lekársku pomoc (ak je to možné, ukážte označenie látky alebo prípravku).SL: Ob nezgodi ali slabem počutju, takoj poiskati zdravniško pomoč. (Po možnosti pokazati etiketo).FI: Onnettomuuden sattuessa tai tunnettaessa pahoinvointia hakeuduttava heti lääkärin hoitoon (näytettävä tätä etikettiä, mikäli mahdollista).SV: Vid olycksfall, illamående eller annan påverkan, kontakta omedelbart läkare. Visa om möjligt etiketten.S46BG: При поглъщане да се потърси незабавно медицинска помощ и да се покаже опаковката или етикета.ES: En caso de ingestión, acúdase inmediatamente al médico y muéstresele la etiqueta o el envase.CS: Při požití okamžitě vyhledejte lékařskou pomoc a ukažte tento obal nebo označení.DA: Ved indtagelse, kontakt odūmgåænde læge og vis denne beholder eller etiket.DE: Bei Verschlucken sofort ärztlichen Rat einholen und Verpackung oder Etikett vorzeigen.ET: Kemikaali allaneelamise korral pöörduda viivitamatult arsti poole ja näidata talle kemikaali pakendit või etiketti.EL: Σε περίπτωση κατάποσης ζητήστε αμέσως ιατρική συμβουλή και δείξτε αυτό το δοχείο ή την ετικέτα.EN: If swallowed, seek medical advice immediately and show this container or label.FR: En cas d'ingestion, consulter immédiatement un médecin et lui montrer l'emballage ou l'étiquette.IT: In caso d'ingestione consultare immediatamente il medico e mostrargli il contenitore o l'etichetta.LV: Ja norīts, nekavējoties meklēt medicīnisku palīdzību un uzrādīt iepakojumu vai tā marķējumu.LT: Prarijus nedelsiant kreiptis į gydytoją ir parodyti šią pakuotę arba etiketę.HU: Lenyelése esetén azonnal orvoshoz kell fordulni, az edényt/csomagolóburkolatot és a címkét az orvosnak meg kell mutatni.MT: Jekk jinbela', ara tabib mill-ewwel u urih dan il-kontenitur jew it-tikketta.NL: In geval van inslikken onmiddellijk een arts raadplegen en verpakking of etiket tonen.PL: W razie połknięcia niezwłocznie zasięgnij porady lekarza — pokaż opakowanie lub etykietę.PT: Em caso de ingestão, consultar imediatamente o médico e mostrar-lhe a embalagem ou o rótulo.RO: În caz de înghiţire, a se consulta imediat medicul şi a i se arăta ambalajul sau eticheta.SK: V prípade požitia, okamžite vyhľadajte lekársku pomoc a ukážte tento obal alebo označenie.SL: Če pride do zaužitja, takoj poiskati zdravniško pomoč in pokazati embalažo ali etiketo.FI: Jos ainetta on nielty, hakeuduttava heti lääkärin hoitoon ja näytettävä tämä pakkaus tai etiketti.SV: Vid förtäring kontakta genast läkare och visa denna förpackning eller etiketten.S47BG: Да се съхранява при температура не по-висока от …oC (посочва се от производителя).ES: Consérvese a una temperatura no superior a …oC (a especificar por el fabricante).CS: Uchovávejte při teplotě nepřesahující …oC (specifikuje výrobce).DA: Må ikke opbevares ved temperaturer på over …oC (angives af fabrikanten).DE: Nicht bei Temperaturen über …oC aufbewahren (vom Hersteller anzugeben).ET: Hoida temperatuuril mitte üle …oC (määrab valmistaja).EL: Να διατηρείται σε θερμοκρασία που δεν υπερβαίνει τους …oC (καθορίζεται από τον παραγωγό).EN: Keep at temperature not exceeding …oC (to be specified by the manufacturer).FR: Conserver à une température ne dépassant pas …oC (à préciser par le fabricant).IT: Conservare a temperatura non superiore a …oC (da precisare da parte del fabbricante).LV: Uzglabāšanas temperatūra nedrīkst pārsniegt …oC (norāda ražotājs).LT: Laikyti ne aukštesnėje negu…oC temperatūroje (nurodo gamintojas).HU: …oC feletti hőmérsékleten nem tárolható (a hőmérsékletet a gyártó határozza meg).MT: Żomm f'temperatura li ma taqbiżx …oC (ikun speċifikat mill-manifattur).NL: Bewaren bij een temperatuur beneden …oC. (aan te geven door de fabrikant).PL: Przechowywać w temperaturze nieprzekraczającej …oC (określi producent).PT: Conservar a uma temperatura que não exceda …oC (a especificar pelo produtor).RO: A se păstra la o temperatură care nu depăşeşte…oC (temperatura va fi specificată de fabricant).SK: Uchovávajte pri teplote nepresahujúcej …oC (teplotu špecifikuje výrobca).SL: Hraniti pri temperaturi, ki ne presega …oC (temperaturo določi proizvajalec).FI: Säilytettävä alle …oC lämpötilassa (valmistaja/maahantuoja ilmoittaa lämpötilan).SV: Förvaras vid en temperatur som inte överstiger …oC (anges av tillverkaren).S48BG: Да се съхранява овлажнен с … (подходящото се посочва от производителя).ES: Consérvese húmedo con … (medio apropiado a especificar por el fabricante).CS: Uchovávejte ve zvlhčeném stavu … (vhodnou látku specifikuje výrobce).DA: Holdes befugtet med … (passende middel angives af fabrikanten).DE: Feucht halten mit … (geeignetes Mittel vom Hersteller anzugeben).ET: Hoida niisutatult … (sobiva kemikaali määrab valmistaja).EL: Να διατηρείται υγρό με … (το κατάλληλο υλικό καθορίζεται από τον παραγωγό).EN: Keep wet with … (appropriate material to be specified by the manufacturer).FR: Maintenir humide avec … (moyen approprié à préciser par le fabricant).IT: Mantenere umido con … (mezzo appropriato da precisare da parte del fabbricante).LV: Uzglabāt samitrinātu ar … (piemērotu vielu norāda ražotājs).LT: Laikyti sudrėkintą …… (kuo — nurodo gamintojas).HU: …-val/-vel nedvesen tartandó (az anyagot a gyártó határozza meg).MT: Żomm umdu b'… (il-materjal adatt ikun speċifikat mill-manifattur).NL: Inhoud vochtig houden met … (middel aan te geven door de fabrikant).PL: Przechowywać produkt zwilżony … (właściwy materiał określi producent).PT: Manter húmido com … (material adequado a especificar pelo produtor).RO: A se păstra umezit cu… (materialul adecvat va fi indicat de fabricant).SK: Uchovávajte vlhké s … (vhodný materiál špecifikuje výrobca).SL: Hraniti prepojeno z/s … (primerno omočilo določi proizvajalec).FI: Säilytettävä kosteana … (valmistaja/maahantuoja ilmoittaa sopivan aineen).SV: Innehållet skall hållas fuktigt med … (lämpligt material anges av tillverkaren).S49BG: Да се съхранява само в оригиналната опаковка.ES: Consérvese únicamente en el recipiente de origen.CS: Uchovávejte pouze v původním obalu.DA: Må kun opbevares i den originale emballage.DE: Nur im Originalbehälter aufbewahren.ET: Hoida ainult originaalpakendis.EL: Διατηρείται μόνο μέσα στο αρχικό δοχείο.EN: Keep only in the original container.FR: Conserver uniquement dans le récipient d'origine.IT: Conservare soltanto nel recipiente originale.LV: Uzglabāt tikai oriģinālajā iepakojumā.LT: Laikyti tik gamintojo pakuotėje.HU: Csak az eredeti edényzetben tárolható.MT: Żomm biss fil-kontenitur oriġinali.NL: Uitsluitend in de oorspronkelijke verpakking bewaren.PL: Przechowywać wyłącznie w oryginalnym opakowaniu.PT: Conservar unicamente no recipiente de origem.RO: A se păstra numai în ambalajul original.SK: Uchovávajte len v pôvodnej nádobe.SL: Hraniti samo v izvirni posodi.FI: Säilytettävä vain alkuperäispakkauksessa.SV: Förvaras endast i originalförpackningen.S50BG: Да не се смесва с … (посочва се от производителя).ES: No mezclar con … (a especificar por el fabricante).CS: Nesměšujte s … (specifikuje výrobce).DA: Må ikke blandes med … (angives af fabrikanten).DE: Nicht mischen mit … (vom Hersteller anzugeben).ET: Mitte kokku segada … (sobimatu kemikaali määrab valmistaja).EL: Να μην αναμιχθεί με … (καθορίζεται από τον παραγωγό).EN: Do not mix with … (to be specified by the manufacturer).FR: Ne pas mélanger avec … (à spécifier par le fabricant).IT: Non mescolare con … (da specificare da parte del fabbricante).LV: Nedrīkst samaisīt ar … (norāda ražotājs).LT: Nemaišyti su …… (nurodo gamintojas).HU: …val/-vel nem keverhető (az anyagot a gyártó határozza meg).MT: Tħallatx ma' … (ikun speċifikat mill-manifattur).NL: Niet vermengen met … (aan te geven door de fabrikant).PL: Nie mieszać z … (określi producent).PT: Não misturar com … (a especificar pelo produtor).RO: A nu se amesteca cu …(va fi indicat de fabricant).SK: Nemiešajte s … (bude špecifikované výrobcom).SL: Ne mešati z/s … (določi proizvajalec).FI: Ei saa sekoittaa … (valmistaja/maahantuoja ilmoittaa aineen) kanssa.SV: Blanda inte med … (anges av tillverkaren).S51BG: Да се използва само на проветриви места.ES: Úsese únicamente en lugares bien ventilados.CS: Používejte pouze v dobře větraných prostorách.DA: Må kun bruges på steder med god ventilation.DE: Nur in gut gelüfteten Bereichen verwenden.ET: Käidelda hästiventileeritavas kohas.EL: Να χρησιμοποιείται μόνο σε καλά αεριζόμενο χώρο.EN: Use only in well-ventilated areas.FR: Utiliser seulement dans des zones bien ventilées.IT: Usare soltanto in luogo ben ventilato.LV: Izmantot tikai labi vēdināmās telpās.LT: Naudoti tik gerai vėdinamose vietose.HU: Csak jól szellőztetett helyen használható.MT: Uża biss fi spazji ventilati tajjeb.NL: Uitsluitend op goed geventileerde plaatsen gebruiken.PL: Stosować wyłącznie w dobrze wentylowanych pomieszczeniach.PT: Utilizar somente em locais bem ventilados.RO: A se utiliza numai în locuri bine ventilate.SK: Používajte len na dobre vetranom mieste.SL: Uporabljati le v dobro prezračevanih prostorih.FI: Huolehdittava hyvästä ilmanvaihdosta.SV: Sörj för god ventilation.S52BG: Не се препоръчва за употреба на големи площи в закрити помещения.ES: No usar sobre grandes superficies en locales habitados.CS: Nedoporučuje se pro použití v interiéru na velké plochy.DA: Bør ikke anvendes til større flader i bebølses- eller opholdsrum.DE: Nicht großflächig für Wohn- und Aufenthaltsräume zu verwenden.ET: Mitte käidelda suletud ruumis laiadel pindadel.EL: Δεν συνιστάται η χρήση σε ευρείες επιφάνειες σε εσωτερικούς χώρους.EN: Not recommended for interior use on large surface areas.FR: Ne pas utiliser sur de grandes surfaces dans les locaux habités.IT: Non utilizzare su grandi superfici in locali abitati.LV: Nav ieteicams izmantot iekštelpās uz lielām virsmām.LT: Nepatartina naudoti vidaus darbams, esant didelio ploto paviršiams.HU: Emberi tartózkodásra szolgáló helyiségekben nagy felületen nem használható.MT: Mhux rakkomandat għal użu fuq spazji ta' superfiċi kbira f'postijiet abitati.NL: Niet voor gebruik op grote oppervlakken in woon- en verblijfruimtes.PL: Nie zaleca się nanoszenia na duże płaszczyzny wewnątrz pomieszczeń.PT: Não utilizar em grandes superfícies nos locais habitados.RO: A nu se utiliza pe suprafeţe mari în încăperi locuite.SK: Nie je doporučené pre použitie v interiéroch na veľkých povrchových plochách.SL: Ne uporabljati na velikih notranjih površinah.FI: Ei suositella sisäkäyttöön laajoilla pinnoilla.SV: Olämpligt för användning inomhus vid behandling av stora ytor.S53BG: Да се избягва експозиция — Получете специални инструкции преди употреба.ES: Evítese la exposición — recábense instrucciones especiales antes del uso.CS: Zamezte expozici — před použitím si obstarejte speciální instrukce.DA: Undgå enhver kontakt — indhent særlige anvisninger før brug.DE: Exposition vermeiden — vor Gebrauch besondere Anweisungen einholen.ET: Ohutu kasutamise tagamiseks tutvuda enne käitlemist kasutusjuhendiga.EL: Αποφεύγετε την έκθεση — εφοδιαστείτε με τις ειδικές οδηγίες πριν από τη χρήση.EN: Avoid exposure — obtain special instructions before use.FR: Éviter l'exposition — se procurer des instructions spéciales avant l'utilisation.IT: Evitare l'esposizione — procurarsi speciali istruzioni prima dell'uso.LV: Izvairīties no saskares, pirms lietošanas iepazīties ar instrukciju.LT: Vengti poveikio — prieš naudojimą gauti specialias instrukcijas.HU: Kerülni kell az expozíciót, — használata előtt szerezze be a külön használati utasítást.MT: Evita li jitħalla espost — ġib istruzzjonijiet speċjali qabel tużah.NL: Blootstelling vermijden — vóór gebruik speciale aanwijzingen raadplegen.PL: Unikać narażenia — przed użyciem zapoznać się z instrukcją.PT: Evitar a exposição — obter instruções específicas antes da utilização.RO: A se evita expunerea — a se procura instrucţiuni speciale înainte de utilizare.SK: Zabráňte expozícii — pred použitím sa oboznámte so špeciálnymi inštrukciami.SL: Izogibati se izpostavljanju — pred uporabo pridobiti posebna navodila.FI: Vältettävä altistumista — ohjeet luettava ennen käyttöä.SV: Undvik exponering — Begär specialinstruktioner före användning.S56BG: Този материал и опаковката му да се изхвърлят само на места за събиране на опасни или специални отпадъци.ES: Elimínense esta sustancia y su recipiente en un punto de recogida pública de residuos especiales o peligrosos.CS: Zneškodněte tento materiál a jeho obal ve sběrném místě pro zvláštní nebo nebezpečné odpady.DA: Aflever dette materiale og dets beholder til et indsamlingssted for farligt affald og problemaffald.DE: Dieses Produkt und seinen Behälter der Problemabfallentsorgung zuführen.ET: Kemikaal ja tema pakend tuleb viia ohtlike jäätmete kogumispunkti.EL: Το υλικό αυτό και ο περιέκτης του να εναποτεθούν σε χώρο συλλογής επικινδύνων ή ειδικών αποβλήτων.EN: Dispose of this material and its container to hazardous or special waste collection point.FR: Éliminer ce produit et son récipient dans un centre de collecte des déchets dangereux ou spéciaux.IT: Smaltire questo materiale e i relativi contenitori in un punto di raccolta rifiuti pericolosi o speciali.LV: Likvidēt šo vielu vai tās iepakojumu bīstamo atkritumu vai īpašā atkritumu savākšanas vietā.LT: Šios medžiagos atliekas ir jos pakuotę išvežti į pavojingų atliekų surinkimo vietas.HU: Az anyagot és edényzetét különleges hulladék- vagy veszélyeshulladék-gyűjtő helyre kell vinni.MT: Itfa' dan il-materjal u l-kontenitur tiegħu f'post fejn jinġabar skart perikoluż jew speċjali.NL: Deze stof en de verpakking naar inzamelpunt voor gevaarlijk of bijzonder afval brengen.PL: Zużyty produkt oraz opakowanie dostarczyć na składowisko odpadów niebezpiecznych.PT: Eliminar este produto e o seu recipiente, enviando-os para local autorizado para a recolha de resíduos perigosos ou especiais.RO: A se depozita produsul şi ambalajul său la un centru de colectare a deşeurilor periculoase sau speciale.SK: Zneškodnite tento materiál a jeho obal v mieste zberu nebezpečného alebo špeciálneho odpadu.SL: Snov/pripravek in embalažo predati odstranjevalcu nevarnih ali posebnih odpadkov.FI: Tämä aine ja sen pakkaus on toimitettava ongelmajätteen vastaanottopaikkaan.SV: Lämna detta material och dess behållare till insamlingsställe för farligt avfall.S57BG: Да се използва подходящ съд, за да се избегне замърсяване на околната среда.ES: Utilícese un envase de seguridad adecuado para evitar la contaminación del medio ambiente.CS: Použijte vhodný obal k zamezení kontaminace životního prostředí.DA: Skal indesluttes forsvarligt for at undgå miljøforurening.DE: Zur Vermeidung einer Kontamination der Umwelt geeigneten Behälter verwenden.ET: Keskkonnasaaste vältimiseks kasutada sobivat pakendit.EL: Να χρησιμοποιηθεί ο κατάλληλος περιέκτης για να αποφευχθεί μόλυνση του περιβάλλοντος.EN: Use appropriate container to avoid environmental contamination.FR: Utiliser un récipient approprié pour éviter toute contamination du milieu ambiant.IT: Usare contenitori adeguati per evitare l'inquinamento ambientale.LV: Izmantot piemērotu tvertni, lai izvairītos no vides piesārņošanas.LT: Naudoti tinkamą pakuotę aplinkos taršai išvengti.HU: A környezetszennyezés elkerülése érdekében megfelelő edényzetet kell használni.MT: Uża kontenitur adatt biex tevita t-tniġġis ta' l-ambjent.NL: Neem passende maatregelen om verspreiding in het milieu te voorkomen.PL: Używać odpowiednich pojemników zapobiegających skażeniu środowiska.PT: Utilizar um recipiente adequado para evitar a contaminação do ambiente.RO: A se utiliza un ambalaj corespunzător pentru evitarea oricărei contaminări a mediului înconjurător.SK: Uskutočnite náležitú kontrolu, aby ste zabránili kontaminácii.SL: S primerno posodo preprečiti onesnaženje okolja.FI: Käytettävä sopivaa säilytystapaa ympäristön likaantumisen ehkäisemiseksi.SV: Förvaras på lämpligt sätt för att undvika miljöförorening.S59BG: Обърнете се към производителя или доставчика за информация относно възстановяването/рециклирането.ES: Remitirse al fabricante o proveedor para obtener información sobre su recuperación/reciclado.CS: Informujte se u výrobce nebo dodavatele o regeneraci nebo recyklaci.DA: Indhent oplysninger om genvinding/genanvendelse hos producentesn/leverandøren.DE: Informationen zur Wiederverwendung/Wiederverwertung beim Hersteller/Lieferanten erfragen.ET: Hankida valmistajalt/tarnijalt teave kemikaali taaskasutamise või ringlussevõtu kohta.EL: Ζητήστε πληροφορίες από τον παραγωγό/προμηθευτή για ανάκτηση/ανακύκλωση.EN: Refer to manufacturer/supplier for information on recovery/recycling.FR: Consulter le fabricant/fournisseur pour des informations relatives à la récupération/au recyclage.IT: Richiedere informazioni al produttore/fornitore per il recupero/riciclaggio.LV: Izmantot ražotāja vai izplatītāja informāciju par vielas reciklēšanu vai reģenerāciju.LT: Kreiptis į gamintoją (tiekėją) informacijai apie šių medžiagų ar preparatų panaudojimą arba perdirbimą gauti.HU: A hulladékanyag visszanyeréséhez/újrahasznosításához a gyártótól/forgalmazótól kell tájékoztatást kérni.MT: Irreferi għall-manifattur/fornitur għal informazzjoni fuq rekuperu/riċiklaġġ.NL: Raadpleeg fabrikant/leverancier voor informatie over terugwinning/recycling.PL: Przestrzegać wskazówek producenta lub dostawcy dotyczących odzysku lub wtórnego wykorzystania.PT: Solicitar ao produtor/fornecedor informações relativas à sua recuperação/reciclagem.RO: Adresaţi-vă fabricantului/furnizorului pentru informaţii privind recuperarea/reciclarea.SK: Obráťte sa na výrobcu s požiadavkou na informácie týkajúce sa obnovenia a recyklácie.SL: Posvetovati se s proizvajalcem/dobaviteljem o ponovni predelavi/recikliranju.FI: Hanki valmistajalta/luovuttajalta tietoja uudelleenkäytöstä/kierrätyksestä.SV: Rådfråga tillverkare/leverantör om återvinning/återanvändning.S60BG: Този материал и неговата опаковка да се третират като опасен отпадък.ES: Elimínense el producto y su recipiente como residuos peligrosos.CS: Tento materiál a jeho obal musí být zneškodněny jako nebezpečný odpad.DA: Dette materiale og dets beholder skal bortskaffes som farligt affald.DE: Dieses Produkt und sein Behälter sind als gefährlicher Abfall zu entsorgen.ET: Kemikaal ja tema pakend kõrvaldada kui ohtlikud jäätmed.EL: Το υλικό και ο περιέκτης του να θεωρηθούν κατά τη διάθεσή τους επικίνδυνα απόβλητα.EN: This material and its container must be disposed of as hazardous waste.FR: Éliminer le produit et son récipient comme un déchet dangereux.IT: Questo materiale e il suo contenitore devono essere smaltiti come rifiuti pericolosi.LV: Apglabāt šo vielu (produktu) un tās iepakojumu kā bīstamos atkritumus.LT: Šios medžiagos atliekos ir jos pakuotė turi būti šalinamos kaip pavojingos atliekos.HU: Az anyagot és/vagy edényzetét veszélyes hulladékként kell ártalmatlanítani.MT: Dan il-materjal u l-kontenitur tiegħu għandhom jintremew ma' skart perikoluż.NL: Deze stof en de verpakking als gevaarlijk afval afvoeren.PL: Produkt i opakowanie usuwać jako odpad niebezpieczny.PT: Este produto e o seu recipiente devem ser eliminados como resíduos perigosos.RO: Acest produs şi ambalajul său se vor depozita ca un deşeu periculos.SK: Tento materiál a príslušná nádoba musia byť zlikvidované ako nebezpečný odpad.SL: Snov/pripravek in embalažo odstraniti kot nevarni odpadek.FI: Tämä aine ja sen pakkaus on käsiteltävä ongelmajätteenä.SV: Detta material och dess behållare skall tas om hand som farligt avfall.S61BG: Да не се допуска изпускане в околната среда. Вижте специалните инструкции/информационния лист за безопасност.ES: Evítese su liberación al medio ambiente. Recábense instrucciones específicas de la ficha de datos de seguridad.CS: Zabraňte uvolnění do životního prostředí. Viz speciální pokyny nebo bezpečnostní listy.DA: Undgå udledning til miljøet. Se særlig vejledning/leverandørbrugsanvisning.DE: Freisetzung in die Umwelt vermeiden. Besondere Anweisungen einholen/Sicherheitsdatenblatt zu Rate ziehen.ET: Vältida kemikaali sattumist keskkonda. Tutvuda erinõuetega/ohutuskaardiga.EL: Αποφύγετε την ελευθέρωσή του στο περιβάλλον. Αναφερθείτε σε ειδικές οδηγίες/Δελτίο δεδομένων ασφαλείας.EN: Avoid release to the environment. Refer to special instructions/Safety data sheets.FR: Éviter le rejet dans l'environnement. Consulter les instructions spéciales/la fiche de données de sécurité.IT: Non disperdere nell'ambiente. Riferirsi alle istruzioni speciali/ schede informative in materia di sicurezza.LV: Nepieļaut nokļūšanu vidē. Ievērot īpašos norādījumus vai izmantot drošības datu lapas.LT: Vengti patekimo į aplinką. Naudotis specialiomis instrukcijomis (saugos duomenų lapais).HU: Kerülni kell az anyag környezetbe jutását. Lásd a külön használati utasítást/biztonsági adatlapot.MT: Titfax fl-ambjent. Irreferi għall-istruzzjonijiet speċjali/informazzjoni fuq sigurtà.NL: Voorkom lozing in het milieu. Vraag om speciale instructies/veiligheidskaart.PL: Unikać zrzutów do środowiska. Postępować zgodnie z instrukcją lub kartą charakterystyki.PT: Evitar a libertação para o ambiente. Obter instruções específicas/fichas de segurança.RO: A se evita aruncarea în mediul înconjurător. A se consulta instrucţiunile speciale/fişa de securitate.SK: Zabráňte uvoľneniu do životného prostredia. Oboznámte sa so špeciálnymi inštrukciami, kartou bezpečnostných údajov.SL: Ne izpuščati/odlagati v okolje. Upoštevati posebna navodila/varnostni list.FI: Vältettävä päästämistä ympäristöön. Lue erityisohjeet/käyttöturvallisuustiedote.SV: Undvik utsläpp till miljön. Läs särskilda instruktioner/varuinformationsblad.S62BG: При поглъщане да не се предизвиква повръщане: незабавно да се потърси медицинска помощ и да се покаже тази опаковка или етикета.ES: En caso de ingestión no provocar el vómito: acúdase inmediatamente al médico y muéstresele la etiqueta o el envase.CS: Při požití nevyvolávejte zvracení: okamžitě vyhledejte lékařskou pomoc a ukažte tento obal nebo označení.DA: Ved indtagelse, undgå at fremprovokere opkastning: kontakt omgåænde læge og vis denne beholder eller etiket.DE: Bei Verschlucken kein Erbrechen herbeiführen. Sofort ärztlichen Rat einholen und Verpackung oder dieses Etikett vorzeigen.ET: Kemikaali allaneelamisel mitte esile kutsuda oksendamist, pöörduda viivitamatult arsti poole ja näidata talle pakendit või etiketti.EL: Σε περίπτωση κατάποσης να μην προκληθεί εμετός: ζητήστε αμέσως ιατρική συμβουλή και δείξτε αυτό το δοχείο η την ετικέτα του.EN: If swallowed, do not induce vomiting: seek medical advice immediately and show this container or label.FR: En cas d'ingestion, ne pas faire vomir. Consulter immédiatement un médecin et lui montrer l'emballage ou l'étiquette.IT: In caso di ingestione non provocare il vomito: consultare immediatamente il medico e mostrargli il contenitore o l'etichetta.LV: Ja norīts, neizraisīt vemšanu, nekavējoties meklēt medicīnisko palīdzību un uzrādīt iepakojumu vai tā marķējumu.LT: Prarijus, neskatinti vėmimo, nedelsiant kreiptis į gydytoją ir parodyti jam šią pakuotę arba etiketę.HU: Lenyelés esetén hánytatni tilos: azonnal orvoshoz kell fordulni és meg kell mutatni az edényzetet vagy a címkét.MT: Jekk jinbela', tippruvax tikkaġuna l-vomitu; mur għand tabib u uri dan il-kontenitur jew it- tikketta.NL: Bij inslikken niet het braken opwekken; direct een arts raadplegen en de verpakking of het etiket tonen.PL: W razie połknięcia nie wywoływać wymiotów, niezwłocznie zasięgnąć porady lekarza i pokazać opakowanie lub etykietę.PT: Em caso de ingestão, não provocar o vómito. Consultar imediatamente um médico e mostrar-lhe a embalagem ou o rótulo.RO: În caz de înghiţire, a nu se provoca voma: a se consulta imediat un medic şi a i se arăta ambalajul sau eticheta.SK: Pri požití nevyvolávať zvracanie; okamžite vyhľadajte lekársku pomoc a ukážte tento obal alebo označenie.SL: Po zaužitju ne izzivati bruhanja: takoj poiskati zdravniško pomoč in pokazati embalažo ali etiketo.FI: Jos kemikaalia on nielty, ei saa oksennuttaa: hakeuduttava välittömästi lääkärin hoitoon ja näytettävä tämä pakkaus tai etiketti.SV: Vid förtäring, framkalla ej kräkning. Kontakta genast läkare och visa denna förpackning eller etiketten.S63BG: В случай на злополука при вдишване пострадалият да се изнесе на чист въздух и да се остави в покой.ES: En caso de accidente por inhalación, alejar a la víctima de la zona contaminada y mantenerla en reposo.CS: V případě nehody při vdechnutí přeneste postiženého na čerstvý vzduch a ponechte jej v klidu.DA: Ved ulykkestilfælde ved indånding bringes tilskadekomne ud i frisk luft og holdes i ro.DE: Bei Unfall durch Einatmen: Verunfallten an die frische Luft bringen und ruhigstellen.ET: Kemikaali sissehingamisest tingitud õnnetuse puhul: viia kannatanu värske õhu kätte ja asetada pikali.EL: Σε περίπτωση ατυχήματος λόγω εισπονής: απομακρύνετε το θύμα από το μολυσμένο χώρο και αφήστε το να ηρεμήσει.EN: In case of accident by inhalation: remove casualty to fresh air and keep at rest.FR: En cas d'accident par inhalation, transporter la victime hors de la zone contaminée et la garder au repos.IT: In caso di incidente per inalazione, allontanare l'infortunato dalla zona contaminata e mantenerlo a riposo.LV: Ja ieelpots, pārvietot cietušo svaigā gaisā un noguldīt.LT: Įkvėpusį ir dėl to blogai pasijutusį nukentėjusįjį išvesti į gryną orą ir jo netrikdyti.HU: Belégzés miatt bekövetkező baleset esetén a sérültet friss levegőre kell vinni és biztosítani kell számára a nyugalmat.MT: F'każ ta' inċident ikkaġunat mix-xamm: ħu l-pazjent fl-arja friska u qiegħdu jistrieħ.NL: Bij een ongeval door inademing: slachtoffer in de frisse lucht brengen en laten rusten.PL: W przypadku zatrucia drogą oddechową wyprowadzić lub wynieść poszkodowanego na świeże powietrze i zapewnić warunki do odpoczynku.PT: Em caso de inalação acidental, remover a vítima da zona contaminada e mantê-la em repouso.RO: În caz de accident prin inhalare, se transportă victima în afara zonei contaminate şi se lasă în stare de repaus.SK: Pri úraze spôsobenom vdýchnutím látky postihnutého vyveďte na čerstvý vzduch a zabezpečte mu kľud.SL: V primeru nezgode pri vdihavanju: prizadeto osebo umakniti na svež zrak in pustiti počivati.FI: Jos ainetta on onnettomuuden sattuessa hengitetty: siirrä henkilö raittiiseen ilmaan ja pidä hänet levossa.SV: Vid olycksfall via inandning, flytta den drabbade till frisk luft och låt vila.S64BG: При поглъщане устата да се изплакне с вода (но само ако пострадалият е в съзнание).ES: En caso de ingestión, enjuáguese la boca con agua (solamente si la persona está consciente).CS: Při požití vypláchněte ústa velkým množstvím vody (pouze je-li postižený při vědomí).DA: Ved indtagelse, skyl munden med vand (kun hvis personen er ved bevidsthed).DE: Bei Verschlucken Mund mit Wasser ausspülen (nur wenn Verunfallter bei Bewusstsein ist).ET: Allaneelamisel loputada suud veega (ainult juhul, kui isik on teadvusel).EL: Σε περίπτωση κατάποσης, ξεπλύνετε το στόμα με νερό (μόνο εφόσον το θύμα διατηρεί τις αισθήσεις του).EN: If swallowed, rinse mouth with water (only if the person is conscious).FR: En cas d'ingestion, rincer la bouche avec de l'eau (seulement si la personne est consciente).IT: In caso di ingestione, sciacquare la bocca con acqua (solamente se l'infortunato è cosciente).LV: Ja norīts, izskalot muti ar ūdeni (ja cietušais ir pie samaņas).LT: Prarijus, praskalauti burną vandeniu (jei nukentėjusysis turi sąmonę).HU: Lenyelés esetén a szájat vízzel ki kell öblíteni (csak abban az esetben ha a sérült nem eszméletlen).MT: Jekk jinbela', laħlaħ il-ħalq bl-ilma (iżda biss jekk il-persuna tkun f'sensiha).NL: Bij inslikken, mond met water spoelen (alleen als de persoon bij bewustzijn is).PL: W przypadku połknięcia wypłukać usta wodą — nigdy nie stosować u osób nieprzytomnych.PT: Em caso de ingestão, lavar repetidamente a boca com água (apenas se a vítima estiver consciente).RO: În caz de înghiţire, se clăteşte gura cu apă (numai dacă persoana este conştientă).SK: Pri požití vypláchnite ústa vodou (iba ak je postihnutý pri vedomí).SL: Pri zaužitju spirati usta z vodo (samo če je oseba pri zavesti).FI: Jos ainetta on nielty, huuhtele suu vedellä (vain jos henkilö on tajuissaan).SV: Vid förtäring, skölj munnen med vatten (endast om personen är vid medvetande).Комбинирани S-фразиCombinación de frases-SKombinace S-větKombination af S-sætningerKombination der S-SätzeS ühendohutuslausedΣυνδυασμός των S- φράσεωνCombination of S-phrasesCombinaison des phrases SCombinazioni delle frasi SS frāžu kombinācijaS frazių derinysÖsszetett S-mondatokTaħlita ta' frażijiet SCombinatie van S-zinnenŁączone zwroty SCombinação das frases SCombinaţii de fraze SKombinácie S-vietSestavljeni stavki SYhdistetyt S-lausekkeetSammansatta S-fraserS1/2BG: Да се съхранява под ключ и далече от достъп на деца.ES: Consérvese bajo llave y manténgase fuera del alcance de los niños.CS: Uchovávejte uzamčené a mimo dosah dětí.DA: Opbevares under lås og utilgængeligt for børn.DE: Unter Verschluss und für Kinder unzugänglich aufbewahren.ET: Hoida lukustatult ja lastele kättesaamatus kohas.EL: Φυλάξτε το κλειδωμένο και μακριά από παιδιά.EN: Keep locked up and out of the reach of children.FR: Conserver sous clef et hors de portée des enfants.IT: Conservare sotto chiave e fuori della portata dei bambini.LV: Turēt noslēgtu un sargāt no bērniem.LT: Laikyti užrakintą vaikams neprieinamoje vietoje.HU: Elzárva és gyermekek számára hozzáférhetetlen helyen tartandó.MT: Żomm maqful u fejn ma jilħqux it-tfal.NL: Achter slot en buiten bereik van kinderen bewaren.PL: Przechowywać pod zamknięciem i chronić przed dziećmi.PT: Guardar fechado à chave e fora do alcance das crianças.RO: Păstraţi încuiat şi nu lăsaţi la îndemâna copiilor.SK: Uchovávajte uzamknutý a mimo dosahu detí.SL: Hraniti zaklenjeno in izven dosega otrok.FI: Säilytettävä lukitussa tilassa ja lasten ulottumattomissa.SV: Förvaras i låst utrymme och oåtkomligt för barn.S3/7BG: Съдът да се съхранява плътно затворен на хладно място.ES: Consérvese el recipiente bien cerrado y en lugar fresco.CS: Uchovávejte obal těsně uzavřený na chladném místě.DA: Emballagen opbevares tæt lukket på et køligt sted.DE: Behälter dicht geschlossen halten und an einem kühlen Ort aufbewahren.ET: Hoida pakend tihedalt suletuna jahedas kohas.EL: Διατηρείστε το δοχείο ερμητικά κλεισμένο σε δροσερό μέρος.EN: Keep container tightly closed in a cool place.FR: Conserver le récipient bien fermé dans un endroit frais.IT: Tenere il recipiente ben chiuso in luogo fresco.LV: Uzglabāt cieši noslēgtu vēsā vietā.LT: Pakuotę laikyti sandariai uždarytą vėsioje vietoje.HU: Az edényzet jól lezárva, hűvös helyen tartandó.MT: Żomm il-kontenitur magħluq tajjeb f'post frisk.NL: Gesloten verpakking op een koele plaats bewaren.PL: Przechowywać pojemnik szczelnie zamknięty w chłodnym miejscu.PT: Conservar em recipiente bem fechado em lugar fresco.RO: Păstraţi ambalajul închis ermetic, într-un loc răcoros.SK: Uchovávajte nádobu tesne uzavretú na chladnom mieste.SL: Hraniti v tesno zaprti posodi na hladnem.FI: Säilytettävä tiivisti suljettuna viileässä paikassa.SV: Förpackningen förvaras väl tillsluten och svalt.S3/9/14BG: Да се съхранява на хладно и добре проветриво място, далече от … (несъвместимите материали се посочват от производителя).ES: Consérvese en lugar fresco y bien ventilado y lejos de … (materiales incompatibles, a especificar por el fabricante).CS: Uchovávejte na chladném, dobře větraném místě odděleně od … (vzájemně se vylučující látky uvede výrobce).DA: Opbevares køligt, godt ventileret og adskilt fra … (uforligelige stoffer angives af fabrikanten).DE: An einem kühlen, gut gelüfteten Ort, entfernt von … aufbewahren (die Stoffe, mit denen Kontakt vermieden werden muss, sind vom Hersteller anzugeben).ET: Hoida jahedas hästi ventileeritavas kohas eraldi … (kokkusobimatud kemikaalid määrab valmistaja).EL: Διατηρείται σε δροσερό και καλά αεριζόμενο μέρος μακριά από … (ασύμβατα υλικά που υποδεικνύονται από τον παραγωγό).EN: Keep in a cool, well-ventilated place away from … (incompatible materials to be indicated by the manufacturer).FR: Conserver dans un endroit frais et bien ventilé à l'écart des … (matières incompatibles à indiquer par le fabricant).IT: Conservare in luogo fresco e ben ventilato lontano da … (materiali incompatibili da precisare da parte del fabbricante).LV: Uzglabāt vēsā, labi vēdināmā vietā, bet ne kopā ar … (ražotājs norāda nesavietojamās vielas).LT: Pakuotę laikyti vėsioje, gerai vėdinamoje vietoje atokiau nuo … (nesuderinamas medžiagas nurodo gamintojas).HU: Hűvös, jól szellőztetett helyen, …-tól/-től távol tartandó (az összeférhetetlen anyag(oka)t a gyártó határozza meg).MT: Żomm f'post frisk u vventilat tajjeb 'il bogħod minn … (materjali li ma jaqblux miegħu jkunu indikati mill-manifattur).NL: Bewaren op een koele, goed geventileerde plaats verwijderd van … (stoffen waarmee contact vermeden dient te worden, aan te geven door de fabrikant).PL: Przechowywać w chłodnym, dobrze wentylowanym miejscu, z dala od … (materiału wskazanego przez producenta).PT: Conservar em lugar fresco e bem ventilado ao abrigo de … (matérias incompatíveis a indicar pelo produtor).RO: Păstraţi într-un loc răcoros, bine ventilat departe de … (materialele incompatibile vor fi indicate de fabricant).SK: Uchovávajte na chladnom, dobre vetranom mieste mimo dosahu … (inkompatibilný materiál bude určený výrobcom).SL: Hraniti na hladnem, dobro prezračevanem mestu, ločeno od … (nezdružljive snovi določi proizvajalec).FI: Säilytettävä erillään … (yhteensopimattomat aineet ilmoittaa valmistaja/maahantuoja) viileässä paikassa, jossa on hyvä ilmanvaihto.SV: Förvaras svalt, på väl ventilerad plats åtskilt från … (oförenliga ämnen anges av tillverkaren).S3/9/14/49BG: Да се съхранява само в оригиналната опаковка на хладно и добре проветриво място, далече от … (несъвместимите материали се посочват от производителя).ES: Consérvese únicamente en el recipiente de origen, en lugar fresco y bien ventilado y lejos de … (materiales incompatibles, a especificar por el fabricante).CS: Uchovávejte pouze v původním obalu na chladném, dobře větraném místě, odděleně od … (vzájemně se vylučující látky uvede výrobce).DA: Må kun opbevares i originalemballagen på et køligt, godt ventileret sted og adskilt fra … (uforligelige stoffer angives af fabrikanten).DE: Nur im Originalbehälter an einem kühlen, gut gelüfteten Ort, entfernt von … aufbewahren (die Stoffe, mit denen Kontakt vermieden werden muss, sind vom Hersteller anzugeben).ET: Hoida ainult originaalpakendis jahedas, hästi ventileeritavas kohas eraldi … (kokkusobimatud kemikaalid määrab valmistaja).EL: Διατηρείται μόνο μέσα στο αρχικό δοχείο σε δροσερό και καλά αεριζόμενο μέρος μακριά από … (ασύμβατα υλικά που υποδεικνύονται από τον παραγωγό).EN: Keep only in the original container in a cool, well-ventilated place away from … (incompatible materials to be indicated by the manufacturer).FR: Conserver uniquement dans le récipient d'origine dans un endroit frais et bien ventilé à l'écart de … (matières incompatibles à indiquer par le fabricant).IT: Conservare soltanto nel contenitore originale in luogo fresco e ben ventilato lontano da … (materiali incompatibili da precisare da parte del fabbricante).LV: Uzglabāt tikai oriģinālajā iepakojumā vēsā, labi vēdināmā vietā, bet ne kopā ar … (ražotājs norāda nesavietojamās vielas).LT: Laikyti tik gamintojo pakuotėje, vėsioje, gerai vėdinamoje vietoje atokiau nuo … (nesuderinamas medžiagas nurodo gamintojas).HU: Hűvös, jól szellőztetett helyen, …-tól/-től távol, csak az eredeti edényzetben tárolható (az összeférhetetlen anyag(oka)t a gyártó határozza meg).MT: Żomm biss fil-kontenitur oriġinali f'post frisk u vventilat tajjeb 'il bogħod minn …(materjali li ma jaqblux miegħu jkunu indikati mill-manifattur).NL: Uitsluitend in de oorspronkelijke verpakking bewaren op een koele, goed geventileerde plaats verwijderd van … (stoffen waarmee contact vermeden dient te worden, aan te geven door de fabrikant).PL: Przechowywać wyłącznie w oryginalnym opakowaniu, w chłodnym, dobrze wentylowanym miejscu; nie przechowywać razem z … (materiałami wskazanymi przez producenta).PT: Conservar unicamente no recipiente de origem, em lugar fresco e bem ventilado ao abrigo de … (matérias incompatíveis a indicar pelo produtor).RO: Păstraţi numai în ambalajul original, într-un loc răcoros, bine ventilat, departe de… (materialele incompatibile vor fi indicate de fabricant).SK: Uchovávajte len v pôvodnej nádobe na chladnom, dobre vetranom mieste, mimo dosahu … (inkompatibilný materiál bude určený výrobcom).SL: Hraniti samo v izvirni posodi, na hladnem, dobro prezračevanem mestu, ločeno od … (nezdružljive snovi določi proizvajalec).FI: Säilytettävä alkuperäispakkauksessa viileässä paikassa, jossa on hyvä ilmanvaihto erillään … (yhteensopimattomat aineet ilmoittaa valmistaja/maahantuoja).SV: Förvaras endast i originalförpackningen på sval, väl ventilerad plats åtskilt från … (oförenliga ämnen anges av tillverkaren).S3/9/49BG: Да се съхранява само в оригиналната опаковка на хладно и добре проветриво място.ES: Consérvese únicamente en el recipiente de origen, en lugar fresco y bien ventilado.CS: Uchovávejte pouze v původním obalu na chladném, dobře větraném místě.DA: Må kun opbevares i originalemballagen på et køligt, godt ventileret sted.DE: Nur im Originalbehälter an einem kühlen, gut gelüfteten Ort aufbewahren.ET: Hoida ainult originaalpakendis jahedas, hästi ventileeritavas kohas.EL: Διατηρείται μόνο μέσα στο αρχικό δοχείο σε δροσερό και καλά αεριζόμενο μέρος.EN: Keep only in the original container in a cool, well-ventilated place.FR: Conserver uniquement dans le récipient d'origine dans un endroit frais et bien ventilé.IT: Conservare soltanto nel contenitore originale in luogo fresco e ben ventilato.LV: Uzglabāt tikai oriģinālajā iepakojumā vēsā, labi vēdināmā vietā.LT: Laikyti tik gamintojo pakuotėje, vėsioje, gerai vėdinamoje vietoje.HU: Hűvös, jól szellőztetett helyen, csak az eredeti edényzetben tárolható.MT: Żomm biss fil-kontenitur oriġinali f'post frisk u vventilat tajjeb.NL: Uitsluitend in de oorspronkelijke verpakking bewaren op een koele, goed geventileerde plaats.PL: Przechowywać wyłącznie w oryginalnym opakowaniu w chłodnym, dobrze wentylowanym miejscu.PT: Conservar unicamente no recipiente de origem, em lugar fresco e bem ventilado.RO: Păstraţi numai în ambalajul original, într-un loc răcoros, bine ventilat.SK: Uchovávajte len v pôvodnej nádobe na chladnom, dobre vetranom mieste.SL: Hraniti samo v izvirni posodi na hladnem in dobro prezračevanem mestu.FI: Säilytettävä alkuperäispakkauksessa viileässä paikassa, jossa on hyvä ilmanvaihto.SV: Förvaras endast i originalförpackningen på sval, väl ventilerad plats.S3/14BG: Да се съхранява на хладно място, далече от … (несъвместимите материали се посочват от производителя).ES: Consérvese en lugar fresco y lejos de … (materiales incompatibles, a especificar por el fabricante).CS: Uchovávejte na chladném místě, odděleně od … (vzájemně se vylučující látky uvede výrobce).DA: Opbevares køligt og adskilt fra … (uforligelige stoffer angives af fabrikanten).DE: An einem kühlen, von … entfernten Ort aufbewahren (die Stoffe, mit denen Kontakt vermieden werden muss, sind vom Hersteller anzugeben).ET: Hoida jahedas, eraldi … (kokkusobimatud kemikaalid määrab valmistaja).EL: Διατηρείται σε δροσερό μέρος μακριά από … (ασύμβατα υλικά που υποδεικνύονται από τον παραγωγό).EN: Keep in a cool place away from … (incompatible materials to be indicated by the manufacturer).FR: Conserver dans un endroit frais à l'écart des … (matières incompatibles à indiquer par le fabricant).IT: Conservare in luogo fresco lontano da … (materiali incompatibili da precisare da parte del fabbricante).LV: Uzglabāt vēsā vietā, bet ne kopā ar … (ražotājs norāda nesavietojamās vielas).LT: Laikyti vėsioje vietoje atokiau nuo … (nesuderinamas medžiagas nurodo gamintojas).HU: Hűvös helyen, …-tól/-től távol tartandó (az összeférhetetlen anyag(oka)t a gyártó határozza meg).MT: Żomm f'post frisk 'il bogħod minn … (materjali li ma jaqblux miegħu ikunu indikati mill-manifattur).NL: Bewaren op een koele plaats verwijderd van … (stoffen waarmee contact vermeden dient te worden, aan te geven door de fabrikant).PL: Przechowywać w chłodnym miejscu; nie przechowywać razem z … (materiałami wskazanymi przez producenta).PT: Conservar em lugar fresco ao abrigo de … (matérias incompatíveis a indicar pelo produtor).RO: Păstraţi într-un loc răcoros, departe de… (materialele incompatibile vor fi indicate de fabricant).SK: Uchovávajte na chladnom mieste mimo dosahu … (inkompatibilný materiál bude určený výrobcom).SL: Hraniti na hladnem, ločeno od … (nezdružljive snovi določi proizvajalec).FI: Säilytettävä viileässä erillään … (yhteensopimattomat aineet ilmoittaa valmistaja/maahantuoja).SV: Förvaras svalt och åtskilt från … (oförenliga ämnen anges av tillverkaren).S7/8BG: Съдът да се съхранява плътно затворен и на сухо място.ES: Manténgase el recipiente bien cerrado y en lugar seco.CS: Uchovávejte obal těsně uzavřený a suchý.DA: Emballagen skal holdes tæt lukket og opbevares tørt.DE: Behälter trocken und dicht geschlossen halten.ET: Hoida pakend tihedalt suletuna ja kuivana.EL: Το δοχείο να διατηρείται ερμητικά κλεισμένο και να προστατεύεται από την υγρασία.EN: Keep container tightly closed and dry.FR: Conserver le récipient bien fermé et à l'abri de l'humidité.IT: Conservare il recipiente ben chiuso e al riparo dall'umidità.LV: Uzglabāt sausu un cieši noslēgtu.LT: Pakuotę laikyti sandariai uždarytą ir sausoje vietoje.HU: Az edényzet légmentesen lezárva, szárazon tartandó.MT: Żomm il-kontenitur magħluq tajjeb u xott.NL: Droog houden en in een goed gesloten verpakking bewaren.PL: Przechowywać pojemnik szczelnie zamknięty w suchym pomieszczeniu.PT: Conservar o recipiente bem fechado e ao abrigo da humidade.RO: Păstraţi ambalajul închis ermetic şi uscat (ferit de umiditate).SK: Uchovávajte nádobu tesne uzavretú a suchú.SL: Hraniti v tesno zaprti posodi na suhem.FI: Säilytettävä kuivana ja tiiviisti suljettuna.SV: Förpackningen förvaras väl tillsluten och torrt.S7/9BG: Съдът да се съхранява плътно затворен и на добре проветриво място.ES: Manténgase el recipiente bien cerrado y en lugar bien ventilado.CS: Uchovávejte obal těsně uzavřený, na dobře větraném místě.DA: Emballagen skal holdes tæt lukket og opbevares på et godt ventileret sted.DE: Behälter dicht geschlossen an einem gut gelüfteten Ort aufbewahren.ET: Hoida pakend tihedalt suletuna hästi ventileeritavas kohas.EL: Το δοχείο να διατηρείται ερμητικά κλεισμένο και σε καλά αεριζόμενο μέρος.EN: Keep container tightly closed and in a well-ventilated place.FR: Conserver le récipient bien fermé et dans un endroit bien ventilé.IT: Tenere il recipiente ben chiuso e in luogo ben ventilato.LV: Uzglabāt cieši noslēgtu labi vēdināmā vietā.LT: Pakuotę laikyti sandariai uždarytą, gerai vėdinamoje vietoje.HU: Az edényzet légmentesen lezárva és jól szellőztetett helyen tartandó.MT: Żomm il-kontenitur magħluq tajjeb u f'post ivventilat tajjeb.NL: Gesloten verpakking op een goed geventileerde plaats bewaren.PL: Przechowywać pojemnik szczelnie zamknięty w miejscu dobrze wentylowanym.PT: Manter o recipiente bem fechado em local bem ventilado.RO: Păstraţi ambalajul închis ermetic şi într-un loc bine ventilat.SK: Uchovávajte nádobu tesne uzavretú a na dobre vetranom mieste.SL: Hraniti v tesno zaprti posodi ne dobro prezračevanem mestu.FI: Säilytettävä tiiviisti suljettuna paikassa, jossa on hyvä ilmanvaihto.SV: Förpackningen förvaras väl tillsluten på väl ventilerad plats.S7/47BG: Съдът да се съхранява плътно затворен и при температура не по-висока от …oC (посочва се от производителя).ES: Manténgase el recipiente bien cerrado y consérvese a una temperatura no superior a … C (a especificar por el fabricante).CS: Uchovávejte obal těsně uzavřený, při teplotě nepřesahující …oC (specifikuje výrobce).DA: Emballagen skal holdes tæt lukket og opbevares ved temperaturer på ikke over …oC (angives af fabrikanten).DE: Behälter dicht geschlossen und nicht bei Temperaturen über …oC aufbewahren (vom Hersteller anzugeben).ET: Hoida pakend tihedalt suletuna temperatuuril mitte üle …oC (määrab valmistaja).EL: Διατηρείστε το δοχείο καλά κλεισμένο σε θερμοκρασία που δεν υπερβαίνει τους … C (να καθοριστεί από τον παραγωγό).EN: Keep container tightly closed and at a temperature not exceeding …oC (to be specified by the manufacturer).FR: Conserver le récipient bien fermé et à une température ne dépassant pas …oC (à préciser par le fabricant).IT: Tenere il recipiente ben chiuso e a temperatura non superiore a …oC (da precisare da parte del fabbricante).LV: Uzglabāt cieši noslēgtu temperatūrā, kas nepārsniedz …oC (norāda ražotājs).LT: Pakuotę laikyti sandariai uždarytą, ne aukštesnėje negu …oC temperatūroje (nurodo gamintojas).HU: Az edényzet légmentesen lezárva ……oC-ot nem meghaladó hőmérsékleten tárolható (a hőmérsékletet a gyártó határozza meg).MT: Żomm il-kontenitur magħluq tajjeb u f'temperatura li ma taqbiżx …oC (tkun speċifikata mill-manifattur).NL: Gesloten verpakking bewaren bij een temperatuur beneden …oC. (aan te geven door de fabrikant).PL: Przechowywać pojemnik szczelnie zamknięty w temperaturze nieprzekraczającej …oC (określi producent).PT: Manter o recipiente bem fechado e conservar a uma temperatura que não exceda …oC (a especificar pelo produtor).RO: Păstraţi ambalajul închis ermetic şi la o temperatură care să nu depăşească …oC (temperatura va fi indicata de fabricant).SK: Uchovávajte nádobu tesne uzavretú a pri teplote nepresahujúcej ….oC (teplota bude špecifikovaná výrobcom).SL: Hraniti v tesno zaprti posodi pri temperaturi, ki ne presega …oC (temperaturo določi proizvajalec).FI: Säilytettävä tiiviisti suljettuna ja alle …oC lämpötilassa (valmistaja/maahantuoja ilmoittaa lämpötilan).SV: Förpackningen förvaras väl tillsluten vid en temperatur som inte överstiger …oC (anges av tillverkaren).S20/21BG: По време на работа да не се яде, пие и пуши.ES: No comer, ni beber, ni fumar durante su utilización.CS: Nejezte, nepijte a nekuřte při používání.DA: Der må ikke spises, drikkes eller ryges under brugen.DE: Bei der Arbeit nicht essen, trinken, rauchen.ET: Käitlemise ajal söömine, joomine ja suitsetamine keelatud.EL: Όταν το χρησιμοποιείτε μην τρώτε, μην πίνετε, μην καπνίζετε.EN: When using do not eat, drink or smoke.FR: Ne pas manger, ne pas boire et ne pas fumer pendant l'utilisation.IT: Non mangiare, né bere, né fumare durante l'impiego.LV: Nedzert, neēst un nesmēķēt, darbojoties ar vielu.LT: Naudojant nevalgyti, negerti ir nerūkyti.HU: A használat közben enni, inni és dohányozni nem szabad.MT: Meta tużah tikolx, tixrobx u tpejjipx.NL: Niet eten, drinken of roken tijdens gebruik.PL: Nie jeść i nie pić oraz nie palić tytoniu podczas stosowania produktu.PT: Não comer, beber ou fumar durante a utilização.RO: Nu mâncaţi, nu beţi şi nu fumaţi în timpul folosirii.SK: Pri používaní nejedzte, nepite ani nefajčite.SL: Med uporabo ne jesti, ne piti in ne kaditi.FI: Syöminen, juominen ja tupakointi kielletty kemikaalia käytettäessä.SV: Ät inte, drick inte eller rök inte under hanteringen.S24/25BG: Да се избягва контакт с очите и кожата.ES: Evítese el contacto con los ojos y la piel.CS: Zamezte styku s kůží a očima.DA: Undgå kontakt med huden og øjnene.DE: Berührung mit den Augen und der Haut vermeiden.ET: Vältida kemikaali sattumist nahale ja silma.EL: Αποφεύγετε επαφή με το δέρμα και με τα μάτια.EN: Avoid contact with skin and eyes.FR: Éviter le contact avec la peau et les yeux.IT: Evitare il contatto con gli occhi e con la pelle.LV: Nepieļaut nokļūšanu uz ādas un acīs.LT: Vengti patekimo ant odos ir į akis.HU: Kerülni kell a bőrrel való érintkezést és a szembe jutást.MT: Evita l-kuntatt mal-ġilda u l-għajnejn.NL: Aanraking met de ogen en de huid vermijden.PL: Unikać zanieczyszczenia skóry i oczu.PT: Evitar o contacto com a pele e os olhos.RO: Evitaţi contactul cu pielea şi ochii.SK: Zabráňte kontaktu s pokožkou a očami.SL: Preprečiti stik s kožo in očmi.FI: Varottava kemikaalin joutumista iholle ja silmiin.SV: Undvik kontakt med huden och ögonen.S27/28BG: След контакт с кожата, незабавно да се съблече цялото замърсено облекло и незабавно да се измие обилно с … (посочва се от производителя).ES: Después del contacto con la piel, quítese inmediatamente toda la ropa manchada o salpicada y lávese inmediata y abundantemente con … (productos a especificar por el fabricante).CS: Po styku s kůží okamžitě odložte veškeré kontaminované oblečení a kůži okamžitě omyjte velkým množstvím … (vhodnou kapalinu specifikuje výrobce).DA: Kommer stof på huden, tages tilsmudset tøj straks af og der vaskes med store mængder … (angives af fabrikanten).DE: Bei Berührung mit der Haut beschmutzte, getränkte Kleidung sofort ausziehen und Haut sofort abwaschen mit viel …(vom Hersteller anzugeben).ET: Nahale sattumisel võtta koheselt seljast saastunud riietus ja pesta koheselt rohke … (määrab valmistaja).EL: Σε περίπτωση επαφής με το δέρμα, αφαιρέστε αμέσως όλα τα μολυσμένα ρούχα και πλύνετε αμέσως με άφθονο … (το είδος του υγρού καθορίζεται από τον παραγωγό).EN: After contact with skin, take off immediately all contaminated clothing, and wash immediately with plenty of … (to be specified by the manufacturer).FR: Après contact avec la peau, enlever immédiatement tout vêtement souillé ou éclaboussé et se laver immédiatement et abondamment avec … (produits appropriés à indiquer par le fabricant).IT: In caso di contatto con la pelle, togliersi di dosso immediatamente gli indumenti contaminati e lavarsi immediatamente e abbondantemente con … (prodotti idonei da indicarsi da parte del fabbricante).LV: Ja nokļūst uz ādas, nekavējoties novilkt visu notraipīto apģērbu un skalot ar lielu daudzumu … (norāda ražotājs).LT: Patekus ant odos, nedelsiant nusivilkti visus užterštus drabužius ir gerai nuplauti … (kuo nurodo gamintojas).HU: Ha az anyag a bőrre jut, a szennyezett ruhát rögtön le kell vetni és a bőrt kellő mennyiségű ….- val/-vel azonnal le kell mosni (az anyagot a gyártó határozza meg).MT: Jekk imiss il-ġilda, inża' mill-ewwel l-ilbies imniġġes kollu, u aħsel immedjatament b'ħafna … (ikun speċifikat mill-manifattur).NL: Na contact met de huid, alle besmette kleding onmiddellijk uittrekken en de huid onmiddellijk wassen met veel … (aan te geven door de fabrikant).PL: W przypadku zanieczyszczenia skóry natychmiast zdjąć całą zanieczyszczoną odzież i przemyć zanieczyszczoną skórę dużą ilością … (rodzaj cieczy określi producent).PT: Em caso de contacto com a pele, retirar imediatamente toda a roupa contaminada e lavar imediata e abundantemente com … (produto adequado a indicar pelo produtor).RO: După contactul cu pielea, scoateţi imediat toată îmbrăcămintea contaminată şi spălaţi imediat cu mult … (va fi indicat de fabricant).SK: Pri kontakte s pokožkou okamžite vyzlečte kontaminovaný odev a pokožku okamžite a dôkladne umyte … (vhodný prípravok uvedie výrobca).SL: Po stiku s kožo nemudoma sleči vso onesnaženo obleko in prizadeto kožo nemudoma izprati z veliko … (sredstvo določi proizvajalec).FI: Ihokosketuksen jälkeen, saastunut vaatetus on riisuttava välittömästi ja roiskeet huuhdeltava välittömästi runsaalla määrällä … (aineen ilmoittaa valmistaja/maahantuoja).SV: Vid kontakt med huden, tag genast av alla nedstänkta kläder och tvätta genast med mycket … (anges av tillverkaren).S29/35BG: Да не се изпуска в канализацията; този материал и неговата опаковка да се третират по безопасен начин.ES: No tirar los residuos por el desagüe; elimínense los residuos del producto y sus recipientes con todas las precauciones posibles.CS: Nevylévejte do kanalizace, tento materiál a jeho obal musí být zneškodněny bezpečným způsobem.DA: Må ikke tømmes i kloakafløb; materialet og dets beholder skal bortskaffes på en sikker måde.DE: Nicht in die Kanalisation gelangen lassen; Abfälle und Behälter müssen in gesicherter Weise beseitigt werden.ET: Mitte valada kanalisatsiooni, kemikaal ja pakend tuleb hävitada ohutult.EL: Μην αδειάζετε το υπόλοιπο του περιεχομένου στην αποχέτευση, διαθέστε αυτό το υλικό και τον περιέκτη του κατά ασφαλή τρόπο.EN: Do not empty into drains; dispose of this material and its container in a safe way.FR: Ne pas jeter les résidus à l'égout; ne se débarrasser de ce produit et de son récipient qu'en prenant toutes les précautions d'usage.IT: Non gettare i residui nelle fognature; non disfarsi del prodotto e del recipiente se non con le dovute precauzioni.LV: Vielu vai produktu aizliegts izliet kanalizācijā, iepakojums likvidējams drošā veidā.LT: Neišleisti į kanalizaciją; atliekos ir pakuotė turi būti saugiai pašalintos.HU: Csatornába engedni nem szabad. Az anyagot és edényzetét megfelelő módon ártalmatlanítani kell.MT: Tarmix fid- drenaġġ: armi l-materjal u l-kontenitur tiegħu b'mod li ma jagħmilx ħsara.NL: Afval niet in de gootsteen werpen; stof en verpakking op veilige wijze afvoeren.PL: Nie wprowadzać do kanalizacji, a produkt i opakowanie usuwać w sposób bezpieczny.PT: Não deitar os resíduos no esgoto; não eliminar o produto e o seu recipiente sem tomar as precauções de segurança devidas.RO: Nu goliţi la canalizare, aruncaţi acest produs şi ambalajul său numai după luarea tuturor măsurilor de precauţie posibile.SK: Nevypúšťajte do kanalizačnej siete; tento materiál aj s obalom zlikvidujte za dodržania obvyklých bezpečnostných opatrení.SL: Ne izprazniti v kanalizacijo; vsebina in embalaža morata biti varno odstranjeni.FI: Ei saa tyhjentää viemäriin; tämä aine ja sen pakkaus on hävitettävä turvallisesti.SV: Töm ej i avloppet, oskadliggör produkt och förpackning på säkert sätt.S29/56BG: Да не се изпуска в канализацията; този материал и опаковката му да се изхвърлят само на места за събиране на опасни или специални отпадъци.ES: No tirar los residuos por el desagüe; elimínese esta sustancia y su recipiente en un punto de recogida pública de residuos especiales o peligrosos.CS: Nevylévejte do kanalizace, zneškodněte tento materiál a jeho obal ve sběrném místě pro zvláštní nebo nebezpečné odpady.DA: Må ikke tømmes i kloakafløb, aflever dette materiale og dets beholder til et indsamlingssted for farligt affald og problemaffald.DE: Nicht in die Kanalisation gelangen lassen; dieses Produkt und seinen Behälter der Problemabfallentsorgung zuführen.ET: Mitte valada kanalisatsiooni. Kemikaal ja tema pakend tuleb viia ohtlike jäätmete kogumispunkti.EL: Μην αδειάζετε το υπόλοιπο του περιεχομένου στην αποχέτευση. Το υλικό αυτό και ο περιέκτης του να εναποτεθούν σε δημόσιο χώρο συλλογής επικινδύνων ή ειδικών αποβλήτων.EN: Do not empty into drains, dispose of this material and its container at hazardous or special waste collection point.FR: Ne pas jeter les résidus à l'égout, éliminer ce produit et son récipient dans un centre de collecte des déchets dangereux ou spéciaux.IT: Non gettare i residui nelle fognature; smaltire questo materiale e i relativi contenitori in un punto di raccolta rifiuti pericolosi o speciali.LV: Vielu vai produktu aizliegts izliet kanalizācijā, vielu, produktu vai iepakojumu likvidē bīstamo atkritumu savākšanas vietā vai īpašā atkritumu savākšanas vietā.LT: Neišleisti į kanalizaciją, šios medžiagos atliekas ir jos pakuotę išvežti į pavojingų atliekų surinkimo vietas.HU: Csatornába engedni nem szabad, az anyagot és edényzetét különleges hulladék- vagy veszélyeshulladék-gyűjtő helyre kell vinni.MT: Tarmix fid- drenaġġ: armi l-materjal u l-kontenitur tiegħu f'post fejn jinġabar skart perikoluż jew speċjali.NL: Afval niet in de gootsteen werpen; deze stof en de verpakking naar een inzamelpunt voor gevaarlijk of bijzonder afval brengen.PL: Nie wprowadzać do kanalizacji, a zużyty produkt i opakowanie dostarczyć na składowisko odpadów niebezpiecznych.PT: Não deitar os resíduos no esgoto, eliminar este produto e o seu recipiente, enviando-os para local autorizado para a recolha de resíduos perigosos ou especiais.RO: Nu goliţi la canalizare, depozitaţi acest produs şi ambalajul său la punctul de colectare a deşeurilor periculoase sau speciale.SK: Nevyprázdňujte do kanalizácie, zneškodnite tento materiál a jeho obal v mieste zberu nebezpečného alebo špeciálneho odpadu.SL: Ne izprazniti v kanalizacijo — snov/pripravek in embalažo predati odstranjevalcu nevarnih ali posebnih odpadkov.FI: Ei saa tyhjentää viemäriin; tämä aine ja sen pakkaus on toimitettava ongelmajätteen vastaanottopaikkaan.SV: Töm ej i avloppet, lämna detta material och dess behållare till insamlingsställe för farligt avfall.S36/37BG: Да се носи подходящо защитно облекло и ръкавици.ES: Úsense indumentaria y guantes de protección adecuados.CS: Používejte vhodný ochranný oděv a ochranné rukavice.DA: Brug særligt arbejdstøj og egnede beskyttelseshandsker.DE: Bei der Arbeit geeignete Schutzhandschuhe und Schutzkleidung tragen.ET: Kanda sobivat kaitseriietust ja –kindaid.EL: Φοράτε κατάλληλη προστατευτική ενδυμασία και γάντια.EN: Wear suitable protective clothing and gloves.FR: Porter un vêtement de protection et des gants appropriés.IT: Usare indumenti protettivi e guanti adatti.LV: Izmantot piemērotu aizsargapģērbu un aizsargcimdus.LT: Dėvėti tinkamus apsauginius drabužius ir mūvėti tinkamas pirštines.HU: Megfelelő védőruházatot és védőkesztyűt kell viselni.MT: Ilbes ilbies protettiv adatt u ingwanti.NL: Draag geschikte handschoenen en beschermende kleding.PL: Nosić odpowiednią odzież ochronną i odpowiednie rękawice ochronne.PT: Usar vestuário de protecção e luvas adequadas.RO: Purtaţi echipament de protecţie şi mănuşi corespunzătoare.SK: Noste vhodný ochranný odev a rukavice.SL: Nositi primerno zaščitno obleko in zaščitne rokavice.FI: Käytettävä sopivaa suojavaatetusta ja suojakäsineitä.SV: Använd lämpliga skyddskläder och skyddshandskar.S36/37/39BG: Да се носи подходящо защитно облекло, ръкавици и предпазни средства за очите/лицето.ES: Úsense indumentaria y guantes adecuados y protección para los ojos/la cara.CS: Používejte vhodný ochranný oděv, ochranné rukavice a ochranné brýle nebo obličejový štít.DA: Brug særligt arbejdstøj, egnede beskyttelseshandsker og -briller/ansigtsskærm.DE: Bei der Arbeit geeignete Schutzkleidung, Schutzhandschuhe und Schutzbrille/Gesichtsschutz tragen.ET: Kanda sobivat kaitseriietust, -kindaid ja silmade või näokaitset.EL: Φοράτε κατάλληλη προστατευτική ενδυμασία, γάντια και συσκευή προστασίας ματιών/προσώπου.EN: Wear suitable protective clothing, gloves and eye/face protection.FR: Porter un vêtement de protection approprié, des gants et un appareil de protection des yeux/du visage.IT: Usare indumenti protettivi e guanti adatti e proteggersi gli occhi/la faccia.LV: Izmantot piemērotu aizsargapģērbu, aizsargcimdus un acu vai sejas aizsargu.LT: Dėvėti tinkamus apsauginius drabužius, mūvėti tinkamas pirštines ir naudoti akių (veido) apsaugos priemones.HU: Megfelelő védőruházatot, védőkesztyűt és szem-/arcvédőt kell viselni.MT: Ilbes ilbies protettiv adatt, ingwanti u protezzjoni għall-għajnejn/wiċċ.NL: Draag geschikte beschermende kleding, handschoenen en een beschermingsmiddel voor de ogen/het gezicht.PL: Nosić odpowiednią odzież ochronną, odpowiednie rękawice ochronne i okulary lub ochronę twarzy.PT: Usar vestuário de protecção e equipamento protector para os olhos /face adequados.RO: Purtaţi echipament de protecţie corespunzător, mănuşi şi mască de protecţie pentru ochi/faţă.SK: Noste vhodný ochranný odev a ochranné prostriedky na oči/tvár.SL: Nositi primerno zaščitno obleko, zaščitne rokavice in zaščito za oči/obraz.FI: Käytettävä sopivaa suojavaatetusta ja silmien- tai kasvonsuojainta.SV: Använd lämpliga skyddskläder och skyddshandskar samt skyddsglasögon eller ansiktsskydd.S36/39BG: Да се носи подходящо защитно облекло и предпазни средства за очите/лицето.ES: Úsense indumentaria adecuada y protección para los ojos/la cara.CS: Používejte vhodný ochranný oděv a ochranné brýle nebo obličejový štít.DA: Brug særligt arbejdstøj og egnede beskyttelsesbriller/ansigtsskærm.DE: Bei der Arbeit geeignete Schutzkleidung und Schutzbrille/Gesichtsschutz tragen.ET: Kanda sobivat kaitseriietust ja silmade või näokaitset.EL: Φοράτε κατάλληλη προστατευτική ενδυμασία και συσκευή προστασίας ματιών/προσώπου.EN: Wear suitable protective clothing and eye/face protection.FR: Porter un vêtement de protection approprié et un appareil de protection des yeux/du visage.IT: Usare indumenti protettivi adatti e proteggersi gli occhi/la faccia.LV: Izmantot piemērotu aizsargapģērbu un acu vai sejas aizsargu.LT: Dėvėti tinkamus apsauginius drabužius ir naudoti akių (veido) apsaugos priemones.HU: Megfelelő védőruházatot és arc-/szemvédőt kell viselni.MT: Ilbes ilbies protettiv adatt u protezzjoni għall-għajnejn/wiċċ.NL: Draag geschikte beschermende kleding en een beschermingsmiddel voor de ogen/het gezicht.PL: Nosić odpowiednią odzież ochronną i okulary lub ochronę twarzy.PT: Usar vestuário de protecção e equipamento protector para os olhos /face adequados.RO: Purtaţi echipament de protecţie corespunzător şi mască de protecţie pentru ochi/faţă.SK: Noste vhodný ochranný odev a ochranné prostriedky na oči/tvár.SL: Nositi primerno zaščitno obleko in zaščito za oči/obraz.FI: Käytettävä sopivaa suojavaatetusta ja silmien- tai kasvonsuojainta.SV: Använd lämpliga skyddskläder samt skyddsglasögon eller ansiktsskydd.S37/39BG: Да се носят подходящи ръкавици и предпазни средства за очите/лицето.ES: Úsense guantes adecuados y protección para los ojos/la cara.CS: Používejte vhodné ochranné rukavice a ochranné brýle nebo obličejový štít.DA: Brug egnede beskyttelseshandsker og -briller/ansigtsskærm under arbejdet.DE: Bei der Arbeit geeignete Schutzhandschuhe und Schutzbrille/Gesichtsschutz tragen.ET: Kanda sobivaid kaitsekindaid ja silmade või näokaitset.EL: Φοράτε κατάλληλα γάντια και συσκευή προστασίας ματιών/προσώπου.EN: Wear suitable gloves and eye/face protection.FR: Porter des gants appropriés et un appareil de protection des yeux/du visage.IT: Usare guanti adatti e proteggersi gli occhi/la faccia.LV: Izmantot aizsargcimdus un acu vai sejas aizsargu.LT: Mūvėti tinkamas pirštines ir naudoti akių (veido) apsaugos priemones.HU: Megfelelő védőkesztyűt és szem-/arcvédőt kell viselni.MT: Ilbes ingwanti adatti u protezzjoni għall-għajnejn/wiċċ.NL: Draag geschikte handschoenen en een beschermingsmiddel voor de ogen/het gezicht.PL: Nosić odpowiednie rękawice ochronne i okulary lub ochronę twarzy.PT: Usar luvas e equipamento protector para os olhos /face adequados.RO: Purtaţi mănuşi corespunzătoare şi mască de protecţie pentru ochi/faţă.SK: Noste vhodné rukavice a ochranné prostriedky na oči a tvár.SL: Nositi primerne zaščitne rokavice in zaščito za oči/obraz.FI: Käytettävä sopivia suojakäsineitä ja silmien- tai kasvonsuojainta.SV: Använd lämpliga skyddshandskar samt skyddsglasögon eller ansiktsskydd.S47/49BG: Да се съхранява само в оригиналната опаковка при температура не по-висока от …oC (посочва се от производителя).ES: Consérvese únicamente en el recipiente de origen y a temperatura no superior a …oC (a especificar por el fabricante).CS: Uchovávejte pouze v původním obalu při teplotě nepřesahující …oC (specifikuje výrobce).DA: Må kun opbevares I originalemballagen ved en temperatur på ikke over …oC (angives af fabrikanten).DE: Nur im Originalbehälter bei einer Temperatur von nicht über …oC (vom Hersteller anzugeben) aufbewahren.ET: Hoida ainult originaalpakendis, temperatuuril mitte üle …oC (määrab valmistaja).EL: Διατηρείται μόνο μέσα στο αρχικό δοχείο σε θερμοκρασία που δεν υπερβαίνει τους …oC (καθορίζεται από τον παραγωγό).EN: Keep only in the original container at a temperature not exceeding …oC (to be specified by the manufacturer).FR: Conserver uniquement dans le récipient d'origine à une température ne dépassant pas …oC (à préciser par le fabricant).IT: Conservare soltanto nel contenitore originale a temperatura non superiore a …oC (da precisare da parte del fabbricante).LV: Uzglabāt tikai oriģinālajā iepakojumā temperatūrā, kas nepārsniedz ….oC (norāda ražotājs).LT: Laikyti tik gamintojo pakuotėje, ne aukštesnėje negu …oC temperatūroje (nurodo gamintojas).HU: Legfeljebb …oC hőmérsékleten, csak az eredeti edényzetben tárolható (a hőmérsékletet a gyártó határozza meg).MT: Żomm biss fil-kontenitur oriġinali f'temperatura li ma taqbiżx …oC (ikun speċifikat mill-manifattur).NL: Uitsluitend in de oorspronkelijke verpakking bewaren bij een temperatuur beneden …oC. (aan te geven door de fabrikant).PL: Przechowywać wyłącznie w oryginalnym opakowaniu w temperaturze nieprzekraczającej…oC (określi producent).PT: Conservar unicamente no recipiente de origem a temperatura que não exceda …oC (a especificar pelo produtor).RO: Păstraţi numai în ambalajul original la o temperatură ce nu depăşeşte…oC (temperatura va fi indicată de fabricant).SK: Uchovávajte len v pôvodnej nádobe pri teplote nepresahujúcej …oC (teplota bude špecifikovaná výrobcom).SL: Hraniti samo v izvirni posodi pri temperaturi, ki ne presega …oC (temperaturo določi proizvajalec).FI: Säilytettävä alkuperäispakkauksessa alle …oC lämpötilassa (valmistaja/maahantuoja ilmoittaa lämpötilan).SV: Förvaras endast i originalförpackningen vid en temperatur som inte överstiger …oC (anges av tillverkaren).’

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to the Treaty of Accession of Bulgaria and Romania(1), and in particular Article 4(3) thereof,

Having regard to the Act of Accession of Bulgaria and Romania, and in particular Article 56 thereof,

Having regard to the proposal from the Commission,

(1) Pursuant to Article 56 of the Act of Accession, where acts of the institutions remain valid beyond 1 January 2007, and require adaptation by reason of accession, and the necessary adaptations have not been provided for in the Act of Accession or its Annexes, the necessary acts are to be adopted by the Council unless the Commission adopted the original act.

(2) The Final Act of the Conference which drew up the Treaty of Accession indicated that the High Contracting Parties had reached political agreement on a set of adaptations to acts adopted by the institutions required by reason of accession and invited the Council and the Commission to adopt these adaptations before accession, completed and updated where necessary to take account of the evolution of the law of the Union.

(3) Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(2)should therefore be amended accordingly,

HAS ADOPTED THIS DIRECTIVE:
Article 1

Directive 67/548/EEC shall be amended as set out in the Annex.
Article 2

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by the date of accession of Bulgaria and Romania to the European Union at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3

This Directive shall enter into force subject to and on the date of the entry into force of the Treaty of Accession of Bulgaria and Romania.
Article 4

This Directive is addressed to the Member States.
THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to the Treaty of Accession of Bulgaria and Romania(1), and in particular Article 4(3) thereof,

Having regard to the Act of Accession of Bulgaria and Romania, and in particular Article 56 thereof,

Having regard to the proposal from the Commission,

(1) Pursuant to Article 56 of the Act of Accession, where acts of the institutions remain valid beyond 1 January 2007, and require adaptation by reason of accession, and the necessary adaptations have not been provided for in the Act of Accession or its Annexes, the necessary acts are to be adopted by the Council unless the Commission adopted the original act.

(2) The Final Act of the Conference which drew up the Treaty of Accession indicated that the High Contracting Parties had reached political agreement on a set of adaptations to acts adopted by the institutions required by reason of accession and invited the Council and the Commission to adopt these adaptations before accession, completed and updated where necessary to take account of the evolution of the law of the Union.

(3) Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(2)should therefore be amended accordingly,

HAS ADOPTED THIS DIRECTIVE:
Directive 67/548/EEC shall be amended as set out in the Annex.
1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by the date of accession of Bulgaria and Romania to the European Union at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
This Directive shall enter into force subject to and on the date of the entry into force of the Treaty of Accession of Bulgaria and Romania.
This Directive is addressed to the Member States.
ANNEXCHEMICALS31967 L 0548: Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ L 196, 16.8.1967, p. 1), as amended by:
— | 31969 L 0081: Council Directive 69/81/CEE of 13.3.1969 (OJ L 68, 19.3.1969, p. 1),

— | 31970 L 0189: Council Directive 70/189/EEC of 6.3.1970 (OJ L 59, 14.3.1970, p. 33),

— | 31971 L 0144: Council Directive 71/144/EEC of 22.3.1971 (OJ L 74, 29.3.1971, p. 15),

— | 31973 L 0146: Council Directive 73/146/EEC of 21.5.1973 (OJ L 167, 25.6.1973, p. 1),

— | 31975 L 0409: Council Directive 75/409/EEC of 24.6.1975 (OJ L 183, 14.7.1975, p. 22),

— | 31976 L 0907: Commission Directive 76/907/EEC of 14.7.1976 (OJ L 360, 30.12.1976, p. 1),

— | 11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),

— | 31979 L 0370: Commission Directive 79/370/EEC of 30.1.1979 (OJ L 88, 7.4.1979, p. 1),

— | 31979 L 0831: Council Directive 79/831/EEC of 18.9.1979 (OJ L 259, 15.10.1979, p. 10),

— | 31980 L 1189: Council Directive 80/1189/EEC of 4.12.1980 (OJ L 366, 31.12.1980, p. 1),

— | 31981 L 0957: Commission Directive 81/957/EEC of 23.10.1981 (OJ L 351, 7.12.1981, p. 5),

— | 31982 L 0232: Commission Directive 82/232/EEC of 25.3.1982 (OJ L 106, 21.4.1982, p. 18),

— | 31983 L 0467: Commission Directive 83/467/EEC of 29.7.1983 (OJ L 257, 16.9.1983, p. 1),

— | 31984 L 0449: Commission Directive 84/449/EEC of 25.4.1984 (OJ L 251, 19.9.1984, p. 1),

— | 11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),

— | 31986 L 0431: Commission Directive 86/431/EEC of 24.6.1986 (OJ L 247, 1.9.1986, p. 1),

— | 31987 L 0432: Council Directive 87/432/EEC of 3.8.1987 (OJ L 239, 21.8.1987, p. 1),

— | 31988 L 0302: Commission Directive 88/302/EEC of 18.11.1987 (OJ L 133, 30.5.1988, p. 1),

— | 31988 L 0490: Commission Directive 88/490/EEC of 22.7.1988 (OJ L 259, 19.9.1988, p. 1),

— | 31990 L 0517: Council Directive 90/517/EEC of 9.10.1990 (OJ L 287, 19.10.1990, p. 37),

— | 31991 L 0325: Commission Directive 91/325/EEC of 1.3.1991 (OJ L 180, 8.7.1991, p. 1),

— | 31991 L 0326: Commission Directive 91/326/EEC of 5.3.1991 (OJ L 180, 8.7.1991, p. 79),

— | 31991 L 0410: Commission Directive 91/410/EEC of 22.7.1991 (OJ L 228, 17.8.1991, p. 67),

— | 31991 L 0632: Commission Directive 91/632/EEC of 28.10.1991 (OJ L 338, 10.12.1991, p. 23),

— | 31992 L 0032: Council Directive 92/32/EEC of 30.4.1992 (OJ L 154, 5.6.1992, p. 1),

— | 31992 L 0037: Commission Directive 92/37/EEC of 30.4.1992 (OJ L 154, 5.6.1992, p. 30),

— | 31993 L 0021: Commission Directive 93/21/EEC of 27.4.1993 (OJ L 110, 4.5.1993, p. 20),

— | 31993 L 0072: Commission Directive 93/72/EEC of 1.9.1993 (OJ L 258, 16.10.1993, p. 29),

— | 31993 L 0101: Commission Directive 93/101/EC of 11.11.1993 (OJ L 13, 15.1.1994, p. 1),

— | 31993 L 0105: Commission Directive 93/105/EC of 25.11.1993 (OJ L 294, 30.11.1993, p. 21),

— | 11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

— | 31994 L 0069: Commission Directive 94/69/EC of 19.12.1994 (OJ L 381, 31.12.1994, p. 1),

— | 31996 L 0054: Commission Directive 96/54/EC of 30.7.1996 (OJ L 248, 30.9.1996, p. 1),

— | 31996 L 0056: Directive 96/56/EC of the European Parliament and the Council of 3.9.1996 (OJ L 236, 18.9.1996, p. 35),

— | 31997 L 0069: Commission Directive 97/69/EC of 5.12.1997 (OJ L 343, 13.12.1997, p. 19),

— | 31998 L 0073: Commission Directive 98/73/EC of 18.9.1998 (OJ L 305, 16.11.1998, p. 1),

— | 31998 L 0098: Commission Directive 98/98/EC of 15.12.1998(OJ L 355, 30.12.1998, p. 1),

— | 31999 L 0033: Directive 1999/33/EC of the European Parliament and of the Council of 10.5.1999 (OJ L 199, 30.7.1999, p. 57),

— | 32000 L 0032: Commission Directive 2000/32/EC of 19.5.2000 (OJ L 136, 8.6.2000, p. 1),

— | 32000 L 0033: Commission Directive 2000/33/EC of 25.4.2000 (OJ L 136, 8.6.2000, p. 90),

— | 32001 L 0059: Commission Directive 2001/59/EC of 6.8.2001 (OJ L 225, 21.8.2001, p. 1),

— | 12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),

— | 32003 R 0807: Council Regulation (EC) No 807/2003 of 14.4.2003 (OJ L 122, 16.5.2003, p. 36),

— | 32004 L 0073: Commission Directive 2004/73/EC of 29.4.2004 (OJ L 152, 30.4.2004, p. 1).

(a) | Table A in the foreword to Annex I is replaced by the following:‘ТАБЛИЦА А — TABLA A — TABULKA A — TABEL A — TABELLE A — TABEL A — ΠΙΝΑΚΑΣ A — TABLE A — TABLEAU A — TABELLA A — A TABULA — A LENTELĖ — A. TÁBLÁZAT — TABELLA A — TABEL A — TABELA A — TABELA A — TABEL A — TABUĽKA A — TABELA A — TAULUKKO A — TABELL AСписък на химичните елементи, подредени по техния атомен номер (Z)Lista de los elementos químicos clasificados por su número atómico (Z)Seznam chemických prvků seřazených podle jejich atomového čísla (Z)Liste over grundstoffer, ordnet efter deres atomvægt (Z)Liste der chemischen Elemente, geordnet nach der Ordnungszahl (Z)Keemiliste elementide nimekiri aatomnumbri (Z) järgiΚατάλογος χημικών στοιχείων ταξινομημένων σύμφωνα με τον ατομικό τους αριθμό (Ζ)List of chemical elements listed according to their atomic number (Z)Liste des éléments chimiques classés selon leur numéro atomique (Z)Elenco degli elementi chimici ordinati secondo il loro numero atomico (Z)Ķīmisko elementu saraksts — sakārtojums pēc atomnumuriem (Z)Cheminių elementų, išdėstytų pagal atominį skaičių (Z), sąrašasKémiai elemek listája, rendszámuk sorrendjében (Z)Lista ta’ elementi kimiċi elenkati skond in-numru atomiku tagħhom (Z)Lijst van chemische elementen, gerangschikt naar atoomgewicht (Z)Lista pierwiastków chemicznych ułożona według wzrastającej liczby atomowej (Z)Lista dos elementos químicos ordenados segundo o seu número atómico (Z)Lista elementelor chimice, în ordinea numerelor atomice (Z)Zoznam chemických prvkov zoradených podľa atómových čísiel (Z)Seznam kemijskih elementov, razvrščenih po vrstnem številu (Z)Alkuaineiden luettelo, järjestysluvun mukaan (Z)Lista över grundämnen, ordnade efter deras atomnummer (Z)ZSymbolBGESCSDADEETELENFRITLV1HВодородHidrógenoVodíkHydrogenWasserstoffVesinikΥδρογόνοHydrogenHydrogèneIdrogenoŪdeņradis2HeХелийHelioHeliumHeliumHeliumHeeliumΉλιοHeliumHéliumElioHēlijs3LiЛитийLitioLithiumLithiumLithiumLiitiumΛίθιοLithiumLithiumLitioLitijs4BeБерилийBerilioBerylliumBerylliumBerylliumBerülliumΒηρύλλιοBerylliumBéryllium(Glucinium)BerillioBerilijs5BБорBoroBorBorBorBoorΒόριοBoronBoreBoroBors6CВъглеродCarbonoUhlíkCarbon (kulstof)KohlenstoffSüsinikΆνθρακαςCarbonCarboneCarbonioOgleklis7NАзотNitrógenoDusíkNitrogenStickstoffLämmastikΆζωτοNitrogenAzoteAzotoSlāpeklis8OКислородOxígenoKyslíkOxygen (ilt)SauerstoffHapnikΟξυγόνοOxygenOxygèneOssigenoSkābeklis9FФлуорFlúorFluorFluorFluorFluorΦθόριοFluorineFluorFluoroFluors10NeНеонNeónNeonNeonNeonNeoonΝέονNeonNéonNeonNeons11NaНатрийSodioSodíkNatriumNatriumNaatriumΝάτριοSodiumSodiumSodioNātrijs12MgМагнезийMagnesioHořčíkMagnesiumMagnesiumMagneesiumΜαγνήσιοMagnesiumMagnésiumMagnesioMagnijs13AlАлуминийAluminioHliníkAluminiumAluminiumAlumiiniumΑργίλλιοAluminiumAluminiumAlluminioAlumīnijs14SiСилицийSilicioKřemíkSiliciumSiliciumRäniΠυρίτιοSiliconSiliciumSilicioSilīcijs15PФосфорFósforoFosforPhosphorPhosphorFosforΦωσφόροςPhosphorusPhosphoreFosforoFosfors16SСяраAzufreSíraSvovlSchwefelVäävelΘείονSulphurSoufreZolfoSērs17ClХлорCloroChlorChlorChlorKloorΧλώριοChlorineChloreCloroHlors18ArАргонArgónArgonArgonArgonArgoonArgόArgonArgonArgonArgons19KКалийPotasioDraslíkKaliumKaliumKaaliumΚάλιοPotassiumPotassiumPotassioKālijs20CaКалцийCalcioVápníkCalciumCalciumKaltsiumΑσβέστιοCalciumCalciumCalcioKalcijs21ScСкандийEscandioSkandiumScandiumScandiumSkandiumΣκάνδιοScandiumScandiumScandioSkandijs22TiТитанTitanioTitanTitanTitanTitaanΤιτάνιοTitaniumTitaneTitanioTitāns23VВанадийVanadioVanadVanadiumVanadiumVanaadiumΒανάδιοVanadiumVanadiumVanadioVanādijs24CrХромCromoChromChromChromKroomΧρώμιοChromiumChromeCromoHroms25MnМанганManganesoManganManganManganMangaanΜαγγάνιοManganeseManganèseManganeseMangāns26FeЖелязоHierroŽelezoJernEisenRaudΣίδηροςIronFerFerroDzelzs27CoКобалтCobaltoKobaltCobaltKobaltKoobaltΚοβάλτιοCobaltCobaltCobaltoKobalts28NiНикелNíquelNiklNikkelNickelNikkelΝικέλιοNickelNickelNichelNiķelis29CuМедCobreMěďKobberKupferVaskΧαλκόςCopperCuivreRameVarš30ZnЦинкZincZinekZinkZinkTsinkΨευδάργυροςZincZincZincoCinks31GaГалийGalioGalliumGalliumGalliumGalliumΓάλλιοGalliumGalliumGallioGallijs32GeГерманийGermanioGermaniumGermaniumGermaniumGermaaniumΓερμάνιοGermaniumGermaniumGermanioGermānijs33AsАрсенArsénicoArsenArsenArsenArseenΑρσενικόArsenicArsenicArsenicoArsēns34SeСеленSelenioSelenSelenSelenSeleenΣελήνιοSeleniumSéléniumSelenioSelēns35BrБромBromoBromBromBromBroomΒρώμιοBromineBromeBromoBroms36KrКриптонCriptónKryptonKryptonKryptonKrüptoonΚρυπτόKryptonKryptonKryptonKriptons37RbРубидийRubidioRubidiumRubidiumRubidiumRubiidiumΡουβήδιοRubidiumRubidiumRubidioRubīdijs38SrСтронцийEstroncioStronciumStrontiumStrontiumStrontsiumΣτρόντιοStrontiumStrontiumStronzioStroncijs39YИтрийItrioYttriumYttriumYttriumÜtriumΎττριοYttriumYttriumIttrioItrijs40ZrЦирконийCirconioZirkoniumZirconiumZirkonTsirkooniumΖιρκόνιοZirconiumZirconiumZirconioCirkonijs41NbНиобийNiobioNiobNiobiumNiobNioobiumΝιόβιοNiobiumNiobiumNiobioNiobijs42MoМолибденMolibdenoMolybdenMolybdenMolybdänMolübdeenΜολυβδένιοMolybdenumMolybdèneMolibdenoMolibdēns43TcТехнецийTecnecioTechneciumTechnetiumTechnetiumTehneetsiumΤεχνήτιοTechnetiumTechnetiumTecnezioTehnēcijs44RuРутенийRutenioRutheniumRutheniumRutheniumRuteeniumΡουθήνιοRutheniumRuthéniumRutenioRutēnijs45RhРодийRodioRhodiumRhodiumRhodiumRoodiumΡόδιοRhodiumRhodiumRodioRodijs46PdПаладийPaladioPalladiumPalladiumPalladiumPallaadiumΠαλλάδιοPalladiumPalladiumPalladioPallādijs47AgСреброPlataStříbroSølvSilberHõbeΆργυροςSilverArgentArgentoSudrabs48CdКадмийCadmioKadmiumCadmiumCadmiumKaadiumΚάδμιοCadmiumCadmiumCadmioKadmijs49InИндийIndioIndiumIndiumIndiumIndiumΊνδιοIndiumIndiumIndioIndijs50SnКалайEstañoCínTinZinnTinaΚασσίτεροςTinÉtainStagnoAlva51SbАнтимонAntimonioAntimonAntimonAntimonAntimonΑντιμόνιοAntimonyAntimoineAntimonioAntimons52TeТелурTelurioTellurTelurTellurTelluurΤελλούριοTelluriumTellureTellurioTelūrs53IЙодYodoJodJodJodJoodΙώδιοIodineIodeIodioJods54XeКсенонXenónXenonXenonXenonKsenoonΞένοXenonXénonXenonKsenons55CsЦезийCesioCesiumCæsiumCaesiumTseesiumΚαίσιοCaesiumCésiumCesioCēzijs56BaБарийBarioBaryumBariumBariumBaariumΒάριοBariumBaryumBarioBārijs57LaЛантанLantanoLanthanLanthanLanthanLantaanΛανδάνιοLanthanumLanthaneLantanioLantāns58CeЦерийCerioCerCeriumCerTseeriumΔημήτριοCeriumCériumCerioCērijs59PrПразеодимPraseodimioPraseodymPraseodymPraseodymPraseodüümΠρασεοδύμιοPraseodymiumPraséodymePraseodimioPrazeodīms60NdНеодимNiodimioNeodymNeodymNeodymNeodüümΝεοδύμιοNeodymiumNéodymeNeodimioNeodīms61PmПрометийPrometioPromethiumPromethiumPromethiumPromeetiumΠρομήθειοPromethiumProméthiumPromezioPrometijs62SmСамарийSamarioSamariumSamariumSamariumSamaariumΣαμάριοSamariumSamariumSamarioSamārijs63EuЕвропийEuropioEuropiumEuropiumEuropiumEuroopiumΕυρώπιοEuropiumEuropiumEuropioEiropijs64GdГадолинийGadolinioGadoliniumGadoliniumGadoliniumGadoliiniumΓαδολίνιοGadoliniumGadoliniumGadolinioGadolīnijs65TbТербийTerbioTerbiumTerbiumTerbiumTerbiumΤέρβιοTerbiumTerbiumTerbioTerbijs66DyДиспросийDisprosioDysprosiumDysprosiumDysprosiumDüsproosiumΔυσπρόσιοDysprosiumDysprosiumDisprosioDisprozijs67HoХолмийHolmioHolmiumHolmiumHolmiumHolmiumΌλμιοHolmiumHolmiumOlmioHolmijs68ErЕрбийErbioErbiumErbiumErbiumErbiumΈρβιοErbiumErbiumErbioErbijs69TmТулийTulioThuliumThuliumThuliumTuuliumΘούλιοThuliumThuliumTulioTūlijs70YbИтербийIterbioYtterbiumYtterbiumYtterbiumÜterbiumΥττέρβιοYtterbiumYtterbiumItterbioIterbijs71LuЛютецийLutecioLuteciumLutetiumLvtéciumLuteetsiumΛουτήτιοLutetiumLutéciumLutezioLutēcijs72HfХафнийHafnioHafniumHafniumHafniumHafniumΆφνιοHafniumHafniumAfnioHafnijs73TaТанталTántaloTantalTantalTantalTantaalΤαντάλιοTantalumTantaleTantalioTantāls74WВолфрамVolframioWolframWolframWolframVolframΒολφράμιο(Τουγκοτένιο)TungstenTungstèneTungstenoVolframs75ReРенийRenioRheniumRheniumRheniumReeniumΡήνιοRheniumRhéniumRenioRēnijs76OsОсмийOsmioOsmiumOsmiumOsmiumOsmiumΌσμιοOsmiumOsmiumOsmioOsmijs77IrИридийIridioIridiumIridiumIridiumIriidiumΙρίδιοIridiumIridiumIridioIrīdijs78PtПлатинаPlatinoPlatinaPlatinPlatinPlaatinaΛευκόχρυσοςPlatinumPlatinePlatinoPlatīns79AuЗлатоOroZlatoGuldGoldKuldΧρυσόςGoldOrOroZelts80HgЖивакMercurioRtuťKviksølvQuecksilberElavhõbeΥδράργυροςMercuryMercureMercurioDzīvsudrabs81TlТалийTalioThalliumThaliumThalliumTalliumΘάλλιοThalliumThalliumTallioTallijs82PbОловоPlomoOlovoBlyBleiPliiΜόλυβδοςLeadPlombPiomboSvins83BiБисмутBismutoBismutBismuthWismuthVismutΒισμούθιοBismuthBismuthBismutoBismuts84PoПолонийPolonioPoloniumPloniumPoloniumPolooniumΠολώνιοPoloniumPoloniumPolonioPolonijs85AtАстатAstatoAstatAstatAstatAstaatΑστάτιοAstatineAstateAstatoAstats86RnРадонRadónRadonRadonRadonRadoonΡαδόνιοRadonRadonRadonRadons87FrФранцийFrancioFranciumFranciumFranciumFrantsiumΦράγκιοFranciumFranciumFrancioFrancijs88RaРадийRadioRadiumRadiumRadiumRaadiumΡάδιοRadiumRadiumRadioRādijs89AcАктинийActinioAktiniumActiniumActiniumAktiiniumΑκτίνιοActiniumActiniumAttinioAktīnijs90ThТорийTorioThoriumThoriumThoriumTooriumΘόριοThoriumThoriumTorioTorijs91PaПротактинийProtactinioProtaktiniumProtactiniumProtactiniumProtaktiiniumΠρωτακτίνιοProtactiniumProtactiniumProtoattinioProtaktīnijs92UУранUranioUranUranUranUraanΟυράνιοUraniumUraniumUranioUrāns93NpНептунийNeptunioNeptuniumNeptuniumNeptuniumNeptuuniumΝεπτούνιο(Ποσειδώνιο)NeptuniumNeptuniumNettunioNeptūnijs94PuПлутонийPlutonioPlutoniumPlutoniumPlutoniumPlutooniumΠλουτώνιοPlutoniumPlutoniumPlutonioPlutonijs95AmАмерицийAmericioAmericiumAmericiumAmericiumAmeriitsiumΑμερίκιοAmericiumAmériciumAmericioAmerīcijs96CmКюрийCurioCuriumCuriumCuriumKuuriumΚιούριοCuriumCuriumCurioKirijs97BkБерклийBerkelioBerkeliumBerkeliumBerkeliumBerkeeliumΜπερκέλιοBerkeliumBerkéliumBerkelioBerklijs98CfКалифорнийCalifornioKaliforniumCaliforniumCaliforniumKaliforniumΚαλιφόρνιοCaliforniumCaliforniumCalifornioKalifornijs99EsАйнщайнийEinstenioEinsteiniumEinsteiniumEinsteiniumEinsteiniumΑϊνστάνιονEinsteiniumEinsteiniumEinstenioEinšteinijs100FmФермийFermioFermiumFermiumFermiumFermiumΦέρμιοFermiumFermiumFermioFermijs101MdМенделеевийMendelevioMendeleviumMendeleviumMendeleviumMendeleeviumΜεντελέβιοMendeleviumMendéléviumMendelevioMendeļejevijs102NoНобелийNobelioNobeliumNobeliumNobeliumNobeeliumΝομπέλιοNobeliumNobéliumNobelioNobēlijs103LwЛоуренсийLaurencioLawrenciumLawrentiumLawrentiumLavrentsiumΛαυρένσιοLawrenciumLawrenciumLawrencioLourensijsZSymbolLTHUMTNLPLPTROSKSLFISV1HVandenilisHidrogénIdroġenuWaterstofWodórHidrogénioHidrogenVodíkVodikVetyVäte2HeHelisHéliumEljuHeliumHelHélioHeliuHéliumHelijHeliumHelium3LiLitisLítiumLitjuLithiumLitLítioLitiuLítiumLitijLitiumLitium4BeBerilisBerilliumBerilljuBerylliumBerylBerílioBeriliuBerýliumBerilijBerylliumBeryllium5BBorasBórBoronBoorBorBoroBorBórBorBooriBor6CAnglisSzénKarbonjuKoolstofWęgielCarbonoCarbonUhlíkOgljikHiiliKol7NAzotasNitrogénAzotuStikstofAzotAzotoAzotDusíkDušikTyppiKväve8ODeguonisOxigénOssiġenuZuurstofTlenOxigénioOxigenKyslíkKisikHappiSyre9FFluorasFluorFluworinFluorFluorFlúorFluorFluórFluorFluoriFluor10NeNeonasNeonNeonNeonNeonNéonNeonNeónNeonNeonNeon11NaNatrisNátriumSodjuNatriumSódSódioSodiuSodíkNatrijNatriumNatrium12MgMagnisMagnéziumManjesjuMagnesiumMagnezMagnésioMagneziuHorčíkMagnezijMagnesiumMagnesium13AlAliuminisAlumíniumAluminjuAluminiumGlinAlumínioAluminiuHliníkAluminijAlumiiniAluminium14SiSilicisSziliciumSilikonSiliciumKrzemSilícioSiliciuKremíkSilicijPiiKisel15PFosforasFoszforFosfruFosforFosforFósforoFosforFosforFosforFosforiFosfor16SSieraKénKubritZwavelSiarkaEnxofreSulfSíraŽveploRikkiSvavel17ClChlorasKlórKloruChloorChlorCloroClorChlórKlorKlooriKlor18ArArgonasArgonArgonArgonArgonÁrgonArgonArgónArgonArgonArgon19KKalisKáliumPotassjuKaliumPotasPotássioPotasiuDraslíkKalijKaliumKalium20CaKalcisKalciumKalċjuCalciumWapńCálcioCalciuVápnikKalcijKalsiumKalcium21ScSkandisSzkandiumSkandjuScandiumSkandEscândioScandiuSkandiumSkandijSkandiumSkandium22TiTitanasTitánTitanjuTitaanTytanTitânioTitanTitánTitanTitaaniTitan23VVanadisVanádiumVanadjuVanadiumWanadVanádioVanadiuVanádVanadijVanadiiniVanadin24CrChromasKrómKromjuChroomChromCrómioCromChrómKromKromiKrom25MnManganasMangánManganiżMangaanManganManganêsManganMangánManganMangaaniMangan26FeGeležisVasĦadidIjzerŻelazoFerroFierŽelezoŽelezoRautaJärn27CoKobaltasKobaltKobaltKobaltKobaltCobaltoCobaltKobaltKobaltKobolttiKobolt28NiNikelisNikkelNikilNikkelNikielNíquelNichelNikelNikeljNikkeliNickel29CuVarisRézRamKoperMiedźCobreCupruMeďBakerKupariKoppar30ZnCinkasCinkŻinguZìnkCynkZincoZincZinokCinkSinkkiZink31GaGalisGalliumGalljuGalliumGalGálioGaliuGáliumGalijGalliumGallium32GeGermanisGermániumĠermanjuGermaniumGermanGermânioGermaniuGermániumGermanijGermaniumGermanium33AsArsenasArzénArsenikuArseenArsenArsénioArsenArzénArzenArseeniArsenik34SeSelenasSzelénSelenjuSeleniumSelenSelénioSeleniuSelénSelenSeleeniSelen35BrBromasBrómBromuBroomBromBromoBromBrómBromBromiBrom36KrKriptonasKriptonKriptonKryptonKryptonKríptonKriptonKryptónKriptonKryptonKrypton37RbRubidisRubídiumRubidjuRubidiumRubidRubídioRubidiuRubídiumRubidijRubidiumRubidium38SrStroncisStronciumStronzjuStrontiumStrontEstrôncioStronţiuStronciumStroncijStrontiumStrontium39YItrisIttriumIttrijuYttriumItrÍtrioYtriuYtriumItrijYttriumYttrium40ZrCirkonisCirkóniumŻirkonjuZirkoniumCyrkonZircónioZirconiuZirkóniumCirkonijZirkoniumZirkonium41NbNiobisNióbiumNijobjuNiobiumNiobNióbioNiobiuNióbNiobijNiobiumNiob42MoMolibdenasMolibdénMolibdenuMolybdeenMolibdenMolibdénioMolibdenMolybdénMolibdenMolybdeeniMolybden43TcTechnecisTechnéciumTeknezjuTechnetiumTechnetTecnécioTehneţiuTechnéciumTehnecijTeknetiumTeknetium44RuRutenisRuténiumRutenjuRutherniumRutenRuténioRuteniuRuténiumRutenijRuteniumRutenium45RhRodisRódiumRodjuRodiumRodRódioRodiuRódiumRodijRodiumRodium46PdPaladisPalládiumPalladjuPalladiumPalladPaládioPaladiuPaládiumPaladijPalladiumPalladium47AgSidabrasEzüstFiddaZilverSrebroPrataArgintStriebroSrebroHopeaSilver48CdKadmisKadmiumKadmjuCadmiumKadmCádmioCadmiuKadmiumKadmijKadmiumKadmium49InIndisIndiumIndjuIndiumIndÍndioIndiuIndiumIndijIndiumIndium50SnAlavasÓnLandaTinCynaEstanhoStaniuCínKositerTinaTenn51SbStibisAntimonAntimonjuAntimoonAntymonAntimónioStibiuAntimónAntimonAntimoniAntimon52TeTelūrasTellúrTellurjuTelluurTellurTelúrioTelurTelúrTelurTelluuriTellur53IJodasJódJodjuJoodJodIodoIodJódJodJodiJod54XeKsenonasXenonKsenoXenonKsenonXénonXenonXenónKsenonKsenonXenon55CsCezisCéziumĊesjuCesiumCezCésioCesiuCésiumCezijCesiumCesium56BaBarisBáriumBarjuBariumBarBárioBariuBáriumBarijBariumBarium57LaLantanasLantánLantanuLanthaanLantanLantânioLantanLantánLantanLantaaniLantan58CeCerisCériumĊerjuCeriumCerCérioCeriuCérCerijCeriumCerium59PrPrazeodimisPrazeodímiumPrasedimjuPraseodymiumPrazeodymPraseodímioPraseodimPrazeodýmPrazeodimPraseodyymiPraseodym60NdNeodimisNeodímiumNeodimjuNeodymiumNeodymNeodímioNeodimNeodýmNeodimNeodyymiNeodym61PmPrometisPrométiumPrometjuPromethiumPrometPromécioPromeţiuPrométiumPrometijPrometiumPrometium62SmSamarisSzamáriumSamarjuSamariumSamarSamárioSamariuSamáriumSamarijSamariumSamarium63EuEuropisEurópiumEwropjuEuropiumEuropEurópioEuropiuEurópiumEvropijEuropiumEuropium64GdGadolinisGadolíniumGadolinjuGadoliniumGadolinGadolínioGadoliniuGadolíniumGadolinijGadoliniumGadolinium65TbTerbisTerbiumTerbjuTerbiumTerbTérbioTerbiuTerbiumTerbijTerbiumTerbium66DyDisprozisDiszpróziumDisprosjuDysprosiumDysprozDisprósioDysprosiuDyspróziumDisprozijDysprosiumDysprosium67HoHolmisHolmiumOlmjuHolmiumHolmHólmioHolmiuHolmiumHolmijHolmiumHolmium68ErErbisErbiumErbjuErbiumErbÉrbioErbiuErbiumErbijErbiumErbium69TmTulisTúliumTuljuThuliumTulTúlioTuliuTúliumTulijTuliumTulium70YbIterbisItterbiumItterbjuYtterbiumIterbItérbioYterbiuYterbiumIterbijYtterbiumYtterbium71LuLiutecisLutéciumLutezjuLutetiumLutetLutécioLuteţiuLutéciumLutecijLutetiumLutetium72HfHafnisHafniumĦafnjuHafniumHafnHáfnioHafniuHafniumHafnijHafniumHafnium73TaTantalasTantálTantaluTantaalTantalTântaloTantalTantalTantalTantaaliTantal74WVolframasVolfrámTungstenuWolframWolframTungsténioWolframVolfrámVolframVolframiWolfram75ReRenisRéniumRênjuReniumRenRénioReniuRéniumRenijReniumRhenium76OsOsmisOzmiumOsmjuOsmiumOsmÓsmioOsmiuOsmiumOsmijOsmiumOsmium77IrIridisIrídiumIridjuIridiumIrydIrídioIridiuIrídiumIridijIridiumIridium78PtPlatinaPlatinaPlatinuPlatinumPlatynaPlatinaPlatinaPlatinaPlatinaPlatinaPlatina79AuAuksasAranyDehebGoudZłotoOuroAurZlatoZlatoKultaGuld80HgGyvsidabrisHiganyMerkurjuKwikRtęćMercúrioMercurOrtuťŽivo srebroElohopeaKvicksilver81TlTalisTalliumTalljuThalliumTalTálioTaliuTáliumTalijTalliumTallium82PbŠvinasÓlomĊombLoodOłówChumboPlumbOlovoSvinecLyijyBly83BiBismutasBizmutBismùtBismuthBizmutBismutoBismutBizmutBizmutVismuttiVismut84PoPolonisPolóniumPolonjuPoloniumPolonPolónioPoloniuPolóniumPolonijPoloniumPolonium85AtAstatinasAsztáciumAstatinaAstaatAstatAstatoAstatiniuAstátAstatAstatiiniAstat86RnRadonasRadonRadonRadonRadonRádonRadonRadónRadonRadonRadon87FrFrancisFranciumFranċjuFranciumFransFrâncioFranciuFranciumFrancijFrankiumFrancium88RaRadisRádiumRadjuRadiumRadRádioRadiuRádiumRadijRadiumRadium89AcAktinisAktíniumAktinjuActiniumAktynActínioActiniuAktíniumAktinijAktiniumAktinium90ThTorisTóriumTorjuThoriumTorTórioToriuTóriumTorijToriumTorium91PaProtaktinisProtaktíniumProtaktinjuProtactiniumProtaktynProtactínioProactiniuProtaktíniumProtaktinijProtaktiniumProtaktinium92UUranasUránUranjuUraniumUranUrânioUraniuUránUranUraaniUran93NpNeptūnisNeptúniumNettunjuNeptuniumNeptunNeptúnioNeptuniuNeptúniumNeptunijNeptuniumNeptunium94PuPlutonisPlutóniumPlutonjuPlutoniumPlutonPlutónioPlutoniuPlutóniumPlutonijPlutoniumPlutonium95AmAmericisAmeríciumAmeriċjuAmericiumAmerykAmerícioAmericiuAmeríciumAmericijAmerikiumAmericium96CmKiurisKűriumKurjuCuriumKiurCúrioCuriuCuriumKirijCuriumCurium97BkBerklisBerkéliumBerkeljuBerkeliumBerkelBerquélioBerkeliuBerkeliumBerkelijBerkeliumBerkelium98CfKalifornisKaliforniumKalifornjuCaliforniumKalifornCalifórnioCaliforniuKaliforniumKalifornijKaliforniumCalifornium99EsEinšteinisEinsteiniumEnstejnjuEinsteiniumEinsteinEinsteinioEinsteiniuEinsteiniumAjnštajnijEinsteiniumEinsteinium100FmFermisFermiumFermjuFermiumFermFérmioFermiuFermiumFermijFermiumFermium101MdMendelevisMendeléviumMendelevjuMendeleviumMendelewMendelévioMendeleeviuMendeleviumMendelevijMendeleviumMendelevium102NoNobelisNobéliumNobeljuNobeliumNobelNobélioNobeliuNobeliumNobelijNobeliumNobelium103LwLorensisLaurenciumLawrenċjuLaurentiumLorensLaurêncioLaurenţiuLaurenciumLavrencijLawrensiumLawrentium’ | Z | Symbol | BG | ES | CS | DA | DE | ET | EL | EN | FR | IT | LV | 1 | H | Водород | Hidrógeno | Vodík | Hydrogen | Wasserstoff | Vesinik | Υδρογόνο | Hydrogen | Hydrogène | Idrogeno | Ūdeņradis | 2 | He | Хелий | Helio | Helium | Helium | Helium | Heelium | Ήλιο | Helium | Hélium | Elio | Hēlijs | 3 | Li | Литий | Litio | Lithium | Lithium | Lithium | Liitium | Λίθιο | Lithium | Lithium | Litio | Litijs | 4 | Be | Берилий | Berilio | Beryllium | Beryllium | Beryllium | Berüllium | Βηρύλλιο | Beryllium | Béryllium(Glucinium) | Berillio | Berilijs | 5 | B | Бор | Boro | Bor | Bor | Bor | Boor | Βόριο | Boron | Bore | Boro | Bors | 6 | C | Въглерод | Carbono | Uhlík | Carbon (kulstof) | Kohlenstoff | Süsinik | Άνθρακας | Carbon | Carbone | Carbonio | Ogleklis | 7 | N | Азот | Nitrógeno | Dusík | Nitrogen | Stickstoff | Lämmastik | Άζωτο | Nitrogen | Azote | Azoto | Slāpeklis | 8 | O | Кислород | Oxígeno | Kyslík | Oxygen (ilt) | Sauerstoff | Hapnik | Οξυγόνο | Oxygen | Oxygène | Ossigeno | Skābeklis | 9 | F | Флуор | Flúor | Fluor | Fluor | Fluor | Fluor | Φθόριο | Fluorine | Fluor | Fluoro | Fluors | 10 | Ne | Неон | Neón | Neon | Neon | Neon | Neoon | Νέον | Neon | Néon | Neon | Neons | 11 | Na | Натрий | Sodio | Sodík | Natrium | Natrium | Naatrium | Νάτριο | Sodium | Sodium | Sodio | Nātrijs | 12 | Mg | Магнезий | Magnesio | Hořčík | Magnesium | Magnesium | Magneesium | Μαγνήσιο | Magnesium | Magnésium | Magnesio | Magnijs | 13 | Al | Алуминий | Aluminio | Hliník | Aluminium | Aluminium | Alumiinium | Αργίλλιο | Aluminium | Aluminium | Alluminio | Alumīnijs | 14 | Si | Силиций | Silicio | Křemík | Silicium | Silicium | Räni | Πυρίτιο | Silicon | Silicium | Silicio | Silīcijs | 15 | P | Фосфор | Fósforo | Fosfor | Phosphor | Phosphor | Fosfor | Φωσφόρος | Phosphorus | Phosphore | Fosforo | Fosfors | 16 | S | Сяра | Azufre | Síra | Svovl | Schwefel | Väävel | Θείον | Sulphur | Soufre | Zolfo | Sērs | 17 | Cl | Хлор | Cloro | Chlor | Chlor | Chlor | Kloor | Χλώριο | Chlorine | Chlore | Cloro | Hlors | 18 | Ar | Аргон | Argón | Argon | Argon | Argon | Argoon | Argό | Argon | Argon | Argon | Argons | 19 | K | Калий | Potasio | Draslík | Kalium | Kalium | Kaalium | Κάλιο | Potassium | Potassium | Potassio | Kālijs | 20 | Ca | Калций | Calcio | Vápník | Calcium | Calcium | Kaltsium | Ασβέστιο | Calcium | Calcium | Calcio | Kalcijs | 21 | Sc | Скандий | Escandio | Skandium | Scandium | Scandium | Skandium | Σκάνδιο | Scandium | Scandium | Scandio | Skandijs | 22 | Ti | Титан | Titanio | Titan | Titan | Titan | Titaan | Τιτάνιο | Titanium | Titane | Titanio | Titāns | 23 | V | Ванадий | Vanadio | Vanad | Vanadium | Vanadium | Vanaadium | Βανάδιο | Vanadium | Vanadium | Vanadio | Vanādijs | 24 | Cr | Хром | Cromo | Chrom | Chrom | Chrom | Kroom | Χρώμιο | Chromium | Chrome | Cromo | Hroms | 25 | Mn | Манган | Manganeso | Mangan | Mangan | Mangan | Mangaan | Μαγγάνιο | Manganese | Manganèse | Manganese | Mangāns | 26 | Fe | Желязо | Hierro | Železo | Jern | Eisen | Raud | Σίδηρος | Iron | Fer | Ferro | Dzelzs | 27 | Co | Кобалт | Cobalto | Kobalt | Cobalt | Kobalt | Koobalt | Κοβάλτιο | Cobalt | Cobalt | Cobalto | Kobalts | 28 | Ni | Никел | Níquel | Nikl | Nikkel | Nickel | Nikkel | Νικέλιο | Nickel | Nickel | Nichel | Niķelis | 29 | Cu | Мед | Cobre | Měď | Kobber | Kupfer | Vask | Χαλκός | Copper | Cuivre | Rame | Varš | 30 | Zn | Цинк | Zinc | Zinek | Zink | Zink | Tsink | Ψευδάργυρος | Zinc | Zinc | Zinco | Cinks | 31 | Ga | Галий | Galio | Gallium | Gallium | Gallium | Gallium | Γάλλιο | Gallium | Gallium | Gallio | Gallijs | 32 | Ge | Германий | Germanio | Germanium | Germanium | Germanium | Germaanium | Γερμάνιο | Germanium | Germanium | Germanio | Germānijs | 33 | As | Арсен | Arsénico | Arsen | Arsen | Arsen | Arseen | Αρσενικό | Arsenic | Arsenic | Arsenico | Arsēns | 34 | Se | Селен | Selenio | Selen | Selen | Selen | Seleen | Σελήνιο | Selenium | Sélénium | Selenio | Selēns | 35 | Br | Бром | Bromo | Brom | Brom | Brom | Broom | Βρώμιο | Bromine | Brome | Bromo | Broms | 36 | Kr | Криптон | Criptón | Krypton | Krypton | Krypton | Krüptoon | Κρυπτό | Krypton | Krypton | Krypton | Kriptons | 37 | Rb | Рубидий | Rubidio | Rubidium | Rubidium | Rubidium | Rubiidium | Ρουβήδιο | Rubidium | Rubidium | Rubidio | Rubīdijs | 38 | Sr | Стронций | Estroncio | Stroncium | Strontium | Strontium | Strontsium | Στρόντιο | Strontium | Strontium | Stronzio | Stroncijs | 39 | Y | Итрий | Itrio | Yttrium | Yttrium | Yttrium | Ütrium | Ύττριο | Yttrium | Yttrium | Ittrio | Itrijs | 40 | Zr | Цирконий | Circonio | Zirkonium | Zirconium | Zirkon | Tsirkoonium | Ζιρκόνιο | Zirconium | Zirconium | Zirconio | Cirkonijs | 41 | Nb | Ниобий | Niobio | Niob | Niobium | Niob | Nioobium | Νιόβιο | Niobium | Niobium | Niobio | Niobijs | 42 | Mo | Молибден | Molibdeno | Molybden | Molybden | Molybdän | Molübdeen | Μολυβδένιο | Molybdenum | Molybdène | Molibdeno | Molibdēns | 43 | Tc | Технеций | Tecnecio | Technecium | Technetium | Technetium | Tehneetsium | Τεχνήτιο | Technetium | Technetium | Tecnezio | Tehnēcijs | 44 | Ru | Рутений | Rutenio | Ruthenium | Ruthenium | Ruthenium | Ruteenium | Ρουθήνιο | Ruthenium | Ruthénium | Rutenio | Rutēnijs | 45 | Rh | Родий | Rodio | Rhodium | Rhodium | Rhodium | Roodium | Ρόδιο | Rhodium | Rhodium | Rodio | Rodijs | 46 | Pd | Паладий | Paladio | Palladium | Palladium | Palladium | Pallaadium | Παλλάδιο | Palladium | Palladium | Palladio | Pallādijs | 47 | Ag | Сребро | Plata | Stříbro | Sølv | Silber | Hõbe | Άργυρος | Silver | Argent | Argento | Sudrabs | 48 | Cd | Кадмий | Cadmio | Kadmium | Cadmium | Cadmium | Kaadium | Κάδμιο | Cadmium | Cadmium | Cadmio | Kadmijs | 49 | In | Индий | Indio | Indium | Indium | Indium | Indium | Ίνδιο | Indium | Indium | Indio | Indijs | 50 | Sn | Калай | Estaño | Cín | Tin | Zinn | Tina | Κασσίτερος | Tin | Étain | Stagno | Alva | 51 | Sb | Антимон | Antimonio | Antimon | Antimon | Antimon | Antimon | Αντιμόνιο | Antimony | Antimoine | Antimonio | Antimons | 52 | Te | Телур | Telurio | Tellur | Telur | Tellur | Telluur | Τελλούριο | Tellurium | Tellure | Tellurio | Telūrs | 53 | I | Йод | Yodo | Jod | Jod | Jod | Jood | Ιώδιο | Iodine | Iode | Iodio | Jods | 54 | Xe | Ксенон | Xenón | Xenon | Xenon | Xenon | Ksenoon | Ξένο | Xenon | Xénon | Xenon | Ksenons | 55 | Cs | Цезий | Cesio | Cesium | Cæsium | Caesium | Tseesium | Καίσιο | Caesium | Césium | Cesio | Cēzijs | 56 | Ba | Барий | Bario | Baryum | Barium | Barium | Baarium | Βάριο | Barium | Baryum | Bario | Bārijs | 57 | La | Лантан | Lantano | Lanthan | Lanthan | Lanthan | Lantaan | Λανδάνιο | Lanthanum | Lanthane | Lantanio | Lantāns | 58 | Ce | Церий | Cerio | Cer | Cerium | Cer | Tseerium | Δημήτριο | Cerium | Cérium | Cerio | Cērijs | 59 | Pr | Празеодим | Praseodimio | Praseodym | Praseodym | Praseodym | Praseodüüm | Πρασεοδύμιο | Praseodymium | Praséodyme | Praseodimio | Prazeodīms | 60 | Nd | Неодим | Niodimio | Neodym | Neodym | Neodym | Neodüüm | Νεοδύμιο | Neodymium | Néodyme | Neodimio | Neodīms | 61 | Pm | Прометий | Prometio | Promethium | Promethium | Promethium | Promeetium | Προμήθειο | Promethium | Prométhium | Promezio | Prometijs | 62 | Sm | Самарий | Samario | Samarium | Samarium | Samarium | Samaarium | Σαμάριο | Samarium | Samarium | Samario | Samārijs | 63 | Eu | Европий | Europio | Europium | Europium | Europium | Euroopium | Ευρώπιο | Europium | Europium | Europio | Eiropijs | 64 | Gd | Гадолиний | Gadolinio | Gadolinium | Gadolinium | Gadolinium | Gadoliinium | Γαδολίνιο | Gadolinium | Gadolinium | Gadolinio | Gadolīnijs | 65 | Tb | Тербий | Terbio | Terbium | Terbium | Terbium | Terbium | Τέρβιο | Terbium | Terbium | Terbio | Terbijs | 66 | Dy | Диспросий | Disprosio | Dysprosium | Dysprosium | Dysprosium | Düsproosium | Δυσπρόσιο | Dysprosium | Dysprosium | Disprosio | Disprozijs | 67 | Ho | Холмий | Holmio | Holmium | Holmium | Holmium | Holmium | Όλμιο | Holmium | Holmium | Olmio | Holmijs | 68 | Er | Ербий | Erbio | Erbium | Erbium | Erbium | Erbium | Έρβιο | Erbium | Erbium | Erbio | Erbijs | 69 | Tm | Тулий | Tulio | Thulium | Thulium | Thulium | Tuulium | Θούλιο | Thulium | Thulium | Tulio | Tūlijs | 70 | Yb | Итербий | Iterbio | Ytterbium | Ytterbium | Ytterbium | Üterbium | Υττέρβιο | Ytterbium | Ytterbium | Itterbio | Iterbijs | 71 | Lu | Лютеций | Lutecio | Lutecium | Lutetium | Lvtécium | Luteetsium | Λουτήτιο | Lutetium | Lutécium | Lutezio | Lutēcijs | 72 | Hf | Хафний | Hafnio | Hafnium | Hafnium | Hafnium | Hafnium | Άφνιο | Hafnium | Hafnium | Afnio | Hafnijs | 73 | Ta | Тантал | Tántalo | Tantal | Tantal | Tantal | Tantaal | Ταντάλιο | Tantalum | Tantale | Tantalio | Tantāls | 74 | W | Волфрам | Volframio | Wolfram | Wolfram | Wolfram | Volfram | Βολφράμιο(Τουγκοτένιο) | Tungsten | Tungstène | Tungsteno | Volframs | 75 | Re | Рений | Renio | Rhenium | Rhenium | Rhenium | Reenium | Ρήνιο | Rhenium | Rhénium | Renio | Rēnijs | 76 | Os | Осмий | Osmio | Osmium | Osmium | Osmium | Osmium | Όσμιο | Osmium | Osmium | Osmio | Osmijs | 77 | Ir | Иридий | Iridio | Iridium | Iridium | Iridium | Iriidium | Ιρίδιο | Iridium | Iridium | Iridio | Irīdijs | 78 | Pt | Платина | Platino | Platina | Platin | Platin | Plaatina | Λευκόχρυσος | Platinum | Platine | Platino | Platīns | 79 | Au | Злато | Oro | Zlato | Guld | Gold | Kuld | Χρυσός | Gold | Or | Oro | Zelts | 80 | Hg | Живак | Mercurio | Rtuť | Kviksølv | Quecksilber | Elavhõbe | Υδράργυρος | Mercury | Mercure | Mercurio | Dzīvsudrabs | 81 | Tl | Талий | Talio | Thallium | Thalium | Thallium | Tallium | Θάλλιο | Thallium | Thallium | Tallio | Tallijs | 82 | Pb | Олово | Plomo | Olovo | Bly | Blei | Plii | Μόλυβδος | Lead | Plomb | Piombo | Svins | 83 | Bi | Бисмут | Bismuto | Bismut | Bismuth | Wismuth | Vismut | Βισμούθιο | Bismuth | Bismuth | Bismuto | Bismuts | 84 | Po | Полоний | Polonio | Polonium | Plonium | Polonium | Poloonium | Πολώνιο | Polonium | Polonium | Polonio | Polonijs | 85 | At | Астат | Astato | Astat | Astat | Astat | Astaat | Αστάτιο | Astatine | Astate | Astato | Astats | 86 | Rn | Радон | Radón | Radon | Radon | Radon | Radoon | Ραδόνιο | Radon | Radon | Radon | Radons | 87 | Fr | Франций | Francio | Francium | Francium | Francium | Frantsium | Φράγκιο | Francium | Francium | Francio | Francijs | 88 | Ra | Радий | Radio | Radium | Radium | Radium | Raadium | Ράδιο | Radium | Radium | Radio | Rādijs | 89 | Ac | Актиний | Actinio | Aktinium | Actinium | Actinium | Aktiinium | Ακτίνιο | Actinium | Actinium | Attinio | Aktīnijs | 90 | Th | Торий | Torio | Thorium | Thorium | Thorium | Toorium | Θόριο | Thorium | Thorium | Torio | Torijs | 91 | Pa | Протактиний | Protactinio | Protaktinium | Protactinium | Protactinium | Protaktiinium | Πρωτακτίνιο | Protactinium | Protactinium | Protoattinio | Protaktīnijs | 92 | U | Уран | Uranio | Uran | Uran | Uran | Uraan | Ουράνιο | Uranium | Uranium | Uranio | Urāns | 93 | Np | Нептуний | Neptunio | Neptunium | Neptunium | Neptunium | Neptuunium | Νεπτούνιο(Ποσειδώνιο) | Neptunium | Neptunium | Nettunio | Neptūnijs | 94 | Pu | Плутоний | Plutonio | Plutonium | Plutonium | Plutonium | Plutoonium | Πλουτώνιο | Plutonium | Plutonium | Plutonio | Plutonijs | 95 | Am | Америций | Americio | Americium | Americium | Americium | Ameriitsium | Αμερίκιο | Americium | Américium | Americio | Amerīcijs | 96 | Cm | Кюрий | Curio | Curium | Curium | Curium | Kuurium | Κιούριο | Curium | Curium | Curio | Kirijs | 97 | Bk | Берклий | Berkelio | Berkelium | Berkelium | Berkelium | Berkeelium | Μπερκέλιο | Berkelium | Berkélium | Berkelio | Berklijs | 98 | Cf | Калифорний | Californio | Kalifornium | Californium | Californium | Kalifornium | Καλιφόρνιο | Californium | Californium | Californio | Kalifornijs | 99 | Es | Айнщайний | Einstenio | Einsteinium | Einsteinium | Einsteinium | Einsteinium | Αϊνστάνιον | Einsteinium | Einsteinium | Einstenio | Einšteinijs | 100 | Fm | Фермий | Fermio | Fermium | Fermium | Fermium | Fermium | Φέρμιο | Fermium | Fermium | Fermio | Fermijs | 101 | Md | Менделеевий | Mendelevio | Mendelevium | Mendelevium | Mendelevium | Mendeleevium | Μεντελέβιο | Mendelevium | Mendélévium | Mendelevio | Mendeļejevijs | 102 | No | Нобелий | Nobelio | Nobelium | Nobelium | Nobelium | Nobeelium | Νομπέλιο | Nobelium | Nobélium | Nobelio | Nobēlijs | 103 | Lw | Лоуренсий | Laurencio | Lawrencium | Lawrentium | Lawrentium | Lavrentsium | Λαυρένσιο | Lawrencium | Lawrencium | Lawrencio | Lourensijs | Z | Symbol | LT | HU | MT | NL | PL | PT | RO | SK | SL | FI | SV | 1 | H | Vandenilis | Hidrogén | Idroġenu | Waterstof | Wodór | Hidrogénio | Hidrogen | Vodík | Vodik | Vety | Väte | 2 | He | Helis | Hélium | Elju | Helium | Hel | Hélio | Heliu | Hélium | Helij | Helium | Helium | 3 | Li | Litis | Lítium | Litju | Lithium | Lit | Lítio | Litiu | Lítium | Litij | Litium | Litium | 4 | Be | Berilis | Berillium | Berillju | Beryllium | Beryl | Berílio | Beriliu | Berýlium | Berilij | Beryllium | Beryllium | 5 | B | Boras | Bór | Boron | Boor | Bor | Boro | Bor | Bór | Bor | Boori | Bor | 6 | C | Anglis | Szén | Karbonju | Koolstof | Węgiel | Carbono | Carbon | Uhlík | Ogljik | Hiili | Kol | 7 | N | Azotas | Nitrogén | Azotu | Stikstof | Azot | Azoto | Azot | Dusík | Dušik | Typpi | Kväve | 8 | O | Deguonis | Oxigén | Ossiġenu | Zuurstof | Tlen | Oxigénio | Oxigen | Kyslík | Kisik | Happi | Syre | 9 | F | Fluoras | Fluor | Fluworin | Fluor | Fluor | Flúor | Fluor | Fluór | Fluor | Fluori | Fluor | 10 | Ne | Neonas | Neon | Neon | Neon | Neon | Néon | Neon | Neón | Neon | Neon | Neon | 11 | Na | Natris | Nátrium | Sodju | Natrium | Sód | Sódio | Sodiu | Sodík | Natrij | Natrium | Natrium | 12 | Mg | Magnis | Magnézium | Manjesju | Magnesium | Magnez | Magnésio | Magneziu | Horčík | Magnezij | Magnesium | Magnesium | 13 | Al | Aliuminis | Alumínium | Aluminju | Aluminium | Glin | Alumínio | Aluminiu | Hliník | Aluminij | Alumiini | Aluminium | 14 | Si | Silicis | Szilicium | Silikon | Silicium | Krzem | Silício | Siliciu | Kremík | Silicij | Pii | Kisel | 15 | P | Fosforas | Foszfor | Fosfru | Fosfor | Fosfor | Fósforo | Fosfor | Fosfor | Fosfor | Fosfori | Fosfor | 16 | S | Siera | Kén | Kubrit | Zwavel | Siarka | Enxofre | Sulf | Síra | Žveplo | Rikki | Svavel | 17 | Cl | Chloras | Klór | Kloru | Chloor | Chlor | Cloro | Clor | Chlór | Klor | Kloori | Klor | 18 | Ar | Argonas | Argon | Argon | Argon | Argon | Árgon | Argon | Argón | Argon | Argon | Argon | 19 | K | Kalis | Kálium | Potassju | Kalium | Potas | Potássio | Potasiu | Draslík | Kalij | Kalium | Kalium | 20 | Ca | Kalcis | Kalcium | Kalċju | Calcium | Wapń | Cálcio | Calciu | Vápnik | Kalcij | Kalsium | Kalcium | 21 | Sc | Skandis | Szkandium | Skandju | Scandium | Skand | Escândio | Scandiu | Skandium | Skandij | Skandium | Skandium | 22 | Ti | Titanas | Titán | Titanju | Titaan | Tytan | Titânio | Titan | Titán | Titan | Titaani | Titan | 23 | V | Vanadis | Vanádium | Vanadju | Vanadium | Wanad | Vanádio | Vanadiu | Vanád | Vanadij | Vanadiini | Vanadin | 24 | Cr | Chromas | Króm | Kromju | Chroom | Chrom | Crómio | Crom | Chróm | Krom | Kromi | Krom | 25 | Mn | Manganas | Mangán | Manganiż | Mangaan | Mangan | Manganês | Mangan | Mangán | Mangan | Mangaani | Mangan | 26 | Fe | Geležis | Vas | Ħadid | Ijzer | Żelazo | Ferro | Fier | Železo | Železo | Rauta | Järn | 27 | Co | Kobaltas | Kobalt | Kobalt | Kobalt | Kobalt | Cobalto | Cobalt | Kobalt | Kobalt | Koboltti | Kobolt | 28 | Ni | Nikelis | Nikkel | Nikil | Nikkel | Nikiel | Níquel | Nichel | Nikel | Nikelj | Nikkeli | Nickel | 29 | Cu | Varis | Réz | Ram | Koper | Miedź | Cobre | Cupru | Meď | Baker | Kupari | Koppar | 30 | Zn | Cinkas | Cink | Żingu | Zìnk | Cynk | Zinco | Zinc | Zinok | Cink | Sinkki | Zink | 31 | Ga | Galis | Gallium | Gallju | Gallium | Gal | Gálio | Galiu | Gálium | Galij | Gallium | Gallium | 32 | Ge | Germanis | Germánium | Ġermanju | Germanium | German | Germânio | Germaniu | Germánium | Germanij | Germanium | Germanium | 33 | As | Arsenas | Arzén | Arseniku | Arseen | Arsen | Arsénio | Arsen | Arzén | Arzen | Arseeni | Arsenik | 34 | Se | Selenas | Szelén | Selenju | Selenium | Selen | Selénio | Seleniu | Selén | Selen | Seleeni | Selen | 35 | Br | Bromas | Bróm | Bromu | Broom | Brom | Bromo | Brom | Bróm | Brom | Bromi | Brom | 36 | Kr | Kriptonas | Kripton | Kripton | Krypton | Krypton | Krípton | Kripton | Kryptón | Kripton | Krypton | Krypton | 37 | Rb | Rubidis | Rubídium | Rubidju | Rubidium | Rubid | Rubídio | Rubidiu | Rubídium | Rubidij | Rubidium | Rubidium | 38 | Sr | Stroncis | Stroncium | Stronzju | Strontium | Stront | Estrôncio | Stronţiu | Stroncium | Stroncij | Strontium | Strontium | 39 | Y | Itris | Ittrium | Ittriju | Yttrium | Itr | Ítrio | Ytriu | Ytrium | Itrij | Yttrium | Yttrium | 40 | Zr | Cirkonis | Cirkónium | Żirkonju | Zirkonium | Cyrkon | Zircónio | Zirconiu | Zirkónium | Cirkonij | Zirkonium | Zirkonium | 41 | Nb | Niobis | Nióbium | Nijobju | Niobium | Niob | Nióbio | Niobiu | Niób | Niobij | Niobium | Niob | 42 | Mo | Molibdenas | Molibdén | Molibdenu | Molybdeen | Molibden | Molibdénio | Molibden | Molybdén | Molibden | Molybdeeni | Molybden | 43 | Tc | Technecis | Technécium | Teknezju | Technetium | Technet | Tecnécio | Tehneţiu | Technécium | Tehnecij | Teknetium | Teknetium | 44 | Ru | Rutenis | Ruténium | Rutenju | Ruthernium | Ruten | Ruténio | Ruteniu | Ruténium | Rutenij | Rutenium | Rutenium | 45 | Rh | Rodis | Ródium | Rodju | Rodium | Rod | Ródio | Rodiu | Ródium | Rodij | Rodium | Rodium | 46 | Pd | Paladis | Palládium | Palladju | Palladium | Pallad | Paládio | Paladiu | Paládium | Paladij | Palladium | Palladium | 47 | Ag | Sidabras | Ezüst | Fidda | Zilver | Srebro | Prata | Argint | Striebro | Srebro | Hopea | Silver | 48 | Cd | Kadmis | Kadmium | Kadmju | Cadmium | Kadm | Cádmio | Cadmiu | Kadmium | Kadmij | Kadmium | Kadmium | 49 | In | Indis | Indium | Indju | Indium | Ind | Índio | Indiu | Indium | Indij | Indium | Indium | 50 | Sn | Alavas | Ón | Landa | Tin | Cyna | Estanho | Staniu | Cín | Kositer | Tina | Tenn | 51 | Sb | Stibis | Antimon | Antimonju | Antimoon | Antymon | Antimónio | Stibiu | Antimón | Antimon | Antimoni | Antimon | 52 | Te | Telūras | Tellúr | Tellurju | Telluur | Tellur | Telúrio | Telur | Telúr | Telur | Telluuri | Tellur | 53 | I | Jodas | Jód | Jodju | Jood | Jod | Iodo | Iod | Jód | Jod | Jodi | Jod | 54 | Xe | Ksenonas | Xenon | Kseno | Xenon | Ksenon | Xénon | Xenon | Xenón | Ksenon | Ksenon | Xenon | 55 | Cs | Cezis | Cézium | Ċesju | Cesium | Cez | Césio | Cesiu | Césium | Cezij | Cesium | Cesium | 56 | Ba | Baris | Bárium | Barju | Barium | Bar | Bário | Bariu | Bárium | Barij | Barium | Barium | 57 | La | Lantanas | Lantán | Lantanu | Lanthaan | Lantan | Lantânio | Lantan | Lantán | Lantan | Lantaani | Lantan | 58 | Ce | Ceris | Cérium | Ċerju | Cerium | Cer | Cério | Ceriu | Cér | Cerij | Cerium | Cerium | 59 | Pr | Prazeodimis | Prazeodímium | Prasedimju | Praseodymium | Prazeodym | Praseodímio | Praseodim | Prazeodým | Prazeodim | Praseodyymi | Praseodym | 60 | Nd | Neodimis | Neodímium | Neodimju | Neodymium | Neodym | Neodímio | Neodim | Neodým | Neodim | Neodyymi | Neodym | 61 | Pm | Prometis | Prométium | Prometju | Promethium | Promet | Promécio | Promeţiu | Prométium | Prometij | Prometium | Prometium | 62 | Sm | Samaris | Szamárium | Samarju | Samarium | Samar | Samário | Samariu | Samárium | Samarij | Samarium | Samarium | 63 | Eu | Europis | Európium | Ewropju | Europium | Europ | Európio | Europiu | Európium | Evropij | Europium | Europium | 64 | Gd | Gadolinis | Gadolínium | Gadolinju | Gadolinium | Gadolin | Gadolínio | Gadoliniu | Gadolínium | Gadolinij | Gadolinium | Gadolinium | 65 | Tb | Terbis | Terbium | Terbju | Terbium | Terb | Térbio | Terbiu | Terbium | Terbij | Terbium | Terbium | 66 | Dy | Disprozis | Diszprózium | Disprosju | Dysprosium | Dysproz | Disprósio | Dysprosiu | Dysprózium | Disprozij | Dysprosium | Dysprosium | 67 | Ho | Holmis | Holmium | Olmju | Holmium | Holm | Hólmio | Holmiu | Holmium | Holmij | Holmium | Holmium | 68 | Er | Erbis | Erbium | Erbju | Erbium | Erb | Érbio | Erbiu | Erbium | Erbij | Erbium | Erbium | 69 | Tm | Tulis | Túlium | Tulju | Thulium | Tul | Túlio | Tuliu | Túlium | Tulij | Tulium | Tulium | 70 | Yb | Iterbis | Itterbium | Itterbju | Ytterbium | Iterb | Itérbio | Yterbiu | Yterbium | Iterbij | Ytterbium | Ytterbium | 71 | Lu | Liutecis | Lutécium | Lutezju | Lutetium | Lutet | Lutécio | Luteţiu | Lutécium | Lutecij | Lutetium | Lutetium | 72 | Hf | Hafnis | Hafnium | Ħafnju | Hafnium | Hafn | Háfnio | Hafniu | Hafnium | Hafnij | Hafnium | Hafnium | 73 | Ta | Tantalas | Tantál | Tantalu | Tantaal | Tantal | Tântalo | Tantal | Tantal | Tantal | Tantaali | Tantal | 74 | W | Volframas | Volfrám | Tungstenu | Wolfram | Wolfram | Tungsténio | Wolfram | Volfrám | Volfram | Volframi | Wolfram | 75 | Re | Renis | Rénium | Rênju | Renium | Ren | Rénio | Reniu | Rénium | Renij | Renium | Rhenium | 76 | Os | Osmis | Ozmium | Osmju | Osmium | Osm | Ósmio | Osmiu | Osmium | Osmij | Osmium | Osmium | 77 | Ir | Iridis | Irídium | Iridju | Iridium | Iryd | Irídio | Iridiu | Irídium | Iridij | Iridium | Iridium | 78 | Pt | Platina | Platina | Platinu | Platinum | Platyna | Platina | Platina | Platina | Platina | Platina | Platina | 79 | Au | Auksas | Arany | Deheb | Goud | Złoto | Ouro | Aur | Zlato | Zlato | Kulta | Guld | 80 | Hg | Gyvsidabris | Higany | Merkurju | Kwik | Rtęć | Mercúrio | Mercur | Ortuť | Živo srebro | Elohopea | Kvicksilver | 81 | Tl | Talis | Tallium | Tallju | Thallium | Tal | Tálio | Taliu | Tálium | Talij | Tallium | Tallium | 82 | Pb | Švinas | Ólom | Ċomb | Lood | Ołów | Chumbo | Plumb | Olovo | Svinec | Lyijy | Bly | 83 | Bi | Bismutas | Bizmut | Bismùt | Bismuth | Bizmut | Bismuto | Bismut | Bizmut | Bizmut | Vismutti | Vismut | 84 | Po | Polonis | Polónium | Polonju | Polonium | Polon | Polónio | Poloniu | Polónium | Polonij | Polonium | Polonium | 85 | At | Astatinas | Asztácium | Astatina | Astaat | Astat | Astato | Astatiniu | Astát | Astat | Astatiini | Astat | 86 | Rn | Radonas | Radon | Radon | Radon | Radon | Rádon | Radon | Radón | Radon | Radon | Radon | 87 | Fr | Francis | Francium | Franċju | Francium | Frans | Frâncio | Franciu | Francium | Francij | Frankium | Francium | 88 | Ra | Radis | Rádium | Radju | Radium | Rad | Rádio | Radiu | Rádium | Radij | Radium | Radium | 89 | Ac | Aktinis | Aktínium | Aktinju | Actinium | Aktyn | Actínio | Actiniu | Aktínium | Aktinij | Aktinium | Aktinium | 90 | Th | Toris | Tórium | Torju | Thorium | Tor | Tório | Toriu | Tórium | Torij | Torium | Torium | 91 | Pa | Protaktinis | Protaktínium | Protaktinju | Protactinium | Protaktyn | Protactínio | Proactiniu | Protaktínium | Protaktinij | Protaktinium | Protaktinium | 92 | U | Uranas | Urán | Uranju | Uranium | Uran | Urânio | Uraniu | Urán | Uran | Uraani | Uran | 93 | Np | Neptūnis | Neptúnium | Nettunju | Neptunium | Neptun | Neptúnio | Neptuniu | Neptúnium | Neptunij | Neptunium | Neptunium | 94 | Pu | Plutonis | Plutónium | Plutonju | Plutonium | Pluton | Plutónio | Plutoniu | Plutónium | Plutonij | Plutonium | Plutonium | 95 | Am | Americis | Amerícium | Ameriċju | Americium | Ameryk | Amerício | Americiu | Amerícium | Americij | Amerikium | Americium | 96 | Cm | Kiuris | Kűrium | Kurju | Curium | Kiur | Cúrio | Curiu | Curium | Kirij | Curium | Curium | 97 | Bk | Berklis | Berkélium | Berkelju | Berkelium | Berkel | Berquélio | Berkeliu | Berkelium | Berkelij | Berkelium | Berkelium | 98 | Cf | Kalifornis | Kalifornium | Kalifornju | Californium | Kaliforn | Califórnio | Californiu | Kalifornium | Kalifornij | Kalifornium | Californium | 99 | Es | Einšteinis | Einsteinium | Enstejnju | Einsteinium | Einstein | Einsteinio | Einsteiniu | Einsteinium | Ajnštajnij | Einsteinium | Einsteinium | 100 | Fm | Fermis | Fermium | Fermju | Fermium | Ferm | Férmio | Fermiu | Fermium | Fermij | Fermium | Fermium | 101 | Md | Mendelevis | Mendelévium | Mendelevju | Mendelevium | Mendelew | Mendelévio | Mendeleeviu | Mendelevium | Mendelevij | Mendelevium | Mendelevium | 102 | No | Nobelis | Nobélium | Nobelju | Nobelium | Nobel | Nobélio | Nobeliu | Nobelium | Nobelij | Nobelium | Nobelium | 103 | Lw | Lorensis | Laurencium | Lawrenċju | Laurentium | Lorens | Laurêncio | Laurenţiu | Laurencium | Lavrencij | Lawrensium | Lawrentium’

Z | Symbol | BG | ES | CS | DA | DE | ET | EL | EN | FR | IT | LV

1 | H | Водород | Hidrógeno | Vodík | Hydrogen | Wasserstoff | Vesinik | Υδρογόνο | Hydrogen | Hydrogène | Idrogeno | Ūdeņradis

2 | He | Хелий | Helio | Helium | Helium | Helium | Heelium | Ήλιο | Helium | Hélium | Elio | Hēlijs

3 | Li | Литий | Litio | Lithium | Lithium | Lithium | Liitium | Λίθιο | Lithium | Lithium | Litio | Litijs

4 | Be | Берилий | Berilio | Beryllium | Beryllium | Beryllium | Berüllium | Βηρύλλιο | Beryllium | Béryllium(Glucinium) | Berillio | Berilijs

5 | B | Бор | Boro | Bor | Bor | Bor | Boor | Βόριο | Boron | Bore | Boro | Bors

6 | C | Въглерод | Carbono | Uhlík | Carbon (kulstof) | Kohlenstoff | Süsinik | Άνθρακας | Carbon | Carbone | Carbonio | Ogleklis

7 | N | Азот | Nitrógeno | Dusík | Nitrogen | Stickstoff | Lämmastik | Άζωτο | Nitrogen | Azote | Azoto | Slāpeklis

8 | O | Кислород | Oxígeno | Kyslík | Oxygen (ilt) | Sauerstoff | Hapnik | Οξυγόνο | Oxygen | Oxygène | Ossigeno | Skābeklis

9 | F | Флуор | Flúor | Fluor | Fluor | Fluor | Fluor | Φθόριο | Fluorine | Fluor | Fluoro | Fluors

10 | Ne | Неон | Neón | Neon | Neon | Neon | Neoon | Νέον | Neon | Néon | Neon | Neons

11 | Na | Натрий | Sodio | Sodík | Natrium | Natrium | Naatrium | Νάτριο | Sodium | Sodium | Sodio | Nātrijs

12 | Mg | Магнезий | Magnesio | Hořčík | Magnesium | Magnesium | Magneesium | Μαγνήσιο | Magnesium | Magnésium | Magnesio | Magnijs

13 | Al | Алуминий | Aluminio | Hliník | Aluminium | Aluminium | Alumiinium | Αργίλλιο | Aluminium | Aluminium | Alluminio | Alumīnijs

14 | Si | Силиций | Silicio | Křemík | Silicium | Silicium | Räni | Πυρίτιο | Silicon | Silicium | Silicio | Silīcijs

15 | P | Фосфор | Fósforo | Fosfor | Phosphor | Phosphor | Fosfor | Φωσφόρος | Phosphorus | Phosphore | Fosforo | Fosfors

16 | S | Сяра | Azufre | Síra | Svovl | Schwefel | Väävel | Θείον | Sulphur | Soufre | Zolfo | Sērs

17 | Cl | Хлор | Cloro | Chlor | Chlor | Chlor | Kloor | Χλώριο | Chlorine | Chlore | Cloro | Hlors

18 | Ar | Аргон | Argón | Argon | Argon | Argon | Argoon | Argό | Argon | Argon | Argon | Argons

19 | K | Калий | Potasio | Draslík | Kalium | Kalium | Kaalium | Κάλιο | Potassium | Potassium | Potassio | Kālijs

20 | Ca | Калций | Calcio | Vápník | Calcium | Calcium | Kaltsium | Ασβέστιο | Calcium | Calcium | Calcio | Kalcijs

21 | Sc | Скандий | Escandio | Skandium | Scandium | Scandium | Skandium | Σκάνδιο | Scandium | Scandium | Scandio | Skandijs

22 | Ti | Титан | Titanio | Titan | Titan | Titan | Titaan | Τιτάνιο | Titanium | Titane | Titanio | Titāns

23 | V | Ванадий | Vanadio | Vanad | Vanadium | Vanadium | Vanaadium | Βανάδιο | Vanadium | Vanadium | Vanadio | Vanādijs

24 | Cr | Хром | Cromo | Chrom | Chrom | Chrom | Kroom | Χρώμιο | Chromium | Chrome | Cromo | Hroms

25 | Mn | Манган | Manganeso | Mangan | Mangan | Mangan | Mangaan | Μαγγάνιο | Manganese | Manganèse | Manganese | Mangāns

26 | Fe | Желязо | Hierro | Železo | Jern | Eisen | Raud | Σίδηρος | Iron | Fer | Ferro | Dzelzs

27 | Co | Кобалт | Cobalto | Kobalt | Cobalt | Kobalt | Koobalt | Κοβάλτιο | Cobalt | Cobalt | Cobalto | Kobalts

28 | Ni | Никел | Níquel | Nikl | Nikkel | Nickel | Nikkel | Νικέλιο | Nickel | Nickel | Nichel | Niķelis

29 | Cu | Мед | Cobre | Měď | Kobber | Kupfer | Vask | Χαλκός | Copper | Cuivre | Rame | Varš

30 | Zn | Цинк | Zinc | Zinek | Zink | Zink | Tsink | Ψευδάργυρος | Zinc | Zinc | Zinco | Cinks

31 | Ga | Галий | Galio | Gallium | Gallium | Gallium | Gallium | Γάλλιο | Gallium | Gallium | Gallio | Gallijs

32 | Ge | Германий | Germanio | Germanium | Germanium | Germanium | Germaanium | Γερμάνιο | Germanium | Germanium | Germanio | Germānijs

33 | As | Арсен | Arsénico | Arsen | Arsen | Arsen | Arseen | Αρσενικό | Arsenic | Arsenic | Arsenico | Arsēns

34 | Se | Селен | Selenio | Selen | Selen | Selen | Seleen | Σελήνιο | Selenium | Sélénium | Selenio | Selēns

35 | Br | Бром | Bromo | Brom | Brom | Brom | Broom | Βρώμιο | Bromine | Brome | Bromo | Broms

36 | Kr | Криптон | Criptón | Krypton | Krypton | Krypton | Krüptoon | Κρυπτό | Krypton | Krypton | Krypton | Kriptons

37 | Rb | Рубидий | Rubidio | Rubidium | Rubidium | Rubidium | Rubiidium | Ρουβήδιο | Rubidium | Rubidium | Rubidio | Rubīdijs

38 | Sr | Стронций | Estroncio | Stroncium | Strontium | Strontium | Strontsium | Στρόντιο | Strontium | Strontium | Stronzio | Stroncijs

39 | Y | Итрий | Itrio | Yttrium | Yttrium | Yttrium | Ütrium | Ύττριο | Yttrium | Yttrium | Ittrio | Itrijs

40 | Zr | Цирконий | Circonio | Zirkonium | Zirconium | Zirkon | Tsirkoonium | Ζιρκόνιο | Zirconium | Zirconium | Zirconio | Cirkonijs

41 | Nb | Ниобий | Niobio | Niob | Niobium | Niob | Nioobium | Νιόβιο | Niobium | Niobium | Niobio | Niobijs

42 | Mo | Молибден | Molibdeno | Molybden | Molybden | Molybdän | Molübdeen | Μολυβδένιο | Molybdenum | Molybdène | Molibdeno | Molibdēns

43 | Tc | Технеций | Tecnecio | Technecium | Technetium | Technetium | Tehneetsium | Τεχνήτιο | Technetium | Technetium | Tecnezio | Tehnēcijs

44 | Ru | Рутений | Rutenio | Ruthenium | Ruthenium | Ruthenium | Ruteenium | Ρουθήνιο | Ruthenium | Ruthénium | Rutenio | Rutēnijs

45 | Rh | Родий | Rodio | Rhodium | Rhodium | Rhodium | Roodium | Ρόδιο | Rhodium | Rhodium | Rodio | Rodijs

46 | Pd | Паладий | Paladio | Palladium | Palladium | Palladium | Pallaadium | Παλλάδιο | Palladium | Palladium | Palladio | Pallādijs

47 | Ag | Сребро | Plata | Stříbro | Sølv | Silber | Hõbe | Άργυρος | Silver | Argent | Argento | Sudrabs

48 | Cd | Кадмий | Cadmio | Kadmium | Cadmium | Cadmium | Kaadium | Κάδμιο | Cadmium | Cadmium | Cadmio | Kadmijs

49 | In | Индий | Indio | Indium | Indium | Indium | Indium | Ίνδιο | Indium | Indium | Indio | Indijs

50 | Sn | Калай | Estaño | Cín | Tin | Zinn | Tina | Κασσίτερος | Tin | Étain | Stagno | Alva

51 | Sb | Антимон | Antimonio | Antimon | Antimon | Antimon | Antimon | Αντιμόνιο | Antimony | Antimoine | Antimonio | Antimons

52 | Te | Телур | Telurio | Tellur | Telur | Tellur | Telluur | Τελλούριο | Tellurium | Tellure | Tellurio | Telūrs

53 | I | Йод | Yodo | Jod | Jod | Jod | Jood | Ιώδιο | Iodine | Iode | Iodio | Jods

54 | Xe | Ксенон | Xenón | Xenon | Xenon | Xenon | Ksenoon | Ξένο | Xenon | Xénon | Xenon | Ksenons

55 | Cs | Цезий | Cesio | Cesium | Cæsium | Caesium | Tseesium | Καίσιο | Caesium | Césium | Cesio | Cēzijs

56 | Ba | Барий | Bario | Baryum | Barium | Barium | Baarium | Βάριο | Barium | Baryum | Bario | Bārijs

57 | La | Лантан | Lantano | Lanthan | Lanthan | Lanthan | Lantaan | Λανδάνιο | Lanthanum | Lanthane | Lantanio | Lantāns

58 | Ce | Церий | Cerio | Cer | Cerium | Cer | Tseerium | Δημήτριο | Cerium | Cérium | Cerio | Cērijs

59 | Pr | Празеодим | Praseodimio | Praseodym | Praseodym | Praseodym | Praseodüüm | Πρασεοδύμιο | Praseodymium | Praséodyme | Praseodimio | Prazeodīms

60 | Nd | Неодим | Niodimio | Neodym | Neodym | Neodym | Neodüüm | Νεοδύμιο | Neodymium | Néodyme | Neodimio | Neodīms

61 | Pm | Прометий | Prometio | Promethium | Promethium | Promethium | Promeetium | Προμήθειο | Promethium | Prométhium | Promezio | Prometijs

62 | Sm | Самарий | Samario | Samarium | Samarium | Samarium | Samaarium | Σαμάριο | Samarium | Samarium | Samario | Samārijs

63 | Eu | Европий | Europio | Europium | Europium | Europium | Euroopium | Ευρώπιο | Europium | Europium | Europio | Eiropijs

64 | Gd | Гадолиний | Gadolinio | Gadolinium | Gadolinium | Gadolinium | Gadoliinium | Γαδολίνιο | Gadolinium | Gadolinium | Gadolinio | Gadolīnijs

65 | Tb | Тербий | Terbio | Terbium | Terbium | Terbium | Terbium | Τέρβιο | Terbium | Terbium | Terbio | Terbijs

66 | Dy | Диспросий | Disprosio | Dysprosium | Dysprosium | Dysprosium | Düsproosium | Δυσπρόσιο | Dysprosium | Dysprosium | Disprosio | Disprozijs

67 | Ho | Холмий | Holmio | Holmium | Holmium | Holmium | Holmium | Όλμιο | Holmium | Holmium | Olmio | Holmijs

68 | Er | Ербий | Erbio | Erbium | Erbium | Erbium | Erbium | Έρβιο | Erbium | Erbium | Erbio | Erbijs

69 | Tm | Тулий | Tulio | Thulium | Thulium | Thulium | Tuulium | Θούλιο | Thulium | Thulium | Tulio | Tūlijs

70 | Yb | Итербий | Iterbio | Ytterbium | Ytterbium | Ytterbium | Üterbium | Υττέρβιο | Ytterbium | Ytterbium | Itterbio | Iterbijs

71 | Lu | Лютеций | Lutecio | Lutecium | Lutetium | Lvtécium | Luteetsium | Λουτήτιο | Lutetium | Lutécium | Lutezio | Lutēcijs

72 | Hf | Хафний | Hafnio | Hafnium | Hafnium | Hafnium | Hafnium | Άφνιο | Hafnium | Hafnium | Afnio | Hafnijs

73 | Ta | Тантал | Tántalo | Tantal | Tantal | Tantal | Tantaal | Ταντάλιο | Tantalum | Tantale | Tantalio | Tantāls

74 | W | Волфрам | Volframio | Wolfram | Wolfram | Wolfram | Volfram | Βολφράμιο(Τουγκοτένιο) | Tungsten | Tungstène | Tungsteno | Volframs

75 | Re | Рений | Renio | Rhenium | Rhenium | Rhenium | Reenium | Ρήνιο | Rhenium | Rhénium | Renio | Rēnijs

76 | Os | Осмий | Osmio | Osmium | Osmium | Osmium | Osmium | Όσμιο | Osmium | Osmium | Osmio | Osmijs

77 | Ir | Иридий | Iridio | Iridium | Iridium | Iridium | Iriidium | Ιρίδιο | Iridium | Iridium | Iridio | Irīdijs

78 | Pt | Платина | Platino | Platina | Platin | Platin | Plaatina | Λευκόχρυσος | Platinum | Platine | Platino | Platīns

79 | Au | Злато | Oro | Zlato | Guld | Gold | Kuld | Χρυσός | Gold | Or | Oro | Zelts

80 | Hg | Живак | Mercurio | Rtuť | Kviksølv | Quecksilber | Elavhõbe | Υδράργυρος | Mercury | Mercure | Mercurio | Dzīvsudrabs

81 | Tl | Талий | Talio | Thallium | Thalium | Thallium | Tallium | Θάλλιο | Thallium | Thallium | Tallio | Tallijs

82 | Pb | Олово | Plomo | Olovo | Bly | Blei | Plii | Μόλυβδος | Lead | Plomb | Piombo | Svins

83 | Bi | Бисмут | Bismuto | Bismut | Bismuth | Wismuth | Vismut | Βισμούθιο | Bismuth | Bismuth | Bismuto | Bismuts

84 | Po | Полоний | Polonio | Polonium | Plonium | Polonium | Poloonium | Πολώνιο | Polonium | Polonium | Polonio | Polonijs

85 | At | Астат | Astato | Astat | Astat | Astat | Astaat | Αστάτιο | Astatine | Astate | Astato | Astats

86 | Rn | Радон | Radón | Radon | Radon | Radon | Radoon | Ραδόνιο | Radon | Radon | Radon | Radons

87 | Fr | Франций | Francio | Francium | Francium | Francium | Frantsium | Φράγκιο | Francium | Francium | Francio | Francijs

88 | Ra | Радий | Radio | Radium | Radium | Radium | Raadium | Ράδιο | Radium | Radium | Radio | Rādijs

89 | Ac | Актиний | Actinio | Aktinium | Actinium | Actinium | Aktiinium | Ακτίνιο | Actinium | Actinium | Attinio | Aktīnijs

90 | Th | Торий | Torio | Thorium | Thorium | Thorium | Toorium | Θόριο | Thorium | Thorium | Torio | Torijs

91 | Pa | Протактиний | Protactinio | Protaktinium | Protactinium | Protactinium | Protaktiinium | Πρωτακτίνιο | Protactinium | Protactinium | Protoattinio | Protaktīnijs

92 | U | Уран | Uranio | Uran | Uran | Uran | Uraan | Ουράνιο | Uranium | Uranium | Uranio | Urāns

93 | Np | Нептуний | Neptunio | Neptunium | Neptunium | Neptunium | Neptuunium | Νεπτούνιο(Ποσειδώνιο) | Neptunium | Neptunium | Nettunio | Neptūnijs

94 | Pu | Плутоний | Plutonio | Plutonium | Plutonium | Plutonium | Plutoonium | Πλουτώνιο | Plutonium | Plutonium | Plutonio | Plutonijs

95 | Am | Америций | Americio | Americium | Americium | Americium | Ameriitsium | Αμερίκιο | Americium | Américium | Americio | Amerīcijs

96 | Cm | Кюрий | Curio | Curium | Curium | Curium | Kuurium | Κιούριο | Curium | Curium | Curio | Kirijs

97 | Bk | Берклий | Berkelio | Berkelium | Berkelium | Berkelium | Berkeelium | Μπερκέλιο | Berkelium | Berkélium | Berkelio | Berklijs

98 | Cf | Калифорний | Californio | Kalifornium | Californium | Californium | Kalifornium | Καλιφόρνιο | Californium | Californium | Californio | Kalifornijs

99 | Es | Айнщайний | Einstenio | Einsteinium | Einsteinium | Einsteinium | Einsteinium | Αϊνστάνιον | Einsteinium | Einsteinium | Einstenio | Einšteinijs

100 | Fm | Фермий | Fermio | Fermium | Fermium | Fermium | Fermium | Φέρμιο | Fermium | Fermium | Fermio | Fermijs

101 | Md | Менделеевий | Mendelevio | Mendelevium | Mendelevium | Mendelevium | Mendeleevium | Μεντελέβιο | Mendelevium | Mendélévium | Mendelevio | Mendeļejevijs

102 | No | Нобелий | Nobelio | Nobelium | Nobelium | Nobelium | Nobeelium | Νομπέλιο | Nobelium | Nobélium | Nobelio | Nobēlijs

103 | Lw | Лоуренсий | Laurencio | Lawrencium | Lawrentium | Lawrentium | Lavrentsium | Λαυρένσιο | Lawrencium | Lawrencium | Lawrencio | Lourensijs

Z | Symbol | LT | HU | MT | NL | PL | PT | RO | SK | SL | FI | SV

1 | H | Vandenilis | Hidrogén | Idroġenu | Waterstof | Wodór | Hidrogénio | Hidrogen | Vodík | Vodik | Vety | Väte

2 | He | Helis | Hélium | Elju | Helium | Hel | Hélio | Heliu | Hélium | Helij | Helium | Helium

3 | Li | Litis | Lítium | Litju | Lithium | Lit | Lítio | Litiu | Lítium | Litij | Litium | Litium

4 | Be | Berilis | Berillium | Berillju | Beryllium | Beryl | Berílio | Beriliu | Berýlium | Berilij | Beryllium | Beryllium

5 | B | Boras | Bór | Boron | Boor | Bor | Boro | Bor | Bór | Bor | Boori | Bor

6 | C | Anglis | Szén | Karbonju | Koolstof | Węgiel | Carbono | Carbon | Uhlík | Ogljik | Hiili | Kol

7 | N | Azotas | Nitrogén | Azotu | Stikstof | Azot | Azoto | Azot | Dusík | Dušik | Typpi | Kväve

8 | O | Deguonis | Oxigén | Ossiġenu | Zuurstof | Tlen | Oxigénio | Oxigen | Kyslík | Kisik | Happi | Syre

9 | F | Fluoras | Fluor | Fluworin | Fluor | Fluor | Flúor | Fluor | Fluór | Fluor | Fluori | Fluor

10 | Ne | Neonas | Neon | Neon | Neon | Neon | Néon | Neon | Neón | Neon | Neon | Neon

11 | Na | Natris | Nátrium | Sodju | Natrium | Sód | Sódio | Sodiu | Sodík | Natrij | Natrium | Natrium

12 | Mg | Magnis | Magnézium | Manjesju | Magnesium | Magnez | Magnésio | Magneziu | Horčík | Magnezij | Magnesium | Magnesium

13 | Al | Aliuminis | Alumínium | Aluminju | Aluminium | Glin | Alumínio | Aluminiu | Hliník | Aluminij | Alumiini | Aluminium

14 | Si | Silicis | Szilicium | Silikon | Silicium | Krzem | Silício | Siliciu | Kremík | Silicij | Pii | Kisel

15 | P | Fosforas | Foszfor | Fosfru | Fosfor | Fosfor | Fósforo | Fosfor | Fosfor | Fosfor | Fosfori | Fosfor

16 | S | Siera | Kén | Kubrit | Zwavel | Siarka | Enxofre | Sulf | Síra | Žveplo | Rikki | Svavel

17 | Cl | Chloras | Klór | Kloru | Chloor | Chlor | Cloro | Clor | Chlór | Klor | Kloori | Klor

18 | Ar | Argonas | Argon | Argon | Argon | Argon | Árgon | Argon | Argón | Argon | Argon | Argon

19 | K | Kalis | Kálium | Potassju | Kalium | Potas | Potássio | Potasiu | Draslík | Kalij | Kalium | Kalium

20 | Ca | Kalcis | Kalcium | Kalċju | Calcium | Wapń | Cálcio | Calciu | Vápnik | Kalcij | Kalsium | Kalcium

21 | Sc | Skandis | Szkandium | Skandju | Scandium | Skand | Escândio | Scandiu | Skandium | Skandij | Skandium | Skandium

22 | Ti | Titanas | Titán | Titanju | Titaan | Tytan | Titânio | Titan | Titán | Titan | Titaani | Titan

23 | V | Vanadis | Vanádium | Vanadju | Vanadium | Wanad | Vanádio | Vanadiu | Vanád | Vanadij | Vanadiini | Vanadin

24 | Cr | Chromas | Króm | Kromju | Chroom | Chrom | Crómio | Crom | Chróm | Krom | Kromi | Krom

25 | Mn | Manganas | Mangán | Manganiż | Mangaan | Mangan | Manganês | Mangan | Mangán | Mangan | Mangaani | Mangan

26 | Fe | Geležis | Vas | Ħadid | Ijzer | Żelazo | Ferro | Fier | Železo | Železo | Rauta | Järn

27 | Co | Kobaltas | Kobalt | Kobalt | Kobalt | Kobalt | Cobalto | Cobalt | Kobalt | Kobalt | Koboltti | Kobolt

28 | Ni | Nikelis | Nikkel | Nikil | Nikkel | Nikiel | Níquel | Nichel | Nikel | Nikelj | Nikkeli | Nickel

29 | Cu | Varis | Réz | Ram | Koper | Miedź | Cobre | Cupru | Meď | Baker | Kupari | Koppar

30 | Zn | Cinkas | Cink | Żingu | Zìnk | Cynk | Zinco | Zinc | Zinok | Cink | Sinkki | Zink

31 | Ga | Galis | Gallium | Gallju | Gallium | Gal | Gálio | Galiu | Gálium | Galij | Gallium | Gallium

32 | Ge | Germanis | Germánium | Ġermanju | Germanium | German | Germânio | Germaniu | Germánium | Germanij | Germanium | Germanium

33 | As | Arsenas | Arzén | Arseniku | Arseen | Arsen | Arsénio | Arsen | Arzén | Arzen | Arseeni | Arsenik

34 | Se | Selenas | Szelén | Selenju | Selenium | Selen | Selénio | Seleniu | Selén | Selen | Seleeni | Selen

35 | Br | Bromas | Bróm | Bromu | Broom | Brom | Bromo | Brom | Bróm | Brom | Bromi | Brom

36 | Kr | Kriptonas | Kripton | Kripton | Krypton | Krypton | Krípton | Kripton | Kryptón | Kripton | Krypton | Krypton

37 | Rb | Rubidis | Rubídium | Rubidju | Rubidium | Rubid | Rubídio | Rubidiu | Rubídium | Rubidij | Rubidium | Rubidium

38 | Sr | Stroncis | Stroncium | Stronzju | Strontium | Stront | Estrôncio | Stronţiu | Stroncium | Stroncij | Strontium | Strontium

39 | Y | Itris | Ittrium | Ittriju | Yttrium | Itr | Ítrio | Ytriu | Ytrium | Itrij | Yttrium | Yttrium

40 | Zr | Cirkonis | Cirkónium | Żirkonju | Zirkonium | Cyrkon | Zircónio | Zirconiu | Zirkónium | Cirkonij | Zirkonium | Zirkonium

41 | Nb | Niobis | Nióbium | Nijobju | Niobium | Niob | Nióbio | Niobiu | Niób | Niobij | Niobium | Niob

42 | Mo | Molibdenas | Molibdén | Molibdenu | Molybdeen | Molibden | Molibdénio | Molibden | Molybdén | Molibden | Molybdeeni | Molybden

43 | Tc | Technecis | Technécium | Teknezju | Technetium | Technet | Tecnécio | Tehneţiu | Technécium | Tehnecij | Teknetium | Teknetium

44 | Ru | Rutenis | Ruténium | Rutenju | Ruthernium | Ruten | Ruténio | Ruteniu | Ruténium | Rutenij | Rutenium | Rutenium

45 | Rh | Rodis | Ródium | Rodju | Rodium | Rod | Ródio | Rodiu | Ródium | Rodij | Rodium | Rodium

46 | Pd | Paladis | Palládium | Palladju | Palladium | Pallad | Paládio | Paladiu | Paládium | Paladij | Palladium | Palladium

47 | Ag | Sidabras | Ezüst | Fidda | Zilver | Srebro | Prata | Argint | Striebro | Srebro | Hopea | Silver

48 | Cd | Kadmis | Kadmium | Kadmju | Cadmium | Kadm | Cádmio | Cadmiu | Kadmium | Kadmij | Kadmium | Kadmium

49 | In | Indis | Indium | Indju | Indium | Ind | Índio | Indiu | Indium | Indij | Indium | Indium

50 | Sn | Alavas | Ón | Landa | Tin | Cyna | Estanho | Staniu | Cín | Kositer | Tina | Tenn

51 | Sb | Stibis | Antimon | Antimonju | Antimoon | Antymon | Antimónio | Stibiu | Antimón | Antimon | Antimoni | Antimon

52 | Te | Telūras | Tellúr | Tellurju | Telluur | Tellur | Telúrio | Telur | Telúr | Telur | Telluuri | Tellur

53 | I | Jodas | Jód | Jodju | Jood | Jod | Iodo | Iod | Jód | Jod | Jodi | Jod

54 | Xe | Ksenonas | Xenon | Kseno | Xenon | Ksenon | Xénon | Xenon | Xenón | Ksenon | Ksenon | Xenon

55 | Cs | Cezis | Cézium | Ċesju | Cesium | Cez | Césio | Cesiu | Césium | Cezij | Cesium | Cesium

56 | Ba | Baris | Bárium | Barju | Barium | Bar | Bário | Bariu | Bárium | Barij | Barium | Barium

57 | La | Lantanas | Lantán | Lantanu | Lanthaan | Lantan | Lantânio | Lantan | Lantán | Lantan | Lantaani | Lantan

58 | Ce | Ceris | Cérium | Ċerju | Cerium | Cer | Cério | Ceriu | Cér | Cerij | Cerium | Cerium

59 | Pr | Prazeodimis | Prazeodímium | Prasedimju | Praseodymium | Prazeodym | Praseodímio | Praseodim | Prazeodým | Prazeodim | Praseodyymi | Praseodym

60 | Nd | Neodimis | Neodímium | Neodimju | Neodymium | Neodym | Neodímio | Neodim | Neodým | Neodim | Neodyymi | Neodym

61 | Pm | Prometis | Prométium | Prometju | Promethium | Promet | Promécio | Promeţiu | Prométium | Prometij | Prometium | Prometium

62 | Sm | Samaris | Szamárium | Samarju | Samarium | Samar | Samário | Samariu | Samárium | Samarij | Samarium | Samarium

63 | Eu | Europis | Európium | Ewropju | Europium | Europ | Európio | Europiu | Európium | Evropij | Europium | Europium

64 | Gd | Gadolinis | Gadolínium | Gadolinju | Gadolinium | Gadolin | Gadolínio | Gadoliniu | Gadolínium | Gadolinij | Gadolinium | Gadolinium

65 | Tb | Terbis | Terbium | Terbju | Terbium | Terb | Térbio | Terbiu | Terbium | Terbij | Terbium | Terbium

66 | Dy | Disprozis | Diszprózium | Disprosju | Dysprosium | Dysproz | Disprósio | Dysprosiu | Dysprózium | Disprozij | Dysprosium | Dysprosium

67 | Ho | Holmis | Holmium | Olmju | Holmium | Holm | Hólmio | Holmiu | Holmium | Holmij | Holmium | Holmium

68 | Er | Erbis | Erbium | Erbju | Erbium | Erb | Érbio | Erbiu | Erbium | Erbij | Erbium | Erbium

69 | Tm | Tulis | Túlium | Tulju | Thulium | Tul | Túlio | Tuliu | Túlium | Tulij | Tulium | Tulium

70 | Yb | Iterbis | Itterbium | Itterbju | Ytterbium | Iterb | Itérbio | Yterbiu | Yterbium | Iterbij | Ytterbium | Ytterbium

71 | Lu | Liutecis | Lutécium | Lutezju | Lutetium | Lutet | Lutécio | Luteţiu | Lutécium | Lutecij | Lutetium | Lutetium

72 | Hf | Hafnis | Hafnium | Ħafnju | Hafnium | Hafn | Háfnio | Hafniu | Hafnium | Hafnij | Hafnium | Hafnium

73 | Ta | Tantalas | Tantál | Tantalu | Tantaal | Tantal | Tântalo | Tantal | Tantal | Tantal | Tantaali | Tantal

74 | W | Volframas | Volfrám | Tungstenu | Wolfram | Wolfram | Tungsténio | Wolfram | Volfrám | Volfram | Volframi | Wolfram

75 | Re | Renis | Rénium | Rênju | Renium | Ren | Rénio | Reniu | Rénium | Renij | Renium | Rhenium

76 | Os | Osmis | Ozmium | Osmju | Osmium | Osm | Ósmio | Osmiu | Osmium | Osmij | Osmium | Osmium

77 | Ir | Iridis | Irídium | Iridju | Iridium | Iryd | Irídio | Iridiu | Irídium | Iridij | Iridium | Iridium

78 | Pt | Platina | Platina | Platinu | Platinum | Platyna | Platina | Platina | Platina | Platina | Platina | Platina

79 | Au | Auksas | Arany | Deheb | Goud | Złoto | Ouro | Aur | Zlato | Zlato | Kulta | Guld

80 | Hg | Gyvsidabris | Higany | Merkurju | Kwik | Rtęć | Mercúrio | Mercur | Ortuť | Živo srebro | Elohopea | Kvicksilver

81 | Tl | Talis | Tallium | Tallju | Thallium | Tal | Tálio | Taliu | Tálium | Talij | Tallium | Tallium

82 | Pb | Švinas | Ólom | Ċomb | Lood | Ołów | Chumbo | Plumb | Olovo | Svinec | Lyijy | Bly

83 | Bi | Bismutas | Bizmut | Bismùt | Bismuth | Bizmut | Bismuto | Bismut | Bizmut | Bizmut | Vismutti | Vismut

84 | Po | Polonis | Polónium | Polonju | Polonium | Polon | Polónio | Poloniu | Polónium | Polonij | Polonium | Polonium

85 | At | Astatinas | Asztácium | Astatina | Astaat | Astat | Astato | Astatiniu | Astát | Astat | Astatiini | Astat

86 | Rn | Radonas | Radon | Radon | Radon | Radon | Rádon | Radon | Radón | Radon | Radon | Radon

87 | Fr | Francis | Francium | Franċju | Francium | Frans | Frâncio | Franciu | Francium | Francij | Frankium | Francium

88 | Ra | Radis | Rádium | Radju | Radium | Rad | Rádio | Radiu | Rádium | Radij | Radium | Radium

89 | Ac | Aktinis | Aktínium | Aktinju | Actinium | Aktyn | Actínio | Actiniu | Aktínium | Aktinij | Aktinium | Aktinium

90 | Th | Toris | Tórium | Torju | Thorium | Tor | Tório | Toriu | Tórium | Torij | Torium | Torium

91 | Pa | Protaktinis | Protaktínium | Protaktinju | Protactinium | Protaktyn | Protactínio | Proactiniu | Protaktínium | Protaktinij | Protaktinium | Protaktinium

92 | U | Uranas | Urán | Uranju | Uranium | Uran | Urânio | Uraniu | Urán | Uran | Uraani | Uran

93 | Np | Neptūnis | Neptúnium | Nettunju | Neptunium | Neptun | Neptúnio | Neptuniu | Neptúnium | Neptunij | Neptunium | Neptunium

94 | Pu | Plutonis | Plutónium | Plutonju | Plutonium | Pluton | Plutónio | Plutoniu | Plutónium | Plutonij | Plutonium | Plutonium

95 | Am | Americis | Amerícium | Ameriċju | Americium | Ameryk | Amerício | Americiu | Amerícium | Americij | Amerikium | Americium

96 | Cm | Kiuris | Kűrium | Kurju | Curium | Kiur | Cúrio | Curiu | Curium | Kirij | Curium | Curium

97 | Bk | Berklis | Berkélium | Berkelju | Berkelium | Berkel | Berquélio | Berkeliu | Berkelium | Berkelij | Berkelium | Berkelium

98 | Cf | Kalifornis | Kalifornium | Kalifornju | Californium | Kaliforn | Califórnio | Californiu | Kalifornium | Kalifornij | Kalifornium | Californium

99 | Es | Einšteinis | Einsteinium | Enstejnju | Einsteinium | Einstein | Einsteinio | Einsteiniu | Einsteinium | Ajnštajnij | Einsteinium | Einsteinium

100 | Fm | Fermis | Fermium | Fermju | Fermium | Ferm | Férmio | Fermiu | Fermium | Fermij | Fermium | Fermium

101 | Md | Mendelevis | Mendelévium | Mendelevju | Mendelevium | Mendelew | Mendelévio | Mendeleeviu | Mendelevium | Mendelevij | Mendelevium | Mendelevium

102 | No | Nobelis | Nobélium | Nobelju | Nobelium | Nobel | Nobélio | Nobeliu | Nobelium | Nobelij | Nobelium | Nobelium

103 | Lw | Lorensis | Laurencium | Lawrenċju | Laurentium | Lorens | Laurêncio | Laurenţiu | Laurencium | Lavrencij | Lawrensium | Lawrentium’

(b) | Table B in the foreword to Annex I is replaced by the following:‘ТАБЛИЦА Б — TABLA B — TABULKA B — TABEL B — TABELLE B — TABEL B — ΠΙΝΑΚΑΣ B — TABLE B — TABLEAU B — TABELLA B — B TABULA — B LENTELĖ — B. TÁBLÁZAT — TABELLA B — TABEL B — TABELA B — TABELA B — TABEL B — TABUĽKA B — TABELA B — TAULUKKO B — TABELL BСпециална класификация на органичните веществаClasificación especial para las sustancias orgánicasSpeciální třídy organických látekSærlig inddeling af organiske stofferSpezielle Anordnung für die organischen StoffeSpetsiaalne orgaaniliste ainete klassifikatsioon’Ειδική ταξινόμηση των οργανικών ουσιώνSpecial classification for organic substancesClassification particulière aux substances organiquesClassificazione speciale per le sostanze organicheOrganisko ķīmisko vielu grupasSpeciali organinių medžiagų klasifikacijaSzerves anyagok speciális osztályozásaKlassifikazzjoni speċjali għal sustanzi organiċiSpeciale indeling voor de organische stoffenNumery klas substancji organicznychClassificação especial para as substâncias orgânicasClasificare specifică pentru substanţele organicePrehľadná klasifikácia organických látokPosebna razvrstitev organskih spojinErityisryhmät orgaanisille aineilleSärskild indelning av organiska ämnen601ВъглеводородиHidrocarburosUhlovodíkyCarbonhydrider (kulbrinter)KohlenwasserstoffeSüsivesinikudΥδρογονάνθρακεςHydrocarbonsHydrocarburesIdrocarburiOgļūdeņražiAngliavandeniliaiSzénhidrogénekIdrokarburiKoolwaterstoffenWęglowodoryHidrocarbonetosHidrocarburiUhľovodíkyOgljikovodikiHiilivedytKolväten602Халогенирани въглеводородиHidrocarburos halogenadosHalogenované uhlovodíkyHalogensubstituerede carbonhydriderHalogen-KohlenwasserstoffeHalogeenitud süsivesinikudΑλογονοπαράγωγα υδρογονανθράκωνHalogenated hydrocarbonsDérivés halogénés des hydrocarburesDerivati idrocarburi alogenatiHalogenētie ogļūdeņražiHalogeninti angliavandeniliaiHalogénezett szénhidrogénekIdrokarburi aloġenatiGehalogeneerde koolwaterstoffenHalogenowe pochodne węglowodorówHidrocarbonetos halogenadosDerivaţi halogenaţi ai hidrocarburilorHalogénované uhľovodíkyHalogenirani ogljikovodikiHalogenoidut hiilivedytHalogenerade kolväten603Алкохоли и техните производниAlcoholes y derivadosAlkoholy a jejich derivátyAlkoholer og deres derivaterAlkohole und ihre DerivateAlkoholid ja nende derivaadidΑλκοόλες και παράγωγά τουςAlcohols and their derivativesAlcools et dérivésAlcoli e derivatiSpirti un to atvasinājumiAlkoholiai ir jų dariniaiAlkoholok és származékaikAlkoħoliċi u derivatiAlcoholen en derivatenAlkohole i ich pochodneÁlcoois e derivadosAlcooli şi derivaţii lorAlkoholy a ich derivátyAlkoholi in njihovi derivatiAlkoholit ja niiden johdannaisetAlkoholer och deras derivat604Феноли и техните производниFenoles y derivadosFenoly a jejich derivátyPhenoler og deres derivaterPhenole und ihre DerivateFenoolid ja nende derivaadidΦαινόλες και παράγωγά τουςPhenols and their derivativesPhénols et dérivésFenoli e derivatiFenoli un to atvasinājumiFenoliai ir jų dariniaiFenolok és származékaikFenoli u derivatiFenolen en derivatenFenole i ich pochodneFenóis e derivadosFenoli şi derivaţii lorFenoly a ich derivátyFenoli in njihovi derivatiFenolit ja niiden johdannaisetFenoler och deras derivat605Алдехиди и техните производниAldehídos y derivadosAldehydy a jejich derivátyAldehyder og deres derivaterAldehyde und ihre DerivateAldehüüdid ja nende derivaadidΑλδεΰδες και παράγωγά τουςAldehydes and their derivativesAldéhydes et dérivésAldeidi e derivatiAldehīdi un to atvasinājumiAldehidai ir jų dariniaiAldehidek és származékaikAldeidi u derivatiAldehyden en derivatenAldehydy i ich pochodneAldeidos e derivadosAldehide şi derivaţii lorAldehydy a ich derivátyAldehidi in njihovi derivatiAldehydit ja niiden johdannaisetAldehyder och deras derivat606Кетони и техните производниCetonas y derivadosKetony a jejich derivátyKetoner og deres derivaterKetone und ihre DerivateKetoonid ja nende derivaadidΚετόνες και παράγωγά τουςKetones and their derivativesCétones et dérivésChetoni e derivatiKetoni un to atvasinājumiKetonai ir jų dariniaiKetonok és származékaikKeton u derivatiKetonen en derivatenKetony i ich pochodneCetonas e derivadosCetone şi derivaţii lorKetóny a ich derivátyKetoni in njihovi derivatiKetonit ja niiden johdannaisetKetoner och deras derivat607Органични киселини и техните производниÁcidos orgánicos y derivadosOrganické kyseliny a jejich derivátyOrganiske syrer og deres derivaterOrganische Säuren und ihre DerivateOrgaanilised happed ja nende derivaadidΟργανικά οξέα και παράγωγά τουςOrganic acids and their derivativesAcides organiques et dérivésAcidi organici e derivatiOrganiskās skābes un to atvasinājumiOrganinės rūgštys ir jų dariniaiSzerves savak és származékaikAċidi organiċi u derivatiOrganische zuren en derivatenKwasy organiczne i ich pochodneÁcidos orgânicos e derivadosAcizi organici şi derivaţii lorOrganické kyseliny a ich derivátyOrganske kisline in njihovi derivatiOrgaaniset hapot ja niiden johdannaisetOrganiska syror och deras derivat608НитрилиNitrilosNitrilyNitrilerNitrileNitriilidΝιτρίλιαNitrilesNitrilesNitriliNitrilsavienojumi un to atvasinājumiNitrilaiNitrilekNitriliNitrillenNitryleNitrilosNitriliNitrilyNitriliNitriilitNitriler609НитросъединенияDerivados nitradosNitrosloučeninyNitroforbindelserNitroverbindungenNitroühendidΝιτροενώσειςNitro compoundsDérivés nitrésNitroderivatiNitrosavienojumiNitrojunginiaiNitrovegyületekKomposti tan-nitruNitroverbindingenNitrozwiązkiDerivados nitradosNitro-derivaţiNitrozlúčeninyNitro spojineNitroyhdisteetKväveföreningar610ХлоронитросъединенияDerivados cloronitradosChlorované nitrosloučeninyChlornitroforbindelserChlornitroverbindungenKloronitroühendidΧλωρονιτροενώσειςChloronitro compoundsDérivés chloronitrésCloronitro derivatiHlornitrosavienojumiChlornitrojunginiaiKlór-nitrovegyületekKomposti tal-kloronitruChloornitroverbindingenChloronitrozwiązkiDerivados cloronitradosClor- nitro-derivaţiChlórované nitrozlúčeninyKloro-nitro spojineKloorinitroyhdisteetKlornitroföreningar611Азокси- и азосъединенияDerivados azoicos y azoxiAzoxysloučeniny a azosloučeninyAzoxy- og azoforbindelserAzoxy- und AzoverbindungenAsoksü- ja asoühendidΆζωξυ- και άζω-ενώσειςAzoxy- and azo compoundsDérivés azoxy et azoïquesAzossi- e azoderivatiAzoksisavienojumi un azosavienojumiAzoksijunginiai ir azojunginiaiAzoxi és azo-vegyületekKomposti ta’ l-azossi u ta’ l-azoAzoxy- en azoverbindingenAzoksy- i azozwiązkiDerivados azoxi e azóicosAzoxi- şi azo-derivaţiAzoxyzlúčeniny a azozlúčeninyAzoksi in azo spojineAtsoksi- ja atsoyhdisteetAzoxi- och azoföreningar612АминосъединенияDerivados aminadosAminosloučeninyAminerAminoverbindungenAmiinühendidΑμινοενώσειςAmine compoundsDérivés aminésAminoderivatiAminosavienojumiAminojunginiaiAmin vegyületekKomposti ta’ l-aminoAminoverbindingenAminozwiązkiDerivados aminadosAmino-derivaţiAminozlúčeninyAmino spojineAmiiniyhdisteetAminer613Хетероциклени основи и техните производниBases heterocíclicas y derivadosHeterocyklické báze a jejich derivátyHeterocykliske baser og deres derivaterHeterocyclische Basen und ihre DerivateHeterotsüklilised alused ja nende derivaadidΕτεροκυκλικές βάσεις και παράγωγά τουςHeterocyclic bases and their derivativesBases hétérocycliques et dérivésBasi eterocicliche e derivatiHeterocikliskie savienojumi un to atvasinājumiHeterociklinės bazės ir jų dariniaiHeterociklusos bázisok és származékaikBażijiet eteroċikliċi u derivatiHeterocyclische basen en hun derivatenZasady heterocykliczne i ich pochodneBases heterocíclicas e derivadosBaze heterociclice şi derivaţii lorHeterocyklické bázy a ich derivátyHeterociklične baze in njihovi derivatiHeterosykliset emäkset ja niiden johdannaisetHeterocykliska baser och deras derivat614Глюкозиди и алкалоидиGlucósidos y alcaloidesGlykosidy a alkaloidyGlycosider og alkaloiderGlycoside und AlkaloideGlükosiidid ja alkaloididΓλυκοζίτες και αλκαλοειδήGlycosides and alkaloidsGlucosides et alcaloïdesGlucosidi e alcaloidiGlikozīdi un alkaloīdiGlikozidai ir alkaloidaiGlikozidok és alkaloidokGlukosidi u alkalojdiGlycosiden en alkaloïdenGlikozydy i alkaloidyGlicósidos e alcalóidesGlicozide şi alcaloiziGlykozidy a alkaloidyGlikozidi in alkaloidiGlykosidit ja alkaloiditGlykosider och alkaloider615Цианати и изоцианатиCianatos e isocianatosKyanáty a isokyanátyCyanater og isocyanaterCyanate und IsocyanateTsüanaadid ja isotsüanaadidΚυανικές και ισοκυανικές ενώσειςCyanates and isocyanatesCyanates et isocyanatesCianati e isocianatiCianāti un izocianātiCianatai ir izocianataiCianátok és izocianátokĊjanati u isoċjanatiCyanaten en isocyanatenCyjaniany i izocyjanianyCianatos e isocianatosCianaţi şi izocianaţiKyanáty a izokyanátyCianati in izocianatiSyanaatit ja isosyanaatitCyanater och isocyanater616Амиди и техните производниAmidas y derivadosAmidy a jejich derivátyAmider og deres derivaterAmide und ihre DerivateAmiidid ja nende derivaadidΑμίδια και παράγωγά τουςAmides and their derivativesAmides et dérivésAmmidi e derivatiAmīdi un to atvasinājumiAmidai ir jų dariniaiAmidok és származékaikAmidi u derivatiAmiden en derivatenAmidy i ich pochodneAmidas e derivadosAmide şi derivaţii lorAmidy a ich derivátyAmidi in njihovi derivatiAmidit ja niiden johdannaisetAmider och deras derivat617Органични пероксидиPeróxidos orgánicosOrganické peroxidyOrganiske peroxiderOrganische PeroxideOrgaanilised peroksiididΟργανικά υπεροξείδιαOrganic peroxidesPeroxydes organiquesPerossidi organiciOrganiskie peroksīdiOrganiniai peroksidaiSzerves peroxidokPerossidi organiċiOrganische peroxidenNadtlenki organicznePeróxidos orgânicosPeroxizi organiciOrganické peroxidyOrganski peroksidiOrgaaniset peroksiditOrganiska peroxider647ЕнзимиEnzimasEnzymyEnzymerEnzymeEnsüümidΈνζυμαEnzymesEnzymesEnzimiEnzīmiEnzimaiEnzimekEnzīmiEnzymenEnzymyEnzimasEnzimeEnzýmyEncimiEntsyymitEnzymer648Комплексни съединения, получени при преработка на въглищаSustancias complejas derivadas del carbónDehtochemické produktyKomplekse kulderivaterAus Kohle abgeleitete komplexe StoffeKivisöest saadud kompleksühendidΣύμπλοκες ουσίες παραγόμενες από άνθρακαComplex substances derived from coalSubstances complexes dérivées du charbonSostanze complesse derivate dal carboneKompleksa sastāva akmeņogļu pārstrādes produktiIš akmens anglių pagamintos sudėtingos medžiagosKomplex kőszénszármazékokSustanzi kumplessi derivati mill-faħamComplexe steenkoolderivatenZłożone związki wytworzone z węgla kamiennegoSubstâncias complexas derivadas do carvãoSubstanţe complexe derivate din cărbuneDechtochemické produktyKompleksne snovi, pridobljene iz premogaMonimutkaiset hiilijohdannaisetKomplexa kolderivat649Комплексни съединения, получени при преработка на нефтSustancias complejas derivadas del petróleoRopné produktyKomplekse oliederivaterAus Erdöl abgeleitete komplexe StoffePetrooleumist saadud kompleksühendidΣύμπλοκες ουσίες παραγόμενες από πετρέλαιοComplex substances derived from petroleumSubstances complexes dérivées du pétroleSostanze complesse derivate dal petrolioKompleksa sastāva naftas pārstrādes produktiIš naftos pagamintos sudėtingos medžiagosKomplex olajszármazékokSustanzi kumplessi derivati mill-pitroljuComplexe aardoliederivatenZłożone związki wytworzone z ropy naftowejSubstâncias complexas derivadas do petróleoSubstanţe complexe derivate din petrolRopné produktyKompleksne snovi pridobljene iz nafteMonimutkaiset öljyjohdannaisetKomplexa oljederivat650Други веществаSustancias diversasRůzné látkyDiverse stofferVerschiedene StoffeSegaainedΔιάφορες ουσίεςMiscellaneous substancesSubstances diversesSostanze diverseDažādas vielasĮvairios medžiagosKülönböző anyagokSustanzi mixxellanjiDiversenRóżne substancjeSubstâncias diversasSubstanţe diverseRôzne chemické látkyOstale snoviMuut aineetDiverse ämnen’ | 601 | ВъглеводородиHidrocarburosUhlovodíkyCarbonhydrider (kulbrinter)KohlenwasserstoffeSüsivesinikudΥδρογονάνθρακεςHydrocarbonsHydrocarburesIdrocarburiOgļūdeņražiAngliavandeniliaiSzénhidrogénekIdrokarburiKoolwaterstoffenWęglowodoryHidrocarbonetosHidrocarburiUhľovodíkyOgljikovodikiHiilivedytKolväten | 602 | Халогенирани въглеводородиHidrocarburos halogenadosHalogenované uhlovodíkyHalogensubstituerede carbonhydriderHalogen-KohlenwasserstoffeHalogeenitud süsivesinikudΑλογονοπαράγωγα υδρογονανθράκωνHalogenated hydrocarbonsDérivés halogénés des hydrocarburesDerivati idrocarburi alogenatiHalogenētie ogļūdeņražiHalogeninti angliavandeniliaiHalogénezett szénhidrogénekIdrokarburi aloġenatiGehalogeneerde koolwaterstoffenHalogenowe pochodne węglowodorówHidrocarbonetos halogenadosDerivaţi halogenaţi ai hidrocarburilorHalogénované uhľovodíkyHalogenirani ogljikovodikiHalogenoidut hiilivedytHalogenerade kolväten | 603 | Алкохоли и техните производниAlcoholes y derivadosAlkoholy a jejich derivátyAlkoholer og deres derivaterAlkohole und ihre DerivateAlkoholid ja nende derivaadidΑλκοόλες και παράγωγά τουςAlcohols and their derivativesAlcools et dérivésAlcoli e derivatiSpirti un to atvasinājumiAlkoholiai ir jų dariniaiAlkoholok és származékaikAlkoħoliċi u derivatiAlcoholen en derivatenAlkohole i ich pochodneÁlcoois e derivadosAlcooli şi derivaţii lorAlkoholy a ich derivátyAlkoholi in njihovi derivatiAlkoholit ja niiden johdannaisetAlkoholer och deras derivat | 604 | Феноли и техните производниFenoles y derivadosFenoly a jejich derivátyPhenoler og deres derivaterPhenole und ihre DerivateFenoolid ja nende derivaadidΦαινόλες και παράγωγά τουςPhenols and their derivativesPhénols et dérivésFenoli e derivatiFenoli un to atvasinājumiFenoliai ir jų dariniaiFenolok és származékaikFenoli u derivatiFenolen en derivatenFenole i ich pochodneFenóis e derivadosFenoli şi derivaţii lorFenoly a ich derivátyFenoli in njihovi derivatiFenolit ja niiden johdannaisetFenoler och deras derivat | 605 | Алдехиди и техните производниAldehídos y derivadosAldehydy a jejich derivátyAldehyder og deres derivaterAldehyde und ihre DerivateAldehüüdid ja nende derivaadidΑλδεΰδες και παράγωγά τουςAldehydes and their derivativesAldéhydes et dérivésAldeidi e derivatiAldehīdi un to atvasinājumiAldehidai ir jų dariniaiAldehidek és származékaikAldeidi u derivatiAldehyden en derivatenAldehydy i ich pochodneAldeidos e derivadosAldehide şi derivaţii lorAldehydy a ich derivátyAldehidi in njihovi derivatiAldehydit ja niiden johdannaisetAldehyder och deras derivat | 606 | Кетони и техните производниCetonas y derivadosKetony a jejich derivátyKetoner og deres derivaterKetone und ihre DerivateKetoonid ja nende derivaadidΚετόνες και παράγωγά τουςKetones and their derivativesCétones et dérivésChetoni e derivatiKetoni un to atvasinājumiKetonai ir jų dariniaiKetonok és származékaikKeton u derivatiKetonen en derivatenKetony i ich pochodneCetonas e derivadosCetone şi derivaţii lorKetóny a ich derivátyKetoni in njihovi derivatiKetonit ja niiden johdannaisetKetoner och deras derivat | 607 | Органични киселини и техните производниÁcidos orgánicos y derivadosOrganické kyseliny a jejich derivátyOrganiske syrer og deres derivaterOrganische Säuren und ihre DerivateOrgaanilised happed ja nende derivaadidΟργανικά οξέα και παράγωγά τουςOrganic acids and their derivativesAcides organiques et dérivésAcidi organici e derivatiOrganiskās skābes un to atvasinājumiOrganinės rūgštys ir jų dariniaiSzerves savak és származékaikAċidi organiċi u derivatiOrganische zuren en derivatenKwasy organiczne i ich pochodneÁcidos orgânicos e derivadosAcizi organici şi derivaţii lorOrganické kyseliny a ich derivátyOrganske kisline in njihovi derivatiOrgaaniset hapot ja niiden johdannaisetOrganiska syror och deras derivat | 608 | НитрилиNitrilosNitrilyNitrilerNitrileNitriilidΝιτρίλιαNitrilesNitrilesNitriliNitrilsavienojumi un to atvasinājumiNitrilaiNitrilekNitriliNitrillenNitryleNitrilosNitriliNitrilyNitriliNitriilitNitriler | 609 | НитросъединенияDerivados nitradosNitrosloučeninyNitroforbindelserNitroverbindungenNitroühendidΝιτροενώσειςNitro compoundsDérivés nitrésNitroderivatiNitrosavienojumiNitrojunginiaiNitrovegyületekKomposti tan-nitruNitroverbindingenNitrozwiązkiDerivados nitradosNitro-derivaţiNitrozlúčeninyNitro spojineNitroyhdisteetKväveföreningar | 610 | ХлоронитросъединенияDerivados cloronitradosChlorované nitrosloučeninyChlornitroforbindelserChlornitroverbindungenKloronitroühendidΧλωρονιτροενώσειςChloronitro compoundsDérivés chloronitrésCloronitro derivatiHlornitrosavienojumiChlornitrojunginiaiKlór-nitrovegyületekKomposti tal-kloronitruChloornitroverbindingenChloronitrozwiązkiDerivados cloronitradosClor- nitro-derivaţiChlórované nitrozlúčeninyKloro-nitro spojineKloorinitroyhdisteetKlornitroföreningar | 611 | Азокси- и азосъединенияDerivados azoicos y azoxiAzoxysloučeniny a azosloučeninyAzoxy- og azoforbindelserAzoxy- und AzoverbindungenAsoksü- ja asoühendidΆζωξυ- και άζω-ενώσειςAzoxy- and azo compoundsDérivés azoxy et azoïquesAzossi- e azoderivatiAzoksisavienojumi un azosavienojumiAzoksijunginiai ir azojunginiaiAzoxi és azo-vegyületekKomposti ta’ l-azossi u ta’ l-azoAzoxy- en azoverbindingenAzoksy- i azozwiązkiDerivados azoxi e azóicosAzoxi- şi azo-derivaţiAzoxyzlúčeniny a azozlúčeninyAzoksi in azo spojineAtsoksi- ja atsoyhdisteetAzoxi- och azoföreningar | 612 | АминосъединенияDerivados aminadosAminosloučeninyAminerAminoverbindungenAmiinühendidΑμινοενώσειςAmine compoundsDérivés aminésAminoderivatiAminosavienojumiAminojunginiaiAmin vegyületekKomposti ta’ l-aminoAminoverbindingenAminozwiązkiDerivados aminadosAmino-derivaţiAminozlúčeninyAmino spojineAmiiniyhdisteetAminer | 613 | Хетероциклени основи и техните производниBases heterocíclicas y derivadosHeterocyklické báze a jejich derivátyHeterocykliske baser og deres derivaterHeterocyclische Basen und ihre DerivateHeterotsüklilised alused ja nende derivaadidΕτεροκυκλικές βάσεις και παράγωγά τουςHeterocyclic bases and their derivativesBases hétérocycliques et dérivésBasi eterocicliche e derivatiHeterocikliskie savienojumi un to atvasinājumiHeterociklinės bazės ir jų dariniaiHeterociklusos bázisok és származékaikBażijiet eteroċikliċi u derivatiHeterocyclische basen en hun derivatenZasady heterocykliczne i ich pochodneBases heterocíclicas e derivadosBaze heterociclice şi derivaţii lorHeterocyklické bázy a ich derivátyHeterociklične baze in njihovi derivatiHeterosykliset emäkset ja niiden johdannaisetHeterocykliska baser och deras derivat | 614 | Глюкозиди и алкалоидиGlucósidos y alcaloidesGlykosidy a alkaloidyGlycosider og alkaloiderGlycoside und AlkaloideGlükosiidid ja alkaloididΓλυκοζίτες και αλκαλοειδήGlycosides and alkaloidsGlucosides et alcaloïdesGlucosidi e alcaloidiGlikozīdi un alkaloīdiGlikozidai ir alkaloidaiGlikozidok és alkaloidokGlukosidi u alkalojdiGlycosiden en alkaloïdenGlikozydy i alkaloidyGlicósidos e alcalóidesGlicozide şi alcaloiziGlykozidy a alkaloidyGlikozidi in alkaloidiGlykosidit ja alkaloiditGlykosider och alkaloider | 615 | Цианати и изоцианатиCianatos e isocianatosKyanáty a isokyanátyCyanater og isocyanaterCyanate und IsocyanateTsüanaadid ja isotsüanaadidΚυανικές και ισοκυανικές ενώσειςCyanates and isocyanatesCyanates et isocyanatesCianati e isocianatiCianāti un izocianātiCianatai ir izocianataiCianátok és izocianátokĊjanati u isoċjanatiCyanaten en isocyanatenCyjaniany i izocyjanianyCianatos e isocianatosCianaţi şi izocianaţiKyanáty a izokyanátyCianati in izocianatiSyanaatit ja isosyanaatitCyanater och isocyanater | 616 | Амиди и техните производниAmidas y derivadosAmidy a jejich derivátyAmider og deres derivaterAmide und ihre DerivateAmiidid ja nende derivaadidΑμίδια και παράγωγά τουςAmides and their derivativesAmides et dérivésAmmidi e derivatiAmīdi un to atvasinājumiAmidai ir jų dariniaiAmidok és származékaikAmidi u derivatiAmiden en derivatenAmidy i ich pochodneAmidas e derivadosAmide şi derivaţii lorAmidy a ich derivátyAmidi in njihovi derivatiAmidit ja niiden johdannaisetAmider och deras derivat | 617 | Органични пероксидиPeróxidos orgánicosOrganické peroxidyOrganiske peroxiderOrganische PeroxideOrgaanilised peroksiididΟργανικά υπεροξείδιαOrganic peroxidesPeroxydes organiquesPerossidi organiciOrganiskie peroksīdiOrganiniai peroksidaiSzerves peroxidokPerossidi organiċiOrganische peroxidenNadtlenki organicznePeróxidos orgânicosPeroxizi organiciOrganické peroxidyOrganski peroksidiOrgaaniset peroksiditOrganiska peroxider | 647 | ЕнзимиEnzimasEnzymyEnzymerEnzymeEnsüümidΈνζυμαEnzymesEnzymesEnzimiEnzīmiEnzimaiEnzimekEnzīmiEnzymenEnzymyEnzimasEnzimeEnzýmyEncimiEntsyymitEnzymer | 648 | Комплексни съединения, получени при преработка на въглищаSustancias complejas derivadas del carbónDehtochemické produktyKomplekse kulderivaterAus Kohle abgeleitete komplexe StoffeKivisöest saadud kompleksühendidΣύμπλοκες ουσίες παραγόμενες από άνθρακαComplex substances derived from coalSubstances complexes dérivées du charbonSostanze complesse derivate dal carboneKompleksa sastāva akmeņogļu pārstrādes produktiIš akmens anglių pagamintos sudėtingos medžiagosKomplex kőszénszármazékokSustanzi kumplessi derivati mill-faħamComplexe steenkoolderivatenZłożone związki wytworzone z węgla kamiennegoSubstâncias complexas derivadas do carvãoSubstanţe complexe derivate din cărbuneDechtochemické produktyKompleksne snovi, pridobljene iz premogaMonimutkaiset hiilijohdannaisetKomplexa kolderivat | 649 | Комплексни съединения, получени при преработка на нефтSustancias complejas derivadas del petróleoRopné produktyKomplekse oliederivaterAus Erdöl abgeleitete komplexe StoffePetrooleumist saadud kompleksühendidΣύμπλοκες ουσίες παραγόμενες από πετρέλαιοComplex substances derived from petroleumSubstances complexes dérivées du pétroleSostanze complesse derivate dal petrolioKompleksa sastāva naftas pārstrādes produktiIš naftos pagamintos sudėtingos medžiagosKomplex olajszármazékokSustanzi kumplessi derivati mill-pitroljuComplexe aardoliederivatenZłożone związki wytworzone z ropy naftowejSubstâncias complexas derivadas do petróleoSubstanţe complexe derivate din petrolRopné produktyKompleksne snovi pridobljene iz nafteMonimutkaiset öljyjohdannaisetKomplexa oljederivat | 650 | Други веществаSustancias diversasRůzné látkyDiverse stofferVerschiedene StoffeSegaainedΔιάφορες ουσίεςMiscellaneous substancesSubstances diversesSostanze diverseDažādas vielasĮvairios medžiagosKülönböző anyagokSustanzi mixxellanjiDiversenRóżne substancjeSubstâncias diversasSubstanţe diverseRôzne chemické látkyOstale snoviMuut aineetDiverse ämnen’

601 | ВъглеводородиHidrocarburosUhlovodíkyCarbonhydrider (kulbrinter)KohlenwasserstoffeSüsivesinikudΥδρογονάνθρακεςHydrocarbonsHydrocarburesIdrocarburiOgļūdeņražiAngliavandeniliaiSzénhidrogénekIdrokarburiKoolwaterstoffenWęglowodoryHidrocarbonetosHidrocarburiUhľovodíkyOgljikovodikiHiilivedytKolväten

602 | Халогенирани въглеводородиHidrocarburos halogenadosHalogenované uhlovodíkyHalogensubstituerede carbonhydriderHalogen-KohlenwasserstoffeHalogeenitud süsivesinikudΑλογονοπαράγωγα υδρογονανθράκωνHalogenated hydrocarbonsDérivés halogénés des hydrocarburesDerivati idrocarburi alogenatiHalogenētie ogļūdeņražiHalogeninti angliavandeniliaiHalogénezett szénhidrogénekIdrokarburi aloġenatiGehalogeneerde koolwaterstoffenHalogenowe pochodne węglowodorówHidrocarbonetos halogenadosDerivaţi halogenaţi ai hidrocarburilorHalogénované uhľovodíkyHalogenirani ogljikovodikiHalogenoidut hiilivedytHalogenerade kolväten

603 | Алкохоли и техните производниAlcoholes y derivadosAlkoholy a jejich derivátyAlkoholer og deres derivaterAlkohole und ihre DerivateAlkoholid ja nende derivaadidΑλκοόλες και παράγωγά τουςAlcohols and their derivativesAlcools et dérivésAlcoli e derivatiSpirti un to atvasinājumiAlkoholiai ir jų dariniaiAlkoholok és származékaikAlkoħoliċi u derivatiAlcoholen en derivatenAlkohole i ich pochodneÁlcoois e derivadosAlcooli şi derivaţii lorAlkoholy a ich derivátyAlkoholi in njihovi derivatiAlkoholit ja niiden johdannaisetAlkoholer och deras derivat

604 | Феноли и техните производниFenoles y derivadosFenoly a jejich derivátyPhenoler og deres derivaterPhenole und ihre DerivateFenoolid ja nende derivaadidΦαινόλες και παράγωγά τουςPhenols and their derivativesPhénols et dérivésFenoli e derivatiFenoli un to atvasinājumiFenoliai ir jų dariniaiFenolok és származékaikFenoli u derivatiFenolen en derivatenFenole i ich pochodneFenóis e derivadosFenoli şi derivaţii lorFenoly a ich derivátyFenoli in njihovi derivatiFenolit ja niiden johdannaisetFenoler och deras derivat

605 | Алдехиди и техните производниAldehídos y derivadosAldehydy a jejich derivátyAldehyder og deres derivaterAldehyde und ihre DerivateAldehüüdid ja nende derivaadidΑλδεΰδες και παράγωγά τουςAldehydes and their derivativesAldéhydes et dérivésAldeidi e derivatiAldehīdi un to atvasinājumiAldehidai ir jų dariniaiAldehidek és származékaikAldeidi u derivatiAldehyden en derivatenAldehydy i ich pochodneAldeidos e derivadosAldehide şi derivaţii lorAldehydy a ich derivátyAldehidi in njihovi derivatiAldehydit ja niiden johdannaisetAldehyder och deras derivat

606 | Кетони и техните производниCetonas y derivadosKetony a jejich derivátyKetoner og deres derivaterKetone und ihre DerivateKetoonid ja nende derivaadidΚετόνες και παράγωγά τουςKetones and their derivativesCétones et dérivésChetoni e derivatiKetoni un to atvasinājumiKetonai ir jų dariniaiKetonok és származékaikKeton u derivatiKetonen en derivatenKetony i ich pochodneCetonas e derivadosCetone şi derivaţii lorKetóny a ich derivátyKetoni in njihovi derivatiKetonit ja niiden johdannaisetKetoner och deras derivat

607 | Органични киселини и техните производниÁcidos orgánicos y derivadosOrganické kyseliny a jejich derivátyOrganiske syrer og deres derivaterOrganische Säuren und ihre DerivateOrgaanilised happed ja nende derivaadidΟργανικά οξέα και παράγωγά τουςOrganic acids and their derivativesAcides organiques et dérivésAcidi organici e derivatiOrganiskās skābes un to atvasinājumiOrganinės rūgštys ir jų dariniaiSzerves savak és származékaikAċidi organiċi u derivatiOrganische zuren en derivatenKwasy organiczne i ich pochodneÁcidos orgânicos e derivadosAcizi organici şi derivaţii lorOrganické kyseliny a ich derivátyOrganske kisline in njihovi derivatiOrgaaniset hapot ja niiden johdannaisetOrganiska syror och deras derivat

608 | НитрилиNitrilosNitrilyNitrilerNitrileNitriilidΝιτρίλιαNitrilesNitrilesNitriliNitrilsavienojumi un to atvasinājumiNitrilaiNitrilekNitriliNitrillenNitryleNitrilosNitriliNitrilyNitriliNitriilitNitriler

609 | НитросъединенияDerivados nitradosNitrosloučeninyNitroforbindelserNitroverbindungenNitroühendidΝιτροενώσειςNitro compoundsDérivés nitrésNitroderivatiNitrosavienojumiNitrojunginiaiNitrovegyületekKomposti tan-nitruNitroverbindingenNitrozwiązkiDerivados nitradosNitro-derivaţiNitrozlúčeninyNitro spojineNitroyhdisteetKväveföreningar

610 | ХлоронитросъединенияDerivados cloronitradosChlorované nitrosloučeninyChlornitroforbindelserChlornitroverbindungenKloronitroühendidΧλωρονιτροενώσειςChloronitro compoundsDérivés chloronitrésCloronitro derivatiHlornitrosavienojumiChlornitrojunginiaiKlór-nitrovegyületekKomposti tal-kloronitruChloornitroverbindingenChloronitrozwiązkiDerivados cloronitradosClor- nitro-derivaţiChlórované nitrozlúčeninyKloro-nitro spojineKloorinitroyhdisteetKlornitroföreningar

611 | Азокси- и азосъединенияDerivados azoicos y azoxiAzoxysloučeniny a azosloučeninyAzoxy- og azoforbindelserAzoxy- und AzoverbindungenAsoksü- ja asoühendidΆζωξυ- και άζω-ενώσειςAzoxy- and azo compoundsDérivés azoxy et azoïquesAzossi- e azoderivatiAzoksisavienojumi un azosavienojumiAzoksijunginiai ir azojunginiaiAzoxi és azo-vegyületekKomposti ta’ l-azossi u ta’ l-azoAzoxy- en azoverbindingenAzoksy- i azozwiązkiDerivados azoxi e azóicosAzoxi- şi azo-derivaţiAzoxyzlúčeniny a azozlúčeninyAzoksi in azo spojineAtsoksi- ja atsoyhdisteetAzoxi- och azoföreningar

612 | АминосъединенияDerivados aminadosAminosloučeninyAminerAminoverbindungenAmiinühendidΑμινοενώσειςAmine compoundsDérivés aminésAminoderivatiAminosavienojumiAminojunginiaiAmin vegyületekKomposti ta’ l-aminoAminoverbindingenAminozwiązkiDerivados aminadosAmino-derivaţiAminozlúčeninyAmino spojineAmiiniyhdisteetAminer

613 | Хетероциклени основи и техните производниBases heterocíclicas y derivadosHeterocyklické báze a jejich derivátyHeterocykliske baser og deres derivaterHeterocyclische Basen und ihre DerivateHeterotsüklilised alused ja nende derivaadidΕτεροκυκλικές βάσεις και παράγωγά τουςHeterocyclic bases and their derivativesBases hétérocycliques et dérivésBasi eterocicliche e derivatiHeterocikliskie savienojumi un to atvasinājumiHeterociklinės bazės ir jų dariniaiHeterociklusos bázisok és származékaikBażijiet eteroċikliċi u derivatiHeterocyclische basen en hun derivatenZasady heterocykliczne i ich pochodneBases heterocíclicas e derivadosBaze heterociclice şi derivaţii lorHeterocyklické bázy a ich derivátyHeterociklične baze in njihovi derivatiHeterosykliset emäkset ja niiden johdannaisetHeterocykliska baser och deras derivat

614 | Глюкозиди и алкалоидиGlucósidos y alcaloidesGlykosidy a alkaloidyGlycosider og alkaloiderGlycoside und AlkaloideGlükosiidid ja alkaloididΓλυκοζίτες και αλκαλοειδήGlycosides and alkaloidsGlucosides et alcaloïdesGlucosidi e alcaloidiGlikozīdi un alkaloīdiGlikozidai ir alkaloidaiGlikozidok és alkaloidokGlukosidi u alkalojdiGlycosiden en alkaloïdenGlikozydy i alkaloidyGlicósidos e alcalóidesGlicozide şi alcaloiziGlykozidy a alkaloidyGlikozidi in alkaloidiGlykosidit ja alkaloiditGlykosider och alkaloider

615 | Цианати и изоцианатиCianatos e isocianatosKyanáty a isokyanátyCyanater og isocyanaterCyanate und IsocyanateTsüanaadid ja isotsüanaadidΚυανικές και ισοκυανικές ενώσειςCyanates and isocyanatesCyanates et isocyanatesCianati e isocianatiCianāti un izocianātiCianatai ir izocianataiCianátok és izocianátokĊjanati u isoċjanatiCyanaten en isocyanatenCyjaniany i izocyjanianyCianatos e isocianatosCianaţi şi izocianaţiKyanáty a izokyanátyCianati in izocianatiSyanaatit ja isosyanaatitCyanater och isocyanater

616 | Амиди и техните производниAmidas y derivadosAmidy a jejich derivátyAmider og deres derivaterAmide und ihre DerivateAmiidid ja nende derivaadidΑμίδια και παράγωγά τουςAmides and their derivativesAmides et dérivésAmmidi e derivatiAmīdi un to atvasinājumiAmidai ir jų dariniaiAmidok és származékaikAmidi u derivatiAmiden en derivatenAmidy i ich pochodneAmidas e derivadosAmide şi derivaţii lorAmidy a ich derivátyAmidi in njihovi derivatiAmidit ja niiden johdannaisetAmider och deras derivat

617 | Органични пероксидиPeróxidos orgánicosOrganické peroxidyOrganiske peroxiderOrganische PeroxideOrgaanilised peroksiididΟργανικά υπεροξείδιαOrganic peroxidesPeroxydes organiquesPerossidi organiciOrganiskie peroksīdiOrganiniai peroksidaiSzerves peroxidokPerossidi organiċiOrganische peroxidenNadtlenki organicznePeróxidos orgânicosPeroxizi organiciOrganické peroxidyOrganski peroksidiOrgaaniset peroksiditOrganiska peroxider

647 | ЕнзимиEnzimasEnzymyEnzymerEnzymeEnsüümidΈνζυμαEnzymesEnzymesEnzimiEnzīmiEnzimaiEnzimekEnzīmiEnzymenEnzymyEnzimasEnzimeEnzýmyEncimiEntsyymitEnzymer

648 | Комплексни съединения, получени при преработка на въглищаSustancias complejas derivadas del carbónDehtochemické produktyKomplekse kulderivaterAus Kohle abgeleitete komplexe StoffeKivisöest saadud kompleksühendidΣύμπλοκες ουσίες παραγόμενες από άνθρακαComplex substances derived from coalSubstances complexes dérivées du charbonSostanze complesse derivate dal carboneKompleksa sastāva akmeņogļu pārstrādes produktiIš akmens anglių pagamintos sudėtingos medžiagosKomplex kőszénszármazékokSustanzi kumplessi derivati mill-faħamComplexe steenkoolderivatenZłożone związki wytworzone z węgla kamiennegoSubstâncias complexas derivadas do carvãoSubstanţe complexe derivate din cărbuneDechtochemické produktyKompleksne snovi, pridobljene iz premogaMonimutkaiset hiilijohdannaisetKomplexa kolderivat

649 | Комплексни съединения, получени при преработка на нефтSustancias complejas derivadas del petróleoRopné produktyKomplekse oliederivaterAus Erdöl abgeleitete komplexe StoffePetrooleumist saadud kompleksühendidΣύμπλοκες ουσίες παραγόμενες από πετρέλαιοComplex substances derived from petroleumSubstances complexes dérivées du pétroleSostanze complesse derivate dal petrolioKompleksa sastāva naftas pārstrādes produktiIš naftos pagamintos sudėtingos medžiagosKomplex olajszármazékokSustanzi kumplessi derivati mill-pitroljuComplexe aardoliederivatenZłożone związki wytworzone z ropy naftowejSubstâncias complexas derivadas do petróleoSubstanţe complexe derivate din petrolRopné produktyKompleksne snovi pridobljene iz nafteMonimutkaiset öljyjohdannaisetKomplexa oljederivat

650 | Други веществаSustancias diversasRůzné látkyDiverse stofferVerschiedene StoffeSegaainedΔιάφορες ουσίεςMiscellaneous substancesSubstances diversesSostanze diverseDažādas vielasĮvairios medžiagosKülönböző anyagokSustanzi mixxellanjiDiversenRóżne substancjeSubstâncias diversasSubstanţe diverseRôzne chemické látkyOstale snoviMuut aineetDiverse ämnen’

(c) | Annex II is replaced by the following:‘ПРИЛОЖЕНИЕ II — ANEXO II — PŘÍLOHA II — BILAG II — ANHANG II — II LISA — ΠΑΡΑΡΤΗΜΑ ΙΙ — ANNEX II — ANNEXE II — ALLEGATO II — II PIELIKUMS — II PRIEDAS — II. MELLÉKLET — ANNESS II — BIJLAGE II — ZAŁĄCZNIK II — ANEXO II — ANEXA II — PRÍLOHA II — PRILOGA II — LIITE II — BILAGA IIПРИЛОЖЕНИЕ IIСимволи и индикации за опасност на опасните вещества и препаратиANEXO IISímbolos e indicaciones de peligro de las sustancias y preparados peligrososPŘÍLOHA IISymboly a označení nebezpečnosti pro nebezpečné látky a přípravkyBILAG IIFaresymboler og farebetegnelser for farlige stoffer og præparaterANHANG IIGefahrensymbole und -bezeichnungen für gefährliche Stoffe und ZubereitungenII LISAOhtlike ainete ja valmististe ohtlikkuse sümbolid ning indikaatoridΠΑΡΑΡΤΗΜΑ ΙΙΣύμβολα και ενδείξεις κινδύνου για επικίνδυνες ουσίες και παρασκευάσματαANNEX IISymbols and indications of danger for dangerous substances and preparationsANNEXE IISymboles et indications de danger des substances et préparations dangereusesALLEGATO IISimboli e indicazioni di pericolo delle sostanze e preparati pericolosiII PIELIKUMSBīstamo vielu un preparātu simboli un bīstamības paskaidrojumiII PRIEDASPavojingų medžiagų ir preparatų pavojingumo simboliai ir nuorodosII. MELLÉKLETVeszélyes anyagok és készítmények veszélyszimbólumai és jeleiANNESS IISimboli u indikazzjonijiet ta’ periklu minn sustanzi u preparazzjonijiet perikolużiBIJLAGE IIGevaarsymbolen en -aanduidingen van gevaarlijke stoffen en preparatenZAŁĄCZNIK IIWzory znaków ostrzegawczych oraz napisy określające ich znaczenieANEXO IISímbolos e indicações de perigo das substâncias e preparações perigosasANEXA IISimboluri şi indicaţii de pericol pentru substanţele şi preparatele periculoasePRÍLOHA IIVýstražné symboly a označenia nebezpečenstva pre nebezpečné látky a prípravkyPRILOGA IIGrafični znaki in napisi za opozarjanje na nevarnost za nevarne snovi in pripravkeLIITE IIvaroitusmerkit ja niiden nimet vaarallisille aineille ja valmisteilleBILAGA IIFarosymboler och farobeteckningar för farliga ämnen och beredningarЗабележка: Буквите E, O, F, F+, T, T+, C, Xn, Xi u N не са част от символа.Nota:Las letras E, O, F, F+, T, T+, C, Xn, Xi y N no forman parte del símbolo.Poznámka:Písmenná vyjádření E, O, F, F+, T, T+, C, Xn, Xi a N nejsou součástí symbolu.Bemærkning:Bogstaverne E, O, F, F+, T, T+, C, Xn, Xi og N udgør ikke en del af symbolet.Anmerkung:Die Buchstaben E, O, F, F+, T, T+, C, Xn, Xi und N sind nicht Bestandteil des Gefahrensymbols.Tähelepanu:tähed E, O, F, F+, T, T+, C, Xn, Xi ja N ei ole ohusümboli osa.Σημείωση:Τα γράμματα E, O, F, F+, T, T+, C, Xn, Xi και N δεν αποτελούν μέρος του συμβόλου.Note:The letters E, O, F, F+, T, T+, C, Xn, Xi and N do not form part of the symbol.Remarque:Les lettres E, O, F, F+, T, T+, C, Xn, Xi et N ne font pas partie du symbole.Nota:Le lettere E, O, F, F+, T, T+, C, Xn, Xi e N non fanno parte del simbolo.Piezīme:Bīstamības apzīmējums ar burtu (burtiem E, O, F, F+, T, T+, C, Xn, Xi un N) nav marķējuma sastāvdaļa.Pastaba:Raidės E, O, F, F+, T, T+, C, Xn, Xi ir N nėra simbolio dalis.Megjegyzés:Az E, O, F, F+, T, T+, C, Xn, Xi és N betűk nem részei a szimbólumnak.Nota:L-ittri E, O, F, F+, T, T+, C, Xn, Xi u N m’humiex parti mis-simbolu.Opmerking:De letters E, O, F, F+, T, T+, C, Xn, Xi en N maken geen deel uit van het gevaarsymbool.Uwaga:litery E, O, F, F+, T, T+, C, Xn, Xi oraz N nie stanowią części znaku ostrzegawczego.Nota:As letras E, O, F, F+, T, T+, C, Xn, Xi e N não fazem parte do símbolo.Notă:Literele E, O, F, F+, T, T+, C, Xn, Xi, şi N nu fac parte din simbol.Poznámka:Písmená E, O, F, F+, T, T+, C, Xn, Xi, a N nie sú súčasťou symbolu.Opomba:črke E, O, F, F+, T, T+, C, Xn, Xi, in N niso del grafičnega znaka.Huomautus:Varoitusmerkkien kirjaintunnukset E, O, F, F+, T, T+, C, Xn, Xi ja N eivät ole osa varoitusmerkkiä.Anmärkning:Bokstäverna E, O, F, F+, T, T+, C, Xn, Xi och N utgör inte en del av symbolen.EBG: ЕксплозивенES: ExplosivoCS: VýbušnýDA: EksplosivDE: ExplosionsgefährlichET: PlahvatusohtlikEL: ΕκρηκτικόEN: ExplosiveFR: ExplosifIT: EsplosivoLV: SprādzienbīstamsLT: SprogstamojiHU: RobbanásveszélyesMT: SplussivNL: OntplofbaarPL: Produkt wybuchowyPT: ExplosivoRO: ExplozivSK: VýbušnýSL: EksplozivnoFI: RäjähtäväSV: ExplosivtOBG: ОксидиращES: ComburenteCS: OxidujícíDA: BrandnærendeDE: BrandförderndET: OksüdeerivEL: ΟξειδωτικόEN: OxidizingFR: ComburantIT: ComburenteLV: Spēcīgs oksidētājsLT: OksiduojantiHU: Égést tápláló, oxidálóMT: IqabbadNL: OxyderendPL: Produkt utleniającyPT: ComburenteRO: OxidantSK: OxidujúciSL: OksidativnoFI: HapettavaSV: OxiderandeFBG: Лесно запалимES: Fácilmente inflamableCS: Vysoce hořlavýDA: Meget brandfarligDE: LeichtentzündlichET: Väga tuleohtlikEL: Πολύ εύφλεκτοEN: Highly flammableFR: Facilement inflammableIT: Facilmente infiammabileLV: Viegli uzliesmojošsLT: Labai degiHU: TűzveszélyesMT: Jaqbad malajrNL: Licht ontvlambaarPL: Produkt wysoce łatwopalnyPT: Facilmente inflamávelRO: Foarte inflamabilSK: Veľmi horľavýSL: Lahko vnetljivoFI: Helposti syttyväSV: Mycket brandfarligtF+BG: Изключително запалимES: Extremadamente inflamableCS: Extrémně hořlavýDA: Yderst brandfarligDE: HochentzündlichET: Eriti tuleohtlikEL: Εξαιρετικά εύφλεκτοEN: Extremely flammableFR: Extrêmement inflammableIT: Estremamente infiammabileLV: Īpaši viegli uzliesmojošsLT: Ypač degiHU: Fokozottan tűzveszélyesMT: Jaqbad malajr ħafnaNL: Zeer licht ontvlambaarPL: Produkt skrajnie łatwopalnyPT: Extremamente inflamávelRO: Extrem de inflamabilSK: Mimoriadne horľavýSL: Zelo lahko vnetljivoFI: Erittäin helposti syttyväSV: Extremt brandfarligtTBG: ТоксиченES: TóxicoCS: ToxickýDA: GiftigDE: GiftigET: MürgineEL: ΤοξικόEN: ToxicFR: ToxiqueIT: TossicoLV: ToksisksLT: ToksiškaHU: MérgezőMT: TossikuNL: VergiftigPL: Produkt toksycznyPT: TóxicoRO: ToxicSK: JedovatýSL: StrupenoFI: MyrkyllinenSV: GiftigT +BG: Силно токсиченES: Muy tóxicoCS: Vysoce toxickýDA: Meget giftigDE: Sehr giftigET: Väga mürgineEL: Πολύ τοξικόEN: Very toxicFR: Très toxiqueIT: Molto tossicoLV: Ļoti toksisksLT: Labai toksiškaHU: Nagyon mérgezőMT: Tossiku ħafnaNL: Zeer vergiftigPL: Produkt bardzo toksycznyPT: Muito tóxicoRO: Foarte toxicSK: Veľmi jedovatýSL: Zelo strupenoFI: Erittäin myrkyllinenSV: Mycket giftigCBG: КорозивенES: CorrosivoCS: ŽíravýDA: ÆtsendeDE: ÄtzendET: SööbivEL: ΔιαβρωτικόEN: CorrosiveFR: CorrosifIT: CorrosivoLV: KodīgsLT: Ardanti (ėsdinanti)HU: MaróMT: KorrużivNL: BijtendPL: Produkt żrącyPT: CorrosivoRO: CorozivSK: ŽieravýSL: JedkoFI: SyövyttäväSV: FrätandeXnBG: ВреденES: NocivoCS: Zdraví škodlivýDA: SundhedsskadeligDE: GesundheitsschädlichET: KahjulikEL: ΕπιβλαβέςEN: HarmfulFR: NocifIT: NocivoLV: KaitīgsLT: KenksmingaHU: ÁrtalmasMT: Jagħmel il-ħsaraNL: SchadelijkPL: Produkt szkodliwyPT: NocivoRO: NocivSK: ŠkodlivýSL: Zdravju škodljivoFI: HaitallinenSV: HälsoskadligXiBG: ДразнещES: IrritanteCS: DráždivýDA: LokalirriterendeDE: ReizendET: ÄrritavEL: ΕρεθιστικόEN: IrritantFR: IrritantIT: IrritanteLV: KairinošsLT: DirginantiHU: IrritatívMT: IrritantiNL: IrriterendPL: Produkt drażniącyPT: IrritanteRO: IritantSK: DráždivýSL: DražilnoFI: ÄrsyttäväSV: IrriterandeNBG: Опасен за околната средаES: Peligroso para el medio ambienteCS: Nebezpečný pro životní prostředíDA: MiljøfarligDE: UmweltgefährlichET: KeskkonnaohtlikEL: Επικίνδυνο για το περιβάλλονEN: Dangerous for the environmentFR: Dangereux pour l’environnementIT: Pericoloso per l’ambienteLV: Bīstams videiLT: Aplinkai pavojingaHU: Környezetre veszélyesMT: Perikoluż għall-ambjentNL: MilieugevaarlijkPL: Produkt niebezpieczny dla środowiskaPT: Perigoso para o ambienteRO: Periculos pentru mediuSK: Nebezpečný pre životné prostredieSL: Okolju nevarnoFI: Ympäristölle vaarallinenSV: Miljöfarlig’

(d) | Annex III is replaced by the following:‘ПРИЛОЖЕНИЕ III — ANEXO III — PŘÍLOHA III — BILAG III — ANHANG III — III LISA — ΠΑΡΑΡΤΗΜΑ ΙΙI — ANNEX III — ANNEXE III — ALLEGATO III — III PIELIKUMS — III PRIEDAS — III. MELLÉKLET — ANNESS III — BIJLAGE III — ZAŁĄCZNIK III — ANEXO III — ANEXA III — PRÍLOHA III — PRILOGA III — LIITE III — BILAGA IIIПРИЛОЖЕНИЕ IIIХарактер на специфичните рискове, свързани с опасните вещества и препаратиANEXO IIINaturaleza de los riesgos específicos atribuidos a las sustancias y preparados peligrososPŘÍLOHA IIIPovaha specifických rizik spojených s nebezpečnými látkami a přípravkyBILAG IIIArten af de saerlige risici, der er forbundet med de farlige stoffer og præparaterANHANG IIIBezeichnungen der besonderen Gefahren bei gefährlichen Stoffen und ZubereitungenIII LISAOhtlike ainete ja valmististe riskilausedΠΑΡΑΡΤΗΜΑ ΙΙΙΦύση των ειδικών κινδύνων που αφορούν επικίνδυνες ουσίες και παρασκευάσματαANNEX IIINature of special risks attributed to dangerous substances and preparationsANNEXE IIINature des risques particuliers attribués aux substances et préparations dangereusesALLEGATO IIINatura dei rischi specifici attribuiti alle sostanze e preparati pericolosiIII PIELIKUMSĶīmisko vielu iedarbības raksturojumi un apvienotie raksturojumiIII PRIEDASPavojingoms medžiagoms ir preparatams priskiriamų ypatingųjų rizikos veiksnių pobūdisIII. MELLÉKLETA veszélyes anyagok és készítmények veszélyeinek/kockázatainak jellege (R-mondatok)ANNESS IIIIn-natura ta’ riskji speċjali attribwiti lil sustanzi u preparazzjonijiet perikolużiBIJLAGE IIIAard der bijzondere gevaren toegeschreven aan gevaarlijke stoffen en preparatenZAŁĄCZNIK IIIZwroty wskazujące rodzaj zagrożenia stwarzanego przez substancję niebezpieczną lub preparat niebezpiecznyANEXO IIINatureza dos riscos específicos atribuídos às substâncias e preparações perigosasANEXA IIINatura riscurilor specifice atribuite substanţelor şi preparatelor periculoasePRÍLOHA IIIZoznam označení špecifického rizika upozorňujúcich na nebezpečné vlastnosti chemickej látky a prípravkuPRILOGA IIIStandardna opozorila za označevanje nevarnih snovi in pripravkovLIITE IIIErityisten vaarojen luonne liittyen vaarallisiin aineisiin ja valmisteisiinBILAGA IIIRiskfraser som tilldelas farliga ämnen och beredningarR1BG: Експлозивен в сухо състояние.ES: Explosivo en estado seco.CS: Výbušný v suchém stavu.DA: Eksplosiv i tør tilstand.DE: In trockenem Zustand explosionsgefährlich.ET: Plahvatusohtlik kuivana.EL: Εκρηκτικό σε ξηρή κατάσταση.EN: Explosive when dry.FR: Explosif à l’état sec.IT: Esplosivo allo stato secco.LV: Sprādzienbīstams sausā veidā.LT: Sausa gali sprogti.HU: Száraz állapotban robbanásveszélyes.MT: Jisplodi meta jinxef.NL: In droge toestand ontplofbaar.PL: Produkt wybuchowy w stanie suchym.PT: Explosivo no estado seco.RO: Exploziv în stare uscată.SK: V suchom stave výbušný.SL: Eksplozivno v suhem stanju.FI: Räjähtävää kuivana.SV: Explosivt i torrt tillstånd.R2BG: Риск от експлозия при удар, триене, огън или други източници на запалване.ES: Riesgo de explosión por choque, fricción, fuego u otras fuentes de ignición.CS: Nebezpečí výbuchu při úderu, tření, ohni nebo působením jiných zdrojů zapálení.DA: Eksplosionsfarlig ved stød, gnidning, ild eller andre antændelseskilder.DE: Durch Schlag, Reibung, Feuer oder andere Zündquellen explosionsgefährlich.ET: Plahvatusohtlik löögi, hõõrdumise, tule või muu süttimisallika toimel.EL: Κίνδυνος εκρήξεως από κρούση, τριβή, φωτιά ή άλλες πηγές αναφλέξεως.EN: Risk of explosion by shock, friction, fire or other sources of ignition.FR: Risque d’explosion par le choc, la friction, le feu ou d’autres sources d’ignition.IT: Rischio di esplosione per urto, sfregamento, fuoco o altre sorgenti d’ignizione.LV: Sprādziena risks trieciena, berzes, liesmas vai cita aizdedzināšanas avota iedarbībā.LT: Sprogimo rizika nuo smūgio, trinties, ugnies ar kitų uždegimo šaltinių.HU: Ütés, súrlódás, tűz vagy más gyújtóforrás robbanást okozhat.MT: Riskju ta’ splużjoni minn xokk, frizzjoni, nar jew għejun oħra ta’ qbid tan-nar.NL: Ontploffingsgevaar door schok, wrijving, vuur of andere ontstekingsoorzaken.PL: Zagrożenie wybuchem wskutek uderzenia, tarcia, kontaktu z ogniem lub innymi źródłami zapłonu.PT: Risco de explosão por choque, fricção, fogo ou outras fontes de ignição.RO: Risc de explozie la şoc, frecare, foc sau alte surse de aprindere.SK: Riziko výbuchu nárazom, trením, horením alebo inými zdrojmi zapálenia.SL: Nevarnost eksplozije ob udarcu, trenju, požaru ali drugih virih vžiga.FI: Räjähtävää iskun, hankauksen, avotulen tai muun sytytyslähteen vaikutuksesta.SV: Explosivt vid stöt, friktion, eld eller annan antändningsorsak.R3BG: Повишен риск от експлозия при удар, триене, огън или други източници на запалване.ES: Alto riesgo de explosión por choque, fricción, fuego u otras fuentes de ignición.CS: Velké nebezpečí výbuchu při úderu, tření, ohni nebo působením jiných zdrojů zapálení.DA: Meget eksplosionsfarlig ved stød, gnidning, ild eller andre antændelseskilder.DE: Durch Schlag, Reibung, Feuer oder andere Zündquellen besonders explosionsgefährlich.ET: Eriti plahvatusohtlik löögi, hõõrdumise, tule või muu süttimisallika toimel.EL: Πολύ μεγάλος κίνδυνος εκρήξεως από κρούση, τριβή, φωτιά ή άλλες πηγές αναφλέξεως.EN: Extreme risk of explosion by shock, friction, fire or other sources of ignition.FR: Grand risque d’explosion par le choc, la friction, le feu ou d’autres sources d’ignition.IT: Elevato rischio di esplosione per urto, sfregamento, fuoco o altre sorgenti d’ignizione.LV: Augsts sprādziena risks trieciena, berzes, liesmas vai cita aizdedzināšanas avota iedarbībā.LT: Ypač didelė sprogimo rizika nuo smūgio, trinties, ugnies ar kitų uždegimo šaltinių.HU: Ütés, súrlódás, tűz vagy egyéb gyújtóforrás rendkívüli mértékben növeli a robbanásveszélyt.MT: Riskju kbir ħafna ta’ splużjoni minn xokk, frizzjoni, nar jew għejun oħra ta’ qbid.NL: Ernstig ontploffingsgevaar door schok, wrijving, vuur of andere ontstekingsoorzaken.PL: Skrajne zagrożenie wybuchem wskutek uderzenia, tarcia, kontaktu z ogniem lub innymi źródłami zapłonu.PT: Grande risco de explosão por choque, fricção, fogo ou outras fontes de ignição.RO: Risc mare de explozie la şoc, frecare, foc sau alte surse de aprindere.SK: Mimoriadne riziko výbuchu nárazom, trením, horením alebo inými zdrojmi zapálenia.SL: Velika nevarnost eksplozije ob udarcu, trenju, požaru ali drugih virih vžiga.FI: Erittäin helposti räjähtävää iskun, hankauksen, avotulen tai muun sytytyslähteen vaikutuksesta.SV: Mycket explosivt vid stöt, friktion, eld eller annan antändningsorsak.R4BG: Образува силно чувствителни експлозивни метални съединения.ES: Forma compuestos metálicos explosivos muy sensibles.CS: Vytváří vysoce výbušné kovové sloučeniny.DA: Danner meget følsomme eksplosive metalforbindelser.DE: Bildet hochempfindliche explosionsgefährliche Metallverbindungen.ET: Moodustab väga plahvatusohtlikke metalliühendeid.EL: Σχηματίζει πολύ ευαίσθητες εκρηκτικές μεταλλικές ενώσεις.EN: Forms very sensitive explosive metallic compounds.FR: Forme des composés métalliques explosifs très sensibles.IT: Forma composti metallici esplosivi molto sensibili.LV: Veido sprādzienbīstamus savienojumus ar metāliem.LT: Sudaro labai jautrius sprogstamuosius metalo junginius.HU: Nagyon érzékeny, robbanásveszélyes fémvegyületeket képez.MT: Jifforma komposti metalliċi esplussivi sensittivi ħafna.NL: Vormt met metalen zeer gemakkelijk ontplofbare verbindingen.PL: Tworzy łatwo wybuchające związki metaliczne.PT: Forma compostos metálicos explosivos muito sensíveis.RO: Formează compuşi metalici explozivi foarte sensibili.SK: Vytvára veľmi citlivé výbušné zlúčeniny kovov.SL: Tvori zelo občutljive eksplozivne kovinske spojine.FI: Muodostaa erittäin herkästi räjähtäviä metalliyhdisteitä.SV: Bildar mycket känsliga explosiva metallföreningar.R5BG: Може да предизвика експлозия при нагряване.ES: Peligro de explosión en caso de calentamiento.CS: Zahřívání může způsobit výbuch.DA: Eksplosionsfarlig ved opvarmning.DE: Beim Erwärmen explosionsfähig.ET: Kuumenemine võib põhjustada plahvatuse.EL: Θέρμανση μπορεί να προκαλέσει έκρηξη.EN: Heating may cause an explosion.FR: Danger d’explosion sous l’action de la chaleur.IT: Pericolo di esplosione per riscaldamento.LV: Karsēšana var izraisīt eksploziju.LT: Kaitinama gali sprogti.HU: Hő hatására robbanhat.MT: Jista’ jisplodi bis-sħana.NL: Ontploffingsgevaar door verwarming.PL: Ogrzanie grozi wybuchem.PT: Perigo de explosão sob a acção do calor.RO: Pericol de explozie sub acţiunea căldurii.SK: Zahriatie môže spôsobiť výbuch.SL: Segrevanje lahko povzroči eksplozijo.FI: Räjähdysvaarallinen kuumennettaessa.SV: Explosivt vid uppvärmning.R6BG: Експлозивен в или без присъствие на въздух.ES: Peligro de explosión, en contacto o sin contacto con el aire.CS: Výbušný za přístupu i bez přístupu vzduchu.DA: Eksplosiv ved og uden kontakt med luft.DE: Mit und ohne Luft explosionsfähig.ET: Plahvatusohtlik õhuga kokkupuutel või kokkupuuteta.EL: Εκρηκτικό σε επαφή ή χωρίς επαφή με τον αέρα.EN: Explosive with or without contact with air.FR: Danger d’explosion en contact ou sans contact avec l’air.IT: Esplosivo a contatto o senza contatto con l’aria.LV: Sprādzienbīstams gaisa un bezgaisa vidē.LT: Gali sprogti ore arba beorėje aplinkoje.HU: Levegővel érintkezve vagy anélkül is robbanásveszélyes.MT: Jista’ jisplodi b’kuntatt jew bla kuntatt ma’ l-arja.NL: Ontplofbaar met en zonder lucht.PL: Produkt wybuchowy z dostępem i bez dostępu powietrza.PT: Perigo de explosão em contacto ou sem contacto com o ar.RO: Pericol de explozie în contact sau fără contact cu aerul.SK: Výbušný pri kontakte alebo bez kontaktu so vzduchom.SL: Eksplozivno na zraku ali brez zraka.FI: Räjähtävää sellaisenaan tai ilman kanssa.SV: Explosivt vid kontakt och utan kontakt med luft.R7BG: Може да предизвика пожар.ES: Puede provocar incendios.CS: Může způsobit požár.DA: Kan forårsage brand.DE: Kann Brand verursachen.ET: Võib põhjustada tulekahju.EL: Μπορεί να προκαλέσει πυρκαγιά.EN: May cause fire.FR: Peut provoquer un incendie.IT: Può provocare un incendio.LV: Var izraisīt ugunsgrēku.LT: Pavojinga gaisro atžvilgiu.HU: Tüzet okozhat.MT: Jista’ jqabbad nar.NL: Kan brand veroorzaken.PL: Może spowodować pożar.PT: Pode provocar incêndio.RO: Poate provoca un incendiu.SK: Môže spôsobiť požiar.SL: Lahko povzroči požar.FI: Aiheuttaa tulipalon vaaran.SV: Kan orsaka brand.R8BG: Пожароопасен при контакт с горими материали.ES: Peligro de fuego en contacto con materias combustibles.CS: Dotek s hořlavým materiálem může způsobit požár.DA: Brandfarlig ved kontakt med brandbare stoffer.DE: Feuergefahr bei Berührung mit brennbaren Stoffen.ET: Kokkupuutel süttiva ainega võib põhjustada tulekahju.EL: Η επαφή με καύσιμο υλικό μπορεί να προκαλέσει πυρκαγιά.EN: Contact with combustible material may cause fire.FR: Favorise l’inflammation des matières combustibles.IT: Può provocare l’accensione di materie combustibili.LV: Saskaroties ar degošu materiālu, var izraisīt ugunsgrēku.LT: Gali užsidegti dėl sąveikos su galinčiomis degti medžiagomis.HU: Éghető anyaggal érintkezve tüzet okozhat.MT: Kuntatt ma’ materjal li jaqbad jista’ jqabbad nar.NL: Bevordert de ontbranding van brandbare stoffen.PL: Kontakt z materiałami zapalnymi może spowodować pożar.PT: Favorece a inflamação de matérias combustíveis.RO: Contactul cu materiale combustibile poate provoca incendiu.SK: Pri kontakte s horľavým materiálom môže spôsobiť požiar.SL: V stiku z vnetljivim materialom lahko povzroči požar.FI: Aiheuttaa tulipalon vaaran palavien aineiden kanssa.SV: Kontakt med brännbart material kan orsaka brand.R9BG: Експлозивен при смесване с горими материали.ES: Peligro de explosión al mezclar con materias combustibles.CS: Výbušný při smíchání s hořlavým materiálem.DA: Eksplosionsfarlig ved blanding med brandbare stoffer.DE: Explosionsgefahr bei Mischung mit brennbaren Stoffen.ET: Plahvatusohtlik segatult süttiva ainega.EL: Εκρηκτικό όταν αναμιχθεί με καύσιμα υλικά.EN: Explosive when mixed with combustible material.FR: Peut exploser en mélange avec des matières combustibles.IT: Esplosivo in miscela con materie combustibili.LV: Sprādzienbīstams, sajaucot ar degošu materiālu.LT: Gali sprogti sumaišyta su galinčiomis degti medžiagomis.HU: Éghető anyaggal keveredve robbanásveszélyes.MT: Jisplodi meta jitħallat ma’ materjal li jaqbad.NL: Ontploffingsgevaar bij menging met brandbare stoffen.PL: Grozi wybuchem po zmieszaniu z materiałem zapalnym.PT: Pode explodir quando misturado com matérias combustíveis.RO: Exploziv în amestec cu materiale combustibile.SK: Výbušný po zmiešaní s horľavým materiálom.SL: Eksplozivno v mešanici z vnetljivim materialom.FI: Räjähtävää sekoitettaessa palavien aineiden kanssa.SV: Explosivt vid blandning med brännbart material.R10BG: Запалим.ES: Inflamable.CS: Hořlavý.DA: Brandfarlig.DE: Entzündlich.ET: Tuleohtlik.EL: Εύφλεκτο.EN: Flammable.FR: Inflammable.IT: Infiammabile.LV: Uzliesmojošs.LT: Degi.HU: Kis mértékben tűzveszélyesMT: Jieħu n-nar.NL: Ontvlambaar.PL: Produkt łatwopalny.PT: Inflamável.RO: Inflamabil.SK: Horľavý.SL: Vnetljivo.FI: Syttyvää.SV: Brandfarligt.R11BG: Лесно запалим.ES: Fácilmente inflamable.CS: Vysoce hořlavý.DA: Meget brandfarlig.DE: Leichtentzündlich.ET: Väga tuleohtlik.EL: Πολύ εύφλεκτο.EN: Highly flammable.FR: Facilement inflammable.IT: Facilmente infiammabile.LV: Viegli uzliesmojošs.LT: Labai degi.HU: Tűzveszélyes.MT: Jieħu n-nar malajr.NL: Licht ontvlambaar.PL: Produkt wysoce łatwopalny.PT: Facilmente inflamável.RO: Foarte inflamabil.SK: Veľmi horľavý.SL: Lahko vnetljivo.FI: Helposti syttyvää.SV: Mycket brandfarligt.R12BG: Изключително запалим.ES: Extremadamente inflamable.CS: Extrémně hořlavý.DA: Yderst brandfarlig.DE: Hochentzündlich.ET: Eriti tuleohtlik.EL: Εξαιρετικά εύφλεκτο.EN: Extremely flammable.FR: Extrêmement inflammable.IT: Estremamente infiammabile.LV: Īpaši viegli uzliesmojošs.LT: Ypač degi.HU: Fokozottan tűzveszélyes.MT: Jieħu n-nar malajr ħafna.NL: Zeer licht ontvlambaar.PL: Produkt skrajnie łatwopalny.PT: Extremamente inflamável.RO: Extrem de inflamabil.SK: Mimoriadne horľavý.SL: Zelo lahko vnetljivo.FI: Erittäin helposti syttyvää.SV: Extremt brandfarligt.R14BG: Реагира бурно с вода.ES: Reacciona violentamente con el agua.CS: Prudce reaguje s vodou.DA: Reagerer voldsomt med vand.DE: Reagiert heftig mit Wasser.ET: Reageerib ägedalt veega.EL: Αντιδρά βίαια με νερό.EN: Reacts violently with water.FR: Réagit violemment au contact de l’eau.IT: Reagisce violentemente con l’acqua.LV: Aktīvi reaģē ar ūdeni.LT: Smarkiai reaguoja su vandeniu.HU: Vízzel hevesen reagál.MT: Jirreaġixxi bil-qawwa meta jmiss l-ilma.NL: Reageert heftig met water.PL: Reaguje gwałtownie z wodą.PT: Reage violentamente em contacto com a água.RO: Reacţionează violent la contactul cu apa.SK: Prudko reaguje s vodou.SL: Burno reagira z vodo.FI: Reagoi voimakkaasti veden kanssa.SV: Reagerar häftigt med vatten.R15BG: При контакт с вода се отделят изключително запалими газове.ES: Reacciona con el agua liberando gases extremadamente inflamables.CS: Při styku s vodou uvolňuje extrémně hořlavé plyny.DA: Reagerer med vand under dannelse af yderst brandfarlige gasser.DE: Reagiert mit Wasser unter Bildung hochentzündlicher Gase.ET: Kokkupuutel veega eraldub väga tuleohtlik gaas.EL: Σε επαφή με το νερό εκλύει εξαιρετικά εύφλεκτα αέρια.EN: Contact with water liberates extremely flammable gases.FR: Au contact de l’eau, dégage des gaz extrêmement inflammables.IT: A contatto con l’acqua libera gas estremamente infiammabili.LV: Saskaroties ar ūdeni, izdala īpaši viegli uzliesmojošas gāzes.LT: Reaguoja su vandeniu, išskirdama ypač degias dujas.HU: Vízzel érintkezve fokozottan tűzveszélyes gázok képződnek.MT: B’kuntatt ma’ l-ilma joħroġ gassijiet li jieħdu n-nar malajr ħafna.NL: Vormt zeer licht ontvlambaar gas in contact met water.PL: W kontakcie z wodą uwalnia skrajnie łatwopalne gazy.PT: Em contacto com a água liberta gases extremamente inflamáveis.RO: La contactul cu apa degajă gaze extrem de inflamabile.SK: Pri kontakte s vodou sa uvoľňujú mimoriadne horľavé plyny.SL: V stiku z vodo se sproščajo zelo lahko vnetljivi plini.FI: Vapauttaa erittäin helposti syttyviä kaasuja veden kanssa.SV: Vid kontakt med vatten bildas extremt brandfarliga gaser.R16BG: Експлозивен при смесване с оксидиращи вещества.ES: Puede explosionar en mezcla con substancias comburentes.CS: Výbušný při smíchání s oxidačními látkami.DA: Eksplosionsfarlig ved blanding med oxiderende stoffer.DE: Explosionsgefährlich in Mischung mit brandfördernden Stoffen.ET: Plahvatusohtlik segatult oksüdeerivate ainetega.EL: Εκρηκτικό όταν αναμιχθεί με οξειδωτικές ουσίες.EN: Explosive when mixed with oxidizing substances.FR: Peut exploser en mélange avec des substances comburantes.IT: Pericolo di esplosione se mescolato con sostanze comburenti.LV: Sprāgst, saskaroties ar oksidētājiem.LT: Gali sprogti sumaišyta su oksiduojančiomis medžiagomis.HU: Oxidáló anyaggal keveredve robbanásveszélyes.MT: Jista’ jisplodi meta jitħallat ma’ sustanzi li jsaddu.NL: Ontploffingsgevaar bij menging met oxyderende stoffen.PL: Produkt wybuchowy po zmieszaniu z substancjami utleniającymi.PT: Explosivo quando misturado com substâncias comburentes.RO: Exploziv în amestec cu substanţe oxidante.SK: Výbušný po zmiešaní s oxidujúcimi látkami.SL: Eksplozivno v mešanici z oksidativnimi snovmi.FI: Räjähtävää hapettavien aineiden kanssa.SV: Explosivt vid blandning med oxiderande ämnen.R17BG: Самозапалва се в присъствие на въздух.ES: Se inflama espontáneamente en contacto con el aire.CS: Samovznětlivý na vzduchu.DA: Selvantændelig i luft.DE: Selbstentzündlich an der Luft.ET: Isesüttiv õhu käes.EL: Αυτοαναφλέγεται στον αέρα.EN: Spontaneously flammable in air.FR: Spontanément inflammable à l’air.IT: Spontaneamente infiammabile all’aria.LV: Spontāni uzliesmo gaisā.LT: Savaime užsideganti ore.HU: Levegőn öngyulladó.MT: Jaqbad waħdu fl-arja.NL: Spontaan ontvlambaar in lucht.PL: Samorzutnie zapala się w powietrzu.PT: Espontaneamente inflamável ao ar.RO: Inflamabil spontan în aer.SK: Vznietivý na vzduchu.SL: Samovnetljivo na zraku.FI: Itsestään syttyvää ilmassa.SV: Självantänder i luft.R18BG: При употреба може да образува запалима или експлозивна паровъздушнa смес.ES: Al usarlo pueden formarse mezclas aire-vapor explosivas/inflamables.CS: Při používání může vytvářet hořlavé nebo výbušné směsi par se vzduchem.DA: Ved brug kan brandbare dampe/eksplosive damp-luftblandinger dannes.DE: Bei Gebrauch Bildung explosionsfähiger/leichtentzündlicher Dampf/Luft-Gemische möglich.ET: Kasutamisel võib moodustuda tule-/plahvatusohtlik auru-õhu segu.EL: Κατά τη χρήση μπορεί να σχηματίσει εύφλεκτα/εκρηκτικά μείγματα ατμού-αέρος.EN: In use, may form flammable/explosive vapour-air mixture.FR: Lors de l’utilisation, formation possible de mélange vapeur-air inflammable/explosif.IT: Durante l’uso può formare con aria miscele esplosive/infiammabili.LV: Izmantojot var veidot uzliesmojošu vai sprādzienbīstamu tvaiku un gaisa maisījumu.LT: Naudojama gali sudaryti degius (sprogius) garų (oro) mišinius.HU: A használat során robbanásveszélyes/tűzveszélyes gáz-levegő elegy keletkezhet.MT: Meta jintuża jista’ jifforma taħlitiet esplussivi jew li jaqbdu jekk jitħallat ma’ l-arja.NL: Kan bij gebruik een ontvlambaar/ontplofbaar damp-luchtmengsel vormen.PL: Podczas stosowania mogą powstawać łatwopalne lub wybuchowe mieszaniny par z powietrzem.PT: Pode formar mistura vapor-ar explosiva/inflamável durante a utilização.RO: La utilizare, vaporii pot forma cu aerul amestecuri explozive/inflamabile.SK: Pri použití môže vytvárať horľavé/výbušné zmesi pár so vzduchom.SL: Pri uporabi lahko tvori vnetljivo/eksplozivno zmes hlapi-zrak.FI: Käytössä voi muodostua syttyvä/räjähtävä höyry-ilma-seos.SV: Vid användning kan brännbara/explosiva ång-luftblandningar bildas.R19BG: Може да образува експлозивни пероксиди.ES: Puede formar peróxidos explosivos.CS: Může vytvářet výbušné peroxidy.DA: Kan danne eksplosive peroxider.DE: Kann explosionsfähige Peroxide bilden.ET: Võib moodustada plahvatusohtlikke peroksiide.EL: Μπορεί να σχηματίσει εκρηκτικά υπεροξείδια.EN: May form explosive peroxides.FR: Peut former des peroxydes explosifs.IT: Può formare perossidi esplosivi.LV: Var veidot sprādzienbīstamus peroksīdus.LT: Gali sudaryti sprogstamuosius peroksidus.HU: Robbanásveszélyes peroxidokat képezhet.MT: Jista’ jifforma perossidi esplussivi.NL: Kan ontplofbare peroxiden vormen.PL: Może tworzyć wybuchowe nadtlenki.PT: Pode formar peróxidos explosivos.RO: Poate forma peroxizi explozivi.SK: Môže vytvárať výbušné peroxidy.SL: Lahko tvori eksplozivne perokside.FI: Saattaa muodostua räjähtäviä peroksideja.SV: Kan bilda explosiva peroxider.R20BG: Вреден при вдишване.ES: Nocivo por inhalación.CS: Zdraví škodlivý při vdechování.DA: Farlig ved indånding.DE: Gesundheitsschädlich beim Einatmen.ET: Kahjulik sissehingamisel.EL: Επιβλαβές όταν εισπνέεται.EN: Harmful by inhalation.FR: Nocif par inhalation.IT: Nocivo per inalazione.LV: Kaitīgs ieelpojot.LT: Kenksminga įkvėpus.HU: Belélegezve ártalmas.MT: Jagħmel ħsara meta jinxtamm.NL: Schadelijk bij inademing.PL: Działa szkodliwie przez drogi oddechowe.PT: Nocivo por inalação.RO: Nociv prin inhalare.SK: Škodlivý pri vdýchnutí.SL: Zdravju škodljivo pri vdihavanju.FI: Terveydelle haitallista hengitettynä.SV: Farligt vid inandning.R21BG: Вреден при контакт с кожата.ES: Nocivo en contacto con la piel.CS: Zdraví škodlivý při styku s kůží.DA: Farlig ved hudkontakt.DE: Gesundheitsschädlich bei Berührung mit der Haut.ET: Kahjulik kokkupuutel nahaga.EL: Επιβλαβές σε επαφή με το δέρμα.EN: Harmful in contact with skin.FR: Nocif par contact avec la peau.IT: Nocivo a contatto con la pelle.LV: Kaitīgs, nonākot saskarē ar ādu.LT: Kenksminga susilietus su oda.HU: Bőrrel érintkezve ártalmas.MT: Jagħmel ħsara meta jmiss il-ġilda.NL: Schadelijk bij aanraking met de huid.PL: Działa szkodliwie w kontakcie ze skórą.PT: Nocivo em contacto com a pele.RO: Nociv în contact cu pielea.SK: Škodlivý pri kontakte s pokožkou.SL: Zdravju škodljivo v stiku s kožo.FI: Terveydelle haitallista joutuessaan iholle.SV: Farligt vid hudkontakt.R22BG: Вреден при поглъщане.ES: Nocivo por ingestión.CS: Zdraví škodlivý při požití.DA: Farlig ved indtagelse.DE: Gesundheitsschädlich beim Verschlucken.ET: Kahjulik allaneelamisel.EL: Επιβλαβές σε περίπτωση καταπόσεως.EN: Harmful if swallowed.FR: Nocif en cas d’ingestion.IT: Nocivo per ingestione.LV: Kaitīgs norijot.LT: Kenksminga prarijus.HU: Lenyelve ártalmas.MT: Jagħmel ħsara meta jinbela’.NL: Schadelijk bij opname door de mond.PL: Działa szkodliwie po połknięciu.PT: Nocivo por ingestão.RO: Nociv în caz de înghiţire.SK: Škodlivý po požití.SL: Zdravju škodljivo pri zaužitju.FI: Terveydelle haitallista nieltynä.SV: Farligt vid förtäring.R23BG: Токсичен при вдишване.ES: Tóxico por inhalación.CS: Toxický při vdechování.DA: Giftig ved indånding.DE: Giftig beim Einatmen.ET: Mürgine sissehingamisel.EL: Τοξικό όταν εισπνέεται.EN: Toxic by inhalation.FR: Toxique par inhalation.IT: Tossico per inalazione.LV: Toksisks ieelpojot.LT: Toksiška įkvėpus.HU: Belélegezve mérgező (toxikus).MT: Tossiku meta jinxtamm.NL: Vergiftig bij inademing.PL: Działa toksycznie przez drogi oddechowe.PT: Tóxico por inalação.RO: Toxic prin inhalare.SK: Jedovatý pri vdýchnutí.SL: Strupeno pri vdihavanju.FI: Myrkyllistä hengitettynä.SV: Giftigt vid inandning.R24BG: Токсичен при контакт с кожата.ES: Tóxico en contacto con la piel.CS: Toxický při styku s kůží.DA: Giftig ved hudkontakt.DE: Giftig bei Berührung mit der Haut.ET: Mürgine kokkupuutel nahaga.EL: Τοξικό σε επαφή με το δέρμα.EN: Toxic in contact with skin.FR: Toxique par contact avec la peau.IT: Tossico a contatto con la pelle.LV: Toksisks, nonākot saskarē ar ādu.LT: Toksiška susilietus su oda.HU: Bőrrel érintkezve mérgező (toxikus).MT: Tossiku meta jmiss il-ġilda.NL: Vergiftig bij aanraking met de huid.PL: Działa toksycznie w kontakcie ze skórą.PT: Tóxico em contacto com a pele.RO: Toxic în contact cu pielea.SK: Jedovatý pri kontakte s pokožkou.SL: Strupeno v stiku s kožo.FI: Myrkyllistä joutuessaan iholle.SV: Giftigt vid hudkontakt.R25BG: Токсичен при поглъщане.ES: Tóxico por ingestión.CS: Toxický při požití.DA: Giftig ved indtagelse.DE: Giftig beim Verschlucken.ET: Mürgine allaneelamisel.EL: Τοξικό σε περίπτωση καταπόσεως.EN: Toxic if swallowed.FR: Toxique en cas d’ingestion.IT: Tossico per ingestione.LV: Toksisks norijot.LT: Toksiška prarijus.HU: Lenyelve mérgező (toxikus).MT: Tossiku jekk jinbela’.NL: Vergiftig bij opname door de mond.PL: Działa toksycznie po połknięciu.PT: Tóxico por ingestão.RO: Toxic în caz de înghiţire.SK: Jedovatý po požití.SL: Strupeno pri zaužitju.FI: Myrkyllistä nieltynä.SV: Giftigt vid förtäring.R26BG: Силно токсичен при вдишване.ES: Muy tóxico por inhalación.CS: Vysoce toxický při vdechování.DA: Meget giftig ved indånding.DE: Sehr giftig beim Einatmen.ET: Väga mürgine sissehingamisel.EL: Πολύ τοξικό όταν εισπνέεται.EN: Very toxic by inhalation.FR: Très toxique par inhalation.IT: Molto tossico per inalazione.LV: Ļoti toksisks ieelpojot.LT: Labai toksiška įkvėpus.HU: Belélegezve nagyon mérgező (toxikus).MT: Tossiku ħafna meta jinxtamm.NL: Zeer vergiftig bij inademing.PL: Działa bardzo toksycznie przez drogi oddechowe.PT: Muito tóxico por inalação.RO: Foarte toxic prin inhalare.SK: Veľmi jedovatý pri vdýchnutí.SL: Zelo strupeno pri vdihavanju.FI: Erittäin myrkyllistä hengitettynä.SV: Mycket giftigt vid inandning.R27BG: Силно токсичен при контакт с кожата.ES: Muy tóxico en contacto con la piel.CS: Vysoce toxický při styku s kůží.DA: Meget giftig ved hudkontakt.DE: Sehr giftig bei Berührung mit der Haut.ET: Väga mürgine kokkupuutel nahaga.EL: Πολύ τοξικό σε επαφή με το δέρμα.EN: Very toxic in contact with skin.FR: Très toxique par contact avec la peau.IT: Molto tossico a contatto con la pelle.LV: Ļoti toksisks, nonākot saskarē ar ādu.LT: Labai toksiška susilietus su oda.HU: Bőrrel érintkezve nagyon mérgező (toxikus).MT: Tossiku ħafna meta jmiss il-ġilda.NL: Zeer vergiftig bij aanraking met de huid.PL: Działa bardzo toksycznie w kontakcie ze skórą.PT: Muito tóxico em contacto com a pele.RO: Foarte toxic în contact cu pielea.SK: Veľmi jedovatý pri kontakte s pokožkou.SL: Zelo strupeno v stiku s kožo.FI: Erittäin myrkyllistä joutuessaan iholle.SV: Mycket giftigt vid hudkontakt.R28BG: Силно токсичен при поглъщане.ES: Muy tóxico por ingestión.CS: Vysoce toxický při požití.DA: Meget giftig ved indtagelse.DE: Sehr giftig beim Verschlucken.ET: Väga mürgine allaneelamisel.EL: Πολύ τοξικό σε περίπτωση καταπόσεως.EN: Very toxic if swallowed.FR: Très toxique en cas d’ingestion.IT: Molto tossico per ingestione.LV: Ļoti toksisks norijot.LT: Labai toksiška prarijus.HU: Lenyelve nagyon mérgező (toxikus).MT: Tossiku ħafna jekk jinbela’.NL: Zeer vergiftig bij opname door de mond.PL: Działa bardzo toksycznie po połknięciu.PT: Muito tóxico por ingestão.RO: Foarte toxic în caz de înghiţire.SK: Veľmi jedovatý po požití.SL: Zelo strupeno pri zaužitju.FI: Erittäin myrkyllistä nieltynä.SV: Mycket giftigt vid förtäring.R29BG: При контакт с вода се отделя токсичен газ.ES: En contacto con agua libera gases tóxicos.CS: Uvolňuje toxický plyn při styku s vodou.DA: Udvikler giftig gas ved kontakt med vand.DE: Entwickelt bei Berührung mit Wasser giftige Gase.ET: Kokkupuutel veega eraldub mürgine gaas.EL: Σε επαφή με το νερό ελευθερώνονται τοξικά αέρια.EN: Contact with water liberates toxic gas.FR: Au contact de l’eau, dégage des gaz toxiques.IT: A contatto con l’acqua libera gas tossici.LV: Saskaroties ar ūdeni, izdala toksiskas gāzes.LT: Reaguodama su vandeniu, išskiria toksiškas dujas.HU: Vízzel érintkezve mérgező gázok képződnek.MT: Jitfa’ gass tossiku meta jmiss l-ilma.NL: Vormt vergiftig gas in contact met water.PL: W kontakcie z wodą uwalnia toksyczne gazy.PT: Em contacto com a água liberta gases tóxicos.RO: La contactul cu apa se degajă gaze toxice.SK: Pri kontakte s vodou uvoľňuje jedovatý plyn.SL: V stiku z vodo se sprošča strupen plin.FI: Kehittää myrkyllistä kaasua veden kanssa.SV: Utvecklar giftig gas vid kontakt med vatten.R30BG: Може да стане лесно запалим при употреба.ES: Puede inflamarse fácilmente al usarlo.CS: Při používání se může stát vysoce hořlavým.DA: Kan blive meget brandfarlig under brug.DE: Kann bei Gebrauch leicht entzündlich werden.ET: Kasutamisel võib muutuda väga tuleohtlikuks.EL: Κατά τη χρήση γίνεται πολύ εύφλεκτο.EN: Can become highly flammable in use.FR: Peut devenir facilement inflammable pendant l’utilisation.IT: Può divenire facilmente infiammabile durante l’uso.LV: Var viegli uzliesmot lietošanas laikā.LT: Naudojama gali tapti labai degi.HU: A használat során tűzveszélyessé válik.MT: Jista’ jaqbad malajr waqt li jintuża.NL: Kan bij gebruik licht ontvlambaar worden.PL: Podczas stosowania może stać się wysoce łatwopalny.PT: Pode-se tornar facilmente inflamável durante o uso.RO: Poate deveni foarte inflamabil în timpul utilizării.SK: Pri použití sa môže stať veľmi horľavým.SL: Med uporabo utegne postati ‘lahko vnetljivo’.FI: Käytettäessä voi muuttua helposti syttyväksi.SV: Kan bli mycket brandfarligt vid användning.R31BG: При контакт с киселини се отделя токсичен газ.ES: En contacto con ácidos libera gases tóxicos.CS: Uvolňuje toxický plyn při styku s kyselinami.DA: Udvikler giftig gas ved kontakt med syre.DE: Entwickelt bei Berührung mit Säure giftige Gase.ET: Kokkupuutel hapetega eraldub mürgine gaas.EL: Σε επαφή με οξέα ελευθερώνονται τοξικά αέρια.EN: Contact with acids liberates toxic gas.FR: Au contact d’un acide, dégage un gaz toxique.IT: A contatto con acidi libera gas tossico.LV: Saskaroties ar skābēm, izdala toksiskas gāzes.LT: Reaguodama su rūgštimis, išskiria toksiškas dujas.HU: Savval érintkezve mérgező gázok képződnek.MT: Jitfa’ gass tossiku meta jmiss l-aċidi.NL: Vormt vergiftige gassen in contact met zuren.PL: W kontakcie z kwasami uwalnia toksyczne gazy.PT: Em contacto com ácidos liberta gases tóxicos.RO: La contactul cu acizii se degajă gaze toxice.SK: Pri kontakte s kyselinami uvoľňuje jedovatý plyn.SL: V stiku s kislinami se sprošča strupen plin.FI: Kehittää myrkyllistä kaasua hapon kanssa.SV: Utvecklar giftig gas vid kontakt med syra.R32BG: При контакт с киселини се отделя силно токсичен газ.ES: En contacto con ácidos libera gases muy tóxicos.CS: Uvolňuje vysoce toxický plyn při styku s kyselinami.DA: Udvikler meget giftig gas ved kontakt med syre.DE: Entwickelt bei Berührung mit Säure sehr giftige Gase.ET: Kokkupuutel hapetega eraldub väga mürgine gaas.EL: Σε επαφή με οξέα ελευθερώνονται πολύ τοξικά αέρια.EN: Contact with acids liberates very toxic gas.FR: Au contact d’un acide, dégage un gaz très toxique.IT: A contatto con acidi libera gas molto tossico.LV: Saskaroties ar skābēm, izdala ļoti toksiskas gāzes.LT: Reaguodama su rūgštimis, išskiria labai toksiškas dujas.HU: Savval érintkezve nagyon mérgező gázok képződnek.MT: Jitfa’ gass tossiku ħafna meta jmiss l-aċidi.NL: Vormt zeer vergiftige gassen in contact met zuren.PL: W kontakcie z kwasami uwalnia bardzo toksyczne gazy.PT: Em contacto com ácidos liberta gases muito tóxicos.RO: La contactul cu acizii se degajă gaze foarte toxice.SK: Pri kontakte s kyselinami uvoľňuje veľmi jedovatý plyn.SL: V stiku s kislinami se sprošča zelo strupen plin.FI: Kehittää erittäin myrkyllistä kaasua hapon kanssa.SV: Utvecklar mycket giftig gas vid kontakt med syra.R33BG: Опасност от кумулативни ефекти.ES: Peligro de efectos acumulativos.CS: Nebezpečí kumulativních účinků.DA: Kan ophobes i kroppen efter gentagen brug.DE: Gefahr kumulativer Wirkungen.ET: Kumulatiivse toime oht.EL: Κίνδυνος αθροιστικών επιδράσεων.EN: Danger of cumulative effects.FR: Danger d’effets cumulatifs.IT: Pericolo di effetti cumulativi.LV: Kaitīgas kumulatīvas ietekmes draudi.LT: Pavojinga — kaupiasi organizme.HU: A halmozódó (kumulatív) hatások miatt veszélyes.MT: Periklu ta’ effetti kumulattivi.NL: Gevaar voor cumulatieve effecten.PL: Niebezpieczeństwo kumulacji w organizmie.PT: Perigo de efeitos cumulativos.RO: Pericol de efecte cumulative.SK: Nebezpečenstvo kumulatívnych účinkov.SL: Nevarnost za zdravje zaradi kopičenja v organizmu.FI: Terveydellisten haittojen vaara pitkäaikaisessa altistuksessa.SV: Kan ansamlas i kroppen och ge skador.R34BG: Предизвиква изгаряния.ES: Provoca quemaduras.CS: Způsobuje poleptání.DA: Ætsningsfare.DE: Verursacht Verätzungen.ET: Põhjustab söövitust.EL: Προκαλεί εγκαύματα.EN: Causes burns.FR: Provoque des brûlures.IT: Provoca ustioni.LV: Rada apdegumus.LT: Nudegina.HU: Égési sérülést okoz.MT: Jikkaġuna l-ħruq (fil-ġisem).NL: Veroorzaakt brandwonden.PL: Powoduje oparzenia.PT: Provoca queimaduras.RO: Provoacă arsuri.SK: Spôsobuje popáleniny/poleptanie.SL: Povzroča opekline.FI: Syövyttävää.SV: Frätande.R35BG: Предизвиква тежки изгаряния.ES: Provoca quemaduras graves.CS: Způsobuje těžké poleptání.DA: Alvorlig ætsningsfare.DE: Verursacht schwere Verätzungen.ET: Põhjustab tugevat söövitust.EL: Προκαλεί σοβαρά εγκαύματα.EN: Causes severe burns.FR: Provoque de graves brûlures.IT: Provoca gravi ustioni.LV: Rada smagus apdegumus.LT: Stipriai nudegina.HU: Súlyos égési sérülést okoz.MT: Jikkaġuna ħruq serju (fil-ġisem).NL: Veroorzaakt ernstige brandwonden.PL: Powoduje poważne oparzenia.PT: Provoca queimaduras graves.RO: Provoacă arsuri grave.SK: Spôsobuje silné popáleniny/poleptanie.SL: Povzroča hude opekline.FI: Voimakkaasti syövyttävää.SV: Starkt frätande.R36BG: Дразни очите.ES: Irrita los ojos.CS: Dráždí oči.DA: Irriterer øjnene.DE: Reizt die Augen.ET: Ärritab silmi.EL: Ερεθίζει τα μάτια.EN: Irritating to eyes.FR: Irritant pour les yeux.IT: Irritante per gli occhi.LV: Kairina acis.LT: Dirgina akis.HU: Szemizgató hatású.MT: Jirrita l-għajnejn.NL: Irriterend voor de ogen.PL: Działa drażniąco na oczy.PT: Irritante para os olhos.RO: Iritant pentru ochi.SK: Dráždi oči.SL: Draži oči.FI: Ärsyttää silmiä.SV: Irriterar ögonen.R37BG: Дразни дихателните пътища.ES: Irrita las vías respiratorias.CS: Dráždí dýchací orgány.DA: Irriterer åndedrætsorganerne.DE: Reizt die Atmungsorgane.ET: Ärritab hingamiselundeid.EL: Ερεθίζει το αναπνευστικό σύστημα.EN: Irritating to respiratory system.FR: Irritant pour les voies respiratoires.IT: Irritante per le vie respiratorie.LV: Kairina elpošanas sistēmu.LT: Dirgina kvėpavimo takus.HU: Izgatja a légutakat.MT: Jirrita s-sistema respiratorja.NL: Irriterend voor de ademhalingswegen.PL: Działa drażniąco na drogi oddechowe.PT: Irritante para as vias respiratórias.RO: Iritant pentru sistemul respirator.SK: Dráždi dýchacie cesty.SL: Draži dihala.FI: Ärsyttää hengityselimiä.SV: Irriterar andningsorganen.R38BG: Дразни кожата.ES: Irrita la piel.CS: Dráždí kůži.DA: Irriterer huden.DE: Reizt die Haut.ET: Ärritab nahka.EL: Ερεθίζει το δέρμα.EN: Irritating to skin.FR: Irritant pour la peau.IT: Irritante per la pelle.LV: Kairina ādu.LT: Dirgina odą.HU: Bőrizgató hatású.MT: Jirrita l-ġilda.NL: Irriterend voor de huid.PL: Działa drażniąco na skórę.PT: Irritante para a pele.RO: Iritant pentru piele.SK: Dráždi pokožku.SL: Draži kožo.FI: Ärsyttää ihoa.SV: Irriterar huden.R39BG: Опасност от много тежки необратими ефекти.ES: Peligro de efectos irreversibles muy graves.CS: Nebezpečí velmi vážných nevratných účinků.DA: Fare for varig alvorlig skade på helbred.DE: Ernste Gefahr irreversiblen Schadens.ET: Väga tõsiste pöördumatute tervisekahjustuste oht.EL: Κίνδυνος πολύ σοβαρών μονίμων επιδράσεων.EN: Danger of very serious irreversible effects.FR: Danger d’effets irréversibles très graves.IT: Pericolo di effetti irreversibili molto gravi.LV: Būtiski neatgriezeniskas iedarbības draudi.LT: Sukelia labai sunkius negrįžtamus sveikatos pakenkimus.HU: Nagyon súlyos és maradandó egészségkárosodást okozhat.MT: Periklu ta’ effetti serji irreversibbli.NL: Gevaar voor ernstige onherstelbare effecten.PL: Zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Perigo de efeitos irreversíveis muito graves.RO: Pericol de efecte ireversibile foarte grave.SK: Nebezpečenstvo veľmi vážnych ireverzibilných účinkov.SL: Nevarnost zelo hudih trajnih okvar zdravja.FI: Erittäin vakavien pysyvien vaurioiden vaara.SV: Risk för mycket allvarliga bestående hälsoskador.R40BG: Съществуващи, но недостатъчни данни за канцерогенен ефект.ES: Posibles efectos cancerígenos.CS: Podezření na karcinogenní účinky.DA: Mulighed for kræftfremkaldende effekt.DE: Verdacht auf krebserzeugende Wirkung.ET: Võimalik vähktõve põhjustaja.EL: Ύποπτο καρκινογένεσης.EN: Limited evidence of a carcinogenic effect.FR: Effet cancérogène suspecté — preuves insuffisantes.IT: Possibilità di effetti cancerogeni — prove insufficienti.LV: Kancerogenitāte ir daļēji pierādīta.LT: Įtariama, kad gali sukelti vėžį.HU: A rákkeltő hatás korlátozott mértékben bizonyított.MT: Possibilità, mhix għal kollox ippruvata, ta’ effetti kanċeroġeni.NL: Carcinogene effecten zijn niet uitgesloten.PL: Ograniczone dowody działania rakotwórczego.PT: Possibilidade de efeitos cancerígenos.RO: Posibil efect cancerigen — dovezi insuficiente.SK: Možnosť karcinogénneho účinku.SL: Možen rakotvoren učinek.FI: Epäillään aiheuttavan syöpäsairauden vaaraa.SV: Misstänks kunna ge cancer.R41BG: Риск от тежко увреждане на очите.ES: Riesgo de lesiones oculares graves.CS: Nebezpečí vážného poškození očí.DA: Risiko for alvorlig øjenskade.DE: Gefahr ernster Augenschäden.ET: Silmade kahjustamise tõsine oht.EL: Κίνδυνος σοβαρών οφθαλμικών βλαβών.EN: Risk of serious damage to eyes.FR: Risque de lésions oculaires graves.IT: Rischio di gravi lesioni oculari.LV: Nopietnu bojājumu draudi acīm.LT: Gali smarkiai pažeisti akis.HU: Súlyos szemkárosodást okozhat.MT: Riskju ta’ ħsara serja lill-għajnejn.NL: Gevaar voor ernstig oogletsel.PL: Ryzyko poważnego uszkodzenia oczu.PT: Risco de lesões oculares graves.RO: Risc de leziuni oculare grave.SK: Riziko vážneho poškodenia očí.SL: Nevarnost hudih poškodb oči.FI: Vakavan silmävaurion vaara.SV: Risk för allvarliga ögonskador.R42BG: Възможна е сенсибилизация при вдишване.ES: Posibilidad de sensibilización por inhalación.CS: Může vyvolat senzibilizaci při vdechování.DA: Kan give overfølsomhed ved indånding.DE: Sensibilisierung durch Einatmen möglich.ET: Sissehingamisel võib põhjustada ülitundlikkust.EL: Μπορεί να προκαλέσει ευαισθητοποίηση όταν εισπνέεται.EN: May cause sensitization by inhalation.FR: Peut entraîner une sensibilisation par inhalation.IT: Può provocare sensibilizzazione per inalazione.LV: Ieelpojot var izraisīt paaugstinātu jutīgumu.LT: Gali sukelti alergiją įkvėpus.HU: Belélegezve túlérzékenységet okozhat (szenzibilizáló hatású lehet).MT: Jista’ jġib sensitizzazzjoni meta jinxtamm.NL: Kan overgevoeligheid veroorzaken bij inademing.PL: Może powodować uczulenie w następstwie narażenia drogą oddechową.PT: Pode causar sensibilização por inalação.RO: Poate provoca o sensibilizare prin inhalare.SK: Môže spôsobiť senzibilizáciu pri vdýchnutí.SL: Vdihavanje lahko povzroči preobčutljivost.FI: Altistuminen hengitysteitse voi aiheuttaa herkistymistä.SV: Kan ge allergi vid inandning.R43BG: Възможна е сенсибилизация при контакт с кожата.ES: Posibilidad de sensibilización en contacto con la piel.CS: Může vyvolat senzibilizaci při styku s kůží.DA: Kan give overfølsomhed ved kontakt med huden.DE: Sensibilisierung durch Hautkontakt möglich.ET: Kokkupuutel nahaga võib põhjustada ülitundlikkust.EL: Μπορεί να προκαλέσει ευαισθητοποίηση σε επαφή με το δέρμα.EN: May cause sensitisation by skin contact.FR: Peut entraîner une sensibilisation par contact avec la peau.IT: Può provocare sensibilizzazione per contatto con la pelle.LV: Saskaroties ar ādu, var izraisīt paaugstinātu jutīgumu.LT: Gali sukelti alergiją susilietus su oda.HU: Bőrrel érintkezve túlérzékenységet okozhat (szenzibilizáló hatású lehet).MT: Jista’ jikkaġuna sensitizzazzjoni meta jmiss il-ġilda.NL: Kan overgevoeligheid veroorzaken bij contact met de huid.PL: Może powodować uczulenie w kontakcie ze skórą.PT: Pode causar sensibilização em contacto com a pele.RO: Poate provoca o sensibilizare în contact cu pielea.SK: Môže spôsobiť senzibilizáciu pri kontakte s pokožkou.SL: Stik s kožo lahko povzroči preobčutljivost.FI: Ihokosketus voi aiheuttaa herkistymistä.SV: Kan ge allergi vid hudkontakt.R44BG: Риск от експлозия при нагряване в затворено пространство.ES: Riesgo de explosión al calentarlo en ambiente confinado.CS: Nebezpečí výbuchu při zahřátí v uzavřeném obalu.DA: Eksplosionsfarlig ved opvarmning under indeslutning.DE: Explosionsgefahr bei Erhitzen unter Einschluss.ET: Plahvatusohtlik kuumutamisel kinnises mahutis.EL: Κίνδυνος εκρήξεως εάν θερμανθεί υπό περιορισμό.EN: Risk of explosion if heated under confinement.FR: Risque d’explosion si chauffé en ambiance confinée.IT: Rischio di esplosione per riscaldamento in ambiente confinato.LV: Sprādziena draudi, karsējot slēgtā vidē.LT: Gali sprogti, jei kaitinama sandariai uždaryta.HU: Zárt térben hő hatására robbanhat.MT: Riskju ta’ splużjoni jekk jissaħħan fil-magħluq.NL: Ontploffingsgevaar bij verwarming in afgesloten toestand.PL: Zagrożenie wybuchem po ogrzaniu w zamkniętym pojemniku.PT: Risco de explosão se aquecido em ambiente fechado.RO: Risc de explozie dacă este încălzit în spaţiu închis.SK: Riziko výbuchu pri zahrievaní v uzavretom priestore.SL: Nevarnost eksplozije ob segrevanju v zaprtem prostoru.FI: Räjähdysvaara kuumennettaessa suljetussa astiassa.SV: Explosionsrisk vid uppvärmning i sluten behållare.R45BG: Може да причини рак.ES: Puede causar cáncer.CS: Může vyvolat rakovinu.DA: Kan fremkalde kræft.DE: Kann Krebs erzeugen.ET: Võib põhjustada vähktõbe.EL: Μπορεί να προκαλέσει καρκίνο.EN: May cause cancer.FR: Peut provoquer le cancer.IT: Può provocare il cancro.LV: Kancerogēna viela.LT: Gali sukelti vėžį.HU: Rákot okozhat (karcinogén hatású lehet).MT: Jista’ jġib il-kanċer.NL: Kan kanker veroorzaken.PL: Może powodować raka.PT: Pode causar cancro.RO: Poate cauza cancer.SK: Môže spôsobiť rakovinu.SL: Lahko povzroči raka.FI: Aiheuttaa syöpäsairauden vaaraa.SV: Kan ge cancer.R46BG: Може да причини наследствено генетично увреждане.ES: Puede causar alteraciones genéticas hereditarias.CS: Může vyvolat poškození dědičných vlastností.DA: Kan forårsage arvelige genetiske skader.DE: Kann vererbbare Schäden verursachen.ET: Võib põhjustada pärilikke kahjustusi.EL: Μπορεί να προκαλέσει κληρονομικές γενετικές βλάβες.EN: May cause heritable genetic damage.FR: Peut provoquer des altérations génétiques héréditaires.IT: Può provocare alterazioni genetiche ereditarie.LV: Var radīt pārmantojamus ģenētiskus defektus.LT: Gali sukelti paveldimus genetinius pakenkimus.HU: Öröklődő genetikai károsodást okozhat (mutagén hatású lehet).MT: Jista’ jikkaġuna ħsara ġenetika li tintiret.NL: Kan erfelijke genetische schade veroorzaken.PL: Może powodować dziedziczne wady genetyczne.PT: Pode causar alterações genéticas hereditárias.RO: Poate provoca modificări genetice ereditare.SK: Môže spôsobiť dedičné genetické poškodenie.SL: Lahko povzroči dedne genetske okvare.FI: Saattaa aiheuttaa periytyviä perimävaurioita.SV: Kan ge ärftliga genetiska skador.R48BG: Опасност от тежко увреждане на здравето при продължителна експозиция.ES: Riesgo de efectos graves para la salud en caso de exposición prolongada.CS: Při dlouhodobé expozici nebezpečí vážného poškození zdraví.DA: Alvorlig sundhedsfare ved længere tids påvirkning.DE: Gefahr ernster Gesundheitsschäden bei längerer Exposition.ET: Pikaajalisel toimel tõsise tervisekahjustuse oht.EL: Κίνδυνος σοβαρής βλάβης της υγείας ύστερα απο παρατεταμένη έκθεση.EN: Danger of serious damage to health by prolonged exposure.FR: Risque d’effets graves pour la santé en cas d’exposition prolongée.IT: Pericolo di gravi danni per la salute in caso di esposizione prolungata.LV: Iespējams nopietns kaitējums veselībai pēc ilgstošas saskares.LT: Veikiant ilgą laiką sukelia sunkius sveikatos sutrikimus.HU: Hosszú időn át hatva súlyos egészségkárosodást okozhat.MT: Periklu ta’ ħsara serja lis-saħħa jekk wieħed ikun espost għalih fit-tul.NL: Gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling.PL: Stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Risco de efeitos graves para a saúde em caso de exposição prolongada.RO: Pericol de efecte grave asupra sănătăţii în caz de expunere prelungită.SK: Nebezpečenstvo vážneho poškodenia zdravia pri dlhodobej expozícii.SL: Nevarnost hudih okvar zdravja pri dolgotrajnejši izpostavljenosti.FI: Pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle.SV: Risk för allvarliga hälsoskador vid långvarig exponering.R49BG: Може да причини рак при вдишване.ES: Puede causar cáncer por inhalación.CS: Může vyvolat rakovinu při vdechování.DA: Kan fremkalde kræft ved indånding.DE: Kann Krebs erzeugen beim Einatmen.ET: Sissehingamisel võib põhjustada vähktõbe.EL: Μπορεί να προκαλέσει καρκίνο όταν εισπνέεται.EN: May cause cancer by inhalation.FR: Peut provoquer le cancer par inhalation.IT: Può provocare il cancro per inalazione.LV: Ieelpojot var izraisīt ļaundabīgus audzējus.LT: Gali sukelti vėžį įkvėpus.HU: Belélegezve rákot okozhat (karcinogén hatású lehet).MT: Jista’ jikkaġuna l-kanċer meta jinxtamm.NL: Kan kanker veroorzaken bij inademing.PL: Może powodować raka w następstwie narażenia drogą oddechową.PT: Pode causar cancro por inalação.RO: Poate cauza cancer prin inhalare.SK: Môže spôsobiť rakovinu pri vdýchnutí.SL: Pri vdihavanju lahko povzroči raka.FI: Aiheuttaa syöpäsairauden vaaraa hengitettynä.SV: Kan ge cancer vid inandning.R50BG: Силно токсичен за водни организми.ES: Muy tóxico para los organismos acuáticos.CS: Vysoce toxický pro vodní organismy.DA: Meget giftig for organismer, der lever i vand.DE: Sehr giftig für Wasserorganismen.ET: Väga mürgine veeorganismidele.EL: Πολύ τοξικό για τους υδρόβιους οργανισμούς.EN: Very toxic to aquatic organisms.FR: Très toxique pour les organismes aquatiques.IT: Altamente tossico per gli organismi acquatici.LV: Ļoti toksisks ūdens organismiem.LT: Labai toksiška vandens organizmams.HU: Nagyon mérgező a vízi szervezetekre.MT: Tossiku ħafna għal organiżmi akwatiċi.NL: Zeer vergiftig voor in het water levende organismen.PL: Działa bardzo toksycznie na organizmy wodne.PT: Muito tóxico para os organismos aquáticos.RO: Foarte toxic pentru organismele acvatice.SK: Veľmi jedovatý pre vodné organizmy.SL: Zelo strupeno za vodne organizme.FI: Erittäin myrkyllistä vesieliöille.SV: Mycket giftigt för vattenlevande organismer.R51BG: Токсичен за водни организми.ES: Tóxico para los organismos acuáticos.CS: Toxický pro vodní organismy.DA: Giftig for organismer, der lever i vand.DE: Giftig für Wasserorganismen.ET: Mürgine veeorganismidele.EL: Τοξικό για τους υδρόβιους οργανισμούς.EN: Toxic to aquatic organisms.FR: Toxique pour les organismes aquatiques.IT: Tossico per gli organismi acquatici.LV: Toksisks ūdens organismiem.LT: Toksiška vandens organizmams.HU: Mérgező a vízi szervezetekre.MT: Tossiku għal organiżmi akwatiċi.NL: Vergiftig voor in het water levende organismen.PL: Działa toksycznie na organizmy wodne.PT: Tóxico para os organismos aquáticos.RO: Toxic pentru organismele acvatice.SK: Jedovatý pre vodné organizmy.SL: Strupeno za vodne organizme.FI: Myrkyllistä vesieliöille.SV: Giftigt för vattenlevande organismer.R52BG: Вреден за водни организми.ES: Nocivo para los organismos acuáticos.CS: Škodlivý pro vodní organismy.DA: Skadelig for organismer, der lever i vand.DE: Schädlich für Wasserorganismen.ET: Kahjulik veeorganismidele.EL: Επιβλαβές για τους υδρόβιους οργανισμούς.EN: Harmful to aquatic organisms.FR: Nocif pour les organismes aquatiques.IT: Nocivo per gli organismi acquatici.LV: Kaitīgs ūdens organismiem.LT: Kenksminga vandens organizmams.HU: Ártalmas a vízi szervezetekre.MT: Jaħmel ħsara lil organiżmi akwatiċi.NL: Schadelijk voor in het water levende organismen.PL: Działa szkodliwie na organizmy wodne.PT: Nocivo para os organismos aquáticos.RO: Nociv pentru organismele acvatice.SK: Škodlivý pre vodné organizmy.SL: Škodljivo za vodne organizme.FI: Haitallista vesieliöille.SV: Skadligt för vattenlevande organismer.R53BG: Може да причини дълготрайни неблагоприятни ефекти във водната среда.ES: Puede provocar a largo plazo efectos negativos en el medio ambiente acuático.CS: Může vyvolat dlouhodobé nepříznivé účinky ve vodním prostředí.DA: Kan forårsage uønskede langtidsvirkninger i vandmiljøet.DE: Kann in Gewässern längerfristig schädliche Wirkungen haben.ET: Võib avaldada pikaajalist veekeskkonda kahjustavat toimet.EL: Μπορεί να προκαλέσει μακροχρόνιες δυσμενείς επιπτώσεις στο υδάτινο περιβάλλον.EN: May cause long-term adverse effects in the aquatic environment.FR: Peut entraîner des effets néfastes à long terme pour l’environnement aquatique.IT: Può provocare a lungo termine effetti negativi per l’ambiente acquatico.LV: Var radīt ilglaicīgu negatīvu ietekmi ūdens vidē.LT: Gali sukelti ilgalaikius nepalankius vandens ekosistemų pakitimus.HU: A vízi környezetben hosszan tartó károsodást okozhat.MT: Jista’ jikkaġuna effetti ħżiena fit-tul lill-ambjent akwatiku.NL: Kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.PL: Może powodować długo utrzymujące się niekorzystne zmiany w środowisku wodnym.PT: Pode causar efeitos nefastos a longo prazo no ambiente aquático.RO: Poate provoca efecte adverse pe termen lung asupra mediului acvatic.SK: Môže spôsobiť dlhodobé škodlivé účinky vo vodnej zložke životného prostredia.SL: Lahko povzroči dolgotrajne škodljive učinke na vodno okolje.FI: Voi aiheuttaa pitkäaikaisia haittavaikutuksia vesiympäristössä.SV: Kan orsaka skadliga långtidseffekter i vattenmiljön.R54BG: Токсичен за флората.ES: Tóxico para la flora.CS: Toxický pro rostliny.DA: Giftig for planter.DE: Giftig für Pflanzen.ET: Mürgine taimedele.EL: Τοξικό για τη χλωρίδα.EN: Toxic to flora.FR: Toxique pour la flore.IT: Tossico per la flora.LV: Toksisks augiem.LT: Toksiška augmenijai.HU: Mérgező a növényekre.MT: Tossiku għall-flora.NL: Vergiftig voor planten.PL: Działa toksycznie na rośliny.PT: Tóxico para a flora.RO: Toxic pentru floră.SK: Jedovatý pre flóru.SL: Strupeno za rastline.FI: Myrkyllistä kasveille.SV: Giftigt för växter.R55BG: Токсичен за фауната.ES: Tóxico para la fauna.CS: Toxický pro živočichy.DA: Giftig for dyr.DE: Giftig für Tiere.ET: Mürgine loomadele.EL: Τοξικό για την πανίδα.EN: Toxic to fauna.FR: Toxique pour la faune.IT: Tossico per la fauna.LV: Toksisks dzīvniekiem.LT: Toksiška gyvūnijai.HU: Mérgező az állatokra.MT: Tossiku għall-fawna.NL: Vergiftig voor dieren.PL: Działa toksycznie na zwierzęta.PT: Tóxico para a fauna.RO: Toxic pentru faună.SK: Jedovatý pre faunu.SL: Strupeno za živali.FI: Myrkyllistä eläimille.SV: Giftigt för djur.R56BG: Токсичен за почвените организми.ES: Tóxico para los organismos del suelo.CS: Toxický pro půdní organismy.DA: Giftig for organismer i jordbunden.DE: Giftig für Bodenorganismen.ET: Mürgine mullaorganismidele.EL: Τοξικό για τους οργανισμούς του εδάφους.EN: Toxic to soil organisms.FR: Toxique pour les organismes du sol.IT: Tossico per gli organismi del terreno.LV: Toksisks augsnes organismiem.LT: Toksiška dirvožemio organizmams.HU: Mérgező a talaj szervezeteire.MT: Tossiku għal organiżmi tal-ħamrija.NL: Vergiftig voor bodemorganismen.PL: Działa toksycznie na organizmy glebowe.RO: Toxic pentru organismele din sol.PT: Tóxico para os organismos do solo.SK: Jedovatý pre pôdne organizmy.SL: Strupeno za organizme v zemlji.FI: Myrkyllistä maaperäeliöille.SV: Giftigt för marklevande organismer.R57BG: Токсичен за пчелите.ES: Tóxico para las abejas.CS: Toxický pro včely.DA: Giftig for bier.DE: Giftig für Bienen.ET: Mürgine mesilastele.EL: Τοξικό για τις μέλισσες.EN: Toxic to bees.FR: Toxique pour les abeilles.IT: Tossico per le api.LV: Toksisks bitēm.LT: Toksiška bitėms.HU: Mérgező a méhekre.MT: Tossiku għan-naħal.NL: Vergiftig voor bijen.PL: Działa toksycznie na pszczoły.PT: Tóxico para as abelhas.RO: Toxic pentru albine.SK: Jedovatý pre včely.SL: Strupeno za čebele.FI: Myrkyllistä mehiläisille.SV: Giftigt för bin.R58BG: Може да причини дълготрайни неблагоприятни ефекти върху околната среда.ES: Puede provocar a largo plazo efectos negativos en el medio ambiente.CS: Může vyvolat dlouhodobé nepříznivé účinky v životním prostředí.DA: Kan forårsage uønskede langtidsvirkninger i miljøet.DE: Kann längerfristig schädliche Wirkungen auf die Umwelt haben.ET: Võib avaldada pikaajalist keskkonda kahjustavat toimet.EL: Μπορεί να προκαλέσει μακροχρόνιες δυσμενείς επιπτώσεις στο περιβάλλον.EN: May cause long-term adverse effects in the environment.FR: Peut entraîner des effets néfastes à long terme pour l’environnement.IT: Può provocare a lungo termine effetti negativi per l’ambiente.LV: Var izraisīt ilglaicīgu negatīvu ietekmi vidē.LT: Gali sukelti ilgalaikius nepalankius aplinkos pakitimus.HU: A környezetben hosszan tartó károsodást okozhat.MT: Jista’ jikkaġuna effetti ħżiena fit-tul lill-ambjent.NL: Kan in het milieu op lange termijn schadelijke effecten veroorzaken.PL: Może powodować długo utrzymujące się niekorzystne zmiany w środowisku.PT: Pode causar efeitos nefastos a longo prazo no ambiente.RO: Poate provoca efecte adverse pe termen lung asupra mediului înconjurător.SK: Môže mať dlhodobé nepriaznivé účinky na životné prostredie.SL: Lahko povzroči dolgotrajne škodljive učinke na okolje.FI: Voi aiheuttaa pitkäaikaisia haittavaikutuksia ympäristössä.SV: Kan orsaka skadliga långtidseffekter i miljön.R59BG: Опасен за озоновия слой.ES: Peligroso para la capa de ozono.CS: Nebezpečný pro ozonovou vrstvu.DA: Farlig for ozonlaget.DE: Gefährlich für die Ozonschicht.ET: Ohtlik osoonikihile.EL: Επικίνδυνο για τη στοιβάδα του όζοντος.EN: Dangerous for the ozone layer.FR: Dangereux pour la couche d’ozone.IT: Pericoloso per lo strato di ozono.LV: Bīstams ozona slānim.LT: Pavojinga ozono sluoksniui.HU: Veszélyes az ózonrétegre.MT: Perikoluż għas-saff ta’ l-ożonu.NL: Gevaarlijk voor de ozonlaag.PL: Stwarza zagrożenie dla warstwy ozonowej.PT: Perigoso para a camada de ozono.RO: Periculos pentru stratul de ozon.SK: Nebezpečný pre ozónovú vrstvu.SL: Nevarno za ozonski plašč.FI: Vaarallista otsonikerrokselle.SV: Farligt för ozonskiktet.R60BG: Може да увреди възпроизводителната функция.ES: Puede perjudicar la fertilidad.CS: Může poškodit reprodukční schopnost.DA: Kan skade forplantningsevnen.DE: Kann die Fortpflanzungsfähigkeit beeinträchtigen.ET: Võib kahjustada sigivust.EL: Μπορεί να εξασθενίσει τη γονιμότητα.EN: May impair fertility.FR: Peut altérer la fertilité.IT: Può ridurre la fertilità.LV: Var kaitēt reproduktīvajām spējām.LT: Kenkia vaisingumui.HU: A fogamzóképességet vagy nemzőképességet (fertilitást) károsíthatja.MT: Jista’ jdgħajjef il-fertilità.NL: Kan de vruchtbaarheid schaden.PL: Może upośledzać płodność.PT: Pode comprometer a fertilidade.RO: Poate afecta fertilitatea.SK: Môže poškodiť plodnosť.SL: Lahko škoduje plodnosti.FI: Voi heikentää hedelmällisyyttä.SV: Kan ge nedsatt fortplantningsförmåga.R61BG: Може да увреди плода при бременност.ES: Riesgo durante el embarazo de efectos adversos para el feto.CS: Může poškodit plod v těle matky.DA: Kan skade barnet under graviditeten.DE: Kann das Kind im Mutterleib schädigen.ET: Võib kahjustada loodet.EL: Μπορεί να βλάψει το έμβρυο κατά τη διάρκεια της κύησης.EN: May cause harm to the unborn child.FR: Risque pendant la grossesse d’effets néfastes pour l’enfant.IT: Può danneggiare i bambini non ancora nati.LV: Var kaitēt augļa attīstībai.LT: Kenkia negimusiam vaikui.HU: A születendő gyermekre ártalmas lehet.MT: Jista’ jagħmel ħsara lit-tarbija fil-ġuf.NL: Kan het ongeboren kind schaden.PL: Może działać szkodliwie na dziecko w łonie matki.PT: Risco durante a gravidez com efeitos adversos na descendência.RO: Poate provoca efecte adverse asupra copilului în timpul sarcinii.SK: Môže spôsobiť poškodenie nenarodeného dieťaťa.SL: Lahko škoduje nerojenemu otroku.FI: Vaarallista sikiölle.SV: Kan ge fosterskador.R62BG: Възможен риск от увреждане на възпроизводителната функция.ES: Posible riesgo de perjudicar la fertilidad.CS: Možné nebezpečí poškození reprodukční schopnosti.DA: Mulighed for skade på forplantningsevnen.DE: Kann möglicherweise die Fortpflanzungsfähigkeit beeinträchtigen.ET: Võimalik sigivuse kahjustamise oht.EL: Πιθανός κίνδυνος για εξασθένηση της γονιμότητας.EN: Possible risk of impaired fertility.FR: Risque possible d’altération de la fertilité.IT: Possibile rischio di ridotta fertilità.LV: Iespējams kaitējuma risks reproduktīvajām spējām.LT: Gali pakenkti vaisingumui.HU: A fogamzóképességre vagy nemzőképességre (fertilitásra) ártalmas lehet.MT: Possibiltà ta’ riskju ta’ fertilità mdgħajjfa.NL: Mogelijk gevaar voor verminderde vruchtbaarheid.PL: Możliwe ryzyko upośledzenia płodności.PT: Possíveis riscos de comprometer a fertilidade.RO: Risc posibil de afectare a fertilităţii.SK: Možné riziko poškodenia plodnosti.SL: Možna nevarnost oslabitve plodnosti.FI: Voi mahdollisesti heikentää hedelmällisyyttä.SV: Möjlig risk för nedsatt fortplantningsförmåga.R63BG: Възможен риск от увреждане на плода при бременност.ES: Posible riesgo durante el embarazo de efectos adversos para el feto.CS: Možné nebezpečí poškození plodu v těle matky.DA: Mulighed for skade på barnet under graviditeten.DE: Kann das Kind im Mutterleib möglicherweise schädigen.ET: Võimalik loote kahjustamise oht.EL: Πιθανός κίνδυνος δυσμενών επιδράσεων στο έμβρυο κατά τη διάρκεια της κύησης.EN: Possible risk of harm to the unborn child.FR: Risque possible pendant la grossesse d’effets néfastes pour l’enfant.IT: Possibile rischio di danni ai bambini non ancora nati.LV: Iespējams kaitējuma risks augļa attīstībai.LT: Gali pakenkti negimusiam vaikui.HU: A születendő gyermeket károsíthatja.MT: Possibiltà ta’ riskju lit-tarbija fil-ġuf.NL: Mogelijk gevaar voor beschadiging van het ongeboren kind.PL: Możliwe ryzyko szkodliwego działania na dziecko w łonie matki.PT: Possíveis riscos durante a gravidez com efeitos adversos na descendência.RO: Risc posibil de a dăuna copilului în timpul sarcinii.SK: Možné riziko poškodenia nenarodeného dieťaťa.SL: Možna nevarnost škodovanja nerojenemu otroku.FI: Voi olla vaarallista sikiölle.SV: Möjlig risk för fosterskador.R64BG: Може да причини увреждане на здравето на кърмачета.ES: Puede perjudicar a los niños alimentados con leche materna.CS: Může poškodit kojené dítě.DA: Kan skade børn i ammeperioden.DE: Kann Säuglinge über die Muttermilch schädigen.ET: Võib olla ohtlik imikule rinnapiima kaudu.EL: Μπορεί να βλάψει τα βρέφη που τρέφονται με μητρικό γάλα.EN: May cause harm to breastfed babies.FR: Risque possible pour les bébés nourris au lait maternel.IT: Possibile rischio per i bambini allattati al seno.LV: Var kaitēt zīdāmam bērnam.LT: Kenkia žindomam vaikui.HU: A szoptatott újszülöttet és csecsemőt károsíthatja.MT: Jista’ jikkaġuna ħsara lil trabi qed jitreddgħu.NL: Kan schadelijk zijn via de borstvoeding.PL: Może oddziaływać szkodliwie na dzieci karmione piersią.PT: Pode causar danos às crianças alimentadas com leite materno.RO: Risc posibil pentru sugarii hrăniţi cu lapte matern.SK: Môže spôsobiť poškodenie dojčiat.SL: Lahko škoduje zdravju dojenčka preko materinega mleka.FI: Saattaa aiheuttaa haittaa rintaruokinnassa oleville lapsille.SV: Kan skada spädbarn under amningsperioden.R65BG: Вреден: може да причини увреждане на белите дробове при поглъщане.ES: Nocivo: si se ingiere puede causar daño pulmonar.CS: Zdraví škodlivý: při požití může vyvolat poškození plic.DA: Farlig: kan give lungeskade ved indtagelse.DE: Gesundheitsschädlich: kann beim Verschlucken Lungenschäden verursachen.ET: Kahjulik: allaneelamisel võib põhjustada kopsukahjustusi.EL: Επιβλαβές: μπορεί να προκαλέσει βλάβη στους πνεύμονες σε περίπτωση κατάποσης.EN: Harmful: may cause lung damage if swallowed.FR: Nocif: peut provoquer une atteinte des poumons en cas d’ingestion.IT: Nocivo: può causare danni ai polmoni in caso di ingestione.LV: Kaitīgs – norijot var izraisīt plaušu bojājumu.LT: Kenksminga — prarijus, gali pakenkti plaučiams.HU: Lenyelve ártalmas, aspiráció (idegen anyagnak a légutakba beszívása) esetén tüdőkárosodást okozhat.MT: Jagħmel ħsara: jista’ jikkaġuna ħsara lill-pulmuni jekk jinbela’.NL: Schadelijk: kan longschade veroorzaken na verslikken.PL: Działa szkodliwie; może powodować uszkodzenie płuc w przypadku połknięcia.PT: Nocivo: pode causar danos nos pulmões se ingerido.RO: Nociv: poate provoca afecţiuni pulmonare în caz de înghiţire.SK: Škodlivý, po požití môže spôsobiť poškodenie pľúc.SL: Zdravju škodljivo: pri zaužitju lahko povzroči poškodbo pljuč.FI: Haitallista: voi aiheuttaa keuhkovaurion nieltäessä.SV: Farligt: kan ge lungskador vid förtäring.R66BG: Повтарящата се експозиция може да предизвика сухота или напукване на кожата.ES: La exposición repetida puede provocar sequedad o formación de grietas en la piel.CS: Opakovaná expozice může způsobit vysušení nebo popraskání kůže.DA: Gentagen udsættelse kan give tør eller revnet hud.DE: Wiederholter Kontakt kann zu spröder oder rissiger Haut führen.ET: Korduv toime võib põhjustada naha kuivust või lõhenemist.EL: Παρατεταμένη έκθεση μπορεί να προκαλέσει ξηρότητα δέρματος ή σκάσιμο.EN: Repeated exposure may cause skin dryness or cracking.FR: L’exposition répétée peut provoquer dessèchement ou gerçures de la peau.IT: L’esposizione ripetuta può provocare secchezza e screpolature della pelle.LV: Atkārtota iedarbība var radīt sausu ādu vai izraisīt tās sprēgāšanu.LT: Pakartotinas poveikis gali sukelti odos džiūvimą arba skilinėjimą.HU: Ismételt expozíció a bőr kiszáradását vagy megrepedezését okozhatja.MT: Espożizzjoni ripetuta tista’ tikkaġuna nxif jew qsim tal-ġilda.NL: Herhaalde blootstelling kan een droge of een gebarsten huid veroorzaken.PL: Powtarzające się narażenie może powodować wysuszanie lub pękanie skóry.PT: Pode provocar secura da pele ou fissuras, por exposição repetida.RO: Expunerea repetată poate provoca uscarea sau crăparea pielii.SK: Opakovaná expozícia môže spôsobiť vysušenie alebo popraskanie pokožky.SL: Ponavljajoča izpostavljenost lahko povzroči nastanek suhe ali razpokane kože.FI: Toistuva altistus voi aiheuttaa ihon kuivumista tai halkeilua.SV: Upprepad kontakt kan ge torr hud eller hudsprickor.R67BG: Парите могат да предизвикат сънливост и световъртеж.ES: La inhalación de vapores puede provocar somnolencia y vértigo.CS: Vdechování par může způsobit ospalost a závratě.DA: Dampe kan give sløvhed og svimmelhed.DE: Dämpfe können Schläfrigkeit und Benommenheit verursachen.ET: Aurud võivad põhjustada uimasust ja peapööritust.EL: H εισπνοή ατμών μπορεί να προκαλέσει υπνηλία και ζάλη.EN: Vapours may cause drowsiness and dizziness.FR: L’inhalation de vapeurs peut provoquer somnolence et vertiges.IT: L’inalazione dei vapori può provocare sonnolenza e vertigini.LV: Tvaiki var radīt miegainību un reiboni.LT: Garai gali sukelti mieguistumą ir galvos svaigimą.HU: A gőzök belégzése álmosságot vagy szédülést okozhat.MT: Ix-xamm tal-fwar jista’ jikkaġuna ħedla ta’ ngħas u sturdamenti.NL: Dampen kunnen slaperigheid en duizeligheid veroorzaken.PL: Pary mogą wywoływać uczucie senności i zawroty głowy.PT: Pode provocar sonolência e vertigens, por inalação dos vapores.RO: Inhalarea vaporilor poate provoca somnolenţă şi ameţeală.SK: Pary môžu spôsobiť ospalosť a závrat.SL: Hlapi lahko povzročijo zaspanost in omotico.FI: Höyryt voivat aiheuttaa uneliaisuutta ja huimausta.SV: Ångor kan göra att man blir dåsig och omtöcknad.R68BG: Възможен риск от необратими ефекти.ES: Posibilidad de efectos irreversibles.CS: Možné nebezpečí nevratných účinků.DA: Mulighed for varig skade på helbred.DE: Irreversibler Schaden möglich.ET: Pöördumatute kahjustuste oht.EL: Πιθανοί κίνδυνοι μονίμων επιδράσεων.EN: Possible risk of irreversible effects.FR: Possibilité d’effets irréversibles.IT: Possibilità di effetti irreversibili.LV: Iespējams neatgriezeniskas iedarbības risks.LT: Gali sukelti negrįžtamus sveikatos pakenkimus.HU: Maradandó egészségkárosodást okozhat.MT: Riskju possibbli ta’ effetti irreversibbli.NL: Onherstelbare effecten zijn niet uitgesloten.PL: Możliwe ryzyko powstania nieodwracalnych zmian w stanie zdrowia.PT: Possibilidade de efeitos irreversíveis.RO: Risc posibil de efecte ireversibile.SK: Možné riziká ireverzibilných účinkov.SL: Možna nevarnost trajnih okvar zdravja.FI: Pysyvien vaurioiden vaara.SV: Möjlig risk för bestående hälsoskador.Комбинирани R-фразиCombinación de frases-RKombinace R-větKombination af R-sætningerKombination der R-SätzeR ühendlausedΣυνδυασμός των R-φράσεωνCombination of R-phrasesCombinaison des phrases RCombinazioni delle frasi RR frāžu kombinācijaR frazių derinysÖsszetett R-mondatokKombinazzjoni ta’ Frażi RCombinatie van R-zinnenŁączone zwroty RCombinação das frases RCombinaţii de fraze RKombinácie R-vietSestavljeni stavki RYhdistetyt R-lausekkeetSammansatta R-fraserR14/15BG: Реагира бурно с вода и се отделят изключително запалими газове.ES: Reacciona violentamente con el agua, liberando gases extremadamente inflamables.CS: Prudce reaguje s vodou za uvolňování extrémně hořlavých plynů.DA: Reagerer voldsomt med vand under dannelse af yderst brandfarlige gasser.DE: Reagiert heftig mit Wasser unter Bildung hochentzündlicher Gase.ET: Reageerib ägedalt veega, eraldades väga tuleohtlikku gaasi.EL: Αντιδρά βίαια σε επαφή με νερό εκλύοντας αέρια εξόχως εύφλεκτα.EN: Reacts violently with water, liberating extremely flammable gases.FR: Réagit violemment au contact de l’eau en dégageant des gaz extrêmement inflammables.IT: Reagisce violentemente con l’acqua liberando gas estremamente infiammabili.LV: Aktīvi reaģē ar ūdeni, izdalot īpaši viegli uzliesmojošas gāzes.LT: Smarkiai reaguoja su vandeniu, išskirdama ypač degias dujas.HU: Vízzel hevesen reagál és közben fokozottan tűzveszélyes gázok képződnek.MT: Jirreaġixxi b’mod vjolenti meta jmiss l-ilma billi jitfa’ gassijiet li jieħdu n-nar malajr ħafna.NL: Reageert heftig met water en vormt daarbij zeer ontvlambaar gas.PL: Reaguje gwałtownie z wodą uwalniając skrajnie łatwopalne gazy.PT: Reage violentamente com a água libertando gases extremamente inflamáveis.RO: Reacţionează violent cu apa, cu degajare de gaze extrem de inflamabile.SK: Prudko reaguje s vodou, pričom uvoľňuje mimoriadne horľavé plyny.SL: Burno reagira z vodo, pri čemer se sprošča zelo lahko vnetljiv plin.FI: Reagoi voimakkaasti veden kanssa vapauttaen helposti syttyviä kaasuja.SV: Reagerar häftigt med vatten varvid extremt brandfarliga gaser bildas.R15/29BG: При контакт с вода се отделят токсични и изключително запалими газове.ES: En contacto con el agua, libera gases tóxicos y extremadamente inflamables.CS: Při styku s vodou uvolňuje toxický, extrémně hořlavý plyn.DA: Reagerer med vand under dannelse af giftige og yderst brandfarlige gasser.DE: Reagiert mit Wasser unter Bildung giftiger und hochentzündlicher Gase.ET: Kokkupuutel veega eraldub mürgine, väga tuleohtlik gaas.EL: Σε επαφή με νερό ελευθερώνονται τοξικά, εξόχως εύφλεκτα αέρια.EN: Contact with water liberates toxic, extremely flammable gas.FR: Au contact de l’eau, dégage des gaz toxiques et extrêmement inflammables.IT: A contatto con acqua libera gas tossici e estremamente infiammabili.LV: Saskaroties ar ūdeni, izdala īpaši viegli uzliesmojošas toksiskas gāzes.LT: Reaguoja su vandeniu, išskirdama toksiškas ir ypač degias dujas.HU: Vízzel érintkezve fokozottan tűzveszélyes és mérgező gázok képződnek.MT: Meta jmiss l-ilma jitfa’ gassijiet tossiċi u li jieħdu n-nar malajr ħafna.NL: Vormt vergiftig en zeer ontvlambaar gas in contact met water.PL: W kontakcie z wodą uwalnia skrajnie łatwopalne, toksyczne gazy.PT: Em contacto com a água liberta gases tóxicos e extremamente inflamáveis.RO: În contact cu apa se degajă gaze toxice şi extrem de inflamabile.SK: Pri kontakte s vodou sa uvoľňuje jedovatý, mimoriadne horľavý plyn.SL: V stiku z vodo se sprošča strupen, zelo lahko vnetljiv plin.FI: Vapauttaa myrkyllisiä, helposti syttyviä kaasuja veden kanssa.SV: Utvecklar giftig och extremt brandfarlig gas vid kontakt med vatten.R20/21BG: Вреден при вдишване и при контакт с кожата.ES: Nocivo por inhalación y en contacto con la piel.CS: Zdraví škodlivý při vdechování a při styku s kůží.DA: Farlig ved indånding og ved hudkontakt.DE: Gesundheitsschädlich beim Einatmen und bei Berührung mit der Haut.ET: Kahjulik sissehingamisel ja kokkupuutel nahaga.EL: Επιβλαβές όταν εισπνέεται και σε επαφή με το δέρμα.EN: Harmful by inhalation and in contact with skin.FR: Nocif par inhalation et par contact avec la peau.IT: Nocivo per inalazione e contatto con la pelle.LV: Kaitīgs ieelpojot un nonākot saskarē ar ādu.LT: Kenksminga įkvėpus ir susilietus su oda.HU: Belélegezve és bőrrel érintkezve ártalmas.MT: Jagħmel ħsara meta jinxtamm u meta jmiss il-ġilda.NL: Schadelijk bij inademing en bij aanraking met de huid.PL: Działa szkodliwie przez drogi oddechowe i w kontakcie ze skórą.PT: Nocivo por inalação e em contacto com a pele.RO: Nociv prin inhalare şi în contact cu pielea.SK: Škodlivý pri vdýchnutí a pri kontakte s pokožkou.SL: Zdravju škodljivo pri vdihavanju in v stiku s kožo.FI: Terveydelle haitallista hengitettynä ja joutuessaan iholle.SV: Farligt vid inandning och hudkontakt.R20/22BG: Вреден при вдишване и при поглъщане.ES: Nocivo por inhalación y por ingestión.CS: Zdraví škodlivý při vdechování a při požití.DA: Farlig ved indånding og ved indtagelse.DE: Gesundheitsschädlich beim Einatmen und Verschlucken.ET: Kahjulik sissehingamisel ja allaneelamisel.EL: Επιβλαβές όταν εισπνέεται και σε περίπτωση καταπόσεως.EN: Harmful by inhalation and if swallowed.FR: Nocif par inhalation et par ingestion.IT: Nocivo per inalazione e ingestione.LV: Kaitīgs ieelpojot un norijot.LT: Kenksminga įkvėpus ir prarijus.HU: Belélegezve és lenyelve ártalmas.MT: Jagħmel ħsara meta jinxtamm jew jinbela’.NL: Schadelijk bij inademing en opname door de mond.PL: Działa szkodliwie przez drogi oddechowe i po połknięciu.PT: Nocivo por inalação e ingestão.RO: Nociv prin inhalare şi prin înghiţire.SK: Škodlivý pri vdýchnutí a po požití.SL: Zdravju škodljivo pri vdihavanju in pri zaužitju.FI: Terveydelle haitallista hengitettynä ja nieltynä.SV: Farligt vid inandning och förtäring.R20/21/22BG: Вреден при вдишване, при контакт с кожата и при поглъщане.ES: Nocivo por inhalación, por ingestión y en contacto con la piel.CS: Zdraví škodlivý při vdechování, styku s kůží a při požití.DA: Farlig ved indånding, ved hudkontakt og ved indtagelse.DE: Gesundheitsschädlich beim Einatmen, Verschlucken und Berührung mit der Haut.ET: Kahjulik sissehingamisel, kokkupuutel nahaga ja allaneelamisel.EL: Επιβλαβές όταν εισπνέεται, σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Harmful by inhalation, in contact with skin and if swallowed.FR: Nocif par inhalation, par contact avec la peau et par ingestion.IT: Nocivo per inalazione, contatto con la pelle e per ingestione.LV: Kaitīgs ieelpojot, nonākot saskarē ar ādu un norijot.LT: Kenksminga įkvėpus, susilietus su oda ir prarijus.HU: Belélegezve, bőrrel érintkezve és lenyelve ártalmas.MT: Jagħmel ħsara meta jinxtamm, imiss il-ġilda jew jinbela’.NL: Schadelijk bij inademing, opname door de mond en aanraking met de huid.PL: Działa szkodliwie przez drogi oddechowe, w kontakcie ze skórą i po połknięciu.PT: Nocivo por inalação, em contacto com a pele e por ingestão.RO: Nociv prin inhalare, în contact cu pielea şi prin înghiţire.SK: Škodlivý pri vdýchnutí, pri kontakte s pokožkou a po požití.SL: Zdravju škodljivo pri vdihavanju, v stiku s kožo in pri zaužitju.FI: Terveydelle haitallista hengitettynä, joutuessaan iholle ja nieltynä.SV: Farligt vid inandning, hudkontakt och förtäring.R21/22BG: Вреден при контакт с кожата и при поглъщане.ES: Nocivo en contacto con la piel y por ingestión.CS: Zdraví škodlivý při styku s kůží a při požití.DA: Farlig ved hudkontakt og ved indtagelse.DE: Gesundheitsschädlich bei Berührung mit der Haut und beim Verschlucken.ET: Kahjulik kokkupuutel nahaga ja allaneelamisel.EL: Επιβλαβές σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Harmful in contact with skin and if swallowed.FR: Nocif par contact avec la peau et par ingestion.IT: Nocivo a contatto con la pelle e per ingestione.LV: Kaitīgs, nonākot saskarē ar ādu un norijot.LT: Kenksminga susilietus su oda ir prarijus.HU: Bőrrel érintkezve és lenyelve ártalmas.MT: Jagħmel ħsara meta jmiss il-ġilda jew jinbela’.NL: Schadelijk bij aanraking met de huid en bij opname door de mond.PL: Działa szkodliwie w kontakcie ze skórą i po połknięciu.PT: Nocivo em contacto com a pele e por ingestão.RO: Nociv în contact cu pielea şi prin înghiţire.SK: Škodlivý pri kontakte s pokožkou a po požití.SL: Zdravju škodljivo v stiku s kožo in pri zaužitju.FI: Terveydelle haitallista joutuessaan iholle ja nieltynä.SV: Farligt vid hudkontakt och förtäring.R23/24BG: Токсичен при вдишване и при контакт с кожата.ES: Tóxico por inhalación y en contacto con la piel.CS: Toxický při vdechování a při styku s kůží.DA: Giftig ved indånding og ved hudkontakt.DE: Giftig beim Einatmen und bei Berührung mit der Haut.ET: Mürgine sissehingamisel ja kokkupuutel nahaga.EL: Τοξικό όταν εισπνέεται και σε επαφή με το δέρμα.EN: Toxic by inhalation and in contact with skin.FR: Toxique par inhalation et par contact avec la peau.IT: Tossico per inalazione e contatto con la pelle.LV: Toksisks ieelpojot un nonākot saskarē ar ādu.LT: Toksiška įkvėpus ir susilietus su oda.HU: Belélegezve és bőrrel érintkezve mérgező.MT: Tossiku meta jinxtamm u meta jmiss il-ġilda.NL: Vergiftig bij inademing en bij aanraking met de huid.PL: Działa toksycznie przez drogi oddechowe i w kontakcie ze skórą.PT: Tóxico por inalação e em contacto com a pele.RO: Toxic prin inhalare şi în contact cu pielea.SK: Jedovatý pri vdýchnutí a pri kontakte s pokožkou.SL: Strupeno pri vdihavanju in v stiku s kožo.FI: Myrkyllistä hengitettynä ja joutuessaan iholle.SV: Giftigt vid inandning och hudkontakt.R23/25BG: Токсичен при вдишване и при поглъщане.ES: Tóxico por inhalación y por ingestión.CS: Toxický při vdechování a při požití.DA: Giftig ved indånding og ved indtagelse.DE: Giftig beim Einatmen und Verschlucken.ET: Mürgine sissehingamisel ja allaneelamisel.EL: Τοξικό όταν εισπνέεται και σε περίπτωση καταπόσεως.EN: Toxic by inhalation and if swallowed.FR: Toxique par inhalation et par ingestion.IT: Tossico per inalazione e ingestione.LV: Toksisks ieelpojot un norijot.LT: Toksiška įkvėpus ir prarijus.HU: Belélegezve és lenyelve mérgező.MT: Tossiku meta jinxtamm jew meta jinbela’.NL: Vergiftig bij inademing en opname door de mond.PL: Działa toksycznie przez drogi oddechowe i po połknięciu.PT: Tóxico por inalação e ingestão.RO: Toxic prin inhalare şi prin înghiţire.SK: Jedovatý pri vdýchnutí a po požití.SL: Strupeno pri vdihavanju in pri zaužitju.FI: Myrkyllistä hengitettynä ja nieltynä.SV: Giftigt vid inandning och förtäring.R23/24/25BG: Токсичен при вдишване, при контакт с кожата и при поглъщане.ES: Tóxico por inhalación, por ingestión y en contacto con la piel.CS: Toxický při vdechování, styku s kůží a při požití.DA: Giftig ved indånding, ved hudkontakt og ved indtagelse.DE: Giftig beim Einatmen, Verschlucken und Berührung mit der Haut.ET: Mürgine sissehingamisel, kokkupuutel nahaga ja allaneelamisel.EL: Τοξικό όταν εισπνέεται, σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Toxic by inhalation, in contact with skin and if swallowed.FR: Toxique par inhalation, par contact avec la peau et par ingestion.IT: Tossico per inalazione, contatto con la pelle e per ingestione.LV: Toksisks ieelpojot, nonākot saskarē ar ādu un norijot.LT: Toksiška įkvėpus, susilietus su oda ir prarijus.HU: Belélegezve, bőrrel érintkezve és lenyelve mérgező.MT: Tossiku meta jinxtamm, imiss il-ġilda jew jinbela’.NL: Vergiftig bij inademing, opname door de mond en aanraking met de huid.PL: Działa toksycznie przez drogi oddechowe, w kontakcie ze skórą i po połknięciu.PT: Tóxico por inalação, em contacto com a pele e por ingestão.RO: Toxic prin inhalare, în contact cu pielea şi prin înghiţire.SK: Jedovatý pri vdýchnutí, pri kontakte s pokožkou a po požití.SL: Strupeno pri vdihavanju, v stiku s kožo in pri zaužitju.FI: Myrkyllistä hengitettynä, joutuessaan iholle ja nieltynä.SV: Giftigt vid inandning, hudkontakt och förtäring.R24/25BG: Токсичен при контакт с кожата и при поглъщане.ES: Tóxico en contacto con la piel y por ingestión.CS: Toxický při styku s kůží a při požití.DA: Giftig ved hudkontakt og ved indtagelse.DE: Giftig bei Berührung mit der Haut und beim Verschlucken.ET: Mürgine kokkupuutel nahaga ja allaneelamisel.EL: Τοξικό σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Toxic in contact with skin and if swallowed.FR: Toxique par contact avec la peau et par ingestion.IT: Tossico a contatto con la pelle e per ingestione.LV: Toksisks, nonākot saskarē ar ādu un norijot.LT: Toksiška susilietus su oda ir prarijus.HU: Bőrrel érintkezve és lenyelve mérgező.MT: Tossiku meta jmiss il-ġilda jew meta jinbela’.NL: Vergiftig bij aanraking met de huid en bij opname door de mond.PL: Działa toksycznie w kontakcie ze skórą i po połknięciu.PT: Tóxico em contacto com a pele e por ingestão.RO: Toxic în contact cu pielea şi prin înghiţire.SK: Jedovatý pri kontakte s pokožkou a po požití.SL: Strupeno v stiku s kožo in pri zaužitju.FI: Myrkyllistä joutuessaan iholle ja nieltynä.SV: Giftigt vid hudkontakt och förtäring.R26/27BG: Силно токсичен при вдишване и при контакт с кожата.ES: Muy tóxico por inhalación y en contacto con la piel.CS: Vysoce toxický při vdechování a při styku s kůží.DA: Meget giftig ved indånding og ved hudkontakt.DE: Sehr giftig beim Einatmen und bei Berührung mit der Haut.ET: Väga mürgine sissehingamisel ja kokkupuutel nahaga.EL: Πολύ τοξικό όταν εισπνέεται και σε επαφή με το δέρμα.EN: Very toxic by inhalation and in contact with skin.FR: Très toxique par inhalation et par contact avec la peau.IT: Molto tossico per inalazione e contatto con la pelle.LV: Ļoti toksisks ieelpojot un nonākot saskarē ar ādu.LT: Labai toksiška įkvėpus ir susilietus su oda.HU: Belélegezve és bőrrel érintkezve nagyon mérgező.MT: Tossiku ħafna meta jinxtamm u meta jmiss il-ġilda.NL: Zeer vergiftig bij inademing en bij aanraking met de huid.PL: Działa bardzo toksycznie przez drogi oddechowe i w kontakcie ze skórą.PT: Muito tóxico por inalação e em contacto com a pele.RO: Foarte toxic prin inhalare şi în contact cu pielea.SK: Veľmi jedovatý pri vdýchnutí a pri kontakte s pokožkou.SL: Zelo strupeno pri vdihavanju in v stiku s kožo.FI: Erittäin myrkyllistä hengitettynä ja joutuessaan iholle.SV: Mycket giftigt vid inandning och hudkontakt.R26/28BG: Силно токсичен при вдишване и при поглъщане.ES: Muy tóxico por inhalación y por ingestión.CS: Vysoce toxický při vdechování a při požití.DA: Meget giftig ved indånding og ved indtagelse.DE: Sehr giftig beim Einatmen und Verschlucken.ET: Väga mürgine sissehingamisel ja allaneelamisel.EL: Πολύ τοξικό όταν εισπνέεται και σε περίπτωση καταπόσεως.EN: Very toxic by inhalation and if swallowed.FR: Très toxique par inhalation et par ingestion.IT: Molto tossico per inalazione e per ingestione.LV: Ļoti toksisks ieelpojot un norijot.LT: Labai toksiška įkvėpus ir prarijus.HU: Belélegezve és lenyelve nagyon mérgező.MT: Tossiku ħafna meta jinxtamm jew meta jinbela’.NL: Zeer vergiftig bij inademing en opname door de mond.PL: Działa bardzo toksycznie przez drogi oddechowe i po połknięciu.PT: Muito tóxico por inalação e ingestão.RO: Foarte toxic prin inhalare şi prin înghiţire.SK: Veľmi jedovatý pri vdýchnutí a po požití.SL: Zelo strupeno pri vdihavanju in pri zaužitju.FI: Erittäin myrkyllistä hengitettynä ja nieltynä.SV: Mycket giftigt vid inandning och förtäring.R26/27/28BG: Силно токсичен при вдишване, при контакт с кожата и при поглъщане.ES: Muy tóxico por inhalación, por ingestión y en contacto con la piel.CS: Vysoce toxický při vdechování, styku s kůží a při požití.DA: Meget giftig ved indånding, ved hudkontakt og ved indtagelse.DE: Sehr giftig beim Einatmen, Verschlucken und Berührung mit der Haut.ET: Väga mürgine sissehingamisel, kokkupuutel nahaga ja allaneelamisel.EL: Πολύ τοξικό όταν εισπνέεται, σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Very toxic by inhalation, in contact with skin and if swallowed.FR: Très toxique par inhalation, par contact avec la peau et par ingestion.IT: Molto tossico per inalazione, contatto con la pelle e per ingestione.LV: Ļoti toksisks ieelpojot, nonākot saskarē ar ādu un norijot.LT: Labai toksiška įkvėpus, susilietus su oda ir prarijus.HU: Belélegezve, bőrrel érintkezve és lenyelve nagyon mérgező.MT: Tossiku ħafna meta jinxtamm, imiss il-ġilda jew meta jinbela’.NL: Zeer vergiftig bij inademing, opname door de mond en aanraking met de huid.PL: Działa bardzo toksycznie przez drogi oddechowe, w kontakcie ze skórą i po połknięciu.PT: Muito tóxico por inalação, em contacto com a pele e por ingestão.RO: Foarte toxic prin inhalare, în contact cu pielea şi prin înghiţire.SK: Veľmi jedovatý pri vdýchnutí, pri kontakte s pokožkou a po požití.SL: Zelo strupeno pri vdihavanju, v stiku s kožo in pri zaužitju.FI: Erittäin myrkyllistä hengitettynä, joutuessaan iholle ja nieltynä.SV: Mycket giftigt vid inandning, hudkontakt och förtäring.R27/28BG: Силно токсичен при контакт с кожата и при поглъщане.ES: Muy tóxico en contacto con la piel y por ingestión.CS: Vysoce toxický při styku s kůží a při požití.DA: Meget giftig ved hudkontakt og ved indtagelse.DE: Sehr giftig bei Berührung mit der Haut und beim Verschlucken.ET: Väga mürgine kokkupuutel nahaga ja allaneelamisel.EL: Πολύ τοξικό σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Very toxic in contact with skin and if swallowed.FR: Très toxique par contact avec la peau et par ingestion.IT: Molto tossico a contatto con la pelle e per ingestione.LV: Ļoti toksisks, nonākot saskarē ar ādu un norijot.LT: Labai toksiška susilietus su oda ir prarijus.HU: Bőrrel érintkezve és lenyelve nagyon mérgező.MT: Tossiku ħafna meta jmiss il-ġilda jew meta jinbela’.NL: Zeer vergiftig bij aanraking met de huid en bij opname door de mond.PL: Działa bardzo toksycznie w kontakcie ze skórą i po połknięciu.PT: Muito tóxico em contacto com a pele e por ingestão.RO: Foarte toxic în contact cu pielea şi prin înghiţire.SK: Veľmi jedovatý pri kontakte s pokožkou a po požití.SL: Zelo strupeno v stiku s kožo in pri zaužitju.FI: Erittäin myrkyllistä joutuessaan iholle ja nieltynä.SV: Mycket giftigt vid hudkontakt och förtäring.R36/37BG: Дразни очите и дихателните пътища.ES: Irrita los ojos y las vías respiratorias.CS: Dráždí oči a dýchací orgány.DA: Irriterer øjnene og åndedrætsorganerne.DE: Reizt die Augen und die Atmungsorgane.ET: Ärritab silmi ja hingamiselundeid.EL: Ερεθίζει τα μάτια και το αναπνευστικό σύστημα.EN: Irritating to eyes and respiratory system.FR: Irritant pour les yeux et les voies respiratoires.IT: Irritante per gli occhi e le vie respiratorie.LV: Kairina acis un elpošanas sistēmu.LT: Dirgina akis ir kvėpavimo takus.HU: Szemizgató hatású, izgatja a légutakat.MT: Jirrita l-għajnejn u s-sistema respiratorja.NL: Irriterend voor de ogen en de ademhalingswegen.PL: Działa drażniąco na oczy i drogi oddechowe.PT: Irritante para os olhos e vias respiratórias.RO: Iritant pentru ochi şi sistemul respirator.SK: Dráždi oči a dýchacie cesty.SL: Draži oči in dihala.FI: Ärsyttää silmiä ja hengityselimiä.SV: Irriterar ögonen och andningsorganen.R36/38BG: Дразни очите и кожата.ES: Irrita los ojos y la piel.CS: Dráždí oči a kůži.DA: Irriterer øjnene og huden.DE: Reizt die Augen und die Haut.ET: Ärritab silmi ja nahka.EL: Ερεθίζει τα μάτια και το δέρμα.EN: Irritating to eyes and skin.FR: Irritant pour les yeux et la peau.IT: Irritante per gli occhi e la pelle.LV: Kairina acis un ādu.LT: Dirgina akis ir odą.HU: Szem- és bőrizgató hatású.MT: Jirrita l-għajnejn u l-ġilda.NL: Irriterend voor de ogen en de huid.PL: Działa drażniąco na oczy i skórę.PT: Irritante para os olhos e pele.RO: Iritant pentru ochi şi pentru piele.SK: Dráždi oči a pokožku.SL: Draži oči in kožo.FI: Ärsyttää silmiä ja ihoa.SV: Irriterar ögonen och huden.R36/37/38BG: Дразни очите, дихателните пътища и кожата.ES: Irrita los ojos, la piel y las vías respiratorias.CS: Dráždí oči, dýchací orgány a kůži.DA: Irriterer øjnene, åndedrætsorganerne og huden.DE: Reizt die Augen, Atmungsorgane und die Haut.ET: Ärritab silmi, hingamiselundeid ja nahka.EL: Ερεθίζει τα μάτια, το αναπνευστικό σύστημα και το δέρμα.EN: Irritating to eyes, respiratory system and skin.FR: Irritant pour les yeux, les voies respiratoires et la peau.IT: Irritante per gli occhi, le vie respiratorie e la pelle.LV: Kairina acis, ādu un elpošanas sistēmu.LT: Dirgina akis, kvėpavimo takus ir odą.HU: Szem- és bőrizgató hatású, izgatja a légutakat.MT: Jirrita l-għajnejn, is-sistema respiratorja u l-ġilda.NL: Irriterend voor de ogen, de ademhalingswegen en de huid.PL: Działa drażniąco na oczy, drogi oddechowe i skórę.PT: Irritante para os olhos, vias respiratórias e pele.RO: Iritant pentru ochi, sistemul respirator şi pentru piele.SK: Dráždi oči, dýchacie cesty a pokožku.SL: Draži oči, dihala in kožo.FI: Ärsyttää silmiä, hengityselimiä ja ihoa.SV: Irriterar ögonen, andningsorganen och huden.R37/38BG: Дразни дихателните пътища и кожата.ES: Irrita las vías respiratorias y la piel.CS: Dráždí dýchací orgány a kůži.DA: Irriterer åndedrætsorganerne og huden.DE: Reizt die Atmungsorgane und die Haut.ET: Ärritab hingamiselundeid ja nahka.EL: Ερεθίζει το αναπνευστικό σύστημα και το δέρμα.EN: Irritating to respiratory system and skin.FR: Irritant pour les voies respiratoires et la peau.IT: Irritante per le vie respiratorie e la pelle.LV: Kairina elpošanas sistēmu un ādu.LT: Dirgina kvėpavimo takus ir odą.HU: Bőrizgató hatású, izgatja a légutakat.MT: Jirrita s-sistema respiratorja u l-ġilda.NL: Irriterend voor de ademhalingswegen en de huid.PL: Działa drażniąco na drogi oddechowe i skórę.PT: Irritante para as vias respiratórias e pele.RO: Iritant pentru sistemul respirator şi pentru piele.SK: Dráždi dýchacie cesty a pokožku.SL: Draži dihala in kožo.FI: Ärsyttää hengityselimiä ja ihoa.SV: Irriterar andningsorganen och huden.R39/23BG: Токсичен: опасност от много тежки необратими ефекти при вдишване.ES: Tóxico: peligro de efectos irreversibles muy graves por inhalación.CS: Toxický: nebezpečí velmi vážných nevratných účinků při vdechování.DA: Giftig: fare for varig alvorlig skade på helbred ved indånding.DE: Giftig: ernste Gefahr irreversiblen Schadens durch Einatmen.ET: Mürgine: väga tõsiste pöördumatute kahjustuste oht sissehingamisel.EL: Τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων όταν εισπνέεται.EN: Toxic: danger of very serious irreversible effects through inhalation.FR: Toxique: danger d’effets irréversibles très graves par inhalation.IT: Tossico: pericolo di effetti irreversibili molto gravi per inalazione.LV: Toksisks – būtiski neatgriezeniskas iedarbības draudi ieelpojot.LT: Toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus įkvėpus.HU: Belélegezve mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku: periklu ta’ effetti irriversibbli serji ħafna meta jinxtamm.NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing.PL: Działa toksycznie przez drogi oddechowe; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Tóxico: perigo de efeitos irreversíveis muito graves por inalação.RO: Toxic: pericol de efecte ireversibile foarte grave prin inhalare.SK: Jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov vdýchnutím.SL: Strupeno: nevarnost zelo hudih trajnih okvar zdravja pri vdihavanju.FI: Myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara hengitettynä.SV: Giftigt: risk för mycket allvarliga bestående hälsoskador vid inandning.R39/24BG: Токсичен: опасност от много тежки необратими ефекти при контакт с кожата.ES: Tóxico: peligro de efectos irreversibles muy graves por contacto con la piel.CS: Toxický: nebezpečí velmi vážných nevratných účinků při styku s kůží.DA: Giftig: fare for varig alvorlig skade på helbred ved hudkontakt.DE: Giftig: ernste Gefahr irreversiblen Schadens bei Berührung mit der Haut.ET: Mürgine: väga tõsiste pöördumatute kahjustuste oht nahale sattumisel.EL: Τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων σε επαφή με το δέρμα.EN: Toxic: danger of very serious irreversible effects in contact with skin.FR: Toxique: danger d’effets irréversibles très graves par contact avec la peau.IT: Tossico: pericolo di effetti irreversibili molto gravi a contatto con la pelle.LV: Toksisks – būtiski neatgriezeniskas iedarbības draudi, nonākot saskarē ar ādu.LT: Toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus susilietus su oda.HU: Bőrrel érintkezve mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku: periklu ta’ effetti irriversibbli serji ħafna meta jmiss il-ġilda.NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij aanraking met de huid.PL: Działa toksycznie w kontakcie ze skórą; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Tóxico: perigo de efeitos irreversíveis muito graves em contacto com a pele.RO: Toxic: pericol de efecte ireversibile foarte grave în contact cu pielea.SK: Jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov pri kontakte s pokožkou.SL: Strupeno: nevarnost zelo hudih trajnih okvar zdravja v stiku s kožo.FI: Myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara joutuessaan iholle.SV: Giftigt: risk för mycket allvarliga bestående hälsoskador vid hudkontakt.R39/25BG: Токсичен: опасност от много тежки необратими ефекти при поглъщане.ES: Tóxico: peligro de efectos irreversibles muy graves por ingestión.CS: Toxický: nebezpečí velmi vážných nevratných účinků při požití.DA: Giftig: fare for varig alvorlig skade på helbred ved indtagelse.DE: Giftig: ernste Gefahr irreversiblen Schadens durch Verschlucken.ET: Mürgine: väga tõsiste pöördumatute kahjustuste oht allaneelamisel.EL: Τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων σε περίπτωση καταπόσεως.EN: Toxic: danger of very serious irreversible effects if swallowed.FR: Toxique: danger d’effets irréversibles très graves par ingestion.IT: Tossico: pericolo di effetti irreversibili molto gravi per ingestione.LV: Toksisks – būtiski neatgriezeniskas iedarbības draudi norijot.LT: Toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus prarijus.HU: Lenyelve mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku: periklu ta’ effetti irriversibbli serji ħafna jekk jinxtamm.NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij opname door de mond.PL: Działa toksycznie po połknięciu; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Tóxico: perigo de efeitos irreversíveis muito graves por ingestão.RO: Toxic: pericol de efecte ireversibile foarte grave prin înghiţire.SK: Jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov po požití.SL: Strupeno: nevarnost zelo hudih trajnih okvar zdravja pri zaužitju.FI: Myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara nieltynä.SV: Giftigt: risk för mycket allvarliga bestående hälsoskador vid förtäring.R39/23/24BG: Токсичен: опасност от много тежки необратими ефекти при вдишване и при контакт с кожата.ES: Tóxico: peligro de efectos irreversibles muy graves por inhalación y contacto con la piel.CS: Toxický: nebezpečí velmi vážných nevratných účinků při vdechování a při styku s kůží.DA: Giftig: fare for varig alvorlig skade på helbred ved indånding og hudkontakt.DE: Giftig: ernste Gefahr irreversiblen Schadens durch Einatmen und bei Berührung mit der Haut.ET: Mürgine: väga tõsiste pöördumatute kahjustuste oht sissehingamisel ja kokkupuutel nahaga.EL: Τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων όταν εισπνέεται και σε επαφή με το δέρμα.EN: Toxic: danger of very serious irreversible effects through inhalation and in contact with skin.FR: Toxique: danger d’effets irréversibles très graves par inhalation et par contact avec la peau.IT: Tossico: pericolo di effetti irreversibili molto gravi per inalazione e a contatto con la pelle.LV: Toksisks – būtiski neatgriezeniskas iedarbības draudi ieelpojot un nonākot saskarē ar ādu.LT: Toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus įkvėpus ir susilietus su oda.HU: Belélegezve és bőrrel érintkezve mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku: periklu ta’ effetti irriversibbli serji ħafna meta jinxtamm u meta jmiss il-ġilda.NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing en aanraking met de huid.PL: Działa toksycznie przez drogi oddechowe i w kontakcie ze skórą; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Tóxico: perigo de efeitos irreversíveis muito graves por inalação e em contacto com a pele.RO: Toxic: pericol de efecte ireversibile foarte grave prin inhalare şi în contact cu pielea.SK: Jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov vdýchnutím a pri kontakte s pokožkou.SL: Strupeno: nevarnost zelo hudih trajnih okvar zdravja pri vdihavanju in v stiku s kožo.FI: Myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara hengitettynä ja joutuessaan iholle.SV: Giftigt: risk för mycket allvarliga bestående hälsoskador vid inandning och hudkontakt.R39/23/25BG: Токсичен: опасност от много тежки необратими ефекти при вдишване и при поглъщане.ES: Tóxico: peligro de efectos irreversibles muy graves por inhalación e ingestión.CS: Toxický: nebezpečí velmi vážných nevratných účinků při vdechování a při požití.DA: Giftig: fare for varig alvorlig skade på helbred ved indånding og indtagelse.DE: Giftig: ernste Gefahr irreversiblen Schadens durch Einatmen und durch Verschlucken.ET: Mürgine: väga tõsiste pöördumatute kahjustuste oht sissehingamisel ja allaneelamisel.EL: Τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων όταν εισπνέεται και σε περίπτωση καταπόσεως.EN: Toxic: danger of very serious irreversible effects through inhalation and if swallowed.FR: Toxique: danger d’effets irréversibles très graves par inhalation et par ingestion.IT: Tossico: pericolo di effetti irreversibili molto gravi per inalazione ed ingestione.LV: Toksisks: būtiski neatgriezeniskas iedarbības draudi ieelpojot un norijot.LT: Toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus įkvėpus ir prarijus.HU: Belélegezve és lenyelve mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku: periklu ta’ effetti irriversibbli serji ħafna meta jinxtamm jew meta jinbela’.NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing en opname door de mond.PL: Działa toksycznie przez drogi oddechowe i po połknięciu; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Tóxico: perigo de efeitos irreversíveis muito graves por inalação e ingestão.RO: Toxic: pericol de efecte ireversibile foarte grave prin inhalare şi prin înghiţire.SK: Jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov vdýchnutím a po požití.SL: Strupeno: nevarnost zelo hudih trajnih okvar zdravja pri vdihavanju in pri zaužitju.FI: Myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara hengitettynä ja nieltynä.SV: Giftigt: risk för mycket allvarliga bestående hälsoskador vid inandning och förtäring.R39/24/25BG: Токсичен: опасност от много тежки необратими ефекти при контакт с кожата и при поглъщане.ES: Tóxico: peligro de efectos irreversibles muy graves por contacto con la piel e ingestión.CS: Toxický: nebezpečí velmi vážných nevratných účinků při styku s kůží a při požití.DA: Giftig: fare for varig alvorlig skade på helbred ved hudkontakt og indtagelse.DE: Giftig: ernste Gefahr irreversiblen Schadens bei Berührung mit der Haut und durch Verschlucken.ET: Mürgine: väga tõsiste pöördumatute kahjustuste oht kokkupuutel nahaga ja allaneelamisel.EL: Τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Toxic: danger of very serious irreversible effects in contact with skin and if swallowed.FR: Toxique: danger d’effets irréversibles très graves par contact avec la peau et par ingestion.IT: Tossico: pericolo di effetti irreversibili molto gravi a contatto con la pelle e per ingestione.LV: Toksisks – būtiski neatgriezeniskas iedarbības draudi, nonākot saskarē ar ādu un norijot.LT: Toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus susilietus su oda ir prarijus.HU: Bőrrel érintkezve és lenyelve mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku: periklu ta’ effetti irriversibbli serji ħafna meta jmiss il-ġilda jew meta jinbela’.NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij aanraking met de huid en opname door de mond.PL: Działa toksycznie w kontakcie ze skórą i po połknięciu; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Tóxico: perigo de efeitos irreversíveis muito graves em contacto com a pele e por ingestão.RO: Toxic: pericol de efecte ireversibile foarte grave în contact cu pielea şi prin înghiţire.SK: Jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov pri kontakte s pokožkou a po požití.SL: Strupeno: nevarnost zelo hudih trajnih okvar zdravja v stiku s kožo in pri zaužitju.FI: Myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara joutuessaan iholle ja nieltynä.SV: Giftigt: risk för mycket allvarliga bestående hälsoskador vid hudkontakt och förtäring.R39/23/24/25BG: Токсичен: опасност от много тежки необратими ефекти при вдишване, при контакт с кожата и при поглъщане.ES: Tóxico: peligro de efectos irreversibles muy graves por inhalación, contacto con la piel e ingestión.CS: Toxický: nebezpečí velmi vážných nevratných účinků při vdechování, styku s kůží a při požití.DA: Giftig: fare for varig alvorlig skade på helbred ved indånding, hudkontakt og indtagelse.DE: Giftig: ernste Gefahr irreversiblen Schadens durch Einatmen, Berührung mit der Haut und durch Verschlucken.ET: Mürgine: väga tõsiste pöördumatute kahjustuste oht sissehingamisel, kokkupuutel nahaga ja allaneelamisel.EL: Τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων όταν εισπνέεται, σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed.FR: Toxique: danger d’effets irréversibles très graves par inhalation, par contact avec la peau et par ingestion.IT: Tossico: pericolo di effetti irreversibili molto gravi per inalazione, a contatto con la pelle e per ingestione.LV: Toksisks – būtiski neatgriezeniskas iedarbības draudi ieelpojot, nonākot saskarē ar ādu un norijot.LT: Toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus įkvėpus, susilietus su oda ir prarijus.HU: Belélegezve, bőrrel érintkezve és lenyelve mérgező: nagyon súlyos, maradandó egészségkárosodást okozhatMT: Tossiku: periklu ta’ effetti irriversibbli serji ħafna meta jinxtamm, imiss il-ġilda jew meta jinbela’.NL: Vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing, aanraking met de huid en opname door de mond.PL: Działa toksycznie przez drogi oddechowe, w kontakcie ze skórą i po połknięciu; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Tóxico: perigo de efeitos irreversíveis muito graves por inalação, em contacto com a pele e por ingestão.RO: Toxic: pericol de efecte ireversibile foarte grave prin inhalare, în contact cu pielea şi prin înghiţire.SK: Jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov vdýchnutím, pri kontakte s pokožkou a po požití.SL: Strupeno: nevarnost zelo hudih trajnih okvar zdravja pri vdihavanju, v stiku s kožo in pri zaužitju.FI: Myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara hengitettynä, joutuessaan iholle ja nieltynä.SV: Giftigt: risk för mycket allvarliga bestående hälsoskador vid inandning, hudkontakt och förtäring.R39/26BG: Силно токсичен: опасност от много тежки необратими ефекти при вдишване.ES: Muy tóxico: peligro de efectos irreversibles muy graves por inhalación.CS: Vysoce toxický: nebezpečí velmi vážných nevratných účinků při vdechování.DA: Meget giftig: fare for varig alvorlig skade på helbred ved indånding.DE: Sehr giftig: ernste Gefahr irreversiblen Schadens durch Einatmen.ET: Väga mürgine: väga tõsiste pöördumatute kahjustuste oht sissehingamisel.EL: Πολύ τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων όταν εισπνέεται.EN: Very toxic: danger of very serious irreversible effects through inhalation.FR: Très toxique: danger d’effets irréversibles très graves par inhalation.IT: Molto tossico: pericolo di effetti irreversibili molto gravi per inalazione.LV: Ļoti toksisks – būtiski neatgriezeniskas iedarbības draudi ieelpojot.LT: Labai toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus įkvėpus.HU: Belélegezve nagyon mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku ħafna: periklu ta’ effetti irriversibbli serji ħafna meta jinxtamm.NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing.PL: Działa bardzo toksycznie przez drogi oddechowe; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Muito tóxico: perigo de efeitos irreversíveis muito graves por inalação.RO: Foarte toxic: pericol de efecte ireversibile foarte grave prin inhalare.SK: Veľmi jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov vdýchnutím.SL: Zelo strupeno: nevarnost zelo hudih trajnih okvar zdravja pri vdihavanju.FI: Erittäin myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara hengitettynä.SV: Mycket giftigt: risk för mycket allvarliga bestående hälsoskador vid inandning.R39/27BG: Силно токсичен: опасност от много тежки необратими ефекти при контакт с кожата.ES: Muy tóxico: peligro de efectos irreversibles muy graves por contacto con la piel.CS: Vysoce toxický: nebezpečí velmi vážných nevratných účinků při styku s kůží.DA: Meget giftig: fare for varig alvorlig skade på helbred ved hudkontakt.DE: Sehr giftig: ernste Gefahr irreversiblen Schadens bei Berührung mit der Haut.ET: Väga mürgine: väga tõsiste pöördumatute kahjustuste oht kokkupuutel nahaga.EL: Πολύ τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων σε επαφή με το δέρμα.EN: Very toxic: danger of very serious irreversible effects in contact with skin.FR: Très toxique: danger d’effets irréversibles très graves par contact avec la peau.IT: Molto tossico: pericolo di effetti irreversibili molto gravi a contatto con la pelle.LV: Ļoti toksisks – būtiski neatgriezeniskas iedarbības draudi, nonākot saskarē ar ādu.LT: Labai toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus susilietus su oda.HU: Bőrrel érintkezve nagyon mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku ħafna: periklu ta’ effetti irriversibbli serji ħafna meta jmiss il-ġilda.NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij aanraking met de huid.PL: Działa bardzo toksycznie w kontakcie ze skórą; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Muito tóxico: perigo de efeitos irreversíveis muito graves em contacto com a pele.RO: Foarte toxic: pericol de efecte ireversibile foarte grave în contact cu pielea.SK: Veľmi jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov pri kontakte s pokožkou.SL: Zelo strupeno: nevarnost zelo hudih trajnih okvar zdravja v stiku s kožo.FI: Erittäin myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara joutuessaan iholle.SV: Mycket giftigt: risk för mycket allvarliga bestående hälsoskador vid hudkontakt.R39/28BG: Силно токсичен: опасност от много тежки необратими ефекти при поглъщане.ES: Muy tóxico: peligro de efectos irreversibles muy graves por ingestión.CS: Vysoce toxický: nebezpečí velmi vážných nevratných účinků při požití.DA: Meget giftig: fare for varig alvorlig skade på helbred ved indtagelse.DE: Sehr giftig: ernste Gefahr irreversiblen Schadens durch Verschlucken.ET: Väga mürgine: väga tõsiste pöördumatute kahjustuste oht allaneelamisel.EL: Πολύ τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων σε περίπτωση καταπόσεως.EN: Very toxic: danger of very serious irreversible effects if swallowed.FR: Très toxique: danger d’effets irréversibles très graves par ingestion.IT: Molto tossico: pericolo di effetti irreversibili molto gravi per ingestione.LV: Ļoti toksisks – būtiski neatgriezeniskas iedarbības draudi norijot.LT: Labai toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus prarijus.HU: Lenyelve nagyon mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku ħafna: periklu ta’ effetti irriversibbli serji ħafna jekk jinbela’.NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij opname door de mond.PL: Działa bardzo toksycznie po połknięciu; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Muito tóxico: perigo de efeitos irreversíveis muito graves por ingestão.RO: Foarte toxic: pericol de efecte ireversibile foarte grave prin înghiţire.SK: Veľmi jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov po požití.SL: Zelo strupeno: nevarnost zelo hudih trajnih okvar zdravja pri zaužitju.FI: Erittäin myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara nieltynä.SV: Mycket giftigt: risk för mycket allvarliga bestående hälsoskador vid förtäring.R39/26/27BG: Силно токсичен: опасност от много тежки необратими ефекти при вдишване и при контакт с кожата.ES: Muy tóxico: peligro de efectos irreversibles muy graves por inhalación y contacto con la piel.CS: Vysoce toxický: nebezpečí velmi vážných nevratných účinků při vdechování a při styku s kůží.DA: Meget giftig: fare for varig alvorlig skade på helbred ved indånding og hudkontakt.DE: Sehr giftig: ernste Gefahr irreversiblen Schadens durch Einatmen und bei Berührung mit der Haut.ET: Väga mürgine: väga tõsiste pöördumatute kahjustuste oht sissehingamisel ja kokkupuutel nahaga.EL: Πολύ τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων όταν εισπνέεται και σε επαφή με το δέρμα.EN: Very toxic: danger of very serious irreversible effects through inhalation and in contact with skin.FR: Très toxique: danger d’effets irréversibles très graves par inhalation et par contact avec la peau.IT: Molto tossico: pericolo di effetti irreversibili molto gravi per inalazione e a contatto con la pelle.LV: Ļoti toksisks – būtiski neatgriezeniskas iedarbības draudi ieelpojot un nonākot saskarē ar ādu.LT: Labai toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus įkvėpus ir susilietus su oda.HU: Belélegezve és bőrrel érintkezve nagyon mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku ħafna: periklu ta’ effetti irriversibbli serji ħafna meta jinxtamm u jmiss il-ġilda.NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing en aanraking met de huid.PL: Działa bardzo toksycznie przez drogi oddechowe i w kontakcie ze skórą; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Muito tóxico: perigo de efeitos irreversíveis muito graves por inalação e em contacto com a pele.RO: Foarte toxic: pericol de efecte ireversibile foarte grave prin inhalare şi în contact cu pielea.SK: Veľmi jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov vdýchnutím a pri kontakte s pokožkou.SL: Zelo strupeno: nevarnost zelo hudih trajnih okvar zdravja pri vdihavanju in v stiku s kožo.FI: Erittäin myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara hengitettynä ja joutuessaan iholle.SV: Mycket giftigt: risk för mycket allvarliga bestående hälsoskador vid inandning och hudkontakt.R39/26/28BG: Силно токсичен: опасност от много тежки необратими ефекти при вдишване и при поглъщане.ES: Muy tóxico: peligro de efectos irreversibles muy graves por inhalación e ingestión.CS: Vysoce toxický: nebezpečí velmi vážných nevratných účinků při vdechování a při požití.DA: Meget giftig: fare for varig alvorlig skade på helbred ved indånding og indtagelse.DE: Sehr giftig: ernste Gefahr irreversiblen Schadens durch Einatmen und durch Verschlucken.ET: Väga mürgine: väga tõsiste pöördumatute kahjustuste oht sissehingamisel ja allaneelamisel.EL: Πολύ τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων όταν εισπνέεται και σε περίπτωση καταπόσεως.EN: Very toxic: danger of very serious irreversible effects through inhalation and if swallowed.FR: Très toxique: danger d’effets irréversibles très graves par inhalation et par ingestion.IT: Molto tossico: pericolo di effetti irreversibili molto gravi per inalazione ed ingestione.LV: Ļoti toksisks – būtiski neatgriezeniskas iedarbības draudi ieelpojot un norijot.LT: Labai toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus įkvėpus ir prarijus.HU: Belélegezve és lenyelve nagyon mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku ħafna: periklu ta’ effetti irriversibbli serji ħafna meta jinxtamm u jekk jinbela’.NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing en opname door de mond.PL: Działa bardzo toksycznie przez drogi oddechowe i po połknięciu; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Muito tóxico: perigo de efeitos irreversíveis muito graves por inalação e ingestão.RO: Foarte toxic: pericol de efecte ireversibile foarte grave prin inhalare şi prin înghiţire.SK: Veľmi jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov vdýchnutím a po požití.SL: Zelo strupeno: nevarnost zelo hudih trajnih okvar zdravja pri vdihavanju in pri zaužitju.FI: Erittäin myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara hengitettynä ja nieltynä.SV: Mycket giftigt: risk för mycket allvarliga bestående hälsoskador vid inandning och förtäring.R39/27/28BG: Силно токсичен: опасност от много тежки необратими ефекти при контакт с кожата и при поглъщане.ES: Muy tóxico: peligro de efectos irreversibles muy graves por contacto con la piel e ingestión.CS: Vysoce toxický: nebezpečí velmi vážných nevratných účinků při styku s kůží a při požití.DA: Meget giftig: fare for varig alvorlig skade på helbred ved hudkontakt og indtagelse.DE: Sehr giftig: ernste Gefahr irreversiblen Schadens bei Berührung mit der Haut und durch Verschlucken.ET: Väga mürgine: väga tõsiste pöördumatute kahjustuste oht kokkupuutel nahaga ja allaneelamisel.EL: Πολύ τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Very toxic: danger of very serious irreversible effects in contact with skin and if swallowed.FR: Très toxique: danger d’effets irréversibles très graves par contact avec la peau et par ingestion.IT: Molto tossico: pericolo di effetti irreversibili molto gravi a contatto con la pelle e per ingestione.LV: Ļoti toksisks – būtiski neatgriezeniskas iedarbības draudi, nonākot saskarē ar ādu un norijot.LT: Labai toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus susilietus su oda ir prarijus.HU: Bőrrel érintkezve és lenyelve nagyon mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku ħafna: periklu ta’ effetti irriversibbli serji ħafna meta jmiss il-ġilda u jekk jinbela’.NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij aanraking met de huid en opname door de mond.PL: Działa bardzo toksycznie w kontakcie ze skórą i po połknięciu; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Muito tóxico: perigo de efeitos irreversíveis muito graves em contacto com a pele e por ingestão.RO: Foarte toxic: pericol de efecte ireversibile foarte grave în contact cu pielea şi prin înghiţire.SK: Veľmi jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov pri kontakte s pokožkou a po požití.SL: Zelo strupeno: nevarnost zelo hudih trajnih okvar zdravja v stiku s kožo in pri zaužitju.FI: Erittäin myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara joutuessaan iholle ja nieltynä.SV: Mycket giftigt: risk för mycket allvarliga bestående hälsoskador vid hudkontakt och förtäring.R39/26/27/28BG: Силно токсичен: опасност от много тежки необратими ефекти при вдишване, при контакт с кожата и при поглъщане.ES: Muy tóxico: peligro de efectos irreversibles muy graves por inhalación, contacto con la piel e ingestión.CS: Vysoce toxický: nebezpečí velmi vážných nevratných účinků při vdechování, styku s kůží a při požití.DA: Meget giftig: fare for varig alvorlig skade på helbred ved indånding, hudkontakt og indtagelse.DE: Sehr giftig: ernste Gefahr irreversiblen Schadens durch Einatmen, Berührung mit der Haut und durch Verschlucken.ET: Väga mürgine: väga tõsiste pöördumatute kahjustuste oht sissehingamisel, kokkupuutel nahaga ja allaneelamisel.EL: Πολύ τοξικό: κίνδυνος πολύ σοβαρών μόνιμων επιδράσεων όταν εισπνέεται, σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Very toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed.FR: Très toxique: danger d’effets irréversibles très graves par inhalation, par contact avec la peau et par ingestion.IT: Molto tossico: pericolo di effetti irreversibili molto gravi per inalazione, a contatto con la pelle e per ingestione.LV: Ļoti toksisks – būtiski neatgriezeniskas iedarbības draudi ieelpojot, nonākot saskarē ar ādu vai norijot.LT: Labai toksiška: sukelia labai sunkius negrįžtamus sveikatos pakenkimus įkvėpus, susilietus su oda ir prarijus.HU: Belélegezve, bőrrel érintkezve, lenyelve nagyon mérgező: nagyon súlyos, maradandó egészségkárosodást okozhat.MT: Tossiku ħafna: periklu ta’ effetti irriversibbli serji ħafna meta jinxtamm, imiss il-ġilda u jekk jinbela’.NL: Zeer vergiftig: gevaar voor ernstige onherstelbare effecten bij inademing, aanraking met de huid en opname door de mond.PL: Działa bardzo toksycznie przez drogi oddechowe, w kontakcie ze skórą i po połknięciu; zagraża powstaniem bardzo poważnych nieodwracalnych zmian w stanie zdrowia.PT: Muito tóxico: perigo de efeitos irreversíveis muito graves por inalação, em contacto com a pele e por ingestão.RO: Foarte toxic: pericol de efecte ireversibile foarte grave prin inhalare, în contact cu pielea şi prin înghiţire.SK: Veľmi jedovatý, nebezpečenstvo veľmi vážnych ireverzibilných účinkov vdýchnutím, pri kontakte s pokožkou a po požití.SL: Zelo strupeno: nevarnost zelo hudih trajnih okvar zdravja pri vdihavanju, v stiku s kožo in pri zaužitju.FI: Erittäin myrkyllistä: erittäin vakavien pysyvien vaurioiden vaara hengitettynä, joutuessaan iholle ja nieltynä.SV: Mycket giftigt: risk för mycket allvarliga bestående hälsoskador vid inandning, hudkontakt och förtäring.R42/43BG: Възможна е сенсибилизация при вдишване и при контакт с кожата.ES: Posibilidad de sensibilización por inhalación y por contacto con la piel.CS: Může vyvolat senzibilizaci při vdechování a při styku s kůží.DA: Kan give overfølsomhed ved indånding og ved kontakt med huden.DE: Sensibilisierung durch Einatmen und Hautkontakt möglich.ET: Võib põhjustada ülitundlikkust sissehingamisel ja kokkupuutel nahaga.EL: Μπορεί να προκαλέσει ευαισθητοποίηση όταν εισπνέεται και σε επαφή με το δέρμα.EN: May cause sensitization by inhalation and skin contact.FR: Peut entraîner une sensibilisation par inhalation et par contact avec la peau.IT: Può provocare sensibilizzazione per inalazione e contatto con la pelle.LV: Saskaroties ar ādu vai ieelpojot, var izraisīt paaugstinātu jutīgumu.LT: Gali sukelti alergiją įkvėpus ir susilietus su oda.HU: Belélegezve és bőrrel érintkezve túlérzékenységet okozhat (szenzibilizáló hatású lehet).MT: Jista’ jikkaġuna sensitizzazzjoni meta jinxtamm u meta jmiss il-ġilda.NL: Kan overgevoeligheid veroorzaken bij inademing of contact met de huid.PL: Może powodować uczulenie w następstwie narażenia drogą oddechową i w kontakcie ze skórą.PT: Pode causar sensibilização por inalação e em contacto com a pele.RO: Poate provoca sensibilizare prin inhalare şi în contact cu pielea.SK: Môže spôsobiť senzibilizáciu po vdýchnutí a po kontakte s pokožkou.SL: Lahko povzroči preobčutljivost pri vdihavanju in v stiku s kožo.FI: Altistuminen hengitysteitse ja ihokosketus voi aiheuttaa herkistymistä.SV: Kan ge allergi vid inandning och hudkontakt.R48/20BG: Вреден: опасност от тежко увреждане на здравето при продължителна експозиция чрез вдишване.ES: Nocivo: riesgo de efectos graves para la salud en caso de exposición prolongada por inhalación.CS: Zdraví škodlivý: nebezpečí vážného poškození zdraví při dlouhodobé expozici vdechováním.DA: Farlig: alvorlig sundhedsfare ved længere tids påvirkning ved indånding.DE: Gesundheitsschädlich: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Einatmen.ET: Kahjulik: tõsise tervisekahjustuse oht pikaajalisel sissehingamisel.EL: Επιβλαβές: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση όταν εισπνέεται.EN: Harmful: danger of serious damage to health by prolonged exposure through inhalation.FR: Nocif: risque d’effets graves pour la santé en cas d’exposition prolongée par inhalation.IT: Nocivo: pericolo di gravi danni per la salute in caso di esposizione prolungata per inalazione.LV: Kaitīgs – ieelpojot iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības.LT: Kenksminga: ilgą laiką pakartotinai įkvepiant sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át belélegezve ártalmas: súlyos egészségkárosodást okozhat.MT: Jagħmel ħsara: periklu ta’ ħsara serja lis-saħħa minn espożizzjoni għat-tul minħabba xamm.NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing.PL: Działa szkodliwie przez drogi oddechowe; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Nocivo: risco de efeitos graves para a saúde em caso de exposição prolongada por inalação.RO: Nociv: pericol de efecte grave asupra sănătăţii la expunere prelungită prin inhalare.SK: Škodlivý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou vdýchnutím.SL: Zdravju škodljivo: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega vdihavanja.FI: Terveydelle haitallista: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettynä.SV: Farligt: risk för allvarliga hälsoskador vid långvarig exponering genom inandning.R48/21BG: Вреден: опасност от тежко увреждане на здравето при продължителна експозиция при контакт с кожата.ES: Nocivo: riesgo de efectos graves para la salud en caso de exposición prolongada por contacto con la piel.CS: Zdraví škodlivý: nebezpečí vážného poškození zdraví při dlouhodobé expozici stykem s kůží.DA: Farlig: alvorlig sundhedsfare ved længere tids påvirkning ved hudkontakt.DE: Gesundheitsschädlich: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Berührung mit der Haut.ET: Kahjulik: tõsise tervisekahjustuse oht pikaajalisel kokkupuutel nahaga.EL: Επιβλαβές: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση σε επαφή με το δέρμα.EN: Harmful: danger of serious damage to health by prolonged exposure in contact with skin.FR: Nocif: risque d’effets graves pour la santé en cas d’exposition prolongée par contact avec la peau.IT: Nocivo: pericolo di gravi danni alla salute in caso di esposizione prolungata a contatto con la pelle.LV: Kaitīgs – iespējams nopietns kaitējums veselībai pēc ilgstošas saskares ar ādu.LT: Kenksminga: ilgą laiką pakartotinai veikiant per odą sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át bőrrel érintkezve ártalmas: súlyos egészségkárosodást okozhat.MT: Jagħmel ħsara: periklu ta’ ħsara serja lis-saħħa minn espożizzjoni għat-tul waqt li jmiss il-ġilda.NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij aanraking met de huid.PL: Działa szkodliwie w kontakcie ze skórą; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Nocivo: risco de efeitos graves para a saúde em caso de exposição prolongada em contacto com a pele.RO: Nociv: pericol de efecte grave asupra sănătăţii la expunere prelungită în contact cu pielea.SK: Škodlivý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou pri kontakte s pokožkou.SL: Zdravju škodljivo: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega stika s kožo.FI: Terveydelle haitallista: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle joutuessaan iholle.SV: Farligt: risk för allvarliga hälsoskador vid långvarig exponering genom hudkontakt.R48/22BG: Вреден: опасност от тежко увреждане на здравето при продължителна експозиция при поглъщане.ES: Nocivo: riesgo de efectos graves para la salud en caso de exposición prolongada por ingestión.CS: Zdraví škodlivý: nebezpečí vážného poškození zdraví při dlouhodobé expozici požíváním.DA: Farlig: alvorlig sundhedsfare ved længere tids påvirkning ved indtagelse.DE: Gesundheitsschädlich: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Verschlucken.ET: Kahjulik: tõsise tervisekahjustuse oht pikaajalisel allaneelamisel.EL: Επιβλαβές: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση σε περίπτωση καταπόσεως.EN: Harmful: danger of serious damage to health by prolonged exposure if swallowed.FR: Nocif: risque d’effets graves pour la santé en cas d’exposition prolongée par ingestion.IT: Nocivo: pericolo di gravi danni alla salute in caso di esposizione prolungata per ingestione.LV: Kaitīgs – norijot iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības.LT: Kenksminga: ilgą laiką pakartotinai praryjant sukelia sunkius sveikatos sutrikimus.HU: Szájon keresztül hosszabb időn át a szervezetbe jutva ártalmas: súlyos egészségkárosodást okozhat.MT: Jagħmel ħsara: periklu ta’ ħsara serja lis-saħħa minn espożizzjoni għat-tul jekk jinbela’.NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij opname door de mond.PL: Działa szkodliwie po połknięciu; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Nocivo: risco de efeitos graves para a saúde em caso de exposição prolongada por ingestão.RO: Nociv: pericol de efecte grave asupra sănătăţii la expunere prelungită prin înghiţire.SK: Škodlivý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou po požití.SL: Zdravju škodljivo: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega zauživanja.FI: Terveydelle haitallista: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle nieltynä.SV: Farligt: risk för allvarliga hälsoskador vid långvarig exponering genom förtäring.R48/20/21BG: Вреден: опасност от тежко увреждане на здравето при продължителна експозиция чрез вдишване и при контакт с кожата.ES: Nocivo: riesgo de efectos graves para la salud en caso de exposición prolongada por inhalación y contacto con la piel.CS: Zdraví škodlivý: nebezpečí vážného poškození zdraví při dlouhodobé expozici vdechováním a stykem s kůží.DA: Farlig: alvorlig sundhedsfare ved længere tids påvirkning ved indånding og hudkontakt.DE: Gesundheitsschädlich: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Einatmen und durch Berührung mit der Haut.ET: Kahjulik: tõsise tervisekahjustuse oht pikaajalisel sissehingamisel ja kokkupuutel nahaga.EL: Επιβλαβές: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση όταν εισπνέεται και σε επαφή με το δέρμα.EN: Harmful: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin.FR: Nocif: risque d’effets graves pour la santé en cas d’exposition prolongée par inhalation et par contact avec la peau.IT: Nocivo: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione e a contatto con la pelle.LV: Kaitīgs – ieelpojot un nonākot saskarē ar ādu, iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības.LT: Kenksminga: ilgą laiką pakartotinai įkvepiant ir veikiant per odą sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át belélegezve és bőrrel érintkezve ártalmas: súlyos egészségkárosodást okozhat.MT: Jagħmel ħsara: periklu ta’ ħsara serja lis-saħħa minn espożizzjoni għat-tul minħabba xamm u mess mal-ġilda.NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing en aanraking met de huid.PL: Działa szkodliwie przez drogi oddechowe i w kontakcie ze skórą; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Nocivo: risco de efeitos graves para a saúde em caso de exposição prolongada por inalação e em contacto com a pele.RO: Nociv: pericol de efecte grave asupra sănătăţii la expunere prelungită prin inhalare şi în contact cu pielea.SK: Škodlivý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou vdýchnutím a pri kontakte s pokožkou.SL: Zdravju škodljivo: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega vdihavanja in stika s kožo.FI: Terveydelle haitallista: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettynä ja joutuessaan iholle.SV: Farligt: risk för allvarliga hälsoskador vid långvarig exponering genom inandning och hudkontakt.R48/20/22BG: Вреден: опасност от тежко увреждане на здравето при продължителна експозиция чрез вдишване и при поглъщане.ES: Nocivo: riesgo de efectos graves para la salud en caso de exposición prolongada por inhalación e ingestión.CS: Zdraví škodlivý: nebezpečí vážného poškození zdraví při dlouhodobé expozici vdechováním a požíváním.DA: Farlig: alvorlig sundhedsfare ved længere tids påvirkning ved indånding og indtagelse.DE: Gesundheitsschädlich: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Einatmen und durch Verschlucken.ET: Kahjulik: tõsise tervisekahjustuse oht pikaajalisel sissehingamisel ja allaneelamisel.EL: Επιβλαβές: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση όταν εισπνέεται και σε περίπτωση καταπόσεως.EN: Harmful: danger of serious damage to health by prolonged exposure through inhalation and if swallowed.FR: Nocif: risque d’effets graves pour la santé en cas d’exposition prolongée par inhalation et par ingestion.IT: Nocivo: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione e ingestione.LV: Kaitīgs – ieelpojot un norijot iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības.LT: Kenksminga: ilgą laiką pakartotinai įkvepiant ir praryjant sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át belélegezve és szájon át a szervezetbe jutva ártalmas: súlyos egészségkárosodást okozhat.MT: Jagħmel ħsara: periklu ta’ ħsara serja lis-saħħa minn espożizzjoni għat-tul minħabba xamm u jekk jinbela’.NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing en opname door de mond.PL: Działa szkodliwie przez drogi oddechowe i po połknięciu; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Nocivo: risco de efeitos graves para a saúde em caso de exposição prolongada por inalação e ingestão.RO: Nociv: pericol de efecte grave asupra sănătăţii la expunere prelungită prin inhalare şi prin înghiţire.SK: Škodlivý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou vdýchnutím a po požití.SL: Zdravju škodljivo: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega vdihavanja in zauživanja.FI: Terveydelle haitallista: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettynä ja nieltynä.SV: Farligt: risk för allvarliga hälsoskador vid långvarig exponering genom inandning och förtäring.R48/21/22BG: Вреден: опасност от тежко увреждане на здравето при продължителна експозиция при контакт с кожата и при поглъщане.ES: Nocivo: riesgo de efectos graves para la salud en caso de exposición prolongada por contacto con la piel e ingestión.CS: Zdraví škodlivý: nebezpečí vážného poškození zdraví při dlouhodobé expozici stykem s kůží a požíváním.DA: Farlig: alvorlig sundhedsfare ved længere tids påvirkning ved hudkontakt og indtagelse.DE: Gesundheitsschädlich: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Berührung mit der Haut und durch Verschlucken.ET: Kahjulik: tõsise tervisekahjustuse oht pikaajalisel kokkupuutel nahaga ja allaneelamisel.EL: Επιβλαβές: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Harmful: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed.FR: Nocif: risque d’effets graves pour la santé en cas d’exposition prolongée par contact avec la peau et par ingestion.IT: Nocivo: pericolo di gravi danni alla salute in caso di esposizione prolungata a contatto con la pelle e per ingestione.LV: Kaitīgs – iespējams nopietns kaitējums veselībai pēc ilgstošas saskares ar ādu un norijot.LT: Kenksminga: ilgą laiką pakartotinai veikiant per odą ir praryjant sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át bőrrel érintkezve és szájon át a szervezetbe jutva ártalmas: súlyos egészségkárosodást okozhat.MT: Jagħmel ħsara: periklu ta’ ħsara serja lis-saħħa minn espożizzjoni għat-tul meta jmiss il-ġilda u jekk jinbela’.NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij aanraking met de huid en opname door de mond.PL: Działa szkodliwie w kontakcie ze skórą i po połknięciu; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Nocivo: risco de efeitos graves para a saúde em caso de exposição prolongada em contacto com a pele e por ingestão.RO: Nociv: pericol de efecte grave asupra sănătăţii la expunere prelungită în contact cu pielea şi prin înghiţire.SK: Škodlivý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou pri kontakte s pokožkou a po požití.SL: Zdravju škodljivo: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega stika s kožo in zauživanja.FI: Terveydelle haitallista: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle joutuessaan iholle ja nieltynä.SV: Farligt: risk för allvarliga hälsoskador vid långvarig exponering genom hudkontakt och förtäring.R48/20/21/22BG: Вреден: опасност от тежко увреждане на здравето при продължителна експозиция чрез вдишване, при контакт с кожата и при поглъщане.ES: Nocivo: riesgo de efectos graves para la salud en caso de exposición prolongada por inhalación, contacto con la piel e ingestión.CS: Zdraví škodlivý: nebezpečí vážného poškození zdraví při dlouhodobé expozici vdechováním, stykem s kůží a požíváním.DA: Farlig: alvorlig sundhedsfare ved længere tids påvirkning ved indånding, hudkontakt og indtagelse.DE: Gesundheitsschädlich: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Einatmen, Berührung mit der Haut und durch Verschlucken.ET: Kahjulik: tõsise tervisekahjustuse oht pikaajalisel sissehingamisel, kokkupuutel nahaga ja allaneelamisel.EL: Επιβλαβές: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση όταν εισπνέεται, σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Harmful: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed.FR: Nocif: risque d’effets graves pour la santé en cas d’exposition prolongée par inhalation, par contact avec la peau et par ingestion.IT: Nocivo: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione, a contatto con la pelle e per ingestione.LV: Kaitīgs – iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības ieelpojot, norijot un nonākot saskarē ar ādu.LT: Kenksminga: ilgą laiką pakartotinai įkvepiant, veikiant per odą ir praryjant sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át belélegezve, bőrrel érintkezve és szájon keresztül a szervezetbe jutva ártalmas: súlyos egészségkárosodást okozhat.MT: Jagħmel ħsara: periklu ta’ ħsara serja lis-saħħa minn espożizzjoni għat-tul minħabba xamm, mess mal-ġilda jew jekk jinbela’.NL: Schadelijk: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing, aanraking met de huid en opname door de mond.PL: Działa szkodliwie przez drogi oddechowe, w kontakcie ze skórą i po połknięciu; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Nocivo: risco de efeitos graves para a saúde em caso de exposição prolongada por inalação, em contacto com a pele e por ingestão.RO: Nociv: pericol de efecte grave asupra sănătăţii la expunere prelungită prin inhalare, în contact cu pielea şi prin înghiţire.SK: Škodlivý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou vdýchnutím, pri kontakte s pokožkou a po požití.SL: Zdravju škodljivo: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega vdihavanja, stika s kožo in zauživanja.FI: Terveydelle haitallista: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettynä, joutuessaan iholle ja nieltynä.SV: Farligt: risk för allvarliga hälsoskador vid långvarig exponering genom inandning, hudkontakt och förtäring.R48/23BG: Токсичен: опасност от тежко увреждане на здравето при продължителна експозиция чрез вдишване.ES: Tóxico: riesgo de efectos graves para la salud en caso de exposición prolongada por inhalación.CS: Toxický: nebezpečí vážného poškození zdraví při dlouhodobé expozici vdechováním.DA: Giftig: alvorlig sundhedsfare ved længere tids påvirkning ved indånding.DE: Giftig: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Einatmen.ET: Mürgine: tõsise tervisekahjustuse oht pikaajalisel sissehingamisel.EL: Τοξικό: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση όταν εισπνέεται.EN: Toxic: danger of serious damage to health by prolonged exposure through inhalation.FR: Toxique: risque d’effets graves pour la santé en cas d’exposition prolongée par inhalation.IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione.LV: Toksisks – iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības ieelpojot.LT: Toksiška: ilgą laiką pakartotinai įkvepiant sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át belélegezve mérgező: súlyos egészségkárosodást okozhat.MT: Tossiku: periklu ta’ ħsara serja lis-saħħa minn espożizzjoni għat-tul minħabba xamm.NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing.PL: Działa toksycznie przez drogi oddechowe; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Tóxico: risco de efeitos graves para a saúde em caso de exposição prolongada por inalação.RO: Toxic: pericol de efecte grave asupra sănătăţii la expunere prelungită prin inhalare.SK: Jedovatý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou vdýchnutím.SL: Strupeno: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega vdihavanja.FI: Myrkyllistä: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettynä.SV: Giftigt: risk för allvarliga hälsoskador vid långvarig exponering genom inandning.R48/24BG: Токсичен: опасност от тежко увреждане на здравето при продължителна експозиция при контакт с кожата.ES: Tóxico: riesgo de efectos graves para la salud en caso de exposición prolongada por contacto con la piel.CS: Toxický: nebezpečí vážného poškození zdraví při dlouhodobé expozici stykem s kůží.DA: Giftig: alvorlig sundhedsfare ved længere tids påvirkning ved hudkontakt.DE: Giftig: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Berührung mit der Haut.ET: Mürgine: tõsise tervisekahjustuse oht pikaajalisel kokkupuutel nahaga.EL: Τοξικό: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση σε επαφή με το δέρμα.EN: Toxic: danger of serious damage to health by prolonged exposure in contact with skin.FR: Toxique: risque d’effets graves pour la santé en cas d’exposition prolongée par contact avec la peau.IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata a contatto con la pelle.LV: Toksisks – iespējams nopietns kaitējums veselībai pēc ilgstošas saskares ar ādu.LT: Toksiška: ilgą laiką pakartotinai veikiant per odą sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át bőrrel érintkezve mérgező: súlyos egészségkárosodást okozhat.MT: Tossiku: periklu ta’ ħsara serja lis-saħħa minn espożizzjoni għat-tul għal mess mal-ġilda.NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij aanraking met de huid.PL: Działa toksycznie w kontakcie ze skórą; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Tóxico: risco de efeitos graves para a saúde em caso de exposição prolongada em contacto com a pele.RO: Toxic: pericol de efecte grave asupra sănătăţii la expunere prelungită în contact cu pielea.SK: Jedovatý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou pri kontakte s pokožkou.SL: Strupeno: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega stika s kožo.FI: Myrkyllistä: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle joutuessaan iholle.SV: Giftigt: risk för allvarliga hälsoskador vid långvarig exponering genom hudkontakt.R48/25BG: Токсичен: опасност от тежко увреждане на здравето при продължителна експозиция при поглъщане.ES: Tóxico: riesgo de efectos graves para la salud en caso de exposición prolongada por ingestión.CS: Toxický: nebezpečí vážného poškození zdraví při dlouhodobé expozici požíváním.DA: Giftig: alvorlig sundhedsfare ved længere tids påvirkning ved indtagelse.DE: Giftig: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Verschlucken.ET: Mürgine: tõsise tervisekahjustuse oht pikaajalisel allaneelamisel.EL: Τοξικό: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση σε περίπτωση καταπόσεως.EN: Toxic: danger of serious damage to health by prolonged exposure if swallowed.FR: Toxique: risque d’effets graves pour la santé en cas d’exposition prolongée par ingestion.IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata per ingestione.LV: Toksisks – iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības norijot.LT: Toksiška: ilgą laiką pakartotinai praryjant sukelia sunkius sveikatos sutrikimus.HU: Szájon keresztül hosszabb időn át a szervezetbe jutva mérgező: súlyos egészségkárosodást okozhat.MT: Tossiku: periklu ta’ ħsara serja lis-saħħa minn espożizzjoni għat-tul jekk jinbela’.NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij opname door de mond.PL: Działa toksycznie po połknięciu; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Tóxico: risco de efeitos graves para a saúde em caso de exposição prolongada por ingestão.RO: Toxic: pericol de efecte grave asupra sănătăţii la expunere prelungită prin înghiţire.SK: Jedovatý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou po požití.SL: Strupeno: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega zauživanja.FI: Myrkyllistä: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle nieltynä.SV: Giftigt: risk för allvarliga hälsoskador vid långvarig exponering genom förtäring.R48/23/24BG: Токсичен: опасност от тежко увреждане на здравето при продължителна експозиция чрез вдишване и при контакт с кожата.ES: Tóxico: riesgo de efectos graves para la salud en caso de exposición prolongada por inhalación y contacto con la piel.CS: Toxický: nebezpečí vážného poškození zdraví při dlouhodobé expozici vdechováním a stykem s kůží.DA: Giftig: alvorlig sundhedsfare ved længere tids påvirkning ved indånding og hudkontakt.DE: Giftig: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Einatmen und durch Berührung mit der Haut.ET: Mürgine: tõsise tervisekahjustuse oht pikaajalisel sissehingamisel ja kokkupuutel nahaga.EL: Τοξικό: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση όταν εισπνέεται και σε επαφή με το δέρμα.EN: Toxic: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin.FR: Toxique: risque d’effets graves pour la santé en cas d’exposition prolongée par inhalation et par contact avec la peau.IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione e a contatto con la pelle.LV: Toksisks – iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības ieelpojot un nonākot saskarē ar ādu.LT: Toksiška: ilgą laiką pakartotinai įkvepiant ir veikiant per odą sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át belélegezve és bőrrel érintkezve mérgező: súlyos egészségkárosodást okozhat.MT: Tossiku: periklu ta’ ħsara serja lis-saħħa minn espożizzjoni għat-tul minħabba xamm u mess mal-ġilda.NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing en aanraking met de huid.PL: Działa toksycznie przez drogi oddechowe i w kontakcie ze skórą; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Tóxico: risco de efeitos graves para a saúde em caso de exposição prolongada por inalação e em contacto com a pele.RO: Toxic: pericol de efecte grave asupra sănătăţii la expunere prelungită prin inhalare şi în contact cu pielea.SK: Jedovatý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou vdýchnutím a pri kontakte s pokožkou.SL: Strupeno: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega vdihavanja in stika s kožo.FI: Myrkyllistä: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettynä ja joutuessaan iholle.SV: Giftigt: risk för allvarliga hälsoskador vid långvarig exponering genom inandning och hudkontakt.R48/23/25BG: Токсичен: опасност от тежко увреждане на здравето при продължителна експозиция чрез вдишване и при поглъщане.ES: Tóxico: riesgo de efectos graves para la salud en caso de exposición prolongada por inhalación e ingestión.CS: Toxický: nebezpečí vážného poškození zdraví při dlouhodobé expozici vdechováním a požíváním.DA: Giftig: alvorlig sundhedsfare ved længere tids påvirkning ved indånding og indtagelse.DE: Giftig: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Einatmen und durch Verschlucken.ET: Mürgine: tõsise tervisekahjustuse oht pikaajalisel sissehingamisel ja allaneelamisel.EL: Τοξικό: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση όταν εισπνέεται και σε περίπτωση καταπόσεως.EN: Toxic: danger of serious damage to health by prolonged exposure through inhalation and if swallowed.FR: Toxique: risque d’effets graves pour la santé en cas d’exposition prolongée par inhalation et par ingestion.IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione ed ingestione.LV: Toksisks – iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības ieelpojot un norijot.LT: Toksiška: ilgą laiką pakartotinai įkvepiant ir praryjant sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át belélegezve és szájon keresztül a szervezetbe jutva mérgező: súlyos egészségkárosodást okozhat.MT: Tossiku: periklu ta’ ħsara serja lis-saħħa minn espożizzjoni għat-tul minħabba xamm u jekk jinbela’.NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing en opname door de mond.PL: Działa toksycznie przez drogi oddechowe i po połknięciu; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Tóxico: risco de efeitos graves para a saúde em caso de exposição prolongada por inalação e ingestão.RO: Toxic: pericol de efecte grave asupra sănătăţii la expunere prelungită prin inhalare şi prin înghiţire.SK: Jedovatý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou vdýchnutím a po požití.SL: Strupeno: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega vdihavanja in zauživanja.FI: Myrkyllistä: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettynä ja nieltynä.SV: Giftigt: risk för allvarliga hälsoskador vid långvarig exponering genom inandning och förtäring.R48/24/25BG: Токсичен: опасност от тежко увреждане на здравето при продължителна експозиция при контакт с кожата и при поглъщане.ES: Tóxico: riesgo de efectos graves para la salud en caso de exposición prolongada por contacto con la piel e ingestión.CS: Toxický: nebezpečí vážného poškození zdraví při dlouhodobé expozici stykem s kůží a požíváním.DA: Giftig: alvorlig sundhedsfare ved længere tids påvirkning ved hudkontakt og indtagelse.DE: Giftig: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Berührung mit der Haut und durch Verschlucken.ET: Mürgine: tõsise tervisekahjustuse oht pikaajalisel kokkupuutel nahaga ja allaneelamisel.EL: Τοξικό: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Toxic: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed.FR: Toxique: risque d’effets graves pour la santé en cas d’exposition prolongée par contact avec la peau et par ingestion.IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata a contatto con la pelle e per ingestione.LV: Toksisks – iespējams nopietns kaitējums veselībai pēc ilgstošas saskares ar ādu un norijot.LT: Toksiška: ilgą laiką pakartotinai veikiant per odą ir praryjant sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át bőrrel érintkezve és szájon keresztül a szervezetbe jutva mérgező: súlyos egészségkárosodást okozhat.MT: Tossiku: periklu ta’ ħsara serja lis-saħħa minn espożizzjoni għat-tul għal mess mal-ġilda u jekk jinbela’.NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij aanraking met de huid en opname door de mond.PL: Działa toksycznie w kontakcie ze skórą i po połknięciu; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Tóxico: risco de efeitos graves para a saúde em caso de exposição prolongada em contacto com a pele e por ingestão.RO: Toxic: pericol de efecte grave asupra sănătăţii la expunere prelungită în contact cu pielea şi prin înghiţire.SK: Jedovatý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou pri kontakte s pokožkou a po požití.SL: Strupeno: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega stika s kožo in zauživanja.FI: Myrkyllistä: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle joutuessaan iholle ja nieltynä.SV: Giftigt: risk för allvarliga hälsoskador vid långvarig exponering genom hudkontakt och förtäring.R48/23/24/25BG: Токсичен: опасност от тежко увреждане на здравето при продължителна експозиция чрез вдишване, при контакт с кожата и при поглъщане.ES: Tóxico: riesgo de efectos graves para la salud en caso de exposición prolongada por inhalación, contacto con la piel e ingestión.CS: Toxický: nebezpečí vážného poškození zdraví při dlouhodobé expozici vdechováním, stykem s kůží a požíváním.DA: Giftig: alvorlig sundhedsfare ved længere tids påvirkning ved indånding, hudkontakt og indtagelse.DE: Giftig: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Einatmen, Berührung mit der Haut und durch Verschlucken.ET: Mürgine: tõsise tervisekahjustuse oht pikaajalisel sissehingamisel, kokkupuutel nahaga ja allaneelamisel.EL: Τοξικό: κίνδυνος σοβαρής βλάβης της υγείας ύστερα από παρατεταμένη έκθεση όταν εισπνέεται, σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed.FR: Toxique: risque d’effets graves pour la santé en cas d’exposition prolongée par inhalation, par contact avec la peau et par ingestion.IT: Tossico: pericolo di gravi danni alla salute in caso di esposizione prolungata per inalazione, a contatto con la pelle e per ingestione.LV: Toksisks – iespējams nopietns kaitējums veselībai pēc ilgstošas iedarbības ieelpojot, nonākot saskarē ar ādu un norijot.LT: Toksiška: ilgą laiką pakartotinai įkvepiant, veikiant per odą ir praryjant sukelia sunkius sveikatos sutrikimus.HU: Hosszabb időn át belélegezve, bőrrel érintkezve és szájon keresztül a szervezetbe jutva mérgező: súlyos egészségkárosodást okozhat.MT: Tossiku: periklu ta’ ħsara serja lis-saħħa minn espożizzjoni għat-tul minħabba xamm, mess mal-ġilda jew jekk jinbela’.NL: Vergiftig: gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling bij inademing, aanraking met de huid en opname door de mond.PL: Działa toksycznie przez drogi oddechowe, w kontakcie ze skórą i po połknięciu; stwarza poważne zagrożenie zdrowia w następstwie długotrwałego narażenia.PT: Tóxico: risco de efeitos graves para a saúde em caso de exposição prolongada por inalação, em contacto com a pele e por ingestão.RO: Toxic: pericol de efecte grave asupra sănătăţii la expunere prelungită prin inhalare, în contact cu pielea şi prin înghiţire.SK: Jedovatý, nebezpečenstvo vážneho poškodenia zdravia dlhodobou expozíciou vdýchnutím, pri kontakte s pokožkou a po požití.SL: Strupeno: nevarnost hudih okvar zdravja zaradi dolgotrajnejšega vdihavanja, stika s kožo in zauživanja.FI: Myrkyllistä: pitkäaikainen altistus voi aiheuttaa vakavaa haittaa terveydelle hengitettynä, joutuessaan iholle ja nieltynä.SV: Giftigt: risk för allvarliga hälsoskador vid långvarig exponering genom inandning, hudkontakt och förtäring.R50/53BG: Силно токсичен за водни организми, може да причини дълготрайни неблагоприятни ефекти във водната среда.ES: Muy tóxico para los organismos acuáticos, puede provocar a largo plazo efectos negativos en el medio ambiente acuático.CS: Vysoce toxický pro vodní organismy, může vyvolat dlouhodobé nepříznivé účinky ve vodním prostředí.DA: Meget giftig for organismer, der lever i vand; kan forårsage uønskede langtidsvirkninger i vandmiljøet.DE: Sehr giftig für Wasserorganismen, kann in Gewässern längerfristig schädliche Wirkungen haben.ET: Väga mürgine veeorganismidele, võib põhjustada pikaajalist veekeskkonda kahjustavat toimet.EL: Πολύ τοξικό για τους υδρόβιους οργανισμούς, μπορεί να προκαλέσει μακροχρόνιες δυσμενείς επιπτώσεις στο υδάτινο περιβάλλον.EN: Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.FR: Très toxique pour les organismes aquatiques, peut entraîner des effets néfastes à long terme pour l’environnement aquatique.IT: Altamente tossico per gli organismi acquatici, può provocare a lungo termine effetti negativi per l’ambiente acquatico.LV: Ļoti toksisks ūdens organismiem, var radīt ilgtermiņa nevēlamu ietekmi ūdens vidē.LT: Labai toksiška vandens organizmams, gali sukelti ilgalaikius nepalankius vandens ekosistemų pakitimus.HU: Nagyon mérgező a vízi szervezetekre, a vízi környezetben hosszan tartó károsodást okozhat.MT: Tossiku ħafna għal organiżmi akwatiċi, jista’ jikkaġuna effetti ħżiena għat-tul fl-ambjent akwatiku.NL: Zeer vergiftig voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.PL: Działa bardzo toksycznie na organizmy wodne; może powodować długo utrzymujące się niekorzystne zmiany w środowisku wodnym.PT: Muito tóxico para os organismos aquáticos, podendo causar efeitos nefastos a longo prazo no ambiente aquático.RO: Foarte toxic pentru organismele acvatice, poate provoca efecte adverse pe termen lung asupra mediului acvatic.SK: Veľmi jedovatý pre vodné organizmy, môže spôsobiť dlhodobé nepriaznivé účinky vo vodnej zložke životného prostredia.SL: Zelo strupeno za vodne organizme: lahko povzroči dolgotrajne škodljive učinke na vodno okolje.FI: Erittäin myrkyllistä vesieliöille, voi aiheuttaa pitkäaikaisia haittavaikutuksia vesiympäristössä.SV: Mycket giftigt för vattenlevande organismer, kan orsaka skadliga långtidseffekter i vattenmiljön.R51/53BG: Токсичен за водни организми, може да причини дълготрайни неблагоприятни ефекти във водната среда.ES: Tóxico para los organismos acuáticos, puede provocar a largo plazo efectos negativos en el medio ambiente acuático.CS: Toxický pro vodní organismy, může vyvolat dlouhodobé nepříznivé účinky ve vodním prostředí.DA: Giftig for organismer, der lever i vand; kan forårsage uønskede langtidsvirkninger i vandmiljøet.DE: Giftig für Wasserorganismen, kann in Gewässern längerfristig schädliche Wirkungen haben.ET: Mürgine veeorganismidele, võib põhjustada pikaajalist veekeskkonda kahjustavat toimet.EL: Τοξικό για τους υδρόβιους οργανισμούς, μπορεί να προκαλέσει μακροχρόνιες δυσμενείς επιπτώσεις στο υδάτινο περιβάλλον.EN: Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.FR: Toxique pour les organismes aquatiques, peut entraîner des effets néfastes à long terme pour l’environnement aquatique.IT: Tossico per gli organismi acquatici, può provocare a lungo termine effetti negativi per l’ambiente acquatico.LV: Toksisks ūdens organismiem, var radīt ilglaicīgu negatīvu ietekmi ūdens vidē.LT: Toksiška vandens organizmams, gali sukelti ilgalaikius nepalankius vandens ekosistemų pakitimus.HU: Mérgező a vízi szervezetekre, a vízi környezetben hosszan tartó károsodást okozhat.MT: Tossiku għal organiżmi akwatiċi; jista’ jikkaġuna effetti ħżiena għat-tul fl-ambjent akwatiku.NL: Vergiftig voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.PL: Działa toksycznie na organizmy wodne; może powodować długo utrzymujące się niekorzystne zmiany w środowisku wodnym.PT: Tóxico para os organismos aquáticos, podendo causar efeitos nefastos a longo prazo no ambiente aquático.RO: Toxic pentru organismele acvatice, poate provoca efecte adverse pe termen lung asupra mediului acvatic.SK: Jedovatý pre vodné organizmy, môže spôsobiť dlhodobé nepriaznivé účinky vo vodnej zložke životného prostredia.SL: Strupeno za vodne organizme: lahko povzroči dolgotrajne škodljive učinke na vodno okolje.FI: Myrkyllistä vesieliöille, voi aiheuttaa pitkäaikaisia haittavaikutuksia vesiympäristössä.SV: Giftigt för vattenlevande organismer, kan orsaka skadliga långtidseffekter i vattenmiljön.R52/53BG: Вреден за водни организми, може да причини дълготрайни неблагоприятни ефекти във водната среда.ES: Nocivo para los organismos acuáticos, puede provocar a largo plazo efectos negativos en el medio ambiente acuático.CS: Škodlivý pro vodní organismy, může vyvolat dlouhodobé nepříznivé účinky ve vodním prostředí.DA: Skadelig for organismer, der lever i vand; kan forårsage uønskede langtidsvirkninger i vandmiljøet.DE: Schädlich für Wasserorganismen, kann in Gewässern längerfristig schädliche Wirkungen haben.ET: Kahjulik veeorganismidele, võib põhjustada pikaajalist veekeskkonda kahjustavat toimet.EL: Επιβλαβές για τους υδρόβιους οργανισμούς, μπορεί να προκαλέσει μακροχρόνιες δυσμενείς επιπτώσεις στο υδάτινο περιβάλλον.EN: Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.FR: Nocif pour les organismes aquatiques, peut entraîner des effets néfastes à long terme pour l’environnement aquatique.IT: Nocivo per gli organismi acquatici, può provocare a lungo termine effetti negativi per l’ambiente acquatico.LV: Bīstams ūdens organismiem, var radīt ilglaicīgu negatīvu ietekmi ūdens vidē.LT: Kenksminga vandens organizmams, gali sukelti ilgalaikius nepalankius vandens ekosistemų pakitimus.HU: Ártalmas a vízi szervezetekre, a vízi környezetben hosszan tartó károsodást okozhat.MT: Jagħmel ħsara lil organiżmi akwatiċi, jista’ jikkaġuna effetti ħżiena għat-tul fl-ambjent akwatiku.NL: Schadelijk voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.PL: Działa szkodliwie na organizmy wodne; może powodować długo utrzymujące się niekorzystne zmiany w środowisku wodnym.PT: Nocivo para os organismos aquáticos, podendo causar efeitos nefastos a longo prazo no ambiente aquático.RO: Nociv pentru organismele acvatice, poate provoca efecte adverse pe termen lung asupra mediului acvatic.SK: Škodlivý pre vodné organizmy, môže spôsobiť dlhodobé nepriaznivé účinky vo vodnej zložke životného prostredia.SL: Škodljivo za vodne organizme: lahko povzroči dolgotrajne škodljive učinke na vodno okolje.FI: Haitallista vesieliöille, voi aiheuttaa pitkäaikaisia haittavaikutuksia vesiympäristössä.SV: Skadligt för vattenlevande organismer, kan orsaka skadliga långtidseffekter i vattenmiljön.R68/20BG: Вреден: възможен риск от необратими ефекти при вдишване.ES: Nocivo: posibilidad de efectos irreversibles por inhalación.CS: Zdraví škodlivý: Možné nebezpečí nevratných účinků při vdechování.DA: Farlig: mulighed for varig skade på helbred ved indånding.DE: Gesundheitsschädlich: Möglichkeit irreversiblen Schadens durch Einatmen.ET: Kahjulik: võimalik pöördumatute kahjustuste oht sissehingamisel.EL: Επιβλαβές: πιθανοί κίνδυνοι μονίμων επιδράσεων όταν εισπνέεται.EN: Harmful: possible risk of irreversible effects through inhalation.FR: Nocif: possibilité d’effets irréversibles par inhalation.IT: Nocivo: possibilità di effetti irreversibili per inalazione.LV: Kaitīgs – iespējams neatgriezeniskas iedarbības risks ieelpojot.LT: Kenksminga: gali sukelti negrįžtamus sveikatos pakenkimus įkvėpus.HU: Belélegezve ártalmas: maradandó egészségkárosodást okozhat.MT: Jagħmel ħsara: riskju possibbli ta’ effetti irreversibbli minħabba xamm.NL: Schadelijk: bij inademing zijn onherstelbare effecten niet uitgesloten.PL: Działa szkodliwie przez drogi oddechowe; możliwe ryzyko powstania nieodwracalnych zmian w stanie zdrowia.PT: Nocivo: possibilidade de efeitos irreversíveis por inalação.RO: Nociv: risc posibil de efecte ireversibile prin inhalare.SK: Škodlivý, možné riziko ireverzibilných účinkov vdýchnutím.SL: Zdravju škodljivo: možna nevarnost trajnih okvar zdravja pri vdihavanju.FI: Terveydelle haitallista: pysyvien vaurioiden vaara hengitettynä.SV: Farligt: möjlig risk för bestående hälsoskador vid inandning.R68/21BG: Вреден: възможен риск от необратими ефекти при контакт с кожата.ES: Nocivo: posibilidad de efectos irreversibles por contacto con la piel.CS: Zdraví škodlivý: Možné nebezpečí nevratných účinků při styku s kůží.DA: Farlig: mulighed for varig skade på helbred ved hudkontakt.DE: Gesundheitsschädlich: Möglichkeit irreversiblen Schadens bei Berührung mit der Haut.ET: Kahjulik: võimalik pöördumatute kahjustuste oht kokkupuutel nahaga.EL: Επιβλαβές: πιθανοί κίνδυνοι μονίμων επιδράσεων σε επαφή με το δέρμα.EN: Harmful: possible risk of irreversible effects in contact with skin.FR: Nocif: possibilité d’effets irréversibles par contact avec la peau.IT: Nocivo: possibilità di effetti irreversibili a contatto con la pelle.LV: Kaitīgs – iespējams neatgriezeniskas iedarbības risks, nonākot saskarē ar ādu.LT: Kenksminga: gali sukelti negrįžtamus sveikatos pakenkimus susilietus su oda.HU: Bőrrel érintkezve ártalmas: maradandó egészségkárosodást okozhat.MT: Jagħmel ħsara: riskju possibbli ta’ effetti irreversibbli meta jmiss il-ġilda.NL: Schadelijk: bij aanraking met de huid zijn onherstelbare effecten niet uitgesloten.PL: Działa szkodliwie w kontakcie ze skórą; możliwe ryzyko powstania nieodwracalnych zmian w stanie zdrowia.PT: Nocivo: possibilidade de efeitos irreversíveis em contacto com a pele.RO: Nociv: risc posibil de efecte ireversibile în contact cu pielea.SK: Škodlivý, možné riziko ireverzibilných účinkov pri kontakte s pokožkou.SL: Zdravju škodljivo: možna nevarnost trajnih okvar zdravja v stiku s kožo.FI: Terveydelle haitallista: pysyvien vaurioiden vaara joutuessaan iholle.SV: Farligt: möjlig risk för bestående hälsoskador vid hudkontakt.R68/22BG: Вреден: възможен риск от необратими ефекти при поглъщане.ES: Nocivo: posibilidad de efectos irreversibles por ingestión.CS: Zdraví škodlivý: Možné nebezpečí nevratných účinků při požití.DA: Farlig: mulighed for varig skade på helbred ved indtagelse.DE: Gesundheitsschädlich: Möglichkeit irreversiblen Schadens durch Verschlucken.ET: Kahjulik: võimalik pöördumatute kahjustuste oht allaneelamisel.EL: Επιβλαβές: πιθανοί κίνδυνοι μονίμων επιδράσεων σε περίπτωση καταπόσεως.EN: Harmful: possible risk of irreversible effects if swallowed.FR: Nocif: possibilité d’effets irréversibles par ingestion.IT: Nocivo: possibilità di effetti irreversibili per ingestione.LV: Kaitīgs – iespējams neatgriezeniskas iedarbības risks norijot.LT: Kenksminga: gali sukelti negrįžtamus sveikatos pakenkimus prarijus.HU: Lenyelve ártalmas: maradandó egészségkárosodást okozhat.MT: Jagħmel ħsara: riskju possibbli ta’ effetti irreversibbli jekk jinbela’.NL: Schadelijk: bij opname door de mond zijn onherstelbare effecten niet uitgesloten.PL: Działa szkodliwie po połknięciu; możliwe ryzyko powstania nieodwracalnych zmian w stanie zdrowia.PT: Nocivo: possibilidade de efeitos irreversíveis por ingestão.RO: Nociv: risc posibil de efecte ireversibile prin înghiţire.SK: Škodlivý, možné riziko ireverzibilných účinkov po požití.SL: Zdravju škodljivo: možna nevarnost trajnih okvar zdravja pri zaužitju.FI: Terveydelle haitallista: pysyvien vaurioiden vaara nieltynä.SV: Farligt: möjlig risk för bestående hälsoskador vid förtäring.R68/20/21BG: Вреден: възможен риск от необратими ефекти при вдишване и при контакт с кожата.ES: Nocivo: posibilidad de efectos irreversibles por inhalación y contacto con la piel.CS: Zdraví škodlivý: Možné nebezpečí nevratných účinků při vdechování a při styku s kůží.DA: Farlig: mulighed for varig skade på helbred ved indånding og hudkontakt.DE: Gesundheitsschädlich: Möglichkeit irreversiblen Schadens durch Einatmen und bei Berührung mit der Haut.ET: Kahjulik: võimalik pöördumatute kahjustuste oht sissehingamisel ja kokkupuutel nahaga.EL: Επιβλαβές: πιθανοί κίνδυνοι μονίμων επιδράσεων όταν εισπνέεται και σε επαφή με το δέρμα.EN: Harmful: possible risk of irreversible effects through inhalation and in contact with skin.FR: Nocif: possibilité d’effets irréversibles par inhalation et par contact avec la peau.IT: Nocivo: possibilità di effetti irreversibili per inalazione e a contatto con la pelle.LV: Kaitīgs – iespējams neatgriezeniskas iedarbības risks ieelpojot un nonākot saskarē ar ādu.LT: Kenksminga: gali sukelti negrįžtamus sveikatos pakenkimus įkvėpus ir susilietus su oda.HU: Belélegezve és bőrrel érintkezve ártalmas: maradandó egészségkárosodást okozhat.MT: Jagħmel ħsara: riskju possibbli ta’ effetti irriversibbli minħabba xamm u meta jmiss il-ġilda.NL: Schadelijk: bij inademing en aanraking met de huid zijn onherstelbare effecten niet uitgesloten.PL: Działa szkodliwie przez drogi oddechowe i w kontakcie ze skórą; możliwe ryzyko powstania nieodwracalnych zmian w stanie zdrowia.PT: Nocivo: possibilidade de efeitos irreversíveis por inalação e em contacto com a pele.RO: Nociv: risc posibil de efecte ireversibile prin inhalare şi în contact cu pielea.SK: Škodlivý, možné riziko ireverzibilných účinkov vdýchnutím a pri kontakte s pokožkou.SL: Zdravju škodljivo: možna nevarnost trajnih okvar zdravja pri vdihavanju in v stiku s kožo.FI: Terveydelle haitallista: pysyvien vaurioiden vaara hengitettynä ja joutuessaan iholle.SV: Farligt: möjlig risk för bestående hälsoskador vid inandning och hudkontakt.R68/20/22BG: Вреден: възможен риск от необратими ефекти при вдишване и при поглъщане.ES: Nocivo: Posibilidad de efectos irreversibles por inhalación e ingestión.CS: Zdraví škodlivý: Možné nebezpečí nevratných účinků při vdechování a při požití.DA: Farlig: mulighed for varig skade på helbred ved indånding og indtagelse.DE: Gesundheitsschädlich: Möglichkeit irreversiblen Schadens durch Einatmen und durch Verschlucken.ET: Kahjulik: võimalik pöördumatute kahjustuste oht sissehingamisel ja allaneelamisel.EL: Επιβλαβές: πιθανοί κίνδυνοι μονίμων επιδράσεων όταν εισπνέεται και σε περίπτωση καταπόσεως.EN: Harmful: possible risk of irreversible effects through inhalation and if swallowed.FR: Nocif: possibilité d’effets irréversibles par inhalation et par ingestion.IT: Nocivo: possibilità di effetti irreversibili per inalazione ed ingestione.LV: Kaitīgs – iespējams neatgriezeniskas iedarbības risks ieelpojot un norijot.LT: Kenksminga: gali sukelti negrįžtamus sveikatos pakenkimus įkvėpus ir prarijus.HU: Belélegezve és lenyelve ártalmas: maradandó egészségkárosodást okozhat.MT: Jagħmel ħsara: riskju possibbli ta’ effetti irreversibbli minħabba xamm u jekk jinbela’.NL: Schadelijk: bij inademing en opname door de mond zijn onherstelbare effecten niet uitgesloten.PL: Działa szkodliwie przez drogi oddechowe i po połknięciu; możliwe ryzyko powstania nieodwracalnych zmian w stanie zdrowia.PT: Nocivo: possibilidade de efeitos irreversíveis por inalação e ingestão.RO: Nociv: risc posibil de efecte ireversibile prin inhalare şi prin înghiţire.SK: Škodlivý, možné riziko ireverzibilných účinkov vdýchnutím a po požití.SL: Zdravju škodljivo: možna nevarnost trajnih okvar zdravja pri vdihavanju in pri zaužitju.FI: Terveydelle haitallista: pysyvien vaurioiden vaara hengitettynä ja nieltynä.SV: Farligt: möjlig risk för bestående hälsoskador vid inandning och förtäring.R68/21/22BG: Вреден: възможен риск от необратими ефекти при контакт с кожата и при поглъщане.ES: Nocivo: posibilidad de efectos irreversibles por contacto con la piel e ingestión.CS: Zdraví škodlivý: Možné nebezpečí nevratných účinků při styku s kůží a při požití.DA: Farlig: mulighed for varig skade på helbred ved hudkontakt og indtagelse.DE: Gesundheitsschädlich: Möglichkeit irreversiblen Schadens bei Berührung mit der Haut und durch Verschlucken.ET: Kahjulik: võimalik pöördumatute kahjustuste oht kokkupuutel nahaga ja allaneelamisel.EL: Επιβλαβές: πιθανοί κίνδυνοι μονίμων επιδράσεων σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Harmful: possible risk of irreversible effects in contact with skin and if swallowed.FR: Nocif: possibilité d’effets irréversibles par contact avec la peau et par ingestion.IT: Nocivo: possibilità di effetti irreversibili a contatto con la pelle e per ingestione.LV: Kaitīgs – iespējams neatgriezeniskas iedarbības risks, nonākot saskarē ar ādu un norijot.LT: Kenksminga: gali sukelti negrįžtamus sveikatos pakenkimus susilietus su oda ir prarijus.HU: Bőrrel érintkezve és lenyelve ártalmas: maradandó egészségkárosodást okozhat.MT: Jagħmel ħsara: riskju possibbli ta’ effetti irreversibbli meta jmiss il-ġilda u jekk jinbela’.NL: Schadelijk: bij aanraking met de huid en opname door de mond zijn onherstelbare effecten niet uitgesloten.PL: Działa szkodliwie w kontakcie ze skórą i po połknięciu; możliwe ryzyko powstania nieodwracalnych zmian w stanie zdrowia.PT: Nocivo: possibilidade de efeitos irreversíveis em contacto com a pele e por ingestão.RO: Nociv: risc posibil de efecte ireversibile în contact cu pielea şi prin înghiţire.SK: Škodlivý, možné riziko ireverzibilných účinkov pri kontakte s pokožkou a po požití.SL: Zdravju škodljivo: možna nevarnost trajnih okvar zdravja v stiku s kožo in pri zaužitju.FI: Terveydelle haitallista: pysyvien vaurioiden vaara joutuessaan iholle ja nieltynä.SV: Farligt: möjlig risk för bestående hälsoskador vid hudkontakt och förtäring.R68/20/21/22BG: Вреден: възможен риск от необратими ефекти при вдишване, при контакт с кожата и при поглъщане.ES: Nocivo: posibilidad de efectos irreversibles por inhalación, contacto con la piel e ingestión.CS: Zdraví škodlivý: Možné nebezpečí nevratných účinků při vdechování, při styku s kůží a při požití.DA: Farlig: mulighed for varig skade på helbred ved indånding, hudkontakt og indtagelse.DE: Gesundheitsschädlich: Möglichkeit irreversiblen Schadens durch Einatmen, Berührung mit der Haut und durch Verschlucken.ET: Kahjulik: võimalik pöördumatute kahjustuste oht sissehingamisel, kokkupuutel nahaga ja allaneelamisel.EL: Επιβλαβές: πιθανοί κίνδυνοι μονίμων επιδράσεων όταν εισπνέεται, σε επαφή με το δέρμα και σε περίπτωση καταπόσεως.EN: Harmful: possible risk of irreversible effects through inhalation, in contact with skin and if swallowed.FR: Nocif: possibilité d’effets irréversibles par inhalation, par contact avec la peau et par ingestion.IT: Nocivo: possibilità di effetti irreversibili per inalazione, a contatto con la pelle e per ingestione.LV: Kaitīgs – iespējams neatgriezeniskas iedarbības risks ieelpojot, nonākot saskarē ar ādu un norijot.LT: Kenksminga: gali sukelti negrįžtamus sveikatos pakenkimus įkvėpus, susilietus su oda ir prarijus.HU: Belélegezve, bőrrel érintkezve és lenyelve ártalmas: maradandó egészségkárosodást okozhat.MT: Jagħmel ħsara: riskju possibbli ta’ effetti irriversibbli minħabba xamm, meta jmiss il-ġilda u jekk jinbela’.NL: Schadelijk: bij inademing, aanraking met de huid en opname door de mond zijn onherstelbare effecten niet uitgesloten.PL: Działa szkodliwie przez drogi oddechowe, w kontakcie ze skórą i po połknięciu; możliwe ryzyko powstania nieodwracalnych zmian w stanie zdrowia.PT: Nocivo: possibilidade de efeitos irreversíveis por inalação, em contacto com a pele e por ingestão.RO: Nociv: risc posibil de efecte ireversibile prin inhalare, în contact cu pielea şi prin înghiţire.SK: Škodlivý, možné riziko ireverzibilných účinkov vdýchnutím, pri kontakte s pokožkou a po požití.SL: Zdravju škodljivo: možna nevarnost trajnih okvar zdravja pri vdihavanju, v stiku s kožo in pri zaužitju.FI: Terveydelle haitallista: pysyvien vaurioiden vaara hengitettynä, joutuessaan iholle ja nieltynä.SV: Farligt: möjlig risk för bestående hälsoskador vid inandning, hudkontakt och förtäring.’

(e) | Annex IV is replaced by the following:‘ПРИЛОЖЕНИЕ IV — ANEXO IV — PŘÍLOHA IV — BILAG IV — IV ANHANG — IV LISA — ΠΑΡΑΡΤΗΜΑ IV — ANNEX IV — ANNEXE IV — ALLEGATO IV — IV PIELIKUMS — IV PRIEDAS — IV. MELLÉKLET — ANNESS IV — BIJLAGE IV — ZAŁĄCZNIK IV — ANEXO IV — ANEXA IV — PRÍLOHA IV — PRILOGA IV — LIITE IV — BILAGA IVПРИЛОЖЕНИЕ IVСъвети за безопасност, свързани с опасните вещества и препаратиANEXO IVConsejos de prudencia relativos a las sustancias y preparados peligrososPŘÍLOHA IVStandardní pokyny pro bezpečné zacházení týkající se nebezpečných látek a přípravkůBILAG IVForsigtighedsregler for farlige stoffer og præparaterANHANG IVSicherheitsratschläge für gefährliche Stoffe und ZubereitungenIV LISAOhtlike ainete ja valmististe ohutuslausedΠΑΡΑΡΤΗΜΑ IVΟδηγίες ασφαλούς χρήσης που αφορούν επικίνδυνες χημικές ουσίες και παρασκευάσματαANNEX IVSafety advice concerning dangerous substances and preparationsANNEXE IVConseils de prudence concernant les substances et préparations dangereusesALLEGATO IVConsigli di prudenza riguardanti le sostanze e preparati pericolosiIV PIELIKUMSDrošības prasību apzīmējumi un apvienotie apzīmējumiIV PRIEDASSaugos patarimai dėl pavojingų medžiagų ir preparatųIV. MELLÉKLETA veszélyes anyagok és készítmények biztonságos használatára vonatkozó útmutatásokANNESS IVPariri ta’ sigurtà dwar sustanzi u preparazzjonijiet perikolużiBIJLAGE IVVeiligheidsaanbevelingen met betrekking tot gevaarlijke stoffen en preparatenZAŁĄCZNIK IVZwroty określające warunki bezpiecznego stosowania substancji niebezpiecznej lub preparatu niebezpiecznegoANEXO IVConselhos de prudência relativos a substâncias e preparações perigosasANEXA IVRecomandări de prudenţă privind substanţele şi preparatele periculoasePRÍLOHA IVZoznam označení na bezpečné používanie chemickej látky a chemického prípravkuPRILOGA IVStandardna obvestila za označevanje nevarnih snovi in pripravkovLIITE IVVaarallisten aineiden ja valmisteiden turvallisuusohjeetBILAGA IVSkyddsfraser för farliga ämnen och beredningarS1BG: Да се съхранява под ключ.ES: Consérvese bajo llave.CS: Uchovávejte uzamčené.DA: Opbevares under lås.DE: Unter Verschluss aufbewahren.ET: Hoida lukustatult.EL: Να φυλάσσεται κλειδωμένο.EN: Keep locked up.FR: Conserver sous clé.IT: Conservare sotto chiave.LV: Turēt noslēgtu.LT: Laikyti užrakintą.HU: Elzárva tartandó.MT: Żomm maqful.NL: Achter slot bewaren.PL: Przechowywać pod zamknięciem.PT: Guardar fechado à chave.RO: A se păstra sub cheie.SK: Uchovávajte uzamknuté.SL: Hraniti zaklenjeno.FI: Säilytettävä lukitussa tilassa.SV: Förvaras i låst utrymme.S2BG: Да се пази далече от достъп на деца.ES: Manténgase fuera del alcance de los niños.CS: Uchovávejte mimo dosah dětí.DA: Opbevares utilgængeligt for børn.DE: Darf nicht in die Hände von Kindern gelangen.ET: Hoida lastele kättesaamatus kohas.EL: Μακριά από παιδιά.EN: Keep out of the reach of children.FR: Conserver hors de la portée des enfants.IT: Conservare fuori della portata dei bambini.LV: Sargāt no bērniem.LT: Saugoti nuo vaikų.HU: Gyermekek kezébe nem kerülhet.MT: Żomm fejn ma jintlaħaqx mit-tfal.NL: Buiten bereik van kinderen bewaren.PL: Chronić przed dziećmi.PT: Manter fora do alcance das crianças.RO: A nu se lăsa la îndemâna copiilor.SK: Uchovávajte mimo dosahu detí.SL: Hraniti izven dosega otrok.FI: Säilytettävä lasten ulottumattomissa.SV: Förvaras oåtkomligt för barn.S3BG: Да се съхранява на хладно място.ES: Consérvese en lugar fresco.CS: Uchovávejte na chladném místě.DA: Opbevares køligt.DE: Kühl aufbewahren.ET: Hoida jahedas.EL: Να φυλάσσεται σε δροσερό μέρος.EN: Keep in a cool place.FR: Conserver dans un endroit frais.IT: Conservare in luogo fresco.LV: Uzglabāt vēsā vietā.LT: Laikyti vėsioje vietoje.HU: Hűvös helyen tartandó.MT: Żomm f’post frisk.NL: Op een koele plaats bewaren.PL: Przechowywać w chłodnym miejscu.PT: Guardar em lugar fresco.RO: A se păstra într-un loc răcoros.SK: Uchovávajte na chladnom mieste.SL: Hraniti na hladnem.FI: Säilytettävä viileässä.SV: Förvaras svalt.S4BG: Да се съхранява далече от жилищни помещения.ES: Manténgase lejos de locales habitados.CS: Uchovávejte mimo obytné objekty.DA: Må ikke opbevares i nærheden af bebølse.DE: Von Wohnplätzen fernhalten.ET: Mitte hoida eluruumides.EL: Μακριά από κατοικημένους χώρους.EN: Keep away from living quarters.FR: Conserver à l’écart de tout local d’habitation.IT: Conservare lontano da locali di abitazione.LV: Neuzglabāt dzīvojamās telpās.LT: Nelaikyti gyvenamosiose patalpose.HU: Lakóterülettől távol tartandó.MT: Żomm ‘il bogħod minn postijiet ta’ abitazzjoni.NL: Verwijderd van woonruimten opbergen.PL: Nie przechowywać w pomieszczeniach mieszkalnych.PT: Manter fora de qualquer zona de habitação.RO: A se păstra departe de zonele locuite.SK: Uchovávajte mimo obývaných priestorov.SL: Hraniti izven bivališč.FI: Ei saa säilyttää asuintiloissa.SV: Förvaras avskilt från bostadsutrymmen.S5BG: Да се съхранява под … (подходяща течност, указана от производителя).ES: Consérvese en … (líquido apropiado a especificar por el fabricante).CS: Uchovávejte pod … (příslušnou kapalinu specifikuje výrobce).DA: Opbevares under … (en egnet væske, som angives af fabikanten).DE: Unter … aufbewahren (geeignete Flüssigkeit vom Hersteller anzugeben).ET: Hoida sisu … all (sobiva vedeliku määrab valmistaja).EL: Να διατηρείται το περιεχόμενο μέσα σε … (το είδος του κατάλληλου υγρού καθορίζεται από τον παραγωγό).EN: Keep contents under … (appropriate liquid to be specified by the manufacturer).FR: Conserver sous … (liquide approprié à spécifier par le fabricant).IT: Conservare sotto … (liquido appropriato da indicarsi da parte del fabbricante).LV: Uzglabāt … (ražotājs norāda šķidrumu, kurā viela vai produkts uzglabājams).LT: Laikyti užpiltą … (tinkamą skystį nurodo gamintojas).HU: … alatt tartandó (a folyadékot a gyártó határozza meg).MT: Żomm taħt… (il-likwidu adatt li jkun indikat mill-manifattur).NL: Onder … houden. (geschikte vloeistof aan te geven door fabrikant).PL: Przechowywać w … (cieczy wskazanej przez producenta).PT: Manter sob … (líquido apropriado a especificar pelo produtor).RO: A se păstra sub… (lichidul adecvat va fi indicat de fabricant).SK: Obsah uchovávajte pod … (vhodnou kvapalinou, ktorú špecifikuje výrobca).SL: Hraniti pod/v … (ustrezno tekočino, v kateri je treba snov ali pripravek hraniti, določi proizvajalec).FI: Sisältö säilytettävä … (tarkoitukseen soveltuvan nesteen ilmoittaa valmistaja/maahantuoja).SV: Förvara innehållet i … (lämplig vätska anges av tillverkaren).S6BG: Да се съхранява под … (инертен газ, указан от производителя).ES: Consérvese en … (gas inerte a especificar por el fabricante).CS: Uchovávejte pod … (inertní plyn specifikuje výrobce).DA: Opbevares under … (en inaktiv gas, som angives af fabrikanten).DE: Unter … aufbewahren (inertes Gas vom Hersteller anzugeben).ET: Hoida … all (inertgaasi määrab valmistaja).EL: Να διατηρείται σε ατμόσφαιρα … (το είδος του αδρανούς αερίου καθορίζεται από τον παραγωγό).EN: Keep under … (inert gas to be specified by the manufacturer).FR: Conserver sous … (gaz inerte à spécifier par le fabricant).IT: Conservare sotto … (gas inerte da indicarsi da parte del fabbricante).LV: Uzglabāt … (ražotājs norāda gāzi, kurā viela vai produkts uzglabājams).LT: Laikyti …. (inertines dujas nurodo gamintojas) aplinkoje.HU: … alatt tartandó (az inert gázt a gyártó határozza meg).MT: Żomm taħt… (gass inerti li jkun speċifikat mill-manifattur).NL: Onder … houden. (inert gas aan te geven door fabrikant).PL: Przechowywać w atmosferze … (obojętnego gazu wskazanego przez producenta).PT: Manter sob … (gás inerte a especificar pelo produtor).RO: A se păstra sub… (gazul inert va fi indicat de fabricant).SK: Uchovávajte pod … (inertným plynom, ktorý špecifikuje výrobca).SL: Hraniti v … (ustrezen inertni plin, v katerem je treba snov ali pripravek hraniti, določi proizvajalec).FI: Säilytettävä … (inertin kaasun ilmoittaa valmistaja/maahantuoja).SV: Förvaras i … (inert gas anges av tillverkaren).S7BG: Съдът да се държи плътно затворен.ES: Manténgase el recipiente bien cerrado.CS: Uchovávejte obal těsně uzavřený.DA: Emballagen skal holdes tæt lukket.DE: Behälter dicht geschlossen halten.ET: Hoida pakend tihedalt suletuna.EL: Το δοχείο να διατηρείται ερμητικά κλεισμένο.EN: Keep container tightly closed.FR: Conserver le récipient bien fermé.IT: Conservare il recipiente ben chiuso.LV: Uzglabāt cieši noslēgtu.LT: Pakuotę laikyti sandariai uždarytą.HU: Az edényzet légmentesen lezárva tartandó.MT: Żomm il-kontenitur magħluq sewwa.NL: In goed gesloten verpakking bewaren.PL: Przechowywać pojemnik szczelnie zamknięty.PT: Manter o recipiente bem fechado.RO: A se păstra ambalajul închis ermetic.SK: Uchovávajte nádobu tesne uzavretú.SL: Hraniti v tesno zaprti posodi.FI: Säilytettävä tiiviisti suljettuna.SV: Förpackningen förvaras väl tillsluten.S8BG: Съдът да се съхранява на сухо място.ES: Manténgase el recipiente en lugar seco.CS: Uchovávejte obal suchý.DA: Emballagen skal opbevares tørt.DE: Behälter trocken halten.ET: Hoida pakend kuivana.EL: Το δοχείο να προστατεύεται από την υγρασία.EN: Keep container dry.FR: Conserver le récipient à l’abri de l’humidité.IT: Conservare al riparo dall’umidità.LV: Uzglabāt sausu.LT: Pakuotę laikyti sausoje vietoje.HU: Az edényzet szárazon tartandó.MT: Żomm il-kontenitur niexef.NL: Verpakking droog houden.PL: Przechowywać pojemnik w suchym pomieszczeniu.PT: Manter o recipiente ao abrigo da humidade.RO: A se păstra ambalajul într-un loc uscat, ferit de umiditate.SK: Uchovávajte nádobu suchú.SL: Posodo hraniti na suhem.FI: Säilytettävä kuivana.SV: Förpackningen förvaras torrt.S9BG: Съдът да се съхранява на добре проветриво място.ES: Consérvese el recipiente en lugar bien ventilado.CS: Uchovávejte obal na dobře větraném místě.DA: Emballagen skal opbevares på et godt ventileret sted.DE: Behälter an einem gut gelüfteten Ort aufbewahren.ET: Hoida pakend hästi ventileeritavas kohas.EL: Το δοχείο να διατηρείται σε καλά αεριζόμενο μέρος.EN: Keep container in a well-ventilated place.FR: Conserver le récipient dans un endroit bien ventilé.IT: Conservare il recipiente in luogo ben ventilato.LV: Uzglabāt labi vēdināmā vietā.LT: Pakuotę laikyti gerai vėdinamoje vietoje.HU: Az edényzet jól szellőztetett helyen tartandó.MT: Żomm il-kontenitur f’post ivventilat sewwa.NL: Op een goed geventileerde plaats bewaren.PL: Przechowywać pojemnik w miejscu dobrze wentylowanym.PT: Manter o recipiente num local bem ventilado.RO: A se păstra ambalajul într-un loc bine ventilat.SK: Uchovávajte nádobu na dobre vetranom mieste.SL: Posodo hraniti na dobro prezračevanem mestu.FI: Säilytettävä paikassa, jossa on hyvä ilmanvaihto.SV: Förpackningen förvaras på väl ventilerad plats.S12BG: Съдът да не се затваря херметично.ES: No cerrar el recipiente herméticamente.CS: Neuchovávejte obal těsně uzavřený.DA: Emballagen må ikke lukkes tæt.DE: Behälter nicht gasdicht verschließen.ET: Mitte hoida hermeetiliselt suletud pakendis.EL: Μη διατηρείτε το δοχείο ερμητικά κλεισμένο.EN: Do not keep the container sealed.FR: Ne pas fermer hermétiquement le récipient.IT: Non chiudere ermeticamente il recipiente.LV: Neuzglabāt slēgtā veidā.LT: Nelaikyti sandariai uždarytos pakuotės.HU: Az edényzetet nem szabad légmentesen lezárni.MT: Tħallix il-kontenitur magħluq.NL: De verpakking niet hermetisch sluiten.PL: Nie przechowywać pojemnika szczelnie zamkniętego.PT: Não fechar o recipiente hermeticamente.RO: A nu se închide ermetic ambalajul.SK: Neuchovávajte nádobu hermeticky uzatvorenú.SL: Posoda ne sme biti tesno zaprta.FI: Pakkausta ei saa sulkea ilmatiiviisti.SV: Förpackningen får inte tillslutas lufttätt.S13BG: Да се съхранява далече от напитки и храни за хора и животни.ES: Manténgase lejos de alimentos, bebidas y piensos.CS: Uchovávejte odděleně od potravin, nápojů a krmiv.DA: Må ikke opbevares sammen med fødevarer, drikkevarer og foderstoffer.DE: Von Nahrungsmitteln, Getränken und Futtermitteln fernhalten.ET: Hoida eemal toiduainest, joogist ja loomasöödast.EL: Μακριά από τρόφιμα, ποτά και ζωοτροφές.EN: Keep away from food, drink and animal feedingstuffs.FR: Conserver à l’écart des aliments et boissons, y compris ceux pour animaux.IT: Conservare lontano da alimenti o mangimi e da bevande.LV: Neuzglabāt kopā ar pārtiku vai dzīvnieku barību.LT: Laikyti atokiau nuo maisto, gėrimų ir gyvulių pašaro.HU: Élelmiszertől, italtól és takarmánytól távol tartandó.MT: Żomm ‘il bogħod minn ikel, xorb u minn għalf ta’ l-annimali.NL: Verwijderd houden van eet- en drinkwaren en van diervoeder.PL: Nie przechowywać razem z żywnością, napojami i paszami dla zwierząt.PT: Manter afastado de alimentos e bebidas incluindo os dos animais.RO: A se păstra departe de hrană, băuturi şi hrană pentru animale.SK: Uchovávajte mimo dosahu potravín, nápojov a krmív pre zvieratá.SL: Hraniti ločeno od hrane, pijače in krmil.FI: Ei saa säilyttää yhdessä elintarvikkeiden eikä eläinravinnon kanssa.SV: Förvaras åtskilt från livsmedel och djurfoder.S14BG: Да се съхранява далече от … (несъвместимите материали се посочват от производителя).ES: Consérvese lejos de … (materiales incompatibles a especificar por el fabricante).CS: Uchovávejte odděleně od … (vzájemně se vylučující látky uvede výrobce).DA: Opbevares adskilt fra … (uforligelige stoffer, som angives af fabrikanten).DE: Von … fernhalten (inkompatible Substanzen sind vom Hersteller anzugeben).ET: Hoida eraldi … (kokkusobimatud kemikaalid määrab valmistaja).EL: Μακριά από … (ασύμβατες ουσίες καθορίζονται από τον παραγωγό).EN: Keep away from … (incompatible materials to be indicated by the manufacturer).FR: Conserver à l’écart des … (matières incompatibles à indiquer par le fabricant).IT: Conservare lontano da … (sostanze incompatibili da precisare da parte del produttore).LV: Neuzglabāt kopā ar … (ražotājs norāda nesavietojamās vielas).LT: Laikyti atokiau nuo…( nesuderinamas medžiagas nurodo gamintojas).HU: …-tól/-től távol tartandó (az összeférhetetlen anyago(ka)t a gyártó határozza meg).MT: Żomm ‘il bogħod minn … (materjal inkompatibbli li jkun indikat mill-manifattur).NL: Verwijderd houden van … (stoffen waarmee contact vermeden dient te worden aan te geven door de fabrikant).PL: Nie przechowywać razem z … (materiałami określonymi przez producenta).PT: Manter afastado de … (matérias incompatíveis a indicar pelo produtor).RO: A se păstra departe de … (materialele incompatibile vor fi indicate de fabricant).SK: Uchovávajte mimo dosahu … (neznášanlivého materiálu, ktorý určí výrobca).SL: Hraniti ločeno od … (nezdružljive snovi določi proizvajalec).FI: Säilytettävä erillään … (yhteensopimattomat aineet ilmoittaa valmistaja/maahantuoja).SV: Förvaras åtskilt från … (oförenliga ämnen anges av tillverkaren).S15BG: Да се съхранява далече от топлина.ES: Conservar alejado del calor.CS: Chraňte před teplem.DA: Må ikke udsættes for varme.DE: Vor Hitze schützen.ET: Hoida eemal soojusallikast.EL: Μακριά από θερμότητα.EN: Keep away from heat.FR: Conserver à l’écart de la chaleur.IT: Conservare lontano dal calore.LV: Sargāt no sasilšanas.LT: Laikyti atokiau nuo šilumos šaltinių.HU: Hőhatástól távol tartandó.MT: Żomm ‘il bogħod mis-sħana.NL: Verwijderd houden van warmte.PL: Przechowywać z dala od źródeł ciepła.PT: Manter afastado do calor.RO: A se păstra departe de căldură.SK: Uchovávajte mimo dosahu tepla.SL: Varovati pred toploto.FI: Suojattava lämmöltä.SV: Får inte utsättas för värme.S16BG: Да се съхранява далече от източници на запалване. Да не се пуши.ES: Conservar alejado de toda llama o fuente de chispas — No fumar.CS: Uchovávejte mimo dosah zdrojů zapálení — Zákaz kouření.DA: Holdes væk fra antændelseskilder — Rygning forbudt.DE: Von Zündquellen fernhalten — Nicht rauchen.ET: Hoida eemal süttimisallikast — Mitte suitsetada!.EL: Μακριά από πηγές ανάφλεξης — Απαγορεύεται το κάπνισμα.EN: Keep away from sources of ignition — No smoking.FR: Conserver à l’écart de toute flamme ou source d’étincelles — Ne pas fumer.IT: Conservare lontano da fiamme e scintille — Non fumare.LV: Sargāt no uguns – nesmēķēt.LT: Laikyti atokiau nuo uždegimo šaltinių. Nerūkyti.HU: Gyújtóforrástól távol tartandó — Tilos a dohányzás.MT: Żomm ‘il bogħod minn fjammi u qbid tan-nar — Tpejjipx.NL: Verwijderd houden van ontstekingsbronnen — Niet roken.PL: Nie przechowywać w pobliżu źródeł zapłonu — nie palić tytoniu.PT: Manter afastado de qualquer chama ou fonte de ignição — Não fumar.RO: A se păstra departe de orice flacără sau sursă de scântei — Fumatul interzis.SK: Uchovávajte mimo dosahu zdrojov zapálenia — Zákaz fajčenia.SL: Hraniti ločeno od virov vžiga — ne kaditi.FI: Eristettävä sytytyslähteistä — Tupakointi kielletty.SV: Förvaras åtskilt från antändningskällor — Rökning förbjuden.S17BG: Да се съхранява далече от горими материали.ES: Manténgase lejos de materias combustibles.CS: Uchovávejte mimo dosah hořlavých materiálů.DA: Holdes væk fra brandbare stoffer.DE: Von brennbaren Stoffen fernhalten.ET: Hoida eemal süttivatest ainetest.EL: Μακριά από καύσιμα υλικά.EN: Keep away from combustible material.FR: Tenir à l’écart des matières combustibles.IT: Tenere lontano da sostanze combustibili.LV: Sargāt no degoša materiāla.LT: Laikyti atokiau nuo galinčių degti medžiagų.HU: Éghető anyagoktól távol tartandó.MT: Żomm ‘il bogħod minn materjal li jieħu n-nar.NL: Verwijderd houden van brandbare stoffen.PL: Nie przechowywać razem z materiałami zapalnymi.PT: Manter afastado de matérias combustíveis.RO: A se păstra departe de materiale combustibile.SK: Uchovávajte mimo dosahu horľavého materiálu.SL: Hraniti ločeno od gorljivih snovi.FI: Säilytettävä erillään syttyvistä kemikaaleista.SV: Förvaras åtskilt från brandfarliga ämnen.S18BG: Съдът да се манипулира и отваря внимателно.ES: Manipúlese y ábrase el recipiente con prudencia.CS: Zacházejte s obalem opatrně a opatrně jej otevírejte.DA: Emballagen skal behandles og åbnes med forsigtighed.DE: Behälter mit Vorsicht öffnen und handhaben.ET: Käidelda ja avada pakend ettevaatlikult.EL: Χειριστείτε και ανοίξτε το δοχείο προσεκτικά.EN: Handle and open container with care.FR: Manipuler et ouvrir le récipient avec prudence.IT: Manipolare ed aprire il recipiente con cautela.LV: Ievērot īpašu piesardzību, darbojoties ar konteineru un atverot to.LT: Pakuotę naudoti ir atidaryti atsargiai.HU: Az edényzetet óvatosan kell kezelni és kinyitni.MT: Attent kif tħarrek u tiftaħ il-kontenitur.NL: Verpakking voorzichtig behandelen en openen.PL: Zachować ostrożność w trakcie otwierania i manipulacji z pojemnikiem.PT: Manipular e abrir o recipiente com prudência.RO: A se manipula şi a se deschide ambalajul cu prudenţă.SK: S nádobou zaobchádzajte a otvárajte opatrne.SL: Previdno ravnati s posodo in jo previdno odpirati.FI: Pakkauksen käsittelyssä ja avaamisessa on noudatettava varovaisuutta.SV: Förpackningen hanteras och öppnas försiktigt.S20BG: Да не се яде и пие по време на работа.ES: No comer ni beber durante su utilización.CS: Nejezte a nepijte při používání.DA: Der må ikke spises eller drikkes under brugen.DE: Bei der Arbeit nicht essen und trinken.ET: Käitlemisel söömine ja joomine keelatud.EL: Μη τρώτε ή πίνετε όταν το χρησιμοποιείτε.EN: When using do not eat or drink.FR: Ne pas manger et ne pas boire pendant l’utilisation.IT: Non mangiare né bere durante l’impiego.LV: Nedzert un neēst, darbojoties ar vielu.LT: Naudojant nevalgyti ir negerti.HU: Használat közben enni, inni nem szabad.MT: Tikolx u tixrobx waqt li qed tużah.NL: Niet eten of drinken tijdens gebruik.PL: Nie jeść i nie pić podczas stosowania produktu.PT: Não comer nem beber durante a utilização.RO: A nu mânca sau bea în timpul utilizării.SK: Pri používaní nejedzte ani nepite.SL: Med uporabo ne jesti in ne piti.FI: Syöminen ja juominen kielletty kemikaalia käsiteltäessä.SV: Ät inte eller drick inte under hanteringen.S21BG: Да не се пуши по време на работа.ES: No fumar durante su utilización.CS: Nekuřte při používání.DA: Der må ikke ryges under brugen.DE: Bei der Arbeit nicht rauchen.ET: Käitlemisel suitsetamine keelatud.EL: Μη καπνίζετε όταν το χρησιμοποιείτε.EN: When using do not smoke.FR: Ne pas fumer pendant l’utilisation.IT: Non fumare durante l’impiego.LV: Nesmēķēt, darbojoties ar vielu.LT: Naudojant nerūkyti.HU: Használat közben tilos a dohányzás.MT: Tpejjipx waqt li qed tużah.NL: Niet roken tijdens gebruik.PL: Nie palić tytoniu podczas stosowania produktu.PT: Não fumar durante a utilização.RO: Fumatul interzis în timpul utilizării.SK: Pri používaní nefajčite.SL: Med uporabo ne kaditi.FI: Tupakointi kielletty kemikaalia käytettäessä.SV: Rök inte under hanteringen.S22BG: Да не се вдишва праха.ES: No respirar el polvo.CS: Nevdechujte prach.DA: Undgå indånding af støv.DE: Staub nicht einatmen.ET: Vältida tolmu sissehingamist.EL: Μη αναπνέετε την σκόνη.EN: Do not breathe dust.FR: Ne pas respirer les poussières.IT: Non respirare le polveri.LV: Izvairīties no putekļu ieelpošanas.LT: Neįkvėpti dulkių.HU: Az anyag porát nem szabad belélegezni.MT: Tiġbidx it-trab ‘il ġewwa b’imnifsejk.NL: Stof niet inademen.PL: Nie wdychać pyłu.PT: Não respirar as poeiras.RO: A nu se inspira praful.SK: Nevdychujte prach.SL: Ne vdihavati prahu.FI: Vältettävä pölyn hengittämistä.SV: Undvik inandning av damm.S23BG: Да не се вдишва газа/дима/парите/аерозола (подходящата дума/подходящите думи се посочва/посочват от производителя).ES: No respirar los gases/humos/vapores/aerosoles (denominación(es) adecuada(s) a especificar por el fabricante).CS: Nevdechujte plyny/dýmy/páry/aerosoly (příslušný výraz specifikuje výrobce).DA: Undgå indånding af gas/røg/dampe/aerosol-tåger (den eller de pågældende betegnelser angives af fabrikanten).DE: Gas/Rauch/Dampf/Aerosol nicht einatmen (geeignete Bezeichnung(en) vom Hersteller anzugeben).ET: Vältida gaasi/suitsu/auru/udu (sobiva mõiste määrab valmistaja) sissehingamist.EL: Μην αναπνέετε αέρια/αναθυμιάσεις/ατμούς/εκνεφώματα (η κατάλληλη διατύπωση καθορίζεται από τον παραγωγό).EN: Do not breathe gas/fumes/vapour/spray (appropriate wording to be specified by the manufacturer).FR: Ne pas respirer les gaz/fumées/vapeurs/aérosols (terme(s) approprié(s) à indiquer par le fabricant).IT: Non respirare i gas/fumi/vapori/aerosoli (termine(i) appropriato(i) da precisare da parte del produttore).LV: Izvairīties no gāzes vai dūmu, vai tvaiku, vai aerosolu ieelpošanas (formulējumu nosaka ražotājs).LT: Neįkvėpti dujų, dūmų, garų, aerozolių (konkrečiai nurodo gamintojas).HU: A keletkező gázt/füstöt/gőzt/permetet nem szabad belélegezni (a megfelelő szöveget a gyártó határozza meg).MT: Tiġbidx gass/dħaħen/fwar/sprej ‘il ġewwa b’imnifsejk (it-terminu jew termini adatti jridu jkunu speċifikati mill-manifattur).NL: Gas/rook/damp/spuitnevel niet inademen. (toepasselijke term(en) aan te geven door de fabrikant).PL: Nie wdychać gazu/dymu/pary/rozpylonej cieczy (rodzaj określi producent).PT: Não respirar os gases/vapores/fumos/aerossóis (termo(s) apropriado(s) a indicar pelo produtor).RO: A nu se inspira gazul/fumul/vaporii/aerosolii (fabricantul va indica termenul(ii) corespunzător(i)).SK: Nevdychujte plyn/dym/pary/aerosóly (Vhodné slovo špecifikuje výrobca).SL: Ne vdihavati plina/dima/hlapov/meglice (ustrezno besedilo določi proizvajalec).FI: Vältettävä kaasun/huurun/höyryn/sumun hengittämistä (oikean sanamuodon valitsee valmistaja/maahantuoja).SV: Undvik inandning av gas/rök/ånga/dimma (lämplig formulering anges av tillverkaren).S24BG: Да се избягва контакт с кожата.ES: Evítese el contacto con la piel.CS: Zamezte styku s kůží.DA: Undgå kontakt med huden.DE: Berührung mit der Haut vermeiden.ET: Vältida kokkupuudet nahaga.EL: Αποφεύγετε την επαφή με το δέρμα.EN: Avoid contact with skin.FR: Éviter le contact avec la peau.IT: Evitare il contatto con la pelle.LV: Nepieļaut nokļūšanu uz ādas.LT: Vengti patekimo ant odos.HU: A bőrrel való érintkezés kerülendő.MT: Evita l-kuntatt mal-ġilda.NL: Aanraking met de huid vermijden.PL: Unikać zanieczyszczenia skóry.PT: Evitar o contacto com a pele.RO: A se evita contactul cu pielea.SK: Zabráňte kontaktu s pokožkou.SL: Preprečiti stik s kožo.FI: Varottava kemikaalin joutumista iholle.SV: Undvik kontakt med huden.S25BG: Да се избягва контакт с очите.ES: Evítese el contacto con los ojos.CS: Zamezte styku s očima.DA: Undgå kontakt med øjnene.DE: Berührung mit den Augen vermeiden.ET: Vältida silma sattumist.EL: Αποφεύγετε την επαφή με τα μάτια.EN: Avoid contact with eyes.FR: Éviter le contact avec les yeux.IT: Evitare il contatto con gli occhi.LV: Nepieļaut nokļūšanu acīs.LT: Vengti patekimo į akis.HU: Kerülni kell a szembe jutást.MT: Evita l-kuntatt ma’ l-għajnejn.NL: Aanraking met de ogen vermijden.PL: Unikać zanieczyszczenia oczu.PT: Evitar o contacto com os olhos.RO: A se evita contactul cu ochii.SK: Zabráňte kontaktu s očami.SL: Preprečiti stik z očmi.FI: Varottava kemikaalin joutumista silmiin.SV: Undvik kontakt med ögonen.S26BG: При контакт с очите, веднага да се изплакнат обилно с вода и да се потърси медицинска помощ.ES: En caso de contacto con los ojos, lávense inmediata y abundantemente con agua y acúdase a un médico.CS: Při zasažení očí okamžitě důkladně vypláchněte vodou a vyhledejte lékařskou pomoc.DA: Kommer stoffet i øjnene, skylles straks grundigt med vand og læge kontaktes.DE: Bei Berührung mit den Augen sofort gründlich mit Wasser abspülen und Arzt konsultieren.ET: Silma sattumisel loputada koheselt rohke veega ja pöörduda arsti poole.EL: Σε περίπτωση επαφής με τα μάτια πλύνετέ τα αμέσως με άφθονο νερό και ζητήστε ιατρική συμβουλή.EN: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.FR: En cas de contact avec les yeux, laver immédiatement et abondamment avec de l’eau et consulter un spécialiste.IT: In caso di contatto con gli occhi, lavare immediatamente e abbondantemente con acqua e consultare un medico.LV: Ja nokļūst acīs, nekavējoties tās skalot ar lielu daudzumu ūdens un meklēt medicīnisku palīdzību.LT: Patekus į akis, nedelsiant gerai praplauti vandeniu ir kreiptis į gydytoją.HU: Ha szembe jut, bő vízzel azonnal ki kell mosni és orvoshoz kell fordulni.MT: F’każ ta’ kuntatt ma’ l-għajnejn, aħsel immedjatament b’ħafna ilma u ara tabib.NL: Bij aanraking met de ogen onmiddellijk met overvloedig water afspoelen en deskundig medisch advies inwinnen.PL: Zanieczyszczone oczy przemyć natychmiast dużą ilością wody i zasięgnąć porady lekarza.PT: Em caso de contacto com os olhos, lavar imediata e abundantemente com água e consultar um especialista.RO: În cazul contactului cu ochii, spălaţi imediat cu multă apă şi consultaţi medicul.SK: V prípade kontaktu s očami je potrebné ihneď ich vymyť s veľkým množstvom vody a vyhľadať lekársku pomoc.SL: Če pride v oči, takoj izpirati z obilo vode in poiskati zdravniško pomoč.FI: Roiskeet silmistä huuhdeltava välittömästi runsaalla vedellä ja mentävä lääkäriin.SV: Vid kontakt med ögonen, spola genast med mycket vatten och kontakta läkare.S27BG: Незабавно да се съблече цялото замърсено облекло.ES: Quítese inmediatamente la ropa manchada o salpicada.CS: Okamžitě odložte veškeré kontaminované oblečení.DA: Tilsmudset tøj tages straks af.DE: Beschmutzte, getränkte Kleidung sofort ausziehen.ET: Võtta koheselt seljast saastunud riietus.EL: Αφαιρέστε αμέσως όλα τα ενδύματα που έχουν μολυνθεί.EN: Take off immediately all contaminated clothing.FR: Enlever immédiatement tout vêtement souillé ou éclaboussé.IT: Togliersi di dosso immediatamente gli indumenti contaminati.LV: Nekavējoties novilkt notraipīto apģērbu.LT: Nedelsiant nusivilkti visus užterštus drabužius.HU: A szennyezett ruhát azonnal le kell vetni.MT: Inża’ mill-ewwel kull ilbies imniġġes.NL: Verontreinigde kleding onmiddellijk uittrekken.PL: Natychmiast zdjąć całą zanieczyszczoną odzież.PT: Retirar imediatamente todo o vestuário contaminado.RO: Scoateţi imediat toată îmbrăcămintea contaminată.SK: Okamžite si vyzlečte kontaminovaný odev.SL: Takoj sleči vso onesnaženo obleko.FI: Riisuttava välittömästi saastunut vaatetus.SV: Tag genast av alla nedstänkta kläder.S28BG: След контакт с кожата, веднага да се измие обилно с … (посочва се от производителя).ES: En caso de contacto con la piel, lávese inmediata y abundantemente con … (productos a especificar por el fabricante).CS: Při styku s kůží okamžitě omyjte velkým množstvím … (vhodnou kapalinu specifikuje výrobce).DA: Kommer stof på huden vaskes straks med store mængder … (angives af fabrikanten).DE: Bei Berührung mit der Haut sofort abwaschen mit viel … (vom Hersteller anzugeben).ET: Nahale sattumisel pesta koheselt rohke … (määrab valmistaja).EL: Σε περίπτωση επαφής με το δέρμα, πλυθείτε αμέσως με άφθονο … (το είδος του υγρού καθορίζεται από τον παραγωγό).EN: After contact with skin, wash immediately with plenty of … (to be specified by the manufacturer).FR: Après contact avec la peau, se laver immédiatement et abondamment avec … (produits appropriés à indiquer par le fabricant).IT: In caso di contatto con la pelle lavarsi immediatamente ed abbondantemente con … (prodotti idonei da indicarsi da parte del fabbricante).LV: Ja nokļūst uz ādas, nekavējoties skalot ar lielu daudzumu … (norāda ražotājs).LT: Patekus ant odos, nedelsiant gerai nuplauti … (kuo — nurodo gamintojas).HU: Ha az anyag a bőrre kerül, …-val/vel bőven azonnal le kell mosni (az anyagot a gyártó határozza meg).MT: F’każ ta’ kuntatt mal-ġilda, aħsel mill-ewwel b’ħafna … (ikun speċifikat mill-manifattur).NL: Na aanraking met de huid onmiddellijk wassen met veel … (aan te geven door de fabrikant).PL: Zanieczyszczoną skórę natychmiast przemyć dużą ilością … (cieczy określonej przez producenta).PT: Após contacto com a pele, lavar imediata e abundantemente com … (produtos adequados a indicar pelo produtor).RO: După contactul cu pielea, spălaţi imediat cu mult … (produsul corespunzător va fi indicat de fabricant).SK: Po kontakte s pokožkou je potrebné ju umyť veľkým množstvom … (bude špecifikované výrobcom).SL: Ob stiku s kožo takoj izprati z obilo … (sredstvo določi proizvajalec).FI: Roiskeet iholta huuhdeltava välittömästi runsaalla määrällä … (aineen ilmoittaa valmistaja/maahantuoja).SV: Vid kontakt med huden tvätta genast med mycket … (anges av tillverkaren).S29BG: Да не се изпуска в канализацията.ES: No tirar los residuos por el desagüe.CS: Nevylévejte do kanalizace.DA: Må ikke tømmes i kloakafløb.DE: Nicht in die Kanalisation gelangen lassen.ET: Mitte valada kanalisatsiooni.EL: Μην αδειάζετε το υπόλοιπο του περιεχομένου στην αποχέτευση.EN: Do not empty into drains.FR: Ne pas jeter les résidus à l’égout.IT: Non gettare i residui nelle fognature.LV: Aizliegts izliet kanalizācijā.LT: Neišleisti į kanalizaciją.HU: Csatornába engedni nem szabad.MT: Titfax il-fdal fid- drenaġġ.NL: Afval niet in de gootsteen werpen.PL: Nie wprowadzać do kanalizacji.PT: Não deitar os resíduos no esgoto.RO: A nu se arunca la canalizare.SK: Nevypúšťať do kanalizačnej siete.SL: Ne izprazniti v kanalizacijo.FI: Ei saa tyhjentää viemäriin.SV: Töm ej i avloppet.S30BG: Никога да не се добавя вода в този продукт.ES: No echar jamás agua a este producto.CS: K tomuto výrobku nikdy nepřidávejte vodu.DA: Hæld aldrig vand på eller i produktet.DE: Niemals Wasser hinzugießen.ET: Kemikaalile vett mitte lisada.EL: Ποτέ μην προσθέτετε νερό στο προϊόν αυτό.EN: Never add water to this product.FR: Ne jamais verser de l’eau dans ce produit.IT: Non versare acqua sul prodotto.LV: Stingri aizliegts pievienot ūdeni.LT: Niekada nemaišyti šios medžiagos su vandeniu.HU: Soha nem szabad vizet hozzáadni.MT: Qatt titfa’ ilma fuq dan il-prodott.NL: Nooit water op deze stof gieten.PL: Nigdy nie dodawać wody do tego produktu.PT: Nunca adicionar água a este produto.RO: A nu se turna niciodată apă peste acest produs.SK: Nikdy nepridávajte vodu k tomuto prípravku.SL: Nikoli dolivati vode.FI: Tuotteeseen ei saa lisätä vettä.SV: Häll aldrig vatten på eller i produkten.S33BG: Да се вземат предпазни мерки срещу статично електричество.ES: Evítese la acumulación de cargas electroestáticas.CS: Proveďte preventivní opatření proti výbojům statické elektřiny.DA: Træf foranstaltninger mod statisk elektricitet.DE: Maßnahmen gegen elektrostatische Aufladungen treffen.ET: Vältida staatilise elektri teket.EL: Λάβετε προστατευτικά μέτρα έναντι ηλεκτροστατικών εκκενώσεων.EN: Take precautionary measures against static discharges.FR: Éviter l’accumulation de charges électrostatiques.IT: Evitare l’accumulo di cariche elettrostatiche.LV: Veikt drošības pasākumus, lai pasargātu no statiskās elektrības iedarbības.LT: Imtis atsargumo priemonių elektrostatinėms iškrovoms išvengti.HU: A sztatikus feltöltődés ellen védekezni kell.MT: Evita l-akkumulazzjoni ta’ kargi elettrostatiċi.NL: Maatregelen treffen tegen ontladingen van statische elektriciteit.PL: Zastosować środki ostrożności zapobiegające wyładowaniom elektrostatycznym.PT: Evitar acumulação de cargas electrostáticas.RO: A se lua măsuri de precauţie pentru evitarea descărcărilor electrostatice.SK: Vykonajte predbežné opatrenia proti statickým výbojom.SL: Preprečiti statično naelektrenje.FI: Estettävä staattisen sähkön aiheuttama kipinöinti.SV: Vidtag åtgärder mot statisk elektricitet.S35BG: Този материал и неговата опаковка да се третират по безопасен начин.ES: Elimínense los residuos del producto y sus recipientes con todas las precauciones posibles.CS: Tento materiál a jeho obal musí být zneškodněny bezpečným způsobem.DA: Materialet og dets beholder skal bortskaffes på en sikker måde.DE: Abfälle und Behälter müssen in gesicherter Weise beseitigt werden.ET: Kemikaal ja pakend tuleb jäätmetena hävitada ohutult.EL: Το υλικό και ο περιέκτης του πρέπει να διατεθεί με ασφαλή τρόπο.EN: This material and its container must be disposed of in a safe way.FR: Ne se débarrasser de ce produit et de son récipient qu’en prenant toutes précautions d’usage.IT: Non disfarsi del prodotto e del recipiente se non con le dovute precauzioni.LV: Šo vielu vai produktu un iepakojumu likvidēt drošā veidā.LT: Atliekos ir pakuotė turi būti saugiai pašalintos.HU: Az anyagot és az edényzetét megfelelő módon ártalmatlanítani kell.MT: Dan il-materjal u l-kontenitur tiegħu għandhom jintremew bil-prekawzjonijiet meħtieġa.NL: Deze stof en de verpakking op veilige wijze afvoeren.PL: Usuwać produkt i jego opakowanie w sposób bezpieczny.PT: Não se desfazer deste produto e do seu recipiente sem tomar as precauções de segurança devidas.RO: A nu se arunca acest produs şi ambalajul său decât după ce sau luat toate precauţiile.SK: Tento materiál a jeho obal uložte na bezpečnom mieste.SL: Vsebina in embalaža morata biti varno odstranjeni.FI: Tämä aine ja sen pakkaus on hävitettävä turvallisesti.SV: Produkt och förpackning skall oskadliggöras på säkert sätt.S36BG: Да се носи подходящо защитно облекло.ES: Úsese indumentaria protectora adecuada.CS: Používejte vhodný ochranný oděv.DA: Brug særligt arbejdstøj.DE: Bei der Arbeit geeignete Schutzkleidung tragen.ET: Kanda sobivat kaitseriietust.EL: Να φοράτε κατάλληλη προστατευτική ενδυμασία.EN: Wear suitable protective clothing.FR: Porter un vêtement de protection approprié.IT: Usare indumenti protettivi adatti.LV: Izmantot piemērotu aizsargapģērbu.LT: Dėvėti tinkamus apsauginius drabužius.HU: Megfelelő védőruházatot kell viselni.MT: Ilbes ilbies protettiv adatt.NL: Draag geschikte beschermende kleding.PL: Nosić odpowiednią odzież ochronną.PT: Usar vestuário de protecção adequado.RO: A se purta echipamentul de protecţie corespunzător.SK: Noste vhodný ochranný odev.SL: Nositi primerno zaščitno obleko.FI: Käytettävä sopivaa suojavaatetusta.SV: Använd lämpliga skyddskläder.S37BG: Да се носят подходящи ръкавици.ES: Úsense guantes adecuados.CS: Používejte vhodné ochranné rukavice.DA: Brug egnede beskyttelseshandsker under arbejdet.DE: Geeignete Schutzhandschuhe tragen.ET: Kanda sobivaid kaitsekindaid.EL: Να φοράτε κατάλληλα γάντια.EN: Wear suitable gloves.FR: Porter des gants appropriés.IT: Usare guanti adatti.LV: Strādāt aizsargcimdos.LT: Mūvėti tinkamas pirštines.HU: Megfelelő védőkesztyűt kell viselni.MT: Ilbes ingwanti adatt.NL: Draag geschikte handschoenen.PL: Nosić odpowiednie rękawice ochronne.PT: Usar luvas adequadas.RO: A se purta mănuşi corespunzătoare.SK: Noste vhodné rukavice.SL: Nositi primerne zaščitne rokavice.FI: Käytettävä sopivia suojakäsineitä.SV: Använd lämpliga skyddshandskar.S38BG: При недостатъчна вентилация, да се използват подходящи средства за дихателна защита.ES: En caso de ventilación insuficiente, úsese equipo respiratorio adecuado.CS: V případě nedostatečného větrání používejte vhodné vybavení pro ochranu dýchacích orgánů.DA: Brug egnet åndedrætsværn, hvis effektiv ventilation ikke er mulig.DE: Bei unzureichender Belüftung Atemschutzgerät anlegen.ET: Ebapiisava ventilatsiooni korral kanda sobivat hingamisteede kaitsevahendit.EL: Σε περίπτωση ανεπαρκούς αερισμού, χρησιμοποιείτε κατάλληλη αναπνευστική συσκευή.EN: In case of insufficient ventilation, wear suitable respiratory equipment.FR: En cas de ventilation insuffisante, porter un appareil respiratoire approprié.IT: In caso di ventilazione insufficiente, usare un apparecchio respiratorio adatto.LV: Nepietiekamas ventilācijas apstākļos aizsargāt elpošanas orgānus.LT: Esant nepakankamam vėdinimui, naudoti tinkamas kvėpavimo takų apsaugos priemones.HU: Ha a szellőzés elégtelen, megfelelő légzőkészüléket kell használni.MT: F’każ ta’ nuqqas ta’ ventilazzjoni biżżejjed, ilbes apparat respiratorju adatt.NL: Bij ontoereikende ventilatie een geschikte adembescherming dragen.PL: W przypadku niedostatecznej wentylacji stosować odpowiednie indywidualne środki ochrony dróg oddechowych.PT: Em caso de ventilação insuficiente, usar equipamento respiratório adequado.RO: În cazul unei ventilaţii insuficiente, a se purta un echipament de respiraţie corespunzător.SK: V prípade nedostatočného vetrania použite vhodný respirátor.SL: Ob nezadostnem prezračevanju nositi primerno dihalno opremo.FI: Kemikaalin käyttö edellyttää tehokasta ilmanvaihtoa tai sopivaa hengityksensuojainta.SV: Använd lämpligt andningsskydd vid otillräcklig ventilation.S39BG: Да се носят предпазни средства за очите/лицето.ES: Úsese protección para los ojos/la cara.CS: Používejte osobní ochranné prostředky pro oči a obličej.DA: Brug beskyttelsesbriller/ansigtsskærm under arbejdet.DE: Schutzbrille/Gesichtsschutz tragen.ET: Kanda silmade/näokaitset.EL: Χρησιμοποιείτε συσκευή προστασίας ματιών/προσώπου.EN: Wear eye/face protection.FR: Porter un appareil de protection des yeux/du visage.IT: Proteggersi gli occhi/la faccia.LV: Valkāt acu vai sejas aizsargu.LT: Naudoti akių (veido) apsaugos priemones.HU: Szem-/arcvédőt kell viselni.MT: Ipproteġi ‘l għajnejk/wiċċek.NL: Een bescherming voor de ogen/voor het gezicht dragen.PL: Nosić okulary lub ochronę twarzy.PT: Usar um equipamento protector para os olhos /face.RO: A se purta mască de protecţie a ochilor/feţei.SK: Použite ochranu očí a tváre.SL: Nositi zaščito za oči/obraz.FI: Käytettävä silmiem-tai kasvonsuojainta.SV: Använd skyddsglasögon eller ansiktsskydd.S40BG: За почистване на пода и всички предмети, замърсени с този продукт, да се използва … (посочва се от производителя).ES: Para limpiar el suelo y los objetos contaminados por este producto, úsese … (a especificar por el fabricante).CS: Podlahy a předměty znečistěné tímto materiálem čistěte … (specifikuje výrobce).DA: Gulvet og tilsmudsede genstande renses med … (midlerne angives af fabrikanten).DE: Fußboden und verunreinigte Gegenstände mit … reinigen (Material vom Hersteller anzugeben).ET: Kemikaaliga saastunud pindade ja esemete puhastamiseks kasuta … (määrab valmistaja)EL: Για τον καθαρισμό του δαπέδου και όλων των αντικειμένων που έχουν μολυνθεί από το υλικό αυτό χρησιμοποιείτε … (το είδος καθορίζεται από τον παραγωγό).EN: To clean the floor and all objects contaminated by this material, use … (to be specified by the manufacturer).FR: Pour nettoyer le sol ou les objets souillés par ce produit, utiliser … (à préciser par le fabricant).IT: Per pulire il pavimento e gli oggetti contaminati da questo prodotto, usare … (da precisare da parte del produttore).LV: Tīrot grīdu un piesārņotos objektus, izmantot … (norāda ražotājs).LT: Šia medžiaga užterštus daiktus ir grindis valyti su … (kuo — nurodo gamintojas).HU: A padlót és a beszennyeződött tárgyakat …-val/-vel kell tisztítani (az anyagot a gyártó határozza meg).MT: Biex taħsel l-art u l-oġġetti kollha mniġġsin b’dan il-materjal, uża … (ikun speċifikat mill-manifattur).NL: Voor de reiniging van de vloer en alle voorwerpen verontreinigd met dit materiaal, … gebruiken. (aan te geven door de fabrikant).PL: Czyścić podłogę i wszystkie inne obiekty zanieczyszczone tym produktem … (środkiem wskazanym przez producenta).PT: Para limpeza do chão e objectos contaminados por este produto, utilizar … (a especificar pelo produtor).RO: Pentru curăţirea pardoselei sau a obiectelor murdărite de acest produs, folosiţi … (va fi indicat de către fabricant).SK: Na vyčistenie podlahy a všetkých predmetov kontaminovaných týmto materiálom použite … (špecifikuje výrobca).SL: Tla in predmete, onesnažene s to snovjo/pripravkom, očistiti s/z … (čistilo določi proizvajalec).FI: Kemikaali puhdistettava pinnoilta käyttäen … (kemikaalin ilmoittaa valmistaja/maahantuoja).SV: Golv och förorenade föremål tvättas med … (anges av tillverkaren).S41BG: В случай на пожар и/или експлозия да не се вдишва дима.ES: En caso de incendio y/o de explosión no respire los humos.CS: V případě požáru nebo výbuchu nevdechujte dýmy.DA: Undgå at indånde røgen ved brand eller eksplosion.DE: Explosions- und Brandgase nicht einatmen.ET: Tulekahju ja/või plahvatuse korral vältida suitsu sissehingamist.EL: Σε περίπτωση πυρκαγιάς και/ή εκρήξεως μην αναπνέετε τους καπνούς.EN: In case of fire and/or explosion do not breathe fumes.FR: En cas d’incendie et/ou d’explosion, ne pas respirer les fumées.IT: In caso di incendio e/o esplosione non respirare i fumi.LV: Ugunsgrēka vai eksplozijas gadījumā neieelpot dūmus.LT: Gaisro arba sprogimo atveju neįkvėpti dūmų.HU: Robbanás és/vagy tűz esetén a keletkező gázokat nem szabad belélegezni.MT: F’każ ta’ nar jew/u splużjoni tiblax id-dħaħen.NL: In geval van brand en/of explosie inademen van rook vermijden.PL: Nie wdychać dymów powstających w wyniku pożaru lub wybuchu.PT: Em caso de incêndio e/ou explosão não respirar os fumos.RO: A nu se inspira fumul în caz de incendiu şi/sau explozie.SK: V prípade požiaru alebo výbuchu nevdychujte výpary.SL: Ne vdihavati plinov, ki nastanejo ob požaru in/ali eksploziji.FI: Vältettävä palamisessa tai räjähdyksessä muodostuvan savun hengittämistä.SV: Undvik inandning av rök vid brand eller explosion.S42BG: При опушване/пръскане да се използват подходящи средства за дихателна защита. (подходящата дума/подходящите думи се посочва/посочват от производителя).ES: Durante las fumigaciones/pulverizaciones, úsese equipo respiratorio adecuado (denominación(es) adecuada(s) a especificar por el fabricante).CS: Při fumigaci nebo rozprašování používejte vhodný ochranný prostředek k ochraně dýchacích orgánů (specifikaci uvede výrobce).DA: Brug egnet åndedrætsværn ved rygning/sprøjtning (den eller de pågældende betegnelser angives af fabrikanten).DE: Beim Räuchern/Versprühen geeignetes Atemschutzgerät anlegen (geeignete Bezeichnung(en) vom Hersteller anzugeben).ET: Suitsutamisel/piserdamisel kanda sobivat hingamiselundite kaitsevahendit (sõnastuse täpsustab valmistaja).EL: Κατά τη διάρκεια υποκαπνισμού/ψεκάσματος χρησιμοποιείτε κατάλληλη αναπνευστική συσκευή (η κατάλληλη διατύπωση καθορίζεται από τον παραγωγό).EN: During fumigation/spraying wear suitable respiratory equipment (appropriate wording to be specified by the manufacturer).FR: Pendant les fumigations/pulvérisations, porter un appareil respiratoire approprié (terme(s) approprié(s) à indiquer par le fabricant).IT: Durante le fumigazioni/polimerizzazioni usare un apparecchio respiratorio adatto (termine(i) appropriato(i) da precisare da parte del produttore).LV: Izsmidzināšanas laikā izmantot šādus elpošanas ceļu aizsardzības līdzekļus … (norāda ražotājs).LT: Purškiant (fumiguojant) naudoti tinkamas kvėpavimo takų apsaugos priemones (konkrečiai nurodo gamintojas).HU: Füst-/permetképződés esetén megfelelő légzőkészüléket kell viselni (a megfelelő szöveget a gyártó határozza meg).MT: Waqt il-fumigazzjoni/l-isprejjar ilbes apparat respiratorju adatt (it-terminu adattat irid ikun speċifikat mill-manifattur).NL: Tijdens de ontsmetting/bespuiting een geschikte adembescherming dragen. (geschikte term(en) door de fabrikant aan te geven).PL: Podczas fumigacji/rozpylania/natryskiwania stosować odpowiednie środki ochrony dróg oddechowych (rodzaj określi producent).PT: Durante as fumigações/pulverizações usar equipamento respiratório adequado (termo(s) adequado(s) a indicar pelo produtor).RO: În timpul fumigaţiilor/pulverizărilor, a se purta un echipament de respiraţie corespunzător (fabricantul va indica termenul(ii) corespunzător(i)).SK: Počas zadymovania/rozprašovania použite vhodný respirátor (špecifikuje výrobca).SL: Med zaplinjanjem/razprševanjem nositi primerno dihalno opremo (natančnejše pogoje določi proizvajalec).FI: Kaasutuksen/ruiskutuksen aikana käytettävä sopivaa hengityksensuojainta (oikean sanamuodon valitsee valmistaja/maahantuoja).SV: Använd lämpligt andningsskydd vid gasning/sprutning (specificeras av tillverkaren).S43BG: При пожар да се използва … (да се посочи точният тип на пожарогасителното устройство. Ако водата увеличава риска, да се добави: “Никога да не се използва вода!”).ES: En caso de incendio, utilizar … (los medios de extinción los debe especificar el fabricante). (Si el agua aumenta el riesgo, se deberá añadir: “No usar nunca agua”).CS: V případě požáru použijte … (uveďte zde konkrétní typ hasicího zařízení. Pokud zvyšuje riziko voda, připojte “Nikdy nepoužívat vodu”).DA: Brug … ved brandslukning (den nøjagtige type brandslukningsudstyr angives af fabrikanten. Såfremt vand ikke må bruges tilføjes: “Brug ikke vand”).DE: Zum Löschen … (vom Hersteller anzugeben) verwenden (wenn Wasser die Gefahr erhöht, anfügen: “Kein Wasser verwenden”).ET: Tulekahju korral kasutada … (näidata täpne kustutusvahendi tüüp. Kui vesi suurendab ohtu, lisada: Vett mitte kasutada).EL: Σε περίπτωση πυρκαγιάς χρησιμοποιείτε … (Αναφέρεται το ακριβές είδος μέσων πυρόσβεσης. Εάν το νερό αυξάνει τον κίνδυνο, προστίθεται: “Μη χρησιμοποιείτε ποτέ νερό”).EN: In case of fire, use … (indicate in the space the precise type of fire-fighting equipment. If water increases risk, add — “Never use water”).FR: En cas d’incendie, utiliser … (moyens d’extinction à préciser par le fabricant. Si l’eau augmente les risques, ajouter: “Ne jamais utiliser d’eau”).IT: In caso di incendio usare … (mezzi estinguenti idonei da indicarsi da parte del fabbricante. Se l’acqua aumenta il rischio precisare “Non usare acqua”).LV: Ugunsgrēka gadījumā izmantot … (precīzi norādīt nepieciešamo ugunsdzēsības līdzekli. Ja ūdens palielina risku, papildināt ar norādi “Aizliegts izmantot ūdeni”).LT: Gaisrui gesinti naudoti … (tiksliai nurodyti gesinimo priemonę. Jeigu vanduo didina riziką, papildomai nurodyti “Nenaudoti vandens”).HU: Tűz esetén …-val/-vel oltandó (az anyagot a gyártó határozza meg). Ha a víz használata fokozza a veszélyt, a “Víz használata tilos.” mondattal is ki kell egészíteni.MT: F’każ ta’ nar uża … (indika fl-ispazju t-tip preċiż ta’ apparat tat-tifi tan-nar. Jekk l-ilma jkabbar ir-riskju, żid “Qatt tuża l-ilma”).NL: In geval van brand … gebruiken. (blusmiddelen aan te duiden door de fabrikant. Indien water het risico vergroot toevoegen: “Nooit water gebruiken”).PL: W przypadku pożaru używać … (podać rodzaj sprzętu przeciwpożarowego. Jeżeli woda zwiększa zagrożenie, dodać “Nigdy nie używać wody”).PT: Em caso de incêndio, utilizar … (meios de extinção a especificar pelo produtor. Se a água aumentar os riscos, acrescentar “Nunca utilizar água”).RO: În caz de incendiu se va utiliza… (Mijloacele de stingere a incendiului vor fi indicate de fabricant. Dacă apa măreşte riscurile, se va adăuga “Niciodată nu folosiţi apă”).SK: V prípade požiaru použite … (uveďte presný typ hasiaceho prístroja. Ak voda zvyšuje riziko, dodajte — “Nikdy nehaste vodou”).SL: Za gašenje uporabiti … (natančno navesti vrsto gasila in opreme za gašenje. Če voda povečuje nevarnost, dodati: “Ne uporabljati vode!”).FI: Sammutukseen käytettävä … (ilmoitettava sopiva sammutusmenetelmä. Jos vesi lisää vaaraa, lisättävä sanat: “Sammutukseen ei saa käyttää vettä”).SV: Vid brandsläckning använd … (ange lämplig metod. Om vatten ökar riskerna, lägg till: “Använd aldrig vatten”).S45BG: При злополука или неразположение да се потърси незабавно медицинска помощ и когато е възможно да се покаже етикета.ES: En caso de accidente o malestar, acúdase inmediatamente al médico (si es posible, muéstresele la etiqueta).CS: V případě nehody, nebo necítíte-li se dobře, okamžitě vyhledejte lékařskou pomoc (je-li možno, ukažte toto označení).DA: Ved ulykkestilfælde eller ved ildebefindende er omgåænde lægebehandling nødvendig; vis etiketten, hvis det er muligt.DE: Bei Unfall oder Unwohlsein sofort Arzt zuziehen (wenn möglich, dieses Etikett vorzeigen).ET: Õnnetusjuhtumi või halva enesetunde korral pöörduda arsti poole (võimaluse korral näidata talle etiketti).EL: Σε περίπτωση ατυχήματος ή αν αισθανθείτε αδιαθεσία ζητήστε αμέσως ιατρική συμβουλή (δείξτε την ετικέτα αν είναι δυνατό).EN: In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible).FR: En cas d’accident ou de malaise, consulter immédiatement un médecin (si possible lui montrer l’étiquette).IT: In caso di incidente o di malessere consultare immediatamente il medico (se possibile, mostrargli l’etichetta).LV: Ja noticis nelaimes gadījums vai jūtami veselības traucējumi, nekavējoties meklēt medicīnisku palīdzību (ja iespējams, uzrādīt marķējumu).LT: Nelaimingo atsitikimo atveju arba pasijutus blogai, nedelsiant kreiptis į gydytoją (jeigu įmanoma, parodyti šią etiketę).HU: Baleset vagy rosszullét esetén azonnal orvoshoz kell fordulni. Ha lehetséges, a címkét meg kell mutatni.MT: F’każ ta’ inċident jew jekk tħossok ma tiflaħx, ara tabib mill-ewwel (jekk hu possibbli, urih it-tikketta).NL: Bij een ongeval of indien men zich onwel voelt, onmiddellijk een arts raadplegen (indien mogelijk hem dit etiket tonen).PL: W przypadku awarii lub jeżeli źle się poczujesz, niezwłocznie zasięgnij porady lekarza –jeżeli to możliwe, pokaż etykietę.PT: Em caso de acidente ou de indisposição, consultar imediatamente o médico (se possível mostrar-lhe o rótulo).RO: În caz de accident sau simptome de boală, consultaţi imediat medicul (Dacă este posibil, i se va arăta eticheta).SK: V prípade nehody alebo ak sa necítite dobre, okamžite vyhľadajte lekársku pomoc (ak je to možné, ukážte označenie látky alebo prípravku).SL: Ob nezgodi ali slabem počutju, takoj poiskati zdravniško pomoč. (Po možnosti pokazati etiketo).FI: Onnettomuuden sattuessa tai tunnettaessa pahoinvointia hakeuduttava heti lääkärin hoitoon (näytettävä tätä etikettiä, mikäli mahdollista).SV: Vid olycksfall, illamående eller annan påverkan, kontakta omedelbart läkare. Visa om möjligt etiketten.S46BG: При поглъщане да се потърси незабавно медицинска помощ и да се покаже опаковката или етикета.ES: En caso de ingestión, acúdase inmediatamente al médico y muéstresele la etiqueta o el envase.CS: Při požití okamžitě vyhledejte lékařskou pomoc a ukažte tento obal nebo označení.DA: Ved indtagelse, kontakt odūmgåænde læge og vis denne beholder eller etiket.DE: Bei Verschlucken sofort ärztlichen Rat einholen und Verpackung oder Etikett vorzeigen.ET: Kemikaali allaneelamise korral pöörduda viivitamatult arsti poole ja näidata talle kemikaali pakendit või etiketti.EL: Σε περίπτωση κατάποσης ζητήστε αμέσως ιατρική συμβουλή και δείξτε αυτό το δοχείο ή την ετικέτα.EN: If swallowed, seek medical advice immediately and show this container or label.FR: En cas d’ingestion, consulter immédiatement un médecin et lui montrer l’emballage ou l’étiquette.IT: In caso d’ingestione consultare immediatamente il medico e mostrargli il contenitore o l’etichetta.LV: Ja norīts, nekavējoties meklēt medicīnisku palīdzību un uzrādīt iepakojumu vai tā marķējumu.LT: Prarijus nedelsiant kreiptis į gydytoją ir parodyti šią pakuotę arba etiketę.HU: Lenyelése esetén azonnal orvoshoz kell fordulni, az edényt/csomagolóburkolatot és a címkét az orvosnak meg kell mutatni.MT: Jekk jinbela’, ara tabib mill-ewwel u urih dan il-kontenitur jew it-tikketta.NL: In geval van inslikken onmiddellijk een arts raadplegen en verpakking of etiket tonen.PL: W razie połknięcia niezwłocznie zasięgnij porady lekarza — pokaż opakowanie lub etykietę.PT: Em caso de ingestão, consultar imediatamente o médico e mostrar-lhe a embalagem ou o rótulo.RO: În caz de înghiţire, a se consulta imediat medicul şi a i se arăta ambalajul sau eticheta.SK: V prípade požitia, okamžite vyhľadajte lekársku pomoc a ukážte tento obal alebo označenie.SL: Če pride do zaužitja, takoj poiskati zdravniško pomoč in pokazati embalažo ali etiketo.FI: Jos ainetta on nielty, hakeuduttava heti lääkärin hoitoon ja näytettävä tämä pakkaus tai etiketti.SV: Vid förtäring kontakta genast läkare och visa denna förpackning eller etiketten.S47BG: Да се съхранява при температура не по-висока от …oC (посочва се от производителя).ES: Consérvese a una temperatura no superior a …oC (a especificar por el fabricante).CS: Uchovávejte při teplotě nepřesahující …oC (specifikuje výrobce).DA: Må ikke opbevares ved temperaturer på over …oC (angives af fabrikanten).DE: Nicht bei Temperaturen über …oC aufbewahren (vom Hersteller anzugeben).ET: Hoida temperatuuril mitte üle …oC (määrab valmistaja).EL: Να διατηρείται σε θερμοκρασία που δεν υπερβαίνει τους …oC (καθορίζεται από τον παραγωγό).EN: Keep at temperature not exceeding …oC (to be specified by the manufacturer).FR: Conserver à une température ne dépassant pas …oC (à préciser par le fabricant).IT: Conservare a temperatura non superiore a …oC (da precisare da parte del fabbricante).LV: Uzglabāšanas temperatūra nedrīkst pārsniegt …oC (norāda ražotājs).LT: Laikyti ne aukštesnėje negu…oC temperatūroje (nurodo gamintojas).HU: …oC feletti hőmérsékleten nem tárolható (a hőmérsékletet a gyártó határozza meg).MT: Żomm f’temperatura li ma taqbiżx …oC (ikun speċifikat mill-manifattur).NL: Bewaren bij een temperatuur beneden …oC. (aan te geven door de fabrikant).PL: Przechowywać w temperaturze nieprzekraczającej …oC (określi producent).PT: Conservar a uma temperatura que não exceda …oC (a especificar pelo produtor).RO: A se păstra la o temperatură care nu depăşeşte…oC (temperatura va fi specificată de fabricant).SK: Uchovávajte pri teplote nepresahujúcej …oC (teplotu špecifikuje výrobca).SL: Hraniti pri temperaturi, ki ne presega …oC (temperaturo določi proizvajalec).FI: Säilytettävä alle …oC lämpötilassa (valmistaja/maahantuoja ilmoittaa lämpötilan).SV: Förvaras vid en temperatur som inte överstiger …oC (anges av tillverkaren).S48BG: Да се съхранява овлажнен с … (подходящото се посочва от производителя).ES: Consérvese húmedo con … (medio apropiado a especificar por el fabricante).CS: Uchovávejte ve zvlhčeném stavu … (vhodnou látku specifikuje výrobce).DA: Holdes befugtet med … (passende middel angives af fabrikanten).DE: Feucht halten mit … (geeignetes Mittel vom Hersteller anzugeben).ET: Hoida niisutatult … (sobiva kemikaali määrab valmistaja).EL: Να διατηρείται υγρό με … (το κατάλληλο υλικό καθορίζεται από τον παραγωγό).EN: Keep wet with … (appropriate material to be specified by the manufacturer).FR: Maintenir humide avec … (moyen approprié à préciser par le fabricant).IT: Mantenere umido con … (mezzo appropriato da precisare da parte del fabbricante).LV: Uzglabāt samitrinātu ar … (piemērotu vielu norāda ražotājs).LT: Laikyti sudrėkintą …… (kuo — nurodo gamintojas).HU: …-val/-vel nedvesen tartandó (az anyagot a gyártó határozza meg).MT: Żomm umdu b’… (il-materjal adatt ikun speċifikat mill-manifattur).NL: Inhoud vochtig houden met … (middel aan te geven door de fabrikant).PL: Przechowywać produkt zwilżony … (właściwy materiał określi producent).PT: Manter húmido com … (material adequado a especificar pelo produtor).RO: A se păstra umezit cu… (materialul adecvat va fi indicat de fabricant).SK: Uchovávajte vlhké s … (vhodný materiál špecifikuje výrobca).SL: Hraniti prepojeno z/s … (primerno omočilo določi proizvajalec).FI: Säilytettävä kosteana … (valmistaja/maahantuoja ilmoittaa sopivan aineen).SV: Innehållet skall hållas fuktigt med … (lämpligt material anges av tillverkaren).S49BG: Да се съхранява само в оригиналната опаковка.ES: Consérvese únicamente en el recipiente de origen.CS: Uchovávejte pouze v původním obalu.DA: Må kun opbevares i den originale emballage.DE: Nur im Originalbehälter aufbewahren.ET: Hoida ainult originaalpakendis.EL: Διατηρείται μόνο μέσα στο αρχικό δοχείο.EN: Keep only in the original container.FR: Conserver uniquement dans le récipient d’origine.IT: Conservare soltanto nel recipiente originale.LV: Uzglabāt tikai oriģinālajā iepakojumā.LT: Laikyti tik gamintojo pakuotėje.HU: Csak az eredeti edényzetben tárolható.MT: Żomm biss fil-kontenitur oriġinali.NL: Uitsluitend in de oorspronkelijke verpakking bewaren.PL: Przechowywać wyłącznie w oryginalnym opakowaniu.PT: Conservar unicamente no recipiente de origem.RO: A se păstra numai în ambalajul original.SK: Uchovávajte len v pôvodnej nádobe.SL: Hraniti samo v izvirni posodi.FI: Säilytettävä vain alkuperäispakkauksessa.SV: Förvaras endast i originalförpackningen.S50BG: Да не се смесва с … (посочва се от производителя).ES: No mezclar con … (a especificar por el fabricante).CS: Nesměšujte s … (specifikuje výrobce).DA: Må ikke blandes med … (angives af fabrikanten).DE: Nicht mischen mit … (vom Hersteller anzugeben).ET: Mitte kokku segada … (sobimatu kemikaali määrab valmistaja).EL: Να μην αναμιχθεί με … (καθορίζεται από τον παραγωγό).EN: Do not mix with … (to be specified by the manufacturer).FR: Ne pas mélanger avec … (à spécifier par le fabricant).IT: Non mescolare con … (da specificare da parte del fabbricante).LV: Nedrīkst samaisīt ar … (norāda ražotājs).LT: Nemaišyti su …… (nurodo gamintojas).HU: …val/-vel nem keverhető (az anyagot a gyártó határozza meg).MT: Tħallatx ma’ … (ikun speċifikat mill-manifattur).NL: Niet vermengen met … (aan te geven door de fabrikant).PL: Nie mieszać z … (określi producent).PT: Não misturar com … (a especificar pelo produtor).RO: A nu se amesteca cu …(va fi indicat de fabricant).SK: Nemiešajte s … (bude špecifikované výrobcom).SL: Ne mešati z/s … (določi proizvajalec).FI: Ei saa sekoittaa … (valmistaja/maahantuoja ilmoittaa aineen) kanssa.SV: Blanda inte med … (anges av tillverkaren).S51BG: Да се използва само на проветриви места.ES: Úsese únicamente en lugares bien ventilados.CS: Používejte pouze v dobře větraných prostorách.DA: Må kun bruges på steder med god ventilation.DE: Nur in gut gelüfteten Bereichen verwenden.ET: Käidelda hästiventileeritavas kohas.EL: Να χρησιμοποιείται μόνο σε καλά αεριζόμενο χώρο.EN: Use only in well-ventilated areas.FR: Utiliser seulement dans des zones bien ventilées.IT: Usare soltanto in luogo ben ventilato.LV: Izmantot tikai labi vēdināmās telpās.LT: Naudoti tik gerai vėdinamose vietose.HU: Csak jól szellőztetett helyen használható.MT: Uża biss fi spazji ventilati tajjeb.NL: Uitsluitend op goed geventileerde plaatsen gebruiken.PL: Stosować wyłącznie w dobrze wentylowanych pomieszczeniach.PT: Utilizar somente em locais bem ventilados.RO: A se utiliza numai în locuri bine ventilate.SK: Používajte len na dobre vetranom mieste.SL: Uporabljati le v dobro prezračevanih prostorih.FI: Huolehdittava hyvästä ilmanvaihdosta.SV: Sörj för god ventilation.S52BG: Не се препоръчва за употреба на големи площи в закрити помещения.ES: No usar sobre grandes superficies en locales habitados.CS: Nedoporučuje se pro použití v interiéru na velké plochy.DA: Bør ikke anvendes til større flader i bebølses- eller opholdsrum.DE: Nicht großflächig für Wohn- und Aufenthaltsräume zu verwenden.ET: Mitte käidelda suletud ruumis laiadel pindadel.EL: Δεν συνιστάται η χρήση σε ευρείες επιφάνειες σε εσωτερικούς χώρους.EN: Not recommended for interior use on large surface areas.FR: Ne pas utiliser sur de grandes surfaces dans les locaux habités.IT: Non utilizzare su grandi superfici in locali abitati.LV: Nav ieteicams izmantot iekštelpās uz lielām virsmām.LT: Nepatartina naudoti vidaus darbams, esant didelio ploto paviršiams.HU: Emberi tartózkodásra szolgáló helyiségekben nagy felületen nem használható.MT: Mhux rakkomandat għal użu fuq spazji ta’ superfiċi kbira f’postijiet abitati.NL: Niet voor gebruik op grote oppervlakken in woon- en verblijfruimtes.PL: Nie zaleca się nanoszenia na duże płaszczyzny wewnątrz pomieszczeń.PT: Não utilizar em grandes superfícies nos locais habitados.RO: A nu se utiliza pe suprafeţe mari în încăperi locuite.SK: Nie je doporučené pre použitie v interiéroch na veľkých povrchových plochách.SL: Ne uporabljati na velikih notranjih površinah.FI: Ei suositella sisäkäyttöön laajoilla pinnoilla.SV: Olämpligt för användning inomhus vid behandling av stora ytor.S53BG: Да се избягва експозиция — Получете специални инструкции преди употреба.ES: Evítese la exposición — recábense instrucciones especiales antes del uso.CS: Zamezte expozici — před použitím si obstarejte speciální instrukce.DA: Undgå enhver kontakt — indhent særlige anvisninger før brug.DE: Exposition vermeiden — vor Gebrauch besondere Anweisungen einholen.ET: Ohutu kasutamise tagamiseks tutvuda enne käitlemist kasutusjuhendiga.EL: Αποφεύγετε την έκθεση — εφοδιαστείτε με τις ειδικές οδηγίες πριν από τη χρήση.EN: Avoid exposure — obtain special instructions before use.FR: Éviter l’exposition — se procurer des instructions spéciales avant l’utilisation.IT: Evitare l’esposizione — procurarsi speciali istruzioni prima dell’uso.LV: Izvairīties no saskares, pirms lietošanas iepazīties ar instrukciju.LT: Vengti poveikio — prieš naudojimą gauti specialias instrukcijas.HU: Kerülni kell az expozíciót, — használata előtt szerezze be a külön használati utasítást.MT: Evita li jitħalla espost — ġib istruzzjonijiet speċjali qabel tużah.NL: Blootstelling vermijden — vóór gebruik speciale aanwijzingen raadplegen.PL: Unikać narażenia — przed użyciem zapoznać się z instrukcją.PT: Evitar a exposição — obter instruções específicas antes da utilização.RO: A se evita expunerea — a se procura instrucţiuni speciale înainte de utilizare.SK: Zabráňte expozícii — pred použitím sa oboznámte so špeciálnymi inštrukciami.SL: Izogibati se izpostavljanju — pred uporabo pridobiti posebna navodila.FI: Vältettävä altistumista — ohjeet luettava ennen käyttöä.SV: Undvik exponering — Begär specialinstruktioner före användning.S56BG: Този материал и опаковката му да се изхвърлят само на места за събиране на опасни или специални отпадъци.ES: Elimínense esta sustancia y su recipiente en un punto de recogida pública de residuos especiales o peligrosos.CS: Zneškodněte tento materiál a jeho obal ve sběrném místě pro zvláštní nebo nebezpečné odpady.DA: Aflever dette materiale og dets beholder til et indsamlingssted for farligt affald og problemaffald.DE: Dieses Produkt und seinen Behälter der Problemabfallentsorgung zuführen.ET: Kemikaal ja tema pakend tuleb viia ohtlike jäätmete kogumispunkti.EL: Το υλικό αυτό και ο περιέκτης του να εναποτεθούν σε χώρο συλλογής επικινδύνων ή ειδικών αποβλήτων.EN: Dispose of this material and its container to hazardous or special waste collection point.FR: Éliminer ce produit et son récipient dans un centre de collecte des déchets dangereux ou spéciaux.IT: Smaltire questo materiale e i relativi contenitori in un punto di raccolta rifiuti pericolosi o speciali.LV: Likvidēt šo vielu vai tās iepakojumu bīstamo atkritumu vai īpašā atkritumu savākšanas vietā.LT: Šios medžiagos atliekas ir jos pakuotę išvežti į pavojingų atliekų surinkimo vietas.HU: Az anyagot és edényzetét különleges hulladék- vagy veszélyeshulladék-gyűjtő helyre kell vinni.MT: Itfa’ dan il-materjal u l-kontenitur tiegħu f’post fejn jinġabar skart perikoluż jew speċjali.NL: Deze stof en de verpakking naar inzamelpunt voor gevaarlijk of bijzonder afval brengen.PL: Zużyty produkt oraz opakowanie dostarczyć na składowisko odpadów niebezpiecznych.PT: Eliminar este produto e o seu recipiente, enviando-os para local autorizado para a recolha de resíduos perigosos ou especiais.RO: A se depozita produsul şi ambalajul său la un centru de colectare a deşeurilor periculoase sau speciale.SK: Zneškodnite tento materiál a jeho obal v mieste zberu nebezpečného alebo špeciálneho odpadu.SL: Snov/pripravek in embalažo predati odstranjevalcu nevarnih ali posebnih odpadkov.FI: Tämä aine ja sen pakkaus on toimitettava ongelmajätteen vastaanottopaikkaan.SV: Lämna detta material och dess behållare till insamlingsställe för farligt avfall.S57BG: Да се използва подходящ съд, за да се избегне замърсяване на околната среда.ES: Utilícese un envase de seguridad adecuado para evitar la contaminación del medio ambiente.CS: Použijte vhodný obal k zamezení kontaminace životního prostředí.DA: Skal indesluttes forsvarligt for at undgå miljøforurening.DE: Zur Vermeidung einer Kontamination der Umwelt geeigneten Behälter verwenden.ET: Keskkonnasaaste vältimiseks kasutada sobivat pakendit.EL: Να χρησιμοποιηθεί ο κατάλληλος περιέκτης για να αποφευχθεί μόλυνση του περιβάλλοντος.EN: Use appropriate container to avoid environmental contamination.FR: Utiliser un récipient approprié pour éviter toute contamination du milieu ambiant.IT: Usare contenitori adeguati per evitare l’inquinamento ambientale.LV: Izmantot piemērotu tvertni, lai izvairītos no vides piesārņošanas.LT: Naudoti tinkamą pakuotę aplinkos taršai išvengti.HU: A környezetszennyezés elkerülése érdekében megfelelő edényzetet kell használni.MT: Uża kontenitur adatt biex tevita t-tniġġis ta’ l-ambjent.NL: Neem passende maatregelen om verspreiding in het milieu te voorkomen.PL: Używać odpowiednich pojemników zapobiegających skażeniu środowiska.PT: Utilizar um recipiente adequado para evitar a contaminação do ambiente.RO: A se utiliza un ambalaj corespunzător pentru evitarea oricărei contaminări a mediului înconjurător.SK: Uskutočnite náležitú kontrolu, aby ste zabránili kontaminácii.SL: S primerno posodo preprečiti onesnaženje okolja.FI: Käytettävä sopivaa säilytystapaa ympäristön likaantumisen ehkäisemiseksi.SV: Förvaras på lämpligt sätt för att undvika miljöförorening.S59BG: Обърнете се към производителя или доставчика за информация относно възстановяването/рециклирането.ES: Remitirse al fabricante o proveedor para obtener información sobre su recuperación/reciclado.CS: Informujte se u výrobce nebo dodavatele o regeneraci nebo recyklaci.DA: Indhent oplysninger om genvinding/genanvendelse hos producentesn/leverandøren.DE: Informationen zur Wiederverwendung/Wiederverwertung beim Hersteller/Lieferanten erfragen.ET: Hankida valmistajalt/tarnijalt teave kemikaali taaskasutamise või ringlussevõtu kohta.EL: Ζητήστε πληροφορίες από τον παραγωγό/προμηθευτή για ανάκτηση/ανακύκλωση.EN: Refer to manufacturer/supplier for information on recovery/recycling.FR: Consulter le fabricant/fournisseur pour des informations relatives à la récupération/au recyclage.IT: Richiedere informazioni al produttore/fornitore per il recupero/riciclaggio.LV: Izmantot ražotāja vai izplatītāja informāciju par vielas reciklēšanu vai reģenerāciju.LT: Kreiptis į gamintoją (tiekėją) informacijai apie šių medžiagų ar preparatų panaudojimą arba perdirbimą gauti.HU: A hulladékanyag visszanyeréséhez/újrahasznosításához a gyártótól/forgalmazótól kell tájékoztatást kérni.MT: Irreferi għall-manifattur/fornitur għal informazzjoni fuq rekuperu/riċiklaġġ.NL: Raadpleeg fabrikant/leverancier voor informatie over terugwinning/recycling.PL: Przestrzegać wskazówek producenta lub dostawcy dotyczących odzysku lub wtórnego wykorzystania.PT: Solicitar ao produtor/fornecedor informações relativas à sua recuperação/reciclagem.RO: Adresaţi-vă fabricantului/furnizorului pentru informaţii privind recuperarea/reciclarea.SK: Obráťte sa na výrobcu s požiadavkou na informácie týkajúce sa obnovenia a recyklácie.SL: Posvetovati se s proizvajalcem/dobaviteljem o ponovni predelavi/recikliranju.FI: Hanki valmistajalta/luovuttajalta tietoja uudelleenkäytöstä/kierrätyksestä.SV: Rådfråga tillverkare/leverantör om återvinning/återanvändning.S60BG: Този материал и неговата опаковка да се третират като опасен отпадък.ES: Elimínense el producto y su recipiente como residuos peligrosos.CS: Tento materiál a jeho obal musí být zneškodněny jako nebezpečný odpad.DA: Dette materiale og dets beholder skal bortskaffes som farligt affald.DE: Dieses Produkt und sein Behälter sind als gefährlicher Abfall zu entsorgen.ET: Kemikaal ja tema pakend kõrvaldada kui ohtlikud jäätmed.EL: Το υλικό και ο περιέκτης του να θεωρηθούν κατά τη διάθεσή τους επικίνδυνα απόβλητα.EN: This material and its container must be disposed of as hazardous waste.FR: Éliminer le produit et son récipient comme un déchet dangereux.IT: Questo materiale e il suo contenitore devono essere smaltiti come rifiuti pericolosi.LV: Apglabāt šo vielu (produktu) un tās iepakojumu kā bīstamos atkritumus.LT: Šios medžiagos atliekos ir jos pakuotė turi būti šalinamos kaip pavojingos atliekos.HU: Az anyagot és/vagy edényzetét veszélyes hulladékként kell ártalmatlanítani.MT: Dan il-materjal u l-kontenitur tiegħu għandhom jintremew ma’ skart perikoluż.NL: Deze stof en de verpakking als gevaarlijk afval afvoeren.PL: Produkt i opakowanie usuwać jako odpad niebezpieczny.PT: Este produto e o seu recipiente devem ser eliminados como resíduos perigosos.RO: Acest produs şi ambalajul său se vor depozita ca un deşeu periculos.SK: Tento materiál a príslušná nádoba musia byť zlikvidované ako nebezpečný odpad.SL: Snov/pripravek in embalažo odstraniti kot nevarni odpadek.FI: Tämä aine ja sen pakkaus on käsiteltävä ongelmajätteenä.SV: Detta material och dess behållare skall tas om hand som farligt avfall.S61BG: Да не се допуска изпускане в околната среда. Вижте специалните инструкции/информационния лист за безопасност.ES: Evítese su liberación al medio ambiente. Recábense instrucciones específicas de la ficha de datos de seguridad.CS: Zabraňte uvolnění do životního prostředí. Viz speciální pokyny nebo bezpečnostní listy.DA: Undgå udledning til miljøet. Se særlig vejledning/leverandørbrugsanvisning.DE: Freisetzung in die Umwelt vermeiden. Besondere Anweisungen einholen/Sicherheitsdatenblatt zu Rate ziehen.ET: Vältida kemikaali sattumist keskkonda. Tutvuda erinõuetega/ohutuskaardiga.EL: Αποφύγετε την ελευθέρωσή του στο περιβάλλον. Αναφερθείτε σε ειδικές οδηγίες/Δελτίο δεδομένων ασφαλείας.EN: Avoid release to the environment. Refer to special instructions/Safety data sheets.FR: Éviter le rejet dans l’environnement. Consulter les instructions spéciales/la fiche de données de sécurité.IT: Non disperdere nell’ambiente. Riferirsi alle istruzioni speciali/ schede informative in materia di sicurezza.LV: Nepieļaut nokļūšanu vidē. Ievērot īpašos norādījumus vai izmantot drošības datu lapas.LT: Vengti patekimo į aplinką. Naudotis specialiomis instrukcijomis (saugos duomenų lapais).HU: Kerülni kell az anyag környezetbe jutását. Lásd a külön használati utasítást/biztonsági adatlapot.MT: Titfax fl-ambjent. Irreferi għall-istruzzjonijiet speċjali/informazzjoni fuq sigurtà.NL: Voorkom lozing in het milieu. Vraag om speciale instructies/veiligheidskaart.PL: Unikać zrzutów do środowiska. Postępować zgodnie z instrukcją lub kartą charakterystyki.PT: Evitar a libertação para o ambiente. Obter instruções específicas/fichas de segurança.RO: A se evita aruncarea în mediul înconjurător. A se consulta instrucţiunile speciale/fişa de securitate.SK: Zabráňte uvoľneniu do životného prostredia. Oboznámte sa so špeciálnymi inštrukciami, kartou bezpečnostných údajov.SL: Ne izpuščati/odlagati v okolje. Upoštevati posebna navodila/varnostni list.FI: Vältettävä päästämistä ympäristöön. Lue erityisohjeet/käyttöturvallisuustiedote.SV: Undvik utsläpp till miljön. Läs särskilda instruktioner/varuinformationsblad.S62BG: При поглъщане да не се предизвиква повръщане: незабавно да се потърси медицинска помощ и да се покаже тази опаковка или етикета.ES: En caso de ingestión no provocar el vómito: acúdase inmediatamente al médico y muéstresele la etiqueta o el envase.CS: Při požití nevyvolávejte zvracení: okamžitě vyhledejte lékařskou pomoc a ukažte tento obal nebo označení.DA: Ved indtagelse, undgå at fremprovokere opkastning: kontakt omgåænde læge og vis denne beholder eller etiket.DE: Bei Verschlucken kein Erbrechen herbeiführen. Sofort ärztlichen Rat einholen und Verpackung oder dieses Etikett vorzeigen.ET: Kemikaali allaneelamisel mitte esile kutsuda oksendamist, pöörduda viivitamatult arsti poole ja näidata talle pakendit või etiketti.EL: Σε περίπτωση κατάποσης να μην προκληθεί εμετός: ζητήστε αμέσως ιατρική συμβουλή και δείξτε αυτό το δοχείο η την ετικέτα του.EN: If swallowed, do not induce vomiting: seek medical advice immediately and show this container or label.FR: En cas d’ingestion, ne pas faire vomir. Consulter immédiatement un médecin et lui montrer l’emballage ou l’étiquette.IT: In caso di ingestione non provocare il vomito: consultare immediatamente il medico e mostrargli il contenitore o l’etichetta.LV: Ja norīts, neizraisīt vemšanu, nekavējoties meklēt medicīnisko palīdzību un uzrādīt iepakojumu vai tā marķējumu.LT: Prarijus, neskatinti vėmimo, nedelsiant kreiptis į gydytoją ir parodyti jam šią pakuotę arba etiketę.HU: Lenyelés esetén hánytatni tilos: azonnal orvoshoz kell fordulni és meg kell mutatni az edényzetet vagy a címkét.MT: Jekk jinbela’, tippruvax tikkaġuna l-vomitu; mur għand tabib u uri dan il-kontenitur jew it- tikketta.NL: Bij inslikken niet het braken opwekken; direct een arts raadplegen en de verpakking of het etiket tonen.PL: W razie połknięcia nie wywoływać wymiotów, niezwłocznie zasięgnąć porady lekarza i pokazać opakowanie lub etykietę.PT: Em caso de ingestão, não provocar o vómito. Consultar imediatamente um médico e mostrar-lhe a embalagem ou o rótulo.RO: În caz de înghiţire, a nu se provoca voma: a se consulta imediat un medic şi a i se arăta ambalajul sau eticheta.SK: Pri požití nevyvolávať zvracanie; okamžite vyhľadajte lekársku pomoc a ukážte tento obal alebo označenie.SL: Po zaužitju ne izzivati bruhanja: takoj poiskati zdravniško pomoč in pokazati embalažo ali etiketo.FI: Jos kemikaalia on nielty, ei saa oksennuttaa: hakeuduttava välittömästi lääkärin hoitoon ja näytettävä tämä pakkaus tai etiketti.SV: Vid förtäring, framkalla ej kräkning. Kontakta genast läkare och visa denna förpackning eller etiketten.S63BG: В случай на злополука при вдишване пострадалият да се изнесе на чист въздух и да се остави в покой.ES: En caso de accidente por inhalación, alejar a la víctima de la zona contaminada y mantenerla en reposo.CS: V případě nehody při vdechnutí přeneste postiženého na čerstvý vzduch a ponechte jej v klidu.DA: Ved ulykkestilfælde ved indånding bringes tilskadekomne ud i frisk luft og holdes i ro.DE: Bei Unfall durch Einatmen: Verunfallten an die frische Luft bringen und ruhigstellen.ET: Kemikaali sissehingamisest tingitud õnnetuse puhul: viia kannatanu värske õhu kätte ja asetada pikali.EL: Σε περίπτωση ατυχήματος λόγω εισπονής: απομακρύνετε το θύμα από το μολυσμένο χώρο και αφήστε το να ηρεμήσει.EN: In case of accident by inhalation: remove casualty to fresh air and keep at rest.FR: En cas d’accident par inhalation, transporter la victime hors de la zone contaminée et la garder au repos.IT: In caso di incidente per inalazione, allontanare l’infortunato dalla zona contaminata e mantenerlo a riposo.LV: Ja ieelpots, pārvietot cietušo svaigā gaisā un noguldīt.LT: Įkvėpusį ir dėl to blogai pasijutusį nukentėjusįjį išvesti į gryną orą ir jo netrikdyti.HU: Belégzés miatt bekövetkező baleset esetén a sérültet friss levegőre kell vinni és biztosítani kell számára a nyugalmat.MT: F’każ ta’ inċident ikkaġunat mix-xamm: ħu l-pazjent fl-arja friska u qiegħdu jistrieħ.NL: Bij een ongeval door inademing: slachtoffer in de frisse lucht brengen en laten rusten.PL: W przypadku zatrucia drogą oddechową wyprowadzić lub wynieść poszkodowanego na świeże powietrze i zapewnić warunki do odpoczynku.PT: Em caso de inalação acidental, remover a vítima da zona contaminada e mantê-la em repouso.RO: În caz de accident prin inhalare, se transportă victima în afara zonei contaminate şi se lasă în stare de repaus.SK: Pri úraze spôsobenom vdýchnutím látky postihnutého vyveďte na čerstvý vzduch a zabezpečte mu kľud.SL: V primeru nezgode pri vdihavanju: prizadeto osebo umakniti na svež zrak in pustiti počivati.FI: Jos ainetta on onnettomuuden sattuessa hengitetty: siirrä henkilö raittiiseen ilmaan ja pidä hänet levossa.SV: Vid olycksfall via inandning, flytta den drabbade till frisk luft och låt vila.S64BG: При поглъщане устата да се изплакне с вода (но само ако пострадалият е в съзнание).ES: En caso de ingestión, enjuáguese la boca con agua (solamente si la persona está consciente).CS: Při požití vypláchněte ústa velkým množstvím vody (pouze je-li postižený při vědomí).DA: Ved indtagelse, skyl munden med vand (kun hvis personen er ved bevidsthed).DE: Bei Verschlucken Mund mit Wasser ausspülen (nur wenn Verunfallter bei Bewusstsein ist).ET: Allaneelamisel loputada suud veega (ainult juhul, kui isik on teadvusel).EL: Σε περίπτωση κατάποσης, ξεπλύνετε το στόμα με νερό (μόνο εφόσον το θύμα διατηρεί τις αισθήσεις του).EN: If swallowed, rinse mouth with water (only if the person is conscious).FR: En cas d’ingestion, rincer la bouche avec de l’eau (seulement si la personne est consciente).IT: In caso di ingestione, sciacquare la bocca con acqua (solamente se l’infortunato è cosciente).LV: Ja norīts, izskalot muti ar ūdeni (ja cietušais ir pie samaņas).LT: Prarijus, praskalauti burną vandeniu (jei nukentėjusysis turi sąmonę).HU: Lenyelés esetén a szájat vízzel ki kell öblíteni (csak abban az esetben ha a sérült nem eszméletlen).MT: Jekk jinbela’, laħlaħ il-ħalq bl-ilma (iżda biss jekk il-persuna tkun f’sensiha).NL: Bij inslikken, mond met water spoelen (alleen als de persoon bij bewustzijn is).PL: W przypadku połknięcia wypłukać usta wodą — nigdy nie stosować u osób nieprzytomnych.PT: Em caso de ingestão, lavar repetidamente a boca com água (apenas se a vítima estiver consciente).RO: În caz de înghiţire, se clăteşte gura cu apă (numai dacă persoana este conştientă).SK: Pri požití vypláchnite ústa vodou (iba ak je postihnutý pri vedomí).SL: Pri zaužitju spirati usta z vodo (samo če je oseba pri zavesti).FI: Jos ainetta on nielty, huuhtele suu vedellä (vain jos henkilö on tajuissaan).SV: Vid förtäring, skölj munnen med vatten (endast om personen är vid medvetande).Комбинирани S-фразиCombinación de frases-SKombinace S-větKombination af S-sætningerKombination der S-SätzeS ühendohutuslausedΣυνδυασμός των S- φράσεωνCombination of S-phrasesCombinaison des phrases SCombinazioni delle frasi SS frāžu kombinācijaS frazių derinysÖsszetett S-mondatokTaħlita ta’ frażijiet SCombinatie van S-zinnenŁączone zwroty SCombinação das frases SCombinaţii de fraze SKombinácie S-vietSestavljeni stavki SYhdistetyt S-lausekkeetSammansatta S-fraserS1/2BG: Да се съхранява под ключ и далече от достъп на деца.ES: Consérvese bajo llave y manténgase fuera del alcance de los niños.CS: Uchovávejte uzamčené a mimo dosah dětí.DA: Opbevares under lås og utilgængeligt for børn.DE: Unter Verschluss und für Kinder unzugänglich aufbewahren.ET: Hoida lukustatult ja lastele kättesaamatus kohas.EL: Φυλάξτε το κλειδωμένο και μακριά από παιδιά.EN: Keep locked up and out of the reach of children.FR: Conserver sous clef et hors de portée des enfants.IT: Conservare sotto chiave e fuori della portata dei bambini.LV: Turēt noslēgtu un sargāt no bērniem.LT: Laikyti užrakintą vaikams neprieinamoje vietoje.HU: Elzárva és gyermekek számára hozzáférhetetlen helyen tartandó.MT: Żomm maqful u fejn ma jilħqux it-tfal.NL: Achter slot en buiten bereik van kinderen bewaren.PL: Przechowywać pod zamknięciem i chronić przed dziećmi.PT: Guardar fechado à chave e fora do alcance das crianças.RO: Păstraţi încuiat şi nu lăsaţi la îndemâna copiilor.SK: Uchovávajte uzamknutý a mimo dosahu detí.SL: Hraniti zaklenjeno in izven dosega otrok.FI: Säilytettävä lukitussa tilassa ja lasten ulottumattomissa.SV: Förvaras i låst utrymme och oåtkomligt för barn.S3/7BG: Съдът да се съхранява плътно затворен на хладно място.ES: Consérvese el recipiente bien cerrado y en lugar fresco.CS: Uchovávejte obal těsně uzavřený na chladném místě.DA: Emballagen opbevares tæt lukket på et køligt sted.DE: Behälter dicht geschlossen halten und an einem kühlen Ort aufbewahren.ET: Hoida pakend tihedalt suletuna jahedas kohas.EL: Διατηρείστε το δοχείο ερμητικά κλεισμένο σε δροσερό μέρος.EN: Keep container tightly closed in a cool place.FR: Conserver le récipient bien fermé dans un endroit frais.IT: Tenere il recipiente ben chiuso in luogo fresco.LV: Uzglabāt cieši noslēgtu vēsā vietā.LT: Pakuotę laikyti sandariai uždarytą vėsioje vietoje.HU: Az edényzet jól lezárva, hűvös helyen tartandó.MT: Żomm il-kontenitur magħluq tajjeb f’post frisk.NL: Gesloten verpakking op een koele plaats bewaren.PL: Przechowywać pojemnik szczelnie zamknięty w chłodnym miejscu.PT: Conservar em recipiente bem fechado em lugar fresco.RO: Păstraţi ambalajul închis ermetic, într-un loc răcoros.SK: Uchovávajte nádobu tesne uzavretú na chladnom mieste.SL: Hraniti v tesno zaprti posodi na hladnem.FI: Säilytettävä tiivisti suljettuna viileässä paikassa.SV: Förpackningen förvaras väl tillsluten och svalt.S3/9/14BG: Да се съхранява на хладно и добре проветриво място, далече от … (несъвместимите материали се посочват от производителя).ES: Consérvese en lugar fresco y bien ventilado y lejos de … (materiales incompatibles, a especificar por el fabricante).CS: Uchovávejte na chladném, dobře větraném místě odděleně od … (vzájemně se vylučující látky uvede výrobce).DA: Opbevares køligt, godt ventileret og adskilt fra … (uforligelige stoffer angives af fabrikanten).DE: An einem kühlen, gut gelüfteten Ort, entfernt von … aufbewahren (die Stoffe, mit denen Kontakt vermieden werden muss, sind vom Hersteller anzugeben).ET: Hoida jahedas hästi ventileeritavas kohas eraldi … (kokkusobimatud kemikaalid määrab valmistaja).EL: Διατηρείται σε δροσερό και καλά αεριζόμενο μέρος μακριά από … (ασύμβατα υλικά που υποδεικνύονται από τον παραγωγό).EN: Keep in a cool, well-ventilated place away from … (incompatible materials to be indicated by the manufacturer).FR: Conserver dans un endroit frais et bien ventilé à l’écart des … (matières incompatibles à indiquer par le fabricant).IT: Conservare in luogo fresco e ben ventilato lontano da … (materiali incompatibili da precisare da parte del fabbricante).LV: Uzglabāt vēsā, labi vēdināmā vietā, bet ne kopā ar … (ražotājs norāda nesavietojamās vielas).LT: Pakuotę laikyti vėsioje, gerai vėdinamoje vietoje atokiau nuo … (nesuderinamas medžiagas nurodo gamintojas).HU: Hűvös, jól szellőztetett helyen, …-tól/-től távol tartandó (az összeférhetetlen anyag(oka)t a gyártó határozza meg).MT: Żomm f’post frisk u vventilat tajjeb ‘il bogħod minn … (materjali li ma jaqblux miegħu jkunu indikati mill-manifattur).NL: Bewaren op een koele, goed geventileerde plaats verwijderd van … (stoffen waarmee contact vermeden dient te worden, aan te geven door de fabrikant).PL: Przechowywać w chłodnym, dobrze wentylowanym miejscu, z dala od … (materiału wskazanego przez producenta).PT: Conservar em lugar fresco e bem ventilado ao abrigo de … (matérias incompatíveis a indicar pelo produtor).RO: Păstraţi într-un loc răcoros, bine ventilat departe de … (materialele incompatibile vor fi indicate de fabricant).SK: Uchovávajte na chladnom, dobre vetranom mieste mimo dosahu … (inkompatibilný materiál bude určený výrobcom).SL: Hraniti na hladnem, dobro prezračevanem mestu, ločeno od … (nezdružljive snovi določi proizvajalec).FI: Säilytettävä erillään … (yhteensopimattomat aineet ilmoittaa valmistaja/maahantuoja) viileässä paikassa, jossa on hyvä ilmanvaihto.SV: Förvaras svalt, på väl ventilerad plats åtskilt från … (oförenliga ämnen anges av tillverkaren).S3/9/14/49BG: Да се съхранява само в оригиналната опаковка на хладно и добре проветриво място, далече от … (несъвместимите материали се посочват от производителя).ES: Consérvese únicamente en el recipiente de origen, en lugar fresco y bien ventilado y lejos de … (materiales incompatibles, a especificar por el fabricante).CS: Uchovávejte pouze v původním obalu na chladném, dobře větraném místě, odděleně od … (vzájemně se vylučující látky uvede výrobce).DA: Må kun opbevares i originalemballagen på et køligt, godt ventileret sted og adskilt fra … (uforligelige stoffer angives af fabrikanten).DE: Nur im Originalbehälter an einem kühlen, gut gelüfteten Ort, entfernt von … aufbewahren (die Stoffe, mit denen Kontakt vermieden werden muss, sind vom Hersteller anzugeben).ET: Hoida ainult originaalpakendis jahedas, hästi ventileeritavas kohas eraldi … (kokkusobimatud kemikaalid määrab valmistaja).EL: Διατηρείται μόνο μέσα στο αρχικό δοχείο σε δροσερό και καλά αεριζόμενο μέρος μακριά από … (ασύμβατα υλικά που υποδεικνύονται από τον παραγωγό).EN: Keep only in the original container in a cool, well-ventilated place away from … (incompatible materials to be indicated by the manufacturer).FR: Conserver uniquement dans le récipient d’origine dans un endroit frais et bien ventilé à l’écart de … (matières incompatibles à indiquer par le fabricant).IT: Conservare soltanto nel contenitore originale in luogo fresco e ben ventilato lontano da … (materiali incompatibili da precisare da parte del fabbricante).LV: Uzglabāt tikai oriģinālajā iepakojumā vēsā, labi vēdināmā vietā, bet ne kopā ar … (ražotājs norāda nesavietojamās vielas).LT: Laikyti tik gamintojo pakuotėje, vėsioje, gerai vėdinamoje vietoje atokiau nuo … (nesuderinamas medžiagas nurodo gamintojas).HU: Hűvös, jól szellőztetett helyen, …-tól/-től távol, csak az eredeti edényzetben tárolható (az összeférhetetlen anyag(oka)t a gyártó határozza meg).MT: Żomm biss fil-kontenitur oriġinali f’post frisk u vventilat tajjeb ‘il bogħod minn …(materjali li ma jaqblux miegħu jkunu indikati mill-manifattur).NL: Uitsluitend in de oorspronkelijke verpakking bewaren op een koele, goed geventileerde plaats verwijderd van … (stoffen waarmee contact vermeden dient te worden, aan te geven door de fabrikant).PL: Przechowywać wyłącznie w oryginalnym opakowaniu, w chłodnym, dobrze wentylowanym miejscu; nie przechowywać razem z … (materiałami wskazanymi przez producenta).PT: Conservar unicamente no recipiente de origem, em lugar fresco e bem ventilado ao abrigo de … (matérias incompatíveis a indicar pelo produtor).RO: Păstraţi numai în ambalajul original, într-un loc răcoros, bine ventilat, departe de… (materialele incompatibile vor fi indicate de fabricant).SK: Uchovávajte len v pôvodnej nádobe na chladnom, dobre vetranom mieste, mimo dosahu … (inkompatibilný materiál bude určený výrobcom).SL: Hraniti samo v izvirni posodi, na hladnem, dobro prezračevanem mestu, ločeno od … (nezdružljive snovi določi proizvajalec).FI: Säilytettävä alkuperäispakkauksessa viileässä paikassa, jossa on hyvä ilmanvaihto erillään … (yhteensopimattomat aineet ilmoittaa valmistaja/maahantuoja).SV: Förvaras endast i originalförpackningen på sval, väl ventilerad plats åtskilt från … (oförenliga ämnen anges av tillverkaren).S3/9/49BG: Да се съхранява само в оригиналната опаковка на хладно и добре проветриво място.ES: Consérvese únicamente en el recipiente de origen, en lugar fresco y bien ventilado.CS: Uchovávejte pouze v původním obalu na chladném, dobře větraném místě.DA: Må kun opbevares i originalemballagen på et køligt, godt ventileret sted.DE: Nur im Originalbehälter an einem kühlen, gut gelüfteten Ort aufbewahren.ET: Hoida ainult originaalpakendis jahedas, hästi ventileeritavas kohas.EL: Διατηρείται μόνο μέσα στο αρχικό δοχείο σε δροσερό και καλά αεριζόμενο μέρος.EN: Keep only in the original container in a cool, well-ventilated place.FR: Conserver uniquement dans le récipient d’origine dans un endroit frais et bien ventilé.IT: Conservare soltanto nel contenitore originale in luogo fresco e ben ventilato.LV: Uzglabāt tikai oriģinālajā iepakojumā vēsā, labi vēdināmā vietā.LT: Laikyti tik gamintojo pakuotėje, vėsioje, gerai vėdinamoje vietoje.HU: Hűvös, jól szellőztetett helyen, csak az eredeti edényzetben tárolható.MT: Żomm biss fil-kontenitur oriġinali f’post frisk u vventilat tajjeb.NL: Uitsluitend in de oorspronkelijke verpakking bewaren op een koele, goed geventileerde plaats.PL: Przechowywać wyłącznie w oryginalnym opakowaniu w chłodnym, dobrze wentylowanym miejscu.PT: Conservar unicamente no recipiente de origem, em lugar fresco e bem ventilado.RO: Păstraţi numai în ambalajul original, într-un loc răcoros, bine ventilat.SK: Uchovávajte len v pôvodnej nádobe na chladnom, dobre vetranom mieste.SL: Hraniti samo v izvirni posodi na hladnem in dobro prezračevanem mestu.FI: Säilytettävä alkuperäispakkauksessa viileässä paikassa, jossa on hyvä ilmanvaihto.SV: Förvaras endast i originalförpackningen på sval, väl ventilerad plats.S3/14BG: Да се съхранява на хладно място, далече от … (несъвместимите материали се посочват от производителя).ES: Consérvese en lugar fresco y lejos de … (materiales incompatibles, a especificar por el fabricante).CS: Uchovávejte na chladném místě, odděleně od … (vzájemně se vylučující látky uvede výrobce).DA: Opbevares køligt og adskilt fra … (uforligelige stoffer angives af fabrikanten).DE: An einem kühlen, von … entfernten Ort aufbewahren (die Stoffe, mit denen Kontakt vermieden werden muss, sind vom Hersteller anzugeben).ET: Hoida jahedas, eraldi … (kokkusobimatud kemikaalid määrab valmistaja).EL: Διατηρείται σε δροσερό μέρος μακριά από … (ασύμβατα υλικά που υποδεικνύονται από τον παραγωγό).EN: Keep in a cool place away from … (incompatible materials to be indicated by the manufacturer).FR: Conserver dans un endroit frais à l’écart des … (matières incompatibles à indiquer par le fabricant).IT: Conservare in luogo fresco lontano da … (materiali incompatibili da precisare da parte del fabbricante).LV: Uzglabāt vēsā vietā, bet ne kopā ar … (ražotājs norāda nesavietojamās vielas).LT: Laikyti vėsioje vietoje atokiau nuo … (nesuderinamas medžiagas nurodo gamintojas).HU: Hűvös helyen, …-tól/-től távol tartandó (az összeférhetetlen anyag(oka)t a gyártó határozza meg).MT: Żomm f’post frisk ‘il bogħod minn … (materjali li ma jaqblux miegħu ikunu indikati mill-manifattur).NL: Bewaren op een koele plaats verwijderd van … (stoffen waarmee contact vermeden dient te worden, aan te geven door de fabrikant).PL: Przechowywać w chłodnym miejscu; nie przechowywać razem z … (materiałami wskazanymi przez producenta).PT: Conservar em lugar fresco ao abrigo de … (matérias incompatíveis a indicar pelo produtor).RO: Păstraţi într-un loc răcoros, departe de… (materialele incompatibile vor fi indicate de fabricant).SK: Uchovávajte na chladnom mieste mimo dosahu … (inkompatibilný materiál bude určený výrobcom).SL: Hraniti na hladnem, ločeno od … (nezdružljive snovi določi proizvajalec).FI: Säilytettävä viileässä erillään … (yhteensopimattomat aineet ilmoittaa valmistaja/maahantuoja).SV: Förvaras svalt och åtskilt från … (oförenliga ämnen anges av tillverkaren).S7/8BG: Съдът да се съхранява плътно затворен и на сухо място.ES: Manténgase el recipiente bien cerrado y en lugar seco.CS: Uchovávejte obal těsně uzavřený a suchý.DA: Emballagen skal holdes tæt lukket og opbevares tørt.DE: Behälter trocken und dicht geschlossen halten.ET: Hoida pakend tihedalt suletuna ja kuivana.EL: Το δοχείο να διατηρείται ερμητικά κλεισμένο και να προστατεύεται από την υγρασία.EN: Keep container tightly closed and dry.FR: Conserver le récipient bien fermé et à l’abri de l’humidité.IT: Conservare il recipiente ben chiuso e al riparo dall’umidità.LV: Uzglabāt sausu un cieši noslēgtu.LT: Pakuotę laikyti sandariai uždarytą ir sausoje vietoje.HU: Az edényzet légmentesen lezárva, szárazon tartandó.MT: Żomm il-kontenitur magħluq tajjeb u xott.NL: Droog houden en in een goed gesloten verpakking bewaren.PL: Przechowywać pojemnik szczelnie zamknięty w suchym pomieszczeniu.PT: Conservar o recipiente bem fechado e ao abrigo da humidade.RO: Păstraţi ambalajul închis ermetic şi uscat (ferit de umiditate).SK: Uchovávajte nádobu tesne uzavretú a suchú.SL: Hraniti v tesno zaprti posodi na suhem.FI: Säilytettävä kuivana ja tiiviisti suljettuna.SV: Förpackningen förvaras väl tillsluten och torrt.S7/9BG: Съдът да се съхранява плътно затворен и на добре проветриво място.ES: Manténgase el recipiente bien cerrado y en lugar bien ventilado.CS: Uchovávejte obal těsně uzavřený, na dobře větraném místě.DA: Emballagen skal holdes tæt lukket og opbevares på et godt ventileret sted.DE: Behälter dicht geschlossen an einem gut gelüfteten Ort aufbewahren.ET: Hoida pakend tihedalt suletuna hästi ventileeritavas kohas.EL: Το δοχείο να διατηρείται ερμητικά κλεισμένο και σε καλά αεριζόμενο μέρος.EN: Keep container tightly closed and in a well-ventilated place.FR: Conserver le récipient bien fermé et dans un endroit bien ventilé.IT: Tenere il recipiente ben chiuso e in luogo ben ventilato.LV: Uzglabāt cieši noslēgtu labi vēdināmā vietā.LT: Pakuotę laikyti sandariai uždarytą, gerai vėdinamoje vietoje.HU: Az edényzet légmentesen lezárva és jól szellőztetett helyen tartandó.MT: Żomm il-kontenitur magħluq tajjeb u f’post ivventilat tajjeb.NL: Gesloten verpakking op een goed geventileerde plaats bewaren.PL: Przechowywać pojemnik szczelnie zamknięty w miejscu dobrze wentylowanym.PT: Manter o recipiente bem fechado em local bem ventilado.RO: Păstraţi ambalajul închis ermetic şi într-un loc bine ventilat.SK: Uchovávajte nádobu tesne uzavretú a na dobre vetranom mieste.SL: Hraniti v tesno zaprti posodi ne dobro prezračevanem mestu.FI: Säilytettävä tiiviisti suljettuna paikassa, jossa on hyvä ilmanvaihto.SV: Förpackningen förvaras väl tillsluten på väl ventilerad plats.S7/47BG: Съдът да се съхранява плътно затворен и при температура не по-висока от …oC (посочва се от производителя).ES: Manténgase el recipiente bien cerrado y consérvese a una temperatura no superior a … C (a especificar por el fabricante).CS: Uchovávejte obal těsně uzavřený, při teplotě nepřesahující …oC (specifikuje výrobce).DA: Emballagen skal holdes tæt lukket og opbevares ved temperaturer på ikke over …oC (angives af fabrikanten).DE: Behälter dicht geschlossen und nicht bei Temperaturen über …oC aufbewahren (vom Hersteller anzugeben).ET: Hoida pakend tihedalt suletuna temperatuuril mitte üle …oC (määrab valmistaja).EL: Διατηρείστε το δοχείο καλά κλεισμένο σε θερμοκρασία που δεν υπερβαίνει τους … C (να καθοριστεί από τον παραγωγό).EN: Keep container tightly closed and at a temperature not exceeding …oC (to be specified by the manufacturer).FR: Conserver le récipient bien fermé et à une température ne dépassant pas …oC (à préciser par le fabricant).IT: Tenere il recipiente ben chiuso e a temperatura non superiore a …oC (da precisare da parte del fabbricante).LV: Uzglabāt cieši noslēgtu temperatūrā, kas nepārsniedz …oC (norāda ražotājs).LT: Pakuotę laikyti sandariai uždarytą, ne aukštesnėje negu …oC temperatūroje (nurodo gamintojas).HU: Az edényzet légmentesen lezárva ……oC-ot nem meghaladó hőmérsékleten tárolható (a hőmérsékletet a gyártó határozza meg).MT: Żomm il-kontenitur magħluq tajjeb u f’temperatura li ma taqbiżx …oC (tkun speċifikata mill-manifattur).NL: Gesloten verpakking bewaren bij een temperatuur beneden …oC. (aan te geven door de fabrikant).PL: Przechowywać pojemnik szczelnie zamknięty w temperaturze nieprzekraczającej …oC (określi producent).PT: Manter o recipiente bem fechado e conservar a uma temperatura que não exceda …oC (a especificar pelo produtor).RO: Păstraţi ambalajul închis ermetic şi la o temperatură care să nu depăşească …oC (temperatura va fi indicata de fabricant).SK: Uchovávajte nádobu tesne uzavretú a pri teplote nepresahujúcej ….oC (teplota bude špecifikovaná výrobcom).SL: Hraniti v tesno zaprti posodi pri temperaturi, ki ne presega …oC (temperaturo določi proizvajalec).FI: Säilytettävä tiiviisti suljettuna ja alle …oC lämpötilassa (valmistaja/maahantuoja ilmoittaa lämpötilan).SV: Förpackningen förvaras väl tillsluten vid en temperatur som inte överstiger …oC (anges av tillverkaren).S20/21BG: По време на работа да не се яде, пие и пуши.ES: No comer, ni beber, ni fumar durante su utilización.CS: Nejezte, nepijte a nekuřte při používání.DA: Der må ikke spises, drikkes eller ryges under brugen.DE: Bei der Arbeit nicht essen, trinken, rauchen.ET: Käitlemise ajal söömine, joomine ja suitsetamine keelatud.EL: Όταν το χρησιμοποιείτε μην τρώτε, μην πίνετε, μην καπνίζετε.EN: When using do not eat, drink or smoke.FR: Ne pas manger, ne pas boire et ne pas fumer pendant l’utilisation.IT: Non mangiare, né bere, né fumare durante l’impiego.LV: Nedzert, neēst un nesmēķēt, darbojoties ar vielu.LT: Naudojant nevalgyti, negerti ir nerūkyti.HU: A használat közben enni, inni és dohányozni nem szabad.MT: Meta tużah tikolx, tixrobx u tpejjipx.NL: Niet eten, drinken of roken tijdens gebruik.PL: Nie jeść i nie pić oraz nie palić tytoniu podczas stosowania produktu.PT: Não comer, beber ou fumar durante a utilização.RO: Nu mâncaţi, nu beţi şi nu fumaţi în timpul folosirii.SK: Pri používaní nejedzte, nepite ani nefajčite.SL: Med uporabo ne jesti, ne piti in ne kaditi.FI: Syöminen, juominen ja tupakointi kielletty kemikaalia käytettäessä.SV: Ät inte, drick inte eller rök inte under hanteringen.S24/25BG: Да се избягва контакт с очите и кожата.ES: Evítese el contacto con los ojos y la piel.CS: Zamezte styku s kůží a očima.DA: Undgå kontakt med huden og øjnene.DE: Berührung mit den Augen und der Haut vermeiden.ET: Vältida kemikaali sattumist nahale ja silma.EL: Αποφεύγετε επαφή με το δέρμα και με τα μάτια.EN: Avoid contact with skin and eyes.FR: Éviter le contact avec la peau et les yeux.IT: Evitare il contatto con gli occhi e con la pelle.LV: Nepieļaut nokļūšanu uz ādas un acīs.LT: Vengti patekimo ant odos ir į akis.HU: Kerülni kell a bőrrel való érintkezést és a szembe jutást.MT: Evita l-kuntatt mal-ġilda u l-għajnejn.NL: Aanraking met de ogen en de huid vermijden.PL: Unikać zanieczyszczenia skóry i oczu.PT: Evitar o contacto com a pele e os olhos.RO: Evitaţi contactul cu pielea şi ochii.SK: Zabráňte kontaktu s pokožkou a očami.SL: Preprečiti stik s kožo in očmi.FI: Varottava kemikaalin joutumista iholle ja silmiin.SV: Undvik kontakt med huden och ögonen.S27/28BG: След контакт с кожата, незабавно да се съблече цялото замърсено облекло и незабавно да се измие обилно с … (посочва се от производителя).ES: Después del contacto con la piel, quítese inmediatamente toda la ropa manchada o salpicada y lávese inmediata y abundantemente con … (productos a especificar por el fabricante).CS: Po styku s kůží okamžitě odložte veškeré kontaminované oblečení a kůži okamžitě omyjte velkým množstvím … (vhodnou kapalinu specifikuje výrobce).DA: Kommer stof på huden, tages tilsmudset tøj straks af og der vaskes med store mængder … (angives af fabrikanten).DE: Bei Berührung mit der Haut beschmutzte, getränkte Kleidung sofort ausziehen und Haut sofort abwaschen mit viel …(vom Hersteller anzugeben).ET: Nahale sattumisel võtta koheselt seljast saastunud riietus ja pesta koheselt rohke … (määrab valmistaja).EL: Σε περίπτωση επαφής με το δέρμα, αφαιρέστε αμέσως όλα τα μολυσμένα ρούχα και πλύνετε αμέσως με άφθονο … (το είδος του υγρού καθορίζεται από τον παραγωγό).EN: After contact with skin, take off immediately all contaminated clothing, and wash immediately with plenty of … (to be specified by the manufacturer).FR: Après contact avec la peau, enlever immédiatement tout vêtement souillé ou éclaboussé et se laver immédiatement et abondamment avec … (produits appropriés à indiquer par le fabricant).IT: In caso di contatto con la pelle, togliersi di dosso immediatamente gli indumenti contaminati e lavarsi immediatamente e abbondantemente con … (prodotti idonei da indicarsi da parte del fabbricante).LV: Ja nokļūst uz ādas, nekavējoties novilkt visu notraipīto apģērbu un skalot ar lielu daudzumu … (norāda ražotājs).LT: Patekus ant odos, nedelsiant nusivilkti visus užterštus drabužius ir gerai nuplauti … (kuo nurodo gamintojas).HU: Ha az anyag a bőrre jut, a szennyezett ruhát rögtön le kell vetni és a bőrt kellő mennyiségű ….- val/-vel azonnal le kell mosni (az anyagot a gyártó határozza meg).MT: Jekk imiss il-ġilda, inża’ mill-ewwel l-ilbies imniġġes kollu, u aħsel immedjatament b’ħafna … (ikun speċifikat mill-manifattur).NL: Na contact met de huid, alle besmette kleding onmiddellijk uittrekken en de huid onmiddellijk wassen met veel … (aan te geven door de fabrikant).PL: W przypadku zanieczyszczenia skóry natychmiast zdjąć całą zanieczyszczoną odzież i przemyć zanieczyszczoną skórę dużą ilością … (rodzaj cieczy określi producent).PT: Em caso de contacto com a pele, retirar imediatamente toda a roupa contaminada e lavar imediata e abundantemente com … (produto adequado a indicar pelo produtor).RO: După contactul cu pielea, scoateţi imediat toată îmbrăcămintea contaminată şi spălaţi imediat cu mult … (va fi indicat de fabricant).SK: Pri kontakte s pokožkou okamžite vyzlečte kontaminovaný odev a pokožku okamžite a dôkladne umyte … (vhodný prípravok uvedie výrobca).SL: Po stiku s kožo nemudoma sleči vso onesnaženo obleko in prizadeto kožo nemudoma izprati z veliko … (sredstvo določi proizvajalec).FI: Ihokosketuksen jälkeen, saastunut vaatetus on riisuttava välittömästi ja roiskeet huuhdeltava välittömästi runsaalla määrällä … (aineen ilmoittaa valmistaja/maahantuoja).SV: Vid kontakt med huden, tag genast av alla nedstänkta kläder och tvätta genast med mycket … (anges av tillverkaren).S29/35BG: Да не се изпуска в канализацията; този материал и неговата опаковка да се третират по безопасен начин.ES: No tirar los residuos por el desagüe; elimínense los residuos del producto y sus recipientes con todas las precauciones posibles.CS: Nevylévejte do kanalizace, tento materiál a jeho obal musí být zneškodněny bezpečným způsobem.DA: Må ikke tømmes i kloakafløb; materialet og dets beholder skal bortskaffes på en sikker måde.DE: Nicht in die Kanalisation gelangen lassen; Abfälle und Behälter müssen in gesicherter Weise beseitigt werden.ET: Mitte valada kanalisatsiooni, kemikaal ja pakend tuleb hävitada ohutult.EL: Μην αδειάζετε το υπόλοιπο του περιεχομένου στην αποχέτευση, διαθέστε αυτό το υλικό και τον περιέκτη του κατά ασφαλή τρόπο.EN: Do not empty into drains; dispose of this material and its container in a safe way.FR: Ne pas jeter les résidus à l’égout; ne se débarrasser de ce produit et de son récipient qu’en prenant toutes les précautions d’usage.IT: Non gettare i residui nelle fognature; non disfarsi del prodotto e del recipiente se non con le dovute precauzioni.LV: Vielu vai produktu aizliegts izliet kanalizācijā, iepakojums likvidējams drošā veidā.LT: Neišleisti į kanalizaciją; atliekos ir pakuotė turi būti saugiai pašalintos.HU: Csatornába engedni nem szabad. Az anyagot és edényzetét megfelelő módon ártalmatlanítani kell.MT: Tarmix fid- drenaġġ: armi l-materjal u l-kontenitur tiegħu b’mod li ma jagħmilx ħsara.NL: Afval niet in de gootsteen werpen; stof en verpakking op veilige wijze afvoeren.PL: Nie wprowadzać do kanalizacji, a produkt i opakowanie usuwać w sposób bezpieczny.PT: Não deitar os resíduos no esgoto; não eliminar o produto e o seu recipiente sem tomar as precauções de segurança devidas.RO: Nu goliţi la canalizare, aruncaţi acest produs şi ambalajul său numai după luarea tuturor măsurilor de precauţie posibile.SK: Nevypúšťajte do kanalizačnej siete; tento materiál aj s obalom zlikvidujte za dodržania obvyklých bezpečnostných opatrení.SL: Ne izprazniti v kanalizacijo; vsebina in embalaža morata biti varno odstranjeni.FI: Ei saa tyhjentää viemäriin; tämä aine ja sen pakkaus on hävitettävä turvallisesti.SV: Töm ej i avloppet, oskadliggör produkt och förpackning på säkert sätt.S29/56BG: Да не се изпуска в канализацията; този материал и опаковката му да се изхвърлят само на места за събиране на опасни или специални отпадъци.ES: No tirar los residuos por el desagüe; elimínese esta sustancia y su recipiente en un punto de recogida pública de residuos especiales o peligrosos.CS: Nevylévejte do kanalizace, zneškodněte tento materiál a jeho obal ve sběrném místě pro zvláštní nebo nebezpečné odpady.DA: Må ikke tømmes i kloakafløb, aflever dette materiale og dets beholder til et indsamlingssted for farligt affald og problemaffald.DE: Nicht in die Kanalisation gelangen lassen; dieses Produkt und seinen Behälter der Problemabfallentsorgung zuführen.ET: Mitte valada kanalisatsiooni. Kemikaal ja tema pakend tuleb viia ohtlike jäätmete kogumispunkti.EL: Μην αδειάζετε το υπόλοιπο του περιεχομένου στην αποχέτευση. Το υλικό αυτό και ο περιέκτης του να εναποτεθούν σε δημόσιο χώρο συλλογής επικινδύνων ή ειδικών αποβλήτων.EN: Do not empty into drains, dispose of this material and its container at hazardous or special waste collection point.FR: Ne pas jeter les résidus à l’égout, éliminer ce produit et son récipient dans un centre de collecte des déchets dangereux ou spéciaux.IT: Non gettare i residui nelle fognature; smaltire questo materiale e i relativi contenitori in un punto di raccolta rifiuti pericolosi o speciali.LV: Vielu vai produktu aizliegts izliet kanalizācijā, vielu, produktu vai iepakojumu likvidē bīstamo atkritumu savākšanas vietā vai īpašā atkritumu savākšanas vietā.LT: Neišleisti į kanalizaciją, šios medžiagos atliekas ir jos pakuotę išvežti į pavojingų atliekų surinkimo vietas.HU: Csatornába engedni nem szabad, az anyagot és edényzetét különleges hulladék- vagy veszélyeshulladék-gyűjtő helyre kell vinni.MT: Tarmix fid- drenaġġ: armi l-materjal u l-kontenitur tiegħu f’post fejn jinġabar skart perikoluż jew speċjali.NL: Afval niet in de gootsteen werpen; deze stof en de verpakking naar een inzamelpunt voor gevaarlijk of bijzonder afval brengen.PL: Nie wprowadzać do kanalizacji, a zużyty produkt i opakowanie dostarczyć na składowisko odpadów niebezpiecznych.PT: Não deitar os resíduos no esgoto, eliminar este produto e o seu recipiente, enviando-os para local autorizado para a recolha de resíduos perigosos ou especiais.RO: Nu goliţi la canalizare, depozitaţi acest produs şi ambalajul său la punctul de colectare a deşeurilor periculoase sau speciale.SK: Nevyprázdňujte do kanalizácie, zneškodnite tento materiál a jeho obal v mieste zberu nebezpečného alebo špeciálneho odpadu.SL: Ne izprazniti v kanalizacijo — snov/pripravek in embalažo predati odstranjevalcu nevarnih ali posebnih odpadkov.FI: Ei saa tyhjentää viemäriin; tämä aine ja sen pakkaus on toimitettava ongelmajätteen vastaanottopaikkaan.SV: Töm ej i avloppet, lämna detta material och dess behållare till insamlingsställe för farligt avfall.S36/37BG: Да се носи подходящо защитно облекло и ръкавици.ES: Úsense indumentaria y guantes de protección adecuados.CS: Používejte vhodný ochranný oděv a ochranné rukavice.DA: Brug særligt arbejdstøj og egnede beskyttelseshandsker.DE: Bei der Arbeit geeignete Schutzhandschuhe und Schutzkleidung tragen.ET: Kanda sobivat kaitseriietust ja –kindaid.EL: Φοράτε κατάλληλη προστατευτική ενδυμασία και γάντια.EN: Wear suitable protective clothing and gloves.FR: Porter un vêtement de protection et des gants appropriés.IT: Usare indumenti protettivi e guanti adatti.LV: Izmantot piemērotu aizsargapģērbu un aizsargcimdus.LT: Dėvėti tinkamus apsauginius drabužius ir mūvėti tinkamas pirštines.HU: Megfelelő védőruházatot és védőkesztyűt kell viselni.MT: Ilbes ilbies protettiv adatt u ingwanti.NL: Draag geschikte handschoenen en beschermende kleding.PL: Nosić odpowiednią odzież ochronną i odpowiednie rękawice ochronne.PT: Usar vestuário de protecção e luvas adequadas.RO: Purtaţi echipament de protecţie şi mănuşi corespunzătoare.SK: Noste vhodný ochranný odev a rukavice.SL: Nositi primerno zaščitno obleko in zaščitne rokavice.FI: Käytettävä sopivaa suojavaatetusta ja suojakäsineitä.SV: Använd lämpliga skyddskläder och skyddshandskar.S36/37/39BG: Да се носи подходящо защитно облекло, ръкавици и предпазни средства за очите/лицето.ES: Úsense indumentaria y guantes adecuados y protección para los ojos/la cara.CS: Používejte vhodný ochranný oděv, ochranné rukavice a ochranné brýle nebo obličejový štít.DA: Brug særligt arbejdstøj, egnede beskyttelseshandsker og -briller/ansigtsskærm.DE: Bei der Arbeit geeignete Schutzkleidung, Schutzhandschuhe und Schutzbrille/Gesichtsschutz tragen.ET: Kanda sobivat kaitseriietust, -kindaid ja silmade või näokaitset.EL: Φοράτε κατάλληλη προστατευτική ενδυμασία, γάντια και συσκευή προστασίας ματιών/προσώπου.EN: Wear suitable protective clothing, gloves and eye/face protection.FR: Porter un vêtement de protection approprié, des gants et un appareil de protection des yeux/du visage.IT: Usare indumenti protettivi e guanti adatti e proteggersi gli occhi/la faccia.LV: Izmantot piemērotu aizsargapģērbu, aizsargcimdus un acu vai sejas aizsargu.LT: Dėvėti tinkamus apsauginius drabužius, mūvėti tinkamas pirštines ir naudoti akių (veido) apsaugos priemones.HU: Megfelelő védőruházatot, védőkesztyűt és szem-/arcvédőt kell viselni.MT: Ilbes ilbies protettiv adatt, ingwanti u protezzjoni għall-għajnejn/wiċċ.NL: Draag geschikte beschermende kleding, handschoenen en een beschermingsmiddel voor de ogen/het gezicht.PL: Nosić odpowiednią odzież ochronną, odpowiednie rękawice ochronne i okulary lub ochronę twarzy.PT: Usar vestuário de protecção e equipamento protector para os olhos /face adequados.RO: Purtaţi echipament de protecţie corespunzător, mănuşi şi mască de protecţie pentru ochi/faţă.SK: Noste vhodný ochranný odev a ochranné prostriedky na oči/tvár.SL: Nositi primerno zaščitno obleko, zaščitne rokavice in zaščito za oči/obraz.FI: Käytettävä sopivaa suojavaatetusta ja silmien- tai kasvonsuojainta.SV: Använd lämpliga skyddskläder och skyddshandskar samt skyddsglasögon eller ansiktsskydd.S36/39BG: Да се носи подходящо защитно облекло и предпазни средства за очите/лицето.ES: Úsense indumentaria adecuada y protección para los ojos/la cara.CS: Používejte vhodný ochranný oděv a ochranné brýle nebo obličejový štít.DA: Brug særligt arbejdstøj og egnede beskyttelsesbriller/ansigtsskærm.DE: Bei der Arbeit geeignete Schutzkleidung und Schutzbrille/Gesichtsschutz tragen.ET: Kanda sobivat kaitseriietust ja silmade või näokaitset.EL: Φοράτε κατάλληλη προστατευτική ενδυμασία και συσκευή προστασίας ματιών/προσώπου.EN: Wear suitable protective clothing and eye/face protection.FR: Porter un vêtement de protection approprié et un appareil de protection des yeux/du visage.IT: Usare indumenti protettivi adatti e proteggersi gli occhi/la faccia.LV: Izmantot piemērotu aizsargapģērbu un acu vai sejas aizsargu.LT: Dėvėti tinkamus apsauginius drabužius ir naudoti akių (veido) apsaugos priemones.HU: Megfelelő védőruházatot és arc-/szemvédőt kell viselni.MT: Ilbes ilbies protettiv adatt u protezzjoni għall-għajnejn/wiċċ.NL: Draag geschikte beschermende kleding en een beschermingsmiddel voor de ogen/het gezicht.PL: Nosić odpowiednią odzież ochronną i okulary lub ochronę twarzy.PT: Usar vestuário de protecção e equipamento protector para os olhos /face adequados.RO: Purtaţi echipament de protecţie corespunzător şi mască de protecţie pentru ochi/faţă.SK: Noste vhodný ochranný odev a ochranné prostriedky na oči/tvár.SL: Nositi primerno zaščitno obleko in zaščito za oči/obraz.FI: Käytettävä sopivaa suojavaatetusta ja silmien- tai kasvonsuojainta.SV: Använd lämpliga skyddskläder samt skyddsglasögon eller ansiktsskydd.S37/39BG: Да се носят подходящи ръкавици и предпазни средства за очите/лицето.ES: Úsense guantes adecuados y protección para los ojos/la cara.CS: Používejte vhodné ochranné rukavice a ochranné brýle nebo obličejový štít.DA: Brug egnede beskyttelseshandsker og -briller/ansigtsskærm under arbejdet.DE: Bei der Arbeit geeignete Schutzhandschuhe und Schutzbrille/Gesichtsschutz tragen.ET: Kanda sobivaid kaitsekindaid ja silmade või näokaitset.EL: Φοράτε κατάλληλα γάντια και συσκευή προστασίας ματιών/προσώπου.EN: Wear suitable gloves and eye/face protection.FR: Porter des gants appropriés et un appareil de protection des yeux/du visage.IT: Usare guanti adatti e proteggersi gli occhi/la faccia.LV: Izmantot aizsargcimdus un acu vai sejas aizsargu.LT: Mūvėti tinkamas pirštines ir naudoti akių (veido) apsaugos priemones.HU: Megfelelő védőkesztyűt és szem-/arcvédőt kell viselni.MT: Ilbes ingwanti adatti u protezzjoni għall-għajnejn/wiċċ.NL: Draag geschikte handschoenen en een beschermingsmiddel voor de ogen/het gezicht.PL: Nosić odpowiednie rękawice ochronne i okulary lub ochronę twarzy.PT: Usar luvas e equipamento protector para os olhos /face adequados.RO: Purtaţi mănuşi corespunzătoare şi mască de protecţie pentru ochi/faţă.SK: Noste vhodné rukavice a ochranné prostriedky na oči a tvár.SL: Nositi primerne zaščitne rokavice in zaščito za oči/obraz.FI: Käytettävä sopivia suojakäsineitä ja silmien- tai kasvonsuojainta.SV: Använd lämpliga skyddshandskar samt skyddsglasögon eller ansiktsskydd.S47/49BG: Да се съхранява само в оригиналната опаковка при температура не по-висока от …oC (посочва се от производителя).ES: Consérvese únicamente en el recipiente de origen y a temperatura no superior a …oC (a especificar por el fabricante).CS: Uchovávejte pouze v původním obalu při teplotě nepřesahující …oC (specifikuje výrobce).DA: Må kun opbevares I originalemballagen ved en temperatur på ikke over …oC (angives af fabrikanten).DE: Nur im Originalbehälter bei einer Temperatur von nicht über …oC (vom Hersteller anzugeben) aufbewahren.ET: Hoida ainult originaalpakendis, temperatuuril mitte üle …oC (määrab valmistaja).EL: Διατηρείται μόνο μέσα στο αρχικό δοχείο σε θερμοκρασία που δεν υπερβαίνει τους …oC (καθορίζεται από τον παραγωγό).EN: Keep only in the original container at a temperature not exceeding …oC (to be specified by the manufacturer).FR: Conserver uniquement dans le récipient d’origine à une température ne dépassant pas …oC (à préciser par le fabricant).IT: Conservare soltanto nel contenitore originale a temperatura non superiore a …oC (da precisare da parte del fabbricante).LV: Uzglabāt tikai oriģinālajā iepakojumā temperatūrā, kas nepārsniedz ….oC (norāda ražotājs).LT: Laikyti tik gamintojo pakuotėje, ne aukštesnėje negu …oC temperatūroje (nurodo gamintojas).HU: Legfeljebb …oC hőmérsékleten, csak az eredeti edényzetben tárolható (a hőmérsékletet a gyártó határozza meg).MT: Żomm biss fil-kontenitur oriġinali f’temperatura li ma taqbiżx …oC (ikun speċifikat mill-manifattur).NL: Uitsluitend in de oorspronkelijke verpakking bewaren bij een temperatuur beneden …oC. (aan te geven door de fabrikant).PL: Przechowywać wyłącznie w oryginalnym opakowaniu w temperaturze nieprzekraczającej…oC (określi producent).PT: Conservar unicamente no recipiente de origem a temperatura que não exceda …oC (a especificar pelo produtor).RO: Păstraţi numai în ambalajul original la o temperatură ce nu depăşeşte…oC (temperatura va fi indicată de fabricant).SK: Uchovávajte len v pôvodnej nádobe pri teplote nepresahujúcej …oC (teplota bude špecifikovaná výrobcom).SL: Hraniti samo v izvirni posodi pri temperaturi, ki ne presega …oC (temperaturo določi proizvajalec).FI: Säilytettävä alkuperäispakkauksessa alle …oC lämpötilassa (valmistaja/maahantuoja ilmoittaa lämpötilan).SV: Förvaras endast i originalförpackningen vid en temperatur som inte överstiger …oC (anges av tillverkaren).’
			

Pending: 32006L0099

                                January 16, 2026                            

20.12.2006
EN
Official Journal of the European Union
L 363/137

(1)
Pursuant to Article 56 of the Act of Accession, where acts of the institutions remain valid beyond 1 January 2007, and require adaptation by reason of accession, and the necessary adaptations have not been provided for in the Act of Accession or its Annexes, the necessary acts are to be adopted by the Council, unless the Commission adopted the original act.

(2)
The Final Act of the Conference which drew up the Treaty of Accession indicated that the High Contracting Parties had reached political agreement on a set of adaptations to acts adopted by the institutions required by reason of accession and invited the Council and the Commission to adopt these adaptations before accession, completed and updated where necessary to take account of the evolution of the law of the Union.

(3)
Directives 68/151/EEC(2), 77/91/EEC(3), 78/660/EEC(4), 78/855/EEC(5), 83/349/EEC(6)and 89/667/EEC(7)should therefore be amended accordingly,

1.
31968 L 0151: First Council Directive 68/151/EEC of 9 March 1968 on coordination of safeguards which, for the protection of the interests of members and others, are required by Member States of companies within the meaning of the second paragraph of Article 58 of the Treaty, with a view to making such safeguards equivalent throughout the Community (OJ L 65, 14.3.1968, p. 8), as amended by:—11972 B: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Denmark, Ireland and the United Kingdom (OJ L 73, 27.3.1972, p. 14),—11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),—11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),—11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),—12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),—32003 L 0058: Directive 2003/58/EC of the European Parliament and of the Council of 15.7.2003 (OJ L 221, 4.9.2003, p. 13).The following is added to Article 1:‘—   in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;—   in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.
—
11972 B: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Denmark, Ireland and the United Kingdom (OJ L 73, 27.3.1972, p. 14),
—
11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),
—
11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),
—
11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),
—
12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),
—
32003 L 0058: Directive 2003/58/EC of the European Parliament and of the Council of 15.7.2003 (OJ L 221, 4.9.2003, p. 13).

—
11972 B: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Denmark, Ireland and the United Kingdom (OJ L 73, 27.3.1972, p. 14),

—
11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),

—
11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),

—
11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

—
12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),

—
32003 L 0058: Directive 2003/58/EC of the European Parliament and of the Council of 15.7.2003 (OJ L 221, 4.9.2003, p. 13).

—
11972 B: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Denmark, Ireland and the United Kingdom (OJ L 73, 27.3.1972, p. 14),

—
11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),

—
11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),

—
11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

—
12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),

—
32003 L 0058: Directive 2003/58/EC of the European Parliament and of the Council of 15.7.2003 (OJ L 221, 4.9.2003, p. 13).

2.
31977 L 0091: Second Council Directive 77/91/EEC of 13 December 1976 on coordination of safeguards which, for the protection of the interests of members and others, are required by Member States of companies within the meaning of the second paragraph of Article 58 of the Treaty, in respect of the formation of public limited liability companies and the maintenance and alteration of their capital, with a view to making such safeguards equivalent (OJ L 26, 31.1.1977, p. 1), as amended by:—11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),—11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),—31992 L 0101: Council Directive 92/101/EEC of 23.11.1992 (OJ L 347, 28.11.1992, p. 64),—11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),—12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).The following is added to Article 1(1):‘—   in Bulgaria:акционерно дружество;—   in Romania:societate pe acţiuni’.
—
11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),
—
11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),
—
31992 L 0101: Council Directive 92/101/EEC of 23.11.1992 (OJ L 347, 28.11.1992, p. 64),
—
11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),
—
12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).

—
11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),

—
11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),

—
31992 L 0101: Council Directive 92/101/EEC of 23.11.1992 (OJ L 347, 28.11.1992, p. 64),

—
11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

—
12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).

—
11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),

—
11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),

—
31992 L 0101: Council Directive 92/101/EEC of 23.11.1992 (OJ L 347, 28.11.1992, p. 64),

—
11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

—
12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).

3.
31978 L 0855: Third Council Directive 78/855/EEC of 9 October 1978 based on Article 54(3)(g) of the Treaty concerning mergers of public limited liability companies (OJ L 295, 20.10.1978, p. 36), as amended by:—11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),—11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),—11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),—12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).The following is added to Article 1(1):‘—   Bulgaria:акционерно дружество;—   Romania:societate pe acţiuni’.
—
11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),
—
11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),
—
11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),
—
12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).

—
11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),

—
11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),

—
11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

—
12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).

—
11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),

—
11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),

—
11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

—
12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).

4.
31989 L 0667: Twelfth Council Company Law Directive 89/667/EEC of 21 December 1989 on single-member private limited-liability companies (OJ L 395, 30.12.1989, p. 40), as amended by:—11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),—12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).The following is added to Article 1:‘—   in Bulgaria:дружество с ограничена отговорност, акционерно дружество;—   in Romania:societate cu răspundere limitată’.
—
11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),
—
12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).

—
11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

—
12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).

—
11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

—
12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).

1.
31978 L 0660: Fourth Council Directive 78/660/EEC of 25 July 1978 based on Article 54(3)(g) of the Treaty on the annual accounts of certain types of companies (OJ L 222, 14.8.1978, p. 11), as amended by:—11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),—31983 L 0349: Seventh Council Directive 83/349/EEC of 13.6.1983 (OJ L 193, 18.7.1983, p. 1),—31984 L 0569: Council Directive 84/569/EEC of 27.11.1984 (OJ L 314, 4.12.1984, p. 28),—11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),—31989 L 0666: Eleventh Council Directive 89/666/EEC of 21.12.1989 (OJ L 395, 30.12.1989, p. 36),—31990 L 0604: Council Directive 90/604/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 57),—31990 L 0605: Council Directive 90/605/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 60),—31994 L 0008: Council Directive 94/8/EC of 21.3.1994 (OJ L 82, 25.3.1994, p. 33),—11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),—31999 L 0060: Council Directive 1999/60/EC of 17.6.1999 (OJ L 162, 26.6.1999, p. 65),—32001 L 0065: Directive 2001/65/EC of the European Parliament and of the Council of 27.9.2001 (OJ L 283, 27.10.2001, p. 28),—12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),—32003 L 0038: Council Directive 2003/38/EC of 13.5.2003 (OJ L 120, 15.5.2003, p. 22),—32003 L 0051: Directive 2003/51/EC of the European Parliament and of the Council of 18.6.2003 (OJ L 178, 17.7.2003, p. 16),—32006 L 0043: Directive 2006/43/EC of the European Parliament and of the Council of 17.5.2006 (OJ L 157, 9.6.2006, p. 87),—32006 L 0046: Directive 2006/46/EC of the European Parliament and of the Council of 14.6.2006 (OJ L 224, 16.8.2006, p. 1).(a)The following is added to Article 1(1), first subparagraph:‘—   in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;—   in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.(b)The following is added to Article 1(1), second subparagraph:‘—(z)in Bulgaria:събирателно дружество, командитно дружество;—(aa)in Romania:asocietate în nume colectiv, societate în comandită simplă’.
—
11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),
—
31983 L 0349: Seventh Council Directive 83/349/EEC of 13.6.1983 (OJ L 193, 18.7.1983, p. 1),
—
31984 L 0569: Council Directive 84/569/EEC of 27.11.1984 (OJ L 314, 4.12.1984, p. 28),
—
11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),
—
31989 L 0666: Eleventh Council Directive 89/666/EEC of 21.12.1989 (OJ L 395, 30.12.1989, p. 36),
—
31990 L 0604: Council Directive 90/604/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 57),
—
31990 L 0605: Council Directive 90/605/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 60),
—
31994 L 0008: Council Directive 94/8/EC of 21.3.1994 (OJ L 82, 25.3.1994, p. 33),
—
11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),
—
31999 L 0060: Council Directive 1999/60/EC of 17.6.1999 (OJ L 162, 26.6.1999, p. 65),
—
32001 L 0065: Directive 2001/65/EC of the European Parliament and of the Council of 27.9.2001 (OJ L 283, 27.10.2001, p. 28),
—
12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),
—
32003 L 0038: Council Directive 2003/38/EC of 13.5.2003 (OJ L 120, 15.5.2003, p. 22),
—
32003 L 0051: Directive 2003/51/EC of the European Parliament and of the Council of 18.6.2003 (OJ L 178, 17.7.2003, p. 16),
—
32006 L 0043: Directive 2006/43/EC of the European Parliament and of the Council of 17.5.2006 (OJ L 157, 9.6.2006, p. 87),
—
32006 L 0046: Directive 2006/46/EC of the European Parliament and of the Council of 14.6.2006 (OJ L 224, 16.8.2006, p. 1).
(a)
The following is added to Article 1(1), first subparagraph:‘—   in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;—   in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.
(b)
The following is added to Article 1(1), second subparagraph:‘—(z)in Bulgaria:събирателно дружество, командитно дружество;—(aa)in Romania:asocietate în nume colectiv, societate în comandită simplă’.
‘—
(z)in Bulgaria:събирателно дружество, командитно дружество;
(z)
in Bulgaria:събирателно дружество, командитно дружество;
—
(aa)in Romania:asocietate în nume colectiv, societate în comandită simplă’.
(aa)
in Romania:asocietate în nume colectiv, societate în comandită simplă’.

—
11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),

—
31983 L 0349: Seventh Council Directive 83/349/EEC of 13.6.1983 (OJ L 193, 18.7.1983, p. 1),

—
31984 L 0569: Council Directive 84/569/EEC of 27.11.1984 (OJ L 314, 4.12.1984, p. 28),

—
11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),

—
31989 L 0666: Eleventh Council Directive 89/666/EEC of 21.12.1989 (OJ L 395, 30.12.1989, p. 36),

—
31990 L 0604: Council Directive 90/604/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 57),

—
31990 L 0605: Council Directive 90/605/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 60),

—
31994 L 0008: Council Directive 94/8/EC of 21.3.1994 (OJ L 82, 25.3.1994, p. 33),

—
11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

—
31999 L 0060: Council Directive 1999/60/EC of 17.6.1999 (OJ L 162, 26.6.1999, p. 65),

—
32001 L 0065: Directive 2001/65/EC of the European Parliament and of the Council of 27.9.2001 (OJ L 283, 27.10.2001, p. 28),

—
12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),

—
32003 L 0038: Council Directive 2003/38/EC of 13.5.2003 (OJ L 120, 15.5.2003, p. 22),

—
32003 L 0051: Directive 2003/51/EC of the European Parliament and of the Council of 18.6.2003 (OJ L 178, 17.7.2003, p. 16),

—
32006 L 0043: Directive 2006/43/EC of the European Parliament and of the Council of 17.5.2006 (OJ L 157, 9.6.2006, p. 87),

—
32006 L 0046: Directive 2006/46/EC of the European Parliament and of the Council of 14.6.2006 (OJ L 224, 16.8.2006, p. 1).

(a)
The following is added to Article 1(1), first subparagraph:‘—   in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;—   in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.

(b)
The following is added to Article 1(1), second subparagraph:‘—(z)in Bulgaria:събирателно дружество, командитно дружество;—(aa)in Romania:asocietate în nume colectiv, societate în comandită simplă’.
‘—
(z)in Bulgaria:събирателно дружество, командитно дружество;
(z)
in Bulgaria:събирателно дружество, командитно дружество;
—
(aa)in Romania:asocietate în nume colectiv, societate în comandită simplă’.
(aa)
in Romania:asocietate în nume colectiv, societate în comandită simplă’.

‘—
(z)in Bulgaria:събирателно дружество, командитно дружество;
(z)
in Bulgaria:събирателно дружество, командитно дружество;

(z)
in Bulgaria:събирателно дружество, командитно дружество;

—
(aa)in Romania:asocietate în nume colectiv, societate în comandită simplă’.
(aa)
in Romania:asocietate în nume colectiv, societate în comandită simplă’.

(aa)
in Romania:asocietate în nume colectiv, societate în comandită simplă’.

—
11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),

—
31983 L 0349: Seventh Council Directive 83/349/EEC of 13.6.1983 (OJ L 193, 18.7.1983, p. 1),

—
31984 L 0569: Council Directive 84/569/EEC of 27.11.1984 (OJ L 314, 4.12.1984, p. 28),

—
11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),

—
31989 L 0666: Eleventh Council Directive 89/666/EEC of 21.12.1989 (OJ L 395, 30.12.1989, p. 36),

—
31990 L 0604: Council Directive 90/604/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 57),

—
31990 L 0605: Council Directive 90/605/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 60),

—
31994 L 0008: Council Directive 94/8/EC of 21.3.1994 (OJ L 82, 25.3.1994, p. 33),

—
11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

—
31999 L 0060: Council Directive 1999/60/EC of 17.6.1999 (OJ L 162, 26.6.1999, p. 65),

—
32001 L 0065: Directive 2001/65/EC of the European Parliament and of the Council of 27.9.2001 (OJ L 283, 27.10.2001, p. 28),

—
12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),

—
32003 L 0038: Council Directive 2003/38/EC of 13.5.2003 (OJ L 120, 15.5.2003, p. 22),

—
32003 L 0051: Directive 2003/51/EC of the European Parliament and of the Council of 18.6.2003 (OJ L 178, 17.7.2003, p. 16),

—
32006 L 0043: Directive 2006/43/EC of the European Parliament and of the Council of 17.5.2006 (OJ L 157, 9.6.2006, p. 87),

—
32006 L 0046: Directive 2006/46/EC of the European Parliament and of the Council of 14.6.2006 (OJ L 224, 16.8.2006, p. 1).

(a)
The following is added to Article 1(1), first subparagraph:‘—   in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;—   in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.

(b)
The following is added to Article 1(1), second subparagraph:‘—(z)in Bulgaria:събирателно дружество, командитно дружество;—(aa)in Romania:asocietate în nume colectiv, societate în comandită simplă’.
‘—
(z)in Bulgaria:събирателно дружество, командитно дружество;
(z)
in Bulgaria:събирателно дружество, командитно дружество;
—
(aa)in Romania:asocietate în nume colectiv, societate în comandită simplă’.
(aa)
in Romania:asocietate în nume colectiv, societate în comandită simplă’.

‘—
(z)in Bulgaria:събирателно дружество, командитно дружество;
(z)
in Bulgaria:събирателно дружество, командитно дружество;

(z)
in Bulgaria:събирателно дружество, командитно дружество;

—
(aa)in Romania:asocietate în nume colectiv, societate în comandită simplă’.
(aa)
in Romania:asocietate în nume colectiv, societate în comandită simplă’.

(aa)
in Romania:asocietate în nume colectiv, societate în comandită simplă’.

‘—
(z)in Bulgaria:събирателно дружество, командитно дружество;
(z)
in Bulgaria:събирателно дружество, командитно дружество;

(z)
in Bulgaria:събирателно дружество, командитно дружество;

(z)
in Bulgaria:събирателно дружество, командитно дружество;

—
(aa)in Romania:asocietate în nume colectiv, societate în comandită simplă’.
(aa)
in Romania:asocietate în nume colectiv, societate în comandită simplă’.

(aa)
in Romania:asocietate în nume colectiv, societate în comandită simplă’.

(aa)
in Romania:asocietate în nume colectiv, societate în comandită simplă’.

2.
31983 L 0349: Seventh Council Directive 83/349/EEC of 13 June 1983 based on Article 54(3)(g) of the Treaty on consolidated accounts (OJ L 193, 18.7.1983, p. 1), as amended by:—11985 l: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),—31989 L 0666: Eleventh Council Directive 89/666/EEC of 21.12.1989 (OJ L 395, 30.12.1989, p. 36),—31990 L 0604: Council Directive 90/604/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 57),—31990 L 0605: Council Directive 90/605/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 60),—11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),—32001 L 0065: Directive 2001/65/EC of the European Parliament and of the Council of 27.9.2001 (OJ L 283, 27.10.2001, p. 28),—12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),—32003 L 0051: Directive 2003/51/EC of the European Parliament and of the Council of 18.6.2003 (OJ L 178, 17.7.2003, p. 16),—32006 L 0043: Directive 2006/43/EC of the European Parliament and of the Council of 17.5.2006 (OJ L 157, 9.6.2006, p. 87),—32006 L 0046: Directive 2006/46/EC of the European Parliament and of the Council of 14.6.2006 (OJ L 224, 16.8.2006, p. 1).The following is added to Article 4(1):‘(z)—in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;(aa)—in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.
—
11985 l: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),
—
31989 L 0666: Eleventh Council Directive 89/666/EEC of 21.12.1989 (OJ L 395, 30.12.1989, p. 36),
—
31990 L 0604: Council Directive 90/604/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 57),
—
31990 L 0605: Council Directive 90/605/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 60),
—
11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),
—
32001 L 0065: Directive 2001/65/EC of the European Parliament and of the Council of 27.9.2001 (OJ L 283, 27.10.2001, p. 28),
—
12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),
—
32003 L 0051: Directive 2003/51/EC of the European Parliament and of the Council of 18.6.2003 (OJ L 178, 17.7.2003, p. 16),
—
32006 L 0043: Directive 2006/43/EC of the European Parliament and of the Council of 17.5.2006 (OJ L 157, 9.6.2006, p. 87),
—
32006 L 0046: Directive 2006/46/EC of the European Parliament and of the Council of 14.6.2006 (OJ L 224, 16.8.2006, p. 1).
‘(z)
—in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;
—
in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;
(aa)
—in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.
—
in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.

—
11985 l: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),

—
31989 L 0666: Eleventh Council Directive 89/666/EEC of 21.12.1989 (OJ L 395, 30.12.1989, p. 36),

—
31990 L 0604: Council Directive 90/604/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 57),

—
31990 L 0605: Council Directive 90/605/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 60),

—
11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

—
32001 L 0065: Directive 2001/65/EC of the European Parliament and of the Council of 27.9.2001 (OJ L 283, 27.10.2001, p. 28),

—
12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),

—
32003 L 0051: Directive 2003/51/EC of the European Parliament and of the Council of 18.6.2003 (OJ L 178, 17.7.2003, p. 16),

—
32006 L 0043: Directive 2006/43/EC of the European Parliament and of the Council of 17.5.2006 (OJ L 157, 9.6.2006, p. 87),

—
32006 L 0046: Directive 2006/46/EC of the European Parliament and of the Council of 14.6.2006 (OJ L 224, 16.8.2006, p. 1).

‘(z)
—in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;
—
in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;

—
in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;

(aa)
—in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.
—
in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.

—
in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.

—
11985 l: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),

—
31989 L 0666: Eleventh Council Directive 89/666/EEC of 21.12.1989 (OJ L 395, 30.12.1989, p. 36),

—
31990 L 0604: Council Directive 90/604/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 57),

—
31990 L 0605: Council Directive 90/605/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 60),

—
11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

—
32001 L 0065: Directive 2001/65/EC of the European Parliament and of the Council of 27.9.2001 (OJ L 283, 27.10.2001, p. 28),

—
12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),

—
32003 L 0051: Directive 2003/51/EC of the European Parliament and of the Council of 18.6.2003 (OJ L 178, 17.7.2003, p. 16),

—
32006 L 0043: Directive 2006/43/EC of the European Parliament and of the Council of 17.5.2006 (OJ L 157, 9.6.2006, p. 87),

—
32006 L 0046: Directive 2006/46/EC of the European Parliament and of the Council of 14.6.2006 (OJ L 224, 16.8.2006, p. 1).

‘(z)
—in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;
—
in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;

—
in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;

—
in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;

(aa)
—in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.
—
in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.

—
in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.

—
in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to the Treaty of Accession of Bulgaria and Romania(1), and in particular Article 4(3) thereof,

Having regard to the Act of Accession of Bulgaria and Romania, and in particular Article 56 thereof,

Having regard to the proposal from the Commission,

(1) Pursuant to Article 56 of the Act of Accession, where acts of the institutions remain valid beyond 1 January 2007, and require adaptation by reason of accession, and the necessary adaptations have not been provided for in the Act of Accession or its Annexes, the necessary acts are to be adopted by the Council, unless the Commission adopted the original act.

(2) The Final Act of the Conference which drew up the Treaty of Accession indicated that the High Contracting Parties had reached political agreement on a set of adaptations to acts adopted by the institutions required by reason of accession and invited the Council and the Commission to adopt these adaptations before accession, completed and updated where necessary to take account of the evolution of the law of the Union.

(3) Directives 68/151/EEC(2), 77/91/EEC(3), 78/660/EEC(4), 78/855/EEC(5), 83/349/EEC(6)and 89/667/EEC(7)should therefore be amended accordingly,

HAS ADOPTED THIS DIRECTIVE:
Article 1

Directives 68/151/EEC, 77/91/EEC, 78/660/EEC, 78/855/EEC, 83/349/EEC and 89/667/EEC shall be amended as set out in the Annex.
Article 2

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by the date of accession of Bulgaria and Romania to the European Union at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3

This Directive shall enter into force subject to and on the date of the entry into force of the Treaty of Accession of Bulgaria and Romania.
Article 4

This Directive is addressed to the Member States.
THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to the Treaty of Accession of Bulgaria and Romania(1), and in particular Article 4(3) thereof,

Having regard to the Act of Accession of Bulgaria and Romania, and in particular Article 56 thereof,

Having regard to the proposal from the Commission,

(1) Pursuant to Article 56 of the Act of Accession, where acts of the institutions remain valid beyond 1 January 2007, and require adaptation by reason of accession, and the necessary adaptations have not been provided for in the Act of Accession or its Annexes, the necessary acts are to be adopted by the Council, unless the Commission adopted the original act.

(2) The Final Act of the Conference which drew up the Treaty of Accession indicated that the High Contracting Parties had reached political agreement on a set of adaptations to acts adopted by the institutions required by reason of accession and invited the Council and the Commission to adopt these adaptations before accession, completed and updated where necessary to take account of the evolution of the law of the Union.

(3) Directives 68/151/EEC(2), 77/91/EEC(3), 78/660/EEC(4), 78/855/EEC(5), 83/349/EEC(6)and 89/667/EEC(7)should therefore be amended accordingly,

HAS ADOPTED THIS DIRECTIVE:
Directives 68/151/EEC, 77/91/EEC, 78/660/EEC, 78/855/EEC, 83/349/EEC and 89/667/EEC shall be amended as set out in the Annex.
1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by the date of accession of Bulgaria and Romania to the European Union at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
This Directive shall enter into force subject to and on the date of the entry into force of the Treaty of Accession of Bulgaria and Romania.
This Directive is addressed to the Member States.
A.   COMPANY LAWANNEXCOMPANY LAW

 | 1. | 31968 L 0151: First Council Directive 68/151/EEC of 9 March 1968 on coordination of safeguards which, for the protection of the interests of members and others, are required by Member States of companies within the meaning of the second paragraph of Article 58 of the Treaty, with a view to making such safeguards equivalent throughout the Community (OJ L 65, 14.3.1968, p. 8), as amended by:—11972 B: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Denmark, Ireland and the United Kingdom (OJ L 73, 27.3.1972, p. 14),—11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),—11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),—11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),—12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),—32003 L 0058: Directive 2003/58/EC of the European Parliament and of the Council of 15.7.2003 (OJ L 221, 4.9.2003, p. 13).The following is added to Article 1:‘—   in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;—   in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’. | — | 11972 B: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Denmark, Ireland and the United Kingdom (OJ L 73, 27.3.1972, p. 14), | — | 11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17), | — | 11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23), | — | 11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21), | — | 12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33), | — | 32003 L 0058: Directive 2003/58/EC of the European Parliament and of the Council of 15.7.2003 (OJ L 221, 4.9.2003, p. 13).

— | 11972 B: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Denmark, Ireland and the United Kingdom (OJ L 73, 27.3.1972, p. 14),

— | 11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),

— | 11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),

— | 11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

— | 12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),

— | 32003 L 0058: Directive 2003/58/EC of the European Parliament and of the Council of 15.7.2003 (OJ L 221, 4.9.2003, p. 13).

 | 2. | 31977 L 0091: Second Council Directive 77/91/EEC of 13 December 1976 on coordination of safeguards which, for the protection of the interests of members and others, are required by Member States of companies within the meaning of the second paragraph of Article 58 of the Treaty, in respect of the formation of public limited liability companies and the maintenance and alteration of their capital, with a view to making such safeguards equivalent (OJ L 26, 31.1.1977, p. 1), as amended by:—11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),—11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),—31992 L 0101: Council Directive 92/101/EEC of 23.11.1992 (OJ L 347, 28.11.1992, p. 64),—11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),—12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).The following is added to Article 1(1):‘—   in Bulgaria:акционерно дружество;—   in Romania:societate pe acţiuni’. | — | 11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17), | — | 11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23), | — | 31992 L 0101: Council Directive 92/101/EEC of 23.11.1992 (OJ L 347, 28.11.1992, p. 64), | — | 11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21), | — | 12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).

— | 11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),

— | 11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),

— | 31992 L 0101: Council Directive 92/101/EEC of 23.11.1992 (OJ L 347, 28.11.1992, p. 64),

— | 11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

— | 12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).

 | 3. | 31978 L 0855: Third Council Directive 78/855/EEC of 9 October 1978 based on Article 54(3)(g) of the Treaty concerning mergers of public limited liability companies (OJ L 295, 20.10.1978, p. 36), as amended by:—11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),—11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),—11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),—12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).The following is added to Article 1(1):‘—   Bulgaria:акционерно дружество;—   Romania:societate pe acţiuni’. | — | 11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17), | — | 11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23), | — | 11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21), | — | 12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).

— | 11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),

— | 11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),

— | 11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

— | 12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).

 | 4. | 31989 L 0667: Twelfth Council Company Law Directive 89/667/EEC of 21 December 1989 on single-member private limited-liability companies (OJ L 395, 30.12.1989, p. 40), as amended by:—11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),—12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).The following is added to Article 1:‘—   in Bulgaria:дружество с ограничена отговорност, акционерно дружество;—   in Romania:societate cu răspundere limitată’. | — | 11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21), | — | 12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).

— | 11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

— | 12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).B.   ACCOUNTING STANDARDS

 | 1. | 31978 L 0660: Fourth Council Directive 78/660/EEC of 25 July 1978 based on Article 54(3)(g) of the Treaty on the annual accounts of certain types of companies (OJ L 222, 14.8.1978, p. 11), as amended by:—11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),—31983 L 0349: Seventh Council Directive 83/349/EEC of 13.6.1983 (OJ L 193, 18.7.1983, p. 1),—31984 L 0569: Council Directive 84/569/EEC of 27.11.1984 (OJ L 314, 4.12.1984, p. 28),—11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),—31989 L 0666: Eleventh Council Directive 89/666/EEC of 21.12.1989 (OJ L 395, 30.12.1989, p. 36),—31990 L 0604: Council Directive 90/604/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 57),—31990 L 0605: Council Directive 90/605/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 60),—31994 L 0008: Council Directive 94/8/EC of 21.3.1994 (OJ L 82, 25.3.1994, p. 33),—11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),—31999 L 0060: Council Directive 1999/60/EC of 17.6.1999 (OJ L 162, 26.6.1999, p. 65),—32001 L 0065: Directive 2001/65/EC of the European Parliament and of the Council of 27.9.2001 (OJ L 283, 27.10.2001, p. 28),—12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),—32003 L 0038: Council Directive 2003/38/EC of 13.5.2003 (OJ L 120, 15.5.2003, p. 22),—32003 L 0051: Directive 2003/51/EC of the European Parliament and of the Council of 18.6.2003 (OJ L 178, 17.7.2003, p. 16),—32006 L 0043: Directive 2006/43/EC of the European Parliament and of the Council of 17.5.2006 (OJ L 157, 9.6.2006, p. 87),—32006 L 0046: Directive 2006/46/EC of the European Parliament and of the Council of 14.6.2006 (OJ L 224, 16.8.2006, p. 1).(a)The following is added to Article 1(1), first subparagraph:‘—   in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;—   in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.(b)The following is added to Article 1(1), second subparagraph:‘—(z)in Bulgaria:събирателно дружество, командитно дружество;—(aa)in Romania:asocietate în nume colectiv, societate în comandită simplă’. | — | 11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17), | — | 31983 L 0349: Seventh Council Directive 83/349/EEC of 13.6.1983 (OJ L 193, 18.7.1983, p. 1), | — | 31984 L 0569: Council Directive 84/569/EEC of 27.11.1984 (OJ L 314, 4.12.1984, p. 28), | — | 11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23), | — | 31989 L 0666: Eleventh Council Directive 89/666/EEC of 21.12.1989 (OJ L 395, 30.12.1989, p. 36), | — | 31990 L 0604: Council Directive 90/604/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 57), | — | 31990 L 0605: Council Directive 90/605/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 60), | — | 31994 L 0008: Council Directive 94/8/EC of 21.3.1994 (OJ L 82, 25.3.1994, p. 33), | — | 11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21), | — | 31999 L 0060: Council Directive 1999/60/EC of 17.6.1999 (OJ L 162, 26.6.1999, p. 65), | — | 32001 L 0065: Directive 2001/65/EC of the European Parliament and of the Council of 27.9.2001 (OJ L 283, 27.10.2001, p. 28), | — | 12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33), | — | 32003 L 0038: Council Directive 2003/38/EC of 13.5.2003 (OJ L 120, 15.5.2003, p. 22), | — | 32003 L 0051: Directive 2003/51/EC of the European Parliament and of the Council of 18.6.2003 (OJ L 178, 17.7.2003, p. 16), | — | 32006 L 0043: Directive 2006/43/EC of the European Parliament and of the Council of 17.5.2006 (OJ L 157, 9.6.2006, p. 87), | — | 32006 L 0046: Directive 2006/46/EC of the European Parliament and of the Council of 14.6.2006 (OJ L 224, 16.8.2006, p. 1). | (a) | The following is added to Article 1(1), first subparagraph:‘—   in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;—   in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’. | (b) | The following is added to Article 1(1), second subparagraph:‘—(z)in Bulgaria:събирателно дружество, командитно дружество;—(aa)in Romania:asocietate în nume colectiv, societate în comandită simplă’. | ‘— | (z)in Bulgaria:събирателно дружество, командитно дружество; | (z) | in Bulgaria:събирателно дружество, командитно дружество; | — | (aa)in Romania:asocietate în nume colectiv, societate în comandită simplă’. | (aa) | in Romania:asocietate în nume colectiv, societate în comandită simplă’.

— | 11979 H: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Hellenic Republic (OJ L 291, 19.11.1979, p. 17),

— | 31983 L 0349: Seventh Council Directive 83/349/EEC of 13.6.1983 (OJ L 193, 18.7.1983, p. 1),

— | 31984 L 0569: Council Directive 84/569/EEC of 27.11.1984 (OJ L 314, 4.12.1984, p. 28),

— | 11985 I: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),

— | 31989 L 0666: Eleventh Council Directive 89/666/EEC of 21.12.1989 (OJ L 395, 30.12.1989, p. 36),

— | 31990 L 0604: Council Directive 90/604/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 57),

— | 31990 L 0605: Council Directive 90/605/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 60),

— | 31994 L 0008: Council Directive 94/8/EC of 21.3.1994 (OJ L 82, 25.3.1994, p. 33),

— | 11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

— | 31999 L 0060: Council Directive 1999/60/EC of 17.6.1999 (OJ L 162, 26.6.1999, p. 65),

— | 32001 L 0065: Directive 2001/65/EC of the European Parliament and of the Council of 27.9.2001 (OJ L 283, 27.10.2001, p. 28),

— | 12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),

— | 32003 L 0038: Council Directive 2003/38/EC of 13.5.2003 (OJ L 120, 15.5.2003, p. 22),

— | 32003 L 0051: Directive 2003/51/EC of the European Parliament and of the Council of 18.6.2003 (OJ L 178, 17.7.2003, p. 16),

— | 32006 L 0043: Directive 2006/43/EC of the European Parliament and of the Council of 17.5.2006 (OJ L 157, 9.6.2006, p. 87),

— | 32006 L 0046: Directive 2006/46/EC of the European Parliament and of the Council of 14.6.2006 (OJ L 224, 16.8.2006, p. 1).

(a) | The following is added to Article 1(1), first subparagraph:‘—   in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;—   in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.

(b) | The following is added to Article 1(1), second subparagraph:‘—(z)in Bulgaria:събирателно дружество, командитно дружество;—(aa)in Romania:asocietate în nume colectiv, societate în comandită simplă’. | ‘— | (z)in Bulgaria:събирателно дружество, командитно дружество; | (z) | in Bulgaria:събирателно дружество, командитно дружество; | — | (aa)in Romania:asocietate în nume colectiv, societate în comandită simplă’. | (aa) | in Romania:asocietate în nume colectiv, societate în comandită simplă’.

‘— | (z)in Bulgaria:събирателно дружество, командитно дружество; | (z) | in Bulgaria:събирателно дружество, командитно дружество;

(z) | in Bulgaria:събирателно дружество, командитно дружество;

— | (aa)in Romania:asocietate în nume colectiv, societate în comandită simplă’. | (aa) | in Romania:asocietate în nume colectiv, societate în comandită simplă’.

(aa) | in Romania:asocietate în nume colectiv, societate în comandită simplă’.

 | 2. | 31983 L 0349: Seventh Council Directive 83/349/EEC of 13 June 1983 based on Article 54(3)(g) of the Treaty on consolidated accounts (OJ L 193, 18.7.1983, p. 1), as amended by:—11985 l: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),—31989 L 0666: Eleventh Council Directive 89/666/EEC of 21.12.1989 (OJ L 395, 30.12.1989, p. 36),—31990 L 0604: Council Directive 90/604/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 57),—31990 L 0605: Council Directive 90/605/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 60),—11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),—32001 L 0065: Directive 2001/65/EC of the European Parliament and of the Council of 27.9.2001 (OJ L 283, 27.10.2001, p. 28),—12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),—32003 L 0051: Directive 2003/51/EC of the European Parliament and of the Council of 18.6.2003 (OJ L 178, 17.7.2003, p. 16),—32006 L 0043: Directive 2006/43/EC of the European Parliament and of the Council of 17.5.2006 (OJ L 157, 9.6.2006, p. 87),—32006 L 0046: Directive 2006/46/EC of the European Parliament and of the Council of 14.6.2006 (OJ L 224, 16.8.2006, p. 1).The following is added to Article 4(1):‘(z)—in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;(aa)—in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’. | — | 11985 l: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23), | — | 31989 L 0666: Eleventh Council Directive 89/666/EEC of 21.12.1989 (OJ L 395, 30.12.1989, p. 36), | — | 31990 L 0604: Council Directive 90/604/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 57), | — | 31990 L 0605: Council Directive 90/605/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 60), | — | 11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21), | — | 32001 L 0065: Directive 2001/65/EC of the European Parliament and of the Council of 27.9.2001 (OJ L 283, 27.10.2001, p. 28), | — | 12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33), | — | 32003 L 0051: Directive 2003/51/EC of the European Parliament and of the Council of 18.6.2003 (OJ L 178, 17.7.2003, p. 16), | — | 32006 L 0043: Directive 2006/43/EC of the European Parliament and of the Council of 17.5.2006 (OJ L 157, 9.6.2006, p. 87), | — | 32006 L 0046: Directive 2006/46/EC of the European Parliament and of the Council of 14.6.2006 (OJ L 224, 16.8.2006, p. 1). | ‘(z) | —in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции; | — | in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции; | (aa) | —in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’. | — | in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.

— | 11985 l: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 23),

— | 31989 L 0666: Eleventh Council Directive 89/666/EEC of 21.12.1989 (OJ L 395, 30.12.1989, p. 36),

— | 31990 L 0604: Council Directive 90/604/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 57),

— | 31990 L 0605: Council Directive 90/605/EEC of 8.11.1990 (OJ L 317, 16.11.1990, p. 60),

— | 11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

— | 32001 L 0065: Directive 2001/65/EC of the European Parliament and of the Council of 27.9.2001 (OJ L 283, 27.10.2001, p. 28),

— | 12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),

— | 32003 L 0051: Directive 2003/51/EC of the European Parliament and of the Council of 18.6.2003 (OJ L 178, 17.7.2003, p. 16),

— | 32006 L 0043: Directive 2006/43/EC of the European Parliament and of the Council of 17.5.2006 (OJ L 157, 9.6.2006, p. 87),

— | 32006 L 0046: Directive 2006/46/EC of the European Parliament and of the Council of 14.6.2006 (OJ L 224, 16.8.2006, p. 1).

‘(z) | —in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции; | — | in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;

— | in Bulgaria:акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;

(aa) | —in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’. | — | in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.

— | in Romania:societate pe acţiuni, societate cu răspundere limitată, societate în comandită pe acţiuni’.

Pending: 32006L0087

                                January 16, 2026                            

30.12.2006
EN
Official Journal of the European Union
L 389/1

(1)
Council Directive 82/714/EEC of 4 October 1982 laying down technical requirements for inland waterway vessels(3)introduced harmonised conditions for issuing technical certificates for inland waterway vessels in all Member States, albeit excluding operations on the Rhine. Nevertheless, at European level, various technical requirements for inland waterway vessels have remained in force. Up to now, the coexistence of various international and national regulations has obstructed efforts to ensure mutual recognition of national navigation certificates without the need for an additional inspection of foreign vessels. Furthermore, the standards contained in Directive 82/714/EEC, in part, no longer reflect current technological developments.

(2)
Essentially, the technical requirements set out in the annexes to Directive 82/714/EEC incorporate the provisions laid down in the Rhine Vessel Inspection Regulation, in the version approved by the Central Commission for Navigation on the Rhine (CCNR) in 1982. The conditions and technical requirements for issuing inland navigation certificates under Article 22 of the Revised Convention for Rhine Navigation have been revised regularly since then and are recognised as reflecting current technological developments. For competition and safety reasons it is desirable, specifically in the interests of promoting harmonisation at European level, to adopt the scope and content of such technical requirements for the whole of the Community's inland waterway network. Account should be taken in this regard of the changes that have occurred in that network.

(3)
Community inland navigation certificates attesting the full compliance of vessels with the aforementioned revised technical requirements should be valid on all Community inland waterways.

(4)
It is desirable to ensure a greater degree of harmonisation between the conditions for the issuing of supplementary Community inland navigation certificates by Member States for operations on Zone 1 and 2 waterways (estuaries), as well as for operations on Zone 4 waterways.

(5)
In the interests of passenger transport safety, it is desirable that the scope of Directive 82/714/EEC be extended to include passenger vessels designed to carry more than 12 passengers, along the lines of the Rhine Vessel Inspection Regulation.

(6)
In the interests of safety, harmonisation of standards should be at a high level and should be achieved in such a way so as not to result in any reduction in safety standards on any Community inland waterway.

(7)
It is appropriate to provide for a transitional regime for vessels in service not yet carrying a Community inland navigation certificate when subjected to a first technical inspection under the revised technical requirements established by this Directive.

(8)
It is appropriate, within certain limits and according to the category of vessel concerned, to determine the period of validity of Community inland navigation certificates in each specific case.

(9)
The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(4).

(10)
It is necessary that the measures provided for in Council Directive 76/135/EEC of 20 January 1976 on reciprocal recognition of navigability licenses for inland waterway vessels(5)remain in force for those vessels not covered by this Directive.

(11)
Given that some vessels fall within the scope of Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft(6)as well as of this Directive, the annexes of the two Directives should be adjusted by the relevant committee procedures as soon as possible if there are any contradictions or inconsistencies between the provisions of those Directives.

(12)
In accordance with point 34 of the Interinstitutional Agreement on better law-making(7), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

(13)
Directive 82/714/EEC should be repealed,

(a)
Zones 1, 2, 3 and 4:(i)Zones 1 and 2: the waterways listed in Chapter 1 of Annex I;(ii)Zone 3: the waterways listed in Chapter 2 of Annex I;(iii)Zone 4: the waterways listed in Chapter 3 of Annex I.
(i)
Zones 1 and 2: the waterways listed in Chapter 1 of Annex I;
(ii)
Zone 3: the waterways listed in Chapter 2 of Annex I;
(iii)
Zone 4: the waterways listed in Chapter 3 of Annex I.

(i)
Zones 1 and 2: the waterways listed in Chapter 1 of Annex I;

(ii)
Zone 3: the waterways listed in Chapter 2 of Annex I;

(iii)
Zone 4: the waterways listed in Chapter 3 of Annex I.

(i)
Zones 1 and 2: the waterways listed in Chapter 1 of Annex I;

(ii)
Zone 3: the waterways listed in Chapter 2 of Annex I;

(iii)
Zone 4: the waterways listed in Chapter 3 of Annex I.

(b)
Zone R: those of the waterways referred to in point (a) for which certificates are to be issued in accordance with Article 22 of the Revised Convention for Rhine Navigation as that Article is worded when this Directive enters into force.

(a)
vessels having a length (L) of 20 metres or more;

(b)
vessels for which the product of length (L), breadth (B) and draught (T) is a volume of 100 m3or more.

(a)
tugs and pushers intended for towing or pushing craft referred to in paragraph 1 or floating equipment or for moving such craft or floating equipment alongside;

(b)
vessels intended for passenger transport which carry more than 12 passengers in addition to the crew;

(c)
floating equipment.

(a)
ferries;

(b)
naval vessels;

(c)
sea-going vessels, including sea-going tugs and pusher craft, which:(i)operate or are based on tidal waters;(ii)operate temporarily on inland waterways, provided that they carry:—a certificate proving conformity with the 1974 International Convention for the Safety of Life at Sea (SOLAS), or equivalent, a certificate proving conformity with the 1966 International Convention on Load Lines, or equivalent, and an international oil pollution prevention (IOPP) certificate proving conformity with the 1973 International Convention for the Prevention of Pollution from Ships (MARPOL); or—in the case of passenger vessels not covered by all of the Conventions referred to in the first indent, a certificate on safety rules and standards for passenger ships issued in conformity with Council Directive 98/18/EC of 17 March 1998 on safety rules and standards for passenger ships(8); or—in the case of recreational craft not covered by all of the Conventions referred to in the first indent, a certificate of the country of which it carries the flag.
(i)
operate or are based on tidal waters;
(ii)
operate temporarily on inland waterways, provided that they carry:—a certificate proving conformity with the 1974 International Convention for the Safety of Life at Sea (SOLAS), or equivalent, a certificate proving conformity with the 1966 International Convention on Load Lines, or equivalent, and an international oil pollution prevention (IOPP) certificate proving conformity with the 1973 International Convention for the Prevention of Pollution from Ships (MARPOL); or—in the case of passenger vessels not covered by all of the Conventions referred to in the first indent, a certificate on safety rules and standards for passenger ships issued in conformity with Council Directive 98/18/EC of 17 March 1998 on safety rules and standards for passenger ships(8); or—in the case of recreational craft not covered by all of the Conventions referred to in the first indent, a certificate of the country of which it carries the flag.
—
a certificate proving conformity with the 1974 International Convention for the Safety of Life at Sea (SOLAS), or equivalent, a certificate proving conformity with the 1966 International Convention on Load Lines, or equivalent, and an international oil pollution prevention (IOPP) certificate proving conformity with the 1973 International Convention for the Prevention of Pollution from Ships (MARPOL); or
—
in the case of passenger vessels not covered by all of the Conventions referred to in the first indent, a certificate on safety rules and standards for passenger ships issued in conformity with Council Directive 98/18/EC of 17 March 1998 on safety rules and standards for passenger ships(8); or
—
in the case of recreational craft not covered by all of the Conventions referred to in the first indent, a certificate of the country of which it carries the flag.

(i)
operate or are based on tidal waters;

(ii)
operate temporarily on inland waterways, provided that they carry:—a certificate proving conformity with the 1974 International Convention for the Safety of Life at Sea (SOLAS), or equivalent, a certificate proving conformity with the 1966 International Convention on Load Lines, or equivalent, and an international oil pollution prevention (IOPP) certificate proving conformity with the 1973 International Convention for the Prevention of Pollution from Ships (MARPOL); or—in the case of passenger vessels not covered by all of the Conventions referred to in the first indent, a certificate on safety rules and standards for passenger ships issued in conformity with Council Directive 98/18/EC of 17 March 1998 on safety rules and standards for passenger ships(8); or—in the case of recreational craft not covered by all of the Conventions referred to in the first indent, a certificate of the country of which it carries the flag.
—
a certificate proving conformity with the 1974 International Convention for the Safety of Life at Sea (SOLAS), or equivalent, a certificate proving conformity with the 1966 International Convention on Load Lines, or equivalent, and an international oil pollution prevention (IOPP) certificate proving conformity with the 1973 International Convention for the Prevention of Pollution from Ships (MARPOL); or
—
in the case of passenger vessels not covered by all of the Conventions referred to in the first indent, a certificate on safety rules and standards for passenger ships issued in conformity with Council Directive 98/18/EC of 17 March 1998 on safety rules and standards for passenger ships(8); or
—
in the case of recreational craft not covered by all of the Conventions referred to in the first indent, a certificate of the country of which it carries the flag.

—
a certificate proving conformity with the 1974 International Convention for the Safety of Life at Sea (SOLAS), or equivalent, a certificate proving conformity with the 1966 International Convention on Load Lines, or equivalent, and an international oil pollution prevention (IOPP) certificate proving conformity with the 1973 International Convention for the Prevention of Pollution from Ships (MARPOL); or

—
in the case of passenger vessels not covered by all of the Conventions referred to in the first indent, a certificate on safety rules and standards for passenger ships issued in conformity with Council Directive 98/18/EC of 17 March 1998 on safety rules and standards for passenger ships(8); or

—
in the case of recreational craft not covered by all of the Conventions referred to in the first indent, a certificate of the country of which it carries the flag.

(i)
operate or are based on tidal waters;

(ii)
operate temporarily on inland waterways, provided that they carry:—a certificate proving conformity with the 1974 International Convention for the Safety of Life at Sea (SOLAS), or equivalent, a certificate proving conformity with the 1966 International Convention on Load Lines, or equivalent, and an international oil pollution prevention (IOPP) certificate proving conformity with the 1973 International Convention for the Prevention of Pollution from Ships (MARPOL); or—in the case of passenger vessels not covered by all of the Conventions referred to in the first indent, a certificate on safety rules and standards for passenger ships issued in conformity with Council Directive 98/18/EC of 17 March 1998 on safety rules and standards for passenger ships(8); or—in the case of recreational craft not covered by all of the Conventions referred to in the first indent, a certificate of the country of which it carries the flag.
—
a certificate proving conformity with the 1974 International Convention for the Safety of Life at Sea (SOLAS), or equivalent, a certificate proving conformity with the 1966 International Convention on Load Lines, or equivalent, and an international oil pollution prevention (IOPP) certificate proving conformity with the 1973 International Convention for the Prevention of Pollution from Ships (MARPOL); or
—
in the case of passenger vessels not covered by all of the Conventions referred to in the first indent, a certificate on safety rules and standards for passenger ships issued in conformity with Council Directive 98/18/EC of 17 March 1998 on safety rules and standards for passenger ships(8); or
—
in the case of recreational craft not covered by all of the Conventions referred to in the first indent, a certificate of the country of which it carries the flag.

—
a certificate proving conformity with the 1974 International Convention for the Safety of Life at Sea (SOLAS), or equivalent, a certificate proving conformity with the 1966 International Convention on Load Lines, or equivalent, and an international oil pollution prevention (IOPP) certificate proving conformity with the 1973 International Convention for the Prevention of Pollution from Ships (MARPOL); or

—
in the case of passenger vessels not covered by all of the Conventions referred to in the first indent, a certificate on safety rules and standards for passenger ships issued in conformity with Council Directive 98/18/EC of 17 March 1998 on safety rules and standards for passenger ships(8); or

—
in the case of recreational craft not covered by all of the Conventions referred to in the first indent, a certificate of the country of which it carries the flag.

—
a certificate proving conformity with the 1974 International Convention for the Safety of Life at Sea (SOLAS), or equivalent, a certificate proving conformity with the 1966 International Convention on Load Lines, or equivalent, and an international oil pollution prevention (IOPP) certificate proving conformity with the 1973 International Convention for the Prevention of Pollution from Ships (MARPOL); or

—
in the case of passenger vessels not covered by all of the Conventions referred to in the first indent, a certificate on safety rules and standards for passenger ships issued in conformity with Council Directive 98/18/EC of 17 March 1998 on safety rules and standards for passenger ships(8); or

—
in the case of recreational craft not covered by all of the Conventions referred to in the first indent, a certificate of the country of which it carries the flag.

(a)
when operating on a Zone R waterway:—either a certificate issued pursuant to Article 22 of the Revised Convention for Rhine Navigation;—or a Community inland navigation certificate issued or renewed after 30 December 2008, and attesting full compliance of the craft, without prejudice to the transitional provisions of Chapter 24 of Annex II, with technical requirements as defined in Annex II for which equivalency with the technical requirements laid down in application of the abovementioned Convention has been established according to the applicable rules and procedures;
—
either a certificate issued pursuant to Article 22 of the Revised Convention for Rhine Navigation;
—
or a Community inland navigation certificate issued or renewed after 30 December 2008, and attesting full compliance of the craft, without prejudice to the transitional provisions of Chapter 24 of Annex II, with technical requirements as defined in Annex II for which equivalency with the technical requirements laid down in application of the abovementioned Convention has been established according to the applicable rules and procedures;

—
either a certificate issued pursuant to Article 22 of the Revised Convention for Rhine Navigation;

—
or a Community inland navigation certificate issued or renewed after 30 December 2008, and attesting full compliance of the craft, without prejudice to the transitional provisions of Chapter 24 of Annex II, with technical requirements as defined in Annex II for which equivalency with the technical requirements laid down in application of the abovementioned Convention has been established according to the applicable rules and procedures;

—
either a certificate issued pursuant to Article 22 of the Revised Convention for Rhine Navigation;

—
or a Community inland navigation certificate issued or renewed after 30 December 2008, and attesting full compliance of the craft, without prejudice to the transitional provisions of Chapter 24 of Annex II, with technical requirements as defined in Annex II for which equivalency with the technical requirements laid down in application of the abovementioned Convention has been established according to the applicable rules and procedures;

(b)
when operating on other waterways, a Community inland navigation certificate, including, where applicable, the specifications referred to in Article 5.

(a)
when operating on Zone 3 and 4 waterways, if they wish to take advantage of the reduction in technical requirements on those waterways;

(b)
when operating on Zone 1 and 2 waterways, or, in respect of passenger vessels, when operating on Zone 3 waterways that are not linked to the navigable inland waterways of another Member State, if the Member State concerned has adopted additional technical requirements for those waterways, in accordance with Article 5(1), (2) and (3).

5.
(a)Where application of the transitional provisions set out in Chapter 24a of Annex II would result in a reduction in existing national safety standards, a Member State may disapply those transitional provisions in respect of inland waterway passenger vessels operating on its inland waterways that are not linked to the navigable inland waterways of another Member State. In such circumstances, the Member State may require that such vessels operating on its non-linked inland waterways comply fully with the technical requirements set out in Annex II from 30 December 2008.(b)A Member State exercising the provision in point (a) shall inform the Commission of its decision and provide the Commission with details of the relevant national standards applying to passenger vessels operating on its inland waterways. The Commission shall inform the Member States.(c)Compliance with the requirements of a Member State for operating on its non-linked inland waterways shall be specified in the Community inland navigation certificate referred to in Article 3 or, where Article 4(2) applies, in the supplementary Community inland navigation certificate.
(a)
Where application of the transitional provisions set out in Chapter 24a of Annex II would result in a reduction in existing national safety standards, a Member State may disapply those transitional provisions in respect of inland waterway passenger vessels operating on its inland waterways that are not linked to the navigable inland waterways of another Member State. In such circumstances, the Member State may require that such vessels operating on its non-linked inland waterways comply fully with the technical requirements set out in Annex II from 30 December 2008.
(b)
A Member State exercising the provision in point (a) shall inform the Commission of its decision and provide the Commission with details of the relevant national standards applying to passenger vessels operating on its inland waterways. The Commission shall inform the Member States.
(c)
Compliance with the requirements of a Member State for operating on its non-linked inland waterways shall be specified in the Community inland navigation certificate referred to in Article 3 or, where Article 4(2) applies, in the supplementary Community inland navigation certificate.

(a)
Where application of the transitional provisions set out in Chapter 24a of Annex II would result in a reduction in existing national safety standards, a Member State may disapply those transitional provisions in respect of inland waterway passenger vessels operating on its inland waterways that are not linked to the navigable inland waterways of another Member State. In such circumstances, the Member State may require that such vessels operating on its non-linked inland waterways comply fully with the technical requirements set out in Annex II from 30 December 2008.

(b)
A Member State exercising the provision in point (a) shall inform the Commission of its decision and provide the Commission with details of the relevant national standards applying to passenger vessels operating on its inland waterways. The Commission shall inform the Member States.

(c)
Compliance with the requirements of a Member State for operating on its non-linked inland waterways shall be specified in the Community inland navigation certificate referred to in Article 3 or, where Article 4(2) applies, in the supplementary Community inland navigation certificate.

(a)
Where application of the transitional provisions set out in Chapter 24a of Annex II would result in a reduction in existing national safety standards, a Member State may disapply those transitional provisions in respect of inland waterway passenger vessels operating on its inland waterways that are not linked to the navigable inland waterways of another Member State. In such circumstances, the Member State may require that such vessels operating on its non-linked inland waterways comply fully with the technical requirements set out in Annex II from 30 December 2008.

(b)
A Member State exercising the provision in point (a) shall inform the Commission of its decision and provide the Commission with details of the relevant national standards applying to passenger vessels operating on its inland waterways. The Commission shall inform the Member States.

(c)
Compliance with the requirements of a Member State for operating on its non-linked inland waterways shall be specified in the Community inland navigation certificate referred to in Article 3 or, where Article 4(2) applies, in the supplementary Community inland navigation certificate.

(a)
vessels, tugs, pushers and floating equipment operating on navigable waterways not linked by inland waterway to the waterways of other Member States;

(b)
craft having a dead weight not exceeding 350 tonnes or craft not intended for the carriage of goods and having a water displacement of less than 100 m3, which were laid down before 1 January 1950 and operate exclusively on a national waterway.

Annex I
List of Community inland waterways divided geographically into Zones 1, 2, 3 and 4
10

Annex II
Minimum technical requirements applicable to vessels on inland waterways of Zones 1, 2, 3 and 4
29

Annex III
Subjects for possible additional technical requirements applicable to vessels on inland waterways of Zones 1 and 2
175

Annex IV
Subjects for possible reductions of the technical requirements applicable to vessels on inland waterways of Zones 3 and 4
176

Annex V
Model Community inland navigation certificates
177

Annex VI
Model register of Community inland navigation certificates
194

Annex VII
Classification societies
197

Annex VIII
Rules of procedure for the carrying out of inspections
199

Annex IX
Requirements applicable to signal lights, radar installations and rate-of-turn indicators
200

Ems
from a line linking the former Greetsiel lighthouse and the western pier of the port entrance at Eemshaven seawards as far as latitude 53° 30' N and longitude 6° 45' E, i.e. slightly seawards of the lightering area for dry-cargo carriers in the Alte Ems(*1)

SCOTLAND

Blue Mull Sound
Between Gutcher and Belmont

Yell Sound
Between Tofts Voe and Ulsta

Sullom Voe
Within a line from the north-east point of Gluss Island to the northern point of Calback Ness

Dales Voe
In winter:within a line from the north point of Kebister Ness to the Coast of Breiwick at longitude 1° 10,8' W

within a line from the north point of Kebister Ness to the Coast of Breiwick at longitude 1° 10,8' W

within a line from the north point of Kebister Ness to the Coast of Breiwick at longitude 1° 10,8' W

Dales Voe
In summer:as for Lerwick

as for Lerwick

as for Lerwick

Lerwick
In winter:within the area bounded to the northward by a line from Scottle Holm to Scarfi Taing on Bressay and to the southward by a line from Twageos Point Lighthouse to Whalpa Taing on Bressay

within the area bounded to the northward by a line from Scottle Holm to Scarfi Taing on Bressay and to the southward by a line from Twageos Point Lighthouse to Whalpa Taing on Bressay

within the area bounded to the northward by a line from Scottle Holm to Scarfi Taing on Bressay and to the southward by a line from Twageos Point Lighthouse to Whalpa Taing on Bressay

Lerwick
In summer:within the area bounded to the northward by a line from Brim Ness to the north east corner of Inner Score and to the southward by a line from the south end of Ness of Sound to Kirkabisterness

within the area bounded to the northward by a line from Brim Ness to the north east corner of Inner Score and to the southward by a line from the south end of Ness of Sound to Kirkabisterness

within the area bounded to the northward by a line from Brim Ness to the north east corner of Inner Score and to the southward by a line from the south end of Ness of Sound to Kirkabisterness

Kirkwall
Between Kirkwall and Rousay not east of a line between Point of Graand (Egilsay) and Galt Ness (Shapinsay) or between Head of Work (Mainland) through Helliar Holm light to the shore of Shapinsay; not north west of the south east tip of Eynhallow Island, not to seaward and a line between the shore on Rousay at 59°10,5' N 002° 57,1' W and the shore on Egilsay at 59° 10' N 002° 56,4' W

Stromness
To Scapa but not outside Scapa Flow

Scapa Flow
Within an area bounded by lines drawn from Point of Cletts on the island of Hoy to Thomson's Hill triangulation point on the island of Fara and thence to Gibraltar Pier on the island of Flotta; from St Vincent Pier on the island of Flotta to the westernmost point of Calf of Flotta; from the easternmost point of the Calf of Flotta to Needle Point on the island of South Ronaldsay and from the Ness on Mainland to Point of Oxan lighthouse on the island of Graemsay and thence to Bu Point on the island of Hoy; and seaward of Zone 2 waters

Balnakiel Bay
Between Eilean Dubh and A'Chleit

Cromarty Firth
Within a line from North Sutor to Nairn Breakwater and seaward of Zone 2 waters

Inverness
Within a line from North Sutor to Nairn Breakwater and seaward of Zone 2 waters

River Tay — Dundee
Within a line from Broughty Castle to Tayport and seaward of Zone 2 waters

Firth of Forth and River Forth
Within a line from Kirkcaldy to River Portobello and seaward of Zone 2 waters

Solway Firth
Within a line from Southerness Point to Silloth

Loch Ryan
Within a line from Finnart's Point to Milleur Point and seaward of Zone 2 waters

The Clyde
Outer limit:a line from Skipness to a position one mile south of Garroch Head thence to Farland HeadInner limit in winter:a line from Cloch Lighthouse to Dunoon PierInner limit in summer:a line from Bogany Point, Isle of Bute to Skelmorlie Castle and a line from Ardlamont Point to the southern extremity of Ettrick Bay inside the Kyles of ButeNote: The above inner summer limit is extended between 5 June and 5 September (both dates inclusive) by a line from a point two miles off the Ayrshire coast at Skelmorlie Castle to Tomont End, Cumbrae, and a line from Portachur Point, Cumbrae to Inner Brigurd Point, Ayrshire

a line from Skipness to a position one mile south of Garroch Head thence to Farland Head

a line from Cloch Lighthouse to Dunoon Pier

a line from Bogany Point, Isle of Bute to Skelmorlie Castle and a line from Ardlamont Point to the southern extremity of Ettrick Bay inside the Kyles of Bute

a line from Skipness to a position one mile south of Garroch Head thence to Farland Head

a line from Cloch Lighthouse to Dunoon Pier

a line from Bogany Point, Isle of Bute to Skelmorlie Castle and a line from Ardlamont Point to the southern extremity of Ettrick Bay inside the Kyles of Bute

Oban
Within an area bounded on the north by a line from Dunollie Point Light to Ard na Chruidh and to the south by a line from Rudha Seanach to Ard na Cuile

Kyle of Lochalsh
Through Loch Alsh to the head of Loch Duich

Loch Gairloch
In winter:noneIn summer:South of a line running east from Rubha na Moine to Eilan Horrisdale and thence to Rubha nan Eanntag

none

South of a line running east from Rubha na Moine to Eilan Horrisdale and thence to Rubha nan Eanntag

none

South of a line running east from Rubha na Moine to Eilan Horrisdale and thence to Rubha nan Eanntag

NORTHERN IRELAND

Belfast Lough
In winter:noneIn summer:within a line from Carrickfergus to Bangorand seaward of Zone 2 waters

none

within a line from Carrickfergus to Bangor

none

within a line from Carrickfergus to Bangor

Loch Neagh
At a greater distance than 2 miles from the shore

EAST COAST OF ENGLAND

River Humber
In winter:within a line from New Holland to PaullIn summer:within a line from Cleethorpes Pier to Patrington Churchand seaward of Zone 2 waters

within a line from New Holland to Paull

within a line from Cleethorpes Pier to Patrington Church

within a line from New Holland to Paull

within a line from Cleethorpes Pier to Patrington Church

WALES AND WEST COAST OF ENGLAND

River Severn
In winter:within a line from Blacknore Point to Caldicot Pill, PorstkewettIn summer:within a line from Barry Dock Pier to Steepholm and thence to Brean Downand seaward of Zone 2 waters

within a line from Blacknore Point to Caldicot Pill, Porstkewett

within a line from Barry Dock Pier to Steepholm and thence to Brean Down

within a line from Blacknore Point to Caldicot Pill, Porstkewett

within a line from Barry Dock Pier to Steepholm and thence to Brean Down

River Wye
In winter:within a line from Blacknore Point to Caldicot Pill, PortskewettIn summer:within a line from Barry Dock Pier to Steepholm and thence to Brean Downand seaward of Zone 2 waters

within a line from Blacknore Point to Caldicot Pill, Portskewett

within a line from Barry Dock Pier to Steepholm and thence to Brean Down

within a line from Blacknore Point to Caldicot Pill, Portskewett

within a line from Barry Dock Pier to Steepholm and thence to Brean Down

Newport
In winter:noneIn summer:within a line from Barry Dock Pier to Steepholm and thence to Brean Downand seaward of Zone 2 waters

none

within a line from Barry Dock Pier to Steepholm and thence to Brean Down

none

within a line from Barry Dock Pier to Steepholm and thence to Brean Down

Cardiff
In winter:noneIn summer:within a line from Barry Dock Pier to Steepholm and thence to Brean Downand seaward of Zone 2 waters

none

within a line from Barry Dock Pier to Steepholm and thence to Brean Down

none

within a line from Barry Dock Pier to Steepholm and thence to Brean Down

Barry
In winter:NoneIn summer:within a line from Barry Dock Pier to Steepholm and thence to Brean Downand seaward of Zone 2 waters

None

within a line from Barry Dock Pier to Steepholm and thence to Brean Down

None

within a line from Barry Dock Pier to Steepholm and thence to Brean Down

Swansea
Within a line joining the seaward ends of the breakwaters

Menai Straits
Within the Menai Straits from a line joining Llanddwyn Island Light to Dinas Dinlleu and lines joining the south end of Puffin Island to Trwyn DuPoint and Llanfairfechan Railway Station, and seaward of Zone 2 waters

River Dee
In winter:within a line from Hilbre Point to Point of AirIn summer:within a line from Formby Point to Point of Airand seaward of Zone 2 waters

within a line from Hilbre Point to Point of Air

within a line from Formby Point to Point of Air

within a line from Hilbre Point to Point of Air

within a line from Formby Point to Point of Air

River Mersey
In winter:NoneIn summer:within a line from Formby Point to Point of Airand seaward of Zone 2 waters

None

within a line from Formby Point to Point of Air

None

within a line from Formby Point to Point of Air

Preston and Southport
Within a line from Southport to Blackpool inside the banksand seaward of Zone 2 waters

Fleetwood
In winter:NoneIn summer:within a line from Rossal Point to Humphrey Headand seaward of Zone 2 waters

None

within a line from Rossal Point to Humphrey Head

None

within a line from Rossal Point to Humphrey Head

River Lune
In winter:NoneIn summer:within a line from Rossal Point to Humphrey Headand seaward of Zone 2 waters

None

within a line from Rossal Point to Humphrey Head

None

within a line from Rossal Point to Humphrey Head

Heysham
In winter:NoneIn summer:within a line from Rossal Point to Humphrey Head

None

within a line from Rossal Point to Humphrey Head

None

within a line from Rossal Point to Humphrey Head

Morecambe
In winter:NoneIn the summer:from within a line from Rossal Point to Humphrey Head

None

from within a line from Rossal Point to Humphrey Head

None

from within a line from Rossal Point to Humphrey Head

Workington
Within a line from Southerness Point to Sillothand seaward of Zone 2 waters

SOUTH OF ENGLAND

River Colne, Colchester
In winter:within a line from Colne Point to WhitstableIn summer:within a line from Clacton Pier to Reculvers

within a line from Colne Point to Whitstable

within a line from Clacton Pier to Reculvers

within a line from Colne Point to Whitstable

within a line from Clacton Pier to Reculvers

River Blackwater
In winter:within a line from Colne Point to WhitstableIn summer:within a line from Clacton Pier to Reculversand seaward of Zone 2 waters

within a line from Colne Point to Whitstable

within a line from Clacton Pier to Reculvers

within a line from Colne Point to Whitstable

within a line from Clacton Pier to Reculvers

River Crouch and River Roach
In winter:within a line from Colne Point to WhitstableIn summer:within a line from Clacton Pier to Reculversand seaward of Zone 2 waters

within a line from Colne Point to Whitstable

within a line from Clacton Pier to Reculvers

within a line from Colne Point to Whitstable

within a line from Clacton Pier to Reculvers

River Thames and its tributaries
In winter:within a line from Colne Point to WhitstableIn summer:within a line from Clacton Pier to Reculversand seaward of Zone 2 waters

within a line from Colne Point to Whitstable

within a line from Clacton Pier to Reculvers

within a line from Colne Point to Whitstable

within a line from Clacton Pier to Reculvers

River Medway and the Swale
In winter:within a line from Colne Point to WhitstableIn summer:within a line from Clacton Pier to Reculversand seaward of Zone 2 waters

within a line from Colne Point to Whitstable

within a line from Clacton Pier to Reculvers

within a line from Colne Point to Whitstable

within a line from Clacton Pier to Reculvers

Chichester
Inside the Isle of Wight within an area bounded by lines drawn between the church spire, West Wittering, to Trinity Church, Bembridge, to the eastward, and the Needles and Hurst Point to the westwardand seaward of Zone 2 waters

Langstone Harbour
Inside the Isle of Wight within an area bounded by lines drawn between the church spire, West Wittering, to Trinity Church, Bembridge, to the eastward, and the Needles and Hurst Point to the westwardand seaward of Zone 2 waters

Portsmouth
Inside the Isle of Wight within an area bounded by lines drawn between the church spire, West Wittering, to Trinity Church, Bembridge, to the eastward, and the Needles and Hurst Point to the westwardand seaward of Zone 2 waters

Bembridge, Isle of Wight
Inside the Isle of Wight within an area bounded by lines drawn between the church spire, West Wittering, to Trinity Church, Bembridge, to the eastward, and the Needles and Hurst Point to the westwardand seaward of Zone 2 waters

Cowes, Isle of Wight
Inside the Isle of Wight within an area bounded by lines drawn between the church spire, West Wittering, to Trinity Church, Bembridge, to the eastward, and the Needles and Hurst Point to the westwardand seaward of Zone 2 waters

Southampton
Inside the Isle of Wight within an area bounded by lines drawn between the church spire, West Wittering, to Trinity Church, Bembridge, to the eastward, and the Needles and Hurst Point to the westwardand seaward of Zone 2 waters

Beaulieu River
Inside the Isle of Wight within an area bounded by lines drawn between the church spire, West Wittering, to Trinity Church, Bembridge, to the eastward, and the Needles and Hurst Point to the westwardand seaward of Zone 2 waters

Keyhaven Lake
Inside the Isle of Wight within an area bounded by lines drawn between the church spire, West Wittering, to Trinity Church, Bembridge, to the eastward, and the Needles and Hurst Point to the westwardand seaward of Zone 2 waters

Weymouth
Within Portland Harbour and between the River Wey and Portland Harbour

Plymouth
Within a line from Cawsand to Breakwater to Staddonand seaward of Zone 2 waters

Falmouth
In winter:within a line from St Anthony Head to RosemullionIn summer:within a line from St Anthony Head to Nare Pointand seaward of Zone 2 waters

within a line from St Anthony Head to Rosemullion

within a line from St Anthony Head to Nare Point

within a line from St Anthony Head to Rosemullion

within a line from St Anthony Head to Nare Point

River Camel
Within a line from Stepper Point to Trebetherick Pointand seaward of Zone 2 waters

Bridgewater
Within the bar and seaward of Zone 2 waters

River Avon (Avon)
In winter:within a line from Blacknore Point to Caldicot Pill, PortskewettIn summer:within a line from Barry Pier to Steepholm and thence to Brean Downand seaward of Zone 2 waters

within a line from Blacknore Point to Caldicot Pill, Portskewett

within a line from Barry Pier to Steepholm and thence to Brean Down

within a line from Blacknore Point to Caldicot Pill, Portskewett

within a line from Barry Pier to Steepholm and thence to Brean Down

within a line from the north point of Kebister Ness to the Coast of Breiwick at longitude 1° 10,8' W

as for Lerwick

within the area bounded to the northward by a line from Scottle Holm to Scarfi Taing on Bressay and to the southward by a line from Twageos Point Lighthouse to Whalpa Taing on Bressay

within the area bounded to the northward by a line from Brim Ness to the north east corner of Inner Score and to the southward by a line from the south end of Ness of Sound to Kirkabisterness

a line from Skipness to a position one mile south of Garroch Head thence to Farland Head

a line from Cloch Lighthouse to Dunoon Pier

a line from Bogany Point, Isle of Bute to Skelmorlie Castle and a line from Ardlamont Point to the southern extremity of Ettrick Bay inside the Kyles of Bute

none

South of a line running east from Rubha na Moine to Eilan Horrisdale and thence to Rubha nan Eanntag

none

within a line from Carrickfergus to Bangor

within a line from New Holland to Paull

within a line from Cleethorpes Pier to Patrington Church

within a line from Blacknore Point to Caldicot Pill, Porstkewett

within a line from Barry Dock Pier to Steepholm and thence to Brean Down

within a line from Blacknore Point to Caldicot Pill, Portskewett

within a line from Barry Dock Pier to Steepholm and thence to Brean Down

none

within a line from Barry Dock Pier to Steepholm and thence to Brean Down

none

within a line from Barry Dock Pier to Steepholm and thence to Brean Down

None

within a line from Barry Dock Pier to Steepholm and thence to Brean Down

within a line from Hilbre Point to Point of Air

within a line from Formby Point to Point of Air

None

within a line from Formby Point to Point of Air

None

within a line from Rossal Point to Humphrey Head

None

within a line from Rossal Point to Humphrey Head

None

within a line from Rossal Point to Humphrey Head

None

from within a line from Rossal Point to Humphrey Head

within a line from Colne Point to Whitstable

within a line from Clacton Pier to Reculvers

within a line from Colne Point to Whitstable

within a line from Clacton Pier to Reculvers

within a line from Colne Point to Whitstable

within a line from Clacton Pier to Reculvers

within a line from Colne Point to Whitstable

within a line from Clacton Pier to Reculvers

within a line from Colne Point to Whitstable

within a line from Clacton Pier to Reculvers

within a line from St Anthony Head to Rosemullion

within a line from St Anthony Head to Nare Point

within a line from Blacknore Point to Caldicot Pill, Portskewett

within a line from Barry Pier to Steepholm and thence to Brean Down

Ems
From a line across the Ems near the entrance to the port of Papenburg between Diemen pumping station and the opening of the dyke at Halte as far as a line linking the former Greetsiel lighthouse and the western pier of the port entrance at Eemshaven

Jade
Inside a line linking the Schillig cross light and Langwarden church tower

Weser
From the north-western edge of the railway bridge in Bremen as far as a line linking Langwarden and Cappel church towers, including the Westergate, Rekumer Loch, Rechter Nebenarm and Schweiburg side branches

Elbe
From the lower limit of the port of Hamburg as far as a line linking the Döse beacon and the western edge of the Friedrichskoog dyke (Dieksand), including the Nebenelbe and the Este, Lühe, Schwinge, Oste, Pinnau, Krückau and Stör tributaries (in each case from the mouth to the barrage)

Meldorfer Bucht
Inside a line linking the western edge of the Friedrichskoog dyke (Dieksand) and the western pier head at Büsum

Eider
From the Gieselau Canal to the Eider barrage

Flensburger Förde
Inside a line linking Kegnäs lighthouse and Birknack

Schlei
Inside a line between the Schleimünde pier heads

Eckernförder Bucht
Inside a line linking Boknis-Eck and the north-eastern point of the mainland near Dänisch Nienhof

Kieler Förde
Inside a line linking the Bülk lighthouse and the Laboe naval memorial

Nord-Ostsee-Kanal (Kiel Canal)
From a line linking the pier heads at Brunsbüttel as far as a line linking the entry lights at Kiel-Holtenau, including Obereidersee and Enge, Audorfer See, Borgstedter See and Enge, Schirnauer See, Flemhuder See and the Achterwehrer Canal

Trave
from the north-western edge of the railway lift bridge and the northern edge of the Holstenbrücke (Stadttrave) in Lübeck as far as a line linking the southern inner and northern outer pier heads at Travemünde, including the Pötenitzer Wiek, Dassower See and the Altarmen at Teerhof island

Leda
From the entrance of the outer harbour of Leer sea lock to the mouth

Hunte
from the port of Oldenburg and from 140 m downstream of the Amalienbrücke in Oldenburg to the mouth

Lesum
From the Bremen-Burg railway bridge to the mouth

Este
From the tail water of Buxtehude lock to the Este barrage

Lühe
From the tail water of the Au-Mühle in Horneburg to the Lühe barrage

Schwinge
From the Salztor lock in Stade to the Schwinge barrage

Oste
From the north-eastern edge of the Bremervörde mill dam to the Oste barrage

Pinnau
From the south-western edge of the railway bridge in Pinneberg to the Pinnau barrage

Krückau
From the south-western edge of the bridge leading to/from the Wedenkamp in Elmshorn to the Krückau barrage

Stör
From Rensing tide gauge to the Stör barrage

Freiburger Hafenpriel
From the eastern edge of the sluice in Freiburg an der Elbe as far as the mouth

Wismarbucht, Kirchsee, Breitling, Salzhaff and Wismar port area
Seawards as far as a line between Hoher Wieschendorf Huk and Timmendorf light and a line linking Gollwitz light on the island of Poel and the southern point of the Wustrow peninsula

Warnow, including the Breitling and side branches
Downstream of the Mühlendamm from the northern edge of the Geinitzbrücke in Rostock towards the sea as far as a line linking the northern points of the western and eastern piers in Warnemünde

Waters enclosed by the mainland and the Darß and Zingst pensinsulas and the islands of Hiddensee and Rügen (including Stralsund port area)
Extending seawards between—the Zingst peninsula and the island of Bock: as far as latitude 54° 26' 42' N—the islands of Bock and Hiddensee: as far as a line linking the northern point of the island of Bock and the southern point of the island of Hiddensee—the island of Hiddensee and the island of Rügen (Bug): as far as a line linking the south-eastern point of Neubessin and Buger Haken
—
the Zingst peninsula and the island of Bock: as far as latitude 54° 26' 42' N
—
the islands of Bock and Hiddensee: as far as a line linking the northern point of the island of Bock and the southern point of the island of Hiddensee
—
the island of Hiddensee and the island of Rügen (Bug): as far as a line linking the south-eastern point of Neubessin and Buger Haken

—
the Zingst peninsula and the island of Bock: as far as latitude 54° 26' 42' N

—
the islands of Bock and Hiddensee: as far as a line linking the northern point of the island of Bock and the southern point of the island of Hiddensee

—
the island of Hiddensee and the island of Rügen (Bug): as far as a line linking the south-eastern point of Neubessin and Buger Haken

Greifswalder Bodden and Greifswald port area, including the Ryck
Seawards as far as a line from the eastern point of Thiessower Haken (Südperd) to the eastern point of the island of Ruden and continuing to the northern point of the island of Usedom (54° 10' 37' N, 13° 47' 51' E)

Waters enclosed by the mainland and the island of Usedom (the Peenestrom, including Wolgast port area and Achterwasser, and the Stettiner Haff)
Eastwards as far as the border with the Republic of Poland in the Stettiner Haff

—
the Zingst peninsula and the island of Bock: as far as latitude 54° 26' 42' N

—
the islands of Bock and Hiddensee: as far as a line linking the northern point of the island of Bock and the southern point of the island of Hiddensee

—
the island of Hiddensee and the island of Rügen (Bug): as far as a line linking the south-eastern point of Neubessin and Buger Haken

Dordogne
Downstream from the stone bridge at Libourne

Garonne and Gironde
Downstream from the stone bridge at Bordeaux

Loire
Downstream from the Haudaudine bridge on the Madeleine arm and downstream from the Pirmil bridge on the Pirmil arm.

Rhône
Downstream of the Trinquetaille bridge in Arles and beyond towards Marseille

Seine
Downstream of the Jeanne-d'Arc bridge in Rouen

SCOTLAND

Scapa Flow
Within an area bounded by lines drawn from Wharth on the island of Flotta to the Martello Tower on South Walls, and from Point Cletts on the island of Hoy to Thomson's Hill triangulation point on the island of Fara and thence to Gibraltar Pier on the island of Flotta

Kyle of Durness
South of Eilean Dubh

Cromarty Firth
Within a line between North Sutor and South Sutor

Inverness
Within a line from Fort George to Chanonry Point

Findhorn Bay
Within the spit

Aberdeen
Within a line from South Jetty to Abercromby Jetty

Montrose Basin
To the west of a line running north-south across the harbour entrance at Scurdie Ness Lighthouse

River Tay — Dundee
Within a line from the tidal basin (fish dock), Dundee to Craig Head, East Newport

Firth of Forth and River Forth
Within the Firth of Forth but not east of the Forth railway bridge

Dumfries
Within a line from Airds Point to Scar Point

Loch Ryan
Within a line from Cairn Point to Kircolm Point

Ayr Harbour
Inside the Bar

The Clyde
Above Zone 1 waters

Kyles of Bute
Between Colintraive and Rhubodach

Campbeltown Harbour
Within a line from Macringan's Point to Ottercharach Point

Loch Etive
Within Loch Etive above the Falls of Lora

Loch Leven
Above the bridge at Ballachulish

Loch Linnhe
North of Corran Point light

Loch Eil
The whole loch

Caledonian Canal
Lochs Lochy, Oich and Ness

Kyle of Lochalsh
Within Kyle Akin not westward of Eilean Ban Light or eastward of Eileanan Dubha

Loch Carron
Between Stromemore and Strome Ferry

Loch Broom, Ullapool
Within a line from Ullapool Point Light to Aultnaharrie

Kylesku
Across Loch Cairnbawn in the area between the easternmost point of Garbh Eilean and the westernmost point of Eilean na Rainich

Stornoway Harbour
Within a line from Arnish Point to Sandwick Bay Lighthouse, north-west side

The Sound of Scalpay
Not east of Berry Cove (Scalpay) and not west of Croc a Loin (Harris)

North Harbour, Scalpay and Tarbert Harbour
Within one mile from the shore of the Island of Harris

Loch Awe
The whole loch

Loch Katrine
The whole loch

Loch Lomond
The whole loch

Loch Tay
The whole loch

Loch Loyal
The whole loch

Loch Hope
The whole loch

Loch Shin
The whole loch

Loch Assynt
The whole loch

Loch Glascarnoch
The whole loch

Loch Fannich
The whole loch

Loch Maree
The whole loch

Loch Gairloch
The whole loch

Loch Monar
The whole loch

Loch Mullardach
The whole loch

Loch Cluanie
The whole loch

Loch Loyne
The whole loch

Loch Garry
The whole loch

Loch Quoich
The whole loch

Loch Arkaig
The whole loch

Loch Morar
The whole loch

Loch Shiel
The whole loch

Loch Earn
The whole loch

Loch Rannoch
The whole loch

Loch Tummel
The whole loch

Loch Ericht
The whole loch

Loch Fionn
The whole loch

Loch Glass
The whole loch

Loch Rimsdale/nan Clar
The whole loch

NORTHERN IRELAND

Strangford Lough
Within a line from Cloghy Point to Dogtail Point

Belfast Lough
Within a line from Holywood to Macedon Point

Larne
Within a line from Larne Pier to the ferry pier on Island Magee

River Bann
From the seaward ends of the breakwaters to Toome Bridge

Lough Erne
Upper and Lower Lough Erne

Lough Neagh
Within two miles of the shore

EAST COAST OF ENGLAND

Berwick
Within the breakwaters

Warkworth
Within the breakwaters

Blyth
Within the Outer Pier Heads

River Tyne
Dunston Staithes to Tyne Pier Heads

River Wear
Fatfield to Sunderland Pier Heads

Seaham
Within the breakwaters

Hartlepool
Within a line from Middleton Jetty to Old Pier HeadWithin a line joining North Pier Head to South Pier Head

River Tees
Within a line extending due west from Government Jetty to Tees Barrage

Whitby
Within Whitby Pier Heads

River Humber
Within a line from North Ferriby to South Ferriby

Grimsby Dock
Within a line from the West Pier of the Tidal Basin to the East Pier of the Fish Docks, North Quay

Boston
Inside the New Cut

Dutch River
The whole canal

River Hull
Beverley Beck to River Humber

Kielder Water
The whole lake

River Ouse
Below Naburn Lock

River Trent
Below Cromwell Lock

River Wharfe
From the junction with River Ouse to Tadcaster Bridge

Scarborough
Within Scarborough Pier Heads

WALES AND WEST COAST OF ENGLAND

River Severn
North of a line running due west from Sharpness Point (51° 43,4' N) to Llanthony and Maisemore Weirs and seaward of Zone 3 waters

River Wye
At Chepstow, north of latitude (51° 38,0' N) to Monmouth

Newport
North of the overhead power cables crossing at Fifoots Points

Cardiff
Within a line from South Jetty to Penarth Headand the enclosed waters to the west of Cardiff Bay Barrage

Barry
Within a line joining the seaward ends of the breakwaters

Port Talbot
Within a line joining the seaward ends of the breakwaters on the River Afran outside enclosed docks

Neath
Within a line running due North from the seaward end of Baglan Bay Tanker Jetty (51° 37,2' N, 3° 50,5' W)

Llanelli and Burry Port
Within an area bounded by a line drawn from Burry Port Western Pier to Whiteford Point

Milford Haven
Within a line from South Hook Point to Thorn Point

Fishguard
Within a line joining the seaward ends of the north and east breakwaters

Cardigan
Within the Narrows at Pen-Yr-Ergyd

Aberystwyth
Within the seaward ends of the breakwaters

Aberdyfi
Within a line from Aberdyfi Railway Station to Twyni Bach Beacon

Barmouth
Within a line from Barmouth Railway Station to Penrhyn Point

Portmadoc
Within a line from Harlech Point to Graig Ddu

Holyhead
Within an area bounded by the main breakwater and a line drawn from the head of the breakwater to Brynglas Point, Towyn Bay

Menai Straits
Within the Menai Straits between a line joining Aber Menai Point to Belan Point and a line joining Beaumaris Pier to Pen-y-Coed Point

Conway
Within a line from Mussel Hill to Tremlyd Point

Llandudno
Within the breakwater

Rhyl
Within the breakwater

River Dee
Above Connah's Quay to Barrelwell Hill water extraction point

River Mersey
Within a line between the Rock Lighthouse and the North West Seaforth Dockbut excluding other docks

Preston and Southport
Within a line from Lytham to Southport and within Preston Docks

Fleetwood
Within a line from Low Light to Knott

River Lune
Within a line from Sunderland Point to Chapel Hill up to and including Glasson Dock

Barrow
Within a line joining Haws Point, Isle of Walney to Roa Island Slipway

Whitehaven
Within the breakwater

Workington
Within the breakwater

Maryport
Within the breakwater

Carlisle
Within a line joining Point Carlisle to Torduff

Coniston Water
The whole lake

Derwentwater
The whole lake

Ullswater
The whole lake

Windermere
The whole lake

SOUTH OF ENGLAND

Blakeney and Morston Harbour and approaches
To the east of a line running south from Blakeney Point to the entrance of the Stiffkey River

River Orwell and River Stour
River Orwell within a line from Blackmanshead breakwater to Landguard Point and seaward of Zone 3 waters

River Blackwater
All waterways within a line from the south-western extremity of Mersea Island to Sales Point

River Crouch and River Roach
River Crouch within a line from Holliwell Point to Foulness Point, including the River Roach

River Thames and its tributaries
River Thames above a line drawn north/south through the eastern extremity of Denton Wharf Pier, Gravesend to Teddington Lock

River Medway and the Swale
River Medway from a line drawn from Garrison Point to the Grain Tower, to Allington Lock; and the Swale from Whitstable to the Medway

River Stour (Kent)
River Stour above the mouth to the landing at Flagstaff Reach

Dover Harbour
Within lines drawn across the east and west entrances to the Harbour

River Rother
River Rother above the Tidal Signal Station at Camber to Scots Float Sluice and to the entrance lock on the River Brede

River Adur and Southwick Canal
Within a line drawn across Shoreham Harbour entrance to Southwick Canal Lock and to the west end of Tarmac Wharf

River Arun
River Arun above Littlehampton Pier to Littlehampton Marina

River Ouse (Sussex) Newhaven
River Ouse from a line drawn across Newhaven Harbour entrance piers to the north end of North Quay

Brighton
Brighton Marina outer harbour within a line from the southern end of West Quay to the north end of South Quay

Chichester
Within a line drawn between Eastoke point and the church spire, West Wittering and seaward of Zone 3 waters

Langstone Harbour
Within a line drawn between Eastney Point and Gunner Point

Portsmouth
Within a line drawn across the harbour entrance from Port Blockhouse to the Round Tower

Bembridge, Isle of Wight
Within Brading Harbour

Cowes, Isle of Wight
The River Medina within a line from the Breakwater Light on the east bank to the House Light on the west bank

Southampton
Within a line from Calshot Castle to Hook Beacon

Beaulieu River
Within Beaulieu River not eastward of a north/south line through Inchmery House

Keyhaven Lake
Within a line drawn due north from Hurst Point Low Light to Keyhaven Marshes

Christchurch
The Run

Poole
Within the line of the Chain Ferry between Sandbanks and South Haven Point

Exeter
Within an east-west line from Warren Point to the Inshore Lifeboat Station opposite Checkstone Ledge

Teignmouth
Within the harbour

River Dart
Within a line from Kettle Point to Battery Point

River Salcombe
Within a line from Splat Point to Limebury Point

Plymouth
Within a line from Mount Batten Pier to Raveness Point through Drake's Islands; the River Yealm within a line from Warren Point to Misery Point

Fowey
Inside the Harbour

Falmouth
Within a line from St. Anthony Head to Pendennis Point

River Camel
Within a line from Gun Point to Brea Hill

Rivers Taw and Torridge
Within a line bearing 200° from the lighthouse on Crow Point to the shore at Skern Point

Bridgewater
South of a line running due East from Stert Point (51° 13,0 'N)

River Avon (Avon)
Within a line from Avonmouth Pier to Wharf Point, to Netham Dam

Danube
From Kelheim (km 2 414,72 ) to the German-Austrian border

Rhine
From the German-Swiss border to the German-Netherlands border

Elbe
From the mouth of the Elbe-Seiten canal to the lower limit of the port of Hamburg

Müritz

—
River Biebrza from the estuary of the Augustowski Channel to the estuary of the river Narwia

—
River Brda from the link with the Bydgoski Channel in Bydgoszcz to the estuary of the river Wisła

—
River Bug from the estuary of the river Muchawiec to the estuary of the river Narwia

—
Lake Dąbie to the frontier with internal sea waters

—
The Augustowski Channel from the link with the river Biebrza to the State border, together with the lakes located along the route of this Channel

—
The Bartnicki Channel from Lake Ruda Woda to Lake Bartężek, together with Lake Bartężek

—
The Bydgoski Channel

—
The Elbląski Channel from Lake Druzno to Lake Jeziorak and Lake Szeląg Wielki, together with these lakes and the lakes on the route of the Channel, and a byway in the direction of Zalewo from Lake Jeziorak to Lake Ewingi, inclusive

—
The Gliwicki Channel together with the Channel Kędzierzyński

—
The Jagielloński Channel from the link with the river Elbląg to the river Nogat

—
The Łączański Channel

—
The Ślesiński Channel with the lakes located along the route of this Channel and Lake Gopło

—
The Żerański Channel

—
River Martwa Wisła from the river Wisła in Przegalina to the frontier with internal sea waters

—
River Narew from the estuary of the river Biebrza to the estuary of the river Wisła, together with Lake Zegrzyński

—
River Nogat from the river Wisła to the estuary of the Lagoon of Wisła

—
River Noteć (upper) from Lake Gopło to the link with the Górnonotecki Channel and the Górnonotecki Channel and River Noteć (lower) from the link of the Bydgoski Channel to the estuary to River Warta

—
River Nysa Łużycka from Gubin to the estuary to River Odra

—
River Odra from the town of Racibórz to the link with River Eastern Odra which turns into River Regalica from the Klucz-Ustowo Piercing, together with that river and its side-branches to Lake Dąbie as well as a byway of River Odra from the Opatowice lock to the lock in Wrocław city

—
River Western Odra from a weir in Widuchowa (704,1 km of River Odra) to a border with internal sea waters, together with side-branches as well as the Klucz-Ustowo Piercing linking River Eastern Odra with River Western Odra

—
River Parnica and the Parnicki Piercing from River Western Odra to a border with internal sea waters

—
River Pisa from Lake Roś to the estuary of River Narew

—
River Szkarpawa from River Wisła to the estuary of the Lagoon of Wisła

—
River Warta from the Ślesińskie Lake to the estuary of River Odra

—
System of Wielkie Jeziora Mazurskie encompassing the lakes linked by the rivers and channels constituting a main route from Lake Roś (inclusive) in Pisz to the Węgorzewski Channel (including that channel) in Węgorzewo, together with Lakes Seksty, Mikołajskie, Tałty, Tałtowisko, Kotek, Szymon, Szymoneckie, Jagodne, Boczne, Tajty, Kisajno, Dargin, Łabap, Kirsajty and Święcajty, together with the Giżycki Channel and the Niegociński Channel and the Piękna Góra Channel, and a byway of Lake Ryńskie (inclusive) in Ryn to Lake Nidzkie (up to 3 km, constituting a border with the ‘Lake Nidzkie’ nature reserve), together with lakes Bełdany, Guzianka Mała and Guzianka Wielka

—
River Wisła from the estuary of River Przemsza to the link with the Łączański Channel as well as from the estuary of that Channel in Skawina to the estuary of River Wisła to the Bay of Gdańsk, excluding the Włocławski Reservoir

SCOTLAND

Leith (Edinburgh)
Within the breakwaters

Glasgow
Strathclyde Loch

Crinan Canal
Crinan to Ardrishaig

Caledonian Canal
The canal sections

NORTHERN IRELAND

River Lagan
Lagan Weir to Stranmillis

EAST OF ENGLAND

River Wear (non-tidal)
Old Railway Bridge, Durham to Prebends Bridge, Durham

River Tees
Upriver from Tees Barrage

Grimsby Dock
Inside of the locks

Immingham Dock
Inside of the locks

Hull Docks
Inside of the locks

Boston Dock
Inside the lock gates

Aire and Calder Navigation
Goole Docks to Leeds; junction with Leeds and Liverpool Canal; Bank Dole Junction to Selby (River Ouse Lock); Castleford Junction to Wakefield (Falling Lock)

River Ancholme
Ferriby Sluice to Brigg

Calder and Hebble Canal
Wakefield (Falling Lock) to Broadcut Top Lock

River Foss
From (Blue Bridge) junction with River Ouse to Monk Bridge

Fossdyke Canal
Junction with River Trent to Brayford Pool

Goole Dock
Inside the lock gates

Hornsea Mere
The whole canal

River Hull
From Struncheon Hill Lock to Beverley Beck

Market Weighton Canal
River Humber Lock to Sod Houses Lock

New Junction Canal
The whole canal

River Ouse
From Naburn Lock to Nun Monkton

Sheffield and South Yorkshire Canal
Keadby Lock to Tinsley Lock

River Trent
Cromwell Lock to Shardlow

River Witham
Boston Sluice to Brayford Poole (Lincoln)

WALES AND WEST OF ENGLAND

River Severn
Above Llanthony and Maisemore Weirs

River Wye
Above Monmouth

Cardiff
Roath Park Lake

Port Talbot
Within the enclosed docks

Swansea
Within the enclosed docks

River Dee
Above Barrelwell Hill water extraction point

River Mersey
The docks (excluding Seaforth Dock)

River Lune
Above Glasson Dock

River Avon (Midland)
Tewkesbury Lock to Evesham

Gloucester
Gloucester City Docks Gloucester/Sharpness Canal

Hollingworth Lake
The whole lake

Manchester Ship Canal
The whole canal and Salford Docks including River Irwell

Pickmere Lake
The whole lake

River Tawe
Between Sea Barrage/Marina and the Morfa Athletics Stadium

Rudyard Lake
The whole lake

River Weaver
Below Northwich

SOUTH OF ENGLAND

River Nene
Wisbech Cut and River Nene to Dog-in-a-Doublet Lock

River Great Ouse
Kings Lynn Cut and River Great Ouse below West Lynn Road Bridge

Yarmouth
River Yare Estuary from a line drawn across the ends of the north and south entrance piers, including Breydon Water

Lowestoft
Lowestoft Harbour below Mutford Lock to a line drawn across the outer harbour entrance piers

Rivers Alde and Ore
Above the entrance to the River Ore to Westrow Point

River Deben
Above the entrance of the River Deben to Felixstowe Ferry

River Orwell and River Stour
From a line drawn from Fagbury Point to Shotley Point on the River Orwell to Ipswich Dock; and from a line drawn north/south through Erwarton Ness on the River Stour to Manningtree

Chelmer & Blackwater Canal
Eastward of Beeleigh Lock

River Thames and its tributaries
River Thames above Teddington Lock to Oxford

River Adur and Southwick Canal
River Adur above the west end of Tarmac Wharf, and within Southwick Canal

River Arun
River Arun above Littlehampton Marina

River Ouse (Sussex), Newhaven
River Ouse above the north end of North Quay

Bewl Water
The whole lake

Grafham Water
The whole lake

Rutland Water
The whole lake

Thorpe Park Lake
The whole lake

Chichester
East of a line joining Cobnor Point and Chalkdock Point

Christchurch
Within Christchurch Harbour excluding the Run

Exeter Canal
The whole canal

River Avon (Avon)
Bristol City DocksNetham Dam to Pulteney Weir

SCOTLAND

Ratho and Linlithgow Union Canal
The whole canal

Glasgow
Forth and Clyde CanalMonkland Canal, Faskine and Drumpellier sectionsHogganfield Loch

EAST OF ENGLAND

River Ancholme
Brigg to Harram Hill Lock

Calder and Hebble Canal
Broadcut Top Lock to Sowerby Bridge

Chesterfield Canal
West Stockwith to Worksop

Cromford Canal
The whole canal

River Derwent
From junction with River Ouse to Stamford Bridge

Driffield Navigation
From Struncheon Hill Lock to Great Driffield

Erewash Canal
Trent Lock to Langley Mill Lock

Huddersfield Canal
Junction with Calder and Hebble at Coopers Bridge to Huddersfield Narrow Canal at HuddersfieldBetween Ashton-Under-Lyne and Huddersfield

Leeds and Liverpool Canal
From Leeds River Lock to Skipton Wharf

Light Water Valley Lake
The whole lake

The Mere, Scarborough
The whole lake

River Ouse
Above Nun Monkton Pool

Pocklington Canal
From the junction with River Derwent to Melbourne Basin

Sheffield and South Yorkshire Canal
Tinsley Lock to Sheffield

River Soar
Trent Junction to Loughborough

Trent and Mersey Canal
Shardlow to Dellow Lane Lock

River Ure and Ripon Canal
From Junction with River Ouse to Ripon Canal (Ripon Basin)

Ashton Canal
The whole canal

WALES AND WEST OF ENGLAND

River Avon (Midland)
Above Evesham

Birmingham Canal Navigation
The whole canal

Birmingham and Fazeley Canal
The whole canal

Coventry Canal
The whole canal

Grand Union Canal (from Napton Junction to Birmingham and Fazeley)
The whole section of the canal

Kennet and Avon Canal (Bath to Newbury)
The whole section of the canal

Lancaster Canal
The whole canal

Leeds and Liverpool Canal
The whole canal

Llangollen Canal
The whole canal

Caldon Canal
The whole canal

Peak Forest Canal
The whole canal

Macclesfield Canal
The whole canal

Monmouthshire and Brecon Canal
The whole canal

Montgomery Canal
The whole canal

Rochdale Canal
The whole canal

Swansea Canal
The whole canal

Neath & Tennant Canal
The whole canal

Shropshire Union Canal
The whole canal

Staffordshire and Worcester Canal
The whole canal

Stratford-upon-Avon Canal
The whole canal

River Trent
The whole river

Trent and Mersey Canal
The whole canal

River Weaver
Above Northwich

Worcester and Birmingham Canal
The whole canal

SOUTH OF ENGLAND

River Nene
Above Dog-in-a-Doublet Lock

River Great Ouse
Kings Lynn above West Lynn Road Bridge; River Great Ouse and all connected Fenland Waterways including the River Cam and Middle Level Navigation

The Norfolk and Suffolk Broads
All navigable tidal and non-tidal rivers, broads, canals and waterways within the Norfolk and Suffolk Broads including Oulton Broad, and Rivers Waveney, Yare, Bure, Ant and Thurne except as specified for Yarmouth and Lowestoft

River Blyth
River Blyth, entrance to Blythburgh

Rivers Alde and Ore
On the River Alde above Westrow Point

River Deben
River Deben above Felixstowe Ferry

River Orwell and River Stour
All waterways on the River Stour above Manningtree

Chelmer & Blackwater Canal
Westward of Beeleigh Lock

River Thames and its tributaries
River Stort and River Lee above Bow Creek; Grand Union Canal above Brentford Lock and Regents Canal above Limehouse Basin and all canals connected therewith; River Wey above Thames Lock; Kennet and Avon Canal; River Thames above Oxford; Oxford Canal

River Medway and the Swale
River Medway above Allington Lock

River Stour (Kent)
River Stour above the landing at Flagstaff Reach

Dover Harbour
The whole harbour

River Rother
River Rother and the Royal Military Canal above Scots Float Sluice and River Brede above the entrance lock

Brighton
Brighton Marina inner harbour above the lock

Wickstead Park Lake
The whole lake

Kennet and Avon Canal
The whole canal

Grand Union Canal
The whole canal

River Avon (Avon)
Above Pulteney Weir

Bridgewater Canal
The whole canal

PART I
38

CHAPTER 1
38

GENERAL
38

Article 1.01 —
Definitions
38

Article 1.02 —
(Left void)
42

Article 1.03 —
(Left void)
42

Article 1.04 —
(Left void)
42

Article 1.05 —
(Left void)
42

Article 1.06 —
Temporary requirements
42

Article 1.07 —
Administrative instructions
42

CHAPTER 2
42

PROCEDURE
42

Article 2.01 —
Inspection bodies
42

Article 2.02 —
Request for an inspection
43

Article 2.03 —
Presentation of the craft for inspection
43

Article 2.04 —
(Left void)
43

Article 2.05 —
Provisional Community certificate
43

Article 2.06 —
Validity of the Community certificate
44

Article 2.07 —
Particulars in and amendments to the Community certificate
44

Article 2.08 —
(Left void)
44

Article 2.09 —
Periodical inspection
44

Article 2.10 —
Voluntary inspection
44

Article 2.11 —
(Left void)
44

Article 2.12 —
(Left void)
44

Article 2.13 —
(Left void)
44

Article 2.14 —
(Left void)
45

Article 2.15 —
Expenses
45

Article 2.16 —
Information
45

Article 2.17 —
Register of Community certificates
45

Article 2.18 —
Official number
45

Article 2.19 —
Equivalences and derogations
45

PART II
46

CHAPTER 3
46

SHIPBUILDING REQUIREMENTS
46

Article 3.01 —
Basic requirement
46

Article 3.02 —
Strength and stability
46

Article 3.03 —
Hull
47

Article 3.04 —
Engine and boiler rooms, bunkers
47

CHAPTER 4
48

SAFETY CLEARANCE, FREEBOARD AND DRAUGHT MARKS
48

Article 4.01 —
Safety clearance
48

Article 4.02 —
Freeboard
48

Article 4.03 —
Minimum freeboard
50

Article 4.04 —
Draught marks
50

Article 4.05 —
Maximum loaded draught of vessels whose holds are not always closed so as to be spray-proof and weathertight
51

Article 4.06 —
Draught scales
51

CHAPTER 5
52

MANOEUVRABILITY
52

Article 5.01 —
General
52

Article 5.02 —
Navigation tests
52

Article 5.03 —
Test area
52

Article 5.04 —
Degree of loading of vessels and convoys during navigation tests
52

Article 5.05 —
Use of on-board facilities for navigation test
52

Article 5.06 —
Prescribed (forward) speed
53

Article 5.07 —
Stopping capacity
53

Article 5.08 —
Capacity for going astern
53

Article 5.09 —
Capacity for taking evasive action
53

Article 5.10 —
Turning capacity
53

CHAPTER 6
53

STEERING SYSTEM
53

Article 6.01 —
General requirements
53

Article 6.02 —
Steering apparatus drive unit
54

Article 6.03 —
Hydraulic steering apparatus drive unit
54

Article 6.04 —
Power source
54

Article 6.05 —
Manual drive
55

Article 6.06 —
Rudder-propeller, water-jet, cycloidal-propeller and bow-thruster systems
55

Article 6.07 —
Indicators and monitoring devices
55

Article 6.08 —
Rate-of-turn regulators
55

Article 6.09 —
Acceptance procedure
55

CHAPTER 7
56

WHEELHOUSE
56

Article 7.01 —
General
56

Article 7.02 —
Unobstructed view
56

Article 7.03 —
General requirements concerning control, indicating and monitoring equipment
57

Article 7.04 —
Specific requirements concerning control, indicating and monitoring equipment of main engines and steering system
57

Article 7.05 —
Navigation lights, light signals and sound signals
58

Article 7.06 —
Radar installations and rate-of-turn indicators
58

Article 7.07 —
Radio telephony systems for vessels with wheelhouses designed for radar navigation by one person
59

Article 7.08 —
Internal communication facilities on board
59

Article 7.09 —
Alarm system
59

Article 7.10 —
Heating and ventilation
59

Article 7.11 —
Stern-anchor operating equipment
59

Article 7.12 —
Retractable wheelhouses
59

Article 7.13 —
Entry in the Community certificate for vessels with wheelhouses designed for radar navigation by one person
60

CHAPTER 8
60

ENGINE DESIGN
60

Article 8.01 —
General
60

Article 8.02 —
Safety equipment
60

Article 8.03 —
Power plant
60

Article 8.04 —
Engine exhaust system
61

Article 8.05 —
Fuel tanks, pipes and accessories
61

Article 8.06 —
Storage of lubricating oil, pipes and accessories
62

Article 8.07 —
Storage of oils used in power transmission systems, control and activating systems and heating systems, pipes and accessories
62

Article 8.08 —
Bilge pumping and drainage systems
63

Article 8.09 —
Oily water and used oil stores
64

Article 8.10 —
Noise emitted by vessels
64

CHAPTER 8a
(Left void)
64

CHAPTER 9
64

ELECTRICAL EQUIPMENT
64

Article 9.01 —
General
64

Article 9.02 —
Electricity supply systems
65

Article 9.03 —
Protection against physical contact, intrusion of solid objects and the ingress of water
65

Article 9.04 —
Protection from explosion
66

Article 9.05 —
Earthing
66

Article 9.06 —
Maximum permissible voltages
66

Article 9.07 —
Distribution systems
67

Article 9.08 —
Connection to shore or other external networks
67

Article 9.09 —
Power supply to other craft
68

Article 9.10 —
Generators and motors
68

Article 9.11 —
Accumulators
68

Article 9.12 —
Switchgear installations
69

Article 9.13 —
Emergency circuit breakers
70

Article 9.14 —
Installation fittings
70

Article 9.15 —
Cables
70

Article 9.16 —
Lighting installations
71

Article 9.17 —
Navigation lights
71

Article 9.18 —
(Left void)
71

Article 9.19 —
Alarm and safety systems for mechanical equipment
71

Article 9.20 —
Electronic equipment
72

Article 9.21 —
Electromagnetic compatibility
73

CHAPTER 10
73

EQUIPMENT
73

Article 10.01 —
Anchor equipment
73

Article 10.02 —
Other equipment
75

Article 10.03 —
Portable fire extinguishers
76

Article 10.03a
Permanently installed fire-fighting systems in accommodation spaces, wheelhouses and passenger spaces
76

Article 10.03b
Permanently installed fire-fighting systems in engine rooms, boiler rooms and pump rooms
77

Article 10.04 —
Ship's boats
81

Article 10.05 —
Lifebuoys and lifejackets
81

CHAPTER 11
81

SAFETY AT WORK STATIONS
81

Article 11.01 —
General
81

Article 11.02 —
Protection against falling
81

Article 11.03 —
Dimensions of working spaces
82

Article 11.04 —
Side decks
82

Article 11.05 —
Access to working spaces
82

Article 11.06 —
Exits and emergency exits
83

Article 11.07 —
Ladders, steps and similar devices
83

Article 11.08 —
Interior spaces
83

Article 11.09 —
Protection against noise and vibration
83

Article 11.10 —
Hatch covers
83

Article 11.11 —
Winches
84

Article 11.12 —
Cranes
84

Article 11.13 —
Storing flammable liquids
85

CHAPTER 12
85

ACCOMMODATION
85

Article 12.01 —
General
85

Article 12.02 —
Special design requirements for accommodation
86

Article 12.03 —
Sanitary installations
86

Article 12.04 —
Galleys
87

Article 12.05 —
Potable water
87

Article 12.06 —
Heating and ventilation
88

Article 12.07 —
Other accommodation installations
88

CHAPTER 13
88

FUEL-FIRED HEATING, COOKING AND REFRIGERATING EQUIPMENT
88

Article 13.01 —
General
88

Article 13.02 —
Use of liquid fuels, oil-fired equipment
88

Article 13.03 —
Vaporising oil burner stoves and atomising oil burner heating appliances
89

Article 13.04 —
Vaporising oil burner stoves
89

Article 13.05 —
Atomising oil burner heating appliances
89

Article 13.06 —
Forced-air heating appliances
89

Article 13.07 —
Solid fuel heating
90

CHAPTER 14
90

LIQUEFIED GAS INSTALLATIONS FOR DOMESTIC PURPOSES
90

Article 14.01 —
General
90

Article 14.02 —
Installations
90

Article 14.03 —
Receptacles
91

Article 14.04 —
Location and arrangement of supply units
91

Article 14.05 —
Spare and empty receptacles
91

Article 14.06 —
Pressure regulators
91

Article 14.07 —
Pressure
92

Article 14.08 —
Piping and flexible tubes
92

Article 14.09 —
Distribution system
92

Article 14.10 —
Gas-consuming appliances and their installation
92

Article 14.11 —
Ventilation and evacuation of combustion gases
93

Article 14.12 —
Operating and safety requirements
93

Article 14.13 —
Acceptance test
93

Article 14.14 —
Tests
93

Article 14.15 —
Attestation
94

CHAPTER 15
94

SPECIFIC REQUIREMENTS APPLICABLE TO PASSENGER VESSELS
94

Article 15.01 —
General provisions
94

Article 15.02 —
Vessels' hulls
94

Article 15.03 —
Stability
96

Article 15.04 —
Safety clearance and freeboard
100

Article 15.05 —
Maximum permitted number of passengers
101

Article 15.06 —
Passenger rooms and areas
101

Article 15.07 —
Propulsion system
104

Article 15.08 —
Safety devices and equipment
104

Article 15.09 —
Life-saving equipment
105

Article 15.10 —
Electrical Equipment
106

Article 15.11 —
Fire protection
107

Article 15.12 —
Fire-fighting
111

Article 15.13 —
Safety organisation
112

Article 15.14 —
Waste water collection and disposal facilities
113

Article 15.15 —
Derogations for certain passenger vessels
113

CHAPTER 15a
114

SPECIFIC REQUIREMENTS FOR PASSENGER SAILING VESSELS
114

Article 15a.01 —
Application of Part II
114

Article 15a.02 —
Exceptions for certain passenger sailing vessels
115

Article 15a.03 —
Stability requirements for vessels under sail
115

Article 15a.04 —
Shipbuilding and mechanical requirements
115

Article 15a.05 —
Rigging in general
116

Article 15a.06 —
Masts and spars in general
116

Article 15a.07 —
Special provisions for masts
116

Article 15a.08 —
Special provisions for topmasts
117

Article 15a.09 —
Special provisions for bowsprits
118

Article 15a.10 —
Special provisions for jib-booms
118

Article 15a.11 —
Special provisions for main booms
118

Article 15a.12 —
Special provisions for gaffs
119

Article 15a.13 —
General provisions for standing and running rigging
119

Article 15a.14 —
Special provisions for standing rigging
119

Article 15a.15 —
Special provisions for running rigging
120

Article 15a.16 —
Fittings and parts of the rigging
121

Article 15a.17 —
Sails
122

Article 15a.18 —
Equipment
122

Article 15a.19 —
Testing
122

CHAPTER 16
122

SPECIFIC REQUIREMENTS APPLICABLE TO CRAFT INTENDED TO FORM PART OF A PUSHED OR TOWED CONVOY OR OF A SIDE-BY-SIDE FORMATION
122

Article 16.01 —
Craft suitable for pushing
122

Article 16.02 —
Craft suitable for being pushed
123

Article 16.03 —
Craft suitable for propelling side-by-side formations
123

Article 16.04 —
Craft suitable for being propelled in convoys
123

Article 16.05 —
Craft suitable for towing
123

Article 16.06 —
Navigation tests on convoys
124

Article 16.07 —
Entries on the Community certificate
124

CHAPTER 17
124

SPECIFIC REQUIREMENTS APPLICABLE TO FLOATING EQUIPMENT
124

Article 17.01 —
General
124

Article 17.02 —
Derogations
124

Article 17.03 —
Additional requirements
125

Article 17.04 —
Residual safety clearance
125

Article 17.05 —
Residual freeboard
125

Article 17.06 —
Heeling test
126

Article 17.07 —
Confirmation of stability
126

Article 17.08 —
Confirmation of stability in the case of reduced residual freeboard
127

Article 17.09 —
Draught marks and draught scales
128

Article 17.10 —
Floating equipment without confirmation of stability
128

CHAPTER 18
128

SPECIFIC REQUIREMENTS APPLICABLE TO WORKSITE CRAFT
128

Article 18.01 —
Operating conditions
128

Article 18.02 —
Application of Part II
128

Article 18.03 —
Derogations
128

Article 18.04 —
Safety clearance and freeboard
129

Article 18.05 —
Ship's boats
129

CHAPTER 19
129

SPECIFIC REQUIREMENTS APPLICABLE TO HISTORIC VESSELS (Left void)
129

CHAPTER 19a
129

SPECIFIC REQUIREMENTS APPLICABLE TO CANAL BARGES (Left void)
129

CHAPTER 19b
129

SPECIFIC REQUIREMENTS APPLICABLE TO VESSELS NAVIGATING ON ZONE 4 WATERWAYS
129

Article 19b.01 —
Application of Chapter 4
129

CHAPTER 20
129

SPECIFIC REQUIREMENTS APPLICABLE TO SEA-GOING VESSELS (Left void)
129

CHAPTER 21
129

SPECIFIC REQUIREMENTS APPLICABLE TO RECREATIONAL CRAFT
129

Article 21.01 —
General
129

Article 21.02 —
Application of Part II
130

Article 21.03 —
(Left void)
130

CHAPTER 22
131

STABILITY OF VESSELS CARRYING CONTAINERS
131

Article 22.01 —
General
131

Article 22.02 —
Limit conditions and method of calculation for confirmation of stability for the transport of non-secured containers
131

Article 22.03 —
Limit conditions and method of calculation for confirmation of stability for the transport of secured containers
133

Article 22.04 —
Procedure for assessing stability on board
134

CHAPTER 22a
134

SPECIFIC REQUIREMENTS APPLICABLE TO CRAFT LONGER THAN 110 M
134

Article 22a.01 —
Application of Part I
134

Article 22a.02 —
Application of Part II
134

Article 22a.03 —
Strength
134

Article 22a.04 —
Buoyancy and stability
134

Article 22a.05 —
Additional requirements
135

Article 22a.06 —
Application of Part IV in the event of conversion
136

CHAPTER 22b
136

SPECIFIC REQUIREMENTS APPLICABLE TO HIGH-SPEED VESSELS
136

Article 22b.01 —
General
136

Article 22b.02 —
Application of Part I
137

Article 22b.03 —
Application of Part II
137

Article 22b.04 —
Seats and safety belts
137

Article 22b.05 —
Freeboard
137

Article 22b.06 —
Buoyancy, stability and subdivision
137

Article 22b.07 —
Wheelhouse
137

Article 22b.08 —
Additional equipment
138

Article 22b.09 —
Closed areas
138

Article 22b.10 —
Exits and escape routes
138

Article 22b.11 —
Fire protection and fire-fighting
139

Article 22b.12 —
Transitional provisions
139

PART III
139

CHAPTER 23
139

EQUIPMENT OF VESSELS WITH REGARD TO MANNING
139

Article 23.01 —
(Left void)
139

Article 23.02 —
(Left void)
139

Article 23.03 —
(Left void)
139

Article 23.04 —
(Left void)
139

Article 23.05 —
(Left void)
139

Article 23.06 —
(Left void)
139

Article 23.07 —
(Left void)
139

Article 23.08 —
(Left void)
139

Article 23.09 —
Vessels' equipment
140

Article 23.10 —
(Left void)
141

Article 23.11 —
(Left void)
141

Article 23.12 —
(Left void)
141

Article 23.13 —
(Left void)
141

Article 23.14 —
(Left void)
141

Article 23.15 —
(Left void)
141

PART IV
141

CHAPTER 24
141

TRANSITIONAL AND FINAL PROVISIONS
141

Article 24.01 —
Applicability of transitional provisions to craft which are already in service
141

Article 24.02 —
Derogations for craft which are already in service
141

Article 24.03 —
Derogations for craft which were laid down on or before 1 April 1976
152

Article 24.04 —
Other derogations
154

Article 24.05 —
(Left void)
154

Article 24.06 —
Derogations for craft not covered by Article 24.01 —
154

Article 24.07 —
(Left void)
163

CHAPTER 24a
163

TRANSITIONAL PROVISIONS FOR CRAFT NOT NAVIGATING ON ZONE R WATERWAYS
163

Article 24a.01 —
Application of transitional provisions to craft already in service and validity of previous Community certificates
163

Article 24a.02 —
Derogations for craft already in service
163

Article 24a.03 —
Derogations for craft the keels of which were laid before 1 January 1985
169

Article 24a.04 —
Other derogations
171

APPENDIX I—
SAFETY SIGNS
172

APPENDIX II—
ADMINISTRATIVE INSTRUCTIONS
174

Types of craft1.‘craft’: a vessel or item of floating equipment;2.‘vessel’: an inland waterway vessel or sea-going ship;3.‘inland waterway vessel’: a vessel intended solely or mainly for navigation on inland waterways;4.‘sea-going ship’: a vessel certificated for sea-going service;5.‘motor vessel’: a motor cargo vessel or a motor tanker;6.‘motor tanker’: a vessel intended for the carriage of goods in fixed tanks and built to navigate independently under its own motive power;7.‘motor cargo vessel’: a vessel, other than a motor tanker, intended for the carriage of goods and built to navigate independently under its own motive power;8.‘canal barge’: an inland waterway vessel not exceeding 38,5 m in length and 5,05 m in breadth and usually operating on the Rhine-Rhône Canal;9.‘tug’: a vessel specially built to perform towing operations;10.‘pusher’: a vessel specially built to propel a pushed convoy;11.‘barge’: a dumb barge or tank barge;12.‘tank barge’: a vessel intended for the carriage of goods in fixed tanks and built to be towed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres;13.‘dumb barge’: a vessel, other than a tank barge, intended for the carriage of goods and built to be towed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres;14.‘lighter’: a tank lighter, cargo lighter or ship-borne lighter;15.‘tank lighter’: a vessel intended for the carriage of goods in fixed tanks, built or specially modified to be pushed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres when not part of a pushed convoy;16.‘cargo lighter’: a vessel, other than a tank lighter, intended for the carriage of goods and built or specially modified to be pushed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres when not part of a pushed convoy;17.‘ship-borne lighter’: a lighter built to be carried aboard sea-going ships and to navigate on inland waterways;18.‘passenger vessel’: a day trip or cabin vessel constructed and equipped to carry more than 12 passengers;19.‘passenger sailing vessel’: a passenger vessel built and fitted out also with a view to propulsion under sail;20.‘day-trip vessel’: a passenger vessel without overnight passenger cabins;21.‘cabin vessel’: a passenger vessel with overnight passenger cabins;22.‘high-speed vessel’: a motorised craft capable of reaching speeds over 40 km/h in relation to water;23.‘floating equipment’: a floating installation carrying working gear such as cranes, dredging equipment, pile drivers or elevators;24.‘worksite craft’: a vessel, appropriately built and equipped for use at worksites, such as a reclamation barge, hopper or pontoon barge, pontoon or stone-dumping vessel;25.‘recreational craft’: a vessel other than a passenger vessel, intended for sport or pleasure;26.‘ship's boat’: a boat for use in transport, rescue, salvage and work duties;27.‘floating establishment’: any floating installation not normally intended to be moved, such as a swimming bath, dock, jetty or boathouse;28.‘floating objec’: a raft or other structure, object or assembly capable of navigation, not being a vessel or floating equipment or establishment;
1.
‘craft’: a vessel or item of floating equipment;
2.
‘vessel’: an inland waterway vessel or sea-going ship;
3.
‘inland waterway vessel’: a vessel intended solely or mainly for navigation on inland waterways;
4.
‘sea-going ship’: a vessel certificated for sea-going service;
5.
‘motor vessel’: a motor cargo vessel or a motor tanker;
6.
‘motor tanker’: a vessel intended for the carriage of goods in fixed tanks and built to navigate independently under its own motive power;
7.
‘motor cargo vessel’: a vessel, other than a motor tanker, intended for the carriage of goods and built to navigate independently under its own motive power;
8.
‘canal barge’: an inland waterway vessel not exceeding 38,5 m in length and 5,05 m in breadth and usually operating on the Rhine-Rhône Canal;
9.
‘tug’: a vessel specially built to perform towing operations;
10.
‘pusher’: a vessel specially built to propel a pushed convoy;
11.
‘barge’: a dumb barge or tank barge;
12.
‘tank barge’: a vessel intended for the carriage of goods in fixed tanks and built to be towed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres;
13.
‘dumb barge’: a vessel, other than a tank barge, intended for the carriage of goods and built to be towed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres;
14.
‘lighter’: a tank lighter, cargo lighter or ship-borne lighter;
15.
‘tank lighter’: a vessel intended for the carriage of goods in fixed tanks, built or specially modified to be pushed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres when not part of a pushed convoy;
16.
‘cargo lighter’: a vessel, other than a tank lighter, intended for the carriage of goods and built or specially modified to be pushed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres when not part of a pushed convoy;
17.
‘ship-borne lighter’: a lighter built to be carried aboard sea-going ships and to navigate on inland waterways;
18.
‘passenger vessel’: a day trip or cabin vessel constructed and equipped to carry more than 12 passengers;
19.
‘passenger sailing vessel’: a passenger vessel built and fitted out also with a view to propulsion under sail;
20.
‘day-trip vessel’: a passenger vessel without overnight passenger cabins;
21.
‘cabin vessel’: a passenger vessel with overnight passenger cabins;
22.
‘high-speed vessel’: a motorised craft capable of reaching speeds over 40 km/h in relation to water;
23.
‘floating equipment’: a floating installation carrying working gear such as cranes, dredging equipment, pile drivers or elevators;
24.
‘worksite craft’: a vessel, appropriately built and equipped for use at worksites, such as a reclamation barge, hopper or pontoon barge, pontoon or stone-dumping vessel;
25.
‘recreational craft’: a vessel other than a passenger vessel, intended for sport or pleasure;
26.
‘ship's boat’: a boat for use in transport, rescue, salvage and work duties;
27.
‘floating establishment’: any floating installation not normally intended to be moved, such as a swimming bath, dock, jetty or boathouse;
28.
‘floating objec’: a raft or other structure, object or assembly capable of navigation, not being a vessel or floating equipment or establishment;

1.
‘craft’: a vessel or item of floating equipment;

2.
‘vessel’: an inland waterway vessel or sea-going ship;

3.
‘inland waterway vessel’: a vessel intended solely or mainly for navigation on inland waterways;

4.
‘sea-going ship’: a vessel certificated for sea-going service;

5.
‘motor vessel’: a motor cargo vessel or a motor tanker;

6.
‘motor tanker’: a vessel intended for the carriage of goods in fixed tanks and built to navigate independently under its own motive power;

7.
‘motor cargo vessel’: a vessel, other than a motor tanker, intended for the carriage of goods and built to navigate independently under its own motive power;

8.
‘canal barge’: an inland waterway vessel not exceeding 38,5 m in length and 5,05 m in breadth and usually operating on the Rhine-Rhône Canal;

9.
‘tug’: a vessel specially built to perform towing operations;

10.
‘pusher’: a vessel specially built to propel a pushed convoy;

11.
‘barge’: a dumb barge or tank barge;

12.
‘tank barge’: a vessel intended for the carriage of goods in fixed tanks and built to be towed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres;

13.
‘dumb barge’: a vessel, other than a tank barge, intended for the carriage of goods and built to be towed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres;

14.
‘lighter’: a tank lighter, cargo lighter or ship-borne lighter;

15.
‘tank lighter’: a vessel intended for the carriage of goods in fixed tanks, built or specially modified to be pushed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres when not part of a pushed convoy;

16.
‘cargo lighter’: a vessel, other than a tank lighter, intended for the carriage of goods and built or specially modified to be pushed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres when not part of a pushed convoy;

17.
‘ship-borne lighter’: a lighter built to be carried aboard sea-going ships and to navigate on inland waterways;

18.
‘passenger vessel’: a day trip or cabin vessel constructed and equipped to carry more than 12 passengers;

19.
‘passenger sailing vessel’: a passenger vessel built and fitted out also with a view to propulsion under sail;

20.
‘day-trip vessel’: a passenger vessel without overnight passenger cabins;

21.
‘cabin vessel’: a passenger vessel with overnight passenger cabins;

22.
‘high-speed vessel’: a motorised craft capable of reaching speeds over 40 km/h in relation to water;

23.
‘floating equipment’: a floating installation carrying working gear such as cranes, dredging equipment, pile drivers or elevators;

24.
‘worksite craft’: a vessel, appropriately built and equipped for use at worksites, such as a reclamation barge, hopper or pontoon barge, pontoon or stone-dumping vessel;

25.
‘recreational craft’: a vessel other than a passenger vessel, intended for sport or pleasure;

26.
‘ship's boat’: a boat for use in transport, rescue, salvage and work duties;

27.
‘floating establishment’: any floating installation not normally intended to be moved, such as a swimming bath, dock, jetty or boathouse;

28.
‘floating objec’: a raft or other structure, object or assembly capable of navigation, not being a vessel or floating equipment or establishment;

1.
‘craft’: a vessel or item of floating equipment;

2.
‘vessel’: an inland waterway vessel or sea-going ship;

3.
‘inland waterway vessel’: a vessel intended solely or mainly for navigation on inland waterways;

4.
‘sea-going ship’: a vessel certificated for sea-going service;

5.
‘motor vessel’: a motor cargo vessel or a motor tanker;

6.
‘motor tanker’: a vessel intended for the carriage of goods in fixed tanks and built to navigate independently under its own motive power;

7.
‘motor cargo vessel’: a vessel, other than a motor tanker, intended for the carriage of goods and built to navigate independently under its own motive power;

8.
‘canal barge’: an inland waterway vessel not exceeding 38,5 m in length and 5,05 m in breadth and usually operating on the Rhine-Rhône Canal;

9.
‘tug’: a vessel specially built to perform towing operations;

10.
‘pusher’: a vessel specially built to propel a pushed convoy;

11.
‘barge’: a dumb barge or tank barge;

12.
‘tank barge’: a vessel intended for the carriage of goods in fixed tanks and built to be towed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres;

13.
‘dumb barge’: a vessel, other than a tank barge, intended for the carriage of goods and built to be towed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres;

14.
‘lighter’: a tank lighter, cargo lighter or ship-borne lighter;

15.
‘tank lighter’: a vessel intended for the carriage of goods in fixed tanks, built or specially modified to be pushed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres when not part of a pushed convoy;

16.
‘cargo lighter’: a vessel, other than a tank lighter, intended for the carriage of goods and built or specially modified to be pushed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres when not part of a pushed convoy;

17.
‘ship-borne lighter’: a lighter built to be carried aboard sea-going ships and to navigate on inland waterways;

18.
‘passenger vessel’: a day trip or cabin vessel constructed and equipped to carry more than 12 passengers;

19.
‘passenger sailing vessel’: a passenger vessel built and fitted out also with a view to propulsion under sail;

20.
‘day-trip vessel’: a passenger vessel without overnight passenger cabins;

21.
‘cabin vessel’: a passenger vessel with overnight passenger cabins;

22.
‘high-speed vessel’: a motorised craft capable of reaching speeds over 40 km/h in relation to water;

23.
‘floating equipment’: a floating installation carrying working gear such as cranes, dredging equipment, pile drivers or elevators;

24.
‘worksite craft’: a vessel, appropriately built and equipped for use at worksites, such as a reclamation barge, hopper or pontoon barge, pontoon or stone-dumping vessel;

25.
‘recreational craft’: a vessel other than a passenger vessel, intended for sport or pleasure;

26.
‘ship's boat’: a boat for use in transport, rescue, salvage and work duties;

27.
‘floating establishment’: any floating installation not normally intended to be moved, such as a swimming bath, dock, jetty or boathouse;

28.
‘floating objec’: a raft or other structure, object or assembly capable of navigation, not being a vessel or floating equipment or establishment;

Assemblies of craft29.‘convoy’: a rigid or towed convoy of craft;30.‘formation’: the manner in which a convoy is assembled;31.‘rigid convoy’: a pushed convoy or side-by-side formation;32.‘pushed convoy’: a rigid assembly of craft of which at least one is positioned in front of the craft providing the power for propelling the convoy, known as the ‘pusher(s)’; a convoy composed of a pusher and a pushed craft coupled so as to permit guided articulation is also considered as rigid;33.‘side-by-side formation’: an assembly of craft coupled rigidly side by side, none of which is positioned in front of the craft propelling the assembly;34.‘towed convoy’: an assembly of one or more craft, floating establishments or floating objects towed by one or more self-propelled craft forming part of the convoy;
29.
‘convoy’: a rigid or towed convoy of craft;
30.
‘formation’: the manner in which a convoy is assembled;
31.
‘rigid convoy’: a pushed convoy or side-by-side formation;
32.
‘pushed convoy’: a rigid assembly of craft of which at least one is positioned in front of the craft providing the power for propelling the convoy, known as the ‘pusher(s)’; a convoy composed of a pusher and a pushed craft coupled so as to permit guided articulation is also considered as rigid;
33.
‘side-by-side formation’: an assembly of craft coupled rigidly side by side, none of which is positioned in front of the craft propelling the assembly;
34.
‘towed convoy’: an assembly of one or more craft, floating establishments or floating objects towed by one or more self-propelled craft forming part of the convoy;

29.
‘convoy’: a rigid or towed convoy of craft;

30.
‘formation’: the manner in which a convoy is assembled;

31.
‘rigid convoy’: a pushed convoy or side-by-side formation;

32.
‘pushed convoy’: a rigid assembly of craft of which at least one is positioned in front of the craft providing the power for propelling the convoy, known as the ‘pusher(s)’; a convoy composed of a pusher and a pushed craft coupled so as to permit guided articulation is also considered as rigid;

33.
‘side-by-side formation’: an assembly of craft coupled rigidly side by side, none of which is positioned in front of the craft propelling the assembly;

34.
‘towed convoy’: an assembly of one or more craft, floating establishments or floating objects towed by one or more self-propelled craft forming part of the convoy;

29.
‘convoy’: a rigid or towed convoy of craft;

30.
‘formation’: the manner in which a convoy is assembled;

31.
‘rigid convoy’: a pushed convoy or side-by-side formation;

32.
‘pushed convoy’: a rigid assembly of craft of which at least one is positioned in front of the craft providing the power for propelling the convoy, known as the ‘pusher(s)’; a convoy composed of a pusher and a pushed craft coupled so as to permit guided articulation is also considered as rigid;

33.
‘side-by-side formation’: an assembly of craft coupled rigidly side by side, none of which is positioned in front of the craft propelling the assembly;

34.
‘towed convoy’: an assembly of one or more craft, floating establishments or floating objects towed by one or more self-propelled craft forming part of the convoy;

Particular areas on board35.‘main engine room’: space where the propulsion engines are installed;36.‘engine room’: space where combustion engines are installed;37.‘boiler room’: a space housing a fuel-operated installation designed to produce steam or heat a thermal fluid;38.‘enclosed superstructure’: a watertight, rigid, continuous structure with rigid walls joined to the deck in a permanent and watertight manner;39.‘wheelhouse’: the area which houses all the control and monitoring instruments necessary for manoeuvring the vessel;40.‘accommodation’: a space intended for the use of persons normally living on board, including galleys, storage space for provisions, toilets and washing facilities, laundry facilities, ante-rooms and passageways, but not the wheelhouse;41.‘passenger area’: areas on board intended for passengers and enclosed areas such as lounges, offices, shops, hairdressing salons, drying rooms, laundries, saunas, toilets, washrooms, passageways, connecting passages and stairs not encapsulated by walls;42.‘control centre’: a wheelhouse, an area which contains an emergency electrical power plant or parts thereof or an area with a centre permanently occupied by on-board personnel or crew members, such as for fire alarm equipment, remote controls of doors or fire dampers;43.‘stairwell’: the well of an internal staircase or of a lift;44.‘lounge’: a room of an accommodation or a passenger area. On board passenger vessels, galleys are not regarded as lounges;45.‘galley’: a room with a stove or a similar cooking appliance;46.‘store room’: a room for the storage of flammable liquids or a room with an area of over 4 m2for storing supplies;47.‘hold’: part of the vessel, bounded fore and aft by bulkheads, opened or closed by means of hatch covers, intended for the carriage of goods, whether packaged or in bulk, or for housing tanks not forming part of the hull;48.‘fixed tank’: a tank joined to the vessel, the walls of the tank consisting either of the hull itself or of a casing separate from the hull;49.‘working station’: an area where members of the crew carry out their duties, including gangway, derrick and ship's boat;50.‘passageway’: an area intended for the normal movement of persons and goods;51.‘safe area’: the area which is externally bounded by a vertical surface running at a distance of 1/5 BWLparallel to the course of the hull in the line of maximum draught;52.‘muster areas’: areas of the vessel which are specially protected and in which passengers muster in the event of danger;53.‘evacuation areas’: part of muster areas of the vessel from which evacuation of persons can be carried out;
35.
‘main engine room’: space where the propulsion engines are installed;
36.
‘engine room’: space where combustion engines are installed;
37.
‘boiler room’: a space housing a fuel-operated installation designed to produce steam or heat a thermal fluid;
38.
‘enclosed superstructure’: a watertight, rigid, continuous structure with rigid walls joined to the deck in a permanent and watertight manner;
39.
‘wheelhouse’: the area which houses all the control and monitoring instruments necessary for manoeuvring the vessel;
40.
‘accommodation’: a space intended for the use of persons normally living on board, including galleys, storage space for provisions, toilets and washing facilities, laundry facilities, ante-rooms and passageways, but not the wheelhouse;
41.
‘passenger area’: areas on board intended for passengers and enclosed areas such as lounges, offices, shops, hairdressing salons, drying rooms, laundries, saunas, toilets, washrooms, passageways, connecting passages and stairs not encapsulated by walls;
42.
‘control centre’: a wheelhouse, an area which contains an emergency electrical power plant or parts thereof or an area with a centre permanently occupied by on-board personnel or crew members, such as for fire alarm equipment, remote controls of doors or fire dampers;
43.
‘stairwell’: the well of an internal staircase or of a lift;
44.
‘lounge’: a room of an accommodation or a passenger area. On board passenger vessels, galleys are not regarded as lounges;
45.
‘galley’: a room with a stove or a similar cooking appliance;
46.
‘store room’: a room for the storage of flammable liquids or a room with an area of over 4 m2for storing supplies;
47.
‘hold’: part of the vessel, bounded fore and aft by bulkheads, opened or closed by means of hatch covers, intended for the carriage of goods, whether packaged or in bulk, or for housing tanks not forming part of the hull;
48.
‘fixed tank’: a tank joined to the vessel, the walls of the tank consisting either of the hull itself or of a casing separate from the hull;
49.
‘working station’: an area where members of the crew carry out their duties, including gangway, derrick and ship's boat;
50.
‘passageway’: an area intended for the normal movement of persons and goods;
51.
‘safe area’: the area which is externally bounded by a vertical surface running at a distance of 1/5 BWLparallel to the course of the hull in the line of maximum draught;
52.
‘muster areas’: areas of the vessel which are specially protected and in which passengers muster in the event of danger;
53.
‘evacuation areas’: part of muster areas of the vessel from which evacuation of persons can be carried out;

35.
‘main engine room’: space where the propulsion engines are installed;

36.
‘engine room’: space where combustion engines are installed;

37.
‘boiler room’: a space housing a fuel-operated installation designed to produce steam or heat a thermal fluid;

38.
‘enclosed superstructure’: a watertight, rigid, continuous structure with rigid walls joined to the deck in a permanent and watertight manner;

39.
‘wheelhouse’: the area which houses all the control and monitoring instruments necessary for manoeuvring the vessel;

40.
‘accommodation’: a space intended for the use of persons normally living on board, including galleys, storage space for provisions, toilets and washing facilities, laundry facilities, ante-rooms and passageways, but not the wheelhouse;

41.
‘passenger area’: areas on board intended for passengers and enclosed areas such as lounges, offices, shops, hairdressing salons, drying rooms, laundries, saunas, toilets, washrooms, passageways, connecting passages and stairs not encapsulated by walls;

42.
‘control centre’: a wheelhouse, an area which contains an emergency electrical power plant or parts thereof or an area with a centre permanently occupied by on-board personnel or crew members, such as for fire alarm equipment, remote controls of doors or fire dampers;

43.
‘stairwell’: the well of an internal staircase or of a lift;

44.
‘lounge’: a room of an accommodation or a passenger area. On board passenger vessels, galleys are not regarded as lounges;

45.
‘galley’: a room with a stove or a similar cooking appliance;

46.
‘store room’: a room for the storage of flammable liquids or a room with an area of over 4 m2for storing supplies;

47.
‘hold’: part of the vessel, bounded fore and aft by bulkheads, opened or closed by means of hatch covers, intended for the carriage of goods, whether packaged or in bulk, or for housing tanks not forming part of the hull;

48.
‘fixed tank’: a tank joined to the vessel, the walls of the tank consisting either of the hull itself or of a casing separate from the hull;

49.
‘working station’: an area where members of the crew carry out their duties, including gangway, derrick and ship's boat;

50.
‘passageway’: an area intended for the normal movement of persons and goods;

51.
‘safe area’: the area which is externally bounded by a vertical surface running at a distance of 1/5 BWLparallel to the course of the hull in the line of maximum draught;

52.
‘muster areas’: areas of the vessel which are specially protected and in which passengers muster in the event of danger;

53.
‘evacuation areas’: part of muster areas of the vessel from which evacuation of persons can be carried out;

35.
‘main engine room’: space where the propulsion engines are installed;

36.
‘engine room’: space where combustion engines are installed;

37.
‘boiler room’: a space housing a fuel-operated installation designed to produce steam or heat a thermal fluid;

38.
‘enclosed superstructure’: a watertight, rigid, continuous structure with rigid walls joined to the deck in a permanent and watertight manner;

39.
‘wheelhouse’: the area which houses all the control and monitoring instruments necessary for manoeuvring the vessel;

40.
‘accommodation’: a space intended for the use of persons normally living on board, including galleys, storage space for provisions, toilets and washing facilities, laundry facilities, ante-rooms and passageways, but not the wheelhouse;

41.
‘passenger area’: areas on board intended for passengers and enclosed areas such as lounges, offices, shops, hairdressing salons, drying rooms, laundries, saunas, toilets, washrooms, passageways, connecting passages and stairs not encapsulated by walls;

42.
‘control centre’: a wheelhouse, an area which contains an emergency electrical power plant or parts thereof or an area with a centre permanently occupied by on-board personnel or crew members, such as for fire alarm equipment, remote controls of doors or fire dampers;

43.
‘stairwell’: the well of an internal staircase or of a lift;

44.
‘lounge’: a room of an accommodation or a passenger area. On board passenger vessels, galleys are not regarded as lounges;

45.
‘galley’: a room with a stove or a similar cooking appliance;

46.
‘store room’: a room for the storage of flammable liquids or a room with an area of over 4 m2for storing supplies;

47.
‘hold’: part of the vessel, bounded fore and aft by bulkheads, opened or closed by means of hatch covers, intended for the carriage of goods, whether packaged or in bulk, or for housing tanks not forming part of the hull;

48.
‘fixed tank’: a tank joined to the vessel, the walls of the tank consisting either of the hull itself or of a casing separate from the hull;

49.
‘working station’: an area where members of the crew carry out their duties, including gangway, derrick and ship's boat;

50.
‘passageway’: an area intended for the normal movement of persons and goods;

51.
‘safe area’: the area which is externally bounded by a vertical surface running at a distance of 1/5 BWLparallel to the course of the hull in the line of maximum draught;

52.
‘muster areas’: areas of the vessel which are specially protected and in which passengers muster in the event of danger;

53.
‘evacuation areas’: part of muster areas of the vessel from which evacuation of persons can be carried out;

Marine engineering terms54.‘plane of maximum draught’: the water plane corresponding to the maximum draught at which the craft is authorised to navigate;55.‘safety clearance’: the distance between the plane of maximum draught and the parallel plane passing through the lowest point above which the craft is no longer deemed to be watertight;56.‘residual safety clearance’: the vertical clearance available, in the event of the vessel heeling over, between the water level and the lowest point of the immersed side, beyond which the vessel is no longer regarded as watertight;57.‘freeboard (f)’: the distance between the plane of maximum draught and a parallel plane passing through the lowest point of the gunwale or, in the absence of a gunwale, the lowest point of the upper edge of the ship's side;58.‘residual freeboard’: the vertical clearance available, in the event of the vessel heeling over, between the water level and the upper surface of the deck at the lowest point of the immersed side or, if there is no deck, the lowest point of the upper surface of the fixed ship's side;59.‘margin line’: an imaginary line drawn on the side plating not less than 10 cm below the bulkhead deck and not less than 10 cm below the lowest non-watertight point of the side plating. If there is no bulkhead deck, a line drawn not less than 10 cm below the lowest line up to which the outer plating is watertight shall be used;60.‘water displacement (∇)’: the immersed volume of the vessel, in m3;61.‘displacement (Δ)’: the total weight of the vessel, inclusive of cargo, in t;62.‘block coefficient (CB)’: the ratio between the water displacement and the product of length LWL, breadth BWLand draught T;63.‘lateral plane above water (AV)’: lateral plane of the vessel above the waterline in m2;64.‘bulkhead deck’: the deck to which the required watertight bulkheads are taken and from which the freeboard is measured;65.‘bulkhead’: a wall of a given height, usually vertical, partitioning the vessel and bounded by the bottom of the vessel, the plating or other bulkheads;66.‘transverse bulkhead’: a bulkhead extending from one side of the vessel to the other;67.‘wall’: a dividing surface, usually vertical;68.‘partition wall’: a non-watertight wall;69.‘length (L)’: the maximum length of the hull in m, excluding rudder and bowsprit;70.‘length overall (LOA)’: the maximum length of the craft in m, including all fixed installations such as parts of the steering system or power plant, mechanical or similar devices;71.‘length of waterline (LWL)’: the length of the hull in m, measured at the maximum draught;72.‘breadth (B)’: the maximum breadth of the hull in m, measured to the outer edge of the shell plating (excluding paddle wheels, rub rails, and similar);73.‘breadth overall (BOA)’: the maximum breadth of the craft in m, including all fixed equipment such as paddle wheels, rub rails, mechanical devices and the like;74.‘breadth of waterline (BWL)’: breadth of the hull in m, measured from the outside of the side plating at the maximum draught line;75.‘height (H)’: the shortest vertical distance in m between the lowest point of the hull or the keel and the lowest point of the deck on the side of the vessel;76.‘draught (T)’: the vertical distance in m between the lowest point of the hull or the keel and the maximum draught line;77.‘forward perpendicular’: the vertical line at the forward point of the intersection of the hull with the maximum draught line;78.‘clear width of side deck’: the distance between the vertical line passing through the most prominent part of the hatch coaming on the side deck side and the vertical line passing through the inside edge of the slip guard (guard-rail, foot rail) on the outer side of the side deck;
54.
‘plane of maximum draught’: the water plane corresponding to the maximum draught at which the craft is authorised to navigate;
55.
‘safety clearance’: the distance between the plane of maximum draught and the parallel plane passing through the lowest point above which the craft is no longer deemed to be watertight;
56.
‘residual safety clearance’: the vertical clearance available, in the event of the vessel heeling over, between the water level and the lowest point of the immersed side, beyond which the vessel is no longer regarded as watertight;
57.
‘freeboard (f)’: the distance between the plane of maximum draught and a parallel plane passing through the lowest point of the gunwale or, in the absence of a gunwale, the lowest point of the upper edge of the ship's side;
58.
‘residual freeboard’: the vertical clearance available, in the event of the vessel heeling over, between the water level and the upper surface of the deck at the lowest point of the immersed side or, if there is no deck, the lowest point of the upper surface of the fixed ship's side;
59.
‘margin line’: an imaginary line drawn on the side plating not less than 10 cm below the bulkhead deck and not less than 10 cm below the lowest non-watertight point of the side plating. If there is no bulkhead deck, a line drawn not less than 10 cm below the lowest line up to which the outer plating is watertight shall be used;
60.
‘water displacement (∇)’: the immersed volume of the vessel, in m3;
61.
‘displacement (Δ)’: the total weight of the vessel, inclusive of cargo, in t;
62.
‘block coefficient (CB)’: the ratio between the water displacement and the product of length LWL, breadth BWLand draught T;
63.
‘lateral plane above water (AV)’: lateral plane of the vessel above the waterline in m2;
64.
‘bulkhead deck’: the deck to which the required watertight bulkheads are taken and from which the freeboard is measured;
65.
‘bulkhead’: a wall of a given height, usually vertical, partitioning the vessel and bounded by the bottom of the vessel, the plating or other bulkheads;
66.
‘transverse bulkhead’: a bulkhead extending from one side of the vessel to the other;
67.
‘wall’: a dividing surface, usually vertical;
68.
‘partition wall’: a non-watertight wall;
69.
‘length (L)’: the maximum length of the hull in m, excluding rudder and bowsprit;
70.
‘length overall (LOA)’: the maximum length of the craft in m, including all fixed installations such as parts of the steering system or power plant, mechanical or similar devices;
71.
‘length of waterline (LWL)’: the length of the hull in m, measured at the maximum draught;
72.
‘breadth (B)’: the maximum breadth of the hull in m, measured to the outer edge of the shell plating (excluding paddle wheels, rub rails, and similar);
73.
‘breadth overall (BOA)’: the maximum breadth of the craft in m, including all fixed equipment such as paddle wheels, rub rails, mechanical devices and the like;
74.
‘breadth of waterline (BWL)’: breadth of the hull in m, measured from the outside of the side plating at the maximum draught line;
75.
‘height (H)’: the shortest vertical distance in m between the lowest point of the hull or the keel and the lowest point of the deck on the side of the vessel;
76.
‘draught (T)’: the vertical distance in m between the lowest point of the hull or the keel and the maximum draught line;
77.
‘forward perpendicular’: the vertical line at the forward point of the intersection of the hull with the maximum draught line;
78.
‘clear width of side deck’: the distance between the vertical line passing through the most prominent part of the hatch coaming on the side deck side and the vertical line passing through the inside edge of the slip guard (guard-rail, foot rail) on the outer side of the side deck;

54.
‘plane of maximum draught’: the water plane corresponding to the maximum draught at which the craft is authorised to navigate;

55.
‘safety clearance’: the distance between the plane of maximum draught and the parallel plane passing through the lowest point above which the craft is no longer deemed to be watertight;

56.
‘residual safety clearance’: the vertical clearance available, in the event of the vessel heeling over, between the water level and the lowest point of the immersed side, beyond which the vessel is no longer regarded as watertight;

57.
‘freeboard (f)’: the distance between the plane of maximum draught and a parallel plane passing through the lowest point of the gunwale or, in the absence of a gunwale, the lowest point of the upper edge of the ship's side;

58.
‘residual freeboard’: the vertical clearance available, in the event of the vessel heeling over, between the water level and the upper surface of the deck at the lowest point of the immersed side or, if there is no deck, the lowest point of the upper surface of the fixed ship's side;

59.
‘margin line’: an imaginary line drawn on the side plating not less than 10 cm below the bulkhead deck and not less than 10 cm below the lowest non-watertight point of the side plating. If there is no bulkhead deck, a line drawn not less than 10 cm below the lowest line up to which the outer plating is watertight shall be used;

60.
‘water displacement (∇)’: the immersed volume of the vessel, in m3;

61.
‘displacement (Δ)’: the total weight of the vessel, inclusive of cargo, in t;

62.
‘block coefficient (CB)’: the ratio between the water displacement and the product of length LWL, breadth BWLand draught T;

63.
‘lateral plane above water (AV)’: lateral plane of the vessel above the waterline in m2;

64.
‘bulkhead deck’: the deck to which the required watertight bulkheads are taken and from which the freeboard is measured;

65.
‘bulkhead’: a wall of a given height, usually vertical, partitioning the vessel and bounded by the bottom of the vessel, the plating or other bulkheads;

66.
‘transverse bulkhead’: a bulkhead extending from one side of the vessel to the other;

67.
‘wall’: a dividing surface, usually vertical;

68.
‘partition wall’: a non-watertight wall;

69.
‘length (L)’: the maximum length of the hull in m, excluding rudder and bowsprit;

70.
‘length overall (LOA)’: the maximum length of the craft in m, including all fixed installations such as parts of the steering system or power plant, mechanical or similar devices;

71.
‘length of waterline (LWL)’: the length of the hull in m, measured at the maximum draught;

72.
‘breadth (B)’: the maximum breadth of the hull in m, measured to the outer edge of the shell plating (excluding paddle wheels, rub rails, and similar);

73.
‘breadth overall (BOA)’: the maximum breadth of the craft in m, including all fixed equipment such as paddle wheels, rub rails, mechanical devices and the like;

74.
‘breadth of waterline (BWL)’: breadth of the hull in m, measured from the outside of the side plating at the maximum draught line;

75.
‘height (H)’: the shortest vertical distance in m between the lowest point of the hull or the keel and the lowest point of the deck on the side of the vessel;

76.
‘draught (T)’: the vertical distance in m between the lowest point of the hull or the keel and the maximum draught line;

77.
‘forward perpendicular’: the vertical line at the forward point of the intersection of the hull with the maximum draught line;

78.
‘clear width of side deck’: the distance between the vertical line passing through the most prominent part of the hatch coaming on the side deck side and the vertical line passing through the inside edge of the slip guard (guard-rail, foot rail) on the outer side of the side deck;

54.
‘plane of maximum draught’: the water plane corresponding to the maximum draught at which the craft is authorised to navigate;

55.
‘safety clearance’: the distance between the plane of maximum draught and the parallel plane passing through the lowest point above which the craft is no longer deemed to be watertight;

56.
‘residual safety clearance’: the vertical clearance available, in the event of the vessel heeling over, between the water level and the lowest point of the immersed side, beyond which the vessel is no longer regarded as watertight;

57.
‘freeboard (f)’: the distance between the plane of maximum draught and a parallel plane passing through the lowest point of the gunwale or, in the absence of a gunwale, the lowest point of the upper edge of the ship's side;

58.
‘residual freeboard’: the vertical clearance available, in the event of the vessel heeling over, between the water level and the upper surface of the deck at the lowest point of the immersed side or, if there is no deck, the lowest point of the upper surface of the fixed ship's side;

59.
‘margin line’: an imaginary line drawn on the side plating not less than 10 cm below the bulkhead deck and not less than 10 cm below the lowest non-watertight point of the side plating. If there is no bulkhead deck, a line drawn not less than 10 cm below the lowest line up to which the outer plating is watertight shall be used;

60.
‘water displacement (∇)’: the immersed volume of the vessel, in m3;

61.
‘displacement (Δ)’: the total weight of the vessel, inclusive of cargo, in t;

62.
‘block coefficient (CB)’: the ratio between the water displacement and the product of length LWL, breadth BWLand draught T;

63.
‘lateral plane above water (AV)’: lateral plane of the vessel above the waterline in m2;

64.
‘bulkhead deck’: the deck to which the required watertight bulkheads are taken and from which the freeboard is measured;

65.
‘bulkhead’: a wall of a given height, usually vertical, partitioning the vessel and bounded by the bottom of the vessel, the plating or other bulkheads;

66.
‘transverse bulkhead’: a bulkhead extending from one side of the vessel to the other;

67.
‘wall’: a dividing surface, usually vertical;

68.
‘partition wall’: a non-watertight wall;

69.
‘length (L)’: the maximum length of the hull in m, excluding rudder and bowsprit;

70.
‘length overall (LOA)’: the maximum length of the craft in m, including all fixed installations such as parts of the steering system or power plant, mechanical or similar devices;

71.
‘length of waterline (LWL)’: the length of the hull in m, measured at the maximum draught;

72.
‘breadth (B)’: the maximum breadth of the hull in m, measured to the outer edge of the shell plating (excluding paddle wheels, rub rails, and similar);

73.
‘breadth overall (BOA)’: the maximum breadth of the craft in m, including all fixed equipment such as paddle wheels, rub rails, mechanical devices and the like;

74.
‘breadth of waterline (BWL)’: breadth of the hull in m, measured from the outside of the side plating at the maximum draught line;

75.
‘height (H)’: the shortest vertical distance in m between the lowest point of the hull or the keel and the lowest point of the deck on the side of the vessel;

76.
‘draught (T)’: the vertical distance in m between the lowest point of the hull or the keel and the maximum draught line;

77.
‘forward perpendicular’: the vertical line at the forward point of the intersection of the hull with the maximum draught line;

78.
‘clear width of side deck’: the distance between the vertical line passing through the most prominent part of the hatch coaming on the side deck side and the vertical line passing through the inside edge of the slip guard (guard-rail, foot rail) on the outer side of the side deck;

Steering system79.‘steering system’: all the equipment necessary for steering the vessel, such as to ensure the manoeuvrability laid down in Chapter 5;80.‘rudder’: the rudder or rudders, with shaft, including the rudder quadrant and the components connecting with the steering apparatus;81.‘steering apparatus’: the part of the steering system which produces the movement of the rudder;82.‘drive unit’: the steering-apparatus drive, between the power source and the steering apparatus;83.‘power source’: the power supply to the steering drive unit and the steering apparatus produced by an on-board network, batteries or an internal combustion engine;84.‘steering control’: the component parts of and circuitry for the operation of a power-driven steering control;85.‘steering apparatus drive unit’: the control for the steering apparatus, its drive unit and its power source;86.‘manual drive’: a system whereby manual operation of the hand wheel moves the rudder by means of a mechanical transmission, without any additional power source;87.‘manually-operated hydraulic drive’: a manual control actuating a hydraulic transmission;88.‘rate-of-turn regulator’: equipment which automatically produces and maintains a given rate of turn of the vessel in accordance with preselected values;89.‘wheelhouse designed for radar navigation by one person’: a wheelhouse arranged in such a way that, during radar navigation, the vessel can be manoeuvred by one person;
79.
‘steering system’: all the equipment necessary for steering the vessel, such as to ensure the manoeuvrability laid down in Chapter 5;
80.
‘rudder’: the rudder or rudders, with shaft, including the rudder quadrant and the components connecting with the steering apparatus;
81.
‘steering apparatus’: the part of the steering system which produces the movement of the rudder;
82.
‘drive unit’: the steering-apparatus drive, between the power source and the steering apparatus;
83.
‘power source’: the power supply to the steering drive unit and the steering apparatus produced by an on-board network, batteries or an internal combustion engine;
84.
‘steering control’: the component parts of and circuitry for the operation of a power-driven steering control;
85.
‘steering apparatus drive unit’: the control for the steering apparatus, its drive unit and its power source;
86.
‘manual drive’: a system whereby manual operation of the hand wheel moves the rudder by means of a mechanical transmission, without any additional power source;
87.
‘manually-operated hydraulic drive’: a manual control actuating a hydraulic transmission;
88.
‘rate-of-turn regulator’: equipment which automatically produces and maintains a given rate of turn of the vessel in accordance with preselected values;
89.
‘wheelhouse designed for radar navigation by one person’: a wheelhouse arranged in such a way that, during radar navigation, the vessel can be manoeuvred by one person;

79.
‘steering system’: all the equipment necessary for steering the vessel, such as to ensure the manoeuvrability laid down in Chapter 5;

80.
‘rudder’: the rudder or rudders, with shaft, including the rudder quadrant and the components connecting with the steering apparatus;

81.
‘steering apparatus’: the part of the steering system which produces the movement of the rudder;

82.
‘drive unit’: the steering-apparatus drive, between the power source and the steering apparatus;

83.
‘power source’: the power supply to the steering drive unit and the steering apparatus produced by an on-board network, batteries or an internal combustion engine;

84.
‘steering control’: the component parts of and circuitry for the operation of a power-driven steering control;

85.
‘steering apparatus drive unit’: the control for the steering apparatus, its drive unit and its power source;

86.
‘manual drive’: a system whereby manual operation of the hand wheel moves the rudder by means of a mechanical transmission, without any additional power source;

87.
‘manually-operated hydraulic drive’: a manual control actuating a hydraulic transmission;

88.
‘rate-of-turn regulator’: equipment which automatically produces and maintains a given rate of turn of the vessel in accordance with preselected values;

89.
‘wheelhouse designed for radar navigation by one person’: a wheelhouse arranged in such a way that, during radar navigation, the vessel can be manoeuvred by one person;

79.
‘steering system’: all the equipment necessary for steering the vessel, such as to ensure the manoeuvrability laid down in Chapter 5;

80.
‘rudder’: the rudder or rudders, with shaft, including the rudder quadrant and the components connecting with the steering apparatus;

81.
‘steering apparatus’: the part of the steering system which produces the movement of the rudder;

82.
‘drive unit’: the steering-apparatus drive, between the power source and the steering apparatus;

83.
‘power source’: the power supply to the steering drive unit and the steering apparatus produced by an on-board network, batteries or an internal combustion engine;

84.
‘steering control’: the component parts of and circuitry for the operation of a power-driven steering control;

85.
‘steering apparatus drive unit’: the control for the steering apparatus, its drive unit and its power source;

86.
‘manual drive’: a system whereby manual operation of the hand wheel moves the rudder by means of a mechanical transmission, without any additional power source;

87.
‘manually-operated hydraulic drive’: a manual control actuating a hydraulic transmission;

88.
‘rate-of-turn regulator’: equipment which automatically produces and maintains a given rate of turn of the vessel in accordance with preselected values;

89.
‘wheelhouse designed for radar navigation by one person’: a wheelhouse arranged in such a way that, during radar navigation, the vessel can be manoeuvred by one person;

Properties of structural components and materials90.‘watertight’: a structural component or device so fitted as to prevent any ingress of water;91.‘spray-proof and weathertight’: a structural component or device so fitted that in normal conditions it allows only a negligible quantity of water to penetrate;92.‘gastight’: a structural component or device so fitted as to prevent the ingress of gas and vapours;93.‘non-combustible’: a substance which neither burns nor produces flammable vapours in such quantities that they ignite spontaneously when heated to approximately 750oC;94.‘flame-retardant’: material which does not readily catch fire, or whose surface at least restricts the spread of flames pursuant to the test procedure referred to in Article 15.11(1)(c);95.‘fire-resistance’: the property of structural components or devices as certified by the test procedure referred to in Article 15.11(1)(d);96.‘Code for Fire Test Procedures’: the International Code for the Application of Fire Test Procedures adopted under Resolution MSC.61(67) by the Maritime Safety Committee of the IMO;
90.
‘watertight’: a structural component or device so fitted as to prevent any ingress of water;
91.
‘spray-proof and weathertight’: a structural component or device so fitted that in normal conditions it allows only a negligible quantity of water to penetrate;
92.
‘gastight’: a structural component or device so fitted as to prevent the ingress of gas and vapours;
93.
‘non-combustible’: a substance which neither burns nor produces flammable vapours in such quantities that they ignite spontaneously when heated to approximately 750oC;
94.
‘flame-retardant’: material which does not readily catch fire, or whose surface at least restricts the spread of flames pursuant to the test procedure referred to in Article 15.11(1)(c);
95.
‘fire-resistance’: the property of structural components or devices as certified by the test procedure referred to in Article 15.11(1)(d);
96.
‘Code for Fire Test Procedures’: the International Code for the Application of Fire Test Procedures adopted under Resolution MSC.61(67) by the Maritime Safety Committee of the IMO;

90.
‘watertight’: a structural component or device so fitted as to prevent any ingress of water;

91.
‘spray-proof and weathertight’: a structural component or device so fitted that in normal conditions it allows only a negligible quantity of water to penetrate;

92.
‘gastight’: a structural component or device so fitted as to prevent the ingress of gas and vapours;

93.
‘non-combustible’: a substance which neither burns nor produces flammable vapours in such quantities that they ignite spontaneously when heated to approximately 750oC;

94.
‘flame-retardant’: material which does not readily catch fire, or whose surface at least restricts the spread of flames pursuant to the test procedure referred to in Article 15.11(1)(c);

95.
‘fire-resistance’: the property of structural components or devices as certified by the test procedure referred to in Article 15.11(1)(d);

96.
‘Code for Fire Test Procedures’: the International Code for the Application of Fire Test Procedures adopted under Resolution MSC.61(67) by the Maritime Safety Committee of the IMO;

90.
‘watertight’: a structural component or device so fitted as to prevent any ingress of water;

91.
‘spray-proof and weathertight’: a structural component or device so fitted that in normal conditions it allows only a negligible quantity of water to penetrate;

92.
‘gastight’: a structural component or device so fitted as to prevent the ingress of gas and vapours;

93.
‘non-combustible’: a substance which neither burns nor produces flammable vapours in such quantities that they ignite spontaneously when heated to approximately 750oC;

94.
‘flame-retardant’: material which does not readily catch fire, or whose surface at least restricts the spread of flames pursuant to the test procedure referred to in Article 15.11(1)(c);

95.
‘fire-resistance’: the property of structural components or devices as certified by the test procedure referred to in Article 15.11(1)(d);

96.
‘Code for Fire Test Procedures’: the International Code for the Application of Fire Test Procedures adopted under Resolution MSC.61(67) by the Maritime Safety Committee of the IMO;

Other definitions97.‘approved classification society’: a classification society which has been recognised in accordance with the criteria and the procedures of Annex VII;98.‘radar installation’: an electronic navigational aid for detecting and displaying the surroundings and traffic;99.‘Inland ECDIS’: a standardised system for displaying electronic navigational charts for inland waters and associated information, that displays selected information from proprietary electronic navigational charts for inland waters and optionally information from other sensors of the craft;100.‘Inland ECDIS installation’: an installation for displaying electronic navigational charts for inland waters that can be operated in two different modes: information mode and navigation mode;101.‘information mode’: use of Inland ECDIS for information purposes only without radar overlay;102.‘navigation mode’: use of Inland ECDIS with radar overlay for navigating a craft;103.‘shipboard personnel’: all employees on board a passenger vessel who are not members of the crew;104.‘persons with reduced mobility’: persons facing particular problems when using public transport, such as the elderly and the handicapped and persons with sensory disabilities, persons in wheelchairs, pregnant women and persons accompanying young children;105.‘Community certificate’: a certificate issued to an inland waterway vessel by the competent authority, signifying compliance with the technical requirements of this Directive.
97.
‘approved classification society’: a classification society which has been recognised in accordance with the criteria and the procedures of Annex VII;
98.
‘radar installation’: an electronic navigational aid for detecting and displaying the surroundings and traffic;
99.
‘Inland ECDIS’: a standardised system for displaying electronic navigational charts for inland waters and associated information, that displays selected information from proprietary electronic navigational charts for inland waters and optionally information from other sensors of the craft;
100.
‘Inland ECDIS installation’: an installation for displaying electronic navigational charts for inland waters that can be operated in two different modes: information mode and navigation mode;
101.
‘information mode’: use of Inland ECDIS for information purposes only without radar overlay;
102.
‘navigation mode’: use of Inland ECDIS with radar overlay for navigating a craft;
103.
‘shipboard personnel’: all employees on board a passenger vessel who are not members of the crew;
104.
‘persons with reduced mobility’: persons facing particular problems when using public transport, such as the elderly and the handicapped and persons with sensory disabilities, persons in wheelchairs, pregnant women and persons accompanying young children;
105.
‘Community certificate’: a certificate issued to an inland waterway vessel by the competent authority, signifying compliance with the technical requirements of this Directive.

97.
‘approved classification society’: a classification society which has been recognised in accordance with the criteria and the procedures of Annex VII;

98.
‘radar installation’: an electronic navigational aid for detecting and displaying the surroundings and traffic;

99.
‘Inland ECDIS’: a standardised system for displaying electronic navigational charts for inland waters and associated information, that displays selected information from proprietary electronic navigational charts for inland waters and optionally information from other sensors of the craft;

100.
‘Inland ECDIS installation’: an installation for displaying electronic navigational charts for inland waters that can be operated in two different modes: information mode and navigation mode;

101.
‘information mode’: use of Inland ECDIS for information purposes only without radar overlay;

102.
‘navigation mode’: use of Inland ECDIS with radar overlay for navigating a craft;

103.
‘shipboard personnel’: all employees on board a passenger vessel who are not members of the crew;

104.
‘persons with reduced mobility’: persons facing particular problems when using public transport, such as the elderly and the handicapped and persons with sensory disabilities, persons in wheelchairs, pregnant women and persons accompanying young children;

105.
‘Community certificate’: a certificate issued to an inland waterway vessel by the competent authority, signifying compliance with the technical requirements of this Directive.

97.
‘approved classification society’: a classification society which has been recognised in accordance with the criteria and the procedures of Annex VII;

98.
‘radar installation’: an electronic navigational aid for detecting and displaying the surroundings and traffic;

99.
‘Inland ECDIS’: a standardised system for displaying electronic navigational charts for inland waters and associated information, that displays selected information from proprietary electronic navigational charts for inland waters and optionally information from other sensors of the craft;

100.
‘Inland ECDIS installation’: an installation for displaying electronic navigational charts for inland waters that can be operated in two different modes: information mode and navigation mode;

101.
‘information mode’: use of Inland ECDIS for information purposes only without radar overlay;

102.
‘navigation mode’: use of Inland ECDIS with radar overlay for navigating a craft;

103.
‘shipboard personnel’: all employees on board a passenger vessel who are not members of the crew;

104.
‘persons with reduced mobility’: persons facing particular problems when using public transport, such as the elderly and the handicapped and persons with sensory disabilities, persons in wheelchairs, pregnant women and persons accompanying young children;

105.
‘Community certificate’: a certificate issued to an inland waterway vessel by the competent authority, signifying compliance with the technical requirements of this Directive.

(a)
an official from the administration that is responsible for inland navigation;

(b)
an expert on the design of inland waterway vessels and their engines;

(c)
a nautical expert in possession of a navigation certificate.

(a)
to craft intended to travel to a certain place with the permission of the competent authority in order to obtain a Community certificate;

(b)
to craft whose Community certificate has been temporarily withdrawn in one of the instances referred to in Article 2.07 or in Articles 12 and 16 of this Directive;

(c)
to craft whose Community certificate is in preparation following a successful inspection;

(d)
to craft where not all of the conditions required for obtaining a Community certificate as set out in Part I of Annex V have been met;

(e)
to craft so damaged that their state no longer complies with the Community certificate;

(f)
to floating installations or equipment where the authorities responsible for special transport operations make the authorisation to carry out a special transport operation, as provided for by the applicable navigational authority regulations of the Member States, subject to obtaining such a Community certificate;

(g)
to craft deviating from the provisions of Part II, as provided for in Article 2.19( 2).

(a)
in the cases referred to in paragraph 1(a), (d) to (f), for a single specific trip to be made within a suitable period that shall not exceed one month;

(b)
in the cases referred to in paragraph 1(b) and (c), for an appropriate duration;

(c)
in the cases referred to in paragraph 1(g), for six months. The provisional Community certificate may be extended for six months at a time until the Committee has taken a decision.

(a)
five years in the case of passenger vessels;

(b)
10 years in the case of all other craft.

(a)
In the case of newly built vessels or major conversions affecting vessel strength, adequate strength shall be demonstrated by presenting design calculation proof. That proof is not required where a classification certificate or a declaration from an approved classification society is submitted.

(b)
Where there is an inspection as referred to in Article 2.09 the minimum thicknesses of the bottom, bilge and side plates shall be checked in accordance with the following conditions:For vessels made from steel minimum thickness tminis given by the highest of the values resulting from the following formulae:1.for vessels that are longer than 40 m: tmin= f · b · c (2,3 + 0,04 L) (mm);for vessels not more than 40 m in length: tmin= f · b · c (1,5 + 0,06 L) (mm), however, not less than 3.00 mm2.where:a=frame spacing (mm);f=frame spacing factor:f=1 for a ≤ 500 mmf=1 + 0,0013 (a — 500) for a > 500 mmb=factor for bottom, side or bilge platesb=1,0 for bottom plates and side platesb=1,25 for bilge plates.f = 1 may be taken for the frame spacing when calculating the minimum thickness of the side plates. However, the minimum thickness of the bilge plates may in no case be less than that of the bottom plates and side plates.c=factor for the type of structure:c=0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coamingc=1,0 for all other types of structure.
1.
for vessels that are longer than 40 m: tmin= f · b · c (2,3 + 0,04 L) (mm);for vessels not more than 40 m in length: tmin= f · b · c (1,5 + 0,06 L) (mm), however, not less than 3.00 mm
2.
where:a=frame spacing (mm);f=frame spacing factor:f=1 for a ≤ 500 mmf=1 + 0,0013 (a — 500) for a > 500 mmb=factor for bottom, side or bilge platesb=1,0 for bottom plates and side platesb=1,25 for bilge plates.f = 1 may be taken for the frame spacing when calculating the minimum thickness of the side plates. However, the minimum thickness of the bilge plates may in no case be less than that of the bottom plates and side plates.c=factor for the type of structure:c=0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coamingc=1,0 for all other types of structure.
a
=
frame spacing (mm);
f
=
frame spacing factor:f=1 for a ≤ 500 mmf=1 + 0,0013 (a — 500) for a > 500 mm
f
=
1 for a ≤ 500 mm
f
=
1 + 0,0013 (a — 500) for a > 500 mm
b
=
factor for bottom, side or bilge platesb=1,0 for bottom plates and side platesb=1,25 for bilge plates.
b
=
1,0 for bottom plates and side plates
b
=
1,25 for bilge plates.
c
=
factor for the type of structure:c=0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coamingc=1,0 for all other types of structure.
c
=
0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coaming
c
=
1,0 for all other types of structure.

1.
for vessels that are longer than 40 m: tmin= f · b · c (2,3 + 0,04 L) (mm);for vessels not more than 40 m in length: tmin= f · b · c (1,5 + 0,06 L) (mm), however, not less than 3.00 mm

2.
where:a=frame spacing (mm);f=frame spacing factor:f=1 for a ≤ 500 mmf=1 + 0,0013 (a — 500) for a > 500 mmb=factor for bottom, side or bilge platesb=1,0 for bottom plates and side platesb=1,25 for bilge plates.f = 1 may be taken for the frame spacing when calculating the minimum thickness of the side plates. However, the minimum thickness of the bilge plates may in no case be less than that of the bottom plates and side plates.c=factor for the type of structure:c=0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coamingc=1,0 for all other types of structure.
a
=
frame spacing (mm);
f
=
frame spacing factor:f=1 for a ≤ 500 mmf=1 + 0,0013 (a — 500) for a > 500 mm
f
=
1 for a ≤ 500 mm
f
=
1 + 0,0013 (a — 500) for a > 500 mm
b
=
factor for bottom, side or bilge platesb=1,0 for bottom plates and side platesb=1,25 for bilge plates.
b
=
1,0 for bottom plates and side plates
b
=
1,25 for bilge plates.
c
=
factor for the type of structure:c=0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coamingc=1,0 for all other types of structure.
c
=
0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coaming
c
=
1,0 for all other types of structure.

a
=
frame spacing (mm);

f
=
frame spacing factor:f=1 for a ≤ 500 mmf=1 + 0,0013 (a — 500) for a > 500 mm
f
=
1 for a ≤ 500 mm
f
=
1 + 0,0013 (a — 500) for a > 500 mm

f
=
1 for a ≤ 500 mm

f
=
1 + 0,0013 (a — 500) for a > 500 mm

b
=
factor for bottom, side or bilge platesb=1,0 for bottom plates and side platesb=1,25 for bilge plates.
b
=
1,0 for bottom plates and side plates
b
=
1,25 for bilge plates.

b
=
1,0 for bottom plates and side plates

b
=
1,25 for bilge plates.

c
=
factor for the type of structure:c=0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coamingc=1,0 for all other types of structure.
c
=
0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coaming
c
=
1,0 for all other types of structure.

c
=
0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coaming

c
=
1,0 for all other types of structure.

1.
for vessels that are longer than 40 m: tmin= f · b · c (2,3 + 0,04 L) (mm);for vessels not more than 40 m in length: tmin= f · b · c (1,5 + 0,06 L) (mm), however, not less than 3.00 mm

2.
where:a=frame spacing (mm);f=frame spacing factor:f=1 for a ≤ 500 mmf=1 + 0,0013 (a — 500) for a > 500 mmb=factor for bottom, side or bilge platesb=1,0 for bottom plates and side platesb=1,25 for bilge plates.f = 1 may be taken for the frame spacing when calculating the minimum thickness of the side plates. However, the minimum thickness of the bilge plates may in no case be less than that of the bottom plates and side plates.c=factor for the type of structure:c=0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coamingc=1,0 for all other types of structure.
a
=
frame spacing (mm);
f
=
frame spacing factor:f=1 for a ≤ 500 mmf=1 + 0,0013 (a — 500) for a > 500 mm
f
=
1 for a ≤ 500 mm
f
=
1 + 0,0013 (a — 500) for a > 500 mm
b
=
factor for bottom, side or bilge platesb=1,0 for bottom plates and side platesb=1,25 for bilge plates.
b
=
1,0 for bottom plates and side plates
b
=
1,25 for bilge plates.
c
=
factor for the type of structure:c=0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coamingc=1,0 for all other types of structure.
c
=
0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coaming
c
=
1,0 for all other types of structure.

a
=
frame spacing (mm);

f
=
frame spacing factor:f=1 for a ≤ 500 mmf=1 + 0,0013 (a — 500) for a > 500 mm
f
=
1 for a ≤ 500 mm
f
=
1 + 0,0013 (a — 500) for a > 500 mm

f
=
1 for a ≤ 500 mm

f
=
1 + 0,0013 (a — 500) for a > 500 mm

b
=
factor for bottom, side or bilge platesb=1,0 for bottom plates and side platesb=1,25 for bilge plates.
b
=
1,0 for bottom plates and side plates
b
=
1,25 for bilge plates.

b
=
1,0 for bottom plates and side plates

b
=
1,25 for bilge plates.

c
=
factor for the type of structure:c=0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coamingc=1,0 for all other types of structure.
c
=
0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coaming
c
=
1,0 for all other types of structure.

c
=
0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coaming

c
=
1,0 for all other types of structure.

a
=
frame spacing (mm);

f
=
frame spacing factor:f=1 for a ≤ 500 mmf=1 + 0,0013 (a — 500) for a > 500 mm
f
=
1 for a ≤ 500 mm
f
=
1 + 0,0013 (a — 500) for a > 500 mm

f
=
1 for a ≤ 500 mm

f
=
1 + 0,0013 (a — 500) for a > 500 mm

b
=
factor for bottom, side or bilge platesb=1,0 for bottom plates and side platesb=1,25 for bilge plates.
b
=
1,0 for bottom plates and side plates
b
=
1,25 for bilge plates.

b
=
1,0 for bottom plates and side plates

b
=
1,25 for bilge plates.

f
=
1 for a ≤ 500 mm

f
=
1 + 0,0013 (a — 500) for a > 500 mm

b
=
1,0 for bottom plates and side plates

b
=
1,25 for bilge plates.

c
=
factor for the type of structure:c=0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coamingc=1,0 for all other types of structure.
c
=
0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coaming
c
=
1,0 for all other types of structure.

c
=
0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coaming

c
=
1,0 for all other types of structure.

c
=
0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coaming

c
=
1,0 for all other types of structure.

(c)
In longitudinally framed vessels with double bottom and wing voids, the minimum value calculated for the plate thickness in accordance with the formulae in paragraph (b) may be reduced to a calculated value certified by an approved classification society for sufficient hull strength (longitudinal, lateral and local strength).Plates shall be renewed if bottom, bilge or side plates are below the permissible value laid down in this way.

(a)
A collision bulkhead at a suitable distance from the bow in such a way that the buoyancy of the laden vessel is ensured, with a residual safety clearance of 100 mm if water enters the watertight compartment ahead of the collision bulkhead.As a general rule, the requirement referred to in paragraph 1 shall be considered to have been met if the collision bulkhead has been installed at a distance of between 0,04 L and 0,04 L + 2 m measured from the forward perpendicular in the plane of maximum draught.If this distance exceeds 0,04 L + 2 m, the requirement set out in paragraph 1 shall be proved by calculation.The distance may be reduced to 0,03 L. In that case the requirement referred to in paragraph 1 shall be proved by calculation on the assumption that the compartment ahead of the collision bulkhead and those adjacent have all been filled with water.

(b)
An aft-peak bulkhead at a suitable distance from the stern where the vessel length L exceeds 25 m.

(a)
the total floor area (average length x average width at the level of the floor plating) of the engine or boiler room does not exceed 35 m2; and

(b)
the path between each point where servicing or maintenance operations are to be carried out and the exit, or foot of the companionway near the exit providing access to the outside, is not longer than 5 m; and

(c)
a fire extinguisher is located at the servicing point that is furthest removed from the exit door and also, by way of derogation from Article 10.03(1)(e), where the installed power of the engines does not exceed 100 kW.

a
is a correction coefficient that takes account of all of the superstructures involved;

βv
is a coefficient for correcting the effect of the forward sheer resulting from the presence of superstructures in the forward quarter of length L of the vessel;

βa
is a coefficient correcting the effect of the aft sheer resulting from the presence of superstructures in the aft quarter of length L of the vessel;

Sev
is the effective forward sheer in mm;

Sea
is the effective aft sheer in mm.

lem
is the effective length, in m, of a superstructure located in the median part corresponding to half of length L of the vessel;

lev
is the effective length, in m, of a superstructure in the forward quarter of vessel length L;

lea
is the effective length, in m, of a superstructure in the aft quarter of vessel length L.

l
is the effective length, in m, of the superstructure involved;

b
is the width, in m, of the superstructure involved;

B1
is the width of the vessel, in m, measured on the outside of the vertical sideplates at deck level halfway along the superstructure involved;

h
is the height, in m, of the superstructure involved. However, in the case of hatches, h is obtained by reducing the height of the coamings by half of the safety distance according to Article 4.01(1) and (2). In no case will a value exceeding 0,36 m be taken for h.

Sev= Sv· p

Sea= Sa· p

Sv
is the actual forward sheer, in mm; however Svshall not be taken to be more than 1 000 mm;

Sa
is the actual aft sheer, in mm; however Samay not be taken to be more than 500 mm;

p
is a coefficient calculated using the following formula:

x
is the abscissa, measured from the extremity of the point where the sheer is 0,25 Svor 0,25 Sa(see figure).Sv or Sa0,25 Sv or 0,25 SaX

(a)
where a vessel is less than 40 m in length it will suffice to affix two pairs of marks at a distance from the bow and stern, respectively, that is equal to a quarter of the length;

(b)
where vessels are not intended for the carriage of goods, a pair of marks located roughly halfway along the vessel will suffice.

(a)
oil level in the hydraulic reservoirs in accordance with Article 6.03(2), and service pressure of the hydraulic system;

(b)
failure of the electrical supply for the steering control;

(c)
failure of the electrical supply for the drive units;

(d)
failure of the rate-of-turn regulator;

(e)
failure of the required buffer devices.

(a)
description of the steering system;

(b)
drawings and information on the drive units and the steering controls;

(c)
information concerning the steering apparatus;

(d)
electrical wiring diagram;

(e)
description of the rate-of-turn regulator;

(f)
operating instructions for the steering system.

(a)
‘navigation lights’ means the masthead, side and stern lights, and the lights visible from all sides, the blue scintillating lights, yellow rapidly scintillating strong lights for high-speed vessels and blue lights for the carriage of dangerous goods;

(b)
‘light signals’ means the lights accompanying the sound signals and assigned to the blue panel.

(a)
the radar screen shall not be shifted significantly out of the helmsman's axis of view in its normal position;

(b)
the radar image shall continue to be perfectly visible, without a mask or screen, whatever the lighting conditions outside the wheelhouse;

(c)
the rate-of-turn indicator shall be installed directly above or below the radar image or be incorporated into this.

(a)
with the bow of the vessel or convoy;

(b)
with the stern of the vessel or convoy if no direct communication is possible from the steering position;

(c)
with the crew accommodation;

(d)
with the boatmaster's cabin.

(a)
the temperature of the main-engine cooling water;

(b)
the lubricating-oil pressure for the main engines and transmissions;

(c)
the oil and air pressure of the main engine reversing units, reversible transmissions or propellers.

10.
(a)Fuel tanks shall be safeguarded against fuel spills during bunkering by means of appropriate onboard technical devices which shall be entered in item 52 of the Community certificate.(b)If fuel is taken on from bunkering stations with their own technical devices to prevent fuel spills on board during bunkering, the equipment requirements in (a) and paragraph 11 shall no longer apply.
(a)
Fuel tanks shall be safeguarded against fuel spills during bunkering by means of appropriate onboard technical devices which shall be entered in item 52 of the Community certificate.
(b)
If fuel is taken on from bunkering stations with their own technical devices to prevent fuel spills on board during bunkering, the equipment requirements in (a) and paragraph 11 shall no longer apply.

(a)
Fuel tanks shall be safeguarded against fuel spills during bunkering by means of appropriate onboard technical devices which shall be entered in item 52 of the Community certificate.

(b)
If fuel is taken on from bunkering stations with their own technical devices to prevent fuel spills on board during bunkering, the equipment requirements in (a) and paragraph 11 shall no longer apply.

(a)
Fuel tanks shall be safeguarded against fuel spills during bunkering by means of appropriate onboard technical devices which shall be entered in item 52 of the Community certificate.

(b)
If fuel is taken on from bunkering stations with their own technical devices to prevent fuel spills on board during bunkering, the equipment requirements in (a) and paragraph 11 shall no longer apply.

Q1= 0,1 · d12(1/min)

Q2= 0,1 · d22(l/min)

l
is the length of the watertight compartment in question, in (m);

d1
is the calculated internal diameter of the main drainage pipe, in (mm);

d2
is the calculated internal diameter of the branch pipe, in (mm).

(a)
general drawings concerning the entire electrical installation;

(b)
switching diagrams for the main switchboard, the emergency switchboard and the distribution switchboard, together with the most important technical data such as the amperage and rated current of the protection and control devices;

(c)
power data concerning the electrical machinery and equipment;

(d)
types of cable and information on conductor cross-sections.

Location
Type of minimum protection(in accordance with IEC publ. 60529: 1992)

Generators
Motors
Trans-formers
PanelsDistributorsSwitches
Fittings
Lighting equipment

Operation rooms, engine rooms, steering-gear compartments
IP 22
IP 22
IP(2)22
IP(1)(2)22
IP 44
IP 22

Holds

IP 55
IP 55

Battery and paint lockers

IP 44u. (Ex)(3)

Free decks and open steering positions

IP 55

IP 55
IP 55
IP 55

Wheelhouse

IP 22
IP 22
IP 22
IP 22
IP 22

Accommodation apart from sanitary facilities and washrooms

IP 22
IP 20
IP 20

Sanitary facilities and washrooms

IP 44
IP 44
IP 44
IP 55
IP 44

Cross-section of outside conductors(mm2)
Minimum cross-section of earthing conductors

within insulated cables(mm2)
fitted separately(mm2)

from 0,5 to 4
same cross-section as that of the outside conductor
4

more than 4 to 16
same cross-section as that of the outside conductor
same cross-section as that of the outside conductor

more than 16 to 35
16
16

more than 35 to 120
half of the cross-section of the outside conductor
half of the cross-section of the outside conductor

more than 120
70
70

Type of installation
Maximum permissible voltage

Direct current
Single-phase alternating current
Three-phase alternating current

a.Power and heating installations including the sockets for general use
a.
Power and heating installations including the sockets for general use
250 V
250 V
500 V

a.
Power and heating installations including the sockets for general use

b.Lighting, communications, command and information installations including the sockets for general use
b.
Lighting, communications, command and information installations including the sockets for general use
250 V
250 V
–

b.
Lighting, communications, command and information installations including the sockets for general use

c.Sockets intended to supply portable devices used on open decks or within narrow or damp metal lockers, apart from boilers and tanks:
c.
Sockets intended to supply portable devices used on open decks or within narrow or damp metal lockers, apart from boilers and tanks:

c.
Sockets intended to supply portable devices used on open decks or within narrow or damp metal lockers, apart from boilers and tanks:

1.In general
1.
In general
50 V(4)
50 V(4)
–

1.
In general

2.Where a protective circuit-separation transformer only supplies one appliance
2.
Where a protective circuit-separation transformer only supplies one appliance
–
250 V(5)
–

2.
Where a protective circuit-separation transformer only supplies one appliance

3.Where protective-insulation (double insulation) appliances are used
3.
Where protective-insulation (double insulation) appliances are used
250 V
250 V
–

3.
Where protective-insulation (double insulation) appliances are used

4.Where ≤ 30 mA default current circuit breakers are used.
4.
Where ≤ 30 mA default current circuit breakers are used.
–
250 V
500 V

4.
Where ≤ 30 mA default current circuit breakers are used.

d.Mobile power consumers such as electrical equipment for containers, motors, blowers and mobile pumps which are not normally moved during service and whose conducting parts which are open to physical contact are earthed by means of an earthing conductor that is incorporated into the connecting cable and which, in addition to that earthing conductor, are connected to the hull by their specific positioning or by an additional conductor
d.
Mobile power consumers such as electrical equipment for containers, motors, blowers and mobile pumps which are not normally moved during service and whose conducting parts which are open to physical contact are earthed by means of an earthing conductor that is incorporated into the connecting cable and which, in addition to that earthing conductor, are connected to the hull by their specific positioning or by an additional conductor
250 V
250 V
500 V

d.
Mobile power consumers such as electrical equipment for containers, motors, blowers and mobile pumps which are not normally moved during service and whose conducting parts which are open to physical contact are earthed by means of an earthing conductor that is incorporated into the connecting cable and which, in addition to that earthing conductor, are connected to the hull by their specific positioning or by an additional conductor

e.Sockets intended to supply portable appliances used inside boilers and tanks
e.
Sockets intended to supply portable appliances used inside boilers and tanks
50 V(4)
50 V(4)
–

e.
Sockets intended to supply portable appliances used inside boilers and tanks

a.
Power and heating installations including the sockets for general use

b.
Lighting, communications, command and information installations including the sockets for general use

c.
Sockets intended to supply portable devices used on open decks or within narrow or damp metal lockers, apart from boilers and tanks:

1.
In general

2.
Where a protective circuit-separation transformer only supplies one appliance

3.
Where protective-insulation (double insulation) appliances are used

4.
Where ≤ 30 mA default current circuit breakers are used.

d.
Mobile power consumers such as electrical equipment for containers, motors, blowers and mobile pumps which are not normally moved during service and whose conducting parts which are open to physical contact are earthed by means of an earthing conductor that is incorporated into the connecting cable and which, in addition to that earthing conductor, are connected to the hull by their specific positioning or by an additional conductor

e.
Sockets intended to supply portable appliances used inside boilers and tanks

(a)
for power installations where their power so requires;

(b)
for special on-board installations such as radio and ignition systems.

(a)
two-conductor systems of which one is earthed (L1/N/PE);

(b)
single-conductor systems using the hull return principle, only for local installations (for example, starting gear for combustion engines, cathodic protection) (L1/PEN);

(c)
two-conductor systems that are insulated from the hull (L1/L2/PE).

(a)
four-conductor systems with earthing of the neutral point, not using the hull return principle (L1/L2/L3/N/PE) = (network TN-S) or (network TT);

(b)
three-conductor systems insulated from the hull (Ll/L2/L3/PE) = (network IT);

(c)
three-conductor systems with earthing of the neutral point using the hull return principle, however, that shall not be allowed for terminal circuits (L1/L2/L3/PEN).

(a)
the measures required to establish the connection;

(b)
the type of current and the nominal voltage and, for alternating current, the frequency.

Q = 0,11 · I · n (m3/h)

I
=
of the maximum current, in A, provided by the charging device;

n
=
the number of cells.

(a)
Appliances, switches, fuses and switchboard instruments shall be clearly arranged and shall be accessible for maintenance and repair.Terminals for voltages up to 50 V, and those for voltages higher than 50 V, shall be kept separate and marked appropriately.

(b)
For all switches and appliances marker plates identifying the circuit shall be affixed to the switchboards.The nominal amperage and the circuit for fuses shall be identified.

(c)
When appliances with an operating voltage greater than 50 V are installed behind doors the live components of those appliances shall be protected against accidental contact while the doors are open.

(d)
The materials of switchboards shall have suitable mechanical strength and be durable, flame-retardant and self-extinguishing; they shall not be hygroscopic.

(e)
If high rupture capacity (HRC)-fuses are installed in electrical switchboards, accessories and personal protective equipment shall be available for installing and removing such fuses.

(a)
Generator circuits and power consumer circuits shall be protected against short circuiting and overload on all non-earthed conductors. Switching devices triggered by short-circuiting and overload or fuses may be used for this purpose.Circuits supplying electric motors of drive units (steering system) and their control circuits shall only be protected against short circuiting. Where circuits include thermal circuit-breakers these shall be neutralised or set at not less than twice the nominal amperage.

(b)
Outputs from the main switchboard to power consumers operating at more than 16 A shall include a load or power switch.

(c)
Power consumers for the propulsion of the craft, the steering system, the rudder position indicator, navigation or safety systems, and power consumers with a nominal amperage greater than 16 A shall be supplied by separate circuits.

(d)
The circuits of power consumers required for propelling and manoeuvring the vessel shall be supplied directly by the main switchboard.

(e)
Circuit-breaking equipment shall be selected on the basis of nominal amperage, thermal or dynamic strength, and breaking capacity. Switches shall simultaneously cut off all live conductors. The switching position shall be identifiable.

(f)
Fuses shall be of the enclosed-melt type and be made of ceramic or an equivalent material. It shall be possible to change them without any danger of physical contact for the operator.

(a)
Generator, accumulator and distribution circuits shall be equipped with measuring and monitoring devices where the safe operation of the installation so requires.

(b)
Non-earthed networks with a voltage of more than 50 V shall be equipped with an earthing detection device capable of giving both visual and audible alarm. In secondary installations such as control circuits, this device may be dispensed with.

(a)
Switchboards shall be located in accessible and well-ventilated spaces and be protected against water and mechanical damage.Piping and air ducts shall be so arranged that in the event of leakage the switchboards cannot be damaged. If their installation near electrical switchboards is inevitable, pipes shall not have detachable connections nearby.

(b)
Cabinets and wall recesses in which unprotected switching devices are installed shall be of a flame-retardant material or be protected by a metal or other flame-retardant sheathing.

(c)
When the voltage is greater than 50 V, insulating gratings or mats shall be placed at the operator's position in front of the main switchboard.

(a)
IEC publications 60332-1:1993, 60332-3:2000; or

(b)
equivalent regulations recognised by one of the Member States.

(a)
Alarm systemsThe alarm systems shall be so designed that no failure in the alarm system can result in failure of the apparatus or installation being monitored.Binary transmitters shall be designed on the quiescent-current principle or on the monitored load-current principle.Visual alarms shall remain visible until the fault has been remedied; an alarm that has been acknowledged shall be distinguishable from an alarm that has not yet been acknowledged. Each alarm shall also comprise an audible warning. It shall be possible to switch off acoustic alarms. Switching off one acoustic alarm shall not prevent another signal from being set off by another cause.Exceptions can be permitted in the case of alarm systems comprising less than five measurement points.

(b)
Safety systemsSafety systems shall be designed to halt or slow down the operation of the affected equipment, or to warn a permanently-manned station to do so before a critical state is reached.Binary transmitters shall be designed according to the load-current principle.If safety systems are not designed to be self-monitoring it shall be possible to check that they are operating correctly .Safety systems shall be independent of other systems.

(a)
The stresses arising from the following tests shall not cause electronic devices to be damaged or to malfunction. The tests in accordance with relevant international standards, such as IEC publication 60092-504:2001, apart from the cold-condition test, shall be carried out with the device switched on. These tests shall include checking of proper operation.

(b)
Variations in voltage and frequencyVariationscontinuousshort-durationGeneralFrequency± 5 %± 10 % 5 sVoltage± 10 %± 20 % 1.5 sBattery operationVoltage+ 30 %/- 25 %

Variations
continuous
short-duration
General
Frequency
± 5 %
± 10 % 5 s
Voltage
± 10 %
± 20 % 1.5 s
Battery operation
Voltage
+ 30 %/- 25 %

Variations

continuous
short-duration

General
Frequency
± 5 %
± 10 % 5 s

Voltage
± 10 %
± 20 % 1.5 s

Battery operation
Voltage
+ 30 %/- 25 %

Variations

continuous
short-duration

General
Frequency
± 5 %
± 10 % 5 s

Voltage
± 10 %
± 20 % 1.5 s

Battery operation
Voltage
+ 30 %/- 25 %

(c)
Heating testThe sample is brought up to a temperature of 55 °C within a half-hour period. After that temperature has been reached it is maintained for 16 hours. An operating test is then carried out.

(d)
Cold-condition testThe sample is switched off and cooled to -25 °C and held at that temperature for two hours. The temperature is then raised to 0 °C and an operating test is carried out.

(e)
Vibration testThe vibration test shall be carried out along the three axes at the resonance frequency of the devices or of components for the period of 90 minutes in each case. If no clear resonance emerges the vibration test shall be carried out at 30 Hz.The vibration test shall be carried out by sinusoidal oscillation within the following limits:General:f = 2,0 to 13,2 Hz; a = ± 1 mm(amplitude a =the vibration width)f = 13,2 Hz to 100 Hz: acceleration ± 0,7 g.Equipment intended to be fitted to diesel engines or steering apparatus shall be tested as follows:f = 2,0 to 25 Hz; a = ± 1,6 mm(amplitude a =the vibration width)f = 25 Hz to 100 Hz; acceleration ± 4 g.The sensors intended to be installed in diesel-engine exhaust pipes may be exposed to considerably higher stresses. Account shall be taken of this during the tests.

(f)
The electromagnetic compatibility test shall be carried out on the basis of IEC publications 61000-4-2:1995, 61000-4-3:2002, 61000-4-4:1995, at test degree number 3.

(g)
Proof that the electronic equipment is adequate for these test conditions shall be provided by their manufacturer. A certificate by an approved classification society shall likewise be considered to be proof.

(a)
disconnection of the transmission paths between the source of interference and affected devices;

(b)
reducing the causes of disturbance at their source;

(c)
reducing the sensitivity of affected devices to interference.

P = k · B · T (kg)

k
is a coefficient that takes account of the relationship between length L and beam B, and of the type of vessel:for lighters, however, k = c will be taken;

c
is an empirical coefficient given in the following table:Dead-weight tonnage in tCoefficient cup to 400 inclusive45from 400 to 650 inclusive55from 650 to 1 000  inclusive65more than 1 00070
Dead-weight tonnage in t
Coefficient c
up to 400 inclusive
45
from 400 to 650 inclusive
55
from 650 to 1 000  inclusive
65
more than 1 000
70

Dead-weight tonnage in t
Coefficient c

up to 400 inclusive
45

from 400 to 650 inclusive
55

from 650 to 1 000  inclusive
65

more than 1 000
70

Dead-weight tonnage in t
Coefficient c

up to 400 inclusive
45

from 400 to 650 inclusive
55

from 650 to 1 000  inclusive
65

more than 1 000
70

P = k · B · T (kg)

k
is the coefficient corresponding to paragraph 1, but where in order to obtain the value of the empirical coefficient (c) the water displacement in m3entered in the Community certificate shall be taken instead of the deadweight tonnage.

(a)
vessels for which the stern anchor mass will be less than 150 kg; in the case of vessels referred to in paragraph 1, final subparagraph, the reduced mass of the bow anchors shall be taken into account;

(b)
lighters.

(a)
40 m for vessels not exceeding 30 m in length;

(b)
10 m longer than the vessel where this is more than 30 m and up to 50 m in length;

(c)
60 m where vessels are more than 50 m in length.

(a)
anchors having a mass up to 500 kg:R = 0,35 · P' (kN);

(b)
anchors having a mass of more than 500 kg and not exceeding 2 000 kg:;

(c)
anchors having a mass of more than 2 000 kg:R = 0,25 · P' (kN).

P'
is the theoretical mass of each anchor determined in accordance with paragraphs 1 to 4 and 6.

(a)
radio-telephone system;

(b)
appliances and devices for giving visual and audible signals as well as daytime and night-time vessel marking;

(c)
stand-alone back-up lights for the prescribed mooring lights;

(d)
a fire-proof, marked receptacle, with cover, to receive oily cleaning cloths;

(e)
a fire-proof, marked receptacle, with cover, to receive hazardous or pollutant solid wastes and a fire-proof, marked receptacle, with cover, to receive hazardous or pollutant liquid wastes according to the relevant applicable navigational authority regulations;

(f)
a fire-proof, marked receptacle, with cover, to receive slops.

(a)
Mooring cables;Vessels shall be equipped with three mooring cables. Their minimum lengths shall be at least the following:—first cable: L + 20 m, but not more than 100 m,—second cable: 2/3 of the first cable,—third cable: 1/3 of the first cable.The shortest cable is not required on board vessels whose L is less than 20 m.The cables shall have a tensile strength Rsthat is calculated using the following formulae;for L · B · T up to 1 000 m3:;for L · B · T exceeding 1 000 m3:.For the required cables a certificate in accordance with European standard EN 10 204:1991, under No 3.1, shall be on board.These cables may be replaced by ropes having the same length and tensile strength. The minimum tensile strength of these ropes shall be indicated in a certificate.

(b)
Towing cables;Tugs shall be equipped with a number of cables that are suitable for their operation.However, the main cable shall be at least 100 m long and have a tensile strength, in kN, not less than one third of the total power, in kW, of the main engine(s).Motor vessels and pushers that are also able to tow shall be equipped with a towing cable that is at least 100 m long and whose tensile strength, in kN, is not less than one quarter of the total power, in kW, of the main engine(s).

Tugs shall be equipped with a number of cables that are suitable for their operation.

However, the main cable shall be at least 100 m long and have a tensile strength, in kN, not less than one third of the total power, in kW, of the main engine(s).

Motor vessels and pushers that are also able to tow shall be equipped with a towing cable that is at least 100 m long and whose tensile strength, in kN, is not less than one quarter of the total power, in kW, of the main engine(s).

Tugs shall be equipped with a number of cables that are suitable for their operation.

However, the main cable shall be at least 100 m long and have a tensile strength, in kN, not less than one third of the total power, in kW, of the main engine(s).

Motor vessels and pushers that are also able to tow shall be equipped with a towing cable that is at least 100 m long and whose tensile strength, in kN, is not less than one quarter of the total power, in kW, of the main engine(s).

Tugs shall be equipped with a number of cables that are suitable for their operation.

However, the main cable shall be at least 100 m long and have a tensile strength, in kN, not less than one third of the total power, in kW, of the main engine(s).

Motor vessels and pushers that are also able to tow shall be equipped with a towing cable that is at least 100 m long and whose tensile strength, in kN, is not less than one quarter of the total power, in kW, of the main engine(s).

(c)
A heaving line;

(d)
A boarding gangway at least 0,4 m wide and 4 m long whose side edges are defined by a brightly-coloured strip; that gangway shall be equipped with a handrail. The inspection body may permit shorter gangways for small vessels;

(e)
A gaff hook;

(f)
An appropriate first-aid kit with a content in accordance with a relevant standard of a Member State. The first-aid kit shall be kept in an accommodation room or in the wheelhouse and be stored in such a way that it is easily and safely accessible if necessary. If first-aid kits are stored under cover, the cover shall be marked by a symbol for first-aid kit according to Figure 8 of Appendix I, having a side length of at least 10 cm;

(g)
A pair of binoculars, 7 x 50 or with larger lens diameter;

(h)
A notice concerning the rescue and revival of persons overboard;

(i)
A searchlight that can be operated from the wheelhouse.

(a)
in the wheelhouse;

(b)
close to each entrance from the deck to accommodation spaces;

(c)
close to each entrance to service spaces which are not accessible from the accommodation spaces and which contain heating, cooking or refrigeration equipment using solid or liquid fuels or liquefied gas;

(d)
at each entrance to engine rooms and boiler rooms;

(e)
at suitable points below deck in engine rooms and boiler rooms such that no position in the space is more than 10 metres walking distance away from an extinguisher.

(a)
before being put into service;

(b)
before being put back into service after they have been triggered;

(c)
after any modification or repair;

(d)
regularly at least every two years.

(a)
external inspection of the entire system;

(b)
functional testing of the safety systems and nozzles;

(c)
functional testing of the pressure tanks and pumping system.

(a)
CO2(carbon dioxide);

(b)
HFC 227ea (heptafluoropropane);

(c)
IG-541 (52 % nitrogen, 40 % argon, 8 % carbon dioxide).

(a)
Combustion air for the propulsion engines shall not be extracted from rooms that are to be protected by permanently installed fire-fighting systems. This shall not apply where there are two mutually independent and hermetically separated main engine rooms or if next to the main engine room there is a separate engine room with a bow thruster, ensuring that the vessel is able to make way under its own power in the event of fire in the main engine room.

(b)
Any forced ventilation present in the room to be protected shall switch off automatically if the fire-fighting system is triggered.

(c)
There shall be devices available with which all apertures which can allow air to enter or gas to escape from the room to be protected can be quickly closed. It shall be clearly recognisable whether they are open or closed.

(d)
The air escaping from relief valves in the compressed-air tanks installed in engine rooms shall be conveyed to the open air.

(e)
Over- or underpressure resulting from the inflow of extinguishing agent shall not destroy the components of the surrounding partitions of the room to be protected. It shall be possible for the pressure to equalise without danger.

(f)
Protected rooms shall have a facility for extracting the extinguishing agent and the combustion gases. Such facilities shall be capable of being operated from positions outside the protected rooms and which would not be made inaccessible by a fire within such spaces. If there are permanently installed extractors, it shall not be possible for these to be switched on while the fire is being extinguished.

(a)
The extinguishing agent shall be conveyed to the room to be protected and distributed there by means of a fixed piping system. Inside the room to be protected the piping and associated fittings shall made of steel. Tank connecting pipes and expansion joints shall be exempt from this provided the materials used have equivalent properties in case of fire. Pipes shall be both internally and externally protected against corrosion.

(b)
Outlet nozzles shall be dimensioned and fitted such that the extinguishing agent is evenly distributed.

(a)
Fire-fighting systems with automatic triggering shall not be permissible.

(b)
It shall be possible to trigger the fire-fighting system from a suitable place outside the room to be protected.

(c)
Triggering devices shall be installed in such a way that they can be operated even in case of a fire and in the event of damage by fire or explosion in the room to be protected the necessary quantity of extinguishing agent can still be conveyed.Non-mechanical triggering devices shall be powered from two different mutually independent energy sources. These energy sources shall be located outside the room to be protected. Control lines in the room to be protected shall be designed so as to remain functional for at least 30 minutes in the event of fire. This requirement shall be fulfilled in the case of electric wiring if it complies with the standard IEC 60331-21:1999.If triggering devices are installed in such a way that they are out of sight the panel covering them shall be identified by the ‘fire-fighting installation’ symbol as shown in Figure 6 of Appendix I, having a side length of at least 10 cm, and the following text in red lettering on a white background:‘FeuerlöscheinrichtungInstallation d'extinctionBrandblusinstallatieFire-fighting installation’.

(d)
If the fire-fighting system is intended for the protection of several rooms, the triggering devices for each room have to be separate and clearly identified.

(e)
Next to each triggering device operating instructions in one of the languages of the Member States shall be posted up visibly and indelibly. They shall contain, in particular, instructions regarding:(aa)triggering of the fire-fighting system;(bb)the need for checking to ensure that all persons have left the room to be protected;(cc)action to be taken by the crew when the fire-fighting system is triggered;(dd)action to be taken by the crew in the case of failure of the fire-fighting system.
(aa)
triggering of the fire-fighting system;
(bb)
the need for checking to ensure that all persons have left the room to be protected;
(cc)
action to be taken by the crew when the fire-fighting system is triggered;
(dd)
action to be taken by the crew in the case of failure of the fire-fighting system.

(aa)
triggering of the fire-fighting system;

(bb)
the need for checking to ensure that all persons have left the room to be protected;

(cc)
action to be taken by the crew when the fire-fighting system is triggered;

(dd)
action to be taken by the crew in the case of failure of the fire-fighting system.

(aa)
triggering of the fire-fighting system;

(bb)
the need for checking to ensure that all persons have left the room to be protected;

(cc)
action to be taken by the crew when the fire-fighting system is triggered;

(dd)
action to be taken by the crew in the case of failure of the fire-fighting system.

(f)
The operating instructions shall point out that before the fire-fighting system is triggered combustion engines drawing air from the room to be protected are to be shut down.

(a)
Permanently installed fire-fighting systems shall be provided with acoustic and optical warning systems.

(b)
The warning system shall be set off automatically as soon as the fire-fighting system is first triggered. The warning signal shall sound for an appropriate time before the extinguishing agent is released and it shall not be possible to switch it off.

(c)
Warning signals shall be clearly visible in the rooms to be protected and outside the accesses to them and clearly audible even under operating conditions producing the loudest inherent noise. They shall be clearly distinct from all other acoustic and optical signals in the room to be protected.

(d)
The acoustic warning signals shall be clearly audible in the adjacent rooms even when connecting doors are closed and under operating conditions producing the loudest inherent noise.

(e)
If the warning system is not self-monitoring as regards short-circuits, wire breaks and voltage drops, it shall be possible to check that it is working properly.

(f)
At every entrance to a room that can be supplied with extinguishing agent, a clearly visible notice shall be put up bearing the following text in red lettering on a white background:‘Vorsicht, Feuerlöscheinrichtung!Bei Ertönen des Warnsignals (Beschreibung des Signals) den Raum sofort verlassen!Attention, installation d'extinction d'incendie!Quitter immédiatement ce local au signal (description du signal)Let op, brandblusinstallatie!Bij het in werking treden van het alarmsignaal (omschrijving van het signaal) deze ruimte onmiddellijk verlaten!Warning, fire-fighting installation!Leave the room as soon as the warning signal sounds (description of signal)’.

(a)
Pressure tanks, fittings and pressure pipes shall comply with the provisions in force in one of the Member States.

(b)
Pressure tanks shall be installed in accordance with the manufacturer's instructions.

(c)
Pressure tanks, fittings and pressure pipes are not to be installed in accommodation spaces.

(d)
The temperature in cabinets and installation spaces containing pressure tanks shall not exceed 50oC.

(e)
Cabinets or installation spaces on deck shall be firmly fixed in place and have air vents which are to be arranged in such a way that in the event of a leak in the pressure tank no gas can escape into the interior of the vessel. Direct connections to other rooms are not permitted.

(a)
The system shall be installed or converted only by a firm specialising in fire-fighting systems. The requirements specified by the extinguishing agent manufacturer and the system manufacturer (product data sheet, safety data sheet) are to be complied with.

(b)
The system shall be checked by an expert:(aa)before being put into service;(bb)before being put back into service after it has been triggered;(cc)after any modification or repair;(dd)regularly at least every two years.
(aa)
before being put into service;
(bb)
before being put back into service after it has been triggered;
(cc)
after any modification or repair;
(dd)
regularly at least every two years.

(aa)
before being put into service;

(bb)
before being put back into service after it has been triggered;

(cc)
after any modification or repair;

(dd)
regularly at least every two years.

(aa)
before being put into service;

(bb)
before being put back into service after it has been triggered;

(cc)
after any modification or repair;

(dd)
regularly at least every two years.

(c)
In the inspection the expert shall check whether the system meets the requirements of this chapter.

(d)
The inspection shall cover at least the following:(aa)external inspection of the entire installation;(bb)tightness check on pipes;(cc)functional checking of control and triggering systems;(dd)checking of tank pressure and content;(ee)checking of tightness and facilities for locking the room to be protected;(ff)checking the fire alarm system;(gg)checking the warning system.
(aa)
external inspection of the entire installation;
(bb)
tightness check on pipes;
(cc)
functional checking of control and triggering systems;
(dd)
checking of tank pressure and content;
(ee)
checking of tightness and facilities for locking the room to be protected;
(ff)
checking the fire alarm system;
(gg)
checking the warning system.

(aa)
external inspection of the entire installation;

(bb)
tightness check on pipes;

(cc)
functional checking of control and triggering systems;

(dd)
checking of tank pressure and content;

(ee)
checking of tightness and facilities for locking the room to be protected;

(ff)
checking the fire alarm system;

(gg)
checking the warning system.

(aa)
external inspection of the entire installation;

(bb)
tightness check on pipes;

(cc)
functional checking of control and triggering systems;

(dd)
checking of tank pressure and content;

(ee)
checking of tightness and facilities for locking the room to be protected;

(ff)
checking the fire alarm system;

(gg)
checking the warning system.

(e)
An inspection certificate shall be issued, signed by the inspector and showing the date of the inspection.

(f)
The number of permanently installed fire-fighting systems shall be entered in the Community certificate.

(a)
CO2containers shall be housed outside the room to be protected in a space or cabinet hermetically separated from other rooms. The doors to these installation spaces and cabinets shall open outwards, be lockable and bear on the outside a symbol for ‘General danger warning’ in accordance with Figure 4 of Appendix I, at least 5 cm in height, together with the marking ‘CO2’ in the same colour and with the same height;

(b)
installation spaces below decks for CO2containers shall be accessible only from the open air. These spaces shall have their own adequate artificial ventilation system with extraction ducts, completely separate from other ventilation systems on board;

(c)
the CO2containers shall not be filled to more than 0,75 kg/l. The specific volume of unpressurised CO2gas is to be taken as 0,56 m3/kg;

(d)
the volume of CO2for the room to be protected shall be at least 40 % of its gross volume. It shall be possible to supply this volume within 120 seconds, and to check whether supply has been completed;

(e)
opening the container valves and operating the flood valve shall be separate control operations;

(f)
the appropriate time mentioned under paragraph 6(b) shall be at least 20 seconds. There shall be a reliable device to ensure the delay before delivery of the CO2gas.

(a)
if there are several rooms to be protected, each with a different gross volume, each room shall be provided with its own fire-fighting system;

(b)
each container of HFC-227ea that is installed in the room to be protected shall be equipped with an overpressure relief valve. This shall harmlessly release the contents of the container into the room to be protected if the container is exposed to the effects of fire and the fire-fighting system has not been triggered;

(c)
each container shall be fitted with a device for checking the gas pressure;

(d)
the containers shall not be filled to more than 1,15 kg/l. The specific volume of the unpressurised HFC-227ea is to be taken as 0,1374 m3/kg;

(e)
the volume of HFC-227ea for the room to be protected shall be at least 8 % of the room's gross volume. This volume shall be supplied within 10 seconds;

(f)
the HFC-227ea containers shall be provided with a pressure monitor which triggers an acoustic and optical alarm signal in the wheelhouse in the event of an unauthorised loss of propellant. If there is no wheelhouse, this alarm signal shall be given outside the room to be protected;

(g)
after flooding, the concentration in the room to be protected shall not exceed 10,5 %;

(h)
the fire-fighting system shall not contain any parts made of aluminium.

(a)
if there are several rooms to be protected, each with a different gross volume, each room shall be provided with its own fire-fighting system;

(b)
each container of IG-541 that is installed in the room to be protected shall be equipped with an overpressure relief valve. This shall harmlessly release the contents of the container into the room to be protected if the container is exposed to the effects of fire and the fire-fighting system has not been triggered;

(c)
each container shall be fitted with a device for checking the contents;

(d)
the filling pressure of the container shall not exceed 200 bar at + 15 °C;

(e)
the volume of IG-541 for the room to be protected shall be at least 44 % and no more than 50 % of the room's gross volume. This volume shall be supplied within 120 seconds.

(a)
motor vessels and barges exceeding 150 t deadweight;

(b)
tugs and pushers with a water displacement of more than 150 m3;

(c)
floating equipment;

(d)
passenger vessels.

(a)
in front of the access opening, there is sufficient room not to impede movement;

(b)
the clear width of the passageway shall be appropriate for the intended use of the working space and shall be not less than 0,60 m, except in the case of craft less than 8 m wide, where it may be reduced to 0,50 m;

(c)
the clear height of the passageway including the sill is not less than 1,90 m.

(a)
manufacturer's name and address;

(b)
the CE marking, together with the year of manufacture;

(c)
series or type reference;

(d)
where applicable, serial number.

(a)
the crane manufacturer's operating instructions, including at least the following information:operating range and function of the controls;maximum permissible safe working load as a function of the reach;maximum permissible inclination of the crane;assembly and maintenance instructions;instructions concerning regular checks;general technical data.

operating range and function of the controls;

maximum permissible safe working load as a function of the reach;

maximum permissible inclination of the crane;

assembly and maintenance instructions;

instructions concerning regular checks;

general technical data.

operating range and function of the controls;

maximum permissible safe working load as a function of the reach;

maximum permissible inclination of the crane;

assembly and maintenance instructions;

instructions concerning regular checks;

general technical data.

operating range and function of the controls;

maximum permissible safe working load as a function of the reach;

maximum permissible inclination of the crane;

assembly and maintenance instructions;

instructions concerning regular checks;

general technical data.

(b)
certificates concerning the checks carried out in accordance with paragraphs 6 to 8 or 9.

(a)
70 dB(A) in communal living quarters;

(b)
60 dB(A) in sleeping quarters. This provision shall not apply to vessels operating exclusively outside the rest periods of the crew as laid down by the national legislation of the Member States. The restriction of the daily operating period shall be entered on the Community certificate.

(a)
they are at least 0,60 m wide;

(b)
the tread is at least 0,15 m deep;

(c)
the steps are non-slip;

(d)
stairways with more than three steps are fitted with at least one handrail or handle.

(a)
one toilet per accommodation unit or per six crew members; it shall be possible to ventilate these with fresh air;

(b)
one washbasin with waste pipe and connected up to hot and cold potable water per accommodation unit or per four crew members;

(c)
one shower or bath connected up to hot and cold potable water per accommodation unit or per six crew members.

(a)
a cooker;

(b)
a sink with waste connection;

(c)
a supply of potable water;

(d)
a refrigerator;

(e)
sufficient storage and working space.

(a)
on their inner surfaces be made of a material which resists corrosion and poses no physiological danger;

(b)
be free of pipe sections where a regular flow of water is not guaranteed, and

(c)
be protected against excessive heating.

(a)
have a capacity of at least 150 l per person normally living on board, and at least per member of the minimum crew;

(b)
have a suitable, lockable opening to enable the inside to be cleaned;

(c)
have a water level indicator;

(d)
have ventilation pipes which lead to the open air or are fitted with appropriate filters.

(a)
fitted with a metal fuel tank whose filling aperture may be locked and which has no soft-solder joints below the maximum filling level, and shall be designed and installed in such a way that the fuel tank cannot be opened or emptied accidentally;

(b)
capable of being lit without the aid of another liquid fuel;

(c)
so installed as to ensure the safe evacuation of combustion gases.

(a)
a second float which closes off the fuel supply safely and reliably when the permitted level is exceeded, or

(b)
an overflow pipe, but only if the drip pan has sufficient capacity to accommodate at least the contents of the fuel tank.

(a)
the drop between the tank and the burner feed may not exceed that laid down in the manufacturer's operating instructions;

(b)
it shall be so installed as to be protected from unacceptable heating;

(c)
it shall be possible to interrupt the fuel supply from the deck.

(a)
adequate ventilation of the burner shall be ensured before the fuel is supplied;

(b)
the fuel supply shall be regulated by a thermostat;

(c)
the fuel shall be ignited by an electric device or by a pilot flame;

(d)
a flame monitoring device shall cut off the fuel supply when the flame goes out;

(e)
the main switch shall be placed at an easily accessible point outside the installation room.

(a)
if the fuel is atomised under pressure the combustion air shall be supplied by a blower;

(b)
the combustion chamber shall be well ventilated before the burner can be lit. Ventilation may be considered complete when the combustion air blower continues to operate after the flame has gone out;

(c)
the fuel supply shall be automatically cut off if:the fire goes out;the supply of combustion air is not sufficient;the heated air exceeds a previously set temperature, orthe power supply of the safety devices fails.In the above cases the fuel supply shall not be re-established automatically after being cut off;

the fire goes out;

the supply of combustion air is not sufficient;

the heated air exceeds a previously set temperature, or

the power supply of the safety devices fails.

In the above cases the fuel supply shall not be re-established automatically after being cut off;

the fire goes out;

the supply of combustion air is not sufficient;

the heated air exceeds a previously set temperature, or

the power supply of the safety devices fails.

In the above cases the fuel supply shall not be re-established automatically after being cut off;

the fire goes out;

the supply of combustion air is not sufficient;

the heated air exceeds a previously set temperature, or

the power supply of the safety devices fails.

In the above cases the fuel supply shall not be re-established automatically after being cut off;

(d)
it shall be possible to switch off the combustion air and heating air blowers from outside the room where the heating appliance is located;

(e)
where heating air is drawn from outside, the intake vents shall be located as far as possible above the deck. They shall be installed in such a manner that rain and spray water cannot enter;

(f)
heating air pipes shall be made of metal;

(g)
it shall not be possible to close the heating air outlet apertures completely;

(h)
it shall not be possible for any leaking fuel to reach the heating air pipes;

(i)
it shall not be possible for forced-air heating appliances to draw their heating air from an engine room.

1.
Medium-pressure pipes between the closing device, referred to in Article 14.09 (4), of the first pressure regulator and the valves fitted before the final pressure regulator:(a)pressure test, carried out with air, an inert gas or a liquid at a pressure 20 bar above atmospheric pressure;(b)tightness test, carried out with air or an inert gas at a pressure 3,5 bar above atmospheric pressure.
(a)
pressure test, carried out with air, an inert gas or a liquid at a pressure 20 bar above atmospheric pressure;
(b)
tightness test, carried out with air or an inert gas at a pressure 3,5 bar above atmospheric pressure.

(a)
pressure test, carried out with air, an inert gas or a liquid at a pressure 20 bar above atmospheric pressure;

(b)
tightness test, carried out with air or an inert gas at a pressure 3,5 bar above atmospheric pressure.

(a)
pressure test, carried out with air, an inert gas or a liquid at a pressure 20 bar above atmospheric pressure;

(b)
tightness test, carried out with air or an inert gas at a pressure 3,5 bar above atmospheric pressure.

2.
Pipes at the service pressure between the closing device, referred to in Article 14.09(4), of the only pressure regulator or the final pressure regulator and the valves fitted before the gas-consuming appliances:tightness test, carried out with air or an inert gas at a pressure of 1 bar above atmospheric pressure.

tightness test, carried out with air or an inert gas at a pressure of 1 bar above atmospheric pressure.

tightness test, carried out with air or an inert gas at a pressure of 1 bar above atmospheric pressure.

tightness test, carried out with air or an inert gas at a pressure of 1 bar above atmospheric pressure.

3.
Pipes situated between the closing device, referred to in Article 14.09 (4), of the only pressure regulator or the final pressure regulator and the controls of gas-consuming appliances:tightness test at a pressure of 0,15 bar above atmospheric pressure.

tightness test at a pressure of 0,15 bar above atmospheric pressure.

tightness test at a pressure of 0,15 bar above atmospheric pressure.

tightness test at a pressure of 0,15 bar above atmospheric pressure.

4.
In the tests referred to in paragraphs 1(b), 2 and 3, the pipes are deemed gastight if, after sufficient time to allow for equalisation with ambient temperature, no decrease in the test pressure is observed during a further 10 minute test period.

5.
Receptacle connectors, pipe joints and other fittings subjected to the pressure in the receptacles, and joints between pressure regulators and the distribution pipe:tightness test, carried out with a foaming substance, at the service pressure.

tightness test, carried out with a foaming substance, at the service pressure.

tightness test, carried out with a foaming substance, at the service pressure.

tightness test, carried out with a foaming substance, at the service pressure.

6.
All gas-consuming appliances shall be brought into service at the nominal capacity and shall be tested for satisfactory and undisturbed combustion at different capacity settings.Flame failure devices shall be checked to ensure that they operate satisfactorily.

7.
After the test referred to in paragraph 6, it shall be verified for each gas-consuming appliance connected to a flue, whether, after five minutes' operation at the nominal capacity, with windows and doors closed and the ventilation devices in operation, any combustion gases are escaping into the room through the air intake.If there is a more than momentary escape of such gases, the cause shall immediately be detected and remedied. The appliance shall not be approved for use until all defects have been eliminated.

(a)
Article 3.02(1)(b);

(b)
Articles 4.01 to 4.03;

(c)
Article 8.08(2), second sentence, and paragraph 7;

(d)
Article 9.14(3), second sentence, for rated voltages of over 50V.

(a)
lamps powered by liquefied gas or liquid fuel according to Article 12.07(3);

(b)
vaporising oil-burner stoves according to Article 13.04;

(c)
solid fuel heaters according to Article 13.07;

(d)
devices fitted with wick burners according to Article 13.02(2) and (3), and

(e)
liquefied gas devices according to Chapter 14.

(a)
the minimum thickness tminof the bottom, bilge and side plating of the outer hull of passenger vessels is determined in accordance with the larger value of the following formulae:;.In these formulae:f=1 + 0,0013 · (a — 500);a=longitudinal or transverse frame spacing (mm), and where the frame spacing is less than 400 mm, a = 400 mm should be entered;
f
=
1 + 0,0013 · (a — 500);
a
=
longitudinal or transverse frame spacing (mm), and where the frame spacing is less than 400 mm, a = 400 mm should be entered;

f
=
1 + 0,0013 · (a — 500);

a
=
longitudinal or transverse frame spacing (mm), and where the frame spacing is less than 400 mm, a = 400 mm should be entered;

f
=
1 + 0,0013 · (a — 500);

a
=
longitudinal or transverse frame spacing (mm), and where the frame spacing is less than 400 mm, a = 400 mm should be entered;

(b)
it is permissible to fall short of the minimum value determined in accordance with (a) above for the plate thickness in cases where the permitted value has been determined and certified on the basis of a mathematical proof for the sufficient strength (longitudinal, transverse and local) of the vessel's hull;

(c)
at no point of the outside plating shall the thickness calculated in accordance with (a) or (b) above be less than 3 mm;

(d)
plate renewals shall be carried out when bottom, bilge or side plate thicknesses have fallen short of the minimum value determined in accordance with (a) or (b), in conjunction with (c) above.

(a)
remain closed at all times and be opened only temporarily to allow access;

(b)
be fitted with suitable devices to enable them to be closed quickly and safely;

(c)
display the following notice on both sides of the doors:‘Close door immediately after passing through’.

(a)
They shall be capable of being closed from both sides of the bulkhead and from an easily accessible point above the bulkhead deck.

(b)
After being closed by remote control the door shall be such that it can be opened again locally and closed safely. Closure shall not be impeded by carpeting, foot rails or other obstructions.

(c)
The time taken for the remote-controlled closure process shall be at least 30 seconds but not more than 60 seconds.

(d)
During the closure procedure an automatic acoustic alarm shall sound by the door.

(e)
The door drive and alarm shall also be capable of operating independently of the on-board power supply. There shall be a device at the location of the remote control that displays whether the door is open or closed.

(a)
If several compartments are openly connected by piping or ventilation ducts, such piping and ducts shall, in an appropriate place, be lead above the waterline corresponding to the worst possible flooding.

(b)
Piping need not meet the requirement under (a) if shut-off devices are fitted in the piping where it passes through the bulkheads and which can be remotely controlled from a point above the bulkhead deck.

(c)
Where a pipework system has no open outlet in a compartment, the pipework shall be regarded as intact in the event of this compartment being damaged, if it runs within the safe area and is more than 0,50 m from the bottom of the vessel.

(a)
at the start of the voyage:100 % passengers, 98 % fuel and fresh water, 10 % waste water;

(b)
during the voyage:100 % passengers, 50 % fuel and fresh water, 50 % waste water;

(c)
at the end of the voyage:100 % passengers, 10 % fuel and fresh water, 98 % waste water;

(d)
unladen vessel:no passengers, 10 % fuel and fresh water, no waste water.

(a)
the maximum righting lever hmaxshall occur at a heeling angle ofφmax≥ 15° and shall not be less than 0,20 m. However, in caseφf<φmaxthe righting lever at the downflooding angleφfshall not be less than 0,20 m;

(b)
the downflooding angleφfshall not be less than 15°;

(c)
the area A under the curve of the righting lever shall, depending on the position ofφfandφmax, reach at least the following values:CaseA1φmax= 15°0,07 m.rad to angleφ= 15°215° <φmax< 30°φmax≤φf0,055+0,001 · (30-φmax) m.rad to angleφmax315° <φf< 30°φmax>φf0,055+0,001 · (30-φf) m.rad to angleφf4φmax≥ 30° andφf≥ 30°0,055 m.rad to angleφ= 30°Wherehmaxis the maximum leverφthe heeling angleφfthe downflooding angle, that is the heeling angle, at which openings in the hull, in the superstructure or deck houses which cannot be closed so as to be weather tight, are immersedφmaxthe heeling angle at which the maximum righting lever occursAarea beneath the curve of the righting levers
Case

A
1
φmax= 15°

0,07 m.rad to angleφ= 15°
2
15° <φmax< 30°
φmax≤φf
0,055+0,001 · (30-φmax) m.rad to angleφmax
3
15° <φf< 30°
φmax>φf
0,055+0,001 · (30-φf) m.rad to angleφf
4
φmax≥ 30° andφf≥ 30°

0,055 m.rad to angleφ= 30°
hmax
is the maximum lever
φ
the heeling angle
φf
the downflooding angle, that is the heeling angle, at which openings in the hull, in the superstructure or deck houses which cannot be closed so as to be weather tight, are immersed
φmax
the heeling angle at which the maximum righting lever occurs
A
area beneath the curve of the righting levers

Case

A

1
φmax= 15°

0,07 m.rad to angleφ= 15°

2
15° <φmax< 30°
φmax≤φf
0,055+0,001 · (30-φmax) m.rad to angleφmax

3
15° <φf< 30°
φmax>φf
0,055+0,001 · (30-φf) m.rad to angleφf

4
φmax≥ 30° andφf≥ 30°

0,055 m.rad to angleφ= 30°

hmax
is the maximum lever

φ
the heeling angle

φf
the downflooding angle, that is the heeling angle, at which openings in the hull, in the superstructure or deck houses which cannot be closed so as to be weather tight, are immersed

φmax
the heeling angle at which the maximum righting lever occurs

A
area beneath the curve of the righting levers

Case

A

1
φmax= 15°

0,07 m.rad to angleφ= 15°

2
15° <φmax< 30°
φmax≤φf
0,055+0,001 · (30-φmax) m.rad to angleφmax

3
15° <φf< 30°
φmax>φf
0,055+0,001 · (30-φf) m.rad to angleφf

4
φmax≥ 30° andφf≥ 30°

0,055 m.rad to angleφ= 30°

hmax
is the maximum lever

φ
the heeling angle

φf
the downflooding angle, that is the heeling angle, at which openings in the hull, in the superstructure or deck houses which cannot be closed so as to be weather tight, are immersed

φmax
the heeling angle at which the maximum righting lever occurs

A
area beneath the curve of the righting levers

(d)
the initial metacentric height, GMo, corrected by the effect of the free surfaces in liquid tanks, shall not be less than 0,15 m;

(e)
in each of the following two cases the heeling angle shall not exceed 12°:(aa)in application of the heeling moment due to passengers and wind according to paragraphs 4 and 5;(bb)in application of the heeling moment due to passengers and turning according to paragraphs 4 and 6.
(aa)
in application of the heeling moment due to passengers and wind according to paragraphs 4 and 5;
(bb)
in application of the heeling moment due to passengers and turning according to paragraphs 4 and 6.

(aa)
in application of the heeling moment due to passengers and wind according to paragraphs 4 and 5;

(bb)
in application of the heeling moment due to passengers and turning according to paragraphs 4 and 6.

(aa)
in application of the heeling moment due to passengers and wind according to paragraphs 4 and 5;

(bb)
in application of the heeling moment due to passengers and turning according to paragraphs 4 and 6.

(f)
for a heeling moment resulting from moments due to passengers, wind and turning according to paragraphs 4, 5 and 6, the residual freeboard shall be not less than 200 mm;

(g)
for vessels with windows or other openings in the hull located below the bulkhead decks and not closed watertight, the residual safety clearance shall be at least 100 mm on the application of the three heeling moments resulting from subparagraph (f).

P
=
total mass of persons on board in (t), calculated by adding up the maximum permitted number of passengers and the maximum number of shipboard personnel and crew under normal operating conditions, assuming an average mass per person of 0,075 t

y
=
lateral distance of centre of gravity of total mass of persons P from centre line in (m)

g
=
acceleration of gravity (g = 9,81 m/s2)

Pi
=
mass of persons accumulated on area Aiin (t)Pi=ni· 0,075 · Ai(t)whereAi=area occupied by persons in (m2)ni=number of persons per square meterni4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person
Pi
=
ni· 0,075 · Ai(t)whereAi=area occupied by persons in (m2)ni=number of persons per square meterni4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person
Ai
=
area occupied by persons in (m2)
ni
=
number of persons per square meterni4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person
ni
4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person

Pi
=
ni· 0,075 · Ai(t)whereAi=area occupied by persons in (m2)ni=number of persons per square meterni4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person
Ai
=
area occupied by persons in (m2)
ni
=
number of persons per square meterni4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person
ni
4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person

Ai
=
area occupied by persons in (m2)

ni
=
number of persons per square meterni4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person
ni
4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person

ni
4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person

yi
=
lateral distance of geometrical centre of area Aifrom centre line in (m).

Pi
=
ni· 0,075 · Ai(t)whereAi=area occupied by persons in (m2)ni=number of persons per square meterni4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person
Ai
=
area occupied by persons in (m2)
ni
=
number of persons per square meterni4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person
ni
4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person

Ai
=
area occupied by persons in (m2)

ni
=
number of persons per square meterni4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person
ni
4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person

ni
4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person

Ai
=
area occupied by persons in (m2)

ni
=
number of persons per square meterni4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person
ni
4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person

ni
4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person

ni
4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, nishall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person

P
=
1,1 · Fmax· 0,075for day trip vessels1,5 · Fmax· 0,075for cabin vesselswhereFmax=maximum permitted number of passengers on board
1,1 · Fmax· 0,075
for day trip vessels
1,5 · Fmax· 0,075
for cabin vessels
Fmax
=
maximum permitted number of passengers on board

1,1 · Fmax· 0,075
for day trip vessels

1,5 · Fmax· 0,075
for cabin vessels

Fmax
=
maximum permitted number of passengers on board

y
=
B/2 in (m).

1,1 · Fmax· 0,075
for day trip vessels

1,5 · Fmax· 0,075
for cabin vessels

Fmax
=
maximum permitted number of passengers on board

Mw= pw· Aw· (lw+T/2) (kNm)

pw
=
the specific wind pressure of 0,25 kN/m2;

Aw
=
lateral plane of the vessel above the plane of draught according to the considered loading condition in m2;

lw
=
distance of the centre of gravity of the lateral plane AWfrom the plane of draught according to the considered loading condition in m.

Mdr= cdr· CB· v2· D/LWL· (KG — T/2) (kNm)

cdr
=
a coefficient of 0,45;

CB
=
block coefficient (if not known, taken as 1,0);

v
=
maximum speed of the vessel in m/s;

KG
=
distance between the centre of gravity and the keel line in m.

One-compartment status
Two-compartment status

Dimension of the side damage

longitudinal l (m)
1,20 + 0,07 · LWL

transverse b (m)
B/5
0,59

vertical h (m)
from vessel bottom to top without delimitation

Dimension of the bottom damage

longitudinal l (m)
1,20 + 0,07 · LWL

transverse b (m)
B/5

vertical h (m)
0,59; pipework installed according to Article 15.02(13)(c), shall be deemed intact

(a)
For one-compartment status the bulkheads can be assumed to be intact if the distance between two adjacent bulkheads is greater than the damage length. Longitudinal bulkheads at a distance of less than B/3 from the outer plating measured perpendicular to centre line from the shell plating at the maximum draught shall not be taken into account for calculation purposes.

(b)
For two-compartment status each bulkhead within the extent of damage will be assumed to be damaged. This means that the position of the bulkheads shall be selected in such a way as to ensure that the passenger vessel remains buoyant after flooding of two or more adjacent compartments in the longitudinal direction.

(c)
The lowest point of every non-watertight opening (e.g. doors, windows, access hatchways) shall lie at least 0,10 m above the damaged waterline. The bulkhead deck shall not be immersed in the final stage of flooding.

(d)
Permeability is assumed to be 95 %. If it is proven by a calculation that the average permeability of any compartment is less than 95 %, the calculated value can be used instead.The values to be adopted shall not be less than:Lounges95 %Engine and boiler rooms85 %Luggage and store rooms75 %Double bottoms, fuel bunkers, ballast and other tanks, depending on whether, according to their intended purpose, they are to be assumed to be full or empty for the vessel floating at the plane of maximum draught0 or 95 %The calculation of free surface effect in intermediate stages of flooding shall be based on the gross surface area of the damaged compartments.
Lounges
95 %
Engine and boiler rooms
85 %
Luggage and store rooms
75 %
Double bottoms, fuel bunkers, ballast and other tanks, depending on whether, according to their intended purpose, they are to be assumed to be full or empty for the vessel floating at the plane of maximum draught
0 or 95 %

Lounges
95 %

Engine and boiler rooms
85 %

Luggage and store rooms
75 %

Double bottoms, fuel bunkers, ballast and other tanks, depending on whether, according to their intended purpose, they are to be assumed to be full or empty for the vessel floating at the plane of maximum draught
0 or 95 %

Lounges
95 %

Engine and boiler rooms
85 %

Luggage and store rooms
75 %

Double bottoms, fuel bunkers, ballast and other tanks, depending on whether, according to their intended purpose, they are to be assumed to be full or empty for the vessel floating at the plane of maximum draught
0 or 95 %

(e)
If damage of a smaller dimension than specified above produces more detrimental effects with respect to heeling or loss of metacentric height, such damage shall be taken into account for calculation purposes.

(a)
the heeling angle j at the equilibrium position of the intermediate stage in question shall not exceed 15°;

(b)
beyond the heel in the equilibrium position of the intermediate stage in question, the positive part of the righting lever curve shall display a righting lever value of GZ ≥ 0,02 m before the first unprotected opening becomes immersed or a heeling angle φ of 25° is reached;

(c)
non-watertight openings shall not be immersed before the heel in the equilibrium position of the intermediate stage in question has been reached.

(a)
the heeling angle φEshall not exceed 10°;

(b)
beyond the equilibrium position the positive part of the righting lever curve shall display a righting lever value of GZR≥ 0,05 m with an area A ≥ 0,0065 mrad. These minimum values for stability shall be met until the immersion of the first unprotected opening or in any case before reaching a heeling angle φm≤ 25°;lever GZ [m]φE ≤ 10°A ≥ 0,065 mradGZR ≥ 0,05 mGZk (lever due to person moment)equilibrium in flooded conditionfirst unprotected opening in the water, but φm ≤ 25°heeling angle φ [°]equilibrium in flooded condition due to person moment

(c)
non-watertight openings shall not be immersed before the equilibrium position has been reached; if such openings are immersed before this point, the rooms affording access are deemed to be flooded for damaged stability calculation purposes.

(a)
for the calculation of cross-flooding, IMO Resolution A.266 (VIII) shall be applied;

(b)
they shall be self-acting;

(c)
they shall not be equipped with shut-off devices;

(d)
the total time allowed for compensation shall not exceed 15 minutes.

(a)
the additional lateral immersion, which, measured on the outside plating, is produced by the permissible heeling angle according to Article 15.03(3)(e), and

(b)
the residual safety clearance according to Article 15.03(3)(g).

(a)
the additional lateral immersion, which, measured on the outside plating, is produced by the heeling angle according to Article 15.03(3)(e), and

(b)
the residual freeboard according to Article 15.03(3)(f).

(a)
number of passengers for whom the existence of an evacuation area according to Article 15.06(8), has been proven;

(b)
number of passengers that has been taken into account for the stability calculation according to Article 15.03;

(c)
number of available berths for passengers on cabin vessels used for voyages including overnight stays.

(a)
on all decks, be located aft of the level of the collision bulkhead and, as long as they are below the bulkhead deck, forward of the level of the aft-peak bulkhead, and

(b)
be separated from the engine and boiler rooms in a gas-tight manner;

(c)
be so arranged, that sight lines in accordance with Article 7.02 do not pass through them.

(a)
rooms or groups of rooms designed or arranged for 30 or more passengers or including berths for 12 or more passengers shall have at least two exits. On day trip vessels one of these two exits can be replaced by two emergency exits;

(b)
if rooms are located below the bulkhead deck, one of the exits can be a watertight bulkhead door, according to Article 15.02(10), leading into an adjacent compartment from which the upper deck can be reached directly. The other exit shall lead directly or, if permitted in accordance with (a), as an emergency exit into the open air, or to the bulkhead deck. This requirement does not apply to individual cabins;

(c)
exits according to (a) and (b) shall be suitably arranged and shall have a clear width of at least 0,80 m and also a clear height of at least 2,00 m. For doors of passenger cabins and other small rooms, the clear width can be reduced to 0,70 m;

(d)
in the case of rooms or groups of rooms intended for more than 80 passengers the sum of the widths of all exits intended for passengers and which shall be used by them in an emergency shall be at least 0,01 m per passenger;

(e)
if the total width of the exits is determined by the number of passengers, the width of each exit shall be at least 0,005 m per passenger;

(f)
emergency exits shall have a shortest side at least 0,60 m long or a minimum diameter of 0,70 m. They shall open in the direction of escape and be marked on both sides;

(g)
exits of rooms intended for use by persons with reduced mobility shall have a clear width of at least 0,90 m. Exits normally used for embarking and disembarking people with reduced mobility shall have a clear width of at least 1,50 m.

(a)
with the exception of doors leading to connecting corridors, they shall be capable of opening outwards or be constructed as sliding doors;

(b)
cabin doors shall be made in such a way that they can also be unlocked from the outside at any time;

(c)
powered doors shall open easily in the event of failure of the power supply to this mechanism;

(d)
for doors intended for use by persons with reduced mobility, there shall be from the direction from which the door opens, a minimum clearance of 0,60 m between the inner edge of the doorframe on the lock side and an adjacent perpendicular wall.

(a)
they shall have a clear width of at least 0,80 m or, if they lead to rooms used by more than 80 passengers, at least 0,01 m per passenger;

(b)
their clear height shall be not less than 2,00 m;

(c)
connecting corridors intended for use by persons with reduced mobility shall have a clear width of 1,30 m. Connecting corridors more than 1,50 m wide shall have handrails on either side;

(d)
where a part of the vessel or a room intended for passengers is served by a single connecting corridor, the clear width thereof shall be at least 1,00 m;

(e)
connecting corridors shall be free of steps;

(f)
they shall lead only to open decks, rooms or staircases;

(g)
dead ends in connecting corridors shall be not longer than two meters.

(a)
stairways, exits and emergency exits shall be so disposed that, in the event of a fire in any given area, the other areas may be evacuated safely;

(b)
the escape routes shall lead by the shortest route to evacuation areas according toparagraph 8;

(c)
escape routes shall not lead through engine rooms or galleys;

(d)
there shall be no rungs, ladders or the like installed at any point along the escape routes;

(e)
doors to escape routes shall be constructed in such a way as not to reduce the minimum width of the escape route referred to in paragraph 5(a) or (d);

(f)
escape routes and emergency exits shall be clearly signed. The signs shall be lit by the emergency lighting system.

(a)
the total area of the muster areas in m2shall correspond to at least the value produced by the following formulae:Day trip vessels:AS= 0,35 · Fmax(m2)Cabin vessels:AS= 0,45 · Fmax(m2)In these formulae the following definition applies:Fmaxmaximum permitted number of passengers on board;
Day trip vessels
:
AS= 0,35 · Fmax(m2)
Cabin vessels
:
AS= 0,45 · Fmax(m2)
Fmax
maximum permitted number of passengers on board;

Day trip vessels
:
AS= 0,35 · Fmax(m2)

Cabin vessels
:
AS= 0,45 · Fmax(m2)

Fmax
maximum permitted number of passengers on board;

Day trip vessels
:
AS= 0,35 · Fmax(m2)

Cabin vessels
:
AS= 0,45 · Fmax(m2)

Fmax
maximum permitted number of passengers on board;

(b)
each individual muster or evacuation area shall be larger than 10 m2;

(c)
the muster areas shall be clear of furniture, whether movable or fixed;

(d)
if movable furniture is located in a room in which muster areas are defined, it shall be secured appropriately to avoid slipping;

(e)
life-saving appliances shall be easily accessible from the evacuation areas;

(f)
it shall be possible to evacuate people safely from these evacuation areas, using either side of the vessel;

(g)
the muster areas shall lie above the margin line;

(h)
the muster and evacuation areas are to be shown as such in the safety plan and signposted on board the vessel;

(i)
if fixed seats or benches are located in a room in which muster areas are defined the corresponding number of persons need not be taken into account when calculating the total area of muster areas according to (a). However, the number of persons for whom fixed seats or benches in a certain room are taken into account must not exceed the number of persons for whom muster areas are available in this room;

(j)
the provisions of (d) and (i) shall also apply to free decks on which muster areas are defined;

(k)
if collective life-saving appliances complying with Article 15.09( 5), are available on board, the number of persons for whom such appliances are available may be disregarded when calculating the total surface area of the muster areas referred to in (a);

(l)
however, in all cases where reductions according to (i) to (k) are applied, the total area according to (a) shall be sufficient for at least 50 % of the maximum permitted number of passengers.

(a)
they shall be constructed in accordance with European standard EN 13056: 2000;

(b)
they shall have a clear width of at least 0,80 m or, if they lead to connecting corridors or areas used by more than 80 passengers, at least 0,01 m per passenger;

(c)
they shall have a clear width of at least 1,00 m if they provide the only means of access to a room intended for passengers;

(d)
where there is not at least one staircase on each side of the vessel in the same room, they shall lie in the safe area;

(e)
in addition, stairs intended for use by persons with reduced mobility shall comply with the following requirements:(aa)The gradient of the stairs shall not exceed 38°;(bb)The stairs shall have a clear width of at least 0,90 m;(cc)Spiral staircases are not allowed;(dd)The stairs shall not run in a direction transverse to the vessel;(ee)The handrails of the stairs shall extend approximately 0,30 m beyond the top and bottom of the stairs without restricting traffic routes;(ff)Handrails, front sides of at least the first and the last step as well as the floor coverings at the ends of the stairs shall be colour highlighted.
(aa)
The gradient of the stairs shall not exceed 38°;
(bb)
The stairs shall have a clear width of at least 0,90 m;
(cc)
Spiral staircases are not allowed;
(dd)
The stairs shall not run in a direction transverse to the vessel;
(ee)
The handrails of the stairs shall extend approximately 0,30 m beyond the top and bottom of the stairs without restricting traffic routes;
(ff)
Handrails, front sides of at least the first and the last step as well as the floor coverings at the ends of the stairs shall be colour highlighted.

(aa)
The gradient of the stairs shall not exceed 38°;

(bb)
The stairs shall have a clear width of at least 0,90 m;

(cc)
Spiral staircases are not allowed;

(dd)
The stairs shall not run in a direction transverse to the vessel;

(ee)
The handrails of the stairs shall extend approximately 0,30 m beyond the top and bottom of the stairs without restricting traffic routes;

(ff)
Handrails, front sides of at least the first and the last step as well as the floor coverings at the ends of the stairs shall be colour highlighted.

(aa)
The gradient of the stairs shall not exceed 38°;

(bb)
The stairs shall have a clear width of at least 0,90 m;

(cc)
Spiral staircases are not allowed;

(dd)
The stairs shall not run in a direction transverse to the vessel;

(ee)
The handrails of the stairs shall extend approximately 0,30 m beyond the top and bottom of the stairs without restricting traffic routes;

(ff)
Handrails, front sides of at least the first and the last step as well as the floor coverings at the ends of the stairs shall be colour highlighted.

(a)
they shall be surrounded by a fixed bulwark or guard rail at least 1,00 m high or a railing according to the European standard EN 711: 1995, construction type PF, PG or PZ. Bulwarks and railings of decks intended for use by persons with reduced mobility shall be at least 1,10 m high;

(b)
openings and equipment for embarking or disembarking and also openings for loading or unloading shall be such that they can be secured and have a clear width of at least 1,00 m. Openings, used normally for the embarking or disembarking of persons with reduced mobility, shall have a clear width of at least 1,50 m;

(c)
if the openings and equipment for embarking or disembarking cannot be observed from the wheelhouse, optical or electronic aids shall be provided;

(d)
passengers sitting down shall not interrupt sight lines in accordance with Article 7.02.

(a)
an alarm system enabling passengers, crew members and shipboard personnel to alert the vessel's command and crew.This alarm should be given only in areas assigned to the vessel's command and to the crew; it should only be possible for the vessel's command to stop the alarm. The alarm shall be capable of being triggered from at least the following places:(aa)in each cabin;(bb)in the corridors, lifts and stairwells, with the distance to the nearest trigger not exceeding 10 m and with at least one trigger per watertight compartment;(cc)in lounges, dining rooms and similar recreation rooms;(dd)in toilets, intended for use by persons with reduced mobility;(ee)in engine rooms, galleys and similar rooms where there is a fire risk;(ff)in the cold-storage rooms and other store rooms.The alarm triggers shall be installed at a height above the floor of 0,85 m to 1,10 m;
(aa)
in each cabin;
(bb)
in the corridors, lifts and stairwells, with the distance to the nearest trigger not exceeding 10 m and with at least one trigger per watertight compartment;
(cc)
in lounges, dining rooms and similar recreation rooms;
(dd)
in toilets, intended for use by persons with reduced mobility;
(ee)
in engine rooms, galleys and similar rooms where there is a fire risk;
(ff)
in the cold-storage rooms and other store rooms.

(aa)
in each cabin;

(bb)
in the corridors, lifts and stairwells, with the distance to the nearest trigger not exceeding 10 m and with at least one trigger per watertight compartment;

(cc)
in lounges, dining rooms and similar recreation rooms;

(dd)
in toilets, intended for use by persons with reduced mobility;

(ee)
in engine rooms, galleys and similar rooms where there is a fire risk;

(ff)
in the cold-storage rooms and other store rooms.

(aa)
in each cabin;

(bb)
in the corridors, lifts and stairwells, with the distance to the nearest trigger not exceeding 10 m and with at least one trigger per watertight compartment;

(cc)
in lounges, dining rooms and similar recreation rooms;

(dd)
in toilets, intended for use by persons with reduced mobility;

(ee)
in engine rooms, galleys and similar rooms where there is a fire risk;

(ff)
in the cold-storage rooms and other store rooms.

(b)
an alarm system enabling the vessel's command to alert passengers.This alarm shall be clearly and unmistakably audible in all rooms accessible to passengers. It shall be capable of being triggered from the wheelhouse and from a location that is permanently staffed;

(c)
an alarm system enabling the vessel's command to alert the crew and shipboard personnel.The alarm system referred to in Article 7.09(1), shall also reach the recreation rooms for the shipboard personnel, the cold-storage rooms and other store rooms.

(a)
individual life-saving equipment according to Article 10.05(2), for shipboard personnel responsible for undertaking duties according to the safety rota;

(b)
individual life-saving equipment according to European standard EN 395: 1998 or EN 396: 1998 for other shipboard personnel.

(a)
bear a notice indicating their purpose and the number of persons for whom they are approved;

(b)
offer adequate seating space for the permitted number of persons;

(c)
provide a buoyancy of at least 750 N per person in fresh water;

(d)
be provided with a rope linked to the passenger vessel to prevent them drifting away;

(e)
be made of suitable materials and be resistant to oil, oil products and temperatures up to 50 °C;

(f)
assume and maintain a stable trim and, in this respect, be fitted with appropriate devices enabling them to be grabbed by the indicated number of persons;

(g)
be fluorescent orange in colour or have fluorescent surfaces, visible from all sides, of at least 100 cm2;

(h)
be such that they can be released from their stowed position and put overboard quickly and safely by one person, or can float free from their stowed position;

(i)
be provided with appropriate means of evacuation from the evacuation areas referred to in Article 15.06(8), onto the life rafts if the vertical distance between the deck of the evacuation areas and the plane of maximum draught is greater than 1 m.

(a)
bear a notice indicating their purpose and the number of persons for whom they are approved;

(b)
provide a buoyancy of at least 100 N per person in fresh water;

(c)
be made of suitable materials and be resistant to oil, oil products and to temperatures of up to 50 °C;

(d)
assume and maintain a stable trim and, in this respect, be fitted with appropriate devices enabling them to be grabbed by the indicated number of persons;

(e)
be fluorescent orange in colour or have fluorescent surfaces, visible from all sides, of at least 100 cm2;

(f)
be such that they can be released from their stowed position and put overboard quickly and safely by one person, or can float free from their stowed position.

(a)
comprise at least two separate air compartments;

(b)
inflate automatically or by manual command when launched;

(c)
assume and maintain a stable trim irrespective of the load to be supported, even when only half the air compartments are inflated.

(a)
locations where life-saving equipment is stored and where such equipment is normally prepared for use;

(b)
escape routes, access for passengers, including gangways, entrances and exits, connecting corridors, lifts and accommodation area companionways, cabin areas and accommodation areas;

(c)
markings on the escape routes and emergency exits;

(d)
in other areas intended for use by persons with reduced mobility;

(e)
operation rooms, engine rooms, steering equipment rooms and their exits;

(f)
wheelhouse;

(g)
emergency power supply room;

(h)
points at which extinguishers and fire extinguishing equipment controls are located;

(i)
areas in which passengers, shipboard personnel and crew muster in the event of danger.

(a)
signal lights;

(b)
audible warning devices;

(c)
emergency lighting in accordance with paragraph 3;

(d)
radiotelephone installations;

(e)
alarm, loudspeaker and on-board message communications systems;

(f)
searchlights according to Article 10.02(2)(i);

(g)
fire alarm system;

(h)
other safety equipment such as automatic pressurised sprinkler systems or fire extinguishing pumps;

(i)
lifts and lifting equipment within the meaning of Article 15.06 (9), second sentence.

(a)
auxiliary generator sets with their own independent fuel supply and independent cooling system which, in the event of a power failure, turn on and take over the supply of power within 30 seconds automatically or, if they are located in the immediate vicinity of the wheelhouse or any other location permanently manned by crew members, can be turned on manually;, or

(b)
accumulator batteries, which, in the event of a power failure, turn on automatically or, if they are located in the immediate vicinity of the wheelhouse or any other location permanently manned by crew members, can be turned on manually. They shall be capable of powering the abovementioned power consumers throughout the prescribed period without recharging and without an unacceptable voltage reduction.

(a)
The test institution shall satisfy:(aa)the Code for Fire Test Procedures; or(bb)European standard EN ISO/IEC 17025: 2000 concerning the general requirements for the competence of testing and calibration laboratories.
(aa)
the Code for Fire Test Procedures; or
(bb)
European standard EN ISO/IEC 17025: 2000 concerning the general requirements for the competence of testing and calibration laboratories.

(aa)
the Code for Fire Test Procedures; or

(bb)
European standard EN ISO/IEC 17025: 2000 concerning the general requirements for the competence of testing and calibration laboratories.

(aa)
the Code for Fire Test Procedures; or

(bb)
European standard EN ISO/IEC 17025: 2000 concerning the general requirements for the competence of testing and calibration laboratories.

(b)
The recognised test methods for determining the non-flammability of materials are:(aa)Annex 1, Part 1, of the Code for Fire Test Procedures; and(bb)the equivalent regulations of one of the Member States.
(aa)
Annex 1, Part 1, of the Code for Fire Test Procedures; and
(bb)
the equivalent regulations of one of the Member States.

(aa)
Annex 1, Part 1, of the Code for Fire Test Procedures; and

(bb)
the equivalent regulations of one of the Member States.

(aa)
Annex 1, Part 1, of the Code for Fire Test Procedures; and

(bb)
the equivalent regulations of one of the Member States.

(c)
The recognised test methods for determining that a material is flame-retardant are:(aa)the respective requirements laid down in Annex 1, Parts 5 (Surface flammability test), 6 (Test for the deck coverings), 7 (Test for hanging textiles and plastics), 8 (Test for upholstered furniture) and 9 (Test for components of bedding) of the Code for Fire Test Procedures; and(bb)the equivalent regulations of one of the Member States.
(aa)
the respective requirements laid down in Annex 1, Parts 5 (Surface flammability test), 6 (Test for the deck coverings), 7 (Test for hanging textiles and plastics), 8 (Test for upholstered furniture) and 9 (Test for components of bedding) of the Code for Fire Test Procedures; and
(bb)
the equivalent regulations of one of the Member States.

(aa)
the respective requirements laid down in Annex 1, Parts 5 (Surface flammability test), 6 (Test for the deck coverings), 7 (Test for hanging textiles and plastics), 8 (Test for upholstered furniture) and 9 (Test for components of bedding) of the Code for Fire Test Procedures; and

(bb)
the equivalent regulations of one of the Member States.

(aa)
the respective requirements laid down in Annex 1, Parts 5 (Surface flammability test), 6 (Test for the deck coverings), 7 (Test for hanging textiles and plastics), 8 (Test for upholstered furniture) and 9 (Test for components of bedding) of the Code for Fire Test Procedures; and

(bb)
the equivalent regulations of one of the Member States.

(d)
The recognised test methods for determining fire resistance are:(aa)IMO Resolution A.754 (18); and(bb)the equivalent regulations of one of the Member States.
(aa)
IMO Resolution A.754 (18); and
(bb)
the equivalent regulations of one of the Member States.

(aa)
IMO Resolution A.754 (18); and

(bb)
the equivalent regulations of one of the Member States.

(aa)
IMO Resolution A.754 (18); and

(bb)
the equivalent regulations of one of the Member States.

Rooms
Control centres
Stairwells
Muster areas
Lounges
Engine rooms
Galleys
Store rooms

Control centres
–
A0
A0/B15(6)
A30
A60
A60
A60

Stairwells

–
A0
A30
A60
A60
A60

Muster areas

–
A30/B15(7)
A60
A60
A60

Lounges

-/B15(8)
A60
A60
A60

Engine rooms

A60/A0(9)
A60
A60

Galleys

A0
A60/B15(10)

Store rooms

–

Rooms
Control centres
Stairwells
Muster areas
Lounges
Engine rooms
Galleys
Store rooms

Control centres
–
A0
A0/B15(11)
A0
A60
A60
A30

Stairwells

–
A0
A0
A60
A30
A0

Muster areas

–
A30/B15(12)
A60
A60
A60

Lounges

-/B0(13)
A60
A30
A0

Engine rooms

A60/A0(14)
A60
A60

Galleys

–
B15

Store rooms

–

(a)
Type A partitions are bulkheads, walls and decks which satisfy the following requirements:(aa)They are made of steel or of another equivalent material;(bb)They are appropriately stiffened;(cc)They are insulated with an approved non-combustible material such that the average temperature on the side facing away from the fire rises to not more than 140 °C above the initial temperature and at no point, including the gaps at the joints, does a temperature increase of more than 180 °C above the initial temperature occur within the following specified periods:Type A6060 minutesType A3030 minutesType A00 minutes;(dd)they are constructed in such a way as to prevent the transmission of smoke and flames until the end of the one-hour normal fire test;
(aa)
They are made of steel or of another equivalent material;
(bb)
They are appropriately stiffened;
(cc)
They are insulated with an approved non-combustible material such that the average temperature on the side facing away from the fire rises to not more than 140 °C above the initial temperature and at no point, including the gaps at the joints, does a temperature increase of more than 180 °C above the initial temperature occur within the following specified periods:Type A6060 minutesType A3030 minutesType A00 minutes;
Type A60
60 minutes
Type A30
30 minutes
Type A0
0 minutes;
(dd)
they are constructed in such a way as to prevent the transmission of smoke and flames until the end of the one-hour normal fire test;

(aa)
They are made of steel or of another equivalent material;

(bb)
They are appropriately stiffened;

(cc)
They are insulated with an approved non-combustible material such that the average temperature on the side facing away from the fire rises to not more than 140 °C above the initial temperature and at no point, including the gaps at the joints, does a temperature increase of more than 180 °C above the initial temperature occur within the following specified periods:Type A6060 minutesType A3030 minutesType A00 minutes;
Type A60
60 minutes
Type A30
30 minutes
Type A0
0 minutes;

Type A60
60 minutes

Type A30
30 minutes

Type A0
0 minutes;

(dd)
they are constructed in such a way as to prevent the transmission of smoke and flames until the end of the one-hour normal fire test;

(aa)
They are made of steel or of another equivalent material;

(bb)
They are appropriately stiffened;

(cc)
They are insulated with an approved non-combustible material such that the average temperature on the side facing away from the fire rises to not more than 140 °C above the initial temperature and at no point, including the gaps at the joints, does a temperature increase of more than 180 °C above the initial temperature occur within the following specified periods:Type A6060 minutesType A3030 minutesType A00 minutes;
Type A60
60 minutes
Type A30
30 minutes
Type A0
0 minutes;

Type A60
60 minutes

Type A30
30 minutes

Type A0
0 minutes;

Type A60
60 minutes

Type A30
30 minutes

Type A0
0 minutes;

(dd)
they are constructed in such a way as to prevent the transmission of smoke and flames until the end of the one-hour normal fire test;

(b)
type B partitions are bulkheads, walls, decks, ceilings or facings that meet the following requirements:(aa)they are made of an approved non-combustible material. Furthermore, all materials used in the manufacture and assembly of partitions shall be non-combustible, except for the facing, which shall be at least flame retardant;(bb)they demonstrate an insulation value such that the average temperature on the side facing away from the fire rises to not more than 140 °C above the initial temperature and at no point, including the gaps at the joints, does a temperature increase of more than 225 °C above the initial temperature occur within the following specified periods:Type B1515 minutesType B00 minutes.(cc)they are constructed in such a way as to prevent the transmission of flames until the end of the first half hour of the normal fire test;
(aa)
they are made of an approved non-combustible material. Furthermore, all materials used in the manufacture and assembly of partitions shall be non-combustible, except for the facing, which shall be at least flame retardant;
(bb)
they demonstrate an insulation value such that the average temperature on the side facing away from the fire rises to not more than 140 °C above the initial temperature and at no point, including the gaps at the joints, does a temperature increase of more than 225 °C above the initial temperature occur within the following specified periods:Type B1515 minutesType B00 minutes.
Type B15
15 minutes
Type B0
0 minutes.
(cc)
they are constructed in such a way as to prevent the transmission of flames until the end of the first half hour of the normal fire test;

(aa)
they are made of an approved non-combustible material. Furthermore, all materials used in the manufacture and assembly of partitions shall be non-combustible, except for the facing, which shall be at least flame retardant;

(bb)
they demonstrate an insulation value such that the average temperature on the side facing away from the fire rises to not more than 140 °C above the initial temperature and at no point, including the gaps at the joints, does a temperature increase of more than 225 °C above the initial temperature occur within the following specified periods:Type B1515 minutesType B00 minutes.
Type B15
15 minutes
Type B0
0 minutes.

Type B15
15 minutes

Type B0
0 minutes.

(cc)
they are constructed in such a way as to prevent the transmission of flames until the end of the first half hour of the normal fire test;

(aa)
they are made of an approved non-combustible material. Furthermore, all materials used in the manufacture and assembly of partitions shall be non-combustible, except for the facing, which shall be at least flame retardant;

(bb)
they demonstrate an insulation value such that the average temperature on the side facing away from the fire rises to not more than 140 °C above the initial temperature and at no point, including the gaps at the joints, does a temperature increase of more than 225 °C above the initial temperature occur within the following specified periods:Type B1515 minutesType B00 minutes.
Type B15
15 minutes
Type B0
0 minutes.

Type B15
15 minutes

Type B0
0 minutes.

Type B15
15 minutes

Type B0
0 minutes.

(cc)
they are constructed in such a way as to prevent the transmission of flames until the end of the first half hour of the normal fire test;

(c)
the inspection body may, in accordance with the Code for Fire Test Procedures, prescribe a test on a sample partition in order to ensure compliance with the above provisions on resistivity and temperature increase.

(a)
they shall satisfy the same requirements set out in paragraph 2 as the partitions themselves;

(b)
they shall be self-closing in the case of doors in partition walls according toparagraph 10 or in the case of enclosures around engine rooms, galleys and stairwells;

(c)
self-closing doors which remain open in normal operation shall be such that they can be closed from a location permanently manned by shipboard personnel or crew members; Once a door has been remotely closed, it shall be possible to reopen and close it safely on the spot;

(d)
watertight doors according to Article 15.02 need not be insulated.

(a)
passenger areas with a total surface area of more than 800 m2;

(b)
passenger areas in which there are cabins, at intervals of not more than 40 m.

(a)
a staircase connecting only two decks does not need to be encapsulated, if on one of the decks the staircase is enclosed according to paragraph 2;

(b)
in a lounge, stairs need not be encapsulated if they are located entirely within the interior of this room, and(aa)if this room extends over only two decks, or(bb)if there is a pressurised sprinkler system according to Article 10.03a installed in this room on all decks, this room has a smoke extraction system according to paragraph 16 and the room has access on all decks to a stairwell.
(aa)
if this room extends over only two decks, or
(bb)
if there is a pressurised sprinkler system according to Article 10.03a installed in this room on all decks, this room has a smoke extraction system according to paragraph 16 and the room has access on all decks to a stairwell.

(aa)
if this room extends over only two decks, or

(bb)
if there is a pressurised sprinkler system according to Article 10.03a installed in this room on all decks, this room has a smoke extraction system according to paragraph 16 and the room has access on all decks to a stairwell.

(aa)
if this room extends over only two decks, or

(bb)
if there is a pressurised sprinkler system according to Article 10.03a installed in this room on all decks, this room has a smoke extraction system according to paragraph 16 and the room has access on all decks to a stairwell.

(a)
they shall be designed in such a way as to ensure that they themselves do not cause the spread of fire and smoke;

(b)
openings for air intake and extraction and air supply systems shall be such that they can be closed off;

(c)
ventilation ducts shall be made from steel or an equivalent non-combustible material and be securely connected to each other and to the superstructure of the vessel;

(d)
when ventilation ducts with a cross-section of more than 0,02 m2are passed through partitions according to paragraph 2 of Type A or partitions according to paragraph 10, they shall be fitted with automatic fire dampers which can be operated from a location permanently manned by shipboard personnel or crew members;

(e)
ventilation systems for galleys and engine rooms shall be separated from ventilation systems which supply other areas;

(f)
air extraction ducts shall be provided with lockable openings for inspection and cleaning. These openings shall be located close to the fire dampers;

(g)
built-in ventilators shall be such that they can be switched off from a central location outside the engine room.

(a)
they shall offer sufficient capacity and reliability;

(b)
they shall comply with the operating conditions for passenger vessels;

(c)
if smoke extraction systems also serve as general ventilators for the rooms, this shall not hinder their function as smoke extraction systems in the event of a fire;

(d)
smoke extraction systems shall have a manually operated triggering device;

(e)
mechanical smoke extraction systems shall additionally be such that they can be operated from a location permanently manned by shipboard personnel or crew members;

(f)
natural smoke extraction systems shall be fitted with an opening mechanism, operated either manually or by a power source inside the extraction system;

(g)
manually operated triggering devices and opening mechanisms shall be accessible from inside or outside the room being protected.

(a)
one portable extinguisher for every 120 m2of gross floor area in passenger areas;

(b)
one portable extinguisher per group of 10 cabins, rounded upwards;

(c)
one portable extinguisher in each galley and in the vicinity of any room in which flammable liquids are stored or used. In galleys the extinguishing agent shall also be suitable for fighting fat fires.

(a)
two motor-driven fire extinguishing pumps of sufficient capacity, at least one of which is permanently installed;

(b)
one fire extinguisher line with a sufficient number of hydrants with permanently connected fire hoses at least 20 m in length and fitted with a nozzle capable of producing both a mist and a jet of water and incorporating a shut-off facility.

(a)
any point of the vessel can be reached from at least two hydrants in different places, each with a single hose length of not more than 20 m;

(b)
the pressure at the hydrants is at least 300 kPa; and

(c)
on all decks a water jet length of at least 6 m can be attained.

(a)
be installed or housed in separate rooms;

(b)
be such that they can be operated independently of each other;

(c)
each be capable, on all decks, of maintaining the necessary pressure at the hydrants and achieving the requisite length of water jet;

(d)
be installed forward of the aft bulkhead.

(a)
two self-contained breathing apparatus sets corresponding to European standard EN 137: 1993 with full-face masks corresponding to European standard EN 136: 1998;

(b)
two sets of equipment consisting of at least a protective suit, helmet, boots, gloves, axe, crowbar, torch and safety-line, and

(c)
four smoke hoods.

(a)
breakdown;

(b)
fire on board;

(c)
evacuation of passengers;

(d)
person overboard.

(a)
areas intended for use by persons with reduced mobility;

(b)
escape routes, emergency exits and muster and evacuation areas as referred to in Article 15.06(8);

(c)
life-saving equipment and ship's boats;

(d)
fire extinguishers and fire extinguishing and pressurised sprinkler systems;

(e)
other safety equipment;

(f)
the alarm system referred to in Article 15.08(3)(a);

(g)
the alarm system referred to in Article 15.(3)(b) and (c);

(h)
the bulkhead doors referred to in Article 15.02(5), and the position of their controls, as well as the other openings referred to in Article 15.02(9), (10) and (13), and Article 15.03(12);

(i)
doors referred to in Article 15.11(8);

(j)
fire dampers;

(k)
fire alarm system;

(l)
emergency power plant;

(m)
ventilation system control units;

(n)
shore connections;

(o)
fuel line shut-offs;

(p)
liquefied gas installations;

(q)
public address systems;

(r)
radiotelephone equipment;

(s)
first-aid kits.

(a)
be duly stamped by the inspection body, and

(b)
be prominently displayed at an appropriate point on each deck.

(a)
designation of emergencies—fire,—flooding,—general hazard;
—
fire,
—
flooding,
—
general hazard;

—
fire,

—
flooding,

—
general hazard;

—
fire,

—
flooding,

—
general hazard;

(b)
description of the various alarm signals;

(c)
instructions concerning the following:—escape routes,—what to do,—need to keep calm;
—
escape routes,
—
what to do,
—
need to keep calm;

—
escape routes,

—
what to do,

—
need to keep calm;

—
escape routes,

—
what to do,

—
need to keep calm;

(d)
instructions concerning the following:—smoking,—use of fire and naked flame,—opening windows,—use of certain items of equipment.
—
smoking,
—
use of fire and naked flame,
—
opening windows,
—
use of certain items of equipment.

—
smoking,

—
use of fire and naked flame,

—
opening windows,

—
use of certain items of equipment.

—
smoking,

—
use of fire and naked flame,

—
opening windows,

—
use of certain items of equipment.

(a)
after symmetrical flooding, the immersion of the vessel shall not exceed the margin line; and

(b)
the metacentric height GMRshall not be less than 0,10 m.

(a)
one person alone shall be able to operate the installation;

(b)
mobile installations are allowed;

(c)
the installations shall be outside the danger area of the propulsion systems; and

(d)
effective communication shall be possible between the boatmaster and the person in charge of the installation.

(a)
a rudder propeller, a cycloidal propeller or a water jet as main propulsion, or

(b)
a main propulsion system with two propulsion units, or

(c)
a main propulsion system and a bow-thruster.

(a)
the vessel has only one deck;

(b)
this door is accessible directly from the deck and is not more than 10 m away from the deck;

(c)
the lower edge of the door opening lies at least 30 cm above the floor of the passenger area, and

(d)
each of the compartments divided by the door is fitted with a bilge level alarm.

(a)
Article 15.04(1), last sentence;

(b)
Article 15.06(6)(c), for the galleys, as long as a second escape route is available;

(c)
Article 15.07.

(a)
Article 3.03(7), provided that anchors are not transported in hawse pipes;

(b)
Article 10.02(2)(d), with regard to length;

(c)
Article 15.08(3)(a);

(d)
Article 15.15(9)(a).

(a)
a constant wind pressure of 0,07 kN/m2shall be applied for the calculation,

(b)
the residual safety clearance shall be at least 100 mm, and

(c)
the residual freeboard shall not be negative.

(a)
reach its maximum value at a heeling angle of 25° or over,

(b)
amount to at least 200 mm at a heeling angle of 30° or over,

(c)
be positive at a heeling angle of up to 60°.

(a)
0,055 mrad up to 30°;

(b)
0,09 mrad up to 40° or at the angle at which an unprotected opening reaches the water surface and which is less than 40°.

(c)
30° and 40°, or

(d)
30° and the angle at which an unprotected opening reaches the water surface and which is less than 40°,

(a)
a strength calculation shall be carried out, or

(b)
confirmation of sufficient strength shall have been obtained from an approved classification society, or

(c)
dimensioning shall be based on the procedures set out in a recognised regulatory framework (e.g. Middendorf, Kusk-Jensen).

(a)
be free of knot concentrations;

(b)
be free of sapwood within the required dimensions;

(c)
as far as possible be straight-grained;

(d)
contain as little as possible twisted growth.

Length(*1)(m)
Diameter on deck(cm)
Diameter on the cross-tree(cm)
Diameter on the mast cap(cm)

10
20
17
15

11
22
17
15

12
24
19
17

13
26
21
18

14
28
23
19

15
30
25
21

16
32
26
22

17
34
28
23

18
36
29
24

19
39
31
25

20
41
33
26

21
43
34
28

22
44
35
29

23
46
37
30

24
49
39
32

25
51
41
33

Length(*2)(m)
Diameter at the foot(cm)
Half-length diameter(cm)
Diameter at fitting(*3)(cm)

4
8
7
6

5
10
9
7

6
13
11
8

7
14
13
10

8
16
15
11

9
18
16
13

10
20
18
15

11
23
20
16

12
25
22
17

13
26
24
18

14
28
25
20

15
31
27
21

Length(*4)(m)
Diameter at stem(cm)
Half-length diameter(cm)

4
14,5
12,5

5
18
16

6
22
19

7
25
23

8
29
25

9
32
29

10
36
32

11
39
35

12
43
39

Length(*5)(m)
2
3
4
5
6
7
8
9
10

Diameter at the stem (cm)
7
10
14
17
21
24
28
31
35

Length(*6)(m)
5
6
7
8
9
10
11
12
13
14
15
16

Diameter (cm)
14
15
16
17
18
20
21
23
24
25
26
27

(a)
there is an angle of less than 65° between the main boom and the after leech and the main sheet is attached to the end of the boom, or

(b)
the attachment point of the sheet is not abreast of the clew,

Length(*7)(m)
4
5
6
7
8
9
10

Diameter (cm)
10
12
14
16
17
18
20

(a)
splicings,

(b)
compression sleeves, or

(c)
sealing sleeves.

Mast length(*8)(m)
11
12
13
14
15
16
17
18

Tensile strength of the forestay (kN)
160
172
185
200
220
244
269
294

Tensile strength of the shrouds (kN)
355
415
450
485
525
540
630
720

Number of shroud cables and ropes per side
3
3
3
3
3
3
4
4

Mast length(*9)(m)
<13
13-18
>18

Tensile strength of the backstay (kN)
89
119
159

Tensile strength of the topmast (kN)
89
119
159

Length of topmast (m)
<6
6-8
>8

Tensile strength of the flying jib-stay (kN)
58
89
119

Length of jib-boom (m)
<5
5-7
>7

Tensile strength of the bow sprit shrouds (kN)
58
89
119

Water displacement divided by the number of masts (m3)
Reduction (%)

>20 to 30
20

10 to 20
35

< 10
60

Type of running rigging
Rope material
Sail area (m2)
Minimum tensile strength (KN)
Diameter of rope (mm)

Staysail halyards
Steel wire
up to 35
20
6

> 35
38
8

Fibre (polypropylene-PP)
Rope diameter of at least 14 mm and one rope sheave for every 25 m2or part thereof

Gaff sail halyardsTop sail halyards
Steel wire
up to 50
20
6

> 50 to 80
30
8

> 80 to 120
60
10

>120 to 160
80
12

Fibre (PP)
Rope diameter of at least 18 mm and one rope sheave for every 30 m2or part thereof

Staysail sheets
Fibre (PP)
up to 40
14

> 40
18

For sail areas of more than 30 m2, the sheet shall take the form of a tackle or shall be capable of being operated by a winch

Gaff-/Top-sail sheets
Steel wire
< 100
60
10

100 to 150
85
12

> 150
116
14

For top sail sheets, elastic connection elements (fore runners) are necessary.

Fibre (PP)
Rope diameter of at least 18 mm and at least three rope sheaves. Where the sail area is greater than 60 m2, one rope sheave per 20 m2

Steel wire (mm)
6
7
8
9
10
11
12

Fibre (mm)
16
18
20
22
24
26
28

Rope sheave (mm)
100
110
120
130
145
155
165

(a)
the sails, including leeches, clews and reef eyes;

(b)
the state of the masts and spars;

(c)
the state of the standing and running rigging together with cable wire connections;

(d)
facilities for taking in the sail swiftly and safely;

(e)
the secure fastening of blocks of halyards and topping lifts;

(f)
the fastening of mast trunks and other fastening points for standing and running rigging that are attached to the vessel;

(g)
the winches for operating the sails;

(h)
other facilities fitted for the purposes of sailing, such as lee-boards and the fittings for operating them;

(i)
the measures taken to prevent the chafing of the spars, the running and standing rigging and the sails;

(j)
the equipment according to Article 15a.18.

(a)
enable crews easily and safely to cross over to the pushed craft with the coupling devices connected;

(b)
enable them to occupy a fixed position in relation to the coupled craft;

(c)
prevent relative movement between the craft themselves.

(a)
Chapters 5 to 7 and 12;

(b)
Article 8.08(2) to (8), Article 10.02 and Article 10.05(1).

(a)
collision bulkheads referred to in Article 3.03(1), can be dispensed with if their front faces are able to bear a load at least 2,5 times that set for the collision bulkheads on inland waterway vessels with the same draught and built in accordance with the requirements of an approved classification society;

(b)
by way of derogation from Article 8.08(1), compartments of the double bottom to which access is difficult do not have to be drainable unless their volume exceeds 5 % of the water displacement of the ship-borne lighter at the maximum authorised loaded draught.

(a)
the towing devices shall be arranged in such a way that their use does not compromise the safety of the craft, crew or cargo;

(b)
tugging and towing craft shall be fitted with a tow hook which shall be capable of being released safely from the wheelhouse; this shall not apply if the design or other fittings prevent capsizing;

(c)
towing devices shall consist of winches or a tow hook. The towing devices shall be located ahead of the propeller plane. This requirement shall not apply to craft that are steered by their propulsion units such as rudder propellers or cycloidal propellers;

(d)
by way of derogation from the requirements of (c), for craft solely giving — in accordance with applicable navigational authority regulations of the Member States — towing assistance to motorised craft, a towing device such as a bollard or an equivalent device shall suffice. Point (b) shall applymutatis mutandis;

(e)
where the towing cables could snag on the stern of the vessel, deflector hoops with cable catchers shall be provided.

(a)
the convoys and formations that have been accepted;

(b)
the types of coupling;

(c)
the maximum coupling forces determined, and

(d)
where appropriate, the minimum tensile strength of the coupling cables for the longitudinal connection and also the number of cable windings.

(a)
Article 3.03(1) and (2), shall applymutatis mutandis;

(b)
Article 7.02 shall applymutatis mutandis;

(c)
the maximum sound pressure levels prescribed by Article 12.02 (5), second sentence, may be exceeded while the floating equipment's working gear is operating, provided that, during service, nobody sleeps on board at night;

(d)
derogations may be granted from other requirements concerning structure, working gear or equipment provided that equal safety is ensured in each case.

(a)
Article 10.01(1), shall not apply if during operation of floating equipment that equipment can be securely anchored by means of a working anchor or piles. However, floating equipment with its own means of propulsion shall have at least one anchor meeting the requirements in Article 10.01 (1), where an empirical coefficient k is taken to be equal to 45, and the smallest height is taken for T;

(b)
Article 12.02(1), second part of sentence, if the accommodation can be adequately lit by means of electricity.

(a)
for Article 8.08(2), second sentence, the bilge pump shall be motor driven;

(b)
for Article 8.10(3), the noise may exceed 65 dB(A) at a lateral distance of 25 m from the ship's side of any stationary floating equipment while its working gear is operating;

(c)
for Article 10.03(1), at least one further portable extinguisher is required if working gear not permanently attached to the craft is placed on the deck;

(d)
for Article 14.02(2), in addition to the liquefied-gas equipment for domestic use, there may also be other liquefied-gas facilities. Those facilities and their accessories shall meet the requirements of one of the Member States.

(a)
scale drawings of floats and working gear and the detailed data relating to these that are needed to confirm stability, such as content of the tanks, openings providing access to the inside of the vessel;

(b)
hydrostatic data or curves;

(c)
righting lever curves for static-stability to the extent required in accordance with paragraph 5 below or Article 17.08;

(d)
description of the operating conditions together with the corresponding data concerning weight and centre of gravity, including its unladen state and the equipment situation as regards transport;

(e)
calculation of the heeling, trimming and righting moments, with a specification of the trim and heeling angles and the corresponding residual freeboard and residual safety clearances;

(f)
a compilation of the results of the calculation with a specification of the limits for operation and the maximum loads.

(a)
specific mass of the dredging products for dredgers:—sands and gravels: 1,5 t/m3,—very wet sands: 2,0 t/m3,—soil, on average: 1,8 t/m3,—mixture of sand and water in the ducts: 1,3 t/m3;
—
sands and gravels: 1,5 t/m3,
—
very wet sands: 2,0 t/m3,
—
soil, on average: 1,8 t/m3,
—
mixture of sand and water in the ducts: 1,3 t/m3;

—
sands and gravels: 1,5 t/m3,

—
very wet sands: 2,0 t/m3,

—
soil, on average: 1,8 t/m3,

—
mixture of sand and water in the ducts: 1,3 t/m3;

—
sands and gravels: 1,5 t/m3,

—
very wet sands: 2,0 t/m3,

—
soil, on average: 1,8 t/m3,

—
mixture of sand and water in the ducts: 1,3 t/m3;

(b)
for clamshell dredgers, the values given under point (a) shall be increased by 15 %;

(c)
for hydraulic dredgers the maximum lifting power shall be considered.

(a)
load;

(b)
asymmetric structure;

(c)
wind pressure;

(d)
turning whilst under way of self-propelled floating equipment;

(e)
cross current, if necessary;

(f)
ballast and provisions;

(g)
deck loads and, where appropriate, cargo;

(h)
free surfaces of liquids;

(i)
inertia forces;

(j)
other mechanical equipment.

c
=
shape-dependent coefficient of resistanceFor frameworks c = 1,2 and for solid-section beams c = 1,6. Both values take account of gusts of wind.The whole area encompassed by the contour line of the framework shall be taken to be the surface area exposed to the wind.

pw
=
specific wind pressure; this shall uniformly be taken to be 0,25 kN/m2;

A
=
lateral plane above the plane of maximum draught in m2;

lw
=
distance from the centre of area of the lateral plane A from the plane of maximum draught, in m.

Ma= 10 · D ·· sinφ(kNm)

=
metacentric height, in m;

φ
=
heeling angle in degrees.

(a)
after correction for the free surfaces of liquids, the metacentric height is not less than 0,15 m;

(b)
for heeling angles between 0 and 30°, there is a righting lever of at leasth = 0,30 – 0,28 · φn(m)φnbeing the heeling angle from which the righting lever curve displays negative values (range of stability); it shall not be less than 20° or 0,35 rad and shall not be introduced into the formula for more than 30° or 0,52 rad, taking the radian (rad) (1° = 0,01745 rad) for the unit of φ°;

(c)
the sum of the trim and heeling angles does not exceed 10°;

(d)
a residual safety clearance meeting the requirements in Article 17.04 remains;

(e)
a residual freeboard of at least 0,05 m remains;

(f)
for heeling angles between 0 and 30°, a residual righting lever of at leasth = 0,20 – 0,23 · φn(m)remains, where φnis the heeling angle from which the righting lever curve displays negative values; it shall not be introduced into the formula for more than 30° or 0,52 rad.

(a)
whose working gear can in no way alter their heeling or trim, and

(b)
where any displacement of the centre of gravity can be reasonably excluded.

(a)
at maximum load the safety clearance shall be at least 300 mm and the freeboard at least 150 mm;

(b)
for apertures which cannot be closed spray-proof and weathertight the safety clearance shall be at least 500 mm.

1.
(a)Article 3.03(1), shall applymutatis mutandis;(b)Chapters 5 and 6 shall applymutatis mutandiswhere the craft is self-propelled;(c)Article 10.02(2)(a) and (b), shall applymutatis mutandis;(d)the inspection body may grant exceptions to the other requirements concerning construction, arrangement and equipment provided that equivalent safety is proven in every case.
(a)
Article 3.03(1), shall applymutatis mutandis;
(b)
Chapters 5 and 6 shall applymutatis mutandiswhere the craft is self-propelled;
(c)
Article 10.02(2)(a) and (b), shall applymutatis mutandis;
(d)
the inspection body may grant exceptions to the other requirements concerning construction, arrangement and equipment provided that equivalent safety is proven in every case.

(a)
Article 3.03(1), shall applymutatis mutandis;

(b)
Chapters 5 and 6 shall applymutatis mutandiswhere the craft is self-propelled;

(c)
Article 10.02(2)(a) and (b), shall applymutatis mutandis;

(d)
the inspection body may grant exceptions to the other requirements concerning construction, arrangement and equipment provided that equivalent safety is proven in every case.

(a)
Article 3.03(1), shall applymutatis mutandis;

(b)
Chapters 5 and 6 shall applymutatis mutandiswhere the craft is self-propelled;

(c)
Article 10.02(2)(a) and (b), shall applymutatis mutandis;

(d)
the inspection body may grant exceptions to the other requirements concerning construction, arrangement and equipment provided that equivalent safety is proven in every case.

(a)
Article 8.08 (2) to (8), if no crew is required;

(b)
Article 10.01(1) and (3), if the worksite craft can be securely anchored by means of working anchors or piles. However, self-propelled worksite craft shall be equipped with at least one anchor meeting the requirements set out in Article 10.01(1), where coefficient k is taken to be 45 and T is taken to be the lowest height;

(c)
Article 10.02(1)(c), if the worksite craft is not self-propelled.

(a)
they are not self-propelled or

(b)
a ship's boat is available elsewhere on the worksite.

(a)
for openings which can be closed spray-proof and weathertight, to 150 mm;

(b)
for openings which cannot be closed spray-proof and weathertight, to 200 mm.

(a)
from Chapter 3:Article 3.01, Article 3.02(1)(a) and 2, Article 3.03(1)(a) and (6), and Article 3.04(1);

Article 3.01, Article 3.02(1)(a) and 2, Article 3.03(1)(a) and (6), and Article 3.04(1);

Article 3.01, Article 3.02(1)(a) and 2, Article 3.03(1)(a) and (6), and Article 3.04(1);

Article 3.01, Article 3.02(1)(a) and 2, Article 3.03(1)(a) and (6), and Article 3.04(1);

(b)
Chapter 5:

(c)
from Chapter 6:Article 6.01(1), and Article 6.08;

Article 6.01(1), and Article 6.08;

Article 6.01(1), and Article 6.08;

Article 6.01(1), and Article 6.08;

(d)
from Chapter 7:Article 7.01(1) and (2), Article 7.02, Article 7.03(1) and (2), Article 7.04(1), Article 7.05(2), Article 7.13 if there is a wheelhouse designed for radar navigation by one person;

Article 7.01(1) and (2), Article 7.02, Article 7.03(1) and (2), Article 7.04(1), Article 7.05(2), Article 7.13 if there is a wheelhouse designed for radar navigation by one person;

Article 7.01(1) and (2), Article 7.02, Article 7.03(1) and (2), Article 7.04(1), Article 7.05(2), Article 7.13 if there is a wheelhouse designed for radar navigation by one person;

Article 7.01(1) and (2), Article 7.02, Article 7.03(1) and (2), Article 7.04(1), Article 7.05(2), Article 7.13 if there is a wheelhouse designed for radar navigation by one person;

(e)
from Chapter 8:Article 8.01(1) and (2), Article 8.02(1) and (2), Article 8.03(1) and (3), Article 8.04, Article 8.05(1) to (10) and (13), Article 8.08 (1), (2), (5), (7) and (10), Article 8.09(1), and Article 8.10;

Article 8.01(1) and (2), Article 8.02(1) and (2), Article 8.03(1) and (3), Article 8.04, Article 8.05(1) to (10) and (13), Article 8.08 (1), (2), (5), (7) and (10), Article 8.09(1), and Article 8.10;

Article 8.01(1) and (2), Article 8.02(1) and (2), Article 8.03(1) and (3), Article 8.04, Article 8.05(1) to (10) and (13), Article 8.08 (1), (2), (5), (7) and (10), Article 8.09(1), and Article 8.10;

Article 8.01(1) and (2), Article 8.02(1) and (2), Article 8.03(1) and (3), Article 8.04, Article 8.05(1) to (10) and (13), Article 8.08 (1), (2), (5), (7) and (10), Article 8.09(1), and Article 8.10;

(f)
from Chapter 9:Article 9.01(1),mutatis mutandis:

Article 9.01(1),mutatis mutandis:

Article 9.01(1),mutatis mutandis:

Article 9.01(1),mutatis mutandis:

(g)
from Chapter 10:Article 10.01( 2), (3) and (5) to (14), Article 10.02(1)(a) to (c), and (2)(a) and (e) to (h), Article 10.03(1)(a), (b) and (d): however, there shall be at least two fire extinguishers on board; Article 10.03(2) to (6), Article 10.03a, Article 10.03b and Article 10.05;

Article 10.01( 2), (3) and (5) to (14), Article 10.02(1)(a) to (c), and (2)(a) and (e) to (h), Article 10.03(1)(a), (b) and (d): however, there shall be at least two fire extinguishers on board; Article 10.03(2) to (6), Article 10.03a, Article 10.03b and Article 10.05;

Article 10.01( 2), (3) and (5) to (14), Article 10.02(1)(a) to (c), and (2)(a) and (e) to (h), Article 10.03(1)(a), (b) and (d): however, there shall be at least two fire extinguishers on board; Article 10.03(2) to (6), Article 10.03a, Article 10.03b and Article 10.05;

Article 10.01( 2), (3) and (5) to (14), Article 10.02(1)(a) to (c), and (2)(a) and (e) to (h), Article 10.03(1)(a), (b) and (d): however, there shall be at least two fire extinguishers on board; Article 10.03(2) to (6), Article 10.03a, Article 10.03b and Article 10.05;

(h)
Chapter 13:

(i)
Chapter 14.

(a)
Article 6.08, if there is a rate-of-turn indicator;

(b)
Article 7.01(2), Article 7.02, Article 7.03(1), and Article 7.13, if there is a wheelhouse designed for radar navigation by one person;

(c)
Article 8.01(2), Article 8.02(1), Article 8.03(3), Article 8.05(5), Article 8.08(2), and Article 8.10;

(d)
Article 10.01(2), (3), (6) and (14), Article 10.02(1)(b) and (c), (2)(a) and (e) to (h), Article 10.03 (1)(b) and (d) and (2) to (6), and Article 10.07;

(e)
Chapter 13;

(f)
from Chapter 14:(aa)Article 14.12;(bb)Article 14.13; the acceptance test after putting into service of the liquefied gas installation shall be carried out in accordance with the requirements of Directive 94/25/EC, and an acceptance report shall be submitted to the inspection body;(cc)Articles 14.14 and 14.15; the liquefied gas installation shall be in accordance with the requirements of Directive 94/25/EC;(dd)Chapter 14 entirely, if the liquefied gas installation is fitted after placing on the market of the recreational craft.
(aa)
Article 14.12;
(bb)
Article 14.13; the acceptance test after putting into service of the liquefied gas installation shall be carried out in accordance with the requirements of Directive 94/25/EC, and an acceptance report shall be submitted to the inspection body;
(cc)
Articles 14.14 and 14.15; the liquefied gas installation shall be in accordance with the requirements of Directive 94/25/EC;
(dd)
Chapter 14 entirely, if the liquefied gas installation is fitted after placing on the market of the recreational craft.

(aa)
Article 14.12;

(bb)
Article 14.13; the acceptance test after putting into service of the liquefied gas installation shall be carried out in accordance with the requirements of Directive 94/25/EC, and an acceptance report shall be submitted to the inspection body;

(cc)
Articles 14.14 and 14.15; the liquefied gas installation shall be in accordance with the requirements of Directive 94/25/EC;

(dd)
Chapter 14 entirely, if the liquefied gas installation is fitted after placing on the market of the recreational craft.

(aa)
Article 14.12;

(bb)
Article 14.13; the acceptance test after putting into service of the liquefied gas installation shall be carried out in accordance with the requirements of Directive 94/25/EC, and an acceptance report shall be submitted to the inspection body;

(cc)
Articles 14.14 and 14.15; the liquefied gas installation shall be in accordance with the requirements of Directive 94/25/EC;

(dd)
Chapter 14 entirely, if the liquefied gas installation is fitted after placing on the market of the recreational craft.

(a)
information on the permissible stability coefficients, the permissible- values or the permissible heights for the centre of gravity of the cargo;

(b)
data concerning spaces that can be filled with ballast water;

(c)
forms for checking stability;

(d)
instructions for use or an example of a calculation for use by the boatmaster.

(a)
Metacentric heightshall be not less than 1,00 m.

(b)
Under the joint action of the centrifugal force resulting from the vessel's turning, wind pressure and the free surfaces of liquids the heeling angle shall not exceed 5° and the edge of the deck shall not be immersed.

(c)
The heeling lever resulting from the centrifugal force caused by the vessel's turning shall be determined in accordance with the following formula:where:cKZparameter (cKZ= 0,04) (s2/m);vthe maximum speed of the vessel in relation to the water (m/s);height of centre of gravity of the laden vessel above its base (m);T'draught of the laden vessel (m).
cKZ
parameter (cKZ= 0,04) (s2/m);
v
the maximum speed of the vessel in relation to the water (m/s);

height of centre of gravity of the laden vessel above its base (m);
T'
draught of the laden vessel (m).

cKZ
parameter (cKZ= 0,04) (s2/m);

v
the maximum speed of the vessel in relation to the water (m/s);

height of centre of gravity of the laden vessel above its base (m);

T'
draught of the laden vessel (m).

cKZ
parameter (cKZ= 0,04) (s2/m);

v
the maximum speed of the vessel in relation to the water (m/s);

height of centre of gravity of the laden vessel above its base (m);

T'
draught of the laden vessel (m).

(d)
The heeling lever resulting from the wind pressure shall be determined in accordance with the following formula:where:cKWparameter (cKW= 0,025) (t/m2);A'lateral plane above the respective plane of draught with the vessel laden (m2);D'displacement of the laden vessel (t);lWheight of the centre of gravity of the lateral plane A' above the respective plane of draught (m);T 'draught of the laden vessel (m).
cKW
parameter (cKW= 0,025) (t/m2);
A'
lateral plane above the respective plane of draught with the vessel laden (m2);
D'
displacement of the laden vessel (t);
lW
height of the centre of gravity of the lateral plane A' above the respective plane of draught (m);
T '
draught of the laden vessel (m).

cKW
parameter (cKW= 0,025) (t/m2);

A'
lateral plane above the respective plane of draught with the vessel laden (m2);

D'
displacement of the laden vessel (t);

lW
height of the centre of gravity of the lateral plane A' above the respective plane of draught (m);

T '
draught of the laden vessel (m).

cKW
parameter (cKW= 0,025) (t/m2);

A'
lateral plane above the respective plane of draught with the vessel laden (m2);

D'
displacement of the laden vessel (t);

lW
height of the centre of gravity of the lateral plane A' above the respective plane of draught (m);

T '
draught of the laden vessel (m).

(e)
The heeling lever resulting from the free surfaces of rainwater and residual water within the hold or the double bottom shall be determined in accordance with the following formula:where:cKfOparameter (cKfO= 0,015) (t/m2)bwidth of hold or section of the hold in question (m);(*10)llength of hold or section of the hold in question (m);(*10)D'displacement of the laden vessel (t).
cKfO
parameter (cKfO= 0,015) (t/m2)
b
width of hold or section of the hold in question (m);(*10)
l
length of hold or section of the hold in question (m);(*10)
D'
displacement of the laden vessel (t).

cKfO
parameter (cKfO= 0,015) (t/m2)

b
width of hold or section of the hold in question (m);(*10)

l
length of hold or section of the hold in question (m);(*10)

D'
displacement of the laden vessel (t).

cKfO
parameter (cKfO= 0,015) (t/m2)

b
width of hold or section of the hold in question (m);(*10)

l
length of hold or section of the hold in question (m);(*10)

D'
displacement of the laden vessel (t).

(f)
Half of the fuel and fresh water supply shall be taken into account for each load condition.

(a)
No value less than 11,5 (11,5 = 1/tan5°) shall be taken for.

(b)
zul=- 1,00 (m)

zul
maximum permissible height of the laden vessel's centre of gravity above its base (m);

height of the metacentre above the base (m) in accordance with the approximation formula in paragraph 3;

F
respective effective freeboard at 1/2 L (m);

Z
parameter for the centrifugal force resulting from turning

v
maximum speed of the vessel in relation to the water (m/s);

Tm
respective average draught (m);

hKW
heeling lever resulting from lateral wind pressure according to paragraph 1(d) (m);

hKfO
sum of the heeling levers resulting from the free surfaces of liquids according to paragraph 1(e) (m).

(a)
for vessels in the shape of a pontoon

(b)
for other vessels

(a)
metacentric heightshall be not less than 0,50 m;

(b)
no hull opening shall be immersed by the joint action of the centrifugal force resulting from the turning of the vessel, the wind pressure and the free surfaces of liquids;

(c)
the heeling levers resulting from the centrifugal force due to the vessel's turning, the wind pressure and the free surfaces of liquids shall be determined in accordance with the formulae referred to in Article 22.02(1)(c) to (e);

(d)
half of the fuel and fresh water supply shall be taken into account for each load condition.

(a)
Text of imageNo value less than 6,6 shall be taken forandno value less than 0 forText of image.

(b)
zul=- 0,50 (m)

I
transverse moment of inertia of water line area at Tm(m4) (for the approximation formula see paragraph 3);

i
transverse moment of inertia of the water line area parallel to the base, at height

water displacement of the vessel at Tm(m3);

F'
ideal freeboard F' = H' — Tm(m) or, the lowest value shall be decisive;

a
the vertical distance between the lower edge of the opening that is first immersed in the event of heeling and the water line in the vessel's upright position (m);

b
distance from that same opening from the centre of the vessel (m);

H'
ideal side height;

q
sum of the volumes of the deckhouses, hatches, trunk decks and other superstructures up to a maximum height of 1,0 m above H or up to the lowest aperture in the volume under consideration, the lowest value being decisive. Parts of volumes located within a range of 0,05 L from the extremities of the vessel shall not be taken into account (m3).

(a)
for vessels in the shape of a pontoonText of image

(b)
for other vesselsText of image

—
either by means of a heeling experiment, or

—
by detailed mass and moment calculation, in which case the lightweight of the vessel shall be verified by checking the draught, with a tolerance limit of +/- 5 % between the mass determined by calculation and the displacement determined by the draught readings.

(a)
Extent of side damage:longitudinal extent:at least 0,10 L,transverse extent:0,59 m,vertical extent:from the base line upwards without limit;
longitudinal extent
:
at least 0,10 L,
transverse extent
:
0,59 m,
vertical extent
:
from the base line upwards without limit;

longitudinal extent
:
at least 0,10 L,

transverse extent
:
0,59 m,

vertical extent
:
from the base line upwards without limit;

longitudinal extent
:
at least 0,10 L,

transverse extent
:
0,59 m,

vertical extent
:
from the base line upwards without limit;

(b)
Extent of bottom damage:longitudinal extent:at least 0,10 L,transverse extent:3,00 m,vertical extent:from the base 0,39 m upwards, the sump excepted.
longitudinal extent
:
at least 0,10 L,
transverse extent
:
3,00 m,
vertical extent
:
from the base 0,39 m upwards, the sump excepted.

longitudinal extent
:
at least 0,10 L,

transverse extent
:
3,00 m,

vertical extent
:
from the base 0,39 m upwards, the sump excepted.

longitudinal extent
:
at least 0,10 L,

transverse extent
:
3,00 m,

vertical extent
:
from the base 0,39 m upwards, the sump excepted.

(c)
Any bulkheads within the damaged area shall be assumed damaged, which means that the subdivision shall be chosen so that the vessel remains afloat after the flooding of two or more adjacent compartments in the longitudinal direction.For the main engine room only the one-compartment standard need be taken into account, i.e. the end bulkheads of the engine room shall be assumed as not damaged.For bottom damage, adjacent athwartship compartments shall also be assumed as flooded.

(d)
PermeabilityPermeability shall be assumed to be 95 %.By way of derogation from this assumption, the following permeability may be assumed:—engine and operation rooms:85 %—double bottoms, fuel tanks, ballast tanks, etc. depending on whether, according to their function, they have to be assumed as full or empty for the vessel floating at the maximum permissible draught:0 or 95 %.If a calculation proves that the average permeability of any compartment is lower, the calculated value may be used.
—engine and operation rooms:
—
engine and operation rooms:
85 %
—double bottoms, fuel tanks, ballast tanks, etc. depending on whether, according to their function, they have to be assumed as full or empty for the vessel floating at the maximum permissible draught:
—
double bottoms, fuel tanks, ballast tanks, etc. depending on whether, according to their function, they have to be assumed as full or empty for the vessel floating at the maximum permissible draught:
0 or 95 %.

—engine and operation rooms:
—
engine and operation rooms:
85 %

—
engine and operation rooms:

—double bottoms, fuel tanks, ballast tanks, etc. depending on whether, according to their function, they have to be assumed as full or empty for the vessel floating at the maximum permissible draught:
—
double bottoms, fuel tanks, ballast tanks, etc. depending on whether, according to their function, they have to be assumed as full or empty for the vessel floating at the maximum permissible draught:
0 or 95 %.

—
double bottoms, fuel tanks, ballast tanks, etc. depending on whether, according to their function, they have to be assumed as full or empty for the vessel floating at the maximum permissible draught:

—engine and operation rooms:
—
engine and operation rooms:
85 %

—
engine and operation rooms:

—double bottoms, fuel tanks, ballast tanks, etc. depending on whether, according to their function, they have to be assumed as full or empty for the vessel floating at the maximum permissible draught:
—
double bottoms, fuel tanks, ballast tanks, etc. depending on whether, according to their function, they have to be assumed as full or empty for the vessel floating at the maximum permissible draught:
0 or 95 %.

—
double bottoms, fuel tanks, ballast tanks, etc. depending on whether, according to their function, they have to be assumed as full or empty for the vessel floating at the maximum permissible draught:

—
engine and operation rooms:

—
double bottoms, fuel tanks, ballast tanks, etc. depending on whether, according to their function, they have to be assumed as full or empty for the vessel floating at the maximum permissible draught:

(e)
The lower edge of any non-watertight openings (e.g. doors, windows, access hatches) shall, at the final stage of flooding, be not less than 100 mm above the damaged waterline.

(a)
at the final stage of flooding a safety clearance of not less than 100 mm remains and the heeling angle of the craft does not exceed 5°; or

(b)
calculations in accordance with the procedure for calculation of damaged stability specified in Part 9 of the ADNR produce a positive result.

(a)
be fitted with a multi-propeller propulsion system, with at least two independent engines of equal power and a bow thruster that is controlled from the wheelhouse and is also effective when the craft is in an unladen state; orhave a single-propeller propulsion system and a bow thruster that is controlled from the wheelhouse with its own power supply and which is also effective when the craft is in an unladen state and makes it possible for the craft to proceed under its own power in the event of a breakdown of the main propulsion system;

(b)
be fitted with a radar navigation system, together with a rate-of-turn indicator in accordance with Article 7.06(1);

(c)
have a permanently-installed bilge pumping system in accordance with Article 8.08;

(d)
meet the requirements of Article 23.09(1)(1).

(a)
are capable of being separated, in the event of an accident, in the middle third of the vessel without the use of heavy salvage equipment while the separated parts of the vessel shall remain afloat after separation;

(b)
are provided with a certificate that shall be carried on board and which is issued by an approved classification society regarding the buoyancy, trim position and stability of the separate parts of the vessel, indicating the degree of loading above which buoyancy of the two parts is no longer ensured;

(c)
are built as double-hull vessels in accordance with the ADNR, where for motor vessels sections 9.1.0.91 to 9.1.0.95, and for tank vessels sections 9.3.2.11.7 and 9.3.2.13 to 9.3.2.15 of Part 9 of the ADNR shall apply;

(d)
are fitted with a multi-screw propulsion system in accordance withparagraph 1(a), first half sentence;

(a)
are built or converted for their highest class under the supervision of an approved classification society, in which case compliance shall be confirmed by means of a certificate issued by the classification society while current class is not necessary;

(b)
eitherhave a double bottom with a height of at least 600 mm and subdivision to ensure that, in the event of flooding of any two adjacent watertight compartments, the vessel does not immerse lower than the margin line and a residual safety clearance of 100 mm remains,orhave a double bottom with a height of at least 600 mm and a double hull with a distance of at least 800 mm between the side wall of the vessel and the longitudinal bulkhead;

(c)
be fitted with a multi-screw propulsion system with at least two independent engines of equal power and a bow thruster system which can be operated from the wheelhouse and which operates longitudinally as well as transversely;

(d)
allow the stern anchor to be operated directly from the wheelhouse;

(a)
appliances fitted with wick burners according to Article 13.02;

(b)
vaporising oil burner stoves according to Articles 13.03 and 13.04;

(c)
solid-fuel heating appliances according Article 13.07;

(d)
liquefied gas installations according to Chapter 14.

(a)
Article 3.04(6), second subparagraph;

(b)
Article 8.08(2), second sentence;

(c)
Article 11.02(4), second and third sentences;

(d)
Article 12.02(4), second sentence;

(e)
Article 15.06(3)(a), second sentence.

(a)
buoyancy and stability characteristics adequate for safety where the craft is operated in the displacement mode, both when intact and when damaged;

(b)
stability characteristics and stabilising systems ensuring the safety of the craft when used in the dynamic buoyancy phase and the transition phase;

(c)
stability characteristics in the non-displacement and transitional modes adequate to transfer the craft safely to displacement mode in case of any system malfunction.

(a)
By way of derogation from Article 7.01(1), wheelhouses shall be arranged in such a way that the helmsman and a second member of the crew may at all times perform their tasks while the vessel is under way.

(b)
The steering position shall be arranged so as to accommodate workstations for the persons mentioned in (a). The instruments for navigation, manoeuvring, monitoring and communication and other important operating controls shall be sufficiently close together to allow a second member of the crew as well as the helmsman to obtain the necessary information and to operate the controls and installations as necessary while seated. The following requirements shall apply in all cases:(aa)the steering position for the helmsman shall be arranged so as to allow radar navigation by one person.(bb)the second member of the crew shall have his own radar screen (slave) at his workstation and shall be able to intervene from his workstation to transmit information and control the propulsion of the vessel.
(aa)
the steering position for the helmsman shall be arranged so as to allow radar navigation by one person.
(bb)
the second member of the crew shall have his own radar screen (slave) at his workstation and shall be able to intervene from his workstation to transmit information and control the propulsion of the vessel.

(aa)
the steering position for the helmsman shall be arranged so as to allow radar navigation by one person.

(bb)
the second member of the crew shall have his own radar screen (slave) at his workstation and shall be able to intervene from his workstation to transmit information and control the propulsion of the vessel.

(aa)
the steering position for the helmsman shall be arranged so as to allow radar navigation by one person.

(bb)
the second member of the crew shall have his own radar screen (slave) at his workstation and shall be able to intervene from his workstation to transmit information and control the propulsion of the vessel.

(c)
The persons mentioned in (a) shall be able to operate the installations mentioned in (b) without any hindrance, including when safety belts are properly worn.

(a)
By way of derogation from Article 7.02(2), the area of obstructed view forward of the bow for the helmsman in a seated position shall not be more than one vessel length irrespective of the amount of cargo.

(b)
By way of derogation from Article 7.02(3), the total arc of blind sectors from right ahead to 22,5° abaft the beam on either side shall not exceed 20°. Each individual blind sector shall not exceed 5°. The clear sector between two blind sectors shall not be less than 10°.

(a)
a radar installation and rate-of-turn indicator according to Article 7.06(1),

(b)
readily accessible individual lifesaving equipment conforming to European Standard EN 395:1998 for the maximum number of persons permitted on board.

(a)
For the purpose of informing passengers of safety measures, all passenger vessels shall be fitted with acoustic and visual installations visible and audible to everyone on board.

(b)
The installations described under (a) shall enable the boatmaster to give instructions to passengers.

(c)
Every passenger shall have access to instructions for emergency situations close to their seat, including a plan of the vessel showing all exits, escape routes, emergency equipment, lifesaving equipment and instructions for the use of lifejackets.

(a)
there shall be easy, safe and quick access from the steering position to spaces and accommodation accessible to the public;

(b)
escape routes leading to emergency exits shall be clearly and permanently marked;

(c)
all exits shall be properly marked. The operation of the opening mechanism shall be obvious from the outside and the inside;

(d)
the escape routes and emergency exits shall have a suitable safety guidance system;

(e)
sufficient space for a member of the crew shall be left next to exits.

(a)
Articles 22b.01, 22b.04, 22b.08, 22b.09, 22b.10, 22b.11(1)when the Community certificate is renewed;

(b)
on 1 April 2013,Article 22b.07(1), (3), (4), (5) and (6);

(c)
on 1 January 2023all other provisions.

(a)
The propulsion systems shall be arranged in such a way that speed can be changed and the direction of the propeller thrust reversed from the steering position.It shall be possible for the auxiliary engines needed for operational purposes to be switched on or off from the steering position, unless this is done automatically or the engines run continuously during each voyage.

(b)
In the danger areas of,—the temperature of the main-engine cooling water,—the lubricating-oil pressure for the main engines and transmissions,—the oil and air pressure of the main-engine reversing units, reversible transmissions or propellers,—the bilge levels in the main engine room,there shall be monitoring by means of instruments which set off acoustic and visual signals in the wheelhouse in the event of malfunction. The acoustic alarm signals may be combined in one audible warning device. They may be switched off as soon as the malfunction has been acknowledged. The visual alarm signals may only be switched off when the malfunctions which set them off have been corrected.
—
the temperature of the main-engine cooling water,
—
the lubricating-oil pressure for the main engines and transmissions,
—
the oil and air pressure of the main-engine reversing units, reversible transmissions or propellers,
—
the bilge levels in the main engine room,

—
the temperature of the main-engine cooling water,

—
the lubricating-oil pressure for the main engines and transmissions,

—
the oil and air pressure of the main-engine reversing units, reversible transmissions or propellers,

—
the bilge levels in the main engine room,

—
the temperature of the main-engine cooling water,

—
the lubricating-oil pressure for the main engines and transmissions,

—
the oil and air pressure of the main-engine reversing units, reversible transmissions or propellers,

—
the bilge levels in the main engine room,

(c)
The fuel shall be supplied and the main engine cooled automatically.

(d)
The steering system shall be able to be operated by one person, even in maximum draught, without requiring particular force.

(e)
It shall be possible to give the visual and acoustic signals required under national or international navigational authority regulations, as appropriate, from the steering position.

(f)
Where there is no direct communication between the steering position and the foresection, the aft, the accommodation and the engine rooms, a voice communication system shall be provided. For communication with the engine rooms, this may be in the form of an optical or acoustic signal.

(g)
The required ship's boat shall be capable of being released by one crew member alone and in an appropriate amount of time.

(h)
There shall be a searchlight which can be operated from the steering position.

(i)
The operation of cranks and similar revolving parts of lifting devices shall not require a force of more than 160 N.

(k)
The towing winches entered in the Community certificate shall be motorised.

(l)
The bilge and deck-wash pumps shall be motorised.

(m)
The principal control units and monitoring instruments shall be ergonomically arranged.

(n)
The equipment required under Article 6.01(1), shall be capable of being remotely operated from the steering position.

(a)
For motor vessels operating seperately:standard S1 and additionally equipped with a bow thruster which can be operated from the steering position;

standard S1 and additionally equipped with a bow thruster which can be operated from the steering position;

standard S1 and additionally equipped with a bow thruster which can be operated from the steering position;

standard S1 and additionally equipped with a bow thruster which can be operated from the steering position;

(b)
For motor vessels propelling in side-by-side formation:standard S1 and additionally equipped with a bow thruster which can be operated from the steering position;

standard S1 and additionally equipped with a bow thruster which can be operated from the steering position;

standard S1 and additionally equipped with a bow thruster which can be operated from the steering position;

standard S1 and additionally equipped with a bow thruster which can be operated from the steering position;

(c)
For motor vessels propelling pushed convoys made up of the motor vessel itself and a craft in front:standard S1 and additionally equipped with hydraulic or electrically operated coupling winches. This equipment is, however, not required if the foremost vehicle in the pushed convoy is equipped with a bow thruster which can be operated from the steering position of the pushing motor vessel;

standard S1 and additionally equipped with hydraulic or electrically operated coupling winches. This equipment is, however, not required if the foremost vehicle in the pushed convoy is equipped with a bow thruster which can be operated from the steering position of the pushing motor vessel;

standard S1 and additionally equipped with hydraulic or electrically operated coupling winches. This equipment is, however, not required if the foremost vehicle in the pushed convoy is equipped with a bow thruster which can be operated from the steering position of the pushing motor vessel;

standard S1 and additionally equipped with hydraulic or electrically operated coupling winches. This equipment is, however, not required if the foremost vehicle in the pushed convoy is equipped with a bow thruster which can be operated from the steering position of the pushing motor vessel;

(d)
For pushers propelling a pushed convoy:standard S1 and additionally equipped with hydraulic or electric coupling winches. This equipment is, however, not required if the foremost craft in the pushed convoy is equipped with a bow thruster which can be operated from the steering position of the pusher;

standard S1 and additionally equipped with hydraulic or electric coupling winches. This equipment is, however, not required if the foremost craft in the pushed convoy is equipped with a bow thruster which can be operated from the steering position of the pusher;

standard S1 and additionally equipped with hydraulic or electric coupling winches. This equipment is, however, not required if the foremost craft in the pushed convoy is equipped with a bow thruster which can be operated from the steering position of the pusher;

standard S1 and additionally equipped with hydraulic or electric coupling winches. This equipment is, however, not required if the foremost craft in the pushed convoy is equipped with a bow thruster which can be operated from the steering position of the pusher;

(e)
For passenger vessels:standard S1 and additionally equipped with a bow thruster which can be operated from the steering position. This equipment is, however, not required if the propulsion system and steering system of the passenger vessel guarantee equal manoeuvrability.

standard S1 and additionally equipped with a bow thruster which can be operated from the steering position. This equipment is, however, not required if the propulsion system and steering system of the passenger vessel guarantee equal manoeuvrability.

standard S1 and additionally equipped with a bow thruster which can be operated from the steering position. This equipment is, however, not required if the propulsion system and steering system of the passenger vessel guarantee equal manoeuvrability.

standard S1 and additionally equipped with a bow thruster which can be operated from the steering position. This equipment is, however, not required if the propulsion system and steering system of the passenger vessel guarantee equal manoeuvrability.

(a)
be adapted to comply with those provisions in accordance with the transitional provisions listed in the table below, and

(b)
until their adaptation, comply with the Rhine Vessel Inspection Regulation in force on 31 December 1994.

—
‘NRC’: the provision does not apply to craft which are already operating, unless the parts concerned are replaced or converted, i.e. the provision applies only toNewly-built craft and to theReplacement orConversion of the parts or areas concerned. If existing parts are replaced by replacement parts using the same technology and of the same type, this does not constitute replacement (‘R’) within the meaning of the transitional provisions.

—
‘Issue or renewal of the Community certificate’: the provision must be complied with the time of the next issue or renewal of the Community certificate after the date indicated.

Article and paragraph
Content
Deadline and comments

CHAPTER 3

3.03(1)(a)
Situation of collision bulkhead
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 2
Accommodations
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

Safety equipment
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 4
Gastight separation of accommodations from engine rooms, boiler rooms and holds
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 5, second subparagraph
Monitoring of doors in aft-peak bulkheads
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 7
Anchors not protruding in foresections of vessels
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2041

3.04(3), second sentence
Insulation material used in engine rooms
NRC, at the latest on issue or renewal of the Community certificate

paragraph 3, third and fourth sentences
Openings and locking devices
NRC, at the latest on issue or renewal of the Community certificate

3.04(6)
Exits of engine rooms
Engine rooms which were not considered as engine rooms according to Article 1.01 before 1995 must be equipped with a second exit at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

CHAPTER 5

5.06(1), first sentence
Minimum speed
For craft laid down before 1996 at the latest on issue or renewal of the Community certificate after 1.1.2035

CHAPTER 6

6.01(1)
Manoeuvrability required by Chapter 5
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 3
Permanent lists and ambient temperatures
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 7
Design of rudder stocks
For craft laid down before 1996: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

6.02(2)
Single operation sufficient to operate second driving unit
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 3
Manoeuvrability required by Chapter 5 ensured by second drive unit/manual drive
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

6.03(1)
Connection of other consumers to hydraulic steering apparatus drive unit
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 2
Separate hydraulic reservoirs
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

6.05(1)
Wheel of manual drive not driven by powered drive unit
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

6.06(1)
Two independent actuation systems
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

6.07(2)(a)
Monitoring devices for level of hydraulic reservoir and service pressure
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 2(e)
Monitoring of buffer devices
NRC, at the latest on issue or renewal of the Community certificate

6.08(1)
Requirements for electrical equipment according to Article 9.20
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

CHAPTER 7

7.02(3), second subparagraph
Unobstructed view in the helmsman's usual axis of vision
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 5
Minimal light transmission
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

7.03(7)
Shutdown of alarms
NRC, at the latest on issue or renewal of the Community certificate, unless the wheelhouse has been designed for radar navigation by one person

paragraph 8
Automatic switch to another power supply
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

7.04(1)
Control of main engines and steering systems
NRC, at the latest on issue or renewal of the Community certificate

paragraph 2
Control of main engine
Unless wheelhouses have been designed for radar navigation by one person: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035 if the direction of motion can be achieved directly; 1.1.2010 for other engines

7.09
Alarm system
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

7.12 first paragraph
Retractable wheelhouses
NRC, at the latest on issue or renewal of the Community certificateNon-hydraulic lowering system: at the latest on issue or renewal of the Community certificate after 1.1.2035

second and third paragraphs

NRC, at the latest on issue or renewal of the Community certificate

CHAPTER 8

8.01 (3)
Only internal-combustion engines burning fuels having a flashpoint of more than 55°C
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

8.02(1)
Securing of engines against unintentional starting
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 4
Automatic protection of engine parts
NRC, at the latest on issue or renewal of the Community certificate

8.03(2)
Monitoring devices
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 3
Automatic protection against overspeed
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 5
Design of shaft bushings
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

8.05(1)
Steel tanks for liquid fuels
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 2
Automatic closing of tank valves
NRC, at the latest on issue or renewal of the Community certificate

paragraph 3
No fuel tanks located forward of the collision bulkhead
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 4
No fuel tanks and their fittings above engines or exhaust pipes
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010. Until then, appropriate devices must ensure the safe evacuation of fuels.

paragraph 6, third to fifth sentences
Installation and measurements of breather pipes and connection pipes
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

8.05(7)
Shutoff device to be operated from the deck
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 9, first sentence
Capacity-gauging devices to be legible up to maximum filling level
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 13
Filling level control not only for main engines but also other engines needed for safe operation of the vessel
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

8.08(8)
Simple closing device not sufficient for connection of ballast spaces to drainage pipes for holds capable of carrying ballast
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 9
Gauging devices in hold bilges
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

8.09(2)
Installations for the collection of oily water and used oil stores
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

8.10(3)
Emission limit of 65 dB(A) for stationary vessels
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

CHAPTER 8a

The transitional provisions on Chapter 8a of the Rhine Vessel Inspection Regulation apply

CHAPTER 9

9.01(1), second sentence
Relevant documents to be submitted to the inspection body
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 2, second indent
Switching diagrams for main, emergency and distribution switchboard to be kept on board
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 3
Ambient inside and deck temperatures
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

9.02(1) to (3)
Electricity supply systems
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

9.05(4)
Cross-section of the earthing conductors
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.11(4)
Effective ventilation when accumulators are installed in a closed compartment, cabinet or chest
NRC, at the latest on issue or renewal of the Community certificate

9.12(2)(d)
Switch-gear installations
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 3(b)
Earth detection device capable of giving both visual and audible alarm
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

9.13
Emergency circuit breakers
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

9.14(3), second sentence
Prohibition of single-pole switches in laundries, bathrooms, washrooms and other rooms with wet facilities
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

9.15(2)
Minimum cross-section of 1,5 mm2per cable
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 9
Cables connected to retractable wheelhouses
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

9.16(3), second sentence
Second circuit
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.19
Alarm and safety systems for mechanical equipment
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.20
Electronic equipment
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

9.21
Electromagnetic compatibility
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

CHAPTER 10

10.01
Anchor equipment
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

10.02(2)(a)
Certificate for mooring and other cables
First cable to be replaced on the vessel: NRC, at the latest 1.1.2008Second and third cables: 1.1.2013

10.03(1)
European standard
For replacement, at the latest 1.1.2010

paragraph 2
Suitability for Class A, B and C fires
For replacement, at the latest 1.1.2010

paragraph 4
Relation of CO2content and size of room
For replacement, at the latest 1.1.2010

10.03a
Permanently installed fire-fighting systems in accommodation spaces, wheelhouses and passenger spaces
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

10.03b
Permanently installed fire-fighting systems in engine rooms, boiler rooms and pump rooms
(17)

10.04
Application of the European standard to dinghies
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

10.05(2)
Inflatable life jackets
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010. Life jackets which have been on board on 30.9.2003 may be used until the issue or renewal of the Community certificate after 1.1.2010.

CHAPTER 11

11.02(4)
Equipment of outer edges of decks, side decks and work stations
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

11.04
Side decks
(18)First issue or renewal of the Community certificate after 1.1.2035, when larger than 7,30 m

11.05 (1)
Access to workplaces
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraphs. 2 and 3
Doors and accesses, exits and passageways where there is more than a 0,50 m difference in floor level
Issue or renewal of the Community certificate

paragraph 4
Stairs in working spaces which are manned continuously
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

11.06 (2)
Exits and emergency exits
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

11.07(1), 2nd sentence
Ladders, steps and similar devices
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraphs 2 and 3

Issue or renewal of the Community certificate

11.10
Hatch covers
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

11.11
Winches
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

11.12(2) to (6) and (8) to (10)
Cranes: manufacturer's plate, maximum permissible loadings, protection devices, calculation test, inspection by experts, certificates on board
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

11.13
Storing of flammable liquids
NRC, at the latest on issue or renewal of the Community certificate

CHAPTER 12

12.01(1)
Accommodation for the persons lodging habitually on board
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

12.02(3)
Situation of floors
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 4
Living and sleeping quarters
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 6
Headroom in the accommodation
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 8
Free floor area of communal living quarters
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 9
Cubic capacity of rooms
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 10
Volume of airspace per person
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 11
Size of doors
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 12(a) and (b)
Situation of stairs
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 13
Pipes carrying dangerous gases or liquids
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

12.03
Sanitary installations
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

12.04
Galleys
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

12.05
Potable water
NRC, at the latest on 31.12.2006

12.06
Heating and ventilation
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

12.07(1), second sentence
Other accommodation installations
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

CHAPTER 15

15.01 (1)(d)
Non-application of Article 9.14 (3) second sentence for rated voltages of over 50V
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 2(c)
Prohibition of solid fuel heaters according to Article 13.07
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010The provision does not apply to craft with solid fuel engines (steam engines).

(e)
Prohibition of liquefied gas devices according to Chapter 14
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.02(2)
Number and position of bulkheads
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 5, second sentence
Margin line if no bulkhead deck
For passenger vessels which have been laid down before 1.1.1996, the requirement applies at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 10(c)
Time for closure process
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 12
Optical warning system
NRC, at the latest on issue or renewal of the Community certificate

paragraph 15
Minimum height of double bottoms, width of wing voids
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.03 (1) to (6)
Intact stability
NRC, and when the maximum number of passengers is raised, at the latest on issue or renewal of the Community certificate after 1.1.2045

Paragraphs 7 and 8
Damaged stability
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 9
Two-compartment status
NRC

paragraphs 10 to 13
Damaged stability
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.05( 2)(a)
Number of passengers for whom the existence of an evacuation area according to Article 15.06(8) has been proven
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

(b)
Number of passengers that has been taken into account for the stability calculation according to Article 15.03
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.06(1)(a)
Passenger rooms on all decks aft of the collision bulkhead and forward of the level of the aft-peak bulkhead
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 3(c), first sentence
Clear height of exits
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

second sentence
Clear width of doors of passenger cabins and other small rooms
For the measurement of 0,7 m, NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045, applies

15.06(3)(f), first sentence
Size of emergency exits
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

(g)
Exits of rooms intended for use by persons with reduced mobility
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 4(d)
Doors intended for use by persons with reduced mobility
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 5
Requirements for connecting corridors
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 6(b)
Escape routes to evacuation areas
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

(d)
No rungs, ladders or the like installed along the escape routes
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 7
Suitable safety guidance system
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 8
Requirements for muster areas
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 9
Requirements for stairs and their landings in the passenger areas
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 10(a), first sentence
Railing according to European standard EN 711: 1995
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

second sentence
Height of bulwarks and railings of decks intended for use by persons with reduced mobility
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.06(10)(b), second sentence
Clear width of openings used normally for the embarking or disembarking of persons with reduced mobility
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 13
Traffic areas and walls in traffic areas intended for use by persons with reduced mobility
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 14, first sentence
Design of glass doors and walls in traffic areas and window panes
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 15
Requirements for superstructures or their roofs consisting completely of panoramic panes
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 16
Potable water systems in accordance with Article 12.05
NRC, at the latest on issue or renewal of the Community certificate after 31.12.2006

paragraph 17, second sentence
Requirements for toilets fitted for use by persons with reduced mobility
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 18
Ventilation system for cabins without an opening window
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 19
Requirements of Article 15.06 for rooms in which crew members or shipboard personnel are accommodated
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.07
Requirements for the propulsion system
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.08(2)
Requirements for loudspeaker systems in passenger areas
For passenger vessels with LWL of less than 40 m or for not more than 75 persons the provision applies at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 3
Requirements for the alarm system
For day-trip vessels the provision applies at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 4
Bilge level alarm for each watertight compartment
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 5
Two motor-driven bilge pumps
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 6
Permanently installed bilge system
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 8
Ventilation system for CO2bar-systems in rooms below deck
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

15.09(3)
Appropriate transfer equipment
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

15.09(4)
Individual life-saving equipment for children
Until the issue or renewal of the Community certificate after 1.1.2010 this equipment is considered an alternative to individual life-saving equipment

Life-saving equipment
For passenger vessels which were equipped with collective life-saving appliances according to Article 15.09(5) before 1.1.2005, these appliances are considered an alternative to individual life-saving equipment.For passenger vessels which were equipped with collective life-saving appliances according to Article 15.09(6) before 1.1.2005, these are considered an alternative to individual life-saving equipment until the issue or renewal of the Community certificate after 1.1.2010.

paragraph 5(b) and (c)
Adequate seating space, buoyancy of at least 750 N
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

(f)
Stable trim and appropriate grabbing devices
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

(i)
Appropriate means of evacuation from evacuation areas on to life rafts
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 10
Ship's boat equipped with engine and searchlight
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

15.10(2)
Article 9.16(3) also applicable to passageways and recreation rooms for passengers
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 3
Adequate emergency lighting
Emergency lighting NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

15.10 (4)
Emergency power plant
For day-trip vessels with LWL of 25 m or less, the provision applies at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

(f)
Emergency supply for searchlights according to Article 10.02 (2)(i)
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

(i)
Emergency supply for lifts and lifting equipment according to Article 15.06(9), second sentence
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 6
Requirements for the emergency power plant:

—Partitions according to Article 15.11(2)
—
Partitions according to Article 15.11(2)
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

—
Partitions according to Article 15.11(2)

—Installation of cables
—
Installation of cables
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

—
Installation of cables

—Emergency power plant above the margin line
—
Emergency power plant above the margin line
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

—
Emergency power plant above the margin line

15.11
Fire protection

paragraph 1
Suitability for fire protection of materials and components
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 2
Design of partitions
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 3
Paints, lacquers and other surface treatment products as well as deck coverings used in rooms except engine rooms and store rooms shall be flame-retardant
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 4
Lounge ceilings and wall claddings manufactured from non-combustible material
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 5
Furniture and fittings in muster areas manufactured from non-combustible material
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 6
Tested according to Code
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 7
Insulation materials in lounges
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 8
Requirements for doors in partitions
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 9
Walls
On cabin vessels without automatic pressurised-water spraying systems, ends of walls between cabins: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 10
Partitions
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.11(11)
Draught stops
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 12, 2nd sentence
Stairs made of steel or another equivalent non-combustible material
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 13
Encapsulation of internal stairs
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 14
Ventilation systems and air supply systems
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 15
Ventilation systems in galleys and stoves with extractors
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 16
Control centres, stairwells, muster areas and smoke extraction systems
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 17
Fire alarm system
For day-trip vessels: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

15.12 (1)
Portable extinguishers
Extinguisher and quenching material in galleys, hairdressing salons and perfumeries: NRC, at the latest on issue or renewal of the Community certificate

paragraph 2
Hydrant system
2nd fire extinguishing pump: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 3
Requirements for hydrant systems
Pressure and water jet length: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 6
Materials, protection against failure
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

15.12 (7)
Avoidance of the possibility of freezing of pipes and hydrants
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 8(b)
Independent operation of fire extinguishing pumps
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

(c)
Water jet length on all decks
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

(d)
Installation of fire extinguishing pumps
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 9
Fire extinguishing system in engine rooms
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.14(1)
Waste water collection and disposal facilities
For cabin vessels with no more than 50 berths and for day-trip vessels: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 2
Requirements for waste water collection tanks
For cabin vessels with no more than 50 berths and for day-trip vessels with no more than 50 passengers: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.15 (1)
Damage stability
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 4
(Left void)

paragraph 5
Equipped with a ship's boat, a platform or an equivalent installation
For passenger vessels licensed for a maximum of 250 passengers or 50 berths: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

15.15(6)
Equipped with a ship's boat, a platform or an equivalent installation
For passenger vessels licensed for a maximum of 250 passengers or 50 berths: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 9(a)
Alarm systems for liquefied gas installations
NRC, at the latest on renewal of the certificate according to Article 14.15

(b)
Collective life-saving appliances according to Article 15.09(5)
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

CHAPTER 16

16.01(2)
Special winches or equivalent coupling devices
The requirement applies to craft licensed before 1.1.1995 for pushing without proper securing equipment, only at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035.

16.01(3), last sentence
Requirements for drive units
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

CHAPTER 17

17.02(3)
Additional requirements
The same transitional provisions as those indicated under the relevant article apply.

17.03(1)
General alarm system
NRC, at the latest on issue or renewal of the Community certificate

paragraph 4
Maximum authorised load
NRC, at the latest on issue or renewal of the Community certificate

17.04(2) and (3)
Residual safety clearance
NRC, at the latest on issue or renewal of the Community certificate

17.05(2) and (3)
Residual freeboard
NRC, at the latest on issue or renewal of the Community certificate

17.06, 17.07 and 17.08
Heeling test and confirmation of stability
NRC, at the latest on issue or renewal of the Community certificate

17.09
Draught marks and draught scales
NRC, at the latest on issue or renewal of the Community certificate

CHAPTER 20

The transitional provisions on Chapter 20 of the Rhine Vessel Inspection Regulation apply

CHAPTER 21

21.01 to 21.02

The requirements apply to recreational craft built before 1.1.1995, only at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035.

—
Partitions according to Article 15.11(2)

—
Installation of cables

—
Emergency power plant above the margin line

—
‘RC’: The provision does not apply to craft which are already operating, unless the parts concerned are replaced or converted, i.e. the provision applies only to theReplacement orConversion of the parts or areas concerned. If existing parts are replaced by replacement parts using the same technology and of the same type, this does not constitute replacement (‘R’) within the meaning of the transitional provisions.

—
‘Issue or renewal of the Community certificate’: The provision must be complied with by the time of the next issue or renewal of the Community certificate after the date indicated.

Article and paragraph
Content
Deadline and comments

CHAPTER 3

3.03(1)(a)
Situation of collision bulkhead
RC, at the latest on issue or renewal of the Community certificate after 1.1.2035

3.04(2)
Common surfaces of bunkers and accommodation and passenger areas
RC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 7
Maximum permissible sound pressure level
Issue or renewal of the Community certificate after 1.1.2015

CHAPTER 4

4.01(2), 4.02 and 4.03
Safety clearance, freeboard, minimum freeboard
Issue or renewal of the Community certificate after 1.1.2015

CHAPTER 7

7.01(2)
Sound pressure generated by the vessel
RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

7.05(2)
Monitoring of navigation lights
Issue or renewal of the Community certificate

CHAPTER 8

8.08 (3) and (4)
Minimum pumping capacity and internal diameter of drainage pipes
Issue or renewal of the Community certificate after 1.1.2015

8.10(2)
Noise generated by a vessel under way
RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

CHAPTER 9

9.01
Requirements for electrical equipment
RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.03
Protection against physical contact, intrusion of solid objects and the ingress of water
RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.06
Maximum permissible voltages
RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.10
Generators and motors
RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.11(2)
Installation of accumulators
RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.12
Switch-gear installations
RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.14
Installation fittings
RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.15
Cables
RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.17
Navigation lights
RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

CHAPTER 12

12.02(5)
Noise and vibration in accommodations
Issue or renewal of the Community certificate after 1.1.2015

CHAPTER 15

15.02(5), (6), first sentence, (7) to (11) and (13)
Margin line if no bulkhead deck
RC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.02(16)
Watertight windows
RC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.04
Safety clearance, freeboard, immersion measures
RC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.05
Number of passengers
Issue or renewal of the Community certificate after 1.1.2015

15.10 (4), ( 6), (7), (8) and (11)
Emergency power plant
RC, at the latest on issue or renewal of the Community certificate after 1.1.2045

(a)
to craft for which a vessel certificate in accordance with the Rhine Vessel Inspection Regulation was issued for the first time between 1 January 1995 and 30 December 2008, provided they were not under construction or undergoing conversion on 31 December 1994;

(b)
to craft which have obtained another traffic licence between 1 January 1995 and 30 December 2008.

—
‘NRC’: The provision does not apply to craft which are already operating, unless the parts concerned are replaced or converted, i.e. the provision applies only toNewly-built craft and to theReplacement orConversion of the parts or areas concerned. If existing parts are replaced by replacement parts using the same technology and of the same type, this does not constitute replacement (‘R’) within the meaning of the transitional provisions.

—
‘Issue or renewal of the Community certificate’: The provision must be complied with by the time of the next issue or renewal of the Community certificate after the date indicated.

Article and paragraph
Content
Deadline and comments
Valid for craft with vessel certificate or traffic licence before

CHAPTER 3

3.03( 7)
Anchors not protruding in foresections of vessels
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2041
1.10.1999

3.04 (3), second sentence
Insulation in engine rooms
NRC, at the latest on issue or renewal of the Community certificate
1.4.2003

paragraph 3, third and fourth sentences
Openings and closing devices
NRC, at the latest on issue or renewal of the Community certificate
1.10.2003

CHAPTER 8

8.02(4)
Protection of engine parts
NRC, at the latest on issue or renewal of the Community certificate
1.4.2003

8.03(3)
Protection against overspeed
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.4.2004

8.05(9), first sentence
Sounding devices must be readable up to the maximum filling level
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.4.1999

paragraph 13
Filling level control not only for main engines but also other engines needed for safe operation of the vessel
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015
1.4.1999

CHAPTER 8a

The transitional provisions on Chapter 8a of the Rhine Vessel Inspection Regulation apply.

CHAPTER 10

10.02(2)(a)
Certification of wire ropes and other ropes
The first rope replaced on the vessel: NRC, at the latest 1.1.2008. Second and third ropes: 1.1.2013.
1.4.2003

10.03(1)
European standard
On replacement, at the latest 1.1.2010
1.4.2002

paragraph 2
Suitable for fire category A, B and C
On replacement, at the latest 1.1.2010
1.4.2002

10.03a
Permanently installed fire-fighting systems in cabins, wheelhouses and passenger areas
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035
1.4.2002

10.03b
Permanently installed fire-fighting systems in engine rooms, boiler rooms and pump rooms
(19)at the latest on issue or renewal of the Community certificate after 1.1.2035
1.4.2002

10.04
Application of the European standard to dinghies
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015
1.10.2003

10.05 (2)
Inflatable life-jackets
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010. Life jackets which have been on board on 30.9.2003 may be used until the issue or renewal of the Community certificate after 1.1.2010.
1.10.2003

CHAPTER 11

11.13
Storage of flammable liquids
NRC, at the latest on issue or renewal of the Community certificate
1.10.2002

CHAPTER 15

15.01(1)(c)
Non-application of Article 8.06 (2), second sentence
NRC, at the latest on issue or renewal of the Community certificate
1.1.2006

(d)
Non-application of Article 9.14(3), second sentence for rated voltages of over 50V
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

paragraph 2(b)
Prohibition of vaporising oil-burner stoves according to Article 13.04
NRC, at the latest on issue or renewal of the Community certificate
1.1.2006

(c)
Prohibition of solid fuel heaters according to Article 13.07
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

(e)
Prohibition of liquefied gas devices according to Chapter 14
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

15.02(2)
Number and position of bulkheads
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 5, second sentence
Margin line if no bulkhead deck
For passenger vessels laid down before 1.1.1996, the requirement applies at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 15
Minimum height of double bottoms, width of wing voids
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

15.03 (1) to (6)
Intact stability
NRC, and when the maximum number of passengers is raised, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

15.03 (7) and (8)
Damaged stability
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 9
2-compartment status
NRC
1.1.2007

paragraphs 10 to 13
Damaged stability
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

15.05(2)(a)
Number of passengers for whom the existence of an evacuation area according to Article 15.06 section 8 has been proven
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

(b)
Number of passengers that has been taken into account for the stability calculation according to Article 15.03
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

15.06 (1)
Passenger rooms on all decks forward of the level of the aft-peak bulkhead
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 2
Cupboards and rooms referred to in Article 11.13 and intended for the storage of flammable liquids
NRC, at the latest on issue or renewal of the Community certificate
1.1.2006

paragraph 3(c), first sentence
Clear height of exits
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

second sentence
Clear width of doors of passenger cabins and other small rooms
For the measurement of 0,7 m, NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045, applies
1.1.2006

15.06(3)(f), first sentence
Size of emergency exits
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

(g)
Exits intended for use by persons with reduced mobility
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 4(d)
Doors intended for use by persons with reduced mobility
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 5
Requirements for connecting corridors
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 6(b)
Escape routes to evacuation areas
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

(c)
No escape routes through engine rooms and galleys
NRC, at the latest on issue or renewal of the Community certificate
1.1.2006

(d)
No rungs, ladders or the like installed along the escape routes
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 7
Suitable safety guidance system
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 8
Requirements for muster areas
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 9(a) to (c), (e), and last sentence
Requirements for stairs and their landings in the passenger areas
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 10(a), first sentence
Railing according to European standard EN 711: 1995
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

second sentence
Height of bulwarks and railings of decks intended for use by persons with reduced mobility
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

(b), second sentence
Clear width of openings used for the embarking or disembarking of persons with reduced mobility
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 12
Gangways in accordance with European standard EN 14206: 2003
NRC, at the latest on issue or renewal of the Community certificate
1.1.2006

paragraph 13
Traffic areas and walls in traffic areas, intended for use by persons with reduced mobility
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 14, first sentence
Design of glass doors and walls in traffic areas and window panes
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 15
Requirements for superstructures or their roofs consisting completely of panoramic panes
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 16
Potable water systems according to Article 12.05
NRC, at the latest on issue or renewal of the Community certificate
1.1.2006

paragraph 17, second sentence
Requirements for toilets fitted for use by persons with reduced mobility
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 18
Ventilation system for cabins without an opening window
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

15.07
Requirements for the propulsion system
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2007

15.08(2)
Requirements for loudspeaker systems in passenger areas
For passenger vessels with LWL of less than 40 m or for not more than 75 persons the provision applies at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

paragraph 3
Requirements for the alarm system
For day-trip vessels the provision applies at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

paragraph 3(c)
Alarm system enabling the vessel's command to alert the crew and shipboard personnel
For cabin vessels the provision applies at NRC, at the latest on issue or renewal of the Community certificate
1.1.2006

paragraph 4
Bilge level alarm for each watertight compartment
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

paragraph 5
Two motor-driven bilge pumps
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

paragraph 6
Permanently installed bilge system according to Article 8.06 section 4
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015
1.1.2006

paragraph 7
Inside opening of cold-storage rooms
NRC, at the latest on issue or renewal of the Community certificate
1.1.2006

paragraph 8
Ventilation system for CO2 bar-systems in rooms below deck
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

paragraph 9
First-aid kits
NRC, at the latest on issue or renewal of the Community certificate
1.1.2006

15.09(1), first sentence
Lifebuoys
NRC, at the latest on issue or renewal of the Community certificate
1.1.2006

paragraph 2
Individual life-saving equipment
NRC, at the latest on issue or renewal of the Community certificate
1.1.2006

paragraph 3
Appropriate transfer equipment
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

15.09(4)
Individual life-saving equipment according to European standard EN 395: 1998 or EN 396: 1998 available for 100% of passengers
NRC, at the latest on issue or renewal of the Community certificate
1.1.2006

Individual life-saving equipment for children
Until the issue or renewal of the Community certificate after 1.1.2010 this equipment is considered an alternative to individual life-saving equipment.
1.1.2006

Life-saving equipment
For passenger vessels which were equipped with collective life-saving appliances according to Article 15.09 section 5 before 1.1.2005, these appliances are considered an alternative to individual life-saving equipment.For passenger vessels which were equipped with collective life-saving appliances according to Article 15.09 section 6 before 1.1.2005, these are considered an alternative to individual life-saving equipment until issue or renewal of the Community certificate after 1.1.2010.
1.1.2006

paragraph 5(b) and (c)
Adequate seating space, buoyancy of at least 750 N
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

(f)
Stable trim and appropriate grabbing devices
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

(i)
Appropriate means of evacuation from the evacuation areas onto the life rafts
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

paragraph 9
Check on life-saving equipment according to the manufacturer's instructions
NRC, at the latest on issue or renewal of the Community certificate
1.1.2006

paragraph 10
Ship's boat equipped with engine and searchlight
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

paragraph 11
Stretcher
NRC, at the latest on issue or renewal of the Community certificate
1.1.2006

Electrical Equipment

1.1.2006

15.10(2)
Article 9.16(3) also applicable to passageways and recreation rooms for passengers
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015
1.1.2006

paragraph 3
Adequate emergency lighting
Emergency lighting NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015
1.1.2006

paragraph 4
Emergency power plant
For day-trip vessels with LWL of 25 m or less, the provision applies at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015
1.1.2006

(f)
Emergency supply for searchlights according to Article 10.02(2)(i
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015
1.1.2006

(i)
Emergency supply for lifts and lifting equipment according to Article 15.06(9), second sentence
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015
1.1.2006

paragraph 6
Requirements for the emergency power plant:

1.1.2006

—Partitions according to Article 15.11 (2)
—
Partitions according to Article 15.11 (2)
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015
1.1.2006

—
Partitions according to Article 15.11 (2)

—Installation of cables
—
Installation of cables
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015
1.1.2006

—
Installation of cables

—Emergency power plant above the margin line
—
Emergency power plant above the margin line
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015
1.1.2006

—
Emergency power plant above the margin line

15.11
Fire protection

1.1.2007

paragraph 1
Suitability for fire protection of materials and components
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

15.11(2)
Design of partitions
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 3
Paints, lacquers and other surface treatment products as well as deck coverings used in rooms except engine rooms and store rooms shall be flame-retardant
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015
1.1.2006

paragraph 4
Lounge ceilings and wall claddings manufactured from non-combustible material
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 5
Furniture and fittings in muster areas manufactured from non-combustible material
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 6
Tested according to Code
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 7
Insulation materials in lounges non-combustible
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 8, (a), (b), (c), second sentence and (d)
Requirements for doors in partitions
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 9
Walls
On cabin vessels without automatic pressurised-water spraying systems, ends of walls between cabins: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

paragraph 10
Partitions
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 12, second sentence
Stairs made of steel or another equivalent non-combustible material
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 13
Encapsulation of internal stairs by walls according to paragraph 2
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 14
Ventilation systems and air supply systems
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 15
Ventilation systems in galleys and stoves with extractors
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 16
Control centres, stairwells, muster areas and smoke extraction systems
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 17
Fire alarm system
For day-trip vessels: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

15.12(1)
Portable extinguishers
Fire extinguisher and fire blanket in galleys, hairdressing salons and perfumeries: NRC, at the latest on issue or renewal of the Community certificate
1.1.2006

paragraph 2
Hydrant system
2nd fire extinguishing pump: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

paragraph 4
Hydrant valves
NRC, at the latest on issue or renewal of the Community certificate
1.1.2006

paragraph 5
Axially connected reel
NRC, at the latest on issue or renewal of the Community certificate
1.1.2006

paragraph 6
Materials, protection against failure
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

paragraph 7
Avoidance of the possibility of freezing of pipes and hydrants
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

paragraph 8(b)
Independent operation of fire extinguishing pumps
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

(d)
Installation of fire extinguishing pumps
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

paragraph 9
Fire extinguishing system in engine rooms
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

15.12( 9)
Fire extinguishing system in engine rooms made from steel or with equivalent properties
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045. The transitional period does not apply to passenger vessels which have been laid down after 31.12.1995, the hull of which is made of wood, aluminium or plastic and the engine rooms of which are not made of a material according to Article 3.04(3) and (4).
1.1.2006

15.13
Safety organisation
For day-trip vessels: NRC, at the latest on issue or renewal of the Community certificate
1.1.2006

15.14 (1)
Waste water collection and disposal facilities
For cabin vessels with 50 or fewer berths, and for day-trip vessels: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 2
Requirements for waste water collection tanks
For cabin vessels with 50 or fewer berths, and for day-trip vessels with 50 or fewer passengers: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

15.15
Derogations for certain passenger vessels

1.1.2006

paragraph 1
Damage stability
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045
1.1.2006

paragraph 4
(Left void)

paragraph 5
Equipped with a ship's boat, a platform or an equivalent installation
For passenger vessels licensed for a maximum of 250 passengers or 50 berths: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

paragraph 6
Equipped with a ship's boat, a platform or an equivalent installation
For passenger vessels licensed for a maximum of 250 passengers or 50 berths: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

15.15(9)(a)
Alarm systems for liquefied gas installations
NRC, at the latest on renewal of the attestation according to Article 14.15
1.1.2006

(b)
Collective life-saving appliances according to Article 15.09 section 5
NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
1.1.2006

—
Partitions according to Article 15.11 (2)

—
Installation of cables

—
Emergency power plant above the margin line

(a)
to craft for which a Community certificate was issued for the first time before 30 December 2008; and

(b)
to craft which obtained another traffic licence before 30 December 2008,

—
‘NRC’: The provision does not apply to craft which are already operating, unless the parts concerned are replaced or converted, i.e. the provision applies only toNewly-built craft and to theReplacement orConversion of the parts or areas concerned. If existing parts are replaced by replacement parts using the same technology and of the same type, this does not constitute replacement (‘R’) within the meaning of the transitional provisions.

—
‘Issue or renewal of the Community certificate’: The provision must be complied with by the time of the issue or next renewal of the Community certificate after 30 December 2008. If the certificate expires between 30 December 2008 and the day before 30 December 2009, that requirement is, however, only mandatory from 30 December 2009.

Article and paragraph
Content
Deadline and comments

CHAPTER 3

3.03(1)(a)
Location of collision bulkhead
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

3.03(2)
Accommodations
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

3.03(2)
Safety equipment
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

3.03(4)
Gastight separation
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

3.03(5), second paragraph
Monitoring of doors in the aft-peak bulkhead

3.03(7)
Anchors not protruding in foresections of vessels
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

3.04(3), second sentence
Insulation in engine rooms
NRC, at the latest on issue or renewal of the Community certificate

3.04(3), third and fourth sentences
Openings and locking devices
NRC, at the latest on issue or renewal of the Community certificate

3.04(6)
Exits from spaces classified as engine rooms as a result of this Directive
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

CHAPTER 4

4.04
Draught marks
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

CHAPTER 5

5.06(1), first sentence
Minimum speed
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

CHAPTER 6

6.01(1)
Manoeuvrability required by Chapter 5
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraph 3
Permanent lists and ambient temperatures
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

6.01(7)
Design of rudder stocks
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

6.02(2)
Placing in service of second drive unit by means of a single operation
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 3
Manoeuvrability required by Chapter 5 ensured by second drive unit/manual service
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

6.03(1)
Connection of other power consumers to the hydraulic steering apparatus drive unit
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 2
Separate hydraulic reservoirs
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

6.05(1)
Wheel of manual drive not driven by powered drive unit
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

6.06(1)
Two independent actuation systems
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

6.07(2)(a)
Monitoring devices for level of hydraulic reservoir and service pressure
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

(e)
Monitoring of buffer devices
NRC, at the latest on issue or renewal of the Community certificate

6.08(1)
Requirements for electronic equipment according to Article 9.20
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

CHAPTER 7

7.02(2) to (7)
Unobstructed view from the wheelhouse,except the following sections:
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

7.02(3), second paragraph
Unobstructed view in the sightline of the helmsman
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

paragraph 5
Minimal light transmission of glazing
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

7.03(7)
Shutdown of alarms
NRC, at the latest on issue or renewal of the Community certificate

paragraph 8
Automatic switch to alternative power supply
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

7.04(1)
Control of main engines and steering devices
NRC, at the latest on issue or renewal of the Community certificate

7.04(2)
Control of main engines
If wheelhouses have not been designed for radar navigation by one person: NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049 if the direction of motion can be achieved directly; at the latest on issue or renewal of the Community certificate after 30 December 2024 for other engines

7.09
Alarm system
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

7.12 first paragraph
Retractable wheelhouses
NRC, at the latest on issue or renewal of the Community certificate. Without automatic retraction: NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

second and third paragraphs

NRC, at the latest on issue or renewal of the Community certificate

CHAPTER 8

8.01(3)
Only internal-combustion engines burning fuels having a flashpoint of more than 55 °C
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

8.02(1)
Securing of engines against unintentional starting
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 4
Protection of machinery parts
NRC, at the latest on issue or renewal of the Community certificate

8.03(2)
Monitoring devices
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 3
Automatic protection against overspeed
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 5
Design of shaft bushings
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

8.05(1)
Steel tanks for liquid fuels
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

8.05(2)
Automatic closing of tank valves
NRC, at the latest on issue or renewal of the Community certificate

paragraph 3
No fuel tanks forward of the collision bulkhead
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 4
No fuel tanks and their fittings above engines or exhaust pipes
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024. Until then, appropriate devices must ensure the safe evacuation of fuels

paragraph 6 third to fifth sentences
Installation and measurements of breather pipes and connection pipes
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 7
Shutoff device to be operated from the deck
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

paragraph 9, first sentence
Capacity-gauging devices to be legible up to maximum filling level
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 13
Filling level control not only for main engines but also other engines needed for safe operation of the vessel
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

8.06
Storage of lubricating oil, pipes and accessories
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

8.07
Storage of oils used in power transmission systems, control and activating systems and heating systems, pipes and accessories
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

8.08( 8)
Simple closing device not sufficient for connection of ballast spaces to drainage pipes for holds capable of carrying ballast
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

8.08( 9)
Gauging devices in hold bilges
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

8.09(2)
Installations for the collection of oily water and used oil stores
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

8.10(3)
Emission limit of 65 dB(A) for stationary craft
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

CHAPTER 9

9.01(1), second sentence
Relevant documents to be submitted to the inspection body
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

9.01(2), second indent
Switching diagrams for main, emergency and distribution switchboard to be kept on board
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 3
Ambient inside and deck temperatures
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

9.02(1) to (3)
Electricity supply systems
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

9.03
Protection against physical contact, intrusion of solid objects and the ingress of water
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

9.05(4)
Cross-section of the earthing conductors
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

9.11(4)
Effective ventilation when accumulators are installed in a closed compartment, cabinet or chest
NRC, at the latest on issue or renewal of the Community certificate

9.12
Switch-gear installations
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

9.12 (3)(b)
Earth detection device capable of giving both visual and audible alarm
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

9.13
Emergency circuit breakers
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

9.14
Installation fittings
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

9.14(3), second sentence
Prohibition of single-pole switches in laundries, bathrooms, washrooms and other rooms with wet facilities
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

9.15(2)
Minimum cross-section of 1,5 mm2per cable
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 10
Cables connected to retractable wheelhouses
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

9.16(3), second sentence
Second circuit
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

9.19
Alarm and safety systems for mechanical equipment
NRC, at the latest on issue or renewal of the Community certificate 30 December 2029

9.20
Electronic equipment
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

9.21
Electromagnetic compatibility
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

CHAPTER 10

10.01
Anchor equipment
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

10.02 (2)(a)
Certificate for mooring and other cables
First cable to be replaced on the vessel: NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024Second and third cables: 30 December 2029

10.03(1)
European standard
At replacement, at the latest 30 December 2024

paragraph 2
Suitability for Class A, B and C fires
At replacement, at the latest 30 December 2024

paragraph 4
Relation of CO2content and size of room
At replacement, at the latest 30 December 2024

10.03a
Permanently installed fire-fighting systems in accommodation spaces, wheelhouses and passenger spaces
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

10.03b
Permanently installed fire-fighting systems in engine rooms, boiler rooms and pump rooms
CO2fire-fighting systems permanently installed before 1 October 1985 may remain in use until the issue or renewal of the Community certificate after 30 December 2049 if they comply with the requirements of Article 13.03 of Annex II of Directive 82/714/EEC

10.04
Application of the European standard to dinghies
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

10.05(2)
Inflatable life jackets
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024Life jackets which are on board on the day before 30 December 2008 can be used until renewal of the Community certificate after 30 December 2024

CHAPTER 11

11.02(4)
Equipment of outer edges of decks, side decks and work stations
NRC, [at the latest on issue or renewal of the Community certificate after 30 December 2029

11.04
Side decks
First issue or renewal of the Community certificate(20)after 30 December 2049 where width exceeds 7,30 m

11.05(1)
Access to workplaces
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraphs 2 and 3
Doors and accesses, exits and passageways where there is more than a 0,50 m difference in floor level
NRC, at the latest on issue or renewal of the Community certificate

paragraph 4
Stairs in working spaces which are manned continuously
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

11.06(2)
Exits and emergency exits
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

11.07(1), second sentence
Ladders, steps and similar devices
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraphs 2 and 3

NRC, at the latest on issue or renewal of the Community certificate

11.10
Hatch covers
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

11.11
Winches
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

11.12(2) to (6) and (8) to (10)
Cranes: manufacturer's plate, maximum permissible loadings, protection devices, calculation test, inspection by experts, certificates on board
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

11.13
Storing of flammable liquids
NRC, at the latest on issue or renewal of the Community certificate

CHAPTER 12

12.01(1)
Accommodation for the persons lodging habitually on board
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

12.02(3)
Situation of floors
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraph 4
Living and sleeping quarters
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

12.02(5)
Noise and vibration in accommodations
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

paragraph 6
Headroom in accommodations
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraph 8
Free floor area of communal living quarters
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraph 9
Cubic capacity of rooms
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraph 10
Volume of airspace per person
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraph 11
Size of doors
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraph 12(a) and (b)
Situation of stairs
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraph 13
Pipes carrying dangerous gases or liquids
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

12.03
Sanitary installations
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

12.04
Galleys
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

12.05
Potable water
NRC, at the latest on issue or renewal of the Community certificate

12.06
Heating and ventilation
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

12.07 section 1, second sentence
Other accommodation installations
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

CHAPTER 15

Passenger vessels
see Article 8 of this Directive

CHAPTER 15a

Passenger sailing vessels
see Article 8 of this Directive

CHAPTER 16

16.01(2)
Special winches or equivalent coupling devices
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraph 3, last sentence
Requirements for drive units
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

CHAPTER 17

Floating equipment
see Article 8 of this Directive

CHAPTER 21

Recreational craft
see Article 8 of this Directive

CHAPTER 22b

22b.03
Second independent steering apparatus drive unit
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

—
‘NRC’: The provision does not apply to craft which are already operating, unless the parts concerned are replaced or converted, i.e. the provision only applies toNewly-built craft and to theReplacement orConversion of the parts or areas concerned. If existing parts are replaced by replacement parts using the same technology and of the same type, this does not constitute replacement (‘R’) within the meaning of these transitional provisions.

—
‘Issue or renewal of the Community certificate’: The provision must be complied with by the time of the first issue or next renewal of the Community certificate after 30 December 2008. If the certificate expires between 30 December 2008 and the day before 30 December 2009, that requirement is, however, only mandatory from 30 December 2009.

Article and paragraph
Content
Deadline and comments

CHAPTER 3

3.03(1)
Watertight collision bulkheads
NRC

3.03(2)
Accommodations, safety installations
NRC

3.03(5)
Openings in watertight bulkheads
NRC

3.04(2)
Surfaces of bunkers
NRC

3.04(7)
Maximum permissible sound pressure level in engine rooms
NRC

CHAPTER 4

4.01
Safety clearance
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2019

4.02
Freeboard
NRC

CHAPTER 6

6.01(3)
Requirements of steering system
NRC

CHAPTER 7

7.01(2)
Maximum permissible sound pressure level in wheelhouse
NRC

7.05(2)
Monitoring of navigation lights
NRC

7.12
Retractable wheelhouses
NRC

CHAPTER 8

8.01(3)
Prohibition of certain liquid fuels
NRC

8.04
Engine exhaust system
NRC, at the latest on issue or renewal of the Community certificate

8.05(13)
Alarm device for level of fuel filling
NRC

8.08(2)
Equipment with bilge pumps
NRC

8.08(3) and (4)
Diameter and minimum pumping capacity of bilge pumps
NRC

8.08(5)
Self-priming bilge pumps
NRC

8.08(6)
Equipment with strainers
NRC

8.08(7)
Automatically closable fitting for aft peak
NRC

8.10(2)
Noise emitted by craft
NRC

CHAPTER 9

9.01(2)
Certificates for electrical equipment
NRC

9.01(3)
Installation of electrical equipment
NRC

9.06
Maximum permissible voltages
NRC

9.10
Generators and motors
NRC

9.11(2)
Accumulators
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

9.12(2)
Switches, protective devices
NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

9.14(3)
Simultaneous switching
NRC

9.15
Cables
NRC

9.16(3)
Lighting in engine rooms
NRC

9.17(1)
Switchboards for navigation lights
NRC

9.17(2)
Power supply for navigation lights
NRC

CHAPTER 10

10.01(9)
Anchor windlasses
NRC

10.04(1)
Dinghies according to standard
NRC

10.05(1)
Lifebuoys according to standard
NRC

10.05(2)
Life jackets according to standard
NRC

CHAPTER 11

11.11(2)
Safety of winches
NRC

CHAPTER 12

12.02(13)
Pipes carrying dangerous gases or liquids
NRC

(a)
European standards EN 50014: 1997; 50015: 1998; 50016: 2002; 50017: 1998; 50018: 2000; 50019: 2000 and 50020: 2002;or

(b)
IEC publication 60079 as of 1 October 2003.

1.
Permanent CO2fire-fighting systems installed before 1 October 1980 may remain in use until the issue or renewal of the Community certificate after 1 January 2035, if they comply with the requirements of Article 7.03(5) of the Rhine Vessel Inspection Regulation in force on 1 April 1976.

2.
Permanent CO2fire-fighting systems installed between 1 April 1992 and 31 December 1994 may remain in use until the issue or renewal of the Community certificate after 1 January 2035, if they comply with the requirements of Article 7.03(5) of the Rhine Vessel Inspection Regulation in force on 31 December 1994.

3.
Recommendations of the CCNR issued between 1 April 1992 and 31 December 1994 with regard to Article 7.03(5) of the Rhine Vessel Inspection Regulation in force on 31 December 1994 remain valid until the issue or renewal of the Community certificate after 1 January 2035.

4.
Article 10.03b(2)(a) is only applicable until the issue or renewal of the Community certificate after 1 January 2035 if those installations have been installed in vessels laid down after 1 October 1992.

(a)
Article 11.04 must be complied with, if the clear width of the side deck before the conversion to a height of 0,90 m, or if the clear width above that height is to be reduced,

(b)
the clear width of the side deck before the conversion to a height of 0,90 m, or the clear width above that height must not be lower than the measurements indicated in Article 11.04.

1.
Permanent CO2fire-fighting systems installed between 1 January 1995 and 31 March 2003 remain authorised until the issue or renewal of the Community certificate after 1 January 2035 if they comply with Article 10.03(5), of the Rhine Vessel Inspection Regulation as applicable on 31 March 2002.

2.
Recommendations of the Central Commission for Navigation on the Rhine issued between 1 January 1995 and 31 March 2002 regarding Article 10.03(5), of the Rhine Vessel Inspection Regulation as applicable on 31 March 2002 remain valid until the issue or renewal of the Community certificate after 1 January 2035.

3.
Article 10.05(2)(a), is applicable until the issue or renewal of the Community certificate after 1 January 2035 only if those systems have been installed in vessels laid down after 1 October 1992.

(a)
Article 11.04 must be complied with if the clear width of the side deck before the conversion to a height of 0,90 m, or the clear width above that height is to be reduced,

(b)
the clear width of the side deck before the conversion, to a height of 0,90 m, or the clear width above that height must not be lower than the measurements indicated in Article 11.04.

Figure 1No entry for unauthorised persons

Colour: red/white/black

Figure 2Fire, naked flame and smoking prohibited

Colour: red/white/black

Figure 3Fire extinguisher

Colour: red/white

Figure 4General danger warning

Colour: black/yellow

Figure 5Extinguisher hose

Colour: red/white

Figure 6Fire-fighting installation

Colour: red/white

Figure 7Wear acoustic protection device

Colour: blue/white

Figure 8First-aid kit

Colour: green/white

1
:
Requirements relating to the capacity for evasive action and turning

2
:
Requirements concerning prescribed minimum speed, stopping capacity and capacity for going astern

3
:
Requirements for coupling systems and coupling devices for craft pushing or being pushed in a rigid assembly

4
:
Noise measurements

5
:
Special reduced mass anchors

6
:
Strength of watertight side-scuttles

7
:
Requirements for automatic pressurised-water spraying systems

8
:
Issue of the ship certificate

9
:
Fuel tanks on floating craft

10
:
Minimum hull thickness for barges

11
:
Used-oil collection facilities

12
:
Vessel movement under its own power

13
:
Appropriate fire alarm system

14
:
Proof of buoyancy, trim and stability of the separate parts of a vessel

15
:
Equipment for vessels which are to be operated with a minimum crew

16
:
Electric cables

17
:
Wheelhouse visibility

1.
Definitions—Necessary for understanding the additional requirements
—
Necessary for understanding the additional requirements

—
Necessary for understanding the additional requirements

—
Necessary for understanding the additional requirements

2.
Stability—Structure reinforcement—Certificate/attestation by an approved Classification Society
—
Structure reinforcement
—
Certificate/attestation by an approved Classification Society

—
Structure reinforcement

—
Certificate/attestation by an approved Classification Society

—
Structure reinforcement

—
Certificate/attestation by an approved Classification Society

3.
Safety clearance and freeboard—Freeboard—Safety clearance
—
Freeboard
—
Safety clearance

—
Freeboard

—
Safety clearance

—
Freeboard

—
Safety clearance

4.
Watertightness of hull openings and superstructures—Superstructures—Doors—Windows and skylights—Hold hatches—Other openings (ventilation pipes, exhaust pipes, etc.)
—
Superstructures
—
Doors
—
Windows and skylights
—
Hold hatches
—
Other openings (ventilation pipes, exhaust pipes, etc.)

—
Superstructures

—
Doors

—
Windows and skylights

—
Hold hatches

—
Other openings (ventilation pipes, exhaust pipes, etc.)

—
Superstructures

—
Doors

—
Windows and skylights

—
Hold hatches

—
Other openings (ventilation pipes, exhaust pipes, etc.)

5.
Equipment—Anchors and anchor chains—Navigation lights—Sound signals—Compass—Radar—Transmitting and receiving installations—Life-saving equipment—Availability of nautical charts
—
Anchors and anchor chains
—
Navigation lights
—
Sound signals
—
Compass
—
Radar
—
Transmitting and receiving installations
—
Life-saving equipment
—
Availability of nautical charts

—
Anchors and anchor chains

—
Navigation lights

—
Sound signals

—
Compass

—
Radar

—
Transmitting and receiving installations

—
Life-saving equipment

—
Availability of nautical charts

—
Anchors and anchor chains

—
Navigation lights

—
Sound signals

—
Compass

—
Radar

—
Transmitting and receiving installations

—
Life-saving equipment

—
Availability of nautical charts

6.
Additional provisions for passenger vessels—Stability (wind strength, criteria)—Life-saving equipment—Freeboard—Safety clearance—Wheelhouse visibility
—
Stability (wind strength, criteria)
—
Life-saving equipment
—
Freeboard
—
Safety clearance
—
Wheelhouse visibility

—
Stability (wind strength, criteria)

—
Life-saving equipment

—
Freeboard

—
Safety clearance

—
Wheelhouse visibility

—
Stability (wind strength, criteria)

—
Life-saving equipment

—
Freeboard

—
Safety clearance

—
Wheelhouse visibility

7.
Convoys and container transport—Pusher connection craft-lighter—Stability of craft or lighters carrying containers
—
Pusher connection craft-lighter
—
Stability of craft or lighters carrying containers

—
Pusher connection craft-lighter

—
Stability of craft or lighters carrying containers

—
Pusher connection craft-lighter

—
Stability of craft or lighters carrying containers

Zone 3—Anchor equipment, including length of anchor chains—(Forward) speed—Collective life-saving appliances—Two-compartment status—Wheelhouse visibility
—
Anchor equipment, including length of anchor chains
—
(Forward) speed
—
Collective life-saving appliances
—
Two-compartment status
—
Wheelhouse visibility

—
Anchor equipment, including length of anchor chains

—
(Forward) speed

—
Collective life-saving appliances

—
Two-compartment status

—
Wheelhouse visibility

—
Anchor equipment, including length of anchor chains

—
(Forward) speed

—
Collective life-saving appliances

—
Two-compartment status

—
Wheelhouse visibility

Zone 4—Anchor equipment, including length of anchor chains—(Forward) speed—Life-saving appliances—Two-compartment status—Wheelhouse visibility—Second independent propulsion system
—
Anchor equipment, including length of anchor chains
—
(Forward) speed
—
Life-saving appliances
—
Two-compartment status
—
Wheelhouse visibility
—
Second independent propulsion system

—
Anchor equipment, including length of anchor chains

—
(Forward) speed

—
Life-saving appliances

—
Two-compartment status

—
Wheelhouse visibility

—
Second independent propulsion system

—
Anchor equipment, including length of anchor chains

—
(Forward) speed

—
Life-saving appliances

—
Two-compartment status

—
Wheelhouse visibility

—
Second independent propulsion system

Part I:
Criteria for the approval of classification societies

Part II:
Procedure for the approval of classification societies

Part III:
List of approved classification societies

1.
the classification society shall be able to document extensive experience in assessing the design and construction of inland waterway vessels, including vessels for the carriage of dangerous goods. The classification society shall have comprehensive rules and regulations for the design, construction and periodic inspection of inland waterway vessels, including vessels for the carriage of dangerous goods, which shall be published at least in Dutch, English, French or German and shall be continuously updated and improved through research and development programmes. The rules and regulations must not conflict with the provisions of Community law or with international agreements in force;

2.
the classification society shall publish its register of vessels annually;

3.
the classification society shall not be controlled by shipowners or shipbuilders or by others engaged commercially in the design, manufacture, fitting-out, repair, operation or insurance of ships. The classification society shall not be dependent on a single commercial enterprise for its revenue;

4.
the headquarters of the classification society or a branch authorised to give a ruling and to act in all areas incumbent on it under the regulations governing inland waterway transport shall be located in one of the Member States;

5.
the classification society and its experts shall have a good reputation in inland waterway transport; the experts shall be able to provide proof of their professional abilities. They shall act on the responsibility of the classification society;

6.
the classification society shall have a significant technical, managerial, support, inspection and research staff, in proportion to the tasks and the vessels classified and catering also for developing capability and updating the regulations. It shall have inspectors in at least one Member State;

7.
the classification society shall be governed by a code of ethics;

8.
the classification society shall be managed and administered in such a way as to ensure the confidentiality of information required by a Member State;

9.
the classification society shall be prepared to provide relevant information to a Member State;

10.
the classification society's management shall have defined and documented its policy and objectives for, and commitment to, quality and ensured that this policy is understood, implemented and maintained at all levels in the classification society;

11.
the classification society shall have prepared and implemented and shall maintain an effective internal quality system based on the relevant parts of internationally recognised quality standards and complying with the EN 45004 (inspection bodies) and EN 29001 standards, as interpreted by the IACS Quality System Certification Scheme Requirements. The quality system must be certified by an independent body of auditors recognised by the administration of the State in which the classification society has its headquarters or branch, as provided for in subparagraph 4, and which,inter alia, ensures that:(a)the classification society's rules and regulations are established and maintained in a systematic manner;(b)the classification society's rules and regulations are complied with;(c)the requirements of the statutory work for which the classification society is authorised are satisfied;(d)the responsibilities, powers and interrelation of personnel whose work affects the quality of the classification society's services are defined and documented;(e)all work is carried out under controlled conditions;(f)a supervisory system is in place which monitors the actions and work carried out by surveyors and technical and administrative staff employed directly by the classification society;(g)the requirements of major statutory work for which the classification society is authorised are only carried out or directly supervised by its exclusive surveyors or by exclusive surveyors of other approved classification societies;(h)a system for qualification of surveyors and continuous updating of their knowledge is implemented;(i)records are maintained, demonstrating achievement of the required standards in the items covered by the services performed, as well as the effective operation of the quality system; and(j)a comprehensive system of planned and documented internal audits of quality-related activities exists in all locations.
(a)
the classification society's rules and regulations are established and maintained in a systematic manner;
(b)
the classification society's rules and regulations are complied with;
(c)
the requirements of the statutory work for which the classification society is authorised are satisfied;
(d)
the responsibilities, powers and interrelation of personnel whose work affects the quality of the classification society's services are defined and documented;
(e)
all work is carried out under controlled conditions;
(f)
a supervisory system is in place which monitors the actions and work carried out by surveyors and technical and administrative staff employed directly by the classification society;
(g)
the requirements of major statutory work for which the classification society is authorised are only carried out or directly supervised by its exclusive surveyors or by exclusive surveyors of other approved classification societies;
(h)
a system for qualification of surveyors and continuous updating of their knowledge is implemented;
(i)
records are maintained, demonstrating achievement of the required standards in the items covered by the services performed, as well as the effective operation of the quality system; and
(j)
a comprehensive system of planned and documented internal audits of quality-related activities exists in all locations.

(a)
the classification society's rules and regulations are established and maintained in a systematic manner;

(b)
the classification society's rules and regulations are complied with;

(c)
the requirements of the statutory work for which the classification society is authorised are satisfied;

(d)
the responsibilities, powers and interrelation of personnel whose work affects the quality of the classification society's services are defined and documented;

(e)
all work is carried out under controlled conditions;

(f)
a supervisory system is in place which monitors the actions and work carried out by surveyors and technical and administrative staff employed directly by the classification society;

(g)
the requirements of major statutory work for which the classification society is authorised are only carried out or directly supervised by its exclusive surveyors or by exclusive surveyors of other approved classification societies;

(h)
a system for qualification of surveyors and continuous updating of their knowledge is implemented;

(i)
records are maintained, demonstrating achievement of the required standards in the items covered by the services performed, as well as the effective operation of the quality system; and

(j)
a comprehensive system of planned and documented internal audits of quality-related activities exists in all locations.

(a)
the classification society's rules and regulations are established and maintained in a systematic manner;

(b)
the classification society's rules and regulations are complied with;

(c)
the requirements of the statutory work for which the classification society is authorised are satisfied;

(d)
the responsibilities, powers and interrelation of personnel whose work affects the quality of the classification society's services are defined and documented;

(e)
all work is carried out under controlled conditions;

(f)
a supervisory system is in place which monitors the actions and work carried out by surveyors and technical and administrative staff employed directly by the classification society;

(g)
the requirements of major statutory work for which the classification society is authorised are only carried out or directly supervised by its exclusive surveyors or by exclusive surveyors of other approved classification societies;

(h)
a system for qualification of surveyors and continuous updating of their knowledge is implemented;

(i)
records are maintained, demonstrating achievement of the required standards in the items covered by the services performed, as well as the effective operation of the quality system; and

(j)
a comprehensive system of planned and documented internal audits of quality-related activities exists in all locations.

12.
the quality system must be certified by an independent body of auditors recognised by the administration of the State in which the classification society has its headquarters or branch, as provided for in paragraph 4;

13.
the classification society shall undertake to bring its requirements into line with the appropriate European Union directives and to provide the Committee with all relevant information in good time;

14.
the classification society shall undertake periodically to consult with the classification societies already approved in order to guarantee the equivalence of their technical standards and of implementation thereof, and should allow participation in the development of its rules and regulations by representatives of a Member State and other parties concerned.

1.
an application for approval shall be submitted to the Commission by the representatives of the State in which the classification society has its headquarters or a branch authorised to give a ruling and act in all areas incumbent on it under the regulations governing inland waterway vessels. Furthermore, the representatives of this State shall send all information and documentation needed to check that the criteria for approval are met;

2.
any Committee member can demand a hearing with the classification society concerned or that further information or documentation be provided;

3.
approval shall be withdrawn in a similar way. Any Committee member can ask for approval to be withdrawn. The representatives of the State asking for the withdrawal shall submit the information and documentation supporting their application;

4.
when making its decisions, the Commission shall take account of decisions made by the Central Commission for Navigation on the Rhine regarding approval of the classification society concerned. Before approving a classification society which has not been approved by the Central Commission for Navigation on the Rhine, the Commission shall consult the Secretariat of the Central Commission;

5.
following each decision on approval of a classification society or the withdrawal of approval, the list of approved societies shall be amended;

6.
the Commission shall inform the classification societies concerned of the Commission's decisions.

1.
Bureau Veritas,

2.
Germanischer Lloyd,

3.
Lloyd's Register of Shipping.

Part I:
Requirements concerning the colour and intensity of lights and the approval of signal lanterns for inland waterway vessels

Part II:
Requirements concerning the conditions for testing and approval of signal lanterns for inland waterway vessels

Part III:
Minimum requirements and test conditions for radar installations used for navigation in inland waterway vessels

Part IV:
Minimum requirements and test conditions for rate-of-turn indicators used in inland waterway vessels

Part V:
Requirements for installation and performance tests for radar equipment and rate-of-turn indicators used in inland waterway vessels

Part VI:
Model list of test institutes, approved equipment and approved installation firms

Chapter 1
Definitions

Article 1.01.
Signal lanterns

1.02.
Signal lights

1.03.
Light sources

1.04.
Optic

1.05.
Filter

1.06.
Relation between IO, IBand t

Chapter 2
Requirements for signal lights

Article 2.01.
Colour of signal lights

2.02.
Luminous intensity and range of signal lights

2.03.
Signal light dispersion

Chapter 3
Requirements for signal lanterns

Article 3.01.
Technical requirements

Chapter 4
Tests, approval and markings

Article 4.01.
Type tests

4.02.
Test procedure

4.03.
Approval certificate

4.04.
Spot checks

4.05.
Markings

Appendix
Model approval certificate for signal lanterns for inland waterway vessels

1.
‘Signal lights’ means the light signals emitted by signal lanterns.

2.
‘Masthead light’ means a white light, visible throughout a horizontal arc of 225° and projecting a uniform uninterrupted beam over 112° 30' on each side, i.e. from the bow to 22° 30' abaft the beam on each side.

3.
‘Side lights’ means a green light to starboard and a red light to port; each of these lights shall be visible throughout a horizontal arc of 112° 30' and project a uniform uninterrupted beam, i.e. from the bow to 22° 30' abaft the beam.

4.
‘Stern light’ means a white light, visible throughout a horizontal arc of 135° and projecting a uniform uninterrupted beam over a sector of 67° 30' along each side from the stern.

5.
‘Yellow stern light’ means a yellow light, visible throughout a horizontal arc of 135° and projecting a uniform uninterrupted beam over a sector of 67° 30' along each side from the stern.

6.
‘Light visible from all directions’ means a light visible throughout a horizontal arc of 360° and projecting a uniform uninterrupted beam.

7.
(a)‘Scintillating light’ means a light flashing at a rate of 40 to 60 light periods per minute.(b)‘Rapidly scintillating light’ means a light flashing at a rate of 100 to 120 light periods per minute.A scintillating light is a series of regular light periods per unit time.
(a)
‘Scintillating light’ means a light flashing at a rate of 40 to 60 light periods per minute.
(b)
‘Rapidly scintillating light’ means a light flashing at a rate of 100 to 120 light periods per minute.

(a)
‘Scintillating light’ means a light flashing at a rate of 40 to 60 light periods per minute.

(b)
‘Rapidly scintillating light’ means a light flashing at a rate of 100 to 120 light periods per minute.

(a)
‘Scintillating light’ means a light flashing at a rate of 40 to 60 light periods per minute.

(b)
‘Rapidly scintillating light’ means a light flashing at a rate of 100 to 120 light periods per minute.

8.
Signal lights are classified according to their luminous intensity as:—ordinary lights,—bright lights,—strong lights.
—
ordinary lights,
—
bright lights,
—
strong lights.

—
ordinary lights,

—
bright lights,

—
strong lights.

—
ordinary lights,

—
bright lights,

—
strong lights.

1.
‘Optic’ means a device comprising refracting, reflecting, or refracting and reflecting components, including their holders. The function of these components is to direct the rays from a light source in new specific directions.

2.
‘Coloured optic’ means an optic which modifies the colour and intensity of the light transmitted.

3.
‘Neutral optic’ means an optic which modifies the intensity of the light transmitted.

1.
‘Coloured filter’ means a selective filter which modifies the colour and intensity of the light transmitted.

2.
‘Neutral filter’ means a non-selective component which modifies the intensity of the light transmitted.

IO
means the photometric luminous intensity in candelas (cd) measured at normal voltage for electric lights.

IB
means the operational luminous intensity in candelas (cd).

t
means the range in kilometres (km).

IB= 0,75 · IO

IB= 0,2 · t2· q-t

—
white,

—
red,

—
green,

—
yellow,

—
blue.

Colour of signal light
Coordinates of the intersecting points

White
x
0,310
0,443
0,500
0,500
0,453
0,310

y
0,283
0,382
0,382
0,440
0,440
0,348

Red
x
0,690
0,710
0,680
0,660

y
0,290
0,290
0,320
0,320

Green
x
0,009
0,284
0,207
0,013

y
0,720
0,520
0,397
0,494

Yellow
x
0,612
0,618
0,575
0,575

y
0,382
0,382
0,425
0,406

Blue
x
0,136
0,218
0,185
0,102

y
0,040
0,142
0,175
0,105

where
2 930 K corresponds to the light of a vacuum filament lamp2 856 K corresponds to the light of a gas-filled filament lamp

Nature of the signal lights
Colour of signal light

White
Green/red
Yellow
Blue

min.
max.
min.
max.
min.
max.
min.
max.

ordinary
IO
2.7
10.0
1.2
4.7
1.1
3.2
0.9
2.7

IB
2.0
7.5
0.9
3.5
0.8
2.4
0.7
2.0

t
2.3
3.7
1.7
2.8
1.6
2.5
1.5
2.3

bright
IO
12.0
33.0
6.7
27.0
4.8
20.0
6.7
27.0

IB
9.0
25.0
5.0
20.0
3.6
15.0
5.0
20.0

t
3.9
5.3
3.2
5.0
2.9
4.6
3.2
5.0

strong
IO
47.0
133.0
–
–
47.0
133.0
–
–

IB
35.0
100.0
–
–
35.0
100.0
–
–

t
5.9
8.0
–
–
5.9
8.0
–
–

1.1.
The luminous intensities indicated in Article 2.02 shall apply to all directions of the horizontal plane passing through the focus of the optic or the luminous centre of gravity of the correctly adjusted light source of a vertically positioned signal lantern.

1.2.
For the masthead lights, stern lights and side lights, the luminous intensities prescribed shall be maintained throughout the horizontal arc within the sector prescribed at least up to within 5° of the limits.As from 5° within the sector prescribed up to the limit, the luminous intensity may decrease by 50 %; it shall subsequently decrease gradually in such a way that, as from 5° beyond the limits of the sector, only a negligible amount of light remains.

1.3.
The side lights shall have the prescribed luminous intensity in the direction parallel to the axis of the vessel forward. The intensities shall decrease practically to zero between 1° and 3° beyond the limits of the prescribed sector.

1.4.
For bi-coloured or tri-coloured lanterns, the dispersion of the luminous intensity shall be uniform so that 3° on either side of the prescribed sector limits, the maximum permitted intensity is not exceeded and the minimum prescribed intensity is reached.

1.5.
The horizontal dispersion of the luminous intensity of the lanterns shall be uniform throughout the sector, so that the minimum and maximum values observed for the photometric luminous intensity do not differ by more than a factor of 1,5.

—
shall be authorised to affix the markings referred to in Article 4.05 to the various parts;

—
may undertake manufacture only in conformity with the plans approved by the testing authority and according to the technique used for the type-tested lanterns;

—
may modify the approved plans and lantern models only with the approval of the testing authority. The latter shall also decide whether the approval certificate issued only requires additions to be made to it or whether a new application for approval is needed.

e. X. YY. nnn

1
=
Germany

2
=
France

3
=
Italy

4
=
Netherlands

5
=
Sweden

6
=
Belgium

7
=
Hungary

8
=
Czech Republic

9
=
Spain

11
=
United Kingdom

12
=
Austria

13
=
Luxembourg

17
=
Finland

18
=
Denmark

20
=
Poland

21
=
Portugal

23
=
Greece

24
=
Ireland

26
=
Slovenia

27
=
Slovakia

29
=
Estonia

32
=
Latvia

36
=
Lithuania

49
=
Cyprus

50
=
Malta

Chapter 1
General provisions

Article 1.01
Standard voltages

1.02
Operating requirements

1.03
Mounting

1.04
Photometric requirements

1.05
Components

1.06
Maintenance

1.07
Safety requirements

1.08
Accessories

1.09
Non-electric signal lanterns

1.10
Double lanterns

Chapter 2
Photometric and colorimetric requirements

Article 2.01
Photometric requirements

2.02
Colorimetric requirements

Chapter 3
Manufacturing requirements

Article 3.01
Electric lanterns

3.02
Filters and optical glasses

3.03
Electric light sources

Chapter 4
Test and approval procedure

Article 4.01
General rules of procedure

4.02
Application

4.03
Test

4.04
Approval

4.05
Cessation of validity of the approval

Appendix
Environment tests

1.
Test concerning protection against splashing water and dust

2.
Humid atmosphere test

3.
Cold test

4.
Heat test

5.
Vibration test

6.
Accelerated weather resistance test

7.
Salt water and weather-resistance test (sea-fog test)

(a)
Type of environment—Type of climate:XAppliances intended for use in places exposed to weather conditions.SAppliances intended for submersion or for prolonged contact with salt water.—Types of vibration:VAppliances and devices intended for installation on masts and at other points particularly exposed to vibrations.—Types of ambient conditions:Ambient conditions are divided into three types:1.Normal ambient conditions:These may regularly occur on board during a long period.2.Extreme ambient conditions:These may exceptionally occur on board in special cases.3.Transport ambient conditions:These may occur during transport and immobilisation other than during the operation of the installations, appliances and accessories.Tests under normal ambient conditions are described as ‘normal ambient tests’, tests under extreme ambient conditions as ‘extreme ambient tests’ and tests under transport ambient conditions as ‘transport ambient tests’.
—
Type of climate:XAppliances intended for use in places exposed to weather conditions.SAppliances intended for submersion or for prolonged contact with salt water.
X
Appliances intended for use in places exposed to weather conditions.
S
Appliances intended for submersion or for prolonged contact with salt water.
—
Types of vibration:VAppliances and devices intended for installation on masts and at other points particularly exposed to vibrations.
V
Appliances and devices intended for installation on masts and at other points particularly exposed to vibrations.
—
Types of ambient conditions:
1.
Normal ambient conditions:These may regularly occur on board during a long period.
2.
Extreme ambient conditions:These may exceptionally occur on board in special cases.
3.
Transport ambient conditions:These may occur during transport and immobilisation other than during the operation of the installations, appliances and accessories.

—
Type of climate:XAppliances intended for use in places exposed to weather conditions.SAppliances intended for submersion or for prolonged contact with salt water.
X
Appliances intended for use in places exposed to weather conditions.
S
Appliances intended for submersion or for prolonged contact with salt water.

X
Appliances intended for use in places exposed to weather conditions.

S
Appliances intended for submersion or for prolonged contact with salt water.

—
Types of vibration:VAppliances and devices intended for installation on masts and at other points particularly exposed to vibrations.
V
Appliances and devices intended for installation on masts and at other points particularly exposed to vibrations.

V
Appliances and devices intended for installation on masts and at other points particularly exposed to vibrations.

—
Types of ambient conditions:

1.
Normal ambient conditions:These may regularly occur on board during a long period.

2.
Extreme ambient conditions:These may exceptionally occur on board in special cases.

3.
Transport ambient conditions:These may occur during transport and immobilisation other than during the operation of the installations, appliances and accessories.

—
Type of climate:XAppliances intended for use in places exposed to weather conditions.SAppliances intended for submersion or for prolonged contact with salt water.
X
Appliances intended for use in places exposed to weather conditions.
S
Appliances intended for submersion or for prolonged contact with salt water.

X
Appliances intended for use in places exposed to weather conditions.

S
Appliances intended for submersion or for prolonged contact with salt water.

X
Appliances intended for use in places exposed to weather conditions.

S
Appliances intended for submersion or for prolonged contact with salt water.

—
Types of vibration:VAppliances and devices intended for installation on masts and at other points particularly exposed to vibrations.
V
Appliances and devices intended for installation on masts and at other points particularly exposed to vibrations.

V
Appliances and devices intended for installation on masts and at other points particularly exposed to vibrations.

V
Appliances and devices intended for installation on masts and at other points particularly exposed to vibrations.

—
Types of ambient conditions:

1.
Normal ambient conditions:These may regularly occur on board during a long period.

2.
Extreme ambient conditions:These may exceptionally occur on board in special cases.

3.
Transport ambient conditions:These may occur during transport and immobilisation other than during the operation of the installations, appliances and accessories.

(b)
RequirementsSignal lanterns and their accessories shall be suited to lengthy operation under the influence of the motion of the sea, and of the vibrations, humidity and temperature variations which must be expected on board ship.Signal lanterns and their accessories shall, on exposure to the ambient conditions listed in the Appendix, meet the requirements of their class of environment, as defined in paragraph 8(a).

(a)
Power supply: during fluctuations in the voltages and frequencies of the supply current from their rated values(1)within the limits specified in the table set out below and oscillations of 5 % in the alternating supply voltage, signal lanterns and their accessories shall operate within the permitted tolerances for on-board operation applicable to them on the basis of the test and approval conditions. Theoretically, the supply voltage for the lanterns shall not deviate by more than ± 5 % from the rated voltage selected.Supply(Rated voltage)Fluctuations in voltage and frequency of the supply current of lanterns and their accessoriesFluctuations in voltageFluctuations in frequencyDurationDirect current of more than 48 V± 10 %± 5 %continuousand alternating current± 20 %± 10 %max. 3 sDirect current up to and including 48 V± 10 %-continuousVoltage peaks of up to ± 1 200 V with a rise time of between 2 and 10 μs and a maximum duration of 20 μs and the reversal of the supply voltage shall not cause damage to the signal lanterns and their accessories. After their occurrence, when safety devices may have cut in, the signal lanterns and their accessories shall operate within the permitted tolerances for on-board operation on the basis of the test and approval conditions.
Supply(Rated voltage)
Fluctuations in voltage and frequency of the supply current of lanterns and their accessories
Fluctuations in voltage
Fluctuations in frequency
Duration
Direct current of more than 48 V
± 10 %
± 5 %
continuous
and alternating current
± 20 %
± 10 %
max. 3 s
Direct current up to and including 48 V
± 10 %
–
continuous

Supply(Rated voltage)
Fluctuations in voltage and frequency of the supply current of lanterns and their accessories

Fluctuations in voltage
Fluctuations in frequency
Duration

Direct current of more than 48 V
± 10 %
± 5 %
continuous

and alternating current
± 20 %
± 10 %
max. 3 s

Direct current up to and including 48 V
± 10 %
–
continuous

Supply(Rated voltage)
Fluctuations in voltage and frequency of the supply current of lanterns and their accessories

Fluctuations in voltage
Fluctuations in frequency
Duration

Direct current of more than 48 V
± 10 %
± 5 %
continuous

and alternating current
± 20 %
± 10 %
max. 3 s

Direct current up to and including 48 V
± 10 %
–
continuous

(b)
Electromagnetic compatibility: all reasonable and practical measures shall be taken to eliminate or reduce the reciprocal electromagnetic effects of lanterns and their accessories and of other installations and appliances forming part of the vessels' equipment.

Normal
Extreme
Transport

Ambient conditions

(a)Ambient air temperature:

Classes of climate:
– 25 to
– 25 to
– 25 to

Climate classes X and S according to paragraph 8(a)
+ 55 °C*
+ 55 °C*
+ 70 °C*

(b)Ambient air humidity:

Constant temperature
+ 20 °C
+ 35 °C
+ 45 °C

Maximum relative humidity
95 %
75 %
65 %

Change of temperature
Possibly reaching dewpoint

(c)Weather conditions on deck:

Sunlight
1 120 W/m2

Wind
50 m/s

Rainfall
15 mm/min

Speed of the water during movement (waves)
10 m/s

Water salinity
30 kg/m3

(d)Magnetic field:

Magnetic field from any direction
80 A/m

(e)   Vibration:Sinusoidal vibration from any directionClass of vibration V according to paragraph 8(a) (severe stress, e.g. on masts)

Frequencies
2 to 10 Hz
2 to 13,2 Hz*

Range
± 1,6 mm
± 1,6 mm

Frequencies
10 to 100 Hz
13,2 to 100 Hz*

Range of acceleration
± 7 m/s2
± 11 m/s2 *

—
protection of connections ( 7.2),

—
protection against electric shocks ( 8.2),

—
insulation resistance and voltage stability ( 10.2 and 10.3),

—
ground and overhead lines ( 11.2),

—
durability and heating ( 12.1, tables X, XI and XII),

—
resistance to heat, fire and to stray currents ( 13.2, 13.3 and 13.4),

—
threaded connections ( 14.2, 14.3 and 14.4).

1.
ease of cleaning, including inside the lantern, and ease of changing the light source, even in darkness;

2.
prevention of the accumulation of condensation;

3.
use of durable elastic fittings only to ensure that demountable parts are leakproof;

4.
ensuring that no light of any colour other than that provided for can escape from the lantern.

1.
the rated power of the source, in so far as different rated powers may give different ranges,

2.
the type of lantern for sector lights,

3.
the zero-direction reference, on sector lights, using a mark immediately above or below the transparent section,

4.
the type of light, e.g. ‘strong’,

5.
the trademark,

6.
the place for the approval mark, for example .F.91.235.

(a)
Filament lamps for the rated voltages of 230 V, 115 V, 110 V and 24 VText of imagePermissible deviation of the filament axis from the socket axis at a light-centre-length of 1,5 mmLight-centre-lengthClearMarktarSocket position: L (2)Lamp socket e.g. P 28s45 ± 2 mm (1)Rated voltageVRated outputWMax. power noted3)WRated lifehTest values measured3)Body of lantern mmHorizontal luminous intensity4)cdColour temperatureKbmmlmm244043452360110 or 11560691 000toto2306569652 856Comments1.Light-centre-length tolerance of the 24 V/40 W lamp: ± 1,5 mm.2.L: the broad lug of the P 28 S cap is on the left when the lamp is upright, seen against the direction of emission.3.Before measurement of the values at the start of the test, filament lamps shall have already been in service at the rated voltage for 60 minutes.4.These limits shall be respected in an area extending ± 10° on either side of the horizontal line passing through the median point of the body of the lantern when the lamp is rotated through 360° on its axis.
Rated voltageV
Rated outputW
Max. power noted3)W
Rated lifeh
Test values measured3)
Body of lantern mm
Horizontal luminous intensity4)cd
Colour temperatureK
bmm
lmm
24
40
43

45
2360

110 or 115
60
69
1 000
to
to

230
65
69

65
2 856

Comments1.Light-centre-length tolerance of the 24 V/40 W lamp: ± 1,5 mm.2.L: the broad lug of the P 28 S cap is on the left when the lamp is upright, seen against the direction of emission.3.Before measurement of the values at the start of the test, filament lamps shall have already been in service at the rated voltage for 60 minutes.4.These limits shall be respected in an area extending ± 10° on either side of the horizontal line passing through the median point of the body of the lantern when the lamp is rotated through 360° on its axis.
1.
Light-centre-length tolerance of the 24 V/40 W lamp: ± 1,5 mm.
2.
L: the broad lug of the P 28 S cap is on the left when the lamp is upright, seen against the direction of emission.
3.
Before measurement of the values at the start of the test, filament lamps shall have already been in service at the rated voltage for 60 minutes.
4.
These limits shall be respected in an area extending ± 10° on either side of the horizontal line passing through the median point of the body of the lantern when the lamp is rotated through 360° on its axis.

Rated voltageV
Rated outputW
Max. power noted3)W
Rated lifeh
Test values measured3)
Body of lantern mm

Horizontal luminous intensity4)cd
Colour temperatureK
bmm
lmm

24
40
43

45
2360

110 or 115
60
69
1 000
to
to

230
65
69

65
2 856

Comments1.Light-centre-length tolerance of the 24 V/40 W lamp: ± 1,5 mm.2.L: the broad lug of the P 28 S cap is on the left when the lamp is upright, seen against the direction of emission.3.Before measurement of the values at the start of the test, filament lamps shall have already been in service at the rated voltage for 60 minutes.4.These limits shall be respected in an area extending ± 10° on either side of the horizontal line passing through the median point of the body of the lantern when the lamp is rotated through 360° on its axis.
1.
Light-centre-length tolerance of the 24 V/40 W lamp: ± 1,5 mm.
2.
L: the broad lug of the P 28 S cap is on the left when the lamp is upright, seen against the direction of emission.
3.
Before measurement of the values at the start of the test, filament lamps shall have already been in service at the rated voltage for 60 minutes.
4.
These limits shall be respected in an area extending ± 10° on either side of the horizontal line passing through the median point of the body of the lantern when the lamp is rotated through 360° on its axis.

1.
Light-centre-length tolerance of the 24 V/40 W lamp: ± 1,5 mm.

2.
L: the broad lug of the P 28 S cap is on the left when the lamp is upright, seen against the direction of emission.

3.
Before measurement of the values at the start of the test, filament lamps shall have already been in service at the rated voltage for 60 minutes.

4.
These limits shall be respected in an area extending ± 10° on either side of the horizontal line passing through the median point of the body of the lantern when the lamp is rotated through 360° on its axis.

Rated voltageV
Rated outputW
Max. power noted3)W
Rated lifeh
Test values measured3)
Body of lantern mm

Horizontal luminous intensity4)cd
Colour temperatureK
bmm
lmm

24
40
43

45
2360

110 or 115
60
69
1 000
to
to

230
65
69

65
2 856

Comments1.Light-centre-length tolerance of the 24 V/40 W lamp: ± 1,5 mm.2.L: the broad lug of the P 28 S cap is on the left when the lamp is upright, seen against the direction of emission.3.Before measurement of the values at the start of the test, filament lamps shall have already been in service at the rated voltage for 60 minutes.4.These limits shall be respected in an area extending ± 10° on either side of the horizontal line passing through the median point of the body of the lantern when the lamp is rotated through 360° on its axis.
1.
Light-centre-length tolerance of the 24 V/40 W lamp: ± 1,5 mm.
2.
L: the broad lug of the P 28 S cap is on the left when the lamp is upright, seen against the direction of emission.
3.
Before measurement of the values at the start of the test, filament lamps shall have already been in service at the rated voltage for 60 minutes.
4.
These limits shall be respected in an area extending ± 10° on either side of the horizontal line passing through the median point of the body of the lantern when the lamp is rotated through 360° on its axis.

1.
Light-centre-length tolerance of the 24 V/40 W lamp: ± 1,5 mm.

2.
L: the broad lug of the P 28 S cap is on the left when the lamp is upright, seen against the direction of emission.

3.
Before measurement of the values at the start of the test, filament lamps shall have already been in service at the rated voltage for 60 minutes.

4.
These limits shall be respected in an area extending ± 10° on either side of the horizontal line passing through the median point of the body of the lantern when the lamp is rotated through 360° on its axis.

1.
Light-centre-length tolerance of the 24 V/40 W lamp: ± 1,5 mm.

2.
L: the broad lug of the P 28 S cap is on the left when the lamp is upright, seen against the direction of emission.

3.
Before measurement of the values at the start of the test, filament lamps shall have already been in service at the rated voltage for 60 minutes.

4.
These limits shall be respected in an area extending ± 10° on either side of the horizontal line passing through the median point of the body of the lantern when the lamp is rotated through 360° on its axis.

(b)
Filament lamps for the rated voltages 24 V and 12 VText of imagePermissible deviation of the filament axis from the socket axis at a light-entre-length of 1 mmlight-centre-lengthClearLamp socket e.g. BAY 15dReference pin35 ± 1 mmRated voltageVRated outputWMax. power noted(2)WRated lifehTest values measured(2)Body of lanternl mmHorizontal luminous intensity(3)cdColour temperature K121018100012 to 202 360 to 2 8569 to 13249 to 17122526.530 to 489 to 1324
Rated voltageV
Rated outputW
Max. power noted(2)W
Rated lifeh
Test values measured(2)
Body of lanternl mm
Horizontal luminous intensity(3)cd
Colour temperature K
12
10
18
1000
12 to 20
2 360 to 2 856
9 to 13
24
9 to 17
12
25
26.5
30 to 48
9 to 13
24

Rated voltageV
Rated outputW
Max. power noted(2)W
Rated lifeh
Test values measured(2)
Body of lanternl mm

Horizontal luminous intensity(3)cd
Colour temperature K

12
10
18
1000
12 to 20
2 360 to 2 856
9 to 13

24
9 to 17

12
25
26.5
30 to 48
9 to 13

24

Rated voltageV
Rated outputW
Max. power noted(2)W
Rated lifeh
Test values measured(2)
Body of lanternl mm

Horizontal luminous intensity(3)cd
Colour temperature K

12
10
18
1000
12 to 20
2 360 to 2 856
9 to 13

24
9 to 17

12
25
26.5
30 to 48
9 to 13

24

(c)
The filament lamps shall be marked on the cap with an indication of the corresponding sizes. If these marks are on the bulb, the operation of the lamp shall not be affected.

(d)
If discharge lamps are used instead of filament lamps, the same requirements as for filament lamps shall be applicable.

(a)
the type of light (e.g. strong);

(b)
the trade name and the description of the lantern type, its light source and accessories if any;

(c)
for electric signal lanterns, the on-board voltage supply required by the lanterns depending on their purpose;

(d)
specifications of all characteristics and capacities;

(e)
a brief technical description indicating the materials of which the sample lantern is made and a wiring diagram with a brief technical description if accessories of the lantern likely to influence operation are included;

(f)
for sample lanterns and, where relevant, their accessories, two copies of:(i)adjustment or mounting instructions with data concerning the light source and the mounting or holding device;(ii)sketch with dimensions and type names and descriptions needed to identify the test sample and lanterns installed on board and their accessories, if any;(iii)other documents such as drawings, lists of parts, wiring diagrams, operating instructions and photographs which concern or may concern all the important details referred to in Chapters 1 to 3 of these test and approval conditions, in so far as they are necessary for verifying the conformity of the lanterns to be manufactured with the test sample. The following data and drawings are particularly relevant:—a longitudinal section showing the details of the structure of the filter and the profile of the light source (filament lamp), as well as the positioning and the mount,—a cross-section of the lantern halfway up the filter showing details of the layout of the light source, filter, the optical glass, if any, and the horizontal dispersion angle for sector lights,—a view from the rear for sector lights, with details of the holder or mount,—a view of circular lights with details of the holder or mount;(iv)data concerning dimensional tolerances in mass produced light sources, filters, optical glasses, mounting or holding devices and of the light source placed in the lantern in relation to the filter;(v)data concerning the horizontal luminous intensity of mass-produced sources at the rated voltage;(vi)data concerning mass-production tolerances for coloured glasses with regard to the colour and transparency of a standard illuminant A (2856 K) or the type of light from the intended light source.
(i)
adjustment or mounting instructions with data concerning the light source and the mounting or holding device;
(ii)
sketch with dimensions and type names and descriptions needed to identify the test sample and lanterns installed on board and their accessories, if any;
(iii)
other documents such as drawings, lists of parts, wiring diagrams, operating instructions and photographs which concern or may concern all the important details referred to in Chapters 1 to 3 of these test and approval conditions, in so far as they are necessary for verifying the conformity of the lanterns to be manufactured with the test sample. The following data and drawings are particularly relevant:—a longitudinal section showing the details of the structure of the filter and the profile of the light source (filament lamp), as well as the positioning and the mount,—a cross-section of the lantern halfway up the filter showing details of the layout of the light source, filter, the optical glass, if any, and the horizontal dispersion angle for sector lights,—a view from the rear for sector lights, with details of the holder or mount,—a view of circular lights with details of the holder or mount;
—
a longitudinal section showing the details of the structure of the filter and the profile of the light source (filament lamp), as well as the positioning and the mount,
—
a cross-section of the lantern halfway up the filter showing details of the layout of the light source, filter, the optical glass, if any, and the horizontal dispersion angle for sector lights,
—
a view from the rear for sector lights, with details of the holder or mount,
—
a view of circular lights with details of the holder or mount;
(iv)
data concerning dimensional tolerances in mass produced light sources, filters, optical glasses, mounting or holding devices and of the light source placed in the lantern in relation to the filter;
(v)
data concerning the horizontal luminous intensity of mass-produced sources at the rated voltage;
(vi)
data concerning mass-production tolerances for coloured glasses with regard to the colour and transparency of a standard illuminant A (2856 K) or the type of light from the intended light source.

(i)
adjustment or mounting instructions with data concerning the light source and the mounting or holding device;

(ii)
sketch with dimensions and type names and descriptions needed to identify the test sample and lanterns installed on board and their accessories, if any;

(iii)
other documents such as drawings, lists of parts, wiring diagrams, operating instructions and photographs which concern or may concern all the important details referred to in Chapters 1 to 3 of these test and approval conditions, in so far as they are necessary for verifying the conformity of the lanterns to be manufactured with the test sample. The following data and drawings are particularly relevant:—a longitudinal section showing the details of the structure of the filter and the profile of the light source (filament lamp), as well as the positioning and the mount,—a cross-section of the lantern halfway up the filter showing details of the layout of the light source, filter, the optical glass, if any, and the horizontal dispersion angle for sector lights,—a view from the rear for sector lights, with details of the holder or mount,—a view of circular lights with details of the holder or mount;
—
a longitudinal section showing the details of the structure of the filter and the profile of the light source (filament lamp), as well as the positioning and the mount,
—
a cross-section of the lantern halfway up the filter showing details of the layout of the light source, filter, the optical glass, if any, and the horizontal dispersion angle for sector lights,
—
a view from the rear for sector lights, with details of the holder or mount,
—
a view of circular lights with details of the holder or mount;

—
a longitudinal section showing the details of the structure of the filter and the profile of the light source (filament lamp), as well as the positioning and the mount,

—
a cross-section of the lantern halfway up the filter showing details of the layout of the light source, filter, the optical glass, if any, and the horizontal dispersion angle for sector lights,

—
a view from the rear for sector lights, with details of the holder or mount,

—
a view of circular lights with details of the holder or mount;

(iv)
data concerning dimensional tolerances in mass produced light sources, filters, optical glasses, mounting or holding devices and of the light source placed in the lantern in relation to the filter;

(v)
data concerning the horizontal luminous intensity of mass-produced sources at the rated voltage;

(vi)
data concerning mass-production tolerances for coloured glasses with regard to the colour and transparency of a standard illuminant A (2856 K) or the type of light from the intended light source.

(i)
adjustment or mounting instructions with data concerning the light source and the mounting or holding device;

(ii)
sketch with dimensions and type names and descriptions needed to identify the test sample and lanterns installed on board and their accessories, if any;

(iii)
other documents such as drawings, lists of parts, wiring diagrams, operating instructions and photographs which concern or may concern all the important details referred to in Chapters 1 to 3 of these test and approval conditions, in so far as they are necessary for verifying the conformity of the lanterns to be manufactured with the test sample. The following data and drawings are particularly relevant:—a longitudinal section showing the details of the structure of the filter and the profile of the light source (filament lamp), as well as the positioning and the mount,—a cross-section of the lantern halfway up the filter showing details of the layout of the light source, filter, the optical glass, if any, and the horizontal dispersion angle for sector lights,—a view from the rear for sector lights, with details of the holder or mount,—a view of circular lights with details of the holder or mount;
—
a longitudinal section showing the details of the structure of the filter and the profile of the light source (filament lamp), as well as the positioning and the mount,
—
a cross-section of the lantern halfway up the filter showing details of the layout of the light source, filter, the optical glass, if any, and the horizontal dispersion angle for sector lights,
—
a view from the rear for sector lights, with details of the holder or mount,
—
a view of circular lights with details of the holder or mount;

—
a longitudinal section showing the details of the structure of the filter and the profile of the light source (filament lamp), as well as the positioning and the mount,

—
a cross-section of the lantern halfway up the filter showing details of the layout of the light source, filter, the optical glass, if any, and the horizontal dispersion angle for sector lights,

—
a view from the rear for sector lights, with details of the holder or mount,

—
a view of circular lights with details of the holder or mount;

—
a longitudinal section showing the details of the structure of the filter and the profile of the light source (filament lamp), as well as the positioning and the mount,

—
a cross-section of the lantern halfway up the filter showing details of the layout of the light source, filter, the optical glass, if any, and the horizontal dispersion angle for sector lights,

—
a view from the rear for sector lights, with details of the holder or mount,

—
a view of circular lights with details of the holder or mount;

(iv)
data concerning dimensional tolerances in mass produced light sources, filters, optical glasses, mounting or holding devices and of the light source placed in the lantern in relation to the filter;

(v)
data concerning the horizontal luminous intensity of mass-produced sources at the rated voltage;

(vi)
data concerning mass-production tolerances for coloured glasses with regard to the colour and transparency of a standard illuminant A (2856 K) or the type of light from the intended light source.

—
subsequently and conclusively, the conditions for its issue no longer exist,

—
the test and approval conditions are no longer met,

—
a lantern does not correspond to the approved sample,

—
the conditions imposed are not complied with, or

—
the holder of the approval proves unreliable.

1.1.
The type of lantern protection shall be guaranteed in accordance with classification IP 55 of the IEC publication — Part 598-1.The test concerning protection of the sample against splashing water and against dust, and the evaluation of the results, shall be carried out in conformity with IEC publication 529, classification IP 55.The first ‘5’ stands for protection against dust. This means: full dust-proof protection of live components and protection against harmful deposits of dust. The penetration of dust is not completely prevented.The second ‘5’ stands for protection against splashing water. This means that a water jet aimed at the lantern from all directions shall have no damaging effect.

1.2.
The protection of the sample against water is evaluated as follows: the protection is considered to be adequate if any water which has entered has no detrimental effect on operation of the sample.No water deposits shall have formed on the insulating materials, if this means that minimum vanishing point values could not be achieved. Live components shall not be wetted and shall not be affected by any water accumulating inside the lantern.

1.
The test is conducted in a test chamber in which, if necessary by means of an air circulation device, the temperature and level of humidity are practically the same at all points. The movement of the air shall not noticeably cool the sample being tested, but should be sufficient to ensure that the prescribed values for air temperature and humidity are maintained in its immediate vicinity.Condensate shall be continuously evacuated from the test chamber. No condensate shall drip on to the sample. Condensate may only be reused for humidification following reprocessing, in particular once chemicals from the sample have been eliminated.

2.
The sample shall not be exposed to heat radiation from the heating of the chamber.

3.
The sample shall have been out of service immediately prior to the test long enough for all its parts to be at ambient temperature.

4.
The sample is placed in a test chamber at an ambient temperature of + 25 ± 10 °C corresponding to its normal use on board.

5.
The chamber is closed. The air temperature is set at -25 ± 3 °C and the relative humidity at 45 to 75 % and those conditions are maintained until the sample has reached the same temperature.

6.
The relative humidity of the air is raised to not less than 95 % in a maximum time of one hour, the air temperature remaining unchanged. This increase may take place during the last hour of temperature conditioning of the sample.

7.
The air temperature in the chamber is increased progressively to +40 ± 2 °C over a period of 3 h ± 0,5 h. As the temperature rises, the relative humidity of the air is maintained at not less than 95 %, and at not less than 90 % during the last 15 minutes. During this temperature rise, the sample becomes damp.

8.
The air temperature is maintained at + 40 ± 2 °C for a time period of 12 h ± 0,5 h measured from the start of phase 7, with a relative air humidity of 93 ± 3 %. During the first 15 and the last 15 minutes of the period during which the temperature is + 40 ± 2 °C, relative air humidity may be between 90 and 100 %.

9.
The air temperature is reduced to + 25 ± 3 °C over a period of three to six hours. The relative humidity of the air must be constantly maintained at over 80 %.

10.
The air temperature is maintained at + 25 ± 3 °C for a period of 24 hours from the start of phase 7, relative air humidity remaining constantly above 95 %.

11.
Phase 7 is repeated.

12.
Phase 8 is repeated.

13.
Not earlier than 10 hours after the start of phase 12 the air conditioning equipment of the sample is switched on. When the climatic data indicated by the manufacturer for the sample have been obtained, the sample is put into operation in accordance with the manufacturer's instructions and at the rated voltage of the on-board network, with a tolerance of ± 3 %.

14.
After the time necessary to achieve normal operation in accordance with the manufacturer's instructions has elapsed, the functions are checked and the operating data of importance for use on board recorded and noted. If the chamber needs to be opened for this purpose, it shall be reclosed as quickly as possible.If more than 30 minutes are required to reach normal operation, this phase shall be extended sufficiently so that, once the operating state has been reached, at least 30 minutes are available to monitor the functions and measure the operating data.

15.
Within a period of one to three hours, with the sample again in service, the air temperature is lowered to ambient temperature, with a tolerance of ± 3 °C, and the relative humidity of the air to under 75 %.

16.
The chamber is opened and the sample exposed to the normal temperature and humidity of the ambient air.

17.
After 3 hours, and when all humidity visible on the sample has evaporated, the functions of the sample are monitored again, and operating data of importance for use on board recorded and noted.

18.
The sample is subjected to a visual inspection. The body of the lantern is opened and the interior examined for any effects of the climatic test and for residual condensate.

2.3.1.
The sample shall function normally under the conditions stipulated in phases 12 to 18. No deterioration shall be observed.

2.3.2.
The operating data for phases 12 and 18 shall be within the tolerances permitted for the sample on the basis of these test and approval conditions.

2.3.3.
There shall be no corrosion or no residual condensate inside the lantern which, as a result of the long-term action of high atmospheric humidity, might cause it to malfunction.

1.
The test is carried out in a test chamber in which, if necessary by means of an air circulation device, the temperature is practically the same at all points. The air humidity must be low enough to ensure that the sample is not wetted by condensation during any of the phases.

2.
The sample is placed in a test chamber at an ambient temperature of + 25 ± 10 °C corresponding to its normal use on board.

3.
The temperature in the chamber is lowered to — 25 ± 3 °C at a rate of not more than 45 °C/h.

4.
The temperature in the chamber is maintained at — 25 ± 3 °C until the sample has reached temperature equilibrium, plus at least a further 2 hours.

5.
The temperature in the chamber is raised to 0 ± 2 °C at a rate of not more than 45 °C/h.

6.
During the last hour of phase (4) in climate class X, the sample is put into operation in accordance with the manufacturer's instructions, at the rated voltage of the on-board network, with a tolerance of ± 3 %. The heat sources contained in the sample must be in operation.After the time necessary to achieve normal operation has elapsed, the functions are checked and the operating data of importance for use on board recorded and noted.

7.
The temperature in the chamber is raised to ambient temperature at a rate of not more than 45oC/h.

8.
Once the sample has reached temperature equilibrium, the chamber is opened.

9.
The functions of the sample are checked again and the operating data of importance for use on board recorded and noted.

Normal
Extreme

Environment tests

Climate classes X and S
+ 55 °C
+ 70 °C

Permissible tolerance ± 2 °C

1.
The test is conducted in a test chamber in which, if necessary by means of an air circulation device, the temperature is practically the same at all points. The movement of the air shall not noticeably cool the sample being tested. The sample shall not be exposed to heat radiation from the heating of the chamber. The air humidity must be low enough to ensure that the sample is not wetted by condensation during any of the phases.

2.
The sample is placed in a test chamber at a temperature of + 25 ± 10 °C corresponding to its normal use on board. The sample is put into operation in accordance with the manufacturer's instructions at the rated voltage of the on-board network with a tolerance of ± 3 %.After the time necessary to achieve normal operation has elapsed, the functions are checked and the operating data of importance for use on board recorded and noted.

3.
The air temperature in the chamber is raised to the test temperature referred to in Article 3.01(10)(a) at a rate of not more than 45 °C/h.

4.
The air temperature is maintained at the test temperature until the sample reaches temperature equilibrium plus a further two hours.During the last two hours, the functions are checked again and the operating data recorded and noted.

5.
The temperature is lowered to ambient temperature over a period of not less than one hour. The chamber is then opened.After bringing the sample to ambient temperature, the functions are again checked and the operating data of importance for use on board recorded and noted.

Normal
Extreme

Environment tests

Vibration class V:

Frequencies
2 to 10 Hz
2 to 13,2 Hz*

Amplitude
± 1,6 mm
± 1,6 mm

Frequencies
10 to 100 Hz
13,2 to 100 Hz*

Acceleration amplitude
± 7 m/s2
± 11 m/s2

1.
Test apparatusThe test is conducted using a vibrating device known as a vibrating table, which enables the sample to be subjected to mechanical vibrations in accordance with the following conditions:—The basic movement shall be sinusoidal and such that the mounting points of the sample basically move in phase and along parallel lines.—The maximum amplitude of vibration of the lateral movement of any mounting point shall not exceed 25 % of the specified amplitude of the basic movement.—The relative importance of the spurious vibration, expressed by the formula(in %)where a1is the effective value of the acceleration produced by the frequency applied,and where atot is the effective value of the total acceleration, including a1, measured in the frequencies < 5 000 Hz,shall not exceed 25 % at the mounting point taken as the point of reference for measurement of the acceleration.—The vibration amplitude shall not differ from its theoretical value by more than:—± 15 % at the mounting point taken as the point of reference and—± 25 % at any other mounting point.In order to determine the characteristic frequencies, it must be possible to adjust the vibration amplitude in small steps between zero and the theoretical value.—The vibration frequency shall not differ from its theoretical value by more than± 0,05 Hzfor frequencies up to 0,25 Hz,± 20%for frequencies higher than 0,25 Hz and up to 5 Hz,± 1Hzfor frequencies higher than 5 Hz and up to 50 Hz,± 2%for frequencies higher than 50 Hz,In order to compare the characteristic frequencies, it must be possible to adjust them at the beginning and end of the vibration test to within:± 0,05 Hz for frequencies up to 0,5 Hz,± 10%± 0,5 Hz for frequencies up to 5 Hz,± 0,5 Hz for frequencies higher than 5 Hz and up to 100 Hz,± 0,5% for frequencies higher than 100 Hz.In order to scan the frequencies, it should be possible for the vibration frequency to vary continuously and exponentially in both directions between the lower and upper limits of the frequency ranges indicated in paragraph 5.1, with a scanning speed of 1 octave/minute ± 10 %.In order to determine the characteristic frequencies, it must be possible to slow the speed of variation of the vibration frequency as desired.—The intensity of the magnetic field created by the vibration device in the vicinity of the sample should not exceed 20 kA/m. The testing authority may require lower permissible values for some samples.
—
The basic movement shall be sinusoidal and such that the mounting points of the sample basically move in phase and along parallel lines.
—
The maximum amplitude of vibration of the lateral movement of any mounting point shall not exceed 25 % of the specified amplitude of the basic movement.
—
The relative importance of the spurious vibration, expressed by the formula(in %)where a1is the effective value of the acceleration produced by the frequency applied,and where atot is the effective value of the total acceleration, including a1, measured in the frequencies < 5 000 Hz,shall not exceed 25 % at the mounting point taken as the point of reference for measurement of the acceleration.
—
The vibration amplitude shall not differ from its theoretical value by more than:—± 15 % at the mounting point taken as the point of reference and—± 25 % at any other mounting point.
—
± 15 % at the mounting point taken as the point of reference and
—
± 25 % at any other mounting point.
—
The vibration frequency shall not differ from its theoretical value by more than± 0,05 Hzfor frequencies up to 0,25 Hz,± 20%for frequencies higher than 0,25 Hz and up to 5 Hz,± 1Hzfor frequencies higher than 5 Hz and up to 50 Hz,± 2%for frequencies higher than 50 Hz,
± 0,05 Hz
for frequencies up to 0,25 Hz,
± 20%
for frequencies higher than 0,25 Hz and up to 5 Hz,
± 1Hz
for frequencies higher than 5 Hz and up to 50 Hz,
± 2%
for frequencies higher than 50 Hz,
± 0,05 Hz for frequencies up to 0,5 Hz,
± 10%
± 0,5 Hz for frequencies up to 5 Hz,
± 0,5 Hz for frequencies higher than 5 Hz and up to 100 Hz,
± 0,5% for frequencies higher than 100 Hz.
—
The intensity of the magnetic field created by the vibration device in the vicinity of the sample should not exceed 20 kA/m. The testing authority may require lower permissible values for some samples.

—
The basic movement shall be sinusoidal and such that the mounting points of the sample basically move in phase and along parallel lines.

—
The maximum amplitude of vibration of the lateral movement of any mounting point shall not exceed 25 % of the specified amplitude of the basic movement.

—
The relative importance of the spurious vibration, expressed by the formula(in %)where a1is the effective value of the acceleration produced by the frequency applied,and where atot is the effective value of the total acceleration, including a1, measured in the frequencies < 5 000 Hz,shall not exceed 25 % at the mounting point taken as the point of reference for measurement of the acceleration.

—
The vibration amplitude shall not differ from its theoretical value by more than:—± 15 % at the mounting point taken as the point of reference and—± 25 % at any other mounting point.
—
± 15 % at the mounting point taken as the point of reference and
—
± 25 % at any other mounting point.

—
± 15 % at the mounting point taken as the point of reference and

—
± 25 % at any other mounting point.

—
The vibration frequency shall not differ from its theoretical value by more than± 0,05 Hzfor frequencies up to 0,25 Hz,± 20%for frequencies higher than 0,25 Hz and up to 5 Hz,± 1Hzfor frequencies higher than 5 Hz and up to 50 Hz,± 2%for frequencies higher than 50 Hz,
± 0,05 Hz
for frequencies up to 0,25 Hz,
± 20%
for frequencies higher than 0,25 Hz and up to 5 Hz,
± 1Hz
for frequencies higher than 5 Hz and up to 50 Hz,
± 2%
for frequencies higher than 50 Hz,

± 0,05 Hz
for frequencies up to 0,25 Hz,

± 20%
for frequencies higher than 0,25 Hz and up to 5 Hz,

± 1Hz
for frequencies higher than 5 Hz and up to 50 Hz,

± 2%
for frequencies higher than 50 Hz,

± 0,05 Hz for frequencies up to 0,5 Hz,

± 10%
± 0,5 Hz for frequencies up to 5 Hz,

± 0,5 Hz for frequencies higher than 5 Hz and up to 100 Hz,

± 0,5% for frequencies higher than 100 Hz.

—
The intensity of the magnetic field created by the vibration device in the vicinity of the sample should not exceed 20 kA/m. The testing authority may require lower permissible values for some samples.

—
The basic movement shall be sinusoidal and such that the mounting points of the sample basically move in phase and along parallel lines.

—
The maximum amplitude of vibration of the lateral movement of any mounting point shall not exceed 25 % of the specified amplitude of the basic movement.

—
The relative importance of the spurious vibration, expressed by the formula(in %)where a1is the effective value of the acceleration produced by the frequency applied,and where atot is the effective value of the total acceleration, including a1, measured in the frequencies < 5 000 Hz,shall not exceed 25 % at the mounting point taken as the point of reference for measurement of the acceleration.

—
The vibration amplitude shall not differ from its theoretical value by more than:—± 15 % at the mounting point taken as the point of reference and—± 25 % at any other mounting point.
—
± 15 % at the mounting point taken as the point of reference and
—
± 25 % at any other mounting point.

—
± 15 % at the mounting point taken as the point of reference and

—
± 25 % at any other mounting point.

—
± 15 % at the mounting point taken as the point of reference and

—
± 25 % at any other mounting point.

—
The vibration frequency shall not differ from its theoretical value by more than± 0,05 Hzfor frequencies up to 0,25 Hz,± 20%for frequencies higher than 0,25 Hz and up to 5 Hz,± 1Hzfor frequencies higher than 5 Hz and up to 50 Hz,± 2%for frequencies higher than 50 Hz,
± 0,05 Hz
for frequencies up to 0,25 Hz,
± 20%
for frequencies higher than 0,25 Hz and up to 5 Hz,
± 1Hz
for frequencies higher than 5 Hz and up to 50 Hz,
± 2%
for frequencies higher than 50 Hz,

± 0,05 Hz
for frequencies up to 0,25 Hz,

± 20%
for frequencies higher than 0,25 Hz and up to 5 Hz,

± 1Hz
for frequencies higher than 5 Hz and up to 50 Hz,

± 2%
for frequencies higher than 50 Hz,

± 0,05 Hz
for frequencies up to 0,25 Hz,

± 20%
for frequencies higher than 0,25 Hz and up to 5 Hz,

± 1Hz
for frequencies higher than 5 Hz and up to 50 Hz,

± 2%
for frequencies higher than 50 Hz,

± 0,05 Hz for frequencies up to 0,5 Hz,

± 10%
± 0,5 Hz for frequencies up to 5 Hz,

± 0,5 Hz for frequencies higher than 5 Hz and up to 100 Hz,

± 0,5% for frequencies higher than 100 Hz.

—
The intensity of the magnetic field created by the vibration device in the vicinity of the sample should not exceed 20 kA/m. The testing authority may require lower permissible values for some samples.

2.
First inspection, mounting and putting into serviceThe sample is inspected visually to verify that it is in impeccable condition as far as is apparent, and that the assembly is impeccable from the point of view of the construction of all the components and groups of components.The sample is mounted on the vibrating table in accordance with the type of mount provided for on-board installation. Samples, the operation and performance of which under the influence of vibrations depend on their position in relation to the vertical, shall be tested in their normal operating position. The mounts and devices used for the mounting shall not noticeably modify the amplitude and the movements of the sample in the range of frequencies used in the test.The sample is put into operation in accordance with the manufacturer's instructions at the rated voltage of the on-board network with a tolerance of ± 3 %.After the time necessary to achieve normal operation has elapsed, the functions are checked and the operating data of importance for use on board recorded and noted.

3.
Preliminary inspection of performance when subjected to vibrationsThis test phase shall be conducted for all samples. For samples which may be used for different purposes with varying vibratory effects, the test shall be conducted for all or some of the various uses.A frequency cycle is effected with the vibrating table so that the frequency range indicated in paragraph 5.1, with its corresponding amplitudes, is covered from the lowest frequency to the highest and conversely, at a rate of one octave per minute. The sample is observed during this operation using the appropriate means of measurement and visually, if necessary using a stroboscope, to check thoroughly for any operating problems, modifications of operating data and mechanical phenomena such as vibrations by resonance and rattling noises occurring in specific frequencies. These frequencies are described as ‘characteristic’.If necessary, in order to determine characteristic frequencies and vibration effects, the frequency variation is slowed down, stopped or reversed and the amplitude of the vibrations reduced. During the gradual modification of the operating data, it is necessary to wait until the final value is reached while maintaining the vibration frequency, although not more than five minutes.During the frequency scan, at least the frequencies and operating data of importance for use on board are recorded, and all characteristic frequencies are noted, with their effects, for subsequent comparison during phase (7).If the response of the sample to mechanical vibrations cannot be adequately determined during operation, an additional vibration response test shall be performed without connecting the sample.If during the frequency scan the operational data noticeably exceed the permissible tolerances, the operation is unacceptably disrupted or if the structural resonance vibrations are likely to cause destruction should the vibration test be continued, the test may be interrupted.

4.
Test of switching functionsThis test phase shall be conducted for all samples where vibratory stress may influence switching functions, for example relays.The sample is subjected to vibrations in the frequency ranges indicated in paragraph 5.1 with frequency variation steps in accordance with the E-12 series(4)and the corresponding amplitudes. At each frequency step, all switching functions which may be sensitive to vibration, if necessary including switching-on and switching-off, are carried out at least twice.Switching functions may also be tested at frequencies occurring between the E-12 series values.

5.
Extended testThis test phase shall be conducted for all samples. For samples which may be used for different purposes with varying vibratory effects, the first part of this phase (when the sample is in service) may be conducted several times, for all or some of the various uses.When the sample is in service as described in phase (2) above, it is subjected to five cycles during which the frequency range indicated as stress producing in paragraph 5.1, with the corresponding amplitudes, is covered each time from the lowest to the highest frequency and conversely, at a rate of one octave per minute.After the fifth cycle, the vibrating table may be stopped, the functions are tested and the operating data of importance for on-board use recorded and noted.

6.
Fixed frequency extended testThis test phase shall be conducted if, on examining vibratory performance during phase (3) above, mechanical resonances are observed during the scan of the frequency range above 5 Hz, which are acceptable for extended use on board according to the manufacturer or his authorised representative, but for which the strength of the parts concerned cannot be taken for granted. In particular, this phase concerns appliances fitted with shock absorbers with a resonance frequency within the frequency range indicated in paragraph 5.1 and higher than 5 Hz.When the sample is in service as described in phase 2 above, for each resonance frequency concerned, it is subjected for two hours to vibrations at the amplitude provided for in the extreme ambient test and at the corresponding frequency as referred to in paragraph 5.1, the direction of vibration being that which in normal use exerts the maximum stress on the parts in question. If necessary, the frequency applied must be rectified so that the resonance vibrations continue at not less than 70 % of their maximum amplitude, or the frequency must be made to vary continuously between two values 2 % below and 2 % above the resonance frequency initially observed, at a rate of at least 0,1 but not more than 1 octave per minute. During the vibratory stress, the functions of the sample are monitored until malfunctions begin to occur, as a result of mechanical parts becoming detached or displaced or of a break in the electrical connection or of a short-circuit.Samples for which the execution of this test phase is relevant when switched off may be tested in that state, provided the mechanical stress on the parts concerned is not less than in normal use.

7.
Final inspection of performance when subjected to vibrationThis test phase must be effected as necessary.The inspection of performance when subjected to vibrations referred to in phase 3 is repeated using the frequencies and amplitudes applied in that phase. The characteristic frequencies observed and the observed effects of vibration stress are compared with the results of phase 3 in order to determine any changes which occurred during the vibration test.

8.
Conclusions of the inspectionOnce the vibrating table has stopped and the time necessary to arrive at an operating state without vibratory stress has elapsed, the functions are tested and the operating data of importance for on-board use recorded and noted.Lastly, the sample is inspected visually to verify that it is in impeccable condition.

(a)
a silicon photo-electric cell as radiation sensor;

(b)
an optical filter placed in front of the photo-electric cell; and

(c)
a coulometer which measures the product (unit: C = A.s) of the intensity of the current produced in the photo-electric cell in proportion to radiation intensity (unit: A) and the duration of radiation (unit: s).

6.10.1.
The samples are placed in mounts so that water cannot collect on the rear surface. The sample mounts must cause only the smallest possible amount of mechanical stress. In order to ensure irradiation and sprinkling are as evenly distributed as possible, the samples are rotated during the test at a rate of one to five revolutions per minute round the source-filter system and the sprinkling device. Normally, a single side of the sample is exposed to the weather conditions. Depending on the applicable provisions of the IEC publication, or as otherwise agreed, the front and back surfaces of a single sample may also be exposed. In this case, each surface is exposed to the same radiation and the same sprinkling.The exposure of the front and back surfaces of a given sample to the same radiation and sprinkling may be produced by the periodic rotation of the sample. This can be done automatically using rotating appliances if the mount is in the form of an open frame.

6.10.2.
The temperature of the black panel at the point where the samples are placed during the dry period is set and regulated in accordance with the IEC publications applicable to the equipment in question. Unless otherwise agreed, the average temperature of the black panel must be kept at + 45 °C. Average temperature of the black panel means the arithmetic mean of the black panel temperature reached at the end of the dry period. During the dry period, a local difference of ± 5 °C is permissible, and ± 3 °C in borderline cases.In order to maintain the required temperature of the black panel and, when necessary, ensure radiation of equal intensity on the front and back surfaces of the sample (see paragraph 6.10.1), the samples may be turned automatically through 180° after each revolution. In this case, the blackpanel thermometer and the irradiation measuring apparatus shall be included in the rotation movement.

6.10.3.
Samples installed in mounts and the sensor of the irradiation measuring apparatus referred to in paragraph 6.9 are evenly exposed to radiation and sprinkled according to the cycle defined below, which is repeated successively:Sprinkling:3 minutesDry period::17 minutesThe relative humidity of the air must be 60 to 80 % during the dry period.
Sprinkling
:
3 minutes
Dry period:
:
17 minutes

Sprinkling
:
3 minutes

Dry period:
:
17 minutes

Sprinkling
:
3 minutes

Dry period:
:
17 minutes

1
Test apparatusThe test is conducted in a test chamber using an atomiser and a saline solution meeting the following conditions:—the materials of the test chamber and the atomiser must not influence the corrosive action of the salt mist,—a fine, homogeneous, wet, thick mist must be diffused inside the test chamber; the distribution must not be affected by eddies or by the presence of the sample. The jet must not touch the sample directly. Drops forming on the inside of the chamber must not be able to fall on the sample;—the test chamber must be adequately ventilated and the ventilation outlet protected against sudden changes in the movement of the air, so as to prevent the formation of a strong air current in the chamber,—the saline solution used must consist, by mass, of 5 ± 1 parts of pure sodium chloride, with a maximum of 0,1 % sodium iodide and 0,3 % impurities, in the dry state, to 95 ± 1 parts of distilled or fully desalinated water. Its pH must be between 6,5 and 7,2 at a temperature of + 20 ± 2 °C and be kept within these limits during the operation. Solution once sprayed must not be reused,—the compressed air used for spraying must be free of impurities such as oil or dust and shall have a humidity level of at least 85 % in order to avoid blockage of the nozzle,—the mist diffused in the chamber must have a density such that, in a clean receptacle with an open horizontal surface area of 80 cm2, placed anywhere in the chamber, the average precipitation over the whole time is between 1.0 ml and 2.0 ml per hour. In order to monitor the density of the mist, at least two receptacles shall be placed in the chamber in such a way as not to be covered by the sample and not to receive drops of condensation. In order to calibrate the quantity of solution sprayed, the duration of spraying shall be at least eight hours,the period of humidity between phases of spraying is spent in an air-conditioned chamber in which the air can be kept at a temperature of + 40 ± 2 °C and at a relative humidity of 93 ± 3 %.
—
the materials of the test chamber and the atomiser must not influence the corrosive action of the salt mist,
—
a fine, homogeneous, wet, thick mist must be diffused inside the test chamber; the distribution must not be affected by eddies or by the presence of the sample. The jet must not touch the sample directly. Drops forming on the inside of the chamber must not be able to fall on the sample;
—
the test chamber must be adequately ventilated and the ventilation outlet protected against sudden changes in the movement of the air, so as to prevent the formation of a strong air current in the chamber,
—
the saline solution used must consist, by mass, of 5 ± 1 parts of pure sodium chloride, with a maximum of 0,1 % sodium iodide and 0,3 % impurities, in the dry state, to 95 ± 1 parts of distilled or fully desalinated water. Its pH must be between 6,5 and 7,2 at a temperature of + 20 ± 2 °C and be kept within these limits during the operation. Solution once sprayed must not be reused,
—
the compressed air used for spraying must be free of impurities such as oil or dust and shall have a humidity level of at least 85 % in order to avoid blockage of the nozzle,
—
the mist diffused in the chamber must have a density such that, in a clean receptacle with an open horizontal surface area of 80 cm2, placed anywhere in the chamber, the average precipitation over the whole time is between 1.0 ml and 2.0 ml per hour. In order to monitor the density of the mist, at least two receptacles shall be placed in the chamber in such a way as not to be covered by the sample and not to receive drops of condensation. In order to calibrate the quantity of solution sprayed, the duration of spraying shall be at least eight hours,the period of humidity between phases of spraying is spent in an air-conditioned chamber in which the air can be kept at a temperature of + 40 ± 2 °C and at a relative humidity of 93 ± 3 %.

—
the materials of the test chamber and the atomiser must not influence the corrosive action of the salt mist,

—
a fine, homogeneous, wet, thick mist must be diffused inside the test chamber; the distribution must not be affected by eddies or by the presence of the sample. The jet must not touch the sample directly. Drops forming on the inside of the chamber must not be able to fall on the sample;

—
the test chamber must be adequately ventilated and the ventilation outlet protected against sudden changes in the movement of the air, so as to prevent the formation of a strong air current in the chamber,

—
the saline solution used must consist, by mass, of 5 ± 1 parts of pure sodium chloride, with a maximum of 0,1 % sodium iodide and 0,3 % impurities, in the dry state, to 95 ± 1 parts of distilled or fully desalinated water. Its pH must be between 6,5 and 7,2 at a temperature of + 20 ± 2 °C and be kept within these limits during the operation. Solution once sprayed must not be reused,

—
the compressed air used for spraying must be free of impurities such as oil or dust and shall have a humidity level of at least 85 % in order to avoid blockage of the nozzle,

—
the mist diffused in the chamber must have a density such that, in a clean receptacle with an open horizontal surface area of 80 cm2, placed anywhere in the chamber, the average precipitation over the whole time is between 1.0 ml and 2.0 ml per hour. In order to monitor the density of the mist, at least two receptacles shall be placed in the chamber in such a way as not to be covered by the sample and not to receive drops of condensation. In order to calibrate the quantity of solution sprayed, the duration of spraying shall be at least eight hours,the period of humidity between phases of spraying is spent in an air-conditioned chamber in which the air can be kept at a temperature of + 40 ± 2 °C and at a relative humidity of 93 ± 3 %.

—
the materials of the test chamber and the atomiser must not influence the corrosive action of the salt mist,

—
a fine, homogeneous, wet, thick mist must be diffused inside the test chamber; the distribution must not be affected by eddies or by the presence of the sample. The jet must not touch the sample directly. Drops forming on the inside of the chamber must not be able to fall on the sample;

—
the test chamber must be adequately ventilated and the ventilation outlet protected against sudden changes in the movement of the air, so as to prevent the formation of a strong air current in the chamber,

—
the saline solution used must consist, by mass, of 5 ± 1 parts of pure sodium chloride, with a maximum of 0,1 % sodium iodide and 0,3 % impurities, in the dry state, to 95 ± 1 parts of distilled or fully desalinated water. Its pH must be between 6,5 and 7,2 at a temperature of + 20 ± 2 °C and be kept within these limits during the operation. Solution once sprayed must not be reused,

—
the compressed air used for spraying must be free of impurities such as oil or dust and shall have a humidity level of at least 85 % in order to avoid blockage of the nozzle,

—
the mist diffused in the chamber must have a density such that, in a clean receptacle with an open horizontal surface area of 80 cm2, placed anywhere in the chamber, the average precipitation over the whole time is between 1.0 ml and 2.0 ml per hour. In order to monitor the density of the mist, at least two receptacles shall be placed in the chamber in such a way as not to be covered by the sample and not to receive drops of condensation. In order to calibrate the quantity of solution sprayed, the duration of spraying shall be at least eight hours,the period of humidity between phases of spraying is spent in an air-conditioned chamber in which the air can be kept at a temperature of + 40 ± 2 °C and at a relative humidity of 93 ± 3 %.

2.
Preliminary inspectionThe sample is inspected visually to verify that it is in impeccable condition, and in particular that it is correctly assembled and that all openings close properly. External surfaces soiled with grease, oil or mud are cleaned. All controls and moving parts are manipulated and checked for proper operation. The mobility of all closures, covers and moving parts intended to be detached or moved during operation or maintenance must be inspected for mobility and correctly replaced.The sample is put into operation in accordance with the manufacturer's instructions at the rated voltage of the on-board network with a tolerance of ± 3 %.After the time required to reach normal operation has elapsed, the functions are tested and the operating data of importance for on-board use and for assessing the action of the salt mist atmosphere are recorded and noted. The sample is then disconnected for exposure to spraying.

3.
Spraying phaseThe sample is put into the salt mist chamber and exposed to the salt mist for two hours at a temperature of +15 °C to +35 °C.

4.
Humidity periodThe sample is placed in the air-conditioned chamber so that the least possible amount of saline solution drips from it. It is kept in the air-conditioned chamber for seven days, at an air temperature of + 40 ± 2 °C and a relative humidity of 93 ± 3 %. It must not come into contact with any other sample or metal object. Several samples may be so arranged as to preclude any mutual influence.

5.
Repetition of the test cycleThe test cycle, including phases 3 and 4, is repeated three times.

6.
Subsequent treatmentFollowing the fourth test cycle, the sample is taken out of the air-conditioned chamber and immediately washed for five minutes in running tap water and rinsed in distilled or desalinated water. Drops adhering to the sample are removed by an air jet or shaken off.The sample is exposed to the normal ambient atmosphere for at least three hours, and in any case long enough for any visible humidity to have evaporated, before being subjected to a final inspection. The sample is dried for an hour at + 55 ± 2 °C after rinsing.

7.
Conclusions of the inspectionThe external appearance of the sample is inspected visually. The nature and extent of deterioration from its initial state are recorded in the test report, with supporting photographs if necessary.The sample is put into operation in accordance with the manufacturer's instructions at the rated voltage of the on-board network with a tolerance of ± 3 %.After the time required to reach normal operation has elapsed, the functions are tested and the operating data of importance for on-board use and for assessing the action of the salt mist atmosphere are recorded and noted.All controls and moving parts are manipulated and checked for proper operation. The mobility of all closures, covers and moving parts intended to be detached or moved during operation or maintenance is checked.

—
hinder its use and operation,

—
prevent to any considerable extent the detachment of closures and covers, or the movement of moving parts in so far as this is necessary for use or maintenance,

—
impair the waterproofness of the housing,

—
be expected to cause malfunctions in the long run.

Chapter 1:
General

Article 1.01
Scope

Article 1.02
Purpose of the radar equipment

Article 1.03
Approval testing

Article 1.04
Application for approval testing

Article 1.05
Type-approval

Article 1.06
Marking of the equipment and approval number

Article 1.07
Manufacturer's declaration

Article 1.08
Modifications to approved equipment

Chapter 2:
General minimum requirements for radar equipment

Article 2.01
Construction, design

Article 2.02
Spurious emissions and electromagnetic compatibility

Article 2.03
Operation

Article 2.04
Operating instructions

Article 2.05
Installation and operating tests

Chapter 3:
Minimum operational requirements for radar equipment

Article 3.01
Operational readiness of radar equipment

Article 3.02
Resolution

Article 3.03
Range scales

Article 3.04
Variable range marker

Article 3.05
Lubber line

Article 3.06
Off-centring

Article 3.07
Bearing scale

Article 3.08
Bearing facilities

Article 3.09
Facilities for reducing sea and rain clutter

Article 3.10
Reduction of interference from other radar equipment

Article 3.11
Compatibility with radar beacons

Article 3.12
Gain control

Article 3.13
Frequency tuning

Article 3.14
Nautical orientation lines and information on the screen

Article 3.15
System sensitivity

Article 3.16
Target trail

Article 3.17
Slave indicators

Chapter 4:
Minimum technical requirements for radar equipment

Article 4.01
Operation

Article 4.02
Display

Article 4.03
Radar picture characteristics

Article 4.04
Colour of the display

Article 4.05
Picture refreshment rate and persistence

Article 4.06
Display linearity

Article 4.07
Accuracy of range and azimuthal measurements

Article 4.08
Antenna characteristics and emission spectrum

Chapter 5
Test conditions and test methods for radar equipment

Article 5.01
Safety, load capacity and interference diffusion

Article 5.02
Spurious emissions and electromagnetic compatibility

Article 5.03
Test procedure

Article 5.04
Antenna measurements

Appendix 1
Angular resolution in ranges up to and including 1 200 m

Appendix 2
Test field for determination of the resolution of radar equipment

(a)
two copies of a detailed technical description;

(b)
two complete sets of installation and service documents;

(c).
two copies of a detailed operator's manual; and

(d)
two copies of a summarised operator's manual.

(e
=
European Union

NN
=
code for the country of approval, where

1
=
Germany

2
=
France

3
=
Italy

4
=
Netherlands

5
=
Sweden

6
=
Belgium

7
=
Hungary

8
=
Czech Republic

9
=
Spain

11
=
United Kingdom

12
=
Austria

13
=
Luxembourg

17
=
Finland

18
=
Denmark

20
=
Poland

21
=
Portugal

23
=
Greece

24
=
Ireland

26
=
Slovenia

27
=
Slovakia

29
=
Estonia

32
=
Latvia

36
=
Lithuania

49
=
Cyprus

50
=
Malta

NNN
=
three-digit number, to be determined by the competent authority).

(a)
activation and operation;

(b)
maintenance and servicing;

(c)
general safety instructions (health hazards, e.g. the influencing of pacemakers, etc. by electromagnetic radiation);

(d)
instructions for correct technical installation.

Range scale 1
500 m one circle every 100 m

Range scale 2
800 m one circle every 200 m

Range scale 3
1 200 m one circle every 200 m

Range scale 4
1 600 m one circle every 400 m

Range scale 5
2 000 m one circle every 400 m

(a)
be clearly distinguishable from the lubber line;

(b)
be displayed quasi-continuously;

(c)
be freely rotatable through 360 degrees left and right;

(d)
be at most 0,5 degrees wide at the edge of the screen;

(e)
extend from origin up to the bearing scale;

(f)
and complete a three- or four-figure decimal degree reading.

(a)
be freely rotatable through 360 degrees left and right;

(b)
extend from the marked origin to the bearing scale;

(c)
bear no further markings; and

(d)
be designed in such a way that echo readings are not obscured unnecessarily.

(a)
rate of turn;

(b)
speed of the vessel;

(c)
rudder position;

(d)
water depth;

(e)
compass course.

(a)
Stand-by/on;

(b)
Range;

(c)
Tuning;

(d)
Gain;

(e)
Seaclutter (STC);

(f)
Rainclutter (FTC);

(g)
Variable range marker (VRM);

(h)
Cursor or electronic bearing line (EBL) (if fitted);

(i)
Ship's heading marker suppression (SHM).

(a)
radar picture;

(b)
fixed range circles;

(c)
variable range circles;

(d)
bearing scale;

(e)
bearing line;

(f)
nautical information as specified in Article 3.14(2).

(a)
radar picture and lubber line;

(b)
fixed range circles;

(c)
variable range circles;

(d)
bearing line and bearing scale and nautical information as specified in Article 3.14(2).

(a)
– 3 dB, width of the main lobe: maximum 1,2 degrees;

(b)
– 20 dB, width of the main lobe: maximum 3,0 degrees;

(c)
side-lobe attenuation within ± 10 degrees around the main lobe: at least — 25 dB;

(d)
side-lobe attenuation outside ± 10 degrees around the main lobe: at least — 32 dB.

(a)
– 3 dB, width of the main lobe: maximum 30 degrees;

(b)
the maximum of the main lobe shall be in the horizontal axis;

(c)
side-lobe attenuation: at least — 25 dB.

a
=
edge length in m

Chapter 1:
General

Article 1.01
Scope

Article 1.02
Purpose of the rate-of-turn indicator

Article 1.03
Approval testing

Article 1.04
Application for approval testing

Article 1.05
Type-approval

Article 1.06
Marking of the equipment and approval number

Article 1.07
Manufacturer's declaration

Article 1.08
Modifications to approved equipment

Chapter 2:
General minimum requirements for rate-of-turn indicators

Article 2.01
Construction, design

Article 2.02
Spurious emissions and electromagnetic compatibility

Article 2.03
Operation

Article 2.04
Operating instructions

Article 2.05
Installation and operating tests

Chapter 3:
Minimum operational requirements for rate-of-turn indicators

Article 3.01
Operational readiness of the rate-of-turn indicator

Article 3.02
Indication of the rate of turn

Article 3.03
Measuring ranges

Article 3.04
Accuracy of the indicated rate of turn

Article 3.05
Sensitivity

Article 3.06
Monitoring of operation

Article 3.07
Insensitivity to other normal movements of the vessel

Article 3.08
Insensitivity to magnetic fields

Article 3.09
Slave indicators

Chapter 4:
Minimum technical requirements for rate-of-turn indicators

Article 4.01
Operation

Article 4.02
Damping devices

Article 4.03
Connection of additional equipment

Chapter 5:
Test conditions and procedures for rate-of-turn indicators

Article 5.01
Safety, load capacity and interference diffusion

Article 5.02
Spurious emissions and electromagnetic compatibility

Article 5.03
Test procedure

Appendix:
Maximum tolerances for indication errors of rate-of-turn indicators

(a)
two copies of a detailed technical description;

(b)
two complete sets of installation and service documents;

(c)
two copies of an operator's manual.

(e
=
European Union

NN
=
code for the country of approval, where

1
=
Germany

2
=
France

3
=
Italy

4
=
Netherlands

5
=
Sweden

6
=
Belgium

7
=
Hungary

8
=
Czech Republic

9
=
Spain

11
=
United Kingdom

12
=
Austria

13
=
Luxembourg

17
=
Finland

18
=
Denmark

20
=
Poland

21
=
Portugal

23
=
Greece

24
=
Ireland

26
=
Slovenia

27
=
Slovakia

29
=
Estonia

32
=
Latvia

36
=
Lithuania

49
=
Cyprus

50
=
Malta

NNN
=
three-digit number, to be determined by the competent authority).

(a)
activation and operation;

(b)
maintenance and servicing;

(c)
general safety instructions.

30°/minute

60°/minute

90°/minute

180°/minute

300°/minute.

(a)
if the rate-of-turn indicator is disconnected; or

(b)
if the rate-of-turn indicator is not in operation; or

(c)
if the operating control has reacted following an excessive error (Article 3.06).

Article 1
Scope

Article 2
Approval of equipment

Article 3
Approved specialised firms

Article 4
Requirements for on-board power supply

Article 5
Installation of the radar antenna

Article 6
Installation of the display unit and the control unit

Article 7
Installation of the rate-of-turn indicator

Article 8
Installation of the position sensor

Article 9
Installation and performance test

Article 10
Installation and performance certificate

Appendix
Model installation and performance certificate for radar equipment and rate-of-turn indicators

(a)
the power supply shall have a separate safety device;

(b)
the operating voltage shall be within the tolerance (Article 2.01 of Part III);

(c)
the cabling and its installation shall satisfy the provisions of Annex II and, if necessary, the ADNR;

(d)
the number of antenna revolutions shall reach at least 24 per minute;

(e)
there shall be no obstruction in the vicinity of the antenna which impairs navigation;

(f)
the safety switch of the antenna shall be in good working order;

(g)
the arrangement of display units, rate-of-turn indicators and control units shall be ergonomic and user-friendly;

(h)
the lubber line of the radar equipment shall not deviate from the ship's fore-and-aft-line by more than 1 degree;

(i)
the accuracy of the range and azimuthal displays shall satisfy the requirements (measurements using known targets);

(k)
linearity in short ranges shall be correct (pushing and pulling);

(l)
the displayed minimum range shall be 15 metres or less;

(m)
the centre of the picture shall be visible and its diameter shall not exceed 1 mm;

(n)
False echoes caused by reflections and unwanted shadows on the lubber line shall not occur or shall not impair the safety of navigation;

(o)
Sea-clutter and rain-clutter suppressors (STC and FTC preset) and the associated controls shall perform correctly;

(p)
the gain adjustment shall be in proper working order;

(q)
focus and picture definition shall be correct;

(r)
the ship's turning direction shall be as indicated on the rate-of-turn indicator and the zero position at dead ahead shall be correct;

(s)
the radar equipment shall not be sensitive to transmissions by the ship's radio equipment or to interference from other on-board sources;

(t)
the radar equipment and/or rate-of-turn indicator shall not interfere with other on-board equipment.

(u)
the statistical positional error affecting the chart shall not exceed 2 m;

(v)
the statistical phase angle error affecting the chart shall not exceed 1 degree.

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 71(1) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee(1),

Following consultation of the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),

(1) Council Directive 82/714/EEC of 4 October 1982 laying down technical requirements for inland waterway vessels(3)introduced harmonised conditions for issuing technical certificates for inland waterway vessels in all Member States, albeit excluding operations on the Rhine. Nevertheless, at European level, various technical requirements for inland waterway vessels have remained in force. Up to now, the coexistence of various international and national regulations has obstructed efforts to ensure mutual recognition of national navigation certificates without the need for an additional inspection of foreign vessels. Furthermore, the standards contained in Directive 82/714/EEC, in part, no longer reflect current technological developments.

(2) Essentially, the technical requirements set out in the annexes to Directive 82/714/EEC incorporate the provisions laid down in the Rhine Vessel Inspection Regulation, in the version approved by the Central Commission for Navigation on the Rhine (CCNR) in 1982. The conditions and technical requirements for issuing inland navigation certificates under Article 22 of the Revised Convention for Rhine Navigation have been revised regularly since then and are recognised as reflecting current technological developments. For competition and safety reasons it is desirable, specifically in the interests of promoting harmonisation at European level, to adopt the scope and content of such technical requirements for the whole of the Community’s inland waterway network. Account should be taken in this regard of the changes that have occurred in that network.

(3) Community inland navigation certificates attesting the full compliance of vessels with the aforementioned revised technical requirements should be valid on all Community inland waterways.

(4) It is desirable to ensure a greater degree of harmonisation between the conditions for the issuing of supplementary Community inland navigation certificates by Member States for operations on Zone 1 and 2 waterways (estuaries), as well as for operations on Zone 4 waterways.

(5) In the interests of passenger transport safety, it is desirable that the scope of Directive 82/714/EEC be extended to include passenger vessels designed to carry more than 12 passengers, along the lines of the Rhine Vessel Inspection Regulation.

(6) In the interests of safety, harmonisation of standards should be at a high level and should be achieved in such a way so as not to result in any reduction in safety standards on any Community inland waterway.

(7) It is appropriate to provide for a transitional regime for vessels in service not yet carrying a Community inland navigation certificate when subjected to a first technical inspection under the revised technical requirements established by this Directive.

(8) It is appropriate, within certain limits and according to the category of vessel concerned, to determine the period of validity of Community inland navigation certificates in each specific case.

(9) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(4).

(10) It is necessary that the measures provided for in Council Directive 76/135/EEC of 20 January 1976 on reciprocal recognition of navigability licenses for inland waterway vessels(5)remain in force for those vessels not covered by this Directive.

(11) Given that some vessels fall within the scope of Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft(6)as well as of this Directive, the annexes of the two Directives should be adjusted by the relevant committee procedures as soon as possible if there are any contradictions or inconsistencies between the provisions of those Directives.

(12) In accordance with point 34 of the Interinstitutional Agreement on better law-making(7), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

(13) Directive 82/714/EEC should be repealed,

HAVE ADOPTED THIS DIRECTIVE:
Classification of waterways

Article 1

1.   For the purposes of this Directive, Community inland waterways shall be classified as follows:

(a)

Zones 1, 2, 3 and 4:

(i)

Zones 1 and 2: the waterways listed in Chapter 1 of Annex I;

(ii)

Zone 3: the waterways listed in Chapter 2 of Annex I;

(iii)

Zone 4: the waterways listed in Chapter 3 of Annex I.

(b)

Zone R: those of the waterways referred to in point (a) for which certificates are to be issued in accordance with Article 22 of the Revised Convention for Rhine Navigation as that Article is worded when this Directive enters into force.

2.   Any Member State may, after consulting the Commission, modify the classification of its waterways into the zones listed in Annex I. The Commission shall be notified of these modifications at least six months before their entry into force and shall inform the other Member States.
Scope of application

Article 2

1.   This Directive shall, in accordance with Article 1.01 of Annex II, apply to the following craft:

(a)

vessels having a length (L) of 20 metres or more;

(b)

vessels for which the product of length (L), breadth (B) and draught (T) is a volume of 100 m3or more.

2.   This Directive shall also apply, in accordance with Article 1.01 of Annex II, to all of the following craft:

(a)

tugs and pushers intended for towing or pushing craft referred to in paragraph 1 or floating equipment or for moving such craft or floating equipment alongside;

(b)

vessels intended for passenger transport which carry more than 12 passengers in addition to the crew;

(c)

floating equipment.

3.   The following craft shall be excluded from this Directive:

(a)

ferries;

(b)

naval vessels;

(c)

sea-going vessels, including sea-going tugs and pusher craft, which:

(i)

operate or are based on tidal waters;

(ii)

operate temporarily on inland waterways, provided that they carry:

—

a certificate proving conformity with the 1974 International Convention for the Safety of Life at Sea (SOLAS), or equivalent, a certificate proving conformity with the 1966 International Convention on Load Lines, or equivalent, and an international oil pollution prevention (IOPP) certificate proving conformity with the 1973 International Convention for the Prevention of Pollution from Ships (MARPOL); or

—

in the case of passenger vessels not covered by all of the Conventions referred to in the first indent, a certificate on safety rules and standards for passenger ships issued in conformity with Council Directive 98/18/EC of 17 March 1998 on safety rules and standards for passenger ships(8); or

—

in the case of recreational craft not covered by all of the Conventions referred to in the first indent, a certificate of the country of which it carries the flag.
Obligation to carry a certificate

Article 3

1.   Craft operating on the Community inland waterways referred to in Article 1 shall carry:

(a)

when operating on a Zone R waterway:

—

either a certificate issued pursuant to Article 22 of the Revised Convention for Rhine Navigation;

—

or a Community inland navigation certificate issued or renewed after 30 December 2008, and attesting full compliance of the craft, without prejudice to the transitional provisions of Chapter 24 of Annex II, with technical requirements as defined in Annex II for which equivalency with the technical requirements laid down in application of the abovementioned Convention has been established according to the applicable rules and procedures;

(b)

when operating on other waterways, a Community inland navigation certificate, including, where applicable, the specifications referred to in Article 5.

2.   The Community inland navigation certificate shall be drawn up following the model set out in Part I of Annex V and shall be issued in accordance with this Directive.
Supplementary Community inland navigation certificates

Article 4

1.   All craft carrying a valid certificate issued pursuant to Article 22 of the Revised Convention for Rhine Navigation may, subject to the provisions of Article 5(5) of this Directive, navigate on Community waterways carrying that certificate only.

2.   However, all craft carrying the certificate referred to in paragraph 1 shall also be provided with a supplementary Community inland navigation certificate:

(a)

when operating on Zone 3 and 4 waterways, if they wish to take advantage of the reduction in technical requirements on those waterways;

(b)

when operating on Zone 1 and 2 waterways, or, in respect of passenger vessels, when operating on Zone 3 waterways that are not linked to the navigable inland waterways of another Member State, if the Member State concerned has adopted additional technical requirements for those waterways, in accordance with Article 5(1), (2) and (3).

3.   The supplementary Community inland navigation certificate shall be drawn up following the model set out in Part II of Annex V and shall be issued by the competent authorities on production of the certificate referred to in paragraph 1 and under the conditions laid down by the authorities competent for the waterways concerned.
Additional or reduced technical requirements for certain zones

Article 5

1.   Each Member State may, after consulting the Commission, and where applicable subject to the requirements of the Revised Convention for Rhine Navigation, adopt technical requirements additional to those in Annex II for craft operating on Zone 1 and 2 waterways within its territory.

2.   In respect of passenger vessels operating on Zone 3 waterways within its territory that are not linked to the navigable inland waterways of another Member State, each Member State may maintain technical requirements additional to those in Annex II. Amendments to such technical requirements shall require the prior approval of the Commission.

3.   The additional requirements shall be restricted to the subjects listed in Annex III. The Commission shall be notified of these additional requirements at least six months before their entry into force and shall inform the other Member States.

4.   Compliance with the additional requirements shall be specified in the Community inland navigation certificate referred to in Article 3 or, where Article 4(2) applies, in the supplementary Community inland navigation certificate. Such proof of compliance shall be recognised on Community waterways of the corresponding zone.

5.

(a)

Where application of the transitional provisions set out in Chapter 24a of Annex II would result in a reduction in existing national safety standards, a Member State may disapply those transitional provisions in respect of inland waterway passenger vessels operating on its inland waterways that are not linked to the navigable inland waterways of another Member State. In such circumstances, the Member State may require that such vessels operating on its non-linked inland waterways comply fully with the technical requirements set out in Annex II from 30 December 2008.

(b)

A Member State exercising the provision in point (a) shall inform the Commission of its decision and provide the Commission with details of the relevant national standards applying to passenger vessels operating on its inland waterways. The Commission shall inform the Member States.

(c)

Compliance with the requirements of a Member State for operating on its non-linked inland waterways shall be specified in the Community inland navigation certificate referred to in Article 3 or, where Article 4(2) applies, in the supplementary Community inland navigation certificate.

6.   Craft operating only on Zone 4 waterways shall qualify for the reduced requirements as specified in Chapter 19b of Annex II on all waterways in that zone. Compliance with those reduced requirements shall be specified in the Community inland navigation certificate referred to in Article 3.

7.   Each Member State may, after consulting the Commission, allow a reduction of the technical requirements of Annex II for craft operating exclusively on Zone 3 and 4 waterways within its territory.

Such a reduction shall be restricted to the subjects listed in Annex IV. Where the technical characteristics of a craft correspond to the reduced technical requirements, this shall be specified in the Community inland navigation certificate or, where Article 4(2) applies, in the supplementary Community inland navigation certificate.

The Commission shall be notified of the reductions of the technical requirements of Annex II at least six months before they come into force and shall inform the other Member States.
Dangerous goods

Article 6

Any craft carrying a certificate issued pursuant to the Regulation for the transport of dangerous substances on the Rhine (the ‘ADNR’) may carry dangerous goods throughout the territory of the Community under the conditions stated in that certificate.

Any Member State may require that craft which do not carry such a certificate shall only be authorised to carry dangerous goods within its territory if the craft comply with requirements additional to those set out in this Directive. The Commission shall be notified of such requirements and shall inform the other Member States.
Derogations

Article 7

1.   Member States may authorise derogations from all or part of this Directive for:

(a)

vessels, tugs, pushers and floating equipment operating on navigable waterways not linked by inland waterway to the waterways of other Member States;

(b)

craft having a dead weight not exceeding 350 tonnes or craft not intended for the carriage of goods and having a water displacement of less than 100 m3, which were laid down before 1 January 1950 and operate exclusively on a national waterway.

2.   Member States may authorise in respect of navigation on their national waterways derogations from one or more provisions of this Directive for limited journeys of local interest or in harbour areas. These derogations and the journeys or area for which they are valid shall be specified in the vessel’s certificate.

3.   The Commission shall be notified of derogations authorised in accordance with paragraphs 1 and 2 and shall inform the other Member States.

4.   Any Member State which, as a result of derogations authorised in accordance with paragraphs 1 and 2, has no craft subject to the provisions of this Directive operating on its waterways shall not be required to comply with Articles 9, 10 and 12.
Issuance of Community inland navigation certificates

Article 8

1.   The Community inland navigation certificate shall be issued to craft laid down as from 30 December 2008 following a technical inspection carried out prior to the craft being put into service and intended to check whether the craft complies with the technical requirements laid down in Annex II.

2.   The Community inland navigation certificate shall be issued to craft excluded from the scope of Directive 82/714/EEC, but covered by this Directive in accordance with Article 2(1) and (2), following a technical inspection which shall be carried out upon expiry of the craft’s current certificate, but in any case no later than 30 December 2018, to check whether the craft complies with the technical requirements laid down in Annex II. In Member States where the validity period of the craft’s current national certificate is shorter than five years, such certificate may be issued until five years after 30 December 2008.

Any failure to meet the technical requirements laid down in Annex II shall be specified in the Community inland navigation certificate. Provided that the competent authorities consider that these shortcomings do not constitute a manifest danger, the craft referred to in the first subparagraph may continue to operate until such time as those components or areas of the craft which have been certified as not meeting those requirements are replaced or altered, whereafter those components or areas shall meet the requirements of Annex II.

3.   Manifest danger within the meaning of this Article shall be presumed in particular when requirements concerning the structural soundness of the shipbuilding, the navigation or manoeuvrability or special features of the craft in accordance with Annex II are affected. Derogations as allowed for in Annex II shall not be identified as shortcomings which constitute a manifest danger.

The replacement of existing parts with identical parts or parts of an equivalent technology and design during routine repairs and maintenance shall not be considered as a replacement within the meaning of this Article.

4.   Compliance of a craft with the additional requirements referred to in Article 5(1), (2) and (3) shall, where appropriate, be checked during the technical inspections provided for in paragraphs 1 and 2 of this Article, or during a technical inspection carried out at the request of the vessel’s owner.
Competent authorities

Article 9

1.   Community inland navigation certificates may be issued by the competent authorities of any Member State.

2.   Each Member State shall draw up a list indicating which of its authorities are competent for issuing the Community inland navigation certificates and shall notify the Commission thereof. The Commission shall inform the other Member States.
Carrying out of technical inspections

Article 10

1.   The technical inspection referred to in Article 8 shall be carried out by the competent authorities which may refrain from subjecting the craft in whole or in part to technical inspection where it is evident from a valid attestation, issued by a recognised classification society in accordance with Article 1.01 of Annex II, that the craft satisfies in whole or in part the technical requirements of Annex II. Classification societies shall only be recognised if they fulfil the criteria listed in Part I of Annex VII.

2.   Each Member State shall draw up a list indicating which of its authorities are competent for carrying out technical inspections and shall notify the Commission thereof. The Commission shall inform the other Member States.
Validity of Community inland navigation certificates

Article 11

1.   The period of validity of Community inland navigation certificates shall be determined in each specific case by the authority competent for issuing such certificates in accordance with Annex II.

2.   Each Member State may, in the cases specified in Articles 12 and 16 and in Annex II, issue provisional Community inland navigation certificates. Provisional Community inland navigation certificates shall be drawn up following the model set out in Part III of Annex V.
Replacement of Community inland navigation certificates

Article 12

Each Member State shall lay down the conditions under which a valid Community inland navigation certificate which has been lost or damaged may be replaced.
Renewal of Community inland navigation certificates

Article 13

1.   The Community inland navigation certificate shall be renewed on expiry of its period of validity in accordance with the conditions laid down in Article 8.

2.   For the renewal of Community inland navigation certificates issued before 30 December 2008, the transitional provisions of Annex II shall apply.

3.   For the renewal of Community inland navigation certificates issued after 30 December 2008, the transitional provisions of Annex II which have come into force after the issuing of such certificates shall apply.
Extension of validity of Community inland navigation certificates

Article 14

The validity of a Community inland navigation certificate may exceptionally be extended without a technical inspection in accordance with Annex II by the authority which issued or renewed it. Such extension shall be indicated on that certificate.
Issuance of new Community inland navigation certificates

Article 15

In the event of major alterations or repairs which affect the structural soundness of the shipbuilding, the navigation or manoeuvrability or special features of the craft in accordance with Annex II, the latter shall again undergo, prior to any further voyage, the technical inspection provided for in Article 8. Following this inspection, a new Community inland navigation certificate stating the technical characteristics of the craft shall be issued or the existing certificate amended accordingly. If this certificate is issued in a Member State other than that which issued or renewed the initial certificate, the competent authority which issued or renewed the certificate shall be informed accordingly within one month.
Refusal to issue or renew, and withdrawal of, Community inland navigation certificates

Article 16

Any decision to refuse to issue or renew a Community inland navigation certificate shall state the grounds on which it is based. The person concerned shall be notified thereof and of the appeal procedure and its time limits in the Member State concerned.

Any valid Community inland navigation certificate may be withdrawn by the competent authority which issued or renewed it if the craft ceases to comply with the technical requirements specified in its certificate.
Additional inspections

Article 17

The competent authorities of a Member State may, in accordance with Annex VIII, check at any time whether a craft is carrying a certificate valid under the terms of this Directive and satisfies the requirements set out in such certificate or constitutes a manifest danger for the persons on board, the environment or the navigation. The competent authorities shall take the necessary measures in accordance with Annex VIII.
Recognition of navigability certificates of craft from third countries

Article 18

Pending the conclusion of agreements on the mutual recognition of navigability certificates between the Community and third countries, the competent authorities of a Member State may recognise the navigability certificates of craft from third countries for navigation on the waterways of that Member State.

The issuance of Community inland navigation certificates to craft from third countries shall be carried out in accordance with Article 8(1).
Committee procedure

Article 19

1.   The Commission shall be assisted by the Committee established under Article 7 of Council Directive 91/672/EEC of 16 December 1991 on the reciprocal recognition of national boatmasters’ certificates for the carriage of goods and passengers by inland waterway(9)(hereinafter referred to as ‘the Committee’).

2.   Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Adaptation of the annexes and recommendations on provisional certificates

Article 20

1.   Any amendments which are necessary to adapt the annexes to this Directive to technical progress or to developments in this area arising from the work of other international organisations, in particular that of the Central Commission for Navigation on the Rhine (CCNR), to ensure that the two certificates referred to in Article 3(1)(a) are issued on the basis of technical requirements which guarantee an equivalent level of safety, or to take account of the cases referred to in Article 5, shall be adopted by the Commission in accordance with the procedure referred to in Article 19(2).

Those amendments shall be made rapidly in order to ensure that the technical requirements necessary for the issuing of the Community inland navigation certificate recognised for navigation on the Rhine give a level of safety equivalent to that required for the issuing of the certificate referred to in Article 22 of the Revised Convention for Rhine Navigation.

2.   The Commission shall decide on recommendations from the Committee on the issuance of provisional Community inland navigation certificates in accordance with Article 2.19 of Annex II.
Continued applicability of Directive 76/135/EEC

Article 21

For those craft outside the scope of Article 2(1) and (2) of this Directive, but falling within the scope of Article 1(a) of Directive 76/135/EEC, the provisions of that Directive shall apply.
National additional or reduced requirements

Article 22

Additional requirements which were in force in a Member State before 30 December 2008 for craft operating within its territory on Zone 1 and 2 waterways or reduced technical requirements for craft operating within its territory on Zone 3 and 4 waterways which were in force in a Member State before that date shall continue to be in force until additional requirements in accordance with Article 5(1) or reductions in accordance with Article 5(7) of the technical prescriptions of Annex II come into force, but only until 30 June 2009.
Transposition

Article 23

1.   Member States which have inland waterways as referred to in Article 1(1) shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 30 December 2008. They shall forthwith inform the Commission thereof.

When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2.   Member States shall immediately communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof.
Penalties

Article 24

Member States shall lay down a system of penalties for breaches of the national provisions adopted pursuant to this Directive and shall take all the measures necessary to ensure that these penalties are applied. The penalties thus provided for shall be effective, proportionate and dissuasive.
Repeal of Directive 82/714/EEC

Article 25

Directive 82/714/EEC shall be repealed with effect from 30 December 2008.
Entry into force

Article 26

This Directive shall enter into force on the day of its publication in theOfficial Journal of the European Union.
Addressees

Article 27

This Directive is addressed to the Member States which have inland waterways as referred to in Article 1(1).
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 71(1) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee(1),

Following consultation of the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),

(1) Council Directive 82/714/EEC of 4 October 1982 laying down technical requirements for inland waterway vessels(3)introduced harmonised conditions for issuing technical certificates for inland waterway vessels in all Member States, albeit excluding operations on the Rhine. Nevertheless, at European level, various technical requirements for inland waterway vessels have remained in force. Up to now, the coexistence of various international and national regulations has obstructed efforts to ensure mutual recognition of national navigation certificates without the need for an additional inspection of foreign vessels. Furthermore, the standards contained in Directive 82/714/EEC, in part, no longer reflect current technological developments.

(2) Essentially, the technical requirements set out in the annexes to Directive 82/714/EEC incorporate the provisions laid down in the Rhine Vessel Inspection Regulation, in the version approved by the Central Commission for Navigation on the Rhine (CCNR) in 1982. The conditions and technical requirements for issuing inland navigation certificates under Article 22 of the Revised Convention for Rhine Navigation have been revised regularly since then and are recognised as reflecting current technological developments. For competition and safety reasons it is desirable, specifically in the interests of promoting harmonisation at European level, to adopt the scope and content of such technical requirements for the whole of the Community’s inland waterway network. Account should be taken in this regard of the changes that have occurred in that network.

(3) Community inland navigation certificates attesting the full compliance of vessels with the aforementioned revised technical requirements should be valid on all Community inland waterways.

(4) It is desirable to ensure a greater degree of harmonisation between the conditions for the issuing of supplementary Community inland navigation certificates by Member States for operations on Zone 1 and 2 waterways (estuaries), as well as for operations on Zone 4 waterways.

(5) In the interests of passenger transport safety, it is desirable that the scope of Directive 82/714/EEC be extended to include passenger vessels designed to carry more than 12 passengers, along the lines of the Rhine Vessel Inspection Regulation.

(6) In the interests of safety, harmonisation of standards should be at a high level and should be achieved in such a way so as not to result in any reduction in safety standards on any Community inland waterway.

(7) It is appropriate to provide for a transitional regime for vessels in service not yet carrying a Community inland navigation certificate when subjected to a first technical inspection under the revised technical requirements established by this Directive.

(8) It is appropriate, within certain limits and according to the category of vessel concerned, to determine the period of validity of Community inland navigation certificates in each specific case.

(9) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(4).

(10) It is necessary that the measures provided for in Council Directive 76/135/EEC of 20 January 1976 on reciprocal recognition of navigability licenses for inland waterway vessels(5)remain in force for those vessels not covered by this Directive.

(11) Given that some vessels fall within the scope of Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft(6)as well as of this Directive, the annexes of the two Directives should be adjusted by the relevant committee procedures as soon as possible if there are any contradictions or inconsistencies between the provisions of those Directives.

(12) In accordance with point 34 of the Interinstitutional Agreement on better law-making(7), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

(13) Directive 82/714/EEC should be repealed,

HAVE ADOPTED THIS DIRECTIVE:
Classification of waterways1.   For the purposes of this Directive, Community inland waterways shall be classified as follows:

(a)

Zones 1, 2, 3 and 4:

(i)

Zones 1 and 2: the waterways listed in Chapter 1 of Annex I;

(ii)

Zone 3: the waterways listed in Chapter 2 of Annex I;

(iii)

Zone 4: the waterways listed in Chapter 3 of Annex I.

(b)

Zone R: those of the waterways referred to in point (a) for which certificates are to be issued in accordance with Article 22 of the Revised Convention for Rhine Navigation as that Article is worded when this Directive enters into force.

2.   Any Member State may, after consulting the Commission, modify the classification of its waterways into the zones listed in Annex I. The Commission shall be notified of these modifications at least six months before their entry into force and shall inform the other Member States.
Scope of application1.   This Directive shall, in accordance with Article 1.01 of Annex II, apply to the following craft:

(a)

vessels having a length (L) of 20 metres or more;

(b)

vessels for which the product of length (L), breadth (B) and draught (T) is a volume of 100 m3or more.

2.   This Directive shall also apply, in accordance with Article 1.01 of Annex II, to all of the following craft:

(a)

tugs and pushers intended for towing or pushing craft referred to in paragraph 1 or floating equipment or for moving such craft or floating equipment alongside;

(b)

vessels intended for passenger transport which carry more than 12 passengers in addition to the crew;

(c)

floating equipment.

3.   The following craft shall be excluded from this Directive:

(a)

ferries;

(b)

naval vessels;

(c)

sea-going vessels, including sea-going tugs and pusher craft, which:

(i)

operate or are based on tidal waters;

(ii)

operate temporarily on inland waterways, provided that they carry:

—

a certificate proving conformity with the 1974 International Convention for the Safety of Life at Sea (SOLAS), or equivalent, a certificate proving conformity with the 1966 International Convention on Load Lines, or equivalent, and an international oil pollution prevention (IOPP) certificate proving conformity with the 1973 International Convention for the Prevention of Pollution from Ships (MARPOL); or

—

in the case of passenger vessels not covered by all of the Conventions referred to in the first indent, a certificate on safety rules and standards for passenger ships issued in conformity with Council Directive 98/18/EC of 17 March 1998 on safety rules and standards for passenger ships(8); or

—

in the case of recreational craft not covered by all of the Conventions referred to in the first indent, a certificate of the country of which it carries the flag.
Obligation to carry a certificate1.   Craft operating on the Community inland waterways referred to in Article 1 shall carry:

(a)

when operating on a Zone R waterway:

—

either a certificate issued pursuant to Article 22 of the Revised Convention for Rhine Navigation;

—

or a Community inland navigation certificate issued or renewed after 30 December 2008, and attesting full compliance of the craft, without prejudice to the transitional provisions of Chapter 24 of Annex II, with technical requirements as defined in Annex II for which equivalency with the technical requirements laid down in application of the abovementioned Convention has been established according to the applicable rules and procedures;

(b)

when operating on other waterways, a Community inland navigation certificate, including, where applicable, the specifications referred to in Article 5.

2.   The Community inland navigation certificate shall be drawn up following the model set out in Part I of Annex V and shall be issued in accordance with this Directive.
Supplementary Community inland navigation certificates1.   All craft carrying a valid certificate issued pursuant to Article 22 of the Revised Convention for Rhine Navigation may, subject to the provisions of Article 5(5) of this Directive, navigate on Community waterways carrying that certificate only.

2.   However, all craft carrying the certificate referred to in paragraph 1 shall also be provided with a supplementary Community inland navigation certificate:

(a)

when operating on Zone 3 and 4 waterways, if they wish to take advantage of the reduction in technical requirements on those waterways;

(b)

when operating on Zone 1 and 2 waterways, or, in respect of passenger vessels, when operating on Zone 3 waterways that are not linked to the navigable inland waterways of another Member State, if the Member State concerned has adopted additional technical requirements for those waterways, in accordance with Article 5(1), (2) and (3).

3.   The supplementary Community inland navigation certificate shall be drawn up following the model set out in Part II of Annex V and shall be issued by the competent authorities on production of the certificate referred to in paragraph 1 and under the conditions laid down by the authorities competent for the waterways concerned.
Additional or reduced technical requirements for certain zones1.   Each Member State may, after consulting the Commission, and where applicable subject to the requirements of the Revised Convention for Rhine Navigation, adopt technical requirements additional to those in Annex II for craft operating on Zone 1 and 2 waterways within its territory.

2.   In respect of passenger vessels operating on Zone 3 waterways within its territory that are not linked to the navigable inland waterways of another Member State, each Member State may maintain technical requirements additional to those in Annex II. Amendments to such technical requirements shall require the prior approval of the Commission.

3.   The additional requirements shall be restricted to the subjects listed in Annex III. The Commission shall be notified of these additional requirements at least six months before their entry into force and shall inform the other Member States.

4.   Compliance with the additional requirements shall be specified in the Community inland navigation certificate referred to in Article 3 or, where Article 4(2) applies, in the supplementary Community inland navigation certificate. Such proof of compliance shall be recognised on Community waterways of the corresponding zone.

5.

(a)

Where application of the transitional provisions set out in Chapter 24a of Annex II would result in a reduction in existing national safety standards, a Member State may disapply those transitional provisions in respect of inland waterway passenger vessels operating on its inland waterways that are not linked to the navigable inland waterways of another Member State. In such circumstances, the Member State may require that such vessels operating on its non-linked inland waterways comply fully with the technical requirements set out in Annex II from 30 December 2008.

(b)

A Member State exercising the provision in point (a) shall inform the Commission of its decision and provide the Commission with details of the relevant national standards applying to passenger vessels operating on its inland waterways. The Commission shall inform the Member States.

(c)

Compliance with the requirements of a Member State for operating on its non-linked inland waterways shall be specified in the Community inland navigation certificate referred to in Article 3 or, where Article 4(2) applies, in the supplementary Community inland navigation certificate.

6.   Craft operating only on Zone 4 waterways shall qualify for the reduced requirements as specified in Chapter 19b of Annex II on all waterways in that zone. Compliance with those reduced requirements shall be specified in the Community inland navigation certificate referred to in Article 3.

7.   Each Member State may, after consulting the Commission, allow a reduction of the technical requirements of Annex II for craft operating exclusively on Zone 3 and 4 waterways within its territory.

Such a reduction shall be restricted to the subjects listed in Annex IV. Where the technical characteristics of a craft correspond to the reduced technical requirements, this shall be specified in the Community inland navigation certificate or, where Article 4(2) applies, in the supplementary Community inland navigation certificate.

The Commission shall be notified of the reductions of the technical requirements of Annex II at least six months before they come into force and shall inform the other Member States.
Dangerous goodsAny craft carrying a certificate issued pursuant to the Regulation for the transport of dangerous substances on the Rhine (the ‘ADNR’) may carry dangerous goods throughout the territory of the Community under the conditions stated in that certificate.

Any Member State may require that craft which do not carry such a certificate shall only be authorised to carry dangerous goods within its territory if the craft comply with requirements additional to those set out in this Directive. The Commission shall be notified of such requirements and shall inform the other Member States.
Derogations1.   Member States may authorise derogations from all or part of this Directive for:

(a)

vessels, tugs, pushers and floating equipment operating on navigable waterways not linked by inland waterway to the waterways of other Member States;

(b)

craft having a dead weight not exceeding 350 tonnes or craft not intended for the carriage of goods and having a water displacement of less than 100 m3, which were laid down before 1 January 1950 and operate exclusively on a national waterway.

2.   Member States may authorise in respect of navigation on their national waterways derogations from one or more provisions of this Directive for limited journeys of local interest or in harbour areas. These derogations and the journeys or area for which they are valid shall be specified in the vessel’s certificate.

3.   The Commission shall be notified of derogations authorised in accordance with paragraphs 1 and 2 and shall inform the other Member States.

4.   Any Member State which, as a result of derogations authorised in accordance with paragraphs 1 and 2, has no craft subject to the provisions of this Directive operating on its waterways shall not be required to comply with Articles 9, 10 and 12.
Issuance of Community inland navigation certificates1.   The Community inland navigation certificate shall be issued to craft laid down as from 30 December 2008 following a technical inspection carried out prior to the craft being put into service and intended to check whether the craft complies with the technical requirements laid down in Annex II.

2.   The Community inland navigation certificate shall be issued to craft excluded from the scope of Directive 82/714/EEC, but covered by this Directive in accordance with Article 2(1) and (2), following a technical inspection which shall be carried out upon expiry of the craft’s current certificate, but in any case no later than 30 December 2018, to check whether the craft complies with the technical requirements laid down in Annex II. In Member States where the validity period of the craft’s current national certificate is shorter than five years, such certificate may be issued until five years after 30 December 2008.

Any failure to meet the technical requirements laid down in Annex II shall be specified in the Community inland navigation certificate. Provided that the competent authorities consider that these shortcomings do not constitute a manifest danger, the craft referred to in the first subparagraph may continue to operate until such time as those components or areas of the craft which have been certified as not meeting those requirements are replaced or altered, whereafter those components or areas shall meet the requirements of Annex II.

3.   Manifest danger within the meaning of this Article shall be presumed in particular when requirements concerning the structural soundness of the shipbuilding, the navigation or manoeuvrability or special features of the craft in accordance with Annex II are affected. Derogations as allowed for in Annex II shall not be identified as shortcomings which constitute a manifest danger.

The replacement of existing parts with identical parts or parts of an equivalent technology and design during routine repairs and maintenance shall not be considered as a replacement within the meaning of this Article.

4.   Compliance of a craft with the additional requirements referred to in Article 5(1), (2) and (3) shall, where appropriate, be checked during the technical inspections provided for in paragraphs 1 and 2 of this Article, or during a technical inspection carried out at the request of the vessel’s owner.
Competent authorities1.   Community inland navigation certificates may be issued by the competent authorities of any Member State.

2.   Each Member State shall draw up a list indicating which of its authorities are competent for issuing the Community inland navigation certificates and shall notify the Commission thereof. The Commission shall inform the other Member States.
Carrying out of technical inspections1.   The technical inspection referred to in Article 8 shall be carried out by the competent authorities which may refrain from subjecting the craft in whole or in part to technical inspection where it is evident from a valid attestation, issued by a recognised classification society in accordance with Article 1.01 of Annex II, that the craft satisfies in whole or in part the technical requirements of Annex II. Classification societies shall only be recognised if they fulfil the criteria listed in Part I of Annex VII.

2.   Each Member State shall draw up a list indicating which of its authorities are competent for carrying out technical inspections and shall notify the Commission thereof. The Commission shall inform the other Member States.
Validity of Community inland navigation certificates1.   The period of validity of Community inland navigation certificates shall be determined in each specific case by the authority competent for issuing such certificates in accordance with Annex II.

2.   Each Member State may, in the cases specified in Articles 12 and 16 and in Annex II, issue provisional Community inland navigation certificates. Provisional Community inland navigation certificates shall be drawn up following the model set out in Part III of Annex V.
Replacement of Community inland navigation certificatesEach Member State shall lay down the conditions under which a valid Community inland navigation certificate which has been lost or damaged may be replaced.
Renewal of Community inland navigation certificates1.   The Community inland navigation certificate shall be renewed on expiry of its period of validity in accordance with the conditions laid down in Article 8.

2.   For the renewal of Community inland navigation certificates issued before 30 December 2008, the transitional provisions of Annex II shall apply.

3.   For the renewal of Community inland navigation certificates issued after 30 December 2008, the transitional provisions of Annex II which have come into force after the issuing of such certificates shall apply.
Extension of validity of Community inland navigation certificatesThe validity of a Community inland navigation certificate may exceptionally be extended without a technical inspection in accordance with Annex II by the authority which issued or renewed it. Such extension shall be indicated on that certificate.
Issuance of new Community inland navigation certificatesIn the event of major alterations or repairs which affect the structural soundness of the shipbuilding, the navigation or manoeuvrability or special features of the craft in accordance with Annex II, the latter shall again undergo, prior to any further voyage, the technical inspection provided for in Article 8. Following this inspection, a new Community inland navigation certificate stating the technical characteristics of the craft shall be issued or the existing certificate amended accordingly. If this certificate is issued in a Member State other than that which issued or renewed the initial certificate, the competent authority which issued or renewed the certificate shall be informed accordingly within one month.
Refusal to issue or renew, and withdrawal of, Community inland navigation certificatesAny decision to refuse to issue or renew a Community inland navigation certificate shall state the grounds on which it is based. The person concerned shall be notified thereof and of the appeal procedure and its time limits in the Member State concerned.

Any valid Community inland navigation certificate may be withdrawn by the competent authority which issued or renewed it if the craft ceases to comply with the technical requirements specified in its certificate.
Additional inspectionsThe competent authorities of a Member State may, in accordance with Annex VIII, check at any time whether a craft is carrying a certificate valid under the terms of this Directive and satisfies the requirements set out in such certificate or constitutes a manifest danger for the persons on board, the environment or the navigation. The competent authorities shall take the necessary measures in accordance with Annex VIII.
Recognition of navigability certificates of craft from third countriesPending the conclusion of agreements on the mutual recognition of navigability certificates between the Community and third countries, the competent authorities of a Member State may recognise the navigability certificates of craft from third countries for navigation on the waterways of that Member State.

The issuance of Community inland navigation certificates to craft from third countries shall be carried out in accordance with Article 8(1).
Committee procedure1.   The Commission shall be assisted by the Committee established under Article 7 of Council Directive 91/672/EEC of 16 December 1991 on the reciprocal recognition of national boatmasters’ certificates for the carriage of goods and passengers by inland waterway(9)(hereinafter referred to as ‘the Committee’).

2.   Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Adaptation of the annexes and recommendations on provisional certificates1.   Any amendments which are necessary to adapt the annexes to this Directive to technical progress or to developments in this area arising from the work of other international organisations, in particular that of the Central Commission for Navigation on the Rhine (CCNR), to ensure that the two certificates referred to in Article 3(1)(a) are issued on the basis of technical requirements which guarantee an equivalent level of safety, or to take account of the cases referred to in Article 5, shall be adopted by the Commission in accordance with the procedure referred to in Article 19(2).

Those amendments shall be made rapidly in order to ensure that the technical requirements necessary for the issuing of the Community inland navigation certificate recognised for navigation on the Rhine give a level of safety equivalent to that required for the issuing of the certificate referred to in Article 22 of the Revised Convention for Rhine Navigation.

2.   The Commission shall decide on recommendations from the Committee on the issuance of provisional Community inland navigation certificates in accordance with Article 2.19 of Annex II.
Continued applicability of Directive 76/135/EECFor those craft outside the scope of Article 2(1) and (2) of this Directive, but falling within the scope of Article 1(a) of Directive 76/135/EEC, the provisions of that Directive shall apply.
National additional or reduced requirementsAdditional requirements which were in force in a Member State before 30 December 2008 for craft operating within its territory on Zone 1 and 2 waterways or reduced technical requirements for craft operating within its territory on Zone 3 and 4 waterways which were in force in a Member State before that date shall continue to be in force until additional requirements in accordance with Article 5(1) or reductions in accordance with Article 5(7) of the technical prescriptions of Annex II come into force, but only until 30 June 2009.
Transposition1.   Member States which have inland waterways as referred to in Article 1(1) shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 30 December 2008. They shall forthwith inform the Commission thereof.

When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2.   Member States shall immediately communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof.
PenaltiesMember States shall lay down a system of penalties for breaches of the national provisions adopted pursuant to this Directive and shall take all the measures necessary to ensure that these penalties are applied. The penalties thus provided for shall be effective, proportionate and dissuasive.
Repeal of Directive 82/714/EECDirective 82/714/EEC shall be repealed with effect from 30 December 2008.
Entry into forceThis Directive shall enter into force on the day of its publication in theOfficial Journal of the European Union.
AddresseesThis Directive is addressed to the Member States which have inland waterways as referred to in Article 1(1).
CHAPTER 1ANNEX ILIST OF COMMUNITY INLAND WATERWAYS DIVIDED GEOGRAPHICALLY INTO ZONES 1, 2, 3 AND 4Zone 1Federal Republic of Germany

Ems | from a line linking the former Greetsiel lighthouse and the western pier of the port entrance at Eemshaven seawards as far as latitude 53° 30′ N and longitude 6° 45′ E, i.e. slightly seawards of the lightering area for dry-cargo carriers in the Alte Ems(*1)Republic of PolandThe part of Pomorska Bay southward from the line linking NordPerd on Rugen Island and the lighthouse Niechorze.

The part of Gdańska Bay southward from the line linking the lighthouse Hel and the entrance buoy to the port of Baltijsk.

United Kingdom of Great Britain and Northern Ireland

SCOTLAND

Blue Mull Sound | Between Gutcher and Belmont

Yell Sound | Between Tofts Voe and Ulsta

Sullom Voe | Within a line from the north-east point of Gluss Island to the northern point of Calback Ness

Dales Voe | In winter:within a line from the north point of Kebister Ness to the Coast of Breiwick at longitude 1° 10,8′ W |  | within a line from the north point of Kebister Ness to the Coast of Breiwick at longitude 1° 10,8′ W

 | within a line from the north point of Kebister Ness to the Coast of Breiwick at longitude 1° 10,8′ W

Dales Voe | In summer:as for Lerwick |  | as for Lerwick

 | as for Lerwick

Lerwick | In winter:within the area bounded to the northward by a line from Scottle Holm to Scarfi Taing on Bressay and to the southward by a line from Twageos Point Lighthouse to Whalpa Taing on Bressay |  | within the area bounded to the northward by a line from Scottle Holm to Scarfi Taing on Bressay and to the southward by a line from Twageos Point Lighthouse to Whalpa Taing on Bressay

 | within the area bounded to the northward by a line from Scottle Holm to Scarfi Taing on Bressay and to the southward by a line from Twageos Point Lighthouse to Whalpa Taing on Bressay

Lerwick | In summer:within the area bounded to the northward by a line from Brim Ness to the north east corner of Inner Score and to the southward by a line from the south end of Ness of Sound to Kirkabisterness |  | within the area bounded to the northward by a line from Brim Ness to the north east corner of Inner Score and to the southward by a line from the south end of Ness of Sound to Kirkabisterness

 | within the area bounded to the northward by a line from Brim Ness to the north east corner of Inner Score and to the southward by a line from the south end of Ness of Sound to Kirkabisterness

Kirkwall | Between Kirkwall and Rousay not east of a line between Point of Graand (Egilsay) and Galt Ness (Shapinsay) or between Head of Work (Mainland) through Helliar Holm light to the shore of Shapinsay; not north west of the south east tip of Eynhallow Island, not to seaward and a line between the shore on Rousay at 59°10,5′ N 002° 57,1′ W and the shore on Egilsay at 59° 10′ N 002° 56,4′ W

Stromness | To Scapa but not outside Scapa Flow

Scapa Flow | Within an area bounded by lines drawn from Point of Cletts on the island of Hoy to Thomson’s Hill triangulation point on the island of Fara and thence to Gibraltar Pier on the island of Flotta; from St Vincent Pier on the island of Flotta to the westernmost point of Calf of Flotta; from the easternmost point of the Calf of Flotta to Needle Point on the island of South Ronaldsay and from the Ness on Mainland to Point of Oxan lighthouse on the island of Graemsay and thence to Bu Point on the island of Hoy; and seaward of Zone 2 waters

Balnakiel Bay | Between Eilean Dubh and A’Chleit

Cromarty Firth | Within a line from North Sutor to Nairn Breakwater and seaward of Zone 2 waters

Inverness | Within a line from North Sutor to Nairn Breakwater and seaward of Zone 2 waters

River Tay — Dundee | Within a line from Broughty Castle to Tayport and seaward of Zone 2 waters

Firth of Forth and River Forth | Within a line from Kirkcaldy to River Portobello and seaward of Zone 2 waters

Solway Firth | Within a line from Southerness Point to Silloth

Loch Ryan | Within a line from Finnart’s Point to Milleur Point and seaward of Zone 2 waters

The Clyde | Outer limit:a line from Skipness to a position one mile south of Garroch Head thence to Farland HeadInner limit in winter:a line from Cloch Lighthouse to Dunoon PierInner limit in summer:a line from Bogany Point, Isle of Bute to Skelmorlie Castle and a line from Ardlamont Point to the southern extremity of Ettrick Bay inside the Kyles of ButeNote: The above inner summer limit is extended between 5 June and 5 September (both dates inclusive) by a line from a point two miles off the Ayrshire coast at Skelmorlie Castle to Tomont End, Cumbrae, and a line from Portachur Point, Cumbrae to Inner Brigurd Point, Ayrshire |  | a line from Skipness to a position one mile south of Garroch Head thence to Farland Head |  | a line from Cloch Lighthouse to Dunoon Pier |  | a line from Bogany Point, Isle of Bute to Skelmorlie Castle and a line from Ardlamont Point to the southern extremity of Ettrick Bay inside the Kyles of Bute

 | a line from Skipness to a position one mile south of Garroch Head thence to Farland Head

 | a line from Cloch Lighthouse to Dunoon Pier

 | a line from Bogany Point, Isle of Bute to Skelmorlie Castle and a line from Ardlamont Point to the southern extremity of Ettrick Bay inside the Kyles of Bute

Oban | Within an area bounded on the north by a line from Dunollie Point Light to Ard na Chruidh and to the south by a line from Rudha Seanach to Ard na Cuile

Kyle of Lochalsh | Through Loch Alsh to the head of Loch Duich

Loch Gairloch | In winter:noneIn summer:South of a line running east from Rubha na Moine to Eilan Horrisdale and thence to Rubha nan Eanntag |  | none |  | South of a line running east from Rubha na Moine to Eilan Horrisdale and thence to Rubha nan Eanntag

 | none

 | South of a line running east from Rubha na Moine to Eilan Horrisdale and thence to Rubha nan Eanntag

NORTHERN IRELAND

Belfast Lough | In winter:noneIn summer:within a line from Carrickfergus to Bangorand seaward of Zone 2 waters |  | none |  | within a line from Carrickfergus to Bangor

 | none

 | within a line from Carrickfergus to Bangor

Loch Neagh | At a greater distance than 2 miles from the shore

EAST COAST OF ENGLAND

River Humber | In winter:within a line from New Holland to PaullIn summer:within a line from Cleethorpes Pier to Patrington Churchand seaward of Zone 2 waters |  | within a line from New Holland to Paull |  | within a line from Cleethorpes Pier to Patrington Church

 | within a line from New Holland to Paull

 | within a line from Cleethorpes Pier to Patrington Church

WALES AND WEST COAST OF ENGLAND

River Severn | In winter:within a line from Blacknore Point to Caldicot Pill, PorstkewettIn summer:within a line from Barry Dock Pier to Steepholm and thence to Brean Downand seaward of Zone 2 waters |  | within a line from Blacknore Point to Caldicot Pill, Porstkewett |  | within a line from Barry Dock Pier to Steepholm and thence to Brean Down

 | within a line from Blacknore Point to Caldicot Pill, Porstkewett

 | within a line from Barry Dock Pier to Steepholm and thence to Brean Down

River Wye | In winter:within a line from Blacknore Point to Caldicot Pill, PortskewettIn summer:within a line from Barry Dock Pier to Steepholm and thence to Brean Downand seaward of Zone 2 waters |  | within a line from Blacknore Point to Caldicot Pill, Portskewett |  | within a line from Barry Dock Pier to Steepholm and thence to Brean Down

 | within a line from Blacknore Point to Caldicot Pill, Portskewett

 | within a line from Barry Dock Pier to Steepholm and thence to Brean Down

Newport | In winter:noneIn summer:within a line from Barry Dock Pier to Steepholm and thence to Brean Downand seaward of Zone 2 waters |  | none |  | within a line from Barry Dock Pier to Steepholm and thence to Brean Down

 | none

 | within a line from Barry Dock Pier to Steepholm and thence to Brean Down

Cardiff | In winter:noneIn summer:within a line from Barry Dock Pier to Steepholm and thence to Brean Downand seaward of Zone 2 waters |  | none |  | within a line from Barry Dock Pier to Steepholm and thence to Brean Down

 | none

 | within a line from Barry Dock Pier to Steepholm and thence to Brean Down

Barry | In winter:NoneIn summer:within a line from Barry Dock Pier to Steepholm and thence to Brean Downand seaward of Zone 2 waters |  | None |  | within a line from Barry Dock Pier to Steepholm and thence to Brean Down

 | None

 | within a line from Barry Dock Pier to Steepholm and thence to Brean Down

Swansea | Within a line joining the seaward ends of the breakwaters

Menai Straits | Within the Menai Straits from a line joining Llanddwyn Island Light to Dinas Dinlleu and lines joining the south end of Puffin Island to Trwyn DuPoint and Llanfairfechan Railway Station, and seaward of Zone 2 waters

River Dee | In winter:within a line from Hilbre Point to Point of AirIn summer:within a line from Formby Point to Point of Airand seaward of Zone 2 waters |  | within a line from Hilbre Point to Point of Air |  | within a line from Formby Point to Point of Air

 | within a line from Hilbre Point to Point of Air

 | within a line from Formby Point to Point of Air

River Mersey | In winter:NoneIn summer:within a line from Formby Point to Point of Airand seaward of Zone 2 waters |  | None |  | within a line from Formby Point to Point of Air

 | None

 | within a line from Formby Point to Point of Air

Preston and Southport | Within a line from Southport to Blackpool inside the banksand seaward of Zone 2 waters

Fleetwood | In winter:NoneIn summer:within a line from Rossal Point to Humphrey Headand seaward of Zone 2 waters |  | None |  | within a line from Rossal Point to Humphrey Head

 | None

 | within a line from Rossal Point to Humphrey Head

River Lune | In winter:NoneIn summer:within a line from Rossal Point to Humphrey Headand seaward of Zone 2 waters |  | None |  | within a line from Rossal Point to Humphrey Head

 | None

 | within a line from Rossal Point to Humphrey Head

Heysham | In winter:NoneIn summer:within a line from Rossal Point to Humphrey Head |  | None |  | within a line from Rossal Point to Humphrey Head

 | None

 | within a line from Rossal Point to Humphrey Head

Morecambe | In winter:NoneIn the summer:from within a line from Rossal Point to Humphrey Head |  | None |  | from within a line from Rossal Point to Humphrey Head

 | None

 | from within a line from Rossal Point to Humphrey Head

Workington | Within a line from Southerness Point to Sillothand seaward of Zone 2 waters

SOUTH OF ENGLAND

River Colne, Colchester | In winter:within a line from Colne Point to WhitstableIn summer:within a line from Clacton Pier to Reculvers |  | within a line from Colne Point to Whitstable |  | within a line from Clacton Pier to Reculvers

 | within a line from Colne Point to Whitstable

 | within a line from Clacton Pier to Reculvers

River Blackwater | In winter:within a line from Colne Point to WhitstableIn summer:within a line from Clacton Pier to Reculversand seaward of Zone 2 waters |  | within a line from Colne Point to Whitstable |  | within a line from Clacton Pier to Reculvers

 | within a line from Colne Point to Whitstable

 | within a line from Clacton Pier to Reculvers

River Crouch and River Roach | In winter:within a line from Colne Point to WhitstableIn summer:within a line from Clacton Pier to Reculversand seaward of Zone 2 waters |  | within a line from Colne Point to Whitstable |  | within a line from Clacton Pier to Reculvers

 | within a line from Colne Point to Whitstable

 | within a line from Clacton Pier to Reculvers

River Thames and its tributaries | In winter:within a line from Colne Point to WhitstableIn summer:within a line from Clacton Pier to Reculversand seaward of Zone 2 waters |  | within a line from Colne Point to Whitstable |  | within a line from Clacton Pier to Reculvers

 | within a line from Colne Point to Whitstable

 | within a line from Clacton Pier to Reculvers

River Medway and the Swale | In winter:within a line from Colne Point to WhitstableIn summer:within a line from Clacton Pier to Reculversand seaward of Zone 2 waters |  | within a line from Colne Point to Whitstable |  | within a line from Clacton Pier to Reculvers

 | within a line from Colne Point to Whitstable

 | within a line from Clacton Pier to Reculvers

Chichester | Inside the Isle of Wight within an area bounded by lines drawn between the church spire, West Wittering, to Trinity Church, Bembridge, to the eastward, and the Needles and Hurst Point to the westwardand seaward of Zone 2 waters

Langstone Harbour | Inside the Isle of Wight within an area bounded by lines drawn between the church spire, West Wittering, to Trinity Church, Bembridge, to the eastward, and the Needles and Hurst Point to the westwardand seaward of Zone 2 waters

Portsmouth | Inside the Isle of Wight within an area bounded by lines drawn between the church spire, West Wittering, to Trinity Church, Bembridge, to the eastward, and the Needles and Hurst Point to the westwardand seaward of Zone 2 waters

Bembridge, Isle of Wight | Inside the Isle of Wight within an area bounded by lines drawn between the church spire, West Wittering, to Trinity Church, Bembridge, to the eastward, and the Needles and Hurst Point to the westwardand seaward of Zone 2 waters

Cowes, Isle of Wight | Inside the Isle of Wight within an area bounded by lines drawn between the church spire, West Wittering, to Trinity Church, Bembridge, to the eastward, and the Needles and Hurst Point to the westwardand seaward of Zone 2 waters

Southampton | Inside the Isle of Wight within an area bounded by lines drawn between the church spire, West Wittering, to Trinity Church, Bembridge, to the eastward, and the Needles and Hurst Point to the westwardand seaward of Zone 2 waters

Beaulieu River | Inside the Isle of Wight within an area bounded by lines drawn between the church spire, West Wittering, to Trinity Church, Bembridge, to the eastward, and the Needles and Hurst Point to the westwardand seaward of Zone 2 waters

Keyhaven Lake | Inside the Isle of Wight within an area bounded by lines drawn between the church spire, West Wittering, to Trinity Church, Bembridge, to the eastward, and the Needles and Hurst Point to the westwardand seaward of Zone 2 waters

Weymouth | Within Portland Harbour and between the River Wey and Portland Harbour

Plymouth | Within a line from Cawsand to Breakwater to Staddonand seaward of Zone 2 waters

Falmouth | In winter:within a line from St Anthony Head to RosemullionIn summer:within a line from St Anthony Head to Nare Pointand seaward of Zone 2 waters |  | within a line from St Anthony Head to Rosemullion |  | within a line from St Anthony Head to Nare Point

 | within a line from St Anthony Head to Rosemullion

 | within a line from St Anthony Head to Nare Point

River Camel | Within a line from Stepper Point to Trebetherick Pointand seaward of Zone 2 waters

Bridgewater | Within the bar and seaward of Zone 2 waters

River Avon (Avon) | In winter:within a line from Blacknore Point to Caldicot Pill, PortskewettIn summer:within a line from Barry Pier to Steepholm and thence to Brean Downand seaward of Zone 2 waters |  | within a line from Blacknore Point to Caldicot Pill, Portskewett |  | within a line from Barry Pier to Steepholm and thence to Brean Down

 | within a line from Blacknore Point to Caldicot Pill, Portskewett

 | within a line from Barry Pier to Steepholm and thence to Brean DownZone 2Czech RepublicDam Lake Lipno

Federal Republic of Germany

Ems | From a line across the Ems near the entrance to the port of Papenburg between Diemen pumping station and the opening of the dyke at Halte as far as a line linking the former Greetsiel lighthouse and the western pier of the port entrance at Eemshaven

Jade | Inside a line linking the Schillig cross light and Langwarden church tower

Weser | From the north-western edge of the railway bridge in Bremen as far as a line linking Langwarden and Cappel church towers, including the Westergate, Rekumer Loch, Rechter Nebenarm and Schweiburg side branches

Elbe | From the lower limit of the port of Hamburg as far as a line linking the Döse beacon and the western edge of the Friedrichskoog dyke (Dieksand), including the Nebenelbe and the Este, Lühe, Schwinge, Oste, Pinnau, Krückau and Stör tributaries (in each case from the mouth to the barrage)

Meldorfer Bucht | Inside a line linking the western edge of the Friedrichskoog dyke (Dieksand) and the western pier head at Büsum

Eider | From the Gieselau Canal to the Eider barrage

Flensburger Förde | Inside a line linking Kegnäs lighthouse and Birknack

Schlei | Inside a line between the Schleimünde pier heads

Eckernförder Bucht | Inside a line linking Boknis-Eck and the north-eastern point of the mainland near Dänisch Nienhof

Kieler Förde | Inside a line linking the Bülk lighthouse and the Laboe naval memorial

Nord-Ostsee-Kanal (Kiel Canal) | From a line linking the pier heads at Brunsbüttel as far as a line linking the entry lights at Kiel-Holtenau, including Obereidersee and Enge, Audorfer See, Borgstedter See and Enge, Schirnauer See, Flemhuder See and the Achterwehrer Canal

Trave | from the north-western edge of the railway lift bridge and the northern edge of the Holstenbrücke (Stadttrave) in Lübeck as far as a line linking the southern inner and northern outer pier heads at Travemünde, including the Pötenitzer Wiek, Dassower See and the Altarmen at Teerhof island

Leda | From the entrance of the outer harbour of Leer sea lock to the mouth

Hunte | from the port of Oldenburg and from 140 m downstream of the Amalienbrücke in Oldenburg to the mouth

Lesum | From the Bremen-Burg railway bridge to the mouth

Este | From the tail water of Buxtehude lock to the Este barrage

Lühe | From the tail water of the Au-Mühle in Horneburg to the Lühe barrage

Schwinge | From the Salztor lock in Stade to the Schwinge barrage

Oste | From the north-eastern edge of the Bremervörde mill dam to the Oste barrage

Pinnau | From the south-western edge of the railway bridge in Pinneberg to the Pinnau barrage

Krückau | From the south-western edge of the bridge leading to/from the Wedenkamp in Elmshorn to the Krückau barrage

Stör | From Rensing tide gauge to the Stör barrage

Freiburger Hafenpriel | From the eastern edge of the sluice in Freiburg an der Elbe as far as the mouth

Wismarbucht, Kirchsee, Breitling, Salzhaff and Wismar port area | Seawards as far as a line between Hoher Wieschendorf Huk and Timmendorf light and a line linking Gollwitz light on the island of Poel and the southern point of the Wustrow peninsula

Warnow, including the Breitling and side branches | Downstream of the Mühlendamm from the northern edge of the Geinitzbrücke in Rostock towards the sea as far as a line linking the northern points of the western and eastern piers in Warnemünde

Waters enclosed by the mainland and the Darß and Zingst pensinsulas and the islands of Hiddensee and Rügen (including Stralsund port area) | Extending seawards between—the Zingst peninsula and the island of Bock: as far as latitude 54° 26′ 42′ N—the islands of Bock and Hiddensee: as far as a line linking the northern point of the island of Bock and the southern point of the island of Hiddensee—the island of Hiddensee and the island of Rügen (Bug): as far as a line linking the south-eastern point of Neubessin and Buger Haken | — | the Zingst peninsula and the island of Bock: as far as latitude 54° 26′ 42′ N | — | the islands of Bock and Hiddensee: as far as a line linking the northern point of the island of Bock and the southern point of the island of Hiddensee | — | the island of Hiddensee and the island of Rügen (Bug): as far as a line linking the south-eastern point of Neubessin and Buger Haken

— | the Zingst peninsula and the island of Bock: as far as latitude 54° 26′ 42′ N

— | the islands of Bock and Hiddensee: as far as a line linking the northern point of the island of Bock and the southern point of the island of Hiddensee

— | the island of Hiddensee and the island of Rügen (Bug): as far as a line linking the south-eastern point of Neubessin and Buger Haken

Greifswalder Bodden and Greifswald port area, including the Ryck | Seawards as far as a line from the eastern point of Thiessower Haken (Südperd) to the eastern point of the island of Ruden and continuing to the northern point of the island of Usedom (54° 10′ 37′ N, 13° 47′ 51′ E)

Waters enclosed by the mainland and the island of Usedom (the Peenestrom, including Wolgast port area and Achterwasser, and the Stettiner Haff) | Eastwards as far as the border with the Republic of Poland in the Stettiner HaffNoteIn the case of vessels whose home port is in another State, account is to be taken of Article 32 of the Ems-Dollart Treaty of 8 April 1960 (BGBl. 1963 II, p. 602).

French Republic

Dordogne | Downstream from the stone bridge at Libourne

Garonne and Gironde | Downstream from the stone bridge at Bordeaux

Loire | Downstream from the Haudaudine bridge on the Madeleine arm and downstream from the Pirmil bridge on the Pirmil arm.

Rhône | Downstream of the Trinquetaille bridge in Arles and beyond towards Marseille

Seine | Downstream of the Jeanne-d’Arc bridge in RouenRepublic of HungaryLake Balaton

Kingdom of the NetherlandsDollard

Eems

Waddenzee: including the links with the North Sea

IJsselmeer: including the Markermeer and IJmeer but excluding the Gouwzee

Nieuwe Waterweg and the Scheur

Calland Kanaal west from the Benelux harbour

Hollands Diep

Breeddiep, Beerkanaal and its connected harbours

Haringvliet and Vuile Gat: including the waterways between Goeree-Overflakkee on the one hand and Voorne-Putten and Hoeksche Waard on the other

Hellegat

Volkerak

Krammer

Grevelingenmeer and Brouwerschavensche Gat: including all the waterways between Schouwen-Duiveland and Goeree-Overflakkee

Keten, Mastgat, Zijpe, Krabbenkreek, Eastern Scheldt and Roompot: including the waterways between Walcheren, Noord-Beveland and Zuid-Beveland on the one hand and Schouwen-Duiveland and Tholen on the other hand, excluding the Scheldt-Rhine Canal

Scheldt and Western Scheldt and its mouth on the sea: including the waterways between Zeeland Flanders, on the one hand, and Walcheren and Zuid-Beveland, on the other, excluding the Scheldt-Rhine Canal

Republic of PolandLagoon of Szczecin

Lagoon of Kamień

Lagoon of Wisła

Bay of Puck

Włocławski Reservoir

Lake Śniardwy

Lake Niegocin

Lake Mamry

United Kingdom of Great Britain and Northern Ireland

SCOTLAND

Scapa Flow | Within an area bounded by lines drawn from Wharth on the island of Flotta to the Martello Tower on South Walls, and from Point Cletts on the island of Hoy to Thomson’s Hill triangulation point on the island of Fara and thence to Gibraltar Pier on the island of Flotta

Kyle of Durness | South of Eilean Dubh

Cromarty Firth | Within a line between North Sutor and South Sutor

Inverness | Within a line from Fort George to Chanonry Point

Findhorn Bay | Within the spit

Aberdeen | Within a line from South Jetty to Abercromby Jetty

Montrose Basin | To the west of a line running north-south across the harbour entrance at Scurdie Ness Lighthouse

River Tay — Dundee | Within a line from the tidal basin (fish dock), Dundee to Craig Head, East Newport

Firth of Forth and River Forth | Within the Firth of Forth but not east of the Forth railway bridge

Dumfries | Within a line from Airds Point to Scar Point

Loch Ryan | Within a line from Cairn Point to Kircolm Point

Ayr Harbour | Inside the Bar

The Clyde | Above Zone 1 waters

Kyles of Bute | Between Colintraive and Rhubodach

Campbeltown Harbour | Within a line from Macringan’s Point to Ottercharach Point

Loch Etive | Within Loch Etive above the Falls of Lora

Loch Leven | Above the bridge at Ballachulish

Loch Linnhe | North of Corran Point light

Loch Eil | The whole loch

Caledonian Canal | Lochs Lochy, Oich and Ness

Kyle of Lochalsh | Within Kyle Akin not westward of Eilean Ban Light or eastward of Eileanan Dubha

Loch Carron | Between Stromemore and Strome Ferry

Loch Broom, Ullapool | Within a line from Ullapool Point Light to Aultnaharrie

Kylesku | Across Loch Cairnbawn in the area between the easternmost point of Garbh Eilean and the westernmost point of Eilean na Rainich

Stornoway Harbour | Within a line from Arnish Point to Sandwick Bay Lighthouse, north-west side

The Sound of Scalpay | Not east of Berry Cove (Scalpay) and not west of Croc a Loin (Harris)

North Harbour, Scalpay and Tarbert Harbour | Within one mile from the shore of the Island of Harris

Loch Awe | The whole loch

Loch Katrine | The whole loch

Loch Lomond | The whole loch

Loch Tay | The whole loch

Loch Loyal | The whole loch

Loch Hope | The whole loch

Loch Shin | The whole loch

Loch Assynt | The whole loch

Loch Glascarnoch | The whole loch

Loch Fannich | The whole loch

Loch Maree | The whole loch

Loch Gairloch | The whole loch

Loch Monar | The whole loch

Loch Mullardach | The whole loch

Loch Cluanie | The whole loch

Loch Loyne | The whole loch

Loch Garry | The whole loch

Loch Quoich | The whole loch

Loch Arkaig | The whole loch

Loch Morar | The whole loch

Loch Shiel | The whole loch

Loch Earn | The whole loch

Loch Rannoch | The whole loch

Loch Tummel | The whole loch

Loch Ericht | The whole loch

Loch Fionn | The whole loch

Loch Glass | The whole loch

Loch Rimsdale/nan Clar | The whole loch

NORTHERN IRELAND

Strangford Lough | Within a line from Cloghy Point to Dogtail Point

Belfast Lough | Within a line from Holywood to Macedon Point

Larne | Within a line from Larne Pier to the ferry pier on Island Magee

River Bann | From the seaward ends of the breakwaters to Toome Bridge

Lough Erne | Upper and Lower Lough Erne

Lough Neagh | Within two miles of the shore

EAST COAST OF ENGLAND

Berwick | Within the breakwaters

Warkworth | Within the breakwaters

Blyth | Within the Outer Pier Heads

River Tyne | Dunston Staithes to Tyne Pier Heads

River Wear | Fatfield to Sunderland Pier Heads

Seaham | Within the breakwaters

Hartlepool | Within a line from Middleton Jetty to Old Pier HeadWithin a line joining North Pier Head to South Pier Head

River Tees | Within a line extending due west from Government Jetty to Tees Barrage

Whitby | Within Whitby Pier Heads

River Humber | Within a line from North Ferriby to South Ferriby

Grimsby Dock | Within a line from the West Pier of the Tidal Basin to the East Pier of the Fish Docks, North Quay

Boston | Inside the New Cut

Dutch River | The whole canal

River Hull | Beverley Beck to River Humber

Kielder Water | The whole lake

River Ouse | Below Naburn Lock

River Trent | Below Cromwell Lock

River Wharfe | From the junction with River Ouse to Tadcaster Bridge

Scarborough | Within Scarborough Pier Heads

WALES AND WEST COAST OF ENGLAND

River Severn | North of a line running due west from Sharpness Point (51° 43,4′ N) to Llanthony and Maisemore Weirs and seaward of Zone 3 waters

River Wye | At Chepstow, north of latitude (51° 38,0′ N) to Monmouth

Newport | North of the overhead power cables crossing at Fifoots Points

Cardiff | Within a line from South Jetty to Penarth Headand the enclosed waters to the west of Cardiff Bay Barrage

Barry | Within a line joining the seaward ends of the breakwaters

Port Talbot | Within a line joining the seaward ends of the breakwaters on the River Afran outside enclosed docks

Neath | Within a line running due North from the seaward end of Baglan Bay Tanker Jetty (51° 37,2′ N, 3° 50,5′ W)

Llanelli and Burry Port | Within an area bounded by a line drawn from Burry Port Western Pier to Whiteford Point

Milford Haven | Within a line from South Hook Point to Thorn Point

Fishguard | Within a line joining the seaward ends of the north and east breakwaters

Cardigan | Within the Narrows at Pen-Yr-Ergyd

Aberystwyth | Within the seaward ends of the breakwaters

Aberdyfi | Within a line from Aberdyfi Railway Station to Twyni Bach Beacon

Barmouth | Within a line from Barmouth Railway Station to Penrhyn Point

Portmadoc | Within a line from Harlech Point to Graig Ddu

Holyhead | Within an area bounded by the main breakwater and a line drawn from the head of the breakwater to Brynglas Point, Towyn Bay

Menai Straits | Within the Menai Straits between a line joining Aber Menai Point to Belan Point and a line joining Beaumaris Pier to Pen-y-Coed Point

Conway | Within a line from Mussel Hill to Tremlyd Point

Llandudno | Within the breakwater

Rhyl | Within the breakwater

River Dee | Above Connah’s Quay to Barrelwell Hill water extraction point

River Mersey | Within a line between the Rock Lighthouse and the North West Seaforth Dockbut excluding other docks

Preston and Southport | Within a line from Lytham to Southport and within Preston Docks

Fleetwood | Within a line from Low Light to Knott

River Lune | Within a line from Sunderland Point to Chapel Hill up to and including Glasson Dock

Barrow | Within a line joining Haws Point, Isle of Walney to Roa Island Slipway

Whitehaven | Within the breakwater

Workington | Within the breakwater

Maryport | Within the breakwater

Carlisle | Within a line joining Point Carlisle to Torduff

Coniston Water | The whole lake

Derwentwater | The whole lake

Ullswater | The whole lake

Windermere | The whole lake

SOUTH OF ENGLAND

Blakeney and Morston Harbour and approaches | To the east of a line running south from Blakeney Point to the entrance of the Stiffkey River

River Orwell and River Stour | River Orwell within a line from Blackmanshead breakwater to Landguard Point and seaward of Zone 3 waters

River Blackwater | All waterways within a line from the south-western extremity of Mersea Island to Sales Point

River Crouch and River Roach | River Crouch within a line from Holliwell Point to Foulness Point, including the River Roach

River Thames and its tributaries | River Thames above a line drawn north/south through the eastern extremity of Denton Wharf Pier, Gravesend to Teddington Lock

River Medway and the Swale | River Medway from a line drawn from Garrison Point to the Grain Tower, to Allington Lock; and the Swale from Whitstable to the Medway

River Stour (Kent) | River Stour above the mouth to the landing at Flagstaff Reach

Dover Harbour | Within lines drawn across the east and west entrances to the Harbour

River Rother | River Rother above the Tidal Signal Station at Camber to Scots Float Sluice and to the entrance lock on the River Brede

River Adur and Southwick Canal | Within a line drawn across Shoreham Harbour entrance to Southwick Canal Lock and to the west end of Tarmac Wharf

River Arun | River Arun above Littlehampton Pier to Littlehampton Marina

River Ouse (Sussex) Newhaven | River Ouse from a line drawn across Newhaven Harbour entrance piers to the north end of North Quay

Brighton | Brighton Marina outer harbour within a line from the southern end of West Quay to the north end of South Quay

Chichester | Within a line drawn between Eastoke point and the church spire, West Wittering and seaward of Zone 3 waters

Langstone Harbour | Within a line drawn between Eastney Point and Gunner Point

Portsmouth | Within a line drawn across the harbour entrance from Port Blockhouse to the Round Tower

Bembridge, Isle of Wight | Within Brading Harbour

Cowes, Isle of Wight | The River Medina within a line from the Breakwater Light on the east bank to the House Light on the west bank

Southampton | Within a line from Calshot Castle to Hook Beacon

Beaulieu River | Within Beaulieu River not eastward of a north/south line through Inchmery House

Keyhaven Lake | Within a line drawn due north from Hurst Point Low Light to Keyhaven Marshes

Christchurch | The Run

Poole | Within the line of the Chain Ferry between Sandbanks and South Haven Point

Exeter | Within an east-west line from Warren Point to the Inshore Lifeboat Station opposite Checkstone Ledge

Teignmouth | Within the harbour

River Dart | Within a line from Kettle Point to Battery Point

River Salcombe | Within a line from Splat Point to Limebury Point

Plymouth | Within a line from Mount Batten Pier to Raveness Point through Drake’s Islands; the River Yealm within a line from Warren Point to Misery Point

Fowey | Inside the Harbour

Falmouth | Within a line from St. Anthony Head to Pendennis Point

River Camel | Within a line from Gun Point to Brea Hill

Rivers Taw and Torridge | Within a line bearing 200° from the lighthouse on Crow Point to the shore at Skern Point

Bridgewater | South of a line running due East from Stert Point (51° 13,0 ‘N)

River Avon (Avon) | Within a line from Avonmouth Pier to Wharf Point, to Netham DamCHAPTER 2Zone 3Kingdom of BelgiumMaritime Scheldt (downstream of Antwerp open anchorage)

Czech RepublicLabe: from the lock Ústí nad Labem-Střekov to the lock Lovosice

Dam Lakes: Baška, Brněnská (Kníničky), Horka (Stráž pod Ralskem), Hracholusky, Jesenice, Nechranice, Olešná, Orlík, Pastviny, Plumov, Rozkoš, Seč, Skalka, Slapy, Těrlicko, Žermanice

Lake Máchovo

Water Area Velké Žernoseky

Ponds: Oleksovice, Svět, Velké Dářko

Mining Gravel Lakes: Dolní Benešov, Ostrožná Nová Ves a Tovačov

Federal Republic of Germany

Danube | From Kelheim (km 2 414,72 ) to the German-Austrian border

Rhine | From the German-Swiss border to the German-Netherlands border

Elbe | From the mouth of the Elbe-Seiten canal to the lower limit of the port of Hamburg

Müritz | French RepublicRhine

Republic of HungaryDanube: from rkm 1812 to rkm 1433

Danube Moson: from rkm 14 to rkm 0

Danube Szentendre: from rkm 32 to rkm 0

Danube Ráckeve: from rkm 58 to rkm 0

River Tisza: from rkm 685 to rkm 160

River Dráva: from rkm 198 to rkm 70

River Bodrog: from rkm 51 to rkm 0

River Kettős-Körös: from rkm 23 to rkm 0

River Hármas-Körös: from rkm 91 to rkm 0

Channel Sió: from rkm 23 to rkm 0

Lake Velence

Lake Fertő

Kingdom of the NetherlandsRhine

Sneekermeer, Koevordermeer, Heegermeer, Fluessen, Slotermeer, Tjeukemeer, Beulakkerwijde, Belterwijde, Ramsdiep, Ketelmeer, Zwartemeer, Veluwemeer, Eemmeer, Alkmaardermeer, Gouwzee, Buiten IJ afgesloten IJ Noordzeekanaal, port of IJmuiden, Rotterdam port area, Nieuwe Maas, Noord, Oude Maas, Beneden Merwede, Nieuwe Merwede, Dordsche Kil, Boven Merwede, Waal, Bijlandsch Canal, Boven Rijn, Pannersdensch Canal, Geldersche IJssel, Neder Rijn, Lek, Amsterdam-Rhine-Canal, Veerse Meer, Schelde-Rhine-Canal as far as the mouth in the Volkerak, Amer, Bergsche Maas, the Meuse below Venlo, Gooimeer, Europort, Calandkanaal (east from the Benelux harbour), Hartelkanaal

Republic of AustriaDanube: from the border with Germany to the border with Slovakia

Inn: from the mouth to the Passau-Ingling Power Station

Traun: from the mouth to km 1,80

Enns: from the mouth to km 2,70

March: to km 6,00

Republic of Poland

 | — | River Biebrza from the estuary of the Augustowski Channel to the estuary of the river Narwia

 | — | River Brda from the link with the Bydgoski Channel in Bydgoszcz to the estuary of the river Wisła

 | — | River Bug from the estuary of the river Muchawiec to the estuary of the river Narwia

 | — | Lake Dąbie to the frontier with internal sea waters

 | — | The Augustowski Channel from the link with the river Biebrza to the State border, together with the lakes located along the route of this Channel

 | — | The Bartnicki Channel from Lake Ruda Woda to Lake Bartężek, together with Lake Bartężek

 | — | The Bydgoski Channel

 | — | The Elbląski Channel from Lake Druzno to Lake Jeziorak and Lake Szeląg Wielki, together with these lakes and the lakes on the route of the Channel, and a byway in the direction of Zalewo from Lake Jeziorak to Lake Ewingi, inclusive

 | — | The Gliwicki Channel together with the Channel Kędzierzyński

 | — | The Jagielloński Channel from the link with the river Elbląg to the river Nogat

 | — | The Łączański Channel

 | — | The Ślesiński Channel with the lakes located along the route of this Channel and Lake Gopło

 | — | The Żerański Channel

 | — | River Martwa Wisła from the river Wisła in Przegalina to the frontier with internal sea waters

 | — | River Narew from the estuary of the river Biebrza to the estuary of the river Wisła, together with Lake Zegrzyński

 | — | River Nogat from the river Wisła to the estuary of the Lagoon of Wisła

 | — | River Noteć (upper) from Lake Gopło to the link with the Górnonotecki Channel and the Górnonotecki Channel and River Noteć (lower) from the link of the Bydgoski Channel to the estuary to River Warta

 | — | River Nysa Łużycka from Gubin to the estuary to River Odra

 | — | River Odra from the town of Racibórz to the link with River Eastern Odra which turns into River Regalica from the Klucz-Ustowo Piercing, together with that river and its side-branches to Lake Dąbie as well as a byway of River Odra from the Opatowice lock to the lock in Wrocław city

 | — | River Western Odra from a weir in Widuchowa (704,1 km of River Odra) to a border with internal sea waters, together with side-branches as well as the Klucz-Ustowo Piercing linking River Eastern Odra with River Western Odra

 | — | River Parnica and the Parnicki Piercing from River Western Odra to a border with internal sea waters

 | — | River Pisa from Lake Roś to the estuary of River Narew

 | — | River Szkarpawa from River Wisła to the estuary of the Lagoon of Wisła

 | — | River Warta from the Ślesińskie Lake to the estuary of River Odra

 | — | System of Wielkie Jeziora Mazurskie encompassing the lakes linked by the rivers and channels constituting a main route from Lake Roś (inclusive) in Pisz to the Węgorzewski Channel (including that channel) in Węgorzewo, together with Lakes Seksty, Mikołajskie, Tałty, Tałtowisko, Kotek, Szymon, Szymoneckie, Jagodne, Boczne, Tajty, Kisajno, Dargin, Łabap, Kirsajty and Święcajty, together with the Giżycki Channel and the Niegociński Channel and the Piękna Góra Channel, and a byway of Lake Ryńskie (inclusive) in Ryn to Lake Nidzkie (up to 3 km, constituting a border with the ‘Lake Nidzkie’ nature reserve), together with lakes Bełdany, Guzianka Mała and Guzianka Wielka

 | — | River Wisła from the estuary of River Przemsza to the link with the Łączański Channel as well as from the estuary of that Channel in Skawina to the estuary of River Wisła to the Bay of Gdańsk, excluding the Włocławski ReservoirSlovak RepublicDanube: from Devín (rkm 1880,26) to the Slovak-Hungarian border

United Kingdom of Great Britain and Northern Ireland

SCOTLAND

Leith (Edinburgh) | Within the breakwaters

Glasgow | Strathclyde Loch

Crinan Canal | Crinan to Ardrishaig

Caledonian Canal | The canal sections

NORTHERN IRELAND

River Lagan | Lagan Weir to Stranmillis

EAST OF ENGLAND

River Wear (non-tidal) | Old Railway Bridge, Durham to Prebends Bridge, Durham

River Tees | Upriver from Tees Barrage

Grimsby Dock | Inside of the locks

Immingham Dock | Inside of the locks

Hull Docks | Inside of the locks

Boston Dock | Inside the lock gates

Aire and Calder Navigation | Goole Docks to Leeds; junction with Leeds and Liverpool Canal; Bank Dole Junction to Selby (River Ouse Lock); Castleford Junction to Wakefield (Falling Lock)

River Ancholme | Ferriby Sluice to Brigg

Calder and Hebble Canal | Wakefield (Falling Lock) to Broadcut Top Lock

River Foss | From (Blue Bridge) junction with River Ouse to Monk Bridge

Fossdyke Canal | Junction with River Trent to Brayford Pool

Goole Dock | Inside the lock gates

Hornsea Mere | The whole canal

River Hull | From Struncheon Hill Lock to Beverley Beck

Market Weighton Canal | River Humber Lock to Sod Houses Lock

New Junction Canal | The whole canal

River Ouse | From Naburn Lock to Nun Monkton

Sheffield and South Yorkshire Canal | Keadby Lock to Tinsley Lock

River Trent | Cromwell Lock to Shardlow

River Witham | Boston Sluice to Brayford Poole (Lincoln)

WALES AND WEST OF ENGLAND

River Severn | Above Llanthony and Maisemore Weirs

River Wye | Above Monmouth

Cardiff | Roath Park Lake

Port Talbot | Within the enclosed docks

Swansea | Within the enclosed docks

River Dee | Above Barrelwell Hill water extraction point

River Mersey | The docks (excluding Seaforth Dock)

River Lune | Above Glasson Dock

River Avon (Midland) | Tewkesbury Lock to Evesham

Gloucester | Gloucester City Docks Gloucester/Sharpness Canal

Hollingworth Lake | The whole lake

Manchester Ship Canal | The whole canal and Salford Docks including River Irwell

Pickmere Lake | The whole lake

River Tawe | Between Sea Barrage/Marina and the Morfa Athletics Stadium

Rudyard Lake | The whole lake

River Weaver | Below Northwich

SOUTH OF ENGLAND

River Nene | Wisbech Cut and River Nene to Dog-in-a-Doublet Lock

River Great Ouse | Kings Lynn Cut and River Great Ouse below West Lynn Road Bridge

Yarmouth | River Yare Estuary from a line drawn across the ends of the north and south entrance piers, including Breydon Water

Lowestoft | Lowestoft Harbour below Mutford Lock to a line drawn across the outer harbour entrance piers

Rivers Alde and Ore | Above the entrance to the River Ore to Westrow Point

River Deben | Above the entrance of the River Deben to Felixstowe Ferry

River Orwell and River Stour | From a line drawn from Fagbury Point to Shotley Point on the River Orwell to Ipswich Dock; and from a line drawn north/south through Erwarton Ness on the River Stour to Manningtree

Chelmer & Blackwater Canal | Eastward of Beeleigh Lock

River Thames and its tributaries | River Thames above Teddington Lock to Oxford

River Adur and Southwick Canal | River Adur above the west end of Tarmac Wharf, and within Southwick Canal

River Arun | River Arun above Littlehampton Marina

River Ouse (Sussex), Newhaven | River Ouse above the north end of North Quay

Bewl Water | The whole lake

Grafham Water | The whole lake

Rutland Water | The whole lake

Thorpe Park Lake | The whole lake

Chichester | East of a line joining Cobnor Point and Chalkdock Point

Christchurch | Within Christchurch Harbour excluding the Run

Exeter Canal | The whole canal

River Avon (Avon) | Bristol City DocksNetham Dam to Pulteney WeirCHAPTER 3Zone 4Kingdom of BelgiumThe entire Belgian network except the waterways in Zone 3

Czech RepublicAll other waterways not listed in Zones 1, 2 and 3

Federal Republic of GermanyAll inland waterways other than those in Zones 1, 2 and 3

French RepublicThe entire French network except the waterways in Zones 1, 2 and 3

Italian RepublicRiver Po: from Piacenza to the mouth

Milan-Cremona Canal, River Po: final stretch of 15 km to the Po

River Mincio: from Mantua, Governolo to the Po

Ferrara Waterway: from the Po (Pontelagoscuro), Ferrara to Porto Garibaldi

Brondolo and Valle Canals: from the eastern Po to the Venice lagoon

Fissero Canal — Tartaro — Canalbianco: from Adria to the eastern Po

Venetian coastline: from the Venice lagoon to Grado

Republic of LithuaniaThe entire Lithuanian network

Grand Duchy of LuxembourgMoselle

Republic of HungaryAll other waterways not listed in Zones 2 and 3

Kingdom of the NetherlandsAll other rivers, canals and inland seas not listed in Zones 1, 2 and 3

Republic of AustriaThaya: up to Bernhardsthal

March: above km 6,00

Republic of PolandAll other waterways not listed in Zones 1, 2 and 3

Slovak RepublicAll other waterways not listed in Zone 3

United Kingdom of Great Britain and Northern Ireland

SCOTLAND

Ratho and Linlithgow Union Canal | The whole canal

Glasgow | Forth and Clyde CanalMonkland Canal, Faskine and Drumpellier sectionsHogganfield Loch

EAST OF ENGLAND

River Ancholme | Brigg to Harram Hill Lock

Calder and Hebble Canal | Broadcut Top Lock to Sowerby Bridge

Chesterfield Canal | West Stockwith to Worksop

Cromford Canal | The whole canal

River Derwent | From junction with River Ouse to Stamford Bridge

Driffield Navigation | From Struncheon Hill Lock to Great Driffield

Erewash Canal | Trent Lock to Langley Mill Lock

Huddersfield Canal | Junction with Calder and Hebble at Coopers Bridge to Huddersfield Narrow Canal at HuddersfieldBetween Ashton-Under-Lyne and Huddersfield

Leeds and Liverpool Canal | From Leeds River Lock to Skipton Wharf

Light Water Valley Lake | The whole lake

The Mere, Scarborough | The whole lake

River Ouse | Above Nun Monkton Pool

Pocklington Canal | From the junction with River Derwent to Melbourne Basin

Sheffield and South Yorkshire Canal | Tinsley Lock to Sheffield

River Soar | Trent Junction to Loughborough

Trent and Mersey Canal | Shardlow to Dellow Lane Lock

River Ure and Ripon Canal | From Junction with River Ouse to Ripon Canal (Ripon Basin)

Ashton Canal | The whole canal

WALES AND WEST OF ENGLAND

River Avon (Midland) | Above Evesham

Birmingham Canal Navigation | The whole canal

Birmingham and Fazeley Canal | The whole canal

Coventry Canal | The whole canal

Grand Union Canal (from Napton Junction to Birmingham and Fazeley) | The whole section of the canal

Kennet and Avon Canal (Bath to Newbury) | The whole section of the canal

Lancaster Canal | The whole canal

Leeds and Liverpool Canal | The whole canal

Llangollen Canal | The whole canal

Caldon Canal | The whole canal

Peak Forest Canal | The whole canal

Macclesfield Canal | The whole canal

Monmouthshire and Brecon Canal | The whole canal

Montgomery Canal | The whole canal

Rochdale Canal | The whole canal

Swansea Canal | The whole canal

Neath & Tennant Canal | The whole canal

Shropshire Union Canal | The whole canal

Staffordshire and Worcester Canal | The whole canal

Stratford-upon-Avon Canal | The whole canal

River Trent | The whole river

Trent and Mersey Canal | The whole canal

River Weaver | Above Northwich

Worcester and Birmingham Canal | The whole canal

SOUTH OF ENGLAND

River Nene | Above Dog-in-a-Doublet Lock

River Great Ouse | Kings Lynn above West Lynn Road Bridge; River Great Ouse and all connected Fenland Waterways including the River Cam and Middle Level Navigation

The Norfolk and Suffolk Broads | All navigable tidal and non-tidal rivers, broads, canals and waterways within the Norfolk and Suffolk Broads including Oulton Broad, and Rivers Waveney, Yare, Bure, Ant and Thurne except as specified for Yarmouth and Lowestoft

River Blyth | River Blyth, entrance to Blythburgh

Rivers Alde and Ore | On the River Alde above Westrow Point

River Deben | River Deben above Felixstowe Ferry

River Orwell and River Stour | All waterways on the River Stour above Manningtree

Chelmer & Blackwater Canal | Westward of Beeleigh Lock

River Thames and its tributaries | River Stort and River Lee above Bow Creek; Grand Union Canal above Brentford Lock and Regents Canal above Limehouse Basin and all canals connected therewith; River Wey above Thames Lock; Kennet and Avon Canal; River Thames above Oxford; Oxford Canal

River Medway and the Swale | River Medway above Allington Lock

River Stour (Kent) | River Stour above the landing at Flagstaff Reach

Dover Harbour | The whole harbour

River Rother | River Rother and the Royal Military Canal above Scots Float Sluice and River Brede above the entrance lock

Brighton | Brighton Marina inner harbour above the lock

Wickstead Park Lake | The whole lake

Kennet and Avon Canal | The whole canal

Grand Union Canal | The whole canal

River Avon (Avon) | Above Pulteney Weir

Bridgewater Canal | The whole canal

(*1)  In the case of vessels whose home port is elsewhere, account is to be taken of Article 32 of the Ems-Dollart Treaty of 8 April 1960 (BGBl. 1963 II, p. 602).
CONTENTSANNEX IIMINIMUM TECHNICAL REQUIREMENTS APPLICABLE TO VESSELS ON INLAND WATERWAYS OF ZONES 1, 2, 3 AND 4

PART I | 38

CHAPTER 1 | 38

GENERAL | 38

Article 1.01 — | Definitions | 38

Article 1.02 — | (Left void) | 42

Article 1.03 — | (Left void) | 42

Article 1.04 — | (Left void) | 42

Article 1.05 — | (Left void) | 42

Article 1.06 — | Temporary requirements | 42

Article 1.07 — | Administrative instructions | 42

CHAPTER 2 | 42

PROCEDURE | 42

Article 2.01 — | Inspection bodies | 42

Article 2.02 — | Request for an inspection | 43

Article 2.03 — | Presentation of the craft for inspection | 43

Article 2.04 — | (Left void) | 43

Article 2.05 — | Provisional Community certificate | 43

Article 2.06 — | Validity of the Community certificate | 44

Article 2.07 — | Particulars in and amendments to the Community certificate | 44

Article 2.08 — | (Left void) | 44

Article 2.09 — | Periodical inspection | 44

Article 2.10 — | Voluntary inspection | 44

Article 2.11 — | (Left void) | 44

Article 2.12 — | (Left void) | 44

Article 2.13 — | (Left void) | 44

Article 2.14 — | (Left void) | 45

Article 2.15 — | Expenses | 45

Article 2.16 — | Information | 45

Article 2.17 — | Register of Community certificates | 45

Article 2.18 — | Official number | 45

Article 2.19 — | Equivalences and derogations | 45

PART II | 46

CHAPTER 3 | 46

SHIPBUILDING REQUIREMENTS | 46

Article 3.01 — | Basic requirement | 46

Article 3.02 — | Strength and stability | 46

Article 3.03 — | Hull | 47

Article 3.04 — | Engine and boiler rooms, bunkers | 47

CHAPTER 4 | 48

SAFETY CLEARANCE, FREEBOARD AND DRAUGHT MARKS | 48

Article 4.01 — | Safety clearance | 48

Article 4.02 — | Freeboard | 48

Article 4.03 — | Minimum freeboard | 50

Article 4.04 — | Draught marks | 50

Article 4.05 — | Maximum loaded draught of vessels whose holds are not always closed so as to be spray-proof and weathertight | 51

Article 4.06 — | Draught scales | 51

CHAPTER 5 | 52

MANOEUVRABILITY | 52

Article 5.01 — | General | 52

Article 5.02 — | Navigation tests | 52

Article 5.03 — | Test area | 52

Article 5.04 — | Degree of loading of vessels and convoys during navigation tests | 52

Article 5.05 — | Use of on-board facilities for navigation test | 52

Article 5.06 — | Prescribed (forward) speed | 53

Article 5.07 — | Stopping capacity | 53

Article 5.08 — | Capacity for going astern | 53

Article 5.09 — | Capacity for taking evasive action | 53

Article 5.10 — | Turning capacity | 53

CHAPTER 6 | 53

STEERING SYSTEM | 53

Article 6.01 — | General requirements | 53

Article 6.02 — | Steering apparatus drive unit | 54

Article 6.03 — | Hydraulic steering apparatus drive unit | 54

Article 6.04 — | Power source | 54

Article 6.05 — | Manual drive | 55

Article 6.06 — | Rudder-propeller, water-jet, cycloidal-propeller and bow-thruster systems | 55

Article 6.07 — | Indicators and monitoring devices | 55

Article 6.08 — | Rate-of-turn regulators | 55

Article 6.09 — | Acceptance procedure | 55

CHAPTER 7 | 56

WHEELHOUSE | 56

Article 7.01 — | General | 56

Article 7.02 — | Unobstructed view | 56

Article 7.03 — | General requirements concerning control, indicating and monitoring equipment | 57

Article 7.04 — | Specific requirements concerning control, indicating and monitoring equipment of main engines and steering system | 57

Article 7.05 — | Navigation lights, light signals and sound signals | 58

Article 7.06 — | Radar installations and rate-of-turn indicators | 58

Article 7.07 — | Radio telephony systems for vessels with wheelhouses designed for radar navigation by one person | 59

Article 7.08 — | Internal communication facilities on board | 59

Article 7.09 — | Alarm system | 59

Article 7.10 — | Heating and ventilation | 59

Article 7.11 — | Stern-anchor operating equipment | 59

Article 7.12 — | Retractable wheelhouses | 59

Article 7.13 — | Entry in the Community certificate for vessels with wheelhouses designed for radar navigation by one person | 60

CHAPTER 8 | 60

ENGINE DESIGN | 60

Article 8.01 — | General | 60

Article 8.02 — | Safety equipment | 60

Article 8.03 — | Power plant | 60

Article 8.04 — | Engine exhaust system | 61

Article 8.05 — | Fuel tanks, pipes and accessories | 61

Article 8.06 — | Storage of lubricating oil, pipes and accessories | 62

Article 8.07 — | Storage of oils used in power transmission systems, control and activating systems and heating systems, pipes and accessories | 62

Article 8.08 — | Bilge pumping and drainage systems | 63

Article 8.09 — | Oily water and used oil stores | 64

Article 8.10 — | Noise emitted by vessels | 64

CHAPTER 8a | (Left void) | 64

CHAPTER 9 | 64

ELECTRICAL EQUIPMENT | 64

Article 9.01 — | General | 64

Article 9.02 — | Electricity supply systems | 65

Article 9.03 — | Protection against physical contact, intrusion of solid objects and the ingress of water | 65

Article 9.04 — | Protection from explosion | 66

Article 9.05 — | Earthing | 66

Article 9.06 — | Maximum permissible voltages | 66

Article 9.07 — | Distribution systems | 67

Article 9.08 — | Connection to shore or other external networks | 67

Article 9.09 — | Power supply to other craft | 68

Article 9.10 — | Generators and motors | 68

Article 9.11 — | Accumulators | 68

Article 9.12 — | Switchgear installations | 69

Article 9.13 — | Emergency circuit breakers | 70

Article 9.14 — | Installation fittings | 70

Article 9.15 — | Cables | 70

Article 9.16 — | Lighting installations | 71

Article 9.17 — | Navigation lights | 71

Article 9.18 — | (Left void) | 71

Article 9.19 — | Alarm and safety systems for mechanical equipment | 71

Article 9.20 — | Electronic equipment | 72

Article 9.21 — | Electromagnetic compatibility | 73

CHAPTER 10 | 73

EQUIPMENT | 73

Article 10.01 — | Anchor equipment | 73

Article 10.02 — | Other equipment | 75

Article 10.03 — | Portable fire extinguishers | 76

Article 10.03a | Permanently installed fire-fighting systems in accommodation spaces, wheelhouses and passenger spaces | 76

Article 10.03b | Permanently installed fire-fighting systems in engine rooms, boiler rooms and pump rooms | 77

Article 10.04 — | Ship’s boats | 81

Article 10.05 — | Lifebuoys and lifejackets | 81

CHAPTER 11 | 81

SAFETY AT WORK STATIONS | 81

Article 11.01 — | General | 81

Article 11.02 — | Protection against falling | 81

Article 11.03 — | Dimensions of working spaces | 82

Article 11.04 — | Side decks | 82

Article 11.05 — | Access to working spaces | 82

Article 11.06 — | Exits and emergency exits | 83

Article 11.07 — | Ladders, steps and similar devices | 83

Article 11.08 — | Interior spaces | 83

Article 11.09 — | Protection against noise and vibration | 83

Article 11.10 — | Hatch covers | 83

Article 11.11 — | Winches | 84

Article 11.12 — | Cranes | 84

Article 11.13 — | Storing flammable liquids | 85

CHAPTER 12 | 85

ACCOMMODATION | 85

Article 12.01 — | General | 85

Article 12.02 — | Special design requirements for accommodation | 86

Article 12.03 — | Sanitary installations | 86

Article 12.04 — | Galleys | 87

Article 12.05 — | Potable water | 87

Article 12.06 — | Heating and ventilation | 88

Article 12.07 — | Other accommodation installations | 88

CHAPTER 13 | 88

FUEL-FIRED HEATING, COOKING AND REFRIGERATING EQUIPMENT | 88

Article 13.01 — | General | 88

Article 13.02 — | Use of liquid fuels, oil-fired equipment | 88

Article 13.03 — | Vaporising oil burner stoves and atomising oil burner heating appliances | 89

Article 13.04 — | Vaporising oil burner stoves | 89

Article 13.05 — | Atomising oil burner heating appliances | 89

Article 13.06 — | Forced-air heating appliances | 89

Article 13.07 — | Solid fuel heating | 90

CHAPTER 14 | 90

LIQUEFIED GAS INSTALLATIONS FOR DOMESTIC PURPOSES | 90

Article 14.01 — | General | 90

Article 14.02 — | Installations | 90

Article 14.03 — | Receptacles | 91

Article 14.04 — | Location and arrangement of supply units | 91

Article 14.05 — | Spare and empty receptacles | 91

Article 14.06 — | Pressure regulators | 91

Article 14.07 — | Pressure | 92

Article 14.08 — | Piping and flexible tubes | 92

Article 14.09 — | Distribution system | 92

Article 14.10 — | Gas-consuming appliances and their installation | 92

Article 14.11 — | Ventilation and evacuation of combustion gases | 93

Article 14.12 — | Operating and safety requirements | 93

Article 14.13 — | Acceptance test | 93

Article 14.14 — | Tests | 93

Article 14.15 — | Attestation | 94

CHAPTER 15 | 94

SPECIFIC REQUIREMENTS APPLICABLE TO PASSENGER VESSELS | 94

Article 15.01 — | General provisions | 94

Article 15.02 — | Vessels’ hulls | 94

Article 15.03 — | Stability | 96

Article 15.04 — | Safety clearance and freeboard | 100

Article 15.05 — | Maximum permitted number of passengers | 101

Article 15.06 — | Passenger rooms and areas | 101

Article 15.07 — | Propulsion system | 104

Article 15.08 — | Safety devices and equipment | 104

Article 15.09 — | Life-saving equipment | 105

Article 15.10 — | Electrical Equipment | 106

Article 15.11 — | Fire protection | 107

Article 15.12 — | Fire-fighting | 111

Article 15.13 — | Safety organisation | 112

Article 15.14 — | Waste water collection and disposal facilities | 113

Article 15.15 — | Derogations for certain passenger vessels | 113

CHAPTER 15a | 114

SPECIFIC REQUIREMENTS FOR PASSENGER SAILING VESSELS | 114

Article 15a.01 — | Application of Part II | 114

Article 15a.02 — | Exceptions for certain passenger sailing vessels | 115

Article 15a.03 — | Stability requirements for vessels under sail | 115

Article 15a.04 — | Shipbuilding and mechanical requirements | 115

Article 15a.05 — | Rigging in general | 116

Article 15a.06 — | Masts and spars in general | 116

Article 15a.07 — | Special provisions for masts | 116

Article 15a.08 — | Special provisions for topmasts | 117

Article 15a.09 — | Special provisions for bowsprits | 118

Article 15a.10 — | Special provisions for jib-booms | 118

Article 15a.11 — | Special provisions for main booms | 118

Article 15a.12 — | Special provisions for gaffs | 119

Article 15a.13 — | General provisions for standing and running rigging | 119

Article 15a.14 — | Special provisions for standing rigging | 119

Article 15a.15 — | Special provisions for running rigging | 120

Article 15a.16 — | Fittings and parts of the rigging | 121

Article 15a.17 — | Sails | 122

Article 15a.18 — | Equipment | 122

Article 15a.19 — | Testing | 122

CHAPTER 16 | 122

SPECIFIC REQUIREMENTS APPLICABLE TO CRAFT INTENDED TO FORM PART OF A PUSHED OR TOWED CONVOY OR OF A SIDE-BY-SIDE FORMATION | 122

Article 16.01 — | Craft suitable for pushing | 122

Article 16.02 — | Craft suitable for being pushed | 123

Article 16.03 — | Craft suitable for propelling side-by-side formations | 123

Article 16.04 — | Craft suitable for being propelled in convoys | 123

Article 16.05 — | Craft suitable for towing | 123

Article 16.06 — | Navigation tests on convoys | 124

Article 16.07 — | Entries on the Community certificate | 124

CHAPTER 17 | 124

SPECIFIC REQUIREMENTS APPLICABLE TO FLOATING EQUIPMENT | 124

Article 17.01 — | General | 124

Article 17.02 — | Derogations | 124

Article 17.03 — | Additional requirements | 125

Article 17.04 — | Residual safety clearance | 125

Article 17.05 — | Residual freeboard | 125

Article 17.06 — | Heeling test | 126

Article 17.07 — | Confirmation of stability | 126

Article 17.08 — | Confirmation of stability in the case of reduced residual freeboard | 127

Article 17.09 — | Draught marks and draught scales | 128

Article 17.10 — | Floating equipment without confirmation of stability | 128

CHAPTER 18 | 128

SPECIFIC REQUIREMENTS APPLICABLE TO WORKSITE CRAFT | 128

Article 18.01 — | Operating conditions | 128

Article 18.02 — | Application of Part II | 128

Article 18.03 — | Derogations | 128

Article 18.04 — | Safety clearance and freeboard | 129

Article 18.05 — | Ship’s boats | 129

CHAPTER 19 | 129

SPECIFIC REQUIREMENTS APPLICABLE TO HISTORIC VESSELS (Left void) | 129

CHAPTER 19a | 129

SPECIFIC REQUIREMENTS APPLICABLE TO CANAL BARGES (Left void) | 129

CHAPTER 19b | 129

SPECIFIC REQUIREMENTS APPLICABLE TO VESSELS NAVIGATING ON ZONE 4 WATERWAYS | 129

Article 19b.01 — | Application of Chapter 4 | 129

CHAPTER 20 | 129

SPECIFIC REQUIREMENTS APPLICABLE TO SEA-GOING VESSELS (Left void) | 129

CHAPTER 21 | 129

SPECIFIC REQUIREMENTS APPLICABLE TO RECREATIONAL CRAFT | 129

Article 21.01 — | General | 129

Article 21.02 — | Application of Part II | 130

Article 21.03 — | (Left void) | 130

CHAPTER 22 | 131

STABILITY OF VESSELS CARRYING CONTAINERS | 131

Article 22.01 — | General | 131

Article 22.02 — | Limit conditions and method of calculation for confirmation of stability for the transport of non-secured containers | 131

Article 22.03 — | Limit conditions and method of calculation for confirmation of stability for the transport of secured containers | 133

Article 22.04 — | Procedure for assessing stability on board | 134

CHAPTER 22a | 134

SPECIFIC REQUIREMENTS APPLICABLE TO CRAFT LONGER THAN 110 M | 134

Article 22a.01 — | Application of Part I | 134

Article 22a.02 — | Application of Part II | 134

Article 22a.03 — | Strength | 134

Article 22a.04 — | Buoyancy and stability | 134

Article 22a.05 — | Additional requirements | 135

Article 22a.06 — | Application of Part IV in the event of conversion | 136

CHAPTER 22b | 136

SPECIFIC REQUIREMENTS APPLICABLE TO HIGH-SPEED VESSELS | 136

Article 22b.01 — | General | 136

Article 22b.02 — | Application of Part I | 137

Article 22b.03 — | Application of Part II | 137

Article 22b.04 — | Seats and safety belts | 137

Article 22b.05 — | Freeboard | 137

Article 22b.06 — | Buoyancy, stability and subdivision | 137

Article 22b.07 — | Wheelhouse | 137

Article 22b.08 — | Additional equipment | 138

Article 22b.09 — | Closed areas | 138

Article 22b.10 — | Exits and escape routes | 138

Article 22b.11 — | Fire protection and fire-fighting | 139

Article 22b.12 — | Transitional provisions | 139

PART III | 139

CHAPTER 23 | 139

EQUIPMENT OF VESSELS WITH REGARD TO MANNING | 139

Article 23.01 — | (Left void) | 139

Article 23.02 — | (Left void) | 139

Article 23.03 — | (Left void) | 139

Article 23.04 — | (Left void) | 139

Article 23.05 — | (Left void) | 139

Article 23.06 — | (Left void) | 139

Article 23.07 — | (Left void) | 139

Article 23.08 — | (Left void) | 139

Article 23.09 — | Vessels’ equipment | 140

Article 23.10 — | (Left void) | 141

Article 23.11 — | (Left void) | 141

Article 23.12 — | (Left void) | 141

Article 23.13 — | (Left void) | 141

Article 23.14 — | (Left void) | 141

Article 23.15 — | (Left void) | 141

PART IV | 141

CHAPTER 24 | 141

TRANSITIONAL AND FINAL PROVISIONS | 141

Article 24.01 — | Applicability of transitional provisions to craft which are already in service | 141

Article 24.02 — | Derogations for craft which are already in service | 141

Article 24.03 — | Derogations for craft which were laid down on or before 1 April 1976 | 152

Article 24.04 — | Other derogations | 154

Article 24.05 — | (Left void) | 154

Article 24.06 — | Derogations for craft not covered by Article 24.01 — | 154

Article 24.07 — | (Left void) | 163

CHAPTER 24a | 163

TRANSITIONAL PROVISIONS FOR CRAFT NOT NAVIGATING ON ZONE R WATERWAYS | 163

Article 24a.01 — | Application of transitional provisions to craft already in service and validity of previous Community certificates | 163

Article 24a.02 — | Derogations for craft already in service | 163

Article 24a.03 — | Derogations for craft the keels of which were laid before 1 January 1985 | 169

Article 24a.04 — | Other derogations | 171

APPENDIX I— | SAFETY SIGNS | 172

APPENDIX II— | ADMINISTRATIVE INSTRUCTIONS | 174PART ICHAPTER 1GENERAL

Article 1.01

Definitions

The following definitions shall apply in this Directive:
Types of craft 1. ‘craft’: a vessel or item of floating equipment; 2. ‘vessel’: an inland waterway vessel or sea-going ship; 3. ‘inland waterway vessel’: a vessel intended solely or mainly for navigation on inland waterways; 4. ‘sea-going ship’: a vessel certificated for sea-going service; 5. ‘motor vessel’: a motor cargo vessel or a motor tanker; 6. ‘motor tanker’: a vessel intended for the carriage of goods in fixed tanks and built to navigate independently under its own motive power; 7. ‘motor cargo vessel’: a vessel, other than a motor tanker, intended for the carriage of goods and built to navigate independently under its own motive power; 8. ‘canal barge’: an inland waterway vessel not exceeding 38,5 m in length and 5,05 m in breadth and usually operating on the Rhine-Rhône Canal; 9. ‘tug’: a vessel specially built to perform towing operations; 10. ‘pusher’: a vessel specially built to propel a pushed convoy; 11. ‘barge’: a dumb barge or tank barge; 12. ‘tank barge’: a vessel intended for the carriage of goods in fixed tanks and built to be towed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres; 13. ‘dumb barge’: a vessel, other than a tank barge, intended for the carriage of goods and built to be towed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres; 14. ‘lighter’: a tank lighter, cargo lighter or ship-borne lighter; 15. ‘tank lighter’: a vessel intended for the carriage of goods in fixed tanks, built or specially modified to be pushed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres when not part of a pushed convoy; 16. ‘cargo lighter’: a vessel, other than a tank lighter, intended for the carriage of goods and built or specially modified to be pushed, either having no motive power of its own or having only sufficient motive power to perform restricted manoeuvres when not part of a pushed convoy; 17. ‘ship-borne lighter’: a lighter built to be carried aboard sea-going ships and to navigate on inland waterways; 18. ‘passenger vessel’: a day trip or cabin vessel constructed and equipped to carry more than 12 passengers; 19. ‘passenger sailing vessel’: a passenger vessel built and fitted out also with a view to propulsion under sail; 20. ‘day-trip vessel’: a passenger vessel without overnight passenger cabins; 21. ‘cabin vessel’: a passenger vessel with overnight passenger cabins; 22. ‘high-speed vessel’: a motorised craft capable of reaching speeds over 40 km/h in relation to water; 23. ‘floating equipment’: a floating installation carrying working gear such as cranes, dredging equipment, pile drivers or elevators; 24. ‘worksite craft’: a vessel, appropriately built and equipped for use at worksites, such as a reclamation barge, hopper or pontoon barge, pontoon or stone-dumping vessel; 25. ‘recreational craft’: a vessel other than a passenger vessel, intended for sport or pleasure; 26. ‘ship’s boat’: a boat for use in transport, rescue, salvage and work duties; 27. ‘floating establishment’: any floating installation not normally intended to be moved, such as a swimming bath, dock, jetty or boathouse; 28. ‘floating objec’: a raft or other structure, object or assembly capable of navigation, not being a vessel or floating equipment or establishment;
Assemblies of craft 29. ‘convoy’: a rigid or towed convoy of craft; 30. ‘formation’: the manner in which a convoy is assembled; 31. ‘rigid convoy’: a pushed convoy or side-by-side formation; 32. ‘pushed convoy’: a rigid assembly of craft of which at least one is positioned in front of the craft providing the power for propelling the convoy, known as the ‘pusher(s)’; a convoy composed of a pusher and a pushed craft coupled so as to permit guided articulation is also considered as rigid; 33. ‘side-by-side formation’: an assembly of craft coupled rigidly side by side, none of which is positioned in front of the craft propelling the assembly; 34. ‘towed convoy’: an assembly of one or more craft, floating establishments or floating objects towed by one or more self-propelled craft forming part of the convoy;
Particular areas on board 35. ‘main engine room’: space where the propulsion engines are installed; 36. ‘engine room’: space where combustion engines are installed; 37. ‘boiler room’: a space housing a fuel-operated installation designed to produce steam or heat a thermal fluid; 38. ‘enclosed superstructure’: a watertight, rigid, continuous structure with rigid walls joined to the deck in a permanent and watertight manner; 39. ‘wheelhouse’: the area which houses all the control and monitoring instruments necessary for manoeuvring the vessel; 40. ‘accommodation’: a space intended for the use of persons normally living on board, including galleys, storage space for provisions, toilets and washing facilities, laundry facilities, ante-rooms and passageways, but not the wheelhouse; 41. ‘passenger area’: areas on board intended for passengers and enclosed areas such as lounges, offices, shops, hairdressing salons, drying rooms, laundries, saunas, toilets, washrooms, passageways, connecting passages and stairs not encapsulated by walls; 42. ‘control centre’: a wheelhouse, an area which contains an emergency electrical power plant or parts thereof or an area with a centre permanently occupied by on-board personnel or crew members, such as for fire alarm equipment, remote controls of doors or fire dampers; 43. ‘stairwell’: the well of an internal staircase or of a lift; 44. ‘lounge’: a room of an accommodation or a passenger area. On board passenger vessels, galleys are not regarded as lounges; 45. ‘galley’: a room with a stove or a similar cooking appliance; 46. ‘store room’: a room for the storage of flammable liquids or a room with an area of over 4 m2 for storing supplies; 47. ‘hold’: part of the vessel, bounded fore and aft by bulkheads, opened or closed by means of hatch covers, intended for the carriage of goods, whether packaged or in bulk, or for housing tanks not forming part of the hull; 48. ‘fixed tank’: a tank joined to the vessel, the walls of the tank consisting either of the hull itself or of a casing separate from the hull; 49. ‘working station’: an area where members of the crew carry out their duties, including gangway, derrick and ship’s boat; 50. ‘passageway’: an area intended for the normal movement of persons and goods; 51. ‘safe area’: the area which is externally bounded by a vertical surface running at a distance of 1/5 BWL parallel to the course of the hull in the line of maximum draught; 52. ‘muster areas’: areas of the vessel which are specially protected and in which passengers muster in the event of danger; 53. ‘evacuation areas’: part of muster areas of the vessel from which evacuation of persons can be carried out;
Marine engineering terms 54. ‘plane of maximum draught’: the water plane corresponding to the maximum draught at which the craft is authorised to navigate; 55. ‘safety clearance’: the distance between the plane of maximum draught and the parallel plane passing through the lowest point above which the craft is no longer deemed to be watertight; 56. ‘residual safety clearance’: the vertical clearance available, in the event of the vessel heeling over, between the water level and the lowest point of the immersed side, beyond which the vessel is no longer regarded as watertight; 57. ‘freeboard (f)’: the distance between the plane of maximum draught and a parallel plane passing through the lowest point of the gunwale or, in the absence of a gunwale, the lowest point of the upper edge of the ship’s side; 58. ‘residual freeboard’: the vertical clearance available, in the event of the vessel heeling over, between the water level and the upper surface of the deck at the lowest point of the immersed side or, if there is no deck, the lowest point of the upper surface of the fixed ship’s side; 59. ‘margin line’: an imaginary line drawn on the side plating not less than 10 cm below the bulkhead deck and not less than 10 cm below the lowest non-watertight point of the side plating. If there is no bulkhead deck, a line drawn not less than 10 cm below the lowest line up to which the outer plating is watertight shall be used; 60. ‘water displacement (∇)’: the immersed volume of the vessel, in m3; 61. ‘displacement (Δ)’: the total weight of the vessel, inclusive of cargo, in t; 62. ‘block coefficient (CB)’: the ratio between the water displacement and the product of length LWL, breadth BWL and draught T; 63. ‘lateral plane above water (AV)’: lateral plane of the vessel above the waterline in m2; 64. ‘bulkhead deck’: the deck to which the required watertight bulkheads are taken and from which the freeboard is measured; 65. ‘bulkhead’: a wall of a given height, usually vertical, partitioning the vessel and bounded by the bottom of the vessel, the plating or other bulkheads; 66. ‘transverse bulkhead’: a bulkhead extending from one side of the vessel to the other; 67. ‘wall’: a dividing surface, usually vertical; 68. ‘partition wall’: a non-watertight wall; 69. ‘length (L)’: the maximum length of the hull in m, excluding rudder and bowsprit; 70. ‘length overall (LOA)’: the maximum length of the craft in m, including all fixed installations such as parts of the steering system or power plant, mechanical or similar devices; 71. ‘length of waterline (LWL)’: the length of the hull in m, measured at the maximum draught; 72. ‘breadth (B)’: the maximum breadth of the hull in m, measured to the outer edge of the shell plating (excluding paddle wheels, rub rails, and similar); 73. ‘breadth overall (BOA)’: the maximum breadth of the craft in m, including all fixed equipment such as paddle wheels, rub rails, mechanical devices and the like; 74. ‘breadth of waterline (BWL)’: breadth of the hull in m, measured from the outside of the side plating at the maximum draught line; 75. ‘height (H)’: the shortest vertical distance in m between the lowest point of the hull or the keel and the lowest point of the deck on the side of the vessel; 76. ‘draught (T)’: the vertical distance in m between the lowest point of the hull or the keel and the maximum draught line; 77. ‘forward perpendicular’: the vertical line at the forward point of the intersection of the hull with the maximum draught line; 78. ‘clear width of side deck’: the distance between the vertical line passing through the most prominent part of the hatch coaming on the side deck side and the vertical line passing through the inside edge of the slip guard (guard-rail, foot rail) on the outer side of the side deck;
Steering system 79. ‘steering system’: all the equipment necessary for steering the vessel, such as to ensure the manoeuvrability laid down in Chapter 5; 80. ‘rudder’: the rudder or rudders, with shaft, including the rudder quadrant and the components connecting with the steering apparatus; 81. ‘steering apparatus’: the part of the steering system which produces the movement of the rudder; 82. ‘drive unit’: the steering-apparatus drive, between the power source and the steering apparatus; 83. ‘power source’: the power supply to the steering drive unit and the steering apparatus produced by an on-board network, batteries or an internal combustion engine; 84. ‘steering control’: the component parts of and circuitry for the operation of a power-driven steering control; 85. ‘steering apparatus drive unit’: the control for the steering apparatus, its drive unit and its power source; 86. ‘manual drive’: a system whereby manual operation of the hand wheel moves the rudder by means of a mechanical transmission, without any additional power source; 87. ‘manually-operated hydraulic drive’: a manual control actuating a hydraulic transmission; 88. ‘rate-of-turn regulator’: equipment which automatically produces and maintains a given rate of turn of the vessel in accordance with preselected values; 89. ‘wheelhouse designed for radar navigation by one person’: a wheelhouse arranged in such a way that, during radar navigation, the vessel can be manoeuvred by one person;
Properties of structural components and materials 90. ‘watertight’: a structural component or device so fitted as to prevent any ingress of water; 91. ‘spray-proof and weathertight’: a structural component or device so fitted that in normal conditions it allows only a negligible quantity of water to penetrate; 92. ‘gastight’: a structural component or device so fitted as to prevent the ingress of gas and vapours; 93. ‘non-combustible’: a substance which neither burns nor produces flammable vapours in such quantities that they ignite spontaneously when heated to approximately 750oC; 94. ‘flame-retardant’: material which does not readily catch fire, or whose surface at least restricts the spread of flames pursuant to the test procedure referred to in Article 15.11(1)(c); 95. ‘fire-resistance’: the property of structural components or devices as certified by the test procedure referred to in Article 15.11(1)(d); 96. ‘Code for Fire Test Procedures’: the International Code for the Application of Fire Test Procedures adopted under Resolution MSC.61(67) by the Maritime Safety Committee of the IMO;
Other definitions 97. ‘approved classification society’: a classification society which has been recognised in accordance with the criteria and the procedures of Annex VII; 98. ‘radar installation’: an electronic navigational aid for detecting and displaying the surroundings and traffic; 99. ‘Inland ECDIS’: a standardised system for displaying electronic navigational charts for inland waters and associated information, that displays selected information from proprietary electronic navigational charts for inland waters and optionally information from other sensors of the craft; 100. ‘Inland ECDIS installation’: an installation for displaying electronic navigational charts for inland waters that can be operated in two different modes: information mode and navigation mode; 101. ‘information mode’: use of Inland ECDIS for information purposes only without radar overlay; 102. ‘navigation mode’: use of Inland ECDIS with radar overlay for navigating a craft; 103. ‘shipboard personnel’: all employees on board a passenger vessel who are not members of the crew; 104. ‘persons with reduced mobility’: persons facing particular problems when using public transport, such as the elderly and the handicapped and persons with sensory disabilities, persons in wheelchairs, pregnant women and persons accompanying young children; 105. ‘Community certificate’: a certificate issued to an inland waterway vessel by the competent authority, signifying compliance with the technical requirements of this Directive.
Article 1.02

(Left void)
Article 1.03

(Left void)
Article 1.04

(Left void)
Article 1.05

(Left void)
Article 1.06

Temporary requirements

Temporary requirements may be adopted, in accordance with the procedure referred to in Article 19(2) of this Directive, where it is found urgently necessary, for the purposes of adaptation to technical progress of inland waterway transport, to allow derogations from the provisions of this Directive before an expected amendment of this Directive itself or to allow tests. The requirements shall be published and shall be valid for a maximum of three years. They shall enter into force at the same time and shall be annulled under the same conditions in all Member States.
Article 1.07

Administrative instructions

In order to make the implementation of this Directive easier and uniform, binding administrative instructions for the inspection may be adopted in accordance with the procedure referred to in Article 19(2) of this Directive.

CHAPTER 2PROCEDURE

Article 2.01

Inspection bodies 1.   Inspection bodies shall be set up by the Member States. 2.   Inspection bodies shall consist of a chairman and experts.

At least the following shall form part of each body as experts:

(a) an official from the administration that is responsible for inland navigation;

(b) an expert on the design of inland waterway vessels and their engines;

(c) a nautical expert in possession of a navigation certificate. 3.   The Chairman and the experts within each body shall be designated by the authorities in the State in which the body is set up. On taking up their duties, the Chairman and the experts shall submit a written declaration that they will perform them completely independently. No declaration shall be required from officials. 4.   Inspection bodies may be assisted by specialist experts in accordance with the national provisions applying.
Article 2.02

Request for an inspection 1.   The procedure for making a request for an inspection and establishing the place and time of that inspection fall within the powers of the authorities issuing the Community certificate. The competent authority shall determine which documents are to be submitted. The procedure shall take place in such a way as to ensure that the inspection may be conducted within a reasonable period following the lodging of the request. 2.   The owner of a craft that is not subject to this Directive, or his representative, may request a Community certificate. His request shall be met if the vessel fulfils the requirements of this Directive.
Article 2.03

Presentation of the craft for inspection 1.   The owner, or his representative, shall present the craft in an unladen, cleaned and equipped state. He shall provide any assistance needed for the inspection, such as providing an appropriate dinghy and staff, and uncovering any parts of the hull or fittings that are not directly accessible or visible. 2.   The inspection body shall demand a dry inspection on the first occasion. That dry inspection may be dispensed with if a classification certificate or a certificate from an approved classification society to the effect that the construction meets its requirements can be produced or if a certificate is produced which shows that a competent authority has already carried out a dry inspection for other purposes. Where there is a periodical inspection or an inspection, as provided for in Article 15 of this Directive, the inspection body may require an inspection out of the water.

The inspection body shall conduct trial runs during an initial inspection of motor vessels or convoys or where major changes are made to the propulsion or steering equipment. 3.   The inspection body may require further operational tests and other supporting documents. That provision shall also apply during the building of the craft.
Article 2.04

(Left void)
Article 2.05

Provisional Community certificate 1.   The competent authority may issue a provisional Community certificate:

(a) to craft intended to travel to a certain place with the permission of the competent authority in order to obtain a Community certificate;

(b) to craft whose Community certificate has been temporarily withdrawn in one of the instances referred to in Article 2.07 or in Articles 12 and 16 of this Directive;

(c) to craft whose Community certificate is in preparation following a successful inspection;

(d) to craft where not all of the conditions required for obtaining a Community certificate as set out in Part I of Annex V have been met;

(e) to craft so damaged that their state no longer complies with the Community certificate;

(f) to floating installations or equipment where the authorities responsible for special transport operations make the authorisation to carry out a special transport operation, as provided for by the applicable navigational authority regulations of the Member States, subject to obtaining such a Community certificate;

(g) to craft deviating from the provisions of Part II, as provided for in Article 2.19( 2). 2.   The provisional Community certificate shall be drawn up using the model set out in Part III of Annex V where the navigability of the craft, floating establishment or floating object seems to have been adequately ensured.

This shall include the conditions considered necessary by the competent authority and shall be valid:

(a) in the cases referred to in paragraph 1(a), (d) to (f), for a single specific trip to be made within a suitable period that shall not exceed one month;

(b) in the cases referred to in paragraph 1(b) and (c), for an appropriate duration;

(c) in the cases referred to in paragraph 1(g), for six months. The provisional Community certificate may be extended for six months at a time until the Committee has taken a decision.
Article 2.06

Validity of the Community certificate 1.   The validity period of Community certificates issued to newly built vessels in accordance with the provisions of this Directive shall be determined by the competent authority up to a maximum of:

(a) five years in the case of passenger vessels;

(b) 10 years in the case of all other craft.

The period of validity shall be entered on the Community certificate. 2.   In the case of vessels already in operation before the inspection, the competent authority shall set the period of validity of the Community certificate case by case, in the light of the results of the inspection. However, the validity may not exceed the periods specified in paragraph 1. 

Article 2.07

Particulars in and amendments to the Community certificate 1.   The owner of a craft, or his representative, shall bring to the notice of the competent authority any change in the name or ownership of a craft, any remeasurement, and any change in the official number, registration or home port, and shall send the Community certificate to that authority for amendment. 2.   Any competent authority may add any information or change to the Community certificate. 3.   Where a competent authority adds any alteration or information to a Community certificate it shall inform the competent authority which issued the Community certificate thereof.
Article 2.08

(Left void)
Article 2.09

Periodical inspection 1.   Craft shall be subjected to a periodical inspection before expiry of their Community certificate. 2.   Following a justified request by the owner or his representative, the competent authority may, by way of an exception, and without any further inspections, grant an extension of the validity of the Community certificate for not more than six months. That extension shall be granted in writing and shall be kept on board the craft. 3.   The competent authority shall again lay down the period of validity of the Community certificate in accordance with the results of that inspection.

The period of validity shall be entered on the Community certificate and brought to the attention of the authority having issued that Community certificate. 4.   If, rather than have its period of validity extended, a Community certificate is replaced by a new version, the earlier Community certificate shall be returned to the competent authority which issued it.
Article 2.10

Voluntary inspection

The owner of a craft, or his representative, may voluntarily request an inspection at any time.

That request for an inspection shall be acted upon.
Article 2.11

(Left void)
Article 2.12

(Left void)
Article 2.13

(Left void)
Article 2.14

(Left void)
Article 2.15

Expenses

The owner of a craft, or his representative, shall bear all of the costs arising from the inspection of the vessel and the issue of the Community certificate in accordance with a special set of charges drawn up by each of the Member States.
Article 2.16

Information

The competent authority may allow persons demonstrating a well-founded interest to be informed of the contents of a Community certificate and may issue those persons with extracts or copies of the Community certificates certified as true and designated as such.
Article 2.17

Register of Community certificates 1.   Competent authorities shall assign an order number to the Community certificates they issue. They shall keep a register in accordance with the model set out in Annex VI of all the Community certificates they issue. 2.   Competent authorities shall keep the original, or a copy of all the Community certificates they have issued, and shall enter on these any information and alterations, together with any Community certificate cancellations and replacements.
Article 2.18

Official number 1.   The competent authority having issued a Community certificate shall enter on that Community certificate the official number assigned to that craft by the competent authority of the Member State in which the craft has been registered or has its home port.

As far as craft from non-Member States are concerned the official number to be entered on the Community certificate shall be assigned by the competent authority issuing that Community certificate.

These requirements shall not apply to recreational craft. 2.   (Left void) 3.   (Left void) 4.   The owner of a craft, or his representative, shall apply to the competent authorities for assignment of the official number. The owner or his representative shall also be responsible for affixing the official number entered in the Community certificate and removing it as soon as it is no longer valid.
Article 2.19

Equivalences and derogations 1.   Where the provisions of Part II require the use, or presence, on board a craft of certain materials, installations or items of equipment, or the adoption of certain design aspects or certain arrangements, the competent authority may permit the use, or presence, on board the said craft of other materials, installations or items of equipment, or the adoption of other design features or other arrangements where, in accordance with the procedure referred to in Article 19(2) of this Directive, these are recognised to be equivalent. 2.   If, in accordance with the procedure referred to in Article 19(2) of this Directive, the Committee reaches no decision on equivalence, as provided for in paragraph 1, the competent authority may issue a provisional Community certificate.

In accordance with the procedure referred to in Article 19(2) of this Directive, the competent authorities shall report to the Committee within one month of issue of the provisional Community certificate in accordance with Article 2.05(1)(g), indicating the name and official number of the craft, the nature of the derogation and the State in which the craft is registered or has its home port. 3.   In accordance with the procedure referred to in Article 19(2) of this Directive, the competent authority may, on the basis of a recommendation by the Committee, issue a Community certificate for trial purposes and for a limited period to a specific craft incorporating new technical specifications that derogate from the requirements of Part II, provided those specifications offer equivalent safety. 4.   The equivalences and derogations referred to in paragraphs 1 and 3 shall be entered in the Community certificate. The Commission shall be informed thereof.

PART IICHAPTER 3SHIPBUILDING REQUIREMENTS

Article 3.01

Basic requirements

Vessels shall be built in accordance with good shipbuilding practice.
Article 3.02

Strength and stability 1.   The hull shall be sufficiently strong to withstand all of the stresses to which it is normally subjected.

(a) In the case of newly built vessels or major conversions affecting vessel strength, adequate strength shall be demonstrated by presenting design calculation proof. That proof is not required where a classification certificate or a declaration from an approved classification society is submitted.

(b) Where there is an inspection as referred to in Article 2.09 the minimum thicknesses of the bottom, bilge and side plates shall be checked in accordance with the following conditions:

For vessels made from steel minimum thickness tmin is given by the highest of the values resulting from the following formulae: 1. for vessels that are longer than 40 m: tmin = f · b · c (2,3 + 0,04 L) (mm);

for vessels not more than 40 m in length: tmin = f · b · c (1,5 + 0,06 L) (mm), however, not less than 3.00 mm 2. where:

a

=

frame spacing (mm);

f

=

frame spacing factor:

f

=

1 for a ≤ 500 mm

f

=

1 + 0,0013 (a — 500) for a > 500 mm

b

=

factor for bottom, side or bilge plates

b

=

1,0 for bottom plates and side plates

b

=

1,25 for bilge plates.

f = 1 may be taken for the frame spacing when calculating the minimum thickness of the side plates. However, the minimum thickness of the bilge plates may in no case be less than that of the bottom plates and side plates.

c

=

factor for the type of structure:

c

=

0,95 for vessels with double bottom and wing void, where the partition between wing void and hold is located vertically in line with the coaming

c

=

1,0 for all other types of structure.

(c) In longitudinally framed vessels with double bottom and wing voids, the minimum value calculated for the plate thickness in accordance with the formulae in paragraph (b) may be reduced to a calculated value certified by an approved classification society for sufficient hull strength (longitudinal, lateral and local strength).

Plates shall be renewed if bottom, bilge or side plates are below the permissible value laid down in this way.

The minimum values calculated in accordance with the method are limit values taking account of normal, uniform wear, and provided that shipbuilding steel is used and that the internal structural components such as frames, frame floor, main longitudinal and transverse structural members are in a good state and that the hull shows no indication of any overloading of the longitudinal strength.

As soon as these values are no longer achieved, the plates in question shall be repaired or replaced. However, lesser thicknesses, of not more than 10 % reduction from calculated values, are acceptable locally for small areas. 2.   Where a material other than steel is used for the construction of the hull, it shall be proved by calculation that the hull strength (longitudinal, lateral and local strength) equals at least the strength that would result from the use of steel under the assumption of minimum thickness in accordance with paragraph1. If a certificate of class or a declaration issued by a recognised classification society is presented, a proof by calculation may be dispensed with. 3.   The stability of vessels shall correspond to their intended use.
Article 3.03

Hull 1.   Bulkheads rising up to the deck or, where there is no deck, up to the gunwale, shall be installed at the following points:

(a) A collision bulkhead at a suitable distance from the bow in such a way that the buoyancy of the laden vessel is ensured, with a residual safety clearance of 100 mm if water enters the watertight compartment ahead of the collision bulkhead.

As a general rule, the requirement referred to in paragraph 1 shall be considered to have been met if the collision bulkhead has been installed at a distance of between 0,04 L and 0,04 L + 2 m measured from the forward perpendicular in the plane of maximum draught.

If this distance exceeds 0,04 L + 2 m, the requirement set out in paragraph 1 shall be proved by calculation.

The distance may be reduced to 0,03 L. In that case the requirement referred to in paragraph 1 shall be proved by calculation on the assumption that the compartment ahead of the collision bulkhead and those adjacent have all been filled with water.

(b) An aft-peak bulkhead at a suitable distance from the stern where the vessel length L exceeds 25 m. 2.   No accommodation or installations needed for vessel safety or operation may be located ahead of the plane of the collision bulkhead. This requirement shall not apply to anchor gear. 3.   The accommodation, engine rooms and boiler rooms, and the workspaces forming part of these shall be separated from the holds by watertight transverse bulkheads that extend up to the deck. 4.   The accommodation shall be separated from engine rooms, boiler rooms and holds in a gastight manner and shall be directly accessible from the deck. If no such access has been provided an emergency exit shall also lead directly to the deck. 5.   The bulkheads specified in paragraphs 1 and 3 and the separation of areas specified in paragraph 4 shall not contain any openings.

However, doors in the aft-peak bulkhead and penetrations, in particular for shafts and pipework, shall be permitted where they are so designed that the effectiveness of those bulkheads and of the separation of areas is not impaired. Doors in the aft-peak bulkhead shall be permitted only if it can be determined by remote monitoring in the wheelhouse whether they are open or closed and shall bear the following readily legible instruction on both sides:

                        ‘Door to be closed immediately after use’. 6.   The water inlets and discharges, and the pipework connected to these, shall be such that no unintentional ingress of water into the vessel is possible. 7.   The foresections of vessels shall be built in such a way that the anchors neither wholly nor partly protrude beyond the side plating.
Article 3.04

Engine and boiler rooms, bunkers 1.   Engine or boiler rooms shall be arranged in such a way that the equipment therein can be operated, serviced and maintained easily and safely. 2.   The liquid-fuel or lubricant bunkers and passenger areas and accommodation may not have any common surfaces which are under the static pressure of the liquid when in normal service. 3.   Engine room, boiler room and bunker bulkheads, ceilings and doors shall be made of steel or another equivalent non-combustible material.

Insulation material used in engine rooms shall be protected against the intrusion of fuel and fuel vapours.

All openings in walls, ceilings, and doors of engine rooms, boiler rooms, and bunker rooms shall be such that they can be closed from outside the room. The locking devices shall be made from steel or an equivalently non-combustible material. 4.   Engine and boiler rooms and other premises in which flammable or toxic gases are likely to escape shall be capable of being adequately ventilated. 5.   Companionways and ladders providing access to engine and boiler rooms and bunkers shall be firmly attached and be made of steel or another shock-resistant and non-combustible material. 6.   Engine and boiler rooms shall have two exits of which one may be an emergency exit.

The second exit may be dispensed with if:

(a) the total floor area (average length x average width at the level of the floor plating) of the engine or boiler room does not exceed 35 m2; and

(b) the path between each point where servicing or maintenance operations are to be carried out and the exit, or foot of the companionway near the exit providing access to the outside, is not longer than 5 m; and

(c) a fire extinguisher is located at the servicing point that is furthest removed from the exit door and also, by way of derogation from Article 10.03(1)(e), where the installed power of the engines does not exceed 100 kW. 7.   The maximum permissible sound pressure level in the engine rooms shall be 110 dB(A). The measuring points shall be selected as a function of the maintenance work needed during normal operation of the plant located therein.

CHAPTER 4SAFETY CLEARANCE, FREEBOARD AND DRAUGHT MARKS

Article 4.01

Safety clearance 1.   The safety clearance shall be at least 300 mm. 2.   The safety clearance in the case of vessels whose openings cannot be closed by spray-proof and weathertight devices, and for vessels sailing with their holds uncovered, shall be increased in such a way that each of those openings shall be at least 500 mm from the plane of maximum draught.
Article 4.02

Freeboard 1.   The freeboard of vessels with a continuous deck, without sheer and superstructures, shall be 150 mm. 2.   The freeboard of vessels with sheer and superstructures shall be calculated using the following formula:

where:

a

is a correction coefficient that takes account of all of the superstructures involved;

βv

is a coefficient for correcting the effect of the forward sheer resulting from the presence of superstructures in the forward quarter of length L of the vessel;

βa

is a coefficient correcting the effect of the aft sheer resulting from the presence of superstructures in the aft quarter of length L of the vessel;

Sev

is the effective forward sheer in mm;

Sea

is the effective aft sheer in mm. 3.   The coefficient α is calculated using the following formula:

where:

lem

is the effective length, in m, of a superstructure located in the median part corresponding to half of length L of the vessel;

lev

is the effective length, in m, of a superstructure in the forward quarter of vessel length L;

lea

is the effective length, in m, of a superstructure in the aft quarter of vessel length L.

The effective length of a superstructure is calculated using the following formulae:

where:

l

is the effective length, in m, of the superstructure involved;

b

is the width, in m, of the superstructure involved;

B1

is the width of the vessel, in m, measured on the outside of the vertical sideplates at deck level halfway along the superstructure involved;

h

is the height, in m, of the superstructure involved. However, in the case of hatches, h is obtained by reducing the height of the coamings by half of the safety distance according to Article 4.01(1) and (2). In no case will a value exceeding 0,36 m be taken for h.

If 

 or 

 is less than 0,6 the effective length le of the superstructure will be zero. 4.   Coefficients βv and βa are calculated using the following formulae: 5.   The effective aft/forward sheers Sev/Sea are calculated using the following formulae:
Sev = Sv · p
Sea = Sa · p

where:

Sv

is the actual forward sheer, in mm; however Sv shall not be taken to be more than 1 000 mm;

Sa

is the actual aft sheer, in mm; however Sa may not be taken to be more than 500 mm;

p

is a coefficient calculated using the following formula:

x

is the abscissa, measured from the extremity of the point where the sheer is 0,25 Sv or 0,25 Sa (see figure).

Sv or Sa

0,25 Sv or 0,25 Sa

X

However, coefficient p will not be taken to be more than 1. 6.   If βa · Sea is greater than βv · Sev, the value βv · Sev of will be taken as being the value for βa · Sea.
Article 4.03

Minimum freeboard

In view of the reductions referred to in Article 4.02 the minimum freeboard shall be not less than 0 mm.
Article 4.04

Draught marks 1.   The plane of maximum draught shall be determined in such a way that the specifications concerning minimum freeboard and minimum safety clearance are both met. However, for safety reasons, the inspection body may lay down a greater value for the safety clearance or freeboard. The plane of maximum draught shall be determined at least for Zone 3. 2.   The plane of maximum draught shall be indicated by means of highly visible, indelible draught marks. 3.   The draught marks for Zone 3 shall consist of a rectangle 300 mm long and 40 mm deep, the base of which is horizontal and coincides with the plane of the maximum authorised draught. Any differing draught marks shall include such a rectangle. 4.   Vessels shall have at least three pairs of draught marks, of which one pair shall be centrally located and the two others located, respectively, at a distance from the bow and stern that is equal to roughly one-sixth of the length.

However,

(a) where a vessel is less than 40 m in length it will suffice to affix two pairs of marks at a distance from the bow and stern, respectively, that is equal to a quarter of the length;

(b) where vessels are not intended for the carriage of goods, a pair of marks located roughly halfway along the vessel will suffice. 5.   Marks or indications which cease to be valid following a further inspection shall be deleted or marked as being no longer valid under the supervision of the inspection body. If a draught mark should disappear, it may only be replaced under the supervision of an inspection body. 6.   Where a vessel has been measured in implementation of the 1966 Convention on the Measurement of Inland Navigation Vessels and the plane of the measurement marks meets the requirements of this Directive, those measurement marks shall take the place of the draught marks; this shall be mentioned in the Community certificate. 7.   For vessels operating on zones of inland waterways other than Zone 3 (Zones 1, 2 or 4) the bow and stern pairs of draught marks provided for in paragraph 4 shall be supplemented by adding a vertical line to which one or, in the case of several zones, several additional draught lines 150 mm long shall be affixed towards the bow, in relation to the draught mark for Zone 3. This vertical line and the horizontal line shall be 30 mm thick. In addition to the draught mark towards the bow of the vessel, the relevant zone numbers shall be indicated in lettering 60 mm high × 40 mm deep (see Figure 1).

Figure 1

measurement mark

freeboard deck

draught mark

plane of maximum draught for zone 3

measurement scale
Article 4.05

Maximum loaded draught of vessels whose holds are not always closed so as to be spray-proof and weathertight

If the plane of maximum draught for Zone 3 of a vessel is determined by assuming that the holds may be closed in such a way as to make them spray-proof and weathertight, and if the distance between the plane of maximum draught and the upper edge of the coamings is less than 500 mm, the maximum draught for sailing with uncovered holds shall be determined.

The following statement shall be entered on the Community certificate:

                     ‘Where the hold hatches are totally or partly uncovered the vessel may only be loaded up to … mm below the draught marks for Zone 3.’

Article 4.06

Draught scales 1.   Vessels whose draught may exceed 1 m shall bear a draught scale on each of their sides towards the stern; they may bear additional draught scales. 2.   The zero points on each draught scale shall be taken vertically to this within the plane running parallel to the plane of maximum draught passing through the lowest point of the hull or of the keel where such exists. The vertical distance above the zero point shall be graduated in decimetres. That graduation shall be located on each scale, from the unladen water line up to 100 mm above the maximum draught by means of punched or chiselled marks, and shall be painted in the form of a highly-visible band in two alternating colours. That graduation shall be identified by figures at a distance of every five decimetres marked next to the scale as well as at the top of the scale. 3.   The two stern measurement scales affixed pursuant to the Convention referred to in Article 4.04 (6), may replace the draught scales, provided that they include a graduation that meets the requirements plus, where appropriate, figures indicating the draught.

CHAPTER 5MANOEUVRABILITY

Article 5.01

General

Vessels and convoys shall display adequate navigability and manoeuvrability.

Unpowered vessels intended to be towed shall meet the specific requirements laid down by the inspection body.

Powered vessels and convoys shall meet the requirements set out in Articles 5.02 to 5.10. 

Article 5.02

Navigation tests 1.   Navigability and manoeuvrability shall be checked by means of navigation tests. Compliance with the requirements of Articles 5.06 to 5.10 shall, in particular, be examined. 2.   The inspection body may dispense with all or part of the tests where compliance with the navigability and manoeuvrability requirements is proven in another manner.
Article 5.03

Test area 1.   The navigation tests referred to in Article 5.02 shall be carried out on areas of inland waterways that have been designated by the competent authorities. 2.   Those test areas shall be situated on a stretch of flowing or standing water that is if possible straight, at least 2 km long and sufficiently wide and is equipped with highly-distinctive marks for determining the position of the vessel. 3.   It shall be possible for the inspection body to plot the hydrological data such as depth of water, width of navigable channel and average speed of the current in the navigation area as a function of the various water levels.
Article 5.04

Degree of loading of vessels and convoys during navigation tests

During navigation tests, vessels and convoys intended to carry goods shall be loaded to at least 70 % of their tonnage and loading, distributed in such a way as to ensure a horizontal attitude as far as possible. If the tests are carried out with a lesser load the approval for downstream navigation shall be restricted to that loading.
Article 5.05

Use of on-board facilities for navigation test 1.   During the navigation test, all of the equipment referred to in items 34 and 52 of the Community certificate which may be actuated from the wheelhouse may be used, apart from anchors. 2.   However, during the test involving turning into the current referred to in Article 5.10, bow anchors may be used.
Article 5.06

Prescribed (forward) speed 1.   Vessels and convoys shall achieve a speed in relation to the water of at least 13 km/h. That condition is not mandatory where pusher tugs are operating solo. 2.   The inspection body may grant exemptions to vessels and convoys operating solely in estuaries and ports. 3.   The inspection body shall check if the unladen vessel is capable of exceeding a speed of 40 km/h in relation to water. If this can be confirmed, the following entry shall be made in item 52 of the Community certificate:

                        ‘The vessel is capable of exceeding a speed of 40 km/h in relation to water.’

Article 5.07

Stopping capacity 1.   Vessels and convoys shall be able to stop facing downstream in good time while remaining adequately manoeuvrable. 2.   Where vessels and convoys are not longer than 86 m and not wider than 22.90 m the stopping capacity mentioned above may be replaced by turning capacity. 3.   The stopping capacity shall be proved by means of stopping manoeuvres carried out within a test area as referred to in Article 5.03 and the turning capacity by turning manoeuvres in accordance with Article 5.10. 

Article 5.08

Capacity for going astern

Where the stopping manoeuvre required by Article 5.07 is carried out in standing water it shall be followed by a navigation test while going astern.
Article 5.09

Capacity for taking evasive action

Vessels and convoys shall be able to take evasive action in good time. That capacity shall be proven by means of evasive manoeuvres carried out within a test area as referred to in Article 5.03. 

Article 5.10

Turning capacity

Vessels and convoys not exceeding 86 m in length or 22,90 m in breadth shall be able to turn in good time.

That turning capacity may be replaced by the stopping capacity referred to in Article 5.07. The turning capacity shall be proven by means of turning manoeuvres against the current.

CHAPTER 6STEERING SYSTEM

Article 6.01

General requirements 1.   Vessels shall be fitted with a reliable steering system which provides at least the manoeuvrability required by Chapter 5. 2.   Powered steering systems shall be designed in such a way that the rudder cannot change position unintentionally. 3.   The steering system as a whole shall be designed for permanent lists of up to 15° and ambient temperatures from — 20 oC to + 50 oC. 4.   The component parts of the steering system shall be rugged enough to always be able to withstand the stresses to which they may be subjected during normal operation. No external forces applied to the rudder shall impair the operating capacity of the steering apparatus and its drive unit. 5.   The steering system shall incorporate a powered drive unit if so required by the forces needed to actuate the rudder. 6.   A steering apparatus with powered drive unit shall be protected against overloads by means of a system that restricts the torque applied by the drive unit. 7.   The penetrations for the rudder stocks shall be so designed as to prevent the spread of water-polluting lubricants.
Article 6.02

Steering apparatus drive unit 1.   If the steering apparatus has a powered drive unit, it shall be possible to bring a second independent drive unit, or manual drive, into use within five seconds if the steering apparatus drive unit fails or malfunctions. 2.   If the second drive unit or manual drive is not placed in service automatically, it shall be possible to do so immediately by means of a single operation by the helmsman that is both simple and quick. 3.   The second drive unit or manual drive shall ensure the manoeuvrability required by Chapter 5 as well.
Article 6.03

Hydraulic steering apparatus drive unit 1.   No other power consumers may be connected to the hydraulic steering apparatus drive unit. Where there are two independent drive units, such a connection to one of the units is however acceptable if the consumers are connected to the return line and may be disconnected from the drive unit by means of an isolating device. 2.   Where there are two hydraulic drive units, a separate hydraulic reservoir is needed for each of the two units. However, double reservoirs are acceptable. Hydraulic reservoirs shall be fitted with a warning system that monitors any drop in the oil level below the lowest content level needed for reliable operation. 3.   The pilot valve does not have to be duplicated if this can be actuated manually or by manually-controlled hydraulic actuation from the wheelhouse. 4.   The dimensions, design and arrangement of the pipework shall as far as possible exclude mechanical damage or damage resulting from fire. 5.   As far as hydraulic drive units are concerned, no separate pipework system shall be required for the second unit if independent operation of the two units is guaranteed and if the pipework system is able to withstand a pressure of at least 1.5 times that of the maximum service pressure. 6.   Flexible piping is only permitted where its use is essential in order to damp vibrations or to allow freedom of movement of components. It shall be designed for a pressure that is at least equal to the maximum service pressure.
Article 6.04

Power source 1.   Steering systems fitted with two powered drive units shall have at least two power sources. 2.   If the second power source for the powered steering apparatus is not constantly available while the vessel is under way, a buffer device carrying adequate capacity shall provide back-up during the period needed for start-up. 3.   In the case of electrical power sources, no other power consumers may be supplied by the main power source for the steering system.
Article 6.05

Manual drive 1.   The manual wheel shall not be driven by a powered drive unit. 2.   Regardless of rudder position, a kick-back of the wheel shall be prevented when the manual drive is engaged automatically.
Article 6.06

Rudder-propeller, water-jet, cycloidal-propeller and bow-thruster systems 1.   Where the thrust vectoring of rudder-propeller, water-jet, cycloidal-propeller or bow-thruster installations is remotely actuated by electric, hydraulic or pneumatic means, there shall be two actuation systems, each independent of the other, between the wheelhouse and the propeller- or thruster-installation which, mutatis mutandis, meet the requirements of Articles 6.01 to 6.05. Such systems are not subject to this paragraph if they are not needed in order to achieve the manoeuvrability required by Chapter 5 or if they are only needed for the stopping test. 2.   Where there are two or more rudder-propeller, water-jet or cycloidal-propeller installations that are independent of each other the second actuation system is not necessary if the vessel retains the manoeuvrability required by Chapter 5 if one of the systems fails.
Article 6.07

Indicators and monitoring devices 1.   The rudder position shall be clearly displayed at the steering position. If the rudder-position indicator is electric it shall have its own power supply. 2.   There shall be at least the following indicators and monitoring devices at the steering position:

(a) oil level in the hydraulic reservoirs in accordance with Article 6.03(2), and service pressure of the hydraulic system;

(b) failure of the electrical supply for the steering control;

(c) failure of the electrical supply for the drive units;

(d) failure of the rate-of-turn regulator;

(e) failure of the required buffer devices.
Article 6.08

Rate-of-turn regulators 1.   Rate-of-turn regulators and their components shall meet the requirements laid down in Article 9.20. 2.   The proper functioning of the rate-of-turn regulator shall be displayed at the steering position by means of a green indicating light.

Any lack of or unacceptable variations in the supply voltage and an unacceptable decrease in the speed of rotation of the gyroscope shall be monitored. 3.   Where, in addition to the rate-of-turn regulator, there are other steering systems, it shall be possible to clearly distinguish at the steering position which of these systems has been activated. It shall be possible to shift from one system to another immediately. The rate-of-turn regulator shall not have any influence on these other steering systems. 4.   The electricity supply to the rate-of-turn regulator shall be independent of other power consumers. 5.   The gyroscopes, detectors and rate-of-turn indicators used in the rate-of-turn regulators shall meet the minimum requirements of the minimum specifications and test conditions concerning rate-of-turn displays for inland waterways, as laid down in Annex IX.
Article 6.09

Acceptance procedure 1.   The compliance of the installed steering system shall be checked by an inspection body. It may, for this purpose, request the following documents:

(a) description of the steering system;

(b) drawings and information on the drive units and the steering controls;

(c) information concerning the steering apparatus;

(d) electrical wiring diagram;

(e) description of the rate-of-turn regulator;

(f) operating instructions for the steering system. 2.   Operation of the entire steering system shall be checked by means of a navigation test. If a rate-of-turn regulator is installed it shall be checked that a predetermined course can be reliably maintained and that bends can be negotiated safely.

CHAPTER 7WHEELHOUSE

Article 7.01

General 1.   Wheelhouses shall be arranged in such a way that the helmsman may at all times perform his task while the vessel is under way. 2.   Under normal operating conditions, sound pressure generated by the vessel and measured at the level of the helmsman’s head at the steering position shall not exceed 70 dB(A). 3.   Where a wheelhouse has been designed for radar navigation by one person, the helmsman shall be able to accomplish his task while seated and all of the display or monitoring instruments and all of the controls needed for operation of the vessel shall be arranged in such a way that the helmsman may use them comfortably while the vessel is under way without leaving his position or losing sight of the radar screen.
Article 7.02

Unobstructed view 1.   There shall be an adequately unobstructed view in all directions from the steering position. 2.   The area of obstructed vision for the helmsman ahead of the vessel in an unladen state with half of its supplies but without ballast shall not exceed two vessel lengths or 250 m, whichever is less, to the surface of the water over an arc from abeam on either side through right ahead of the vessel.

Optical and electronic means for reducing the area of obstructed vision may not be taken into account during the inspection.

To further reduce any area of obstructed vision, only suitable electronic devices shall be used. 3.   The helmsman’s field of unobstructed vision at his normal position shall be at least 240° of the horizon and at least 140° within the forward semicircle.

No window frame, post or superstructure shall lie within the helmsman’s usual axis of vision.

Even in the case where a field of unobstructed vision of at least 240° of the horizon is provided, the inspection body may require other measures and in particular the installation of suitable auxiliary optical or electronic devices if no sufficiently unobstructed view is provided towards the rear.

The height of the lower edge of the side windows shall be kept as low as possible and the height of the upper edge of the side and rear windows shall be kept as high as possible.

In determining whether the requirements in this Article for visibility from the wheelhouse are met, the helmsman shall be assumed to have a height of eye of 1 650 mm above the deck at the steering position. 4.   The upper edge of the forward facing windows of the wheelhouse shall be high enough to allow a person at the steering position with height of eye of 1 800 mm a clear forward view to at least 10 degrees above the horizontal at eye-level height. 5.   There shall in all weathers be suitable means of providing a clear view through the windscreen. 6.   The glazing used in wheelhouses shall be made of safety glass and have a light transmission of at least 75 %.

To avoid reflections, the bridge front windows shall be glare-free and inclined from the vertical plane, so as to form an outward angle of not less than 10° and not more than 25°.
Article 7.03

General requirements concerning control, indicating and monitoring equipment 1.   Control equipment needed to operate the vessel shall be brought into its operating position easily. That position shall be unambiguously clear. 2.   Monitoring instruments shall be easily legible. It shall be possible to adjust their lighting steplessly down to their extinction. Light sources shall be neither intrusive nor impair the legibility of the monitoring instruments. 3.   There shall be a system for testing the warning and indicating lights. 4.   It shall be possible to clearly establish whether a system is in operation. If its functioning is indicated by means of an indicating light, this shall be green. 5.   Any malfunctioning or failure of systems that require monitoring shall be indicated by means of red warning lights. 6.   An audible warning shall sound at the same time that a red warning light lights up. Audible warnings may be given by a single, collective signal. The sound pressure level of that signal shall exceed the maximum sound pressure level of the ambient noise at the steering position by at least 3 dB(A). 7.   The audible warning shall be capable of being switched off after a malfunction or failure has been acknowledged. Such shutdown shall not prevent the alarm signal from being triggered by other malfunctions. The red warning lights shall only go out when the malfunction has been corrected. 8.   The monitoring and indicating devices shall be automatically switched to an alternative power supply if their own power supply fails.
Article 7.04

Specific requirements concerning control, indicating and monitoring equipment of main engines and steering system 1.   It shall be possible to control and monitor the main engines and steering systems from the steering position. Main engines fitted with a clutch which can be actuated from the steering position, or driving a controllable pitch propeller which can be controlled from the steering position, need only to be capable of being started up and shut down from the engine room. 2.   The control for each main engine shall take the form of a single lever which prescribes an arc within a vertical plane that is approximately parallel to the longitudinal axis of the vessel. Movement of that lever towards the bow of the vessel shall cause forward motion, whereas movement of the lever towards the stern shall cause the vessel to go astern. Clutch engagement and reversal of the direction of motion shall take place about the neutral position of that lever. The lever shall catch in the neutral position. 3.   The direction of the propulsion thrust imparted to the vessel and the rotational speed of the propeller or main engines shall be displayed inside wheelhouses that have been designed for radar navigation by one person. 4.   The indicating and monitoring devices required by Article 6.07(2), Article 8.03( 2), and Article 8.05 (13), shall be located at the steering position. 5.   Vessels with wheelhouses designed for radar navigation by one person shall be steered by means of a lever. It shall be possible to move that lever easily by hand. The position of the lever in relation to the longitudinal axis of the vessel shall correspond precisely to the position of the rudder blades. It shall be possible to release hold of the lever in any given position without that of the rudder blades changing. The neutral position of the lever shall be clearly perceptible. 6.   Where the vessel is fitted with bow rudders or special rudders, particularly for going astern, these shall be actuated in wheelhouses designed for radar navigation by one person by special levers which, mutatis mutandis, meet the requirements set out in paragraph 5. That requirement shall also apply where, in convoys, the steering system fitted to craft other than those powering the convoy is used. 7.   Where rate-of-turn regulators are used, it shall be possible for the rate-of-turn control to be released in any given position without altering the speed selected.

The control shall turn through a wide enough arc to guarantee adequately precise positioning. The neutral position shall be clearly perceptible from the other positions. The scale illumination shall be steplessly variable. 8.   The remote-control equipment for the entire steering system shall be installed in a permanent manner and be arranged in such a way that the course selected is clearly visible. If the remote control equipment can be disengaged, it shall be equipped with an indicating device displaying the respective operational conditions ‘in service’ or ‘out of service’. The disposition and manipulation of the controls shall be functional.

For systems that are subsidiary to the steering system, such as active bow thrusters, remote-control equipment not permanently installed shall be acceptable provided that such a subsidiary installation can be activated by means of an override at any time within the wheelhouse. 9.   In the case of rudder-propeller, water-jet, cycloidal-propeller and bow-thruster systems, equivalent devices shall be acceptable as control, indicating and monitoring devices.

The requirements set out in paragraphs 1 to 8 shall apply, mutatis mutandis, in view of the specific characteristics and arrangements selected for the abovementioned active steering and propulsion units. The position of the indicating device shall clearly show for each installation the direction of the thrust acting on the vessel or the direction of the jet .
Article 7.05

Navigation lights, light signals and sound signals 1.   In this Article the term:

(a) ‘navigation lights’ means the masthead, side and stern lights, and the lights visible from all sides, the blue scintillating lights, yellow rapidly scintillating strong lights for high-speed vessels and blue lights for the carriage of dangerous goods;

(b) ‘light signals’ means the lights accompanying the sound signals and assigned to the blue panel. 2.   Current indicating lights or other equivalent devices, such as repeater lights, for monitoring the navigation lights shall be installed in the wheelhouse unless that monitoring can be performed direct from the wheelhouse. 3.   In wheelhouses designed for radar navigation by one person, repeater lights shall be installed on the control panel in order to monitor the navigation lights and the light signals. Switches of navigation lights shall be included in the repeater lights or be adjacent to these and shall be clearly assigned to them.

The arrangement and colour of the repeater lights for the navigation lights and light signals shall correspond to the actual position and colour of those lights and signals.

The failure of a navigation light or light signal to function shall cause the corresponding repeater light either to go out or to provide a signal in another manner. 4.   In wheelhouses designed for radar navigation by one person it shall be possible to activate the sound signals by a foot operated switch. That requirement shall not apply to the ‘do not approach’ signal in accordance with the applicable navigational authority regulations of the Member States. 5.   Navigation lights shall meet the requirements set out in Annex IX, Part I.
Article 7.06

Radar installations and rate-of-turn indicators 1.   The radar equipment and rate-of-turn indicators shall be of a type that has been approved by the competent authority. The requirements concerning installation and operational testing of radar equipment and rate-of-turn indicators, as laid down in Annex IX, shall be met. Inland ECDIS equipment which can be operated in navigation mode shall be regarded as radar equipment. In addition the requirements of the Inland ECDIS standard shall be met.

The rate-of-turn indicator shall be located ahead of the helmsman and within his field of vision. 2.   In wheelhouses designed for radar navigation by one person:

(a) the radar screen shall not be shifted significantly out of the helmsman’s axis of view in its normal position;

(b) the radar image shall continue to be perfectly visible, without a mask or screen, whatever the lighting conditions outside the wheelhouse;

(c) the rate-of-turn indicator shall be installed directly above or below the radar image or be incorporated into this.
Article 7.07

Radio telephony systems for vessels with wheelhouses designed for radar navigation by one person 1.   Where vessel wheelhouses have been designed for radar navigation by one person, reception from the vessel-vessel networks and that of nautical information shall be via a loudspeaker, and outgoing communications via a fixed microphone. Send/receive shall be selected by means of a push-button.

It shall not be possible to use the microphones of those networks for the public correspondence network. 2.   Where vessel wheelhouses designed for radar navigation by one person are equipped with a radio telephone system for the public correspondence network, reception shall be possible from the helmsman’s seat.
Article 7.08

Internal communication facilities on board

There shall be internal communication facilities on board vessels with a wheelhouse designed for radar navigation by one person.

It shall be possible to establish communication links from the steering position:

(a) with the bow of the vessel or convoy;

(b) with the stern of the vessel or convoy if no direct communication is possible from the steering position;

(c) with the crew accommodation;

(d) with the boatmaster’s cabin.

Reception at all positions of these internal communication links shall be via loudspeaker, and transmission shall be via a fixed microphone. The link with the bow and stern of the vessel or convoy may be of the radio-telephone type.
Article 7.09

Alarm system 1.   There shall be an independent alarm system enabling the accommodation, engine rooms and, where appropriate, the separate pump rooms to be reached. 2.   The helmsman shall have within reach an on/off switch controlling the alarm signal; switches which automatically return to the off position when released are not acceptable. 3.   The sound pressure level for the alarm signal shall be at least 75 dB(A) within the accommodation area.

In engine rooms and pump rooms the alarm signal shall take the form of a flashing light that is visible on all sides and clearly perceptible at all points.
Article 7.10

Heating and ventilation

Wheelhouses shall be equipped with an effective heating and ventilation system that can be regulated.
Article 7.11

Stern-anchor operating equipment

On board vessels and convoys whose wheelhouse has been designed for radar navigation by one person and exceeding 86 m in length or 22,90 m in breadth it shall be possible for the helmsman to drop the stern anchors from his position.
Article 7.12

Retractable wheelhouses

Retractable wheelhouses shall be fitted with an emergency lowering system.

All lowering operations shall automatically trigger a clearly audible acoustic warning signal. That requirement shall not apply if the risk of injury which may result from the lowering is prevented by appropriate design features.

It shall be possible to leave the wheelhouse safely whatever its position.
Article 7.13

Entry in the Community certificate for vessels with wheelhouses designed for radar navigation by one person

Where a vessel complies with the special provisions for wheelhouses designed for radar navigation by one person as set out in Articles 7.01, 7.04 to 7.08 and 7.11, the following entry shall be made in the Community certificate:

                     ‘The vessel has a wheelhouse designed for radar navigation by one person’.

CHAPTER 8ENGINE DESIGN

Article 8.01

General 1.   Engines and their ancillaries shall be designed, built and installed in accordance with best practice. 2.   Installations requiring regular inspection, particularly steam boilers, other pressure vessels and their accessories, and lifts, shall meet the regulations applying in one of the Member States of the Community. 3.   Only internal-combustion engines burning fuels having a flashpoint of more than 55 oC may be installed.
Article 8.02

Safety equipment 1.   Engines shall be installed and fitted in such a way as to be adequately accessible for operation and maintenance and shall not endanger the persons assigned to those tasks. It shall be possible to make them secure against unintentional starting. 2.   Main engines, auxiliaries, boilers and pressure vessels, and their accessories, shall be fitted with safety devices. 3.   In case of emergency, it shall also be possible to shut down the motors driving the blower and suction fans from outside the space in which they are located, and from outside the engine room. 4.   Where necessary, connections of pipes which carry fuel oil, lubricating oil, and oils used in power transmission systems, control and activating systems and heating systems shall be screened or otherwise suitably protected to avoid oil spray or leakages onto hot surfaces, into machinery air intakes, or other sources of ignition. The number of connections in such piping systems shall be kept to a minimum. 5.   External high pressure fuel delivery pipes of diesel engines, between the high pressure fuel pumps and fuel injectors, shall be protected with a jacketed piping system capable of containing fuel from a high pressure pipe failure. The jacketed piping system shall include a means for collection of leakages and arrangements shall be provided for an alarm to be given of a fuel pipe failure, except that an alarm is not required for engines with no more than two cylinders. Jacketed piping systems need not be applied to engines on open decks operating windlasses and capstans. 6.   Insulation of engine parts shall meet the requirements of Article 3.04(3), second paragraph.
Article 8.03

Power plant 1.   It shall be possible to start, stop or reverse the ship’s propulsion reliably and quickly. 2.   The following shall be monitored by suitable devices which trigger an alarm once a critical level has been reached:

(a) the temperature of the main-engine cooling water;

(b) the lubricating-oil pressure for the main engines and transmissions;

(c) the oil and air pressure of the main engine reversing units, reversible transmissions or propellers. 3.   Where vessels have only one main engine, that engine shall not be shut down automatically except in order to protect against overspeed. 4.   Where vessels have only one main engine, that engine may be equipped with an automatic device for the reduction of the engine speed only if an automatic reduction of the engine speed is indicated both optically and acoustically in the wheelhouse and the device for the reduction of the engine speed can be switched off from the helmsman’s position. 5.   Shaft bushings shall be designed in such a way as to prevent the spread of water-polluting lubricants.
Article 8.04

Engine exhaust system 1.   The exhaust gases shall be completely ducted out of the vessel. 2.   All suitable measures shall be taken to avoid ingress of the exhaust gases into the various compartments. Exhaust pipes passing through accommodation or the wheelhouse shall, within these, be covered by protective gas-tight sheathing. The gap between the exhaust pipe and this sheathing shall be open to the outside air. 3.   The exhaust pipes shall be arranged and protected in such a way that they cannot cause a fire. 4.   The exhaust pipes shall be suitably insulated or cooled in the engine rooms. Protection against physical contact may suffice outside the engine rooms.
Article 8.05

Fuel tanks, pipes and accessories 1.   Liquid fuels shall be stored in steel tanks which are either an integral part of the hull or which are firmly attached to the hull. If so required by the design of the vessel, an equivalent material in terms of fire-resistance may be used. These requirements shall not apply to tanks having a capacity of no more than 12 litres that have been incorporated in auxiliaries during their manufacture. Fuel tanks shall not have common partitions with drinking-water tanks. 2.   Tanks and their pipework and other accessories shall be laid out and arranged in such a way that neither fuel nor fuel vapours may accidentally reach the inside of the vessel. Tank valves intended for fuel sampling or water drainage shall close automatically. 3.   No fuel tanks may be located forward of the collision bulkhead. 4.   Fuel tanks and their fittings shall not be located directly above engines or exhaust pipes. 5.   The filler orifices for fuel tanks shall be marked distinctly. 6.   The orifice for the fuel tank filler necks shall be on the deck, except for the daily-supply tanks. The filler neck shall be fitted with a connection piece in accordance with European standard EN 12827:1999. Such tanks shall be fitted with a breather pipe terminating in the open air above the deck and arranged in such a way that no water ingress is possible. The cross-section of the breather pipe shall be at least 1,25 times the cross-section of the filler neck.

If tanks are interconnected, the cross-section of the connecting pipe shall be at least 1,25 times the cross-section of the filler neck. 7.   Directly at tank outlets the pipework for the distribution of fuels shall be fitted with a shutoff device that can be operated from the deck

This requirement shall not apply to tanks mounted directly on the engine. 8.   Fuel pipes, their connections, seals and fittings shall be made of materials that are able to withstand the mechanical, chemical and thermal stresses to which they are likely to be subjected. The fuel pipes shall not be subjected to any adverse influence of heat and it shall be possible to inspect them throughout their length. 9.   Fuel tanks shall be provided with a suitable capacity-gauging device. Capacity-gauging devices shall be legible right up to the maximum filling level. Glass gauges shall be effectively protected against impacts, shall be fitted with an automatic closing device at their base and their upper end shall be connected to the tanks above their maximum filling level. The material used for glass gauges shall not deform under normal ambient temperatures. Sounding pipes shall not terminate in accommodation spaces. Sounding pipes terminating in an engine or boiler room shall be fitted with suitable self-closing devices. 10. (a) Fuel tanks shall be safeguarded against fuel spills during bunkering by means of appropriate onboard technical devices which shall be entered in item 52 of the Community certificate.

(b) If fuel is taken on from bunkering stations with their own technical devices to prevent fuel spills on board during bunkering, the equipment requirements in (a) and paragraph 11 shall no longer apply. 11.   If fuel tanks are fitted with an automatic shut-off device, the sensors shall stop fuelling when the tank is 97 % full; this equipment shall meet the ‘failsafe’ requirements.

If the sensor activates an electrical contact, which can break the circuit provided by the bunkering station by a binary signal, it shall be possible to transmit the signal to the bunkering station by means of a watertight connection plug meeting the requirements of IEC publication 60309-1:1999 for 40 to 50 V DC, housing colour white, earthing contact position ten o’clock. 12.   Fuel tanks shall be provided with openings having leak-proof closures that are intended to permit cleaning and inspection. 13.   Fuel tanks directly supplying the main engines and engines needed for safe operation of the vessel shall be fitted with a device emitting both visual and audible signals in the wheelhouse if their level of filling is not sufficient to ensure further safe operation.
Article 8.06

Storage of lubricating oil, pipes and accessories 1.   Lubricating oil shall be stored in steel tanks which are either an integral part of the hull or which are firmly attached to the hull. If so required by the design of the vessel, an equivalent material in terms of fire-resistance may be used. These requirements shall not apply to tanks having a capacity of no more than 25 litres. Lubricating oil tanks shall not have common partitions with drinking-water tanks. 2.   Lubricating oil tanks and their pipework and other accessories shall be laid out and arranged in such a way that neither lubricating oil nor lubricating oil vapour may accidentally reach the inside of the vessel. 3.   No lubricating oil tanks may be located forward of the collision bulkhead. 4.   Lubricating oil tanks and their fittings shall not be located directly above engines or exhaust pipes. 5.   The filler orifices for lubricating oil tanks shall be marked distinctly. 6.   Lubricating oil pipes, their connections, seals and fittings shall be made of materials that are able to withstand the mechanical, chemical and thermal stresses to which they are likely to be subjected. The pipes shall not be subjected to any adverse influence of heat and it shall be possible to inspect them throughout their length. 7.   Lubricating oil tanks shall be provided with a suitable capacity-gauging device. Capacity-gauging devices shall be legible right up to the maximum filling level. Glass gauges shall be effectively protected against impacts, shall be fitted with an automatic closing device at their base and their upper end shall be connected to the tanks above their maximum filling level. The material used for glass gauges shall not deform under normal ambient temperatures. Sounding pipes shall not terminate in accommodation spaces. Sounding pipes terminating in an engine or boiler room shall be fitted with suitable self-closing devices.
Article 8.07

Storage of oils used in power transmission systems, control and activating systems and heating systems, pipes and accessories 1.   Oils used in power transmission systems, control and activating systems and heating systems shall be stored in steel tanks which are either an integral part of the hull or which are firmly attached to the hull. If so required by the design of the vessel, an equivalent material in terms of fire-resistance may be used. These requirements shall not apply to tanks having a capacity of no more than 25 litres. Such oil tanks shall not have common partitions with drinking-water tanks. 2.   Such oil tanks and their pipework and other accessories shall be laid out and arranged in such a way that neither such oil nor such oil vapour may accidentally reach the inside of the vessel. 3.   No such oil tanks may be located forward of the collision bulkhead. 4.   Such oil tanks and their fittings shall not be located directly above engines or exhaust pipes. 5.   The filler orifices for such oil tanks shall be marked distinctly. 6.   Such oil pipes, their connections, seals and fittings shall be made of materials that are able to withstand the mechanical, chemical and thermal stresses to which they are likely to be subjected. The pipes shall not be subjected to any adverse influence of heat and it shall be possible to inspect them throughout their length. 7.   Such oil tanks shall be provided with a suitable capacity-gauging device. Capacity-gauging devices shall be legible right up to the maximum filling level. Glass gauges shall be effectively protected against impacts, shall be fitted with an automatic closing device at their base and their upper end shall be connected to the tanks above their maximum filling level. The material used for glass gauges shall not deform under normal ambient temperatures. Sounding pipes shall not terminate in accommodation spaces. Sounding pipes terminating in an engine or boiler room shall be fitted with suitable self-closing devices.
Article 8.08

Bilge pumping and drainage systems 1.   It shall be possible to pump out each watertight compartment separately. However, that requirement shall not apply to watertight compartments that are normally sealed hermetically during operation. 2.   Vessels requiring a crew shall be equipped with two independent bilge pumps which shall not be installed within the same space. At least one of these shall be motor driven. However, for vessels with a power of less than 225 kW or with a deadweight of less than 350 t, or where vessels not intended for the carriage of goods have a displacement of less than 250 m3, one pump will suffice which can be either manually-operated or motor-driven.

Each of the required pumps shall be capable of use on each watertight compartment. 3.   The minimum pumping capacity Q1 of the first bilge pump shall be calculated using the following formula:
Q1 = 0,1 · d1

2 (1/min)

d1 is calculated via the formula:

The minimum pumping capacity Q2 of the second bilge pump shall be calculated using the following formula:
Q2 = 0,1 · d2

2 (l/min)

d2 is calculated using the formula:

However, the value d2 need not exceed value d1. For the calculation of Q2 l shall be taken to be the length of the longest watertight compartment.

In these formulae:

l

is the length of the watertight compartment in question, in (m);

d1

is the calculated internal diameter of the main drainage pipe, in (mm);

d2

is the calculated internal diameter of the branch pipe, in (mm). 4.   Where the bilge pumps are connected to a drainage system the drainage pipes shall have an internal diameter of at least d1, in mm, and the branch pipes an internal diameter of at least d2, in mm.

Where vessels are less than 25 m in length the values d1 and d2 may be reduced to 35 mm. 5.   Only self-priming bilge pumps are permitted. 6.   There shall be at least one suction on both the starboard and port sides of all flat-bottomed, drainable compartments that are wider than 5 m. 7.   It may be possible to drain the aft peak via the main engine room by means of an easily accessible, automatically closable fitting. 8.   Branch pipes of single compartments shall be connected to the main drainage pipe by means of a lockable non-return valve.

Compartments or other spaces that are capable of carrying ballast need to be connected to the drainage system only by means of a simple closing device. That requirement shall not apply to holds that are capable of carrying ballast. Such holds shall be filled with ballast water by means of ballast piping that is permanently installed and independent of the drainage pipes, or by means of branch pipes that can be connected to the main drainage pipe by flexible pipes or flexible adaptors. Water intake valves located in the bottom of the hold shall not be permitted for this purpose. 9.   Hold bilges shall be fitted with gauging devices. 10.   Where a drainage system incorporates permanently installed pipework the bilge-bottom drainage pipes intended to extract oily water shall be equipped with closures that have been sealed in position by an inspection body. The number and position of those closures shall be entered on the Community certificate. 11.   Locking the closures in position shall be regarded as equivalent to sealing in accordance with paragraph 10. The key or keys for the locking of the closures shall be indicated accordingly and kept in a marked and easily accessible location in the engine room.
Article 8.09

Oily water and used oil stores 1.   It shall be possible to store, on board, oily water accumulated during operation. The engine-room bilge is considered to be a store for this purpose. 2.   In order to store used oils there shall, in the engine room, be one or several specific receptacles whose capacity corresponds to at least 1,5 times the quantity of the used oils from the sumps of all of the internal combustion engines and transmissions installed, together with the hydraulic fluids from the hydraulic-fluid tanks.

The connections used in order to empty the receptacles referred to above shall comply with European standard EN 1305:1996. 3.   Where vessels are only used on short-haul operation the inspection body may grant exceptions from the requirements ofparagraph 2. 

Article 8.10

Noise emitted by vessels 1.   The noise produced by a vessel under way, and in particular the engine air intake and exhaust noises, shall be damped by using appropriate means. 2.   The noise generated by a vessel under way shall not exceed 75 dB(A) at a lateral distance of 25 m from the ship’s side. 3.   Apart from transhipment operations the noise generated by a stationary vessel shall not exceed 65 dB(A) at a lateral distance of 25 m from the ship’s side.

CHAPTER 8a

(Left void)

CHAPTER 9ELECTRICAL EQUIPMENT

Article 9.01

General 1.   Where there are no specific requirements concerning certain parts of an installation the safety level shall be considered satisfactory where those parts have been produced in accordance with a European standard in force or in accordance with the requirements of an approved classification society.

The relevant documents shall be submitted to the inspection body. 2.   Documents containing the following, and duly stamped by the inspection body, shall be kept on board:

(a) general drawings concerning the entire electrical installation;

(b) switching diagrams for the main switchboard, the emergency switchboard and the distribution switchboard, together with the most important technical data such as the amperage and rated current of the protection and control devices;

(c) power data concerning the electrical machinery and equipment;

(d) types of cable and information on conductor cross-sections.

It is not necessary to keep such documents on board unmanned craft, but they shall be available at all times with the owner. 3.   The equipment shall be designed for permanent lists of up to 15° and ambient inside temperatures of between 0 and + 40 °C, and on the deck between – 20 °C and + 40 °C. It shall function perfectly within those limits. 4.   The electrical and electronic equipment and appliances shall be fully accessible and easy to maintain.
Article 9.02

Electricity supply systems 1.   Where craft are fitted with an electrical system, that system shall in principle have at least two power sources in such a way that where one power source fails the remaining source is able to supply the power consumers needed for safe navigation for at least 30 minutes. 2.   Adequate rating of the power supply shall be demonstrated by means of a power balance. An appropriate simultaneity factor may be taken into account. 3.   Independently of paragraph 1, Article 6.04 shall apply to the power source for the steering system (rudder installations).
Article 9.03

Protection against physical contact, intrusion of solid objects and the ingress of water

The type of minimum protection for permanently installed parts of an installation shall be as set out in the following table:

Location

Type of minimum protection

(in accordance with IEC publ. 60529: 1992)

Generators

Motors

Trans-formers

Panels

Distributors

Switches

Fittings

Lighting equipment

Operation rooms, engine rooms, steering-gear compartments

IP 22

IP 22

IP (2) 22

IP (1)  (2) 22

IP 44

IP 22

Holds

IP 55

IP 55

Battery and paint lockers
IP 44

u. (Ex) (3) Free decks and open steering positions
IP 55
IP 55

IP 55

IP 55

Wheelhouse
IP 22

IP 22

IP 22

IP 22

IP 22

Accommodation apart from sanitary facilities and washrooms
IP 22

IP 20

IP 20

Sanitary facilities and washrooms
IP 44

IP 44

IP 44

IP 55

IP 44
Article 9.04

Protection from explosion

Only explosion-proof electrical equipment (certified safety) may be installed in spaces where potentially explosive gases or mixtures of gases are likely to accumulate, such as compartments dedicated for accumulators or the storage of highly inflammable products. No light switches or switches for other electrical appliances shall be installed in these spaces. The protection from explosion shall take account of the characteristics of the potentially explosive gases or mixtures of gases that are likely to arise (explosion-potential group, temperature class).
Article 9.05

Earthing 1.   Systems under a voltage of more than 50 V need to be earthed. 2.   Metal parts that are open to physical contact and which, during normal operation, are not electrically live, such as engine frames and casings, appliances and lighting equipment, shall be earthed separately where they are not in electrical contact with the hull as a result of their installation. 3.   The casings of mobile power consumers and portable devices shall, during normal use, be earthed by means of an additional earthing conductor that is incorporated into the power cable.

That provision shall not apply where a protective circuit-separation transformer is used, nor to appliances fitted with protective insulation (double insulation). 4.   The cross-sections of the earthing conductors shall be not less than given in the following table:

Cross-section of outside conductors

(mm2)

Minimum cross-section of earthing conductors

within insulated cables

(mm2)

fitted separately

(mm2)

from 0,5 to 4

same cross-section as that of the outside conductor

4

more than 4 to 16

same cross-section as that of the outside conductor

same cross-section as that of the outside conductor

more than 16 to 35

16

16

more than 35 to 120

half of the cross-section of the outside conductor

half of the cross-section of the outside conductor

more than 120

70

70
Article 9.06

Maximum permissible voltages 1.   The following voltages shall not be exceeded:

Type of installation

Maximum permissible voltage

Direct current

Single-phase alternating current

Three-phase alternating current

a.

Power and heating installations including the sockets for general use

250 V

250 V

500 V

b.

Lighting, communications, command and information installations including the sockets for general use

250 V

250 V

–

c.

Sockets intended to supply portable devices used on open decks or within narrow or damp metal lockers, apart from boilers and tanks:

  1. In general

50 V (4) 50 V (4) – 2. Where a protective circuit-separation transformer only supplies one appliance

–

250 V (5) – 3. Where protective-insulation (double insulation) appliances are used

250 V

250 V

– 4. Where ≤ 30 mA default current circuit breakers are used.

–

250 V

500 V

d.

Mobile power consumers such as electrical equipment for containers, motors, blowers and mobile pumps which are not normally moved during service and whose conducting parts which are open to physical contact are earthed by means of an earthing conductor that is incorporated into the connecting cable and which, in addition to that earthing conductor, are connected to the hull by their specific positioning or by an additional conductor

250 V

250 V

500 V

e.

Sockets intended to supply portable appliances used inside boilers and tanks

50 V (4) 50 V (4) – 2.   By way of derogation from paragraph1, if the necessary protective measures are applied higher voltages shall be acceptable:

(a) for power installations where their power so requires;

(b) for special on-board installations such as radio and ignition systems.
Article 9.07

Distribution systems 1.   The following distribution systems are allowed for direct current and single-phase alternating current:

(a) two-conductor systems of which one is earthed (L1/N/PE);

(b) single-conductor systems using the hull return principle, only for local installations (for example, starting gear for combustion engines, cathodic protection) (L1/PEN);

(c) two-conductor systems that are insulated from the hull (L1/L2/PE). 2.   The following distribution systems are allowed for three-phase alternating current:

(a) four-conductor systems with earthing of the neutral point, not using the hull return principle (L1/L2/L3/N/PE) = (network TN-S) or (network TT);

(b) three-conductor systems insulated from the hull (Ll/L2/L3/PE) = (network IT);

(c) three-conductor systems with earthing of the neutral point using the hull return principle, however, that shall not be allowed for terminal circuits (L1/L2/L3/PEN). 3.   The inspection body may allow the use of other systems.
Article 9.08

Connection to shore or other external networks 1.   Incoming supply lines from shore networks or other external networks to the installations of the onboard network shall have a permanent connection on board in the form of fixed terminals or fixed plug sockets. The cable connections shall not be subjected to any pulling load. 2.   The hull shall be capable of being earthed effectively when the connection voltage exceeds 50 V. The earthing connection shall be specially marked. 3.   The switching devices for the connection shall be arranged such as to prevent the concurrent operation of the onboard network generators and the shore network or another external network. A brief period of concurrent operation shall be permitted when changing from one system to another without a break in voltage. 4.   The connection shall be protected against short circuiting and overload. 5.   The main switchboard shall indicate whether the connection is live. 6.   Indicator devices shall be installed to enable comparison of polarity in the case of direct current and phase sequence in the case of three-phase alternating current, between the connection and the onboard network. 7.   A panel adjacent to the connection shall indicate:

(a) the measures required to establish the connection;

(b) the type of current and the nominal voltage and, for alternating current, the frequency.
Article 9.09

Power supply to other craft 1.   When power is supplied to other craft, a separate connection shall be used. If power sockets rated at more than 16 A are used to supply current to other craft, devices (such as switches or interlocks) shall be provided to ensure that connection and disconnection can take place only when the line is dead. 2.   Cable connections shall not be subjected to any pulling load. 3.   Article 9.08, paragraphs 3 to 7, shall apply mutatis mutandis.
Article 9.10

Generators and motors 1.   Generators, motors and their terminal boxes shall be accessible for inspections, measurements and repairs. The type of protection shall correspond to their location (see Article 9.03). 2.   Generators driven by the main engine, the propeller shaft or by an auxiliary set intended for other purposes shall be designed with respect to the range of rotational speeds which can occur during normal operation.
Article 9.11

Accumulators 1.   Accumulators shall be accessible and so arranged as not to shift due to movements of the craft. They shall not be placed where they will be exposed to excessive heat, extreme cold, spray, steam or vapour.

They shall not be installed in the wheelhouse, accommodation or holds. This requirement shall not apply to accumulators for portable appliances, or to accumulators requiring a charging power of less than 0,2 kW. 2.   Accumulators requiring a charging power of more than 2,0 kW (calculated on the basis of the maximum charging current and the nominal voltage of the accumulator and taking into account the characteristic charging curve of the charging appliance) shall be installed in a special room. If placed on deck enclosing them in a cabinet will suffice.

Accumulators requiring a charging power not exceeding 2,0 kW may be installed in a cabinet or chest not only if placed on deck but also below decks. They may also be installed in an engine room or any other well-ventilated space provided that they are protected against falling objects and dripping water. 3.   The interior surfaces of all rooms, cabinets or boxes, shelving or other built-in features intended for accumulators shall be protected against the harmful effects of electrolytes. 4.   Provision shall be made for effective ventilation when accumulators are installed in a closed compartment, cabinet or chest. Forced-draught ventilation shall be provided for nickel-cadmium accumulators requiring a charging power of more than 2 kW and for lead-acid accumulators requiring more than 3 kW.

The air shall enter at the bottom and be discharged at the top so as to ensure total gas extraction.

Ventilation ducts shall not include any devices which obstruct the air flow, such as stop valves. 5.   The required air throughput (Q) shall be calculated using the following formula:
Q = 0,11 · I · n (m3/h)

where:

I

=

 of the maximum current, in A, provided by the charging device;

n

=

the number of cells.

In the case of buffer accumulators within the onboard network other methods of calculation taking into account the characteristic charging curve of the charging device may be accepted by the inspection body, provided that these methods are based on the provisions of approved classification societies or on relevant standards. 6.   Where natural ventilation is used the cross-section of the ducts shall be sufficient for the required air throughput on the basis of an air-flow velocity of 0,5 m/section. However, the cross-section shall be at least 80 cm2 for lead-acid accumulators and 120 cm2 for nickel-cadmium accumulators. 7.   Where forced-draught ventilation is used a fan shall be provided, preferably of the suction type, whose motor shall be clear of the gas or air stream.

Fans shall be so designed as to preclude the generation of sparks through contact between a blade and the fan casing and to avoid any electrostatic charges. 8.   ‘Fire, naked flame and smoking prohibited’ signs according to Figure 2 of Appendix I having a minimum diameter of 10 cm shall be affixed to the doors or covers of compartments, cabinets and chests containing accumulators.
Article 9.12

Switchgear installations 1.   Electrical switchboards

(a) Appliances, switches, fuses and switchboard instruments shall be clearly arranged and shall be accessible for maintenance and repair.

Terminals for voltages up to 50 V, and those for voltages higher than 50 V, shall be kept separate and marked appropriately.

(b) For all switches and appliances marker plates identifying the circuit shall be affixed to the switchboards.

The nominal amperage and the circuit for fuses shall be identified.

(c) When appliances with an operating voltage greater than 50 V are installed behind doors the live components of those appliances shall be protected against accidental contact while the doors are open.

(d) The materials of switchboards shall have suitable mechanical strength and be durable, flame-retardant and self-extinguishing; they shall not be hygroscopic.

(e) If high rupture capacity (HRC)-fuses are installed in electrical switchboards, accessories and personal protective equipment shall be available for installing and removing such fuses. 2.   Switches, protective devices

(a) Generator circuits and power consumer circuits shall be protected against short circuiting and overload on all non-earthed conductors. Switching devices triggered by short-circuiting and overload or fuses may be used for this purpose.

Circuits supplying electric motors of drive units (steering system) and their control circuits shall only be protected against short circuiting. Where circuits include thermal circuit-breakers these shall be neutralised or set at not less than twice the nominal amperage.

(b) Outputs from the main switchboard to power consumers operating at more than 16 A shall include a load or power switch.

(c) Power consumers for the propulsion of the craft, the steering system, the rudder position indicator, navigation or safety systems, and power consumers with a nominal amperage greater than 16 A shall be supplied by separate circuits.

(d) The circuits of power consumers required for propelling and manoeuvring the vessel shall be supplied directly by the main switchboard.

(e) Circuit-breaking equipment shall be selected on the basis of nominal amperage, thermal or dynamic strength, and breaking capacity. Switches shall simultaneously cut off all live conductors. The switching position shall be identifiable.

(f) Fuses shall be of the enclosed-melt type and be made of ceramic or an equivalent material. It shall be possible to change them without any danger of physical contact for the operator. 3.   Measuring and monitoring devices

(a) Generator, accumulator and distribution circuits shall be equipped with measuring and monitoring devices where the safe operation of the installation so requires.

(b) Non-earthed networks with a voltage of more than 50 V shall be equipped with an earthing detection device capable of giving both visual and audible alarm. In secondary installations such as control circuits, this device may be dispensed with. 4.   Location of electrical switchboards

(a) Switchboards shall be located in accessible and well-ventilated spaces and be protected against water and mechanical damage.

Piping and air ducts shall be so arranged that in the event of leakage the switchboards cannot be damaged. If their installation near electrical switchboards is inevitable, pipes shall not have detachable connections nearby.

(b) Cabinets and wall recesses in which unprotected switching devices are installed shall be of a flame-retardant material or be protected by a metal or other flame-retardant sheathing.

(c) When the voltage is greater than 50 V, insulating gratings or mats shall be placed at the operator’s position in front of the main switchboard.
Article 9.13

Emergency circuit breakers

Emergency circuit breakers for oil burners, fuel pumps, fuel separators and engine-room ventilators shall be installed centrally outside the spaces containing the equipment.
Article 9.14

Installation fittings 1.   Cable entries shall be sized as a function of the cables to be connected and be appropriate to the types of cable used. 2.   Sockets for distribution circuits at different voltages or frequencies shall be impossible to confuse. 3.   Switches shall simultaneously switch all non-earthed conductors within a circuit. However, single-pole switches within non-earthed circuitry shall be permitted in accommodation-lighting circuits apart from in laundries, bathrooms, washrooms and other rooms with wet facilities. 4.   Where amperage exceeds 16 A it shall be possible to lock the sockets by means of a switch in such a way that the plug can only be inserted and withdrawn with the power switched off.
Article 9.15

Cables 1.   Cables shall be flame-retardant, self-extinguishing and resistant to water and oil.

In accommodation, other types of cable may be used, provided that they are effectively protected, have flame-retardant characteristics and are self-extinguishing.

Flame-retardant standards of electric cables shall be in accordance with:

(a) IEC publications 60332-1:1993, 60332-3:2000; or

(b) equivalent regulations recognised by one of the Member States. 2.   Conductors of cables used for power and lighting circuits shall have a minimum cross-section of 1,5 mm2. 3.   Metal armouring, shielding and sheathing of cables shall not, under normal operating conditions, be used as conductors or for earthing. 4.   Metal shielding and sheathing of cables in power and lighting installations shall be earthed at least at one end. 5.   The cross-section of conductors shall take account of their maximum permissible end-temperature (current-carrying capacity) and of the permissible voltage drop. The voltage drop between the main switchboard and the least favourable point of the installation shall not be more than 5 % for lighting or more than 7 % for power or heating circuits, referred to the nominal voltage. 6.   Cables shall be protected against mechanical damage. 7.   The means of fixing the cables shall ensure that any pulling load remains within the permissible limits. 8.   When cables pass through bulkheads or decks, the mechanical strength, watertightness and fire resistance of these bulkheads and decks shall not be affected by the penetrations. 9.   Terminations and joints in all conductors shall be so made as to retain the original electrical, mechanical, flame-retardant and, where necessary, fire resistant properties. 10.   Cables connected to retractable wheelhouses shall be sufficiently flexible and shall have insulation with sufficient flexibility down to — 20 °C and resistance to steam and vapour, ultraviolet rays and ozone.
Article 9.16

Lighting installations 1.   Lighting appliances shall be so installed that the heat they emit cannot set fire to nearby inflammable objects or components. 2.   Lighting appliances on open decks shall be so installed as not to impede the recognition of navigation lights. 3.   When two or more lighting appliances are installed in an engine room or boiler room, they shall be supplied by at least two different circuits. This requirement shall also apply to spaces where cooling machinery, hydraulic machinery, or electric motors are installed.
Article 9.17

Navigation lights 1.   Switchboards for navigation lights shall be installed in the wheelhouse. They shall be supplied by a separate feeder from the main switchboard or by two independent secondary distributions. 2.   Navigation lights shall be supplied, protected and switched separately from the navigation lights switchboard. 3.   No fault in the monitoring installation, as provided for in Article 7.05(2), shall affect the operation of the light which it monitors. 4.   Several lights forming a functional unit and installed together at the same point may be jointly supplied, switched and monitored. The monitoring installation shall be capable of identifying the failure of any one of these lights. However, it shall not be possible to use both light sources in a double light (two lights mounted one above the other or in the same housing) simultaneously.
Article 9.18

(Left void)
Article 9.19

Alarm and safety systems for mechanical equipment

The alarm and safety systems for monitoring and protecting mechanical equipment shall meet the following requirements:

(a) Alarm systems

The alarm systems shall be so designed that no failure in the alarm system can result in failure of the apparatus or installation being monitored.

Binary transmitters shall be designed on the quiescent-current principle or on the monitored load-current principle.

Visual alarms shall remain visible until the fault has been remedied; an alarm that has been acknowledged shall be distinguishable from an alarm that has not yet been acknowledged. Each alarm shall also comprise an audible warning. It shall be possible to switch off acoustic alarms. Switching off one acoustic alarm shall not prevent another signal from being set off by another cause.

Exceptions can be permitted in the case of alarm systems comprising less than five measurement points.

(b) Safety systems

Safety systems shall be designed to halt or slow down the operation of the affected equipment, or to warn a permanently-manned station to do so before a critical state is reached.

Binary transmitters shall be designed according to the load-current principle.

If safety systems are not designed to be self-monitoring it shall be possible to check that they are operating correctly .

Safety systems shall be independent of other systems.
Article 9.20

Electronic equipment 1.   General

The test conditions in paragraph 2 below shall apply only to electronic devices that are necessary for the steering system and the craft’s power plants, including their ancillaries. 2.   Test conditions

(a) The stresses arising from the following tests shall not cause electronic devices to be damaged or to malfunction. The tests in accordance with relevant international standards, such as IEC publication 60092-504:2001, apart from the cold-condition test, shall be carried out with the device switched on. These tests shall include checking of proper operation.

(b) Variations in voltage and frequency
Variations

continuous

short-duration

General

Frequency

± 5 %

± 10 % 5 s

Voltage

± 10 %

± 20 % 1.5 s

Battery operation

Voltage

+ 30 %/- 25 %
(c) Heating test

The sample is brought up to a temperature of 55 °C within a half-hour period. After that temperature has been reached it is maintained for 16 hours. An operating test is then carried out.

(d) Cold-condition test

The sample is switched off and cooled to -25 °C and held at that temperature for two hours. The temperature is then raised to 0 °C and an operating test is carried out.

(e) Vibration test

The vibration test shall be carried out along the three axes at the resonance frequency of the devices or of components for the period of 90 minutes in each case. If no clear resonance emerges the vibration test shall be carried out at 30 Hz.

The vibration test shall be carried out by sinusoidal oscillation within the following limits:

General:

f = 2,0 to 13,2 Hz; a = ± 1 mm

(amplitude a = 

 the vibration width)

f = 13,2 Hz to 100 Hz: acceleration ± 0,7 g.

Equipment intended to be fitted to diesel engines or steering apparatus shall be tested as follows:

f = 2,0 to 25 Hz; a = ± 1,6 mm

(amplitude a = 

 the vibration width)

f = 25 Hz to 100 Hz; acceleration ± 4 g.

The sensors intended to be installed in diesel-engine exhaust pipes may be exposed to considerably higher stresses. Account shall be taken of this during the tests.

(f) The electromagnetic compatibility test shall be carried out on the basis of IEC publications 61000-4-2:1995, 61000-4-3:2002, 61000-4-4:1995, at test degree number 3. (g) Proof that the electronic equipment is adequate for these test conditions shall be provided by their manufacturer. A certificate by an approved classification society shall likewise be considered to be proof.
Article 9.21

Electromagnetic compatibility

The operation of the electric and electronic systems shall not be impaired by electromagnetic interference. General measures shall, with equal importance, extend to:

(a) disconnection of the transmission paths between the source of interference and affected devices;

(b) reducing the causes of disturbance at their source;

(c) reducing the sensitivity of affected devices to interference.

CHAPTER 10EQUIPMENT

Article 10.01

Anchor equipment 1.   Vessels intended for the carriage of goods, apart from ship-borne lighters whose length L does not exceed 40m, shall be equipped with bow anchors whose total mass P is obtained using the following formula:
P = k · B · T (kg)

where

k

is a coefficient that takes account of the relationship between length L and beam B, and of the type of vessel:

for lighters, however, k = c will be taken;

c

is an empirical coefficient given in the following table:

Dead-weight tonnage in t

Coefficient c

up to 400 inclusive

45

from 400 to 650 inclusive

55

from 650 to 1 000  inclusive

65

more than 1 000 

70

On vessels whose dead-weight tonnage is not greater than 400 t and which, owing to their design and intended purpose, are used only on predetermined short-haul sections, the inspection body may accept that only two-thirds of total mass P is required for the bow anchors. 2.   Passenger vessels and vessels not intended for the carriage of goods, apart from pushers, shall be fitted with bow anchors whose total mass P is obtained using the following formula:
P = k · B · T (kg)

where:

k

is the coefficient corresponding to paragraph 1, but where in order to obtain the value of the empirical coefficient (c) the water displacement in m3 entered in the Community certificate shall be taken instead of the deadweight tonnage. 3.   Vessels referred to in paragraph 1 whose maximum length does not exceed 86 m shall be equipped with stern anchors whose total mass is equal to 25 % of mass P.

Vessels whose maximum length exceeds 86 m shall be equipped with stern anchors whose total mass is equal to 50 % of mass P calculated in accordance with paragraph 1 or 2. Stern anchors are not required for:

(a) vessels for which the stern anchor mass will be less than 150 kg; in the case of vessels referred to in paragraph 1, final subparagraph, the reduced mass of the bow anchors shall be taken into account;

(b) lighters. 4.   Vessels intended to propel rigid convoys which do not exceed 86 m in length shall be equipped with stern anchors whose total mass is equal to 25 % of maximum mass P calculated in accordance with paragraph1 for the formations (considered to be a nautical unit) permitted and entered in the Community certificate.

Vessels intended to propel rigid convoys which exceed 86 m in length downstream shall be equipped with stern anchors whose total mass is equal to 50 % of the maximum mass P calculated in accordance with paragraph 1 for the formations (considered to be a nautical unit) permitted and entered in the Community certificate. 5.   The anchor masses established in accordance withparagraphs 1 to 4 may be reduced for certain special anchors. 6.   The total mass P specified for bow anchors may be distributed between one or two anchors. It may be reduced by 15 % where the vessel is equipped with only a single bow anchor and the hawse pipe is located amidships.

The total mass required for stern anchors for pushers and vessels whose maximum length exceeds 86 m may be distributed between one or two anchors.

The mass of the lightest anchor shall not be less than 45 % of that total mass. 7.   Cast iron anchors shall not be permitted. 8.   On anchors their mass shall be indicated in characters which stand out in relief in a durable manner. 9.   Anchors having a mass in excess of 50 kg shall be equipped with windlasses. 10.   Each bow anchor chain shall have a minimum length of:

(a) 40 m for vessels not exceeding 30 m in length;

(b) 10 m longer than the vessel where this is more than 30 m and up to 50 m in length;

(c) 60 m where vessels are more than 50 m in length.

Each of the stern anchor chains shall be at least 40 m long. However, where vessels need to stop facing downstream they shall have stern anchor chains that are each at least 60 m in length. 11.   The minimum tensile strength R of the anchor chains shall be calculated using the following formulae:

(a) anchors having a mass up to 500 kg:

R = 0,35 · P’ (kN);

(b) anchors having a mass of more than 500 kg and not exceeding 2 000 kg:

;

(c) anchors having a mass of more than 2 000 kg:

R = 0,25 · P’ (kN).

where

P’

is the theoretical mass of each anchor determined in accordance with paragraphs 1 to 4 and 6. The tensile strength of anchor chains shall be stated according to a standard in force in a Member State.

Where the anchors have a mass greater than that required by paragraphs 1 to 6, the tensile strength of the anchor chain shall be determined as a function of the actual anchor mass. 12.   In cases where heavier anchors with correspondingly stronger anchor chains are aboard, only the minimum masses and minimum tensile strengths required according to paragraphs 1 to 6 and 11 shall be entered in the Community certificate. 13.   Connecting pieces (swivels) between anchor and chain shall withstand a tensile load 20 % higher than the tensile strength of the corresponding chain. 14.   The use of cables instead of anchor chains is permitted. The cables shall have the same tensile strength as that required for chains, but shall be 20 % longer.
Article 10.02

Other equipment 1.   According to the applicable navigational authority regulations in force in the Member States, at least the following equipment shall be on board:

(a) radio-telephone system;

(b) appliances and devices for giving visual and audible signals as well as daytime and night-time vessel marking;

(c) stand-alone back-up lights for the prescribed mooring lights;

(d) a fire-proof, marked receptacle, with cover, to receive oily cleaning cloths;

(e) a fire-proof, marked receptacle, with cover, to receive hazardous or pollutant solid wastes and a fire-proof, marked receptacle, with cover, to receive hazardous or pollutant liquid wastes according to the relevant applicable navigational authority regulations;

(f) a fire-proof, marked receptacle, with cover, to receive slops. 2.   In addition, the equipment shall include at least:

(a) Mooring cables;

Vessels shall be equipped with three mooring cables. Their minimum lengths shall be at least the following:

—   first cable: L + 20 m, but not more than 100 m,

—   second cable: 2/3 of the first cable,

—   third cable: 1/3 of the first cable.

The shortest cable is not required on board vessels whose L is less than 20 m.

The cables shall have a tensile strength Rs that is calculated using the following formulae;

for L · B · T up to 1 000 m3: 

;

for L · B · T exceeding 1 000 m3: 

.

For the required cables a certificate in accordance with European standard EN 10 204:1991, under No 3.1, shall be on board.

These cables may be replaced by ropes having the same length and tensile strength. The minimum tensile strength of these ropes shall be indicated in a certificate.

(b) Towing cables;
Tugs shall be equipped with a number of cables that are suitable for their operation.
However, the main cable shall be at least 100 m long and have a tensile strength, in kN, not less than one third of the total power, in kW, of the main engine(s).
Motor vessels and pushers that are also able to tow shall be equipped with a towing cable that is at least 100 m long and whose tensile strength, in kN, is not less than one quarter of the total power, in kW, of the main engine(s).

(c) A heaving line;

(d) A boarding gangway at least 0,4 m wide and 4 m long whose side edges are defined by a brightly-coloured strip; that gangway shall be equipped with a handrail. The inspection body may permit shorter gangways for small vessels;

(e) A gaff hook;

(f) An appropriate first-aid kit with a content in accordance with a relevant standard of a Member State. The first-aid kit shall be kept in an accommodation room or in the wheelhouse and be stored in such a way that it is easily and safely accessible if necessary. If first-aid kits are stored under cover, the cover shall be marked by a symbol for first-aid kit according to Figure 8 of Appendix I, having a side length of at least 10 cm;

(g) A pair of binoculars, 7 x 50 or with larger lens diameter;

(h) A notice concerning the rescue and revival of persons overboard;

(i) A searchlight that can be operated from the wheelhouse. 3.   There shall be an embarkation stairway or ladder on vessels whose side height above the unladen waterline exceeds 1,50 m.
Article 10.03

Portable fire extinguishers 1.   There shall be at least one portable fire extinguisher in accordance with European standard EN 3:1996 at each of the following places:

(a) in the wheelhouse;

(b) close to each entrance from the deck to accommodation spaces;

(c) close to each entrance to service spaces which are not accessible from the accommodation spaces and which contain heating, cooking or refrigeration equipment using solid or liquid fuels or liquefied gas;

(d) at each entrance to engine rooms and boiler rooms;

(e) at suitable points below deck in engine rooms and boiler rooms such that no position in the space is more than 10 metres walking distance away from an extinguisher. 2.   For the portable fire extinguishers required by paragraph 1, only powder-type extinguishers with a content of at least 6 kg or other portable fire extinguishers with the same extinguishing capacity may be used. They shall be suitable for Class A, B and C fires and for fires in electrical systems of up to 1000 V. 3.   In addition powder, water or foam fire extinguishers may be used which are suitable at least for the class of fire most likely to occur in the room for which they are intended. 4.   Portable fire extinguishers with CO2 as the extinguishing agent may be used only for extinguishing fires in galleys and electrical installations. The content of these fire extinguishers shall be no more than 1 kg per 15 m3 of the room in which they are made available for use. 5.   Portable fire extinguishers shall be checked at least every two years. An inspection certificate shall be issued, signed by the inspector and showing the date of inspection. 6.   If portable fire extinguishers are installed in such a way that they are out of sight the panel covering them shall be identified by a symbol for fire extinguishers as shown in Figure 3 of Appendix I, and having a side length of at least 10 cm.
Article 10.03a

Permanently installed fire-fighting systems in accommodation spaces, wheelhouses and passenger spaces 1.   Fire protection in accommodation spaces, wheelhouses and passenger spaces is to be provided only by suitable automatic pressurised water sprinklers as permanently installed fire-fighting systems. 2.   Installation or conversion of the systems shall be carried out only by specialised firms. 3.   The systems shall be made of steel or equivalent non-combustible materials. 4.   The systems shall be able to spray water at a rate of at least 5 l/m2 per minute over the area of the largest room to be protected. 5.   Systems spraying smaller quantities of water shall have a type-approval pursuant to IMO Resolution A 800(19) or another standard recognised in accordance with the procedure referred to in Article 19(2) of this Directive. Type-approval shall be carried out by an approved classification society or an accredited testing institution. The accredited testing institution shall comply with the European standard for general requirements for the competence of testing and calibrating laboratories (EN ISO/IEC 17025: 2000). 6.   The systems shall be checked by an expert:

(a) before being put into service;

(b) before being put back into service after they have been triggered;

(c) after any modification or repair;

(d) regularly at least every two years. 7.   When carrying out the check in accordance with paragraph 6, the expert shall verify whether the systems meet the requirements of this paragraph.

The check shall at least include:

(a) external inspection of the entire system;

(b) functional testing of the safety systems and nozzles;

(c) functional testing of the pressure tanks and pumping system. 8.   An inspection certificate, signed by the inspector, shall be issued, showing the date of inspection. 9.   The number of installed systems shall be entered in the Community certificate. 10.   For protecting objects in accommodation spaces, wheelhouses and passenger spaces, permanently installed fire-fighting systems shall be permissible only on the basis of recommendations from the Committee.
Article 10.03b

Permanently installed fire-fighting systems in engine rooms, boiler rooms and pump rooms 1.   Extinguishing agents

For protecting engine rooms, boiler rooms and pump rooms, the following extinguishing agents may be used in permanently installed fire-fighting systems:

(a) CO2 (carbon dioxide);

(b) HFC 227ea (heptafluoropropane);

(c) IG-541 (52 % nitrogen, 40 % argon, 8 % carbon dioxide).

Other extinguishing agents shall be permissible only in accordance with the procedure referred to in Article 19(2) of this Directive. 2.   Ventilation, air intake

(a) Combustion air for the propulsion engines shall not be extracted from rooms that are to be protected by permanently installed fire-fighting systems. This shall not apply where there are two mutually independent and hermetically separated main engine rooms or if next to the main engine room there is a separate engine room with a bow thruster, ensuring that the vessel is able to make way under its own power in the event of fire in the main engine room.

(b) Any forced ventilation present in the room to be protected shall switch off automatically if the fire-fighting system is triggered.

(c) There shall be devices available with which all apertures which can allow air to enter or gas to escape from the room to be protected can be quickly closed. It shall be clearly recognisable whether they are open or closed.

(d) The air escaping from relief valves in the compressed-air tanks installed in engine rooms shall be conveyed to the open air.

(e) Over- or underpressure resulting from the inflow of extinguishing agent shall not destroy the components of the surrounding partitions of the room to be protected. It shall be possible for the pressure to equalise without danger.

(f) Protected rooms shall have a facility for extracting the extinguishing agent and the combustion gases. Such facilities shall be capable of being operated from positions outside the protected rooms and which would not be made inaccessible by a fire within such spaces. If there are permanently installed extractors, it shall not be possible for these to be switched on while the fire is being extinguished. 3.   Fire alarm system

The room to be protected shall be monitored by means of an appropriate fire alarm system. The alarm shall be noticeable in the wheelhouse, the accommodation spaces and the room to be protected. 4.   Piping system

(a) The extinguishing agent shall be conveyed to the room to be protected and distributed there by means of a fixed piping system. Inside the room to be protected the piping and associated fittings shall made of steel. Tank connecting pipes and expansion joints shall be exempt from this provided the materials used have equivalent properties in case of fire. Pipes shall be both internally and externally protected against corrosion.

(b) Outlet nozzles shall be dimensioned and fitted such that the extinguishing agent is evenly distributed. 5.   Triggering device

(a) Fire-fighting systems with automatic triggering shall not be permissible.

(b) It shall be possible to trigger the fire-fighting system from a suitable place outside the room to be protected.

(c) Triggering devices shall be installed in such a way that they can be operated even in case of a fire and in the event of damage by fire or explosion in the room to be protected the necessary quantity of extinguishing agent can still be conveyed.

Non-mechanical triggering devices shall be powered from two different mutually independent energy sources. These energy sources shall be located outside the room to be protected. Control lines in the room to be protected shall be designed so as to remain functional for at least 30 minutes in the event of fire. This requirement shall be fulfilled in the case of electric wiring if it complies with the standard IEC 60331-21:1999. If triggering devices are installed in such a way that they are out of sight the panel covering them shall be identified by the ‘fire-fighting installation’ symbol as shown in Figure 6 of Appendix I, having a side length of at least 10 cm, and the following text in red lettering on a white background:

                                       ‘Feuerlöscheinrichtung

Installation d’extinction

Brandblusinstallatie

Fire-fighting installation’.

(d) If the fire-fighting system is intended for the protection of several rooms, the triggering devices for each room have to be separate and clearly identified.

(e) Next to each triggering device operating instructions in one of the languages of the Member States shall be posted up visibly and indelibly. They shall contain, in particular, instructions regarding:

(aa)

triggering of the fire-fighting system;

(bb)

the need for checking to ensure that all persons have left the room to be protected;

(cc) action to be taken by the crew when the fire-fighting system is triggered;

(dd) action to be taken by the crew in the case of failure of the fire-fighting system.

(f) The operating instructions shall point out that before the fire-fighting system is triggered combustion engines drawing air from the room to be protected are to be shut down. 6.   Warning system

(a) Permanently installed fire-fighting systems shall be provided with acoustic and optical warning systems.

(b) The warning system shall be set off automatically as soon as the fire-fighting system is first triggered. The warning signal shall sound for an appropriate time before the extinguishing agent is released and it shall not be possible to switch it off.

(c) Warning signals shall be clearly visible in the rooms to be protected and outside the accesses to them and clearly audible even under operating conditions producing the loudest inherent noise. They shall be clearly distinct from all other acoustic and optical signals in the room to be protected.

(d) The acoustic warning signals shall be clearly audible in the adjacent rooms even when connecting doors are closed and under operating conditions producing the loudest inherent noise.

(e) If the warning system is not self-monitoring as regards short-circuits, wire breaks and voltage drops, it shall be possible to check that it is working properly.

(f) At every entrance to a room that can be supplied with extinguishing agent, a clearly visible notice shall be put up bearing the following text in red lettering on a white background:

                                       ‘Vorsicht, Feuerlöscheinrichtung!

Bei Ertönen des Warnsignals (Beschreibung des Signals) den Raum sofort verlassen!

Attention, installation d’extinction d’incendie!

Quitter immédiatement ce local au signal (description du signal)

Let op, brandblusinstallatie!

Bij het in werking treden van het alarmsignaal (omschrijving van het signaal) deze ruimte onmiddellijk verlaten!

Warning, fire-fighting installation!

Leave the room as soon as the warning signal sounds (description of signal)’. 7.   Pressure tanks, fittings and pressure pipes

(a) Pressure tanks, fittings and pressure pipes shall comply with the provisions in force in one of the Member States.

(b) Pressure tanks shall be installed in accordance with the manufacturer’s instructions.

(c) Pressure tanks, fittings and pressure pipes are not to be installed in accommodation spaces.

(d) The temperature in cabinets and installation spaces containing pressure tanks shall not exceed 50 oC.

(e) Cabinets or installation spaces on deck shall be firmly fixed in place and have air vents which are to be arranged in such a way that in the event of a leak in the pressure tank no gas can escape into the interior of the vessel. Direct connections to other rooms are not permitted. 8.   Quantity of extinguishing agent

If the quantity of extinguishing agent is intended for protecting more than one room, the total amount of extinguishing agent available does not need to be greater than the quantity necessary for the largest room to be protected. 9.   Installation, inspection and documentation

(a) The system shall be installed or converted only by a firm specialising in fire-fighting systems. The requirements specified by the extinguishing agent manufacturer and the system manufacturer (product data sheet, safety data sheet) are to be complied with.

(b) The system shall be checked by an expert:

(aa)

before being put into service;

(bb)

before being put back into service after it has been triggered;

(cc) after any modification or repair;

(dd) regularly at least every two years.

(c) In the inspection the expert shall check whether the system meets the requirements of this chapter.

(d) The inspection shall cover at least the following:

(aa)

external inspection of the entire installation;

(bb)

tightness check on pipes;

(cc) functional checking of control and triggering systems;

(dd) checking of tank pressure and content;

(ee)

checking of tightness and facilities for locking the room to be protected;

(ff)

checking the fire alarm system;

(gg)

checking the warning system.

(e) An inspection certificate shall be issued, signed by the inspector and showing the date of the inspection.

(f) The number of permanently installed fire-fighting systems shall be entered in the Community certificate. 10.   CO2 fire-fighting systems

Fire-fighting systems using CO2 as the extinguishing agent shall comply with the following provisions in addition to the requirements under paragraphs1 to 9:

(a) CO2 containers shall be housed outside the room to be protected in a space or cabinet hermetically separated from other rooms. The doors to these installation spaces and cabinets shall open outwards, be lockable and bear on the outside a symbol for ‘General danger warning’ in accordance with Figure 4 of Appendix I, at least 5 cm in height, together with the marking ‘CO2’ in the same colour and with the same height;

(b) installation spaces below decks for CO2 containers shall be accessible only from the open air. These spaces shall have their own adequate artificial ventilation system with extraction ducts, completely separate from other ventilation systems on board;

(c) the CO2 containers shall not be filled to more than 0,75 kg/l. The specific volume of unpressurised CO2 gas is to be taken as 0,56 m3/kg;

(d) the volume of CO2 for the room to be protected shall be at least 40 % of its gross volume. It shall be possible to supply this volume within 120 seconds, and to check whether supply has been completed;

(e) opening the container valves and operating the flood valve shall be separate control operations;

(f) the appropriate time mentioned under paragraph 6(b) shall be at least 20 seconds. There shall be a reliable device to ensure the delay before delivery of the CO2 gas. 11.   HFC-227ea — fire-fighting systems

Fire-fighting systems using HFC-227ea as the extinguishing agent shall comply with the following provisions in addition to the requirements under paragraphs 1 to 9:

(a) if there are several rooms to be protected, each with a different gross volume, each room shall be provided with its own fire-fighting system;

(b) each container of HFC-227ea that is installed in the room to be protected shall be equipped with an overpressure relief valve. This shall harmlessly release the contents of the container into the room to be protected if the container is exposed to the effects of fire and the fire-fighting system has not been triggered;

(c) each container shall be fitted with a device for checking the gas pressure;

(d) the containers shall not be filled to more than 1,15 kg/l. The specific volume of the unpressurised HFC-227ea is to be taken as 0,1374 m3/kg;

(e) the volume of HFC-227ea for the room to be protected shall be at least 8 % of the room’s gross volume. This volume shall be supplied within 10 seconds;

(f) the HFC-227ea containers shall be provided with a pressure monitor which triggers an acoustic and optical alarm signal in the wheelhouse in the event of an unauthorised loss of propellant. If there is no wheelhouse, this alarm signal shall be given outside the room to be protected;

(g) after flooding, the concentration in the room to be protected shall not exceed 10,5 %;

(h) the fire-fighting system shall not contain any parts made of aluminium. 12.   IG-541 — fire-fighting systems

Fire-fighting systems using IG-541 as the extinguishing agent shall comply with the following provisions in addition to the requirements under paragraphs 1 to 9:

(a) if there are several rooms to be protected, each with a different gross volume, each room shall be provided with its own fire-fighting system;

(b) each container of IG-541 that is installed in the room to be protected shall be equipped with an overpressure relief valve. This shall harmlessly release the contents of the container into the room to be protected if the container is exposed to the effects of fire and the fire-fighting system has not been triggered;

(c) each container shall be fitted with a device for checking the contents;

(d) the filling pressure of the container shall not exceed 200 bar at + 15 °C;

(e) the volume of IG-541 for the room to be protected shall be at least 44 % and no more than 50 % of the room’s gross volume. This volume shall be supplied within 120 seconds. 13.   Fire-fighting systems for protecting objects

For protecting objects in engine rooms, boiler rooms and pump rooms, permanently installed fire-fighting systems shall be permissible only on the basis of recommendations from the Committee.
Article 10.04

Ship’s boats 1.   The following craft shall carry a ship’s boat according to European standard EN 1914: 1997:

(a) motor vessels and barges exceeding 150 t deadweight;

(b) tugs and pushers with a water displacement of more than 150 m3;

(c) floating equipment;

(d) passenger vessels. 2.   It shall be possible for one person to launch such ship’s boats safely within five minutes from the first manual action necessary. If a powered launching device is used this shall be such that safe, quick launching shall not be impaired if its power supply fails. 3.   Inflatable ship’s boats shall be inspected according to manufacturer’s instructions.
Article 10.05

Lifebuoys and lifejackets 1.   On board craft there shall be at least three lifebuoys in accordance with European standard EN 14144: 2002. They shall be ready for use and attached to the deck at appropriate points without being attached to their mounting. At least one lifebuoy shall be in the immediate vicinity of the wheelhouse and shall be equipped with a self-igniting, battery-powered light that will not be extinguished in water. 2.   A personalised, automatically inflatable lifejacket in accordance with European standards EN 395: 1998 or EN 396: 1998 shall be within reach of every person who is regularly on board a craft.

Non-inflatable lifejackets in accordance with these standards shall also be admissible for children. 3.   Lifejackets shall be inspected in accordance with the manufacturer’s instructions.

CHAPTER 11SAFETY AT WORK STATIONS

Article 11.01

General 1.   Vessels shall be built, arranged and equipped in such a way as to enable persons to work and move about in safety. 2.   Permanently installed facilities that are necessary for working on board shall be arranged, laid out and secured in such a way as to permit safe and easy operation, use and maintenance. If necessary, mobile or high-temperature components shall be fitted with protective devices.
Article 11.02

Protection against falling 1.   Decks and side decks shall be flat and at no point be likely to cause tripping; it shall be impossible for puddles to form. 2.   Decks, side decks, engine-room floors, landings, stairways and the tops of side deck bollards shall have non-slip surfaces. 3.   The tops of side deck bollards and obstacles in passageways, such as the edges of steps, shall be painted in a colour contrasting with the surrounding deck. 4.   The outer edges of decks, as well as work stations where persons might fall more than 1 m, shall be fitted with bulwarks or coamings that are at least 0,70 m high or with a guard rail in accordance with European standard EN 711:1995, which shall comprise a handrail, a rail at knee height and a foot-rail. Side decks shall be fitted with a foot-rail and a continuous handrail that is secured to the coaming. Coaming handrails shall not be required where side decks are fitted with non-retractable shipside guard rails. 5.   At work stations where there is danger of falling more than 1 m the inspection body may require appropriate fittings and equipment to ensure safe working.
Article 11.03

Dimensions of working spaces

Working spaces shall be large enough to provide every person working in them with adequate freedom of movement.
Article 11.04

Side decks 1.   The clear width of a side deck shall be at least 0,60 m. That figure may be reduced to 0,50 m at certain points that are necessary for the operation of the vessel such as deck-washing valves. It may be reduced to 0,40 m at bollards and cleats. 2.   Up to a height of 0,90 m above the side deck, the clear width of the side deck may be reduced to 0,54 m provided that the clear width above, between the outer edge of the hull and the inner edge of the hold, is not less than 0,65 m. In this case, the clear width of the side deck may be reduced to 0,50 m if the outer edge of the side deck is fitted with a guard rail in accordance with European standard EN 711:1995 to prevent falling. On vessels 55 m or less in length with only aft accommodation, the guard rail may be dispensed with. 3.   The requirements of paragraphs 1 and 2 shall apply up to a height of 2,00 m above the side deck.
Article 11.05

Access to working spaces 1.   Points of access and passageways for the movement of persons and objects shall be of sufficient size and so arranged that:

(a) in front of the access opening, there is sufficient room not to impede movement;

(b) the clear width of the passageway shall be appropriate for the intended use of the working space and shall be not less than 0,60 m, except in the case of craft less than 8 m wide, where it may be reduced to 0,50 m;

(c) the clear height of the passageway including the sill is not less than 1,90 m. 2.   Doors shall be so arranged that they can be opened and closed safely from either side. They shall be protected against accidental opening or closing. 3.   Appropriate stairs, ladders or steps shall be installed in accesses, exits and passageways where there is more than a 0,50 m difference in floor level. 4.   Working spaces which are manned continuously shall be fitted with stairs if there is a difference in floor level of more than 1,00 m. This requirement shall not apply to emergency exits. 5.   Vessels with holds shall have at least one permanently installed means of access at each end of each hold.

By way of derogation from the first sentence the permanently installed means of access may be dispensed with if at least two movable ladders are provided which reach at least 3 rungs over the hatch coaming at an angle of inclination of 60o.
Article 11.06

Exits and emergency exits 1.   The number, arrangement and dimensions of exits, including emergency exits, shall be in keeping with the purpose and dimensions of the relevant space. Where one of the exits is an emergency exit, it shall be clearly marked as such. 2.   Emergency exits or windows or the covers of skylights to be used as emergency exits shall have a clear opening of not less than 0,36 m2, and the smallest dimension shall be not less than 0,50 m.
Article 11.07

Ladders, steps and similar devices 1.   Stairs and ladders shall be securely fixed. Stairs shall be not less than 0,60 m wide and the clear width between handrails shall be not less than 0,60 m; steps shall be not less than 0,15 m deep; steps shall have non-slip surfaces and stairs with more than three steps shall be fitted with handrails. 2.   Ladders and separately attached rungs shall have a clear width of not less than 0,30 m; rungs shall be not more than 0,30 m apart and the distance between rungs and structures shall be not less than 0,15 m. 3.   Ladders and separately attached rungs shall be clearly recognisable from above and shall be equipped with safety handles above exit openings. 4.   Movable ladders shall be at least 0,40 m wide, and at least 0,50 m wide at the base; it shall be possible to ensure that they will not topple or skid; the rungs shall be securely fixed in the uprights.
Article 11.08

Interior spaces 1.   The dimensions, arrangement and layout of interior working spaces shall be in keeping with the work to be carried out and shall meet the health and safety requirements. They shall be equipped with sufficient non-dazzle lighting and with sufficient ventilation arrangements. If necessary, they shall be fitted with heating appliances capable of maintaining an adequate temperature. 2.   The floors of interior working spaces shall be solid and durable, and shall be designed not to cause tripping or slipping. Openings in decks and floors shall, when open, be secured against the danger of falling, and windows and skylights shall be so arranged and fitted that they can be operated and cleaned safely.
Article 11.09

Protection against noise and vibration 1.   Working spaces shall be so situated, equipped and designed that crew members are not exposed to harmful vibrations. 2.   Permanent working spaces shall, in addition, be so constructed and soundproofed that the health and safety of crew members are not affected by noise. 3.   For crew members who are likely to be exposed to noise levels exceeding 85 dB(A) every day individual acoustic protection devices shall be available. In working spaces where noise levels exceed 90 dB(A) it shall be indicated that wearing of acoustic protection devices is mandatory by a symbol ‘Wear acoustic protection device’ with a diameter of at least 10 cm in accordance with Figure 7 of Appendix I.
Article 11.10

Hatch covers 1.   Hatch covers shall be easily accessible and safe to handle. Hatch-cover components weighing more than 40 kg shall be designed to slide or pivot or be fitted with mechanical opening devices. Hatch covers operated by lifting gear shall be fitted with adequate and easily accessible attachment devices. Non-interchangeable hatch covers and upper sills shall be clearly marked to show the hatches to which they belong and their correct position on those hatches. 2.   Hatch covers shall be secured against being tilted by the wind or by loading gear. Sliding covers shall be fitted with catches to prevent accidental horizontal movement of more than 0,40 m; they shall be capable of being locked in their final position. Appropriate devices shall be fitted to hold stacked hatch covers in position. 3.   The power supply for mechanically operated hatch covers shall be cut off automatically when the control switch is released. 4.   Hatch covers shall be capable of bearing the loads to which they are likely to be subjected: Hatch covers designed to be walked on shall be capable of bearing concentrated loads of at least 75 kg. Hatch covers not designed to be walked on shall be marked as such. Hatch covers designed to receive deck cargo shall have the permissible load in t/m2 marked on them. Where supports are needed to achieve the maximum permissible load this shall be indicated in an appropriate place; in this case the relevant drawings shall be kept on board.
Article 11.11

Winches 1.   Winches shall be designed in such a way as to enable work to be carried out safely. They shall be fitted with devices that prevent unintentional load release. Winches that do not lock automatically shall be fitted with a brake that is adequate to deal with their tractive force. 2.   Hand-operated winches shall be fitted with devices to prevent kickback of the crank. Winches that are both power- and manually driven shall be designed in such a way that the motive-power control cannot actuate the manual control.
Article 11.12

Cranes 1.   Cranes shall be built in accordance with best practice. The forces arising during their operation shall be safely transmitted into the vessel’s structure; they shall not impair its stability. 2.   A manufacturer’s plate containing the following information shall be affixed to cranes:

(a) manufacturer’s name and address;

(b) the CE marking, together with the year of manufacture;

(c) series or type reference;

(d) where applicable, serial number. 3.   The maximum permissible loadings shall be permanently marked in a clearly legible manner on cranes.

Where a crane’s safe working load does not exceed 2 000 kg it will be sufficient if the safe working load at the maximum reach is permanently marked in a clearly legible manner on the crane. 4.   There shall be devices to protect against crushing or shearing accidents. The outer parts of the crane shall leave a safety clearance of 0,5 m upwards, downwards and to the sides, between them and all surrounding objects. The safety clearance to the sides shall not be required outside work stations and passageways. 5.   It shall be possible to protect power driven cranes against unauthorised use. It shall only be possible to start these up from the crane’s driving position. The control shall be of the automatic-return type (buttons without stops); their operating direction shall be unambiguously clear.

If the motive power fails it shall not be possible for the load to drop uncontrolled. Unintentional crane movements shall be prevented.

Any upward movement of the hoisting device and any exceeding of the safe working load shall be limited by an appropriate device. Any downward movement of the hoisting device shall be limited if under any envisaged operating conditions at the moment of attaching the hook there can be less than two cable windings on the drum. The corresponding counter movement shall still be possible after the automatic limiting devices have been actuated.

The tensile strength of the cables for running rigging shall correspond to five times the cable’s permissible loading. The cable construction shall be faultless and the design shall be suitable for use on cranes. 6.   Before putting into service for the first time or before putting back into service following major alteration, calculations and a load test shall provide proof of adequate strength and stability.

Where a crane’s safe working load does not exceed 2 000 kg the expert may decide that the proof by calculation may be fully or partly replaced by a test with a load 1,25 times the safe working load carried out over the full working range.

The acceptance test according to the first or second paragraph shall be carried out by an expert recognised by the inspection body. 7.   Cranes shall be checked regularly and in any case at least every 12 months, by an expert. During that inspection the safe working condition of the crane shall be determined by a visual check and an operating check. 8.   Every 10 years, at the latest, after the acceptance test the crane shall again be inspected by an expert recognised by the inspection body. 9.   Cranes with a safe working load exceeding 2 000 kg, or which are used for transhipment of cargo, or which are mounted on board lifting jacks, pontoons and other floating equipment or worksite craft shall in addition meet the requirements of one of the Member States. 10.   For all cranes at least the following documents shall be kept on board:

(a) the crane manufacturer’s operating instructions, including at least the following information:
operating range and function of the controls;
maximum permissible safe working load as a function of the reach;
maximum permissible inclination of the crane;
assembly and maintenance instructions;
instructions concerning regular checks;
general technical data.

(b) certificates concerning the checks carried out in accordance with paragraphs 6 to 8 or 9. 

Article 11.13

Storing flammable liquids

To store flammable liquids with a flash point of less than 55oC there shall be a ventilated cupboard made of non-combustible material on deck. On its outside there shall be a symbol ‘Fire, naked flame and smoking prohibited’ with a diameter of at least 10 cm in accordance with Figure 2 of Appendix I.

CHAPTER 12ACCOMMODATION

Article 12.01

General 1.   Vessels shall have accommodation for the persons lodging habitually on board, and at least for the minimum crew. 2.   Accommodation shall be so designed, arranged and fitted out as to meet the health, safety and comfort needs of those on board. It shall be of safe and easy access and adequately insulated against heat and cold. 3.   The inspection body may authorise exceptions to the provisions of this Chapter if the health and safety of those on board are ensured by other means. 4.   The inspection body shall enter on the Community certificate any restrictions on the vessel’s daily operating periods and its operating mode resulting from the exceptions referred to in paragraph 3. 

Article 12.02

Special design requirements for accommodation 1.   It shall be possible to ventilate accommodation adequately even when the doors are closed; in addition, communal living quarters shall receive adequate daylight and, as far as possible, provide a view out. 2.   Where there is no deck-level access to the accommodation and the difference in level is 0,30 m or more the accommodation shall be accessible by means of stairs. 3.   In the foresection of the vessel no floor shall be more than 1,20 m below the plane of maximum draught. 4.   Living and sleeping quarters shall have at least two exits which are as far apart from each other as possible and which serve as escape routes. One exit may be designed as an emergency exit. This does not apply to rooms with an exit leading directly onto the deck or into a corridor which serves as an escape route, provided the corridor has two exits apart from each other leading to port and starboard. Emergency exits, which may include skylights and windows, shall have a clear opening of at least 0,36 m2 and a shortest side no less than 0,50 m and permit rapid evacuation in an emergency. Insulation and cladding of escape routes shall be made of flame-retardant materials and the usability of escape routes shall be guaranteed at all times by appropriate means such as ladders or separately attached rungs. 5.   Accommodation shall be protected against inadmissible noise and vibration. Sound pressure levels shall not exceed:

(a) 70 dB(A) in communal living quarters;

(b) 60 dB(A) in sleeping quarters. This provision shall not apply to vessels operating exclusively outside the rest periods of the crew as laid down by the national legislation of the Member States. The restriction of the daily operating period shall be entered on the Community certificate. 6.   Headroom in the accommodation shall be not less than 2,00 m. 7.   As a general rule, vessels shall have at least one communal living room partitioned off from the sleeping quarters. 8.   The free floor area of communal living quarters shall be not less than 2 m2 per person, and in any event not less than 8 m2 in total (not counting furniture, except tables and chairs). 9.   The cubic capacity of private living and sleeping rooms shall be not less than 7 m3 each. 10.   The volume of airspace per person shall be at least 3,5 m3 in private living quarters. In sleeping quarters it shall be at least 5 m3 for the first occupant and at least 3 m3 for each additional occupant (not counting volume of furniture). Sleeping cabins shall, as far as possible, be intended for no more than two persons. Berths shall be not less than 0,30 m above the floor. Where one berth is placed over another, the headroom above each berth shall be not less than 0,60 m. 11.   Doors shall have an opening whose upper edge is at least 1,90 m above deck or above the floor and a clear width of at least 0,60 m. The prescribed height may be achieved by means of sliding or hinged covers or flaps. Doors shall open to the outside and it shall be possible to open them from either side. Sills shall not be more than 0,40 m high, but shall nonetheless comply with the provisions of other safety regulations. 12.   Stairways shall be permanently fixed and safely negotiable. They shall be deemed to be so when:

(a) they are at least 0,60 m wide;

(b) the tread is at least 0,15 m deep;

(c) the steps are non-slip;

(d) stairways with more than three steps are fitted with at least one handrail or handle. 13.   Pipes carrying dangerous gases or liquids, and particularly those under such a high pressure that a leak could pose a danger to persons, shall not be located in the accommodation or in corridors leading to the accommodation. This does not apply to steam pipes and hydraulic system pipes, provided they are fitted in metal sleeves, and for the pipes of liquefied gas installations for domestic purposes.
Article 12.03

Sanitary installations 1.   At least the following sanitary installations shall be provided in vessels with accommodation:

(a) one toilet per accommodation unit or per six crew members; it shall be possible to ventilate these with fresh air;

(b) one washbasin with waste pipe and connected up to hot and cold potable water per accommodation unit or per four crew members;

(c) one shower or bath connected up to hot and cold potable water per accommodation unit or per six crew members. 2.   The sanitary installations shall be in close proximity to the accommodation. Toilets shall not have direct access to galleys, mess rooms or combined communal living quarters/galleys. 3.   Toilet compartments shall have a floor space of at least 1 m2, not less than 0,75 m wide and not less than 1,10 m long. Toilet compartments in cabins for no more than two persons may be smaller. Where a toilet contains a wash basin and/or shower, the floor space shall be increased at least by the floor space occupied by the wash basin and/or shower (or bath).
Article 12.04

Galleys 1.   Galleys may be combined with communal living quarters. 2.   Galleys shall comprise:

(a) a cooker;

(b) a sink with waste connection;

(c) a supply of potable water;

(d) a refrigerator;

(e) sufficient storage and working space. 3.   The eating area of combined galleys/communal living quarters shall be large enough to accommodate the number of crew normally using it at the same time. Seats shall be not less than 0,60 m wide.
Article 12.05

Potable water 1.   Vessels with accommodation shall have a potable water installation. Potable water tank filling apertures and potable water hoses shall be marked as being intended exclusively for potable water. Potable water filler necks shall be installed above the deck. 2.   Potable water installations shall:

(a) on their inner surfaces be made of a material which resists corrosion and poses no physiological danger;

(b) be free of pipe sections where a regular flow of water is not guaranteed, and

(c) be protected against excessive heating. 3.   In addition to paragraph 2, potable water tanks shall:

(a) have a capacity of at least 150 l per person normally living on board, and at least per member of the minimum crew;

(b) have a suitable, lockable opening to enable the inside to be cleaned;

(c) have a water level indicator;

(d) have ventilation pipes which lead to the open air or are fitted with appropriate filters. 4.   Potable water tanks shall not share walls with other tanks. Potable water pipes shall not pass through tanks containing other liquids. Connections are not permitted between the potable water supply system and other pipes. Pipes carrying gas or liquids other than potable water shall not pass through potable water tanks. 5.   Potable water pressure vessels shall operate only on uncontaminated compressed air. Where it is produced by means of compressors, appropriate air filters and oil separators shall be installed directly in front of the pressure vessel unless the water and the air are separated by a diaphragm.
Article 12.06

Heating and ventilation 1.   It shall be possible to heat accommodation in accordance with its intended use. Heating installations shall be appropriate for the weather conditions which may arise. 2.   It shall be possible to ventilate the living and sleeping quarters adequately even when the doors are closed. Ventilation shall ensure adequate air circulation in all climatic conditions. 3.   The accommodation shall be so designed and arranged as to prevent as far as possible the entry of foul air from other areas of the vessel such as engine rooms or holds; where forced-air ventilation is used, the intake vents shall be so placed as to satisfy the above requirements.
Article 12.07

Other accommodation installations 1.   Each crew member living on board shall have an individual berth and an individual clothes locker fitted with a lock. The internal measurements of the berth shall be not less than 2,00 × 0,90 m. 2.   Suitable places for storing and drying work clothes shall be provided, but not in the sleeping quarters. 3.   All accommodation areas shall be fitted with electric lighting. Additional lamps using gas or liquid fuel may only be used in communal living quarters. Lighting devices using liquid fuel shall be made of metal and shall burn only fuels with a flash point above 55 oC or commercial paraffin oil. They shall be placed or attached so as not to constitute a fire hazard.

CHAPTER 13FUEL-FIRED HEATING, COOKING AND REFRIGERATING EQUIPMENT

Article 13.01

General 1.   Heating, cooking and refrigeration equipment running on liquefied gas shall meet the requirements of Chapter 14. 2.   Heating, cooking and refrigeration equipment, together with its accessories, shall be so designed and installed that it is not dangerous even in the event of overheating. It shall be so installed that it cannot overturn or be moved accidentally. 3.   The equipment referred to inparagraph 2 shall not be installed in areas in which substances with a flash point below 55 °C are used or stored. No flues from these installations may pass through such areas. 4.   The supply of air necessary for combustion shall be ensured. 5.   Heating appliances shall be securely connected to flues, which shall be fitted with suitable cowls or devices affording protection against the wind. They shall be arranged in such a manner as to permit cleaning.
Article 13.02

Use of liquid fuels, oil-fired equipment 1.   Heating, cooking and refrigeration equipment which uses liquid fuel may be operated only with fuels whose flash point is above 55 °C. 2.   By way of derogation fromparagraph 1, cooking appliances and heating and refrigeration appliances fitted with burners with wicks and running on commercial paraffin oil may be permitted in the accommodation and wheelhouse provided the capacity of the fuel tank does not exceed 12 litres. 3.   Appliances fitted with burners with wicks shall be:

(a) fitted with a metal fuel tank whose filling aperture may be locked and which has no soft-solder joints below the maximum filling level, and shall be designed and installed in such a way that the fuel tank cannot be opened or emptied accidentally;

(b) capable of being lit without the aid of another liquid fuel;

(c) so installed as to ensure the safe evacuation of combustion gases.
Article 13.03

Vaporising oil burner stoves and atomising oil burner heating appliances 1.   Vaporising oil burner stoves and atomising oil burner heating appliances shall be built in accordance with best practice. 2.   Where a vaporising oil burner stove or an atomising oil burner heating appliance is installed in an engine room, the air supply to the heating appliance and the engines shall be so designed that the heating appliance and the engines can operate properly and safely independently of one another. Where necessary, there shall be a separate air supply. The equipment shall be installed in such a way that no flame from the burner can reach other parts of the engine room installations.
Article 13.04

Vaporising oil burner stoves 1.   It shall be possible to light vaporising oil burner stoves without the aid of another combustible liquid. They shall be fixed above a metal drip pan which encompasses all the fuel-carrying parts, whose sides are at least 20 mm high and which has a capacity of at least two litres. 2.   For vaporising oil burner stoves installed in an engine room, the sides of the metal drip pan prescribed in paragraph 1 shall be at least 200 mm high. The lower edge of the vaporising burner shall be located above the edge of the drip pan. In addition, the upper edge of the drip pan shall extend at least 100 mm above the floor. 3.   Vaporising oil burner stoves shall be fitted with a suitable regulator which, at all settings, ensures a virtually constant flow of fuel to the burner and which prevents any fuel leak should the flame go out. Regulators shall be considered suitable which function properly even when exposed to vibration and inclined up to 12° and which, in addition to a level-regulating float, have

(a) a second float which closes off the fuel supply safely and reliably when the permitted level is exceeded, or

(b) an overflow pipe, but only if the drip pan has sufficient capacity to accommodate at least the contents of the fuel tank. 4.   Where the fuel tank of a vaporising oil burner stove is installed separately:

(a) the drop between the tank and the burner feed may not exceed that laid down in the manufacturer’s operating instructions;

(b) it shall be so installed as to be protected from unacceptable heating;

(c) it shall be possible to interrupt the fuel supply from the deck. 5.   The flues of vaporising oil burner stoves shall be fitted with a device to prevent draught inversion.
Article 13.05

Atomising oil burner heating appliances

Atomising oil burner heating appliances shall in particular meet the following requirements:

(a) adequate ventilation of the burner shall be ensured before the fuel is supplied;

(b) the fuel supply shall be regulated by a thermostat;

(c) the fuel shall be ignited by an electric device or by a pilot flame;

(d) a flame monitoring device shall cut off the fuel supply when the flame goes out;

(e) the main switch shall be placed at an easily accessible point outside the installation room.
Article 13.06

Forced-air heating appliances

Forced-air heating appliances consisting of a combustion chamber around which the heating air is conducted under pressure to a distribution system or to a room shall meet the following requirements:

(a) if the fuel is atomised under pressure the combustion air shall be supplied by a blower;

(b) the combustion chamber shall be well ventilated before the burner can be lit. Ventilation may be considered complete when the combustion air blower continues to operate after the flame has gone out;

(c) the fuel supply shall be automatically cut off if:
the fire goes out;
the supply of combustion air is not sufficient;
the heated air exceeds a previously set temperature, or
the power supply of the safety devices fails.
In the above cases the fuel supply shall not be re-established automatically after being cut off;

(d) it shall be possible to switch off the combustion air and heating air blowers from outside the room where the heating appliance is located;

(e) where heating air is drawn from outside, the intake vents shall be located as far as possible above the deck. They shall be installed in such a manner that rain and spray water cannot enter;

(f) heating air pipes shall be made of metal;

(g) it shall not be possible to close the heating air outlet apertures completely;

(h) it shall not be possible for any leaking fuel to reach the heating air pipes;

(i) it shall not be possible for forced-air heating appliances to draw their heating air from an engine room.
Article 13.07

Solid fuel heating 1.   Solid fuel heating appliances shall be placed on a metal plate with raised edges such that no burning fuel or hot cinders fall outside the plate.

This requirement does not apply to appliances installed in compartments built of non-combustible materials and intended solely to house boilers. 2.   Solid fuel boilers shall be fitted with thermostatic controls to regulate the flow of combustion air. 3.   A means by which cinders can be quickly doused shall be placed in the vicinity of each heating appliance.

CHAPTER 14LIQUEFIED GAS INSTALLATIONS FOR DOMESTIC PURPOSES

Article 14.01

General 1.   Liquefied gas installations consist essentially of a supply unit comprising one or more gas receptacles, and of one or more pressure regulators, a distribution system and a number of gas-consuming appliances.

Spare and empty receptacles not in the supply unit shall not be considered part of the installation. Article 14.05 shall apply to them mutatis mutandis. 2.   Installations may be operated only with commercial propane.
Article 14.02

Installations 1.   Liquefied gas installations shall be suitable throughout for use with propane and shall be built and installed in accordance with best practice. 2.   Liquefied gas installations may be used only for domestic purposes in the accommodation and the wheelhouse, and for corresponding purposes on passenger vessels. 3.   There may be a number of separate installations on board. A single installation shall not be used to serve accommodation areas separated by a hold or a fixed tank. 4.   No part of a liquefied gas installation shall be located in the engine room.
Article 14.03

Receptacles 1.   Only receptacles with an approved content of between 5 and 35 kg are permitted. In the case of passenger vessels, the inspection body may approve the use of receptacles with a larger content. 2.   Receptacles shall bear the official stamp certifying that they have been accepted following the required tests.
Article 14.04

Location and arrangement of supply units 1.   Supply units shall be installed on deck in a freestanding or wall cupboard located outside the accommodation in a position such that it does not interfere with movement on board. They shall not, however, be installed against the fore or aft bulwark. The cupboard may be a wall cupboard set into the superstructure provided that it is gastight and can only be opened from outside the superstructure. It shall be so located that the distribution pipes leading to the gas consumption points are as short as possible.

No more receptacles may be in operation simultaneously than are necessary for the functioning of the installation. Several receptacles may be connected only if a reversing coupler is used. Up to four receptacles may be connected per supply unit. The number of receptacles on board, including spare receptacles, shall not exceed six per installation.

Up to six receptacles may be connected on passenger vessels with galleys or canteens for passengers. The number of receptacles on board, including spare receptacles, shall not exceed nine per installation.

Pressure regulators, or in case of two-stage regulation the first pressure regulator, shall be fitted to a wall in the same cupboard as the receptacles. 2.   Supply units shall be so installed that any leaking gas can escape from the cupboard into the open without any risk of it penetrating inside the vessel or coming into contact with a source of ignition. 3.   Cupboards shall be constructed of flame-retardant materials and shall be sufficiently ventilated by apertures in the top and bottom. Receptacles shall be placed upright in the cupboards in such a way that they cannot overturn. 4.   Cupboards shall be so built and placed that the temperature of the receptacles cannot exceed 50 °C. 5.   The words ‘Liquefied gas’ and a ‘Fire, naked flame and smoking prohibited’ symbol at least 10 cm in diameter in accordance with Figure 2 of Appendix I shall be affixed to the outer wall of the cupboard.
Article 14.05

Spare and empty receptacles

Spare and empty receptacles not located in the supply unit shall be stored outside the accommodation and the wheelhouse in a cupboard built in accordance with Article 14.04. 

Article 14.06

Pressure regulators 1.   Gas-consuming appliances may be connected to receptacles only through a distribution system fitted with one or more pressure regulators to bring the gas pressure down to the utilisation pressure. The pressure may be reduced in one or two stages. All pressure regulators shall be set permanently at a pressure determined in accordance with Article 14.07. 2.   The final pressure regulators shall be either fitted with or immediately followed by a device to protect the pipe automatically against excess pressure in the event of a malfunctioning of the pressure regulator. It shall be ensured that in the event of a leak in the protection device any leaking gas can escape into the open without any risk of it penetrating inside the vessel or coming into contact with a source of ignition; if necessary, a special pipe shall be fitted for this purpose. 3.   The protection devices and vents shall be protected against the entry of water.
Article 14.07

Pressure 1.   Where two-stage regulating systems are used, the mean pressure shall be not more than 2,5 bar above atmospheric pressure. 2.   The pressure at the outlet from the last pressure regulator shall be not more than 0,05 bar above atmospheric pressure, with a tolerance of 10 %.
Article 14.08

Piping and flexible tubes 1.   Pipes shall consist of permanently installed steel or copper tubing.

However, pipes connecting with the receptacles shall be high-pressure flexible tubes or spiral tubes suitable for propane. Gas-consuming appliances may, if not permanently installed, be connected by means of suitable flexible tubes not more than 1 m long. 2.   Pipes shall be able to withstand any stresses, in particular regarding corrosion and strength, which may occur under normal operating conditions on board and their characteristics and layout shall be such that they ensure a satisfactory flow of gas at the appropriate pressure to the gas-consuming appliances. 3.   Pipes shall have as few joints as possible. Both pipes and joints shall be gastight and shall remain gastight despite any vibration or expansion to which they may be subjected. 4.   Pipes shall be readily accessible, properly fixed and protected at every point where they might be subject to impact or friction, particularly where they pass through steel bulkheads or metal walls. The entire surface of steel pipes shall be treated against corrosion. 5.   Flexible pipes and their joints shall be able to withstand any stresses which may occur under normal operating conditions on board. They shall be installed in such a way that they are free of tension, cannot be heated excessively and can be inspected over their entire length.
Article 14.09

Distribution system 1.   It shall be possible to shut off the entire distribution system by means of a main valve which is at all times easily and rapidly accessible. 2.   Each gas-consuming appliance shall be supplied by a separate branch of the distribution system, and each branch shall be controlled by a separate closing device. 3.   Valves shall be fitted at points where they are protected from the weather and from impact. 4.   An inspection connection shall be fitted after each pressure regulator. It shall be ensured using a closing device that in pressure tests the pressure regulator is not exposed to the test pressure.
Article 14.10

Gas-consuming appliances and their installation 1.   The only appliances that may be installed are propane-consuming appliances approved in one of the Member States and equipped with devices that effectively prevent the escape of gas in the event of either the flame or the pilot light being extinguished. 2.   Appliances shall be so placed and connected that they cannot overturn or be accidentally moved and any risk of accidental wrenching of the connecting pipes is avoided. 3.   Heating and water-heating appliances and refrigerators shall be connected to a flue for evacuating combustion gases into the open air. 4.   The installation of gas-consuming appliances in the wheelhouse is permitted only if the wheelhouse is so constructed that no leaking gas can escape into the lower parts of the craft, in particular through the penetrations for control lines to the engine room. 5.   Gas-consuming appliances may be installed in sleeping quarters only if combustion is independent of ambient air in the quarters. 6.   Gas-consuming appliances in which combustion depends on ambient air shall be installed in rooms which are sufficiently large.
Article 14.11

Ventilation and evacuation of combustion gases 1.   In rooms containing gas-consuming appliances in which combustion depends on ambient air, fresh air shall be supplied and combustion gases evacuated by means of ventilation apertures of adequate dimensions, with a clear section of at least 150 cm2 per aperture. 2.   Ventilation apertures shall not have any closing device and shall not lead to sleeping quarters. 3.   Evacuation devices shall be so designed as to ensure the safe evacuation of combustion gases. They shall be reliable in operation and made of non-combustible materials. Their operation shall not be affected by forced ventilation.
Article 14.12

Operating and safety requirements

An operating instruction shall be affixed on board in a suitable place. It shall contain at least the following:

                     ‘The valves of receptacles not connected to the distribution system shall be closed, even if the receptacles are presumed empty’;

                     ‘Flexible pipes shall be replaced as soon as their condition so requires’;

                     ‘All gas-consuming appliances shall be connected or the corresponding connecting pipes shall be sealed’.
Article 14.13

Acceptance test

Before a liquefied gas installation is put into service, after any modification or repair and on every renewal of the attestation referred to in Article 14.15, the entire installation shall be accepted by an expert recognised by the inspection body. During the acceptance test the expert shall verify whether the installation conforms to the requirements of this Chapter. He shall submit an acceptance report to the inspection body.
Article 14.14

Tests

Tests on the installation shall be carried out under the following conditions: 1. Medium-pressure pipes between the closing device, referred to in Article 14.09 (4), of the first pressure regulator and the valves fitted before the final pressure regulator:

(a) pressure test, carried out with air, an inert gas or a liquid at a pressure 20 bar above atmospheric pressure;

(b) tightness test, carried out with air or an inert gas at a pressure 3,5 bar above atmospheric pressure. 2. Pipes at the service pressure between the closing device, referred to in Article 14.09(4), of the only pressure regulator or the final pressure regulator and the valves fitted before the gas-consuming appliances:
tightness test, carried out with air or an inert gas at a pressure of 1 bar above atmospheric pressure. 3. Pipes situated between the closing device, referred to in Article 14.09 (4), of the only pressure regulator or the final pressure regulator and the controls of gas-consuming appliances:
tightness test at a pressure of 0,15 bar above atmospheric pressure. 4. In the tests referred to in paragraphs 1(b), 2 and 3, the pipes are deemed gastight if, after sufficient time to allow for equalisation with ambient temperature, no decrease in the test pressure is observed during a further 10 minute test period. 5. Receptacle connectors, pipe joints and other fittings subjected to the pressure in the receptacles, and joints between pressure regulators and the distribution pipe:
tightness test, carried out with a foaming substance, at the service pressure. 6. All gas-consuming appliances shall be brought into service at the nominal capacity and shall be tested for satisfactory and undisturbed combustion at different capacity settings.

Flame failure devices shall be checked to ensure that they operate satisfactorily. 7. After the test referred to in paragraph 6, it shall be verified for each gas-consuming appliance connected to a flue, whether, after five minutes’ operation at the nominal capacity, with windows and doors closed and the ventilation devices in operation, any combustion gases are escaping into the room through the air intake.

If there is a more than momentary escape of such gases, the cause shall immediately be detected and remedied. The appliance shall not be approved for use until all defects have been eliminated.
Article 14.15

Attestation 1.   The Community certificate shall include an attestation to the effect that all liquefied gas installations conform to the requirements of this Chapter. 2.   The attestation will be issued by the inspection body following the acceptance test referred to in Article 14.13. 3.   The attestation shall be valid for a period not exceeding three years. It may be renewed only after a further acceptance test carried out in accordance with Article 14.13. Exceptionally, where the owner of a vessel or his representative submits a reasoned request, the inspection body may extend the validity of the attestation for not more than three months without carrying out the acceptance test referred to in Article 14.13. Such extension shall be entered in the Community certificate.

CHAPTER 15SPECIFIC REQUIREMENTS APPLICABLE TO PASSENGER VESSELS

Article 15.01

General provisions 1.   The following provisions shall not apply:

(a) Article 3.02(1)(b);

(b) Articles 4.01 to 4.03;

(c) Article 8.08(2), second sentence, and paragraph 7;

(d) Article 9.14(3), second sentence, for rated voltages of over 50V. 2.   The following items of equipment are prohibited on passenger vessels:

(a) lamps powered by liquefied gas or liquid fuel according to Article 12.07(3);

(b) vaporising oil-burner stoves according to Article 13.04;

(c) solid fuel heaters according to Article 13.07;

(d) devices fitted with wick burners according to Article 13.02(2) and (3), and

(e) liquefied gas devices according to Chapter 14. 3.   Vessels without their own power cannot be licensed for passenger transport. 4.   On passenger vessels, areas shall be provided for use by persons with reduced mobility, according to the provisions of this Chapter. If the application of provisions of this Chapter which take into account the specific safety needs of persons with reduced mobility is difficult in practice or incurs unreasonable costs, the inspection body may allow derogations from these provisions on the basis of recommendations in accordance with the procedure referred to in Article 19(2) of this Directive. These derogations shall be mentioned in the Community certificate.
Article 15.02

Vessels’ hulls 1.   In the course of the inspections referred to in Article 2.09, the thickness of the outside plating of steel passenger vessels shall be determined as follows:

(a) the minimum thickness tmin of the bottom, bilge and side plating of the outer hull of passenger vessels is determined in accordance with the larger value of the following formulae:

;

.

In these formulae:

f

=

1 + 0,0013 · (a — 500);

a

=

longitudinal or transverse frame spacing (mm), and where the frame spacing is less than 400 mm, a = 400 mm should be entered;

(b) it is permissible to fall short of the minimum value determined in accordance with (a) above for the plate thickness in cases where the permitted value has been determined and certified on the basis of a mathematical proof for the sufficient strength (longitudinal, transverse and local) of the vessel’s hull;

(c) at no point of the outside plating shall the thickness calculated in accordance with (a) or (b) above be less than 3 mm;

(d) plate renewals shall be carried out when bottom, bilge or side plate thicknesses have fallen short of the minimum value determined in accordance with (a) or (b), in conjunction with (c) above. 2.   The number and position of bulkheads shall be selected such that, in the event of flooding, the vessel remains buoyant according to Article 15.03(7) to (13). Every portion of the internal structure which affects the efficiency of the subdivision of such vessels shall be watertight, and shall be of a design which will maintain the integrity of the subdivision. 3.   The distance between the collision bulkhead and the forward perpendicular shall be at least 0,04 LWL and not more than 0,04 LWL + 2 m. 4.   A transverse bulkhead may be fitted with a bulkhead recess, if all parts of this offset lie within the safe area. 5.   The bulkheads, which are taken into account in the damaged stability calculation according to Article 15.03(7) to (13), shall be watertight and be installed up to the bulkhead deck. Where there is no bulkhead deck, these bulkheads shall extend to a height at least 20 cm above the margin line. 6.   The number of openings in these bulkheads shall be kept as low as is consistent with the type of construction and normal operation of the vessel. Openings and penetrations shall not have a detrimental effect on the watertight function of the bulkheads. 7.   Collision bulkheads shall have no openings and no doors. 8.   Bulkheads according to paragraph 5 separating the engine rooms from passenger areas or crew and shipboard personnel accommodation shall have no doors. 9.   Manually operated doors without remote control in bulkheads referred to in paragraph 5, are permitted only in areas not accessible to passengers. They shall:

(a) remain closed at all times and be opened only temporarily to allow access;

(b) be fitted with suitable devices to enable them to be closed quickly and safely;

(c) display the following notice on both sides of the doors:

                                       ‘Close door immediately after passing through’. 10.   Doors in bulkheads referred to inparagraph 5 that are open for long periods shall comply with the following requirements:

(a) They shall be capable of being closed from both sides of the bulkhead and from an easily accessible point above the bulkhead deck.

(b) After being closed by remote control the door shall be such that it can be opened again locally and closed safely. Closure shall not be impeded by carpeting, foot rails or other obstructions.

(c) The time taken for the remote-controlled closure process shall be at least 30 seconds but not more than 60 seconds.

(d) During the closure procedure an automatic acoustic alarm shall sound by the door.

(e) The door drive and alarm shall also be capable of operating independently of the on-board power supply. There shall be a device at the location of the remote control that displays whether the door is open or closed. 11.   Doors in bulkheads referred to in paragraph 5, and their actuators shall be located in the safe area. 12.   There shall be a warning system in the wheelhouse to indicate which of the doors in bulkheads referred to in paragraph 5 are open. 13.   Open-ended piping and ventilation ducts shall be offset in such a way that, in any conceivable flooding, no additional spaces or tanks are flooded through them.

(a) If several compartments are openly connected by piping or ventilation ducts, such piping and ducts shall, in an appropriate place, be lead above the waterline corresponding to the worst possible flooding.

(b) Piping need not meet the requirement under (a) if shut-off devices are fitted in the piping where it passes through the bulkheads and which can be remotely controlled from a point above the bulkhead deck.

(c) Where a pipework system has no open outlet in a compartment, the pipework shall be regarded as intact in the event of this compartment being damaged, if it runs within the safe area and is more than 0,50 m from the bottom of the vessel. 14.   Remote controls of bulkhead doors according to paragraph 10 and shut-off devices according to paragraph 13(b) above the bulkhead deck shall be clearly indicated as such. 15.   Where double bottoms are fitted, their height shall be at least 0,60 m, and where wing voids are fitted, their width shall be at least 0,60 m. 16.   Windows may be situated below the margin line if they are watertight, cannot be opened, possess sufficient strength and conform to Article 15.06(14).
Article 15.03

Stability 1.   The applicant shall prove by a calculation based on the results from the application of a standard for intact stability that the intact stability of the vessel is appropriate. All calculations shall be carried out free to trim and sinkage. 2.   The intact stability shall be proven for the following standard load conditions:

(a) at the start of the voyage:

100 % passengers, 98 % fuel and fresh water, 10 % waste water;

(b) during the voyage:

100 % passengers, 50 % fuel and fresh water, 50 % waste water;

(c) at the end of the voyage:

100 % passengers, 10 % fuel and fresh water, 98 % waste water;

(d) unladen vessel:

no passengers, 10 % fuel and fresh water, no waste water.

For all standard load conditions, the ballast tanks shall be considered as either empty or full in accordance with normal operational conditions.

As a precondition for changing the ballast whilst under way, the requirement ofparagraph 3(d) shall be proved for the following load condition:

100 % passengers, 50 % fuel and fresh water, 50 % waste water, all other liquid (including ballast) tanks are considered filled to 50 %.

If this condition cannot be met, an entry shall be made in item 52 of the Community certificate to the effect that, whilst under way, the ballast tanks can only be empty or full and that, whilst under way, the ballast conditions must not be changed. 3.   The proof of adequate intact stability by means of a calculation shall be produced using the following definitions for the intact stability and for the standard load conditions mentioned in paragraph 2(a) to (d):

(a) the maximum righting lever hmax shall occur at a heeling angle of φ

max ≥ 15° and shall not be less than 0,20 m. However, in case φ

f < φ

max the righting lever at the downflooding angle φ

f shall not be less than 0,20 m;

(b) the downflooding angle φ

f shall not be less than 15°;

(c) the area A under the curve of the righting lever shall, depending on the position of φ

f and φ

max, reach at least the following values:

Case
A

1

φ

max = 15°
0,07 m.rad to angle φ = 15°

2

15° < φ

max < 30°

φ

max ≤ φ

f

0,055+0,001 · (30- φ

max) m.rad to angle φ

max

3

15° < φ

f < 30°

φ

max > φ

f

0,055+0,001 · (30- φ f) m.rad to angle φ

f

4

φ

max≥ 30° and φ

f≥ 30°
0,055 m.rad to angle φ = 30°

Where

hmax

is the maximum lever

φ

the heeling angle

φ

f

the downflooding angle, that is the heeling angle, at which openings in the hull, in the superstructure or deck houses which cannot be closed so as to be weather tight, are immersed

φ

max

the heeling angle at which the maximum righting lever occurs

A

area beneath the curve of the righting levers

(d) the initial metacentric height, GMo, corrected by the effect of the free surfaces in liquid tanks, shall not be less than 0,15 m;

(e) in each of the following two cases the heeling angle shall not exceed 12°:

(aa)

in application of the heeling moment due to passengers and wind according to paragraphs 4 and 5;

(bb)

in application of the heeling moment due to passengers and turning according to paragraphs 4 and 6. (f) for a heeling moment resulting from moments due to passengers, wind and turning according to paragraphs 4, 5 and 6, the residual freeboard shall be not less than 200 mm;

(g) for vessels with windows or other openings in the hull located below the bulkhead decks and not closed watertight, the residual safety clearance shall be at least 100 mm on the application of the three heeling moments resulting from subparagraph (f). 4.   The heeling moment due to one-sided accumulation of persons shall be calculated according to the following formula:

Mp = g · P · y = g · ΣPi · yi (kNm)

where:

P

=

total mass of persons on board in (t), calculated by adding up the maximum permitted number of passengers and the maximum number of shipboard personnel and crew under normal operating conditions, assuming an average mass per person of 0,075 t

y

=

lateral distance of centre of gravity of total mass of persons P from centre line in (m) g

=

acceleration of gravity (g = 9,81 m/s2)

Pi

=

mass of persons accumulated on area Ai in (t) Pi

=

ni · 0,075 · Ai (t) where

Ai

=

area occupied by persons in (m2)

ni

=

number of persons per square meter

ni

4 for free deck areas and deck areas with movable furniture; for deck areas with fixed seating furniture such as benches, ni shall be calculated by assuming an area of 0,45 m in width and 0,75 m in seat depth per person

yi

=

lateral distance of geometrical centre of area Ai from centre line in (m).

The calculation shall be carried out for an accumulation of persons both to starboard and to port.

The distribution of persons shall correspond to the most unfavourable one from the point of view of stability. Cabins shall be assumed unoccupied for the calculation of the persons’ moment.

For the calculation of the loading cases, the centre of gravity of a person shall be taken as 1 m above the lowest point of the deck at 0,5 LWL, ignoring any deck curvature and assuming a mass of 0,075 t per person.

A detailed calculation of deck areas which are occupied by persons may be dispensed with if the following values are used:

P

=

1,1 · Fmax · 0,075

for day trip vessels

1,5 · Fmax · 0,075

for cabin vessels

where

Fmax

=

maximum permitted number of passengers on board

y

=

B/2 in (m). 5.   The moment due to wind pressure (Mw) shall be calculated as follows:
Mw = pw · Aw · (lw+T/2) (kNm)

where

pw

=

the specific wind pressure of 0,25 kN/m2;

Aw

=

lateral plane of the vessel above the plane of draught according to the considered loading condition in m2;

lw

=

distance of the centre of gravity of the lateral plane AW from the plane of draught according to the considered loading condition in m. 6.   The moment due to centrifugal force (Mdr), caused by the turning of the vessel, shall be calculated as follows:
Mdr = cdr · CB · v2 · D/LWL · (KG — T/2) (kNm)

where

cdr

=

a coefficient of 0,45;

CB

=

block coefficient (if not known, taken as 1,0);

v

=

maximum speed of the vessel in m/s;

KG

=

distance between the centre of gravity and the keel line in m.

For passenger vessels with propulsion systems according to Article 6.06, Mdr shall be derived from full-scale or model tests or else from corresponding calculations. 7.   The applicant shall prove, by means of a calculation based on the method of lost buoyancy, that the damaged stability of the vessel is appropriate in the event of flooding. All calculations shall be carried out free to trim and sinkage. 8.   Buoyancy of the vessel in the event of flooding shall be proven for the standard load conditions specified in paragraph 2. Accordingly, mathematical proof of sufficient stability shall be determined for the three intermediate stages of flooding (25, 50 and 75 % of flood build-up) and for the final stage of flooding. 9.   Passenger vessels shall comply with the one-compartment status and the two-compartment status.

The following assumptions concerning the extent of damage shall be taken into account in the event of flooding:
One-compartment status

Two-compartment status

Dimension of the side damage
longitudinal l (m) 1,20 + 0,07 · LWL

transverse b (m) B/5

0,59

vertical h (m) from vessel bottom to top without delimitation

Dimension of the bottom damage
longitudinal l (m) 1,20 + 0,07 · LWL

transverse b (m) B/5

vertical h (m) 0,59; pipework installed according to Article 15.02(13)(c), shall be deemed intact

(a) For one-compartment status the bulkheads can be assumed to be intact if the distance between two adjacent bulkheads is greater than the damage length. Longitudinal bulkheads at a distance of less than B/3 from the outer plating measured perpendicular to centre line from the shell plating at the maximum draught shall not be taken into account for calculation purposes.

(b) For two-compartment status each bulkhead within the extent of damage will be assumed to be damaged. This means that the position of the bulkheads shall be selected in such a way as to ensure that the passenger vessel remains buoyant after flooding of two or more adjacent compartments in the longitudinal direction.

(c) The lowest point of every non-watertight opening (e.g. doors, windows, access hatchways) shall lie at least 0,10 m above the damaged waterline. The bulkhead deck shall not be immersed in the final stage of flooding.

(d) Permeability is assumed to be 95 %. If it is proven by a calculation that the average permeability of any compartment is less than 95 %, the calculated value can be used instead.

The values to be adopted shall not be less than:

Lounges

95 %

Engine and boiler rooms

85 %

Luggage and store rooms

75 %

Double bottoms, fuel bunkers, ballast and other tanks, depending on whether, according to their intended purpose, they are to be assumed to be full or empty for the vessel floating at the plane of maximum draught

0 or 95 %

The calculation of free surface effect in intermediate stages of flooding shall be based on the gross surface area of the damaged compartments.

(e) If damage of a smaller dimension than specified above produces more detrimental effects with respect to heeling or loss of metacentric height, such damage shall be taken into account for calculation purposes. 10.   For all intermediate stages of flooding referred to in paragraph 8, the following criteria shall be met:

(a) the heeling angle j at the equilibrium position of the intermediate stage in question shall not exceed 15°;

(b) beyond the heel in the equilibrium position of the intermediate stage in question, the positive part of the righting lever curve shall display a righting lever value of GZ ≥ 0,02 m before the first unprotected opening becomes immersed or a heeling angle φ of 25° is reached;

(c) non-watertight openings shall not be immersed before the heel in the equilibrium position of the intermediate stage in question has been reached. 11.   During the final stage of flooding, the following criteria shall be met taking into account the heeling moment due to persons in accordance with paragraph 4:

(a) the heeling angle φE shall not exceed 10°;

(b) beyond the equilibrium position the positive part of the righting lever curve shall display a righting lever value of GZR ≥ 0,05 m with an area A ≥ 0,0065 mrad. These minimum values for stability shall be met until the immersion of the first unprotected opening or in any case before reaching a heeling angle φm ≤ 25°;

lever GZ [m]

φE ≤ 10°

A ≥ 0,065 mrad

GZR ≥ 0,05 m

GZk (lever due to person moment)

equilibrium in flooded condition

first unprotected opening in the water, but φm ≤ 25°

heeling angle φ [°]

equilibrium in flooded condition due to person moment

(c) non-watertight openings shall not be immersed before the equilibrium position has been reached; if such openings are immersed before this point, the rooms affording access are deemed to be flooded for damaged stability calculation purposes. 12.   The shut-off devices which shall be able to be closed watertight shall be marked accordingly. 13.   If cross-flood openings to reduce asymmetrical flooding are provided, they shall meet the following conditions:

(a) for the calculation of cross-flooding, IMO Resolution A.266 (VIII) shall be applied;

(b) they shall be self-acting;

(c) they shall not be equipped with shut-off devices;

(d) the total time allowed for compensation shall not exceed 15 minutes.
Article 15.04

Safety clearance and freeboard 1.   The safety clearance shall be at least equal to the sum of:

(a) the additional lateral immersion, which, measured on the outside plating, is produced by the permissible heeling angle according to Article 15.03(3)(e), and

(b) the residual safety clearance according to Article 15.03(3)(g).

For vessels without a bulkhead deck, the safety clearance shall be at least 500 mm. 2.   The freeboard shall be at least equal to the sum of:

(a) the additional lateral immersion, which, measured on the outside plating, is produced by the heeling angle according to Article 15.03(3)(e), and

(b) the residual freeboard according to Article 15.03(3)(f).

However, the freeboard shall be at least 300 mm. 3.   The plane of maximum draught is to be set so as to ensure compliance with the safety clearance according to paragraph 1, and the freeboard according to paragraph 2 and Articles 15.02 and 15.03. 4.   For safety reasons, the inspection body may stipulate a greater safety clearance or a greater freeboard.
Article 15.05

Maximum permitted number of passengers 1.   The inspection body shall set the maximum permitted number of passengers and shall enter this number on the Community certificate. 2.   The maximum permitted number of passengers shall not exceed any of the following values:

(a) number of passengers for whom the existence of an evacuation area according to Article 15.06(8), has been proven;

(b) number of passengers that has been taken into account for the stability calculation according to Article 15.03;

(c) number of available berths for passengers on cabin vessels used for voyages including overnight stays. 3.   For cabin vessels which are also used as day trip vessels, the number of passengers shall be calculated for use both as a day trip vessel and as a cabin vessel and entered on the Community certificate. 4.   The maximum permitted number of passengers shall be displayed on clearly legible and prominently positioned notices on board the vessel.
Article 15.06

Passenger rooms and areas 1.   Passenger rooms shall:

(a) on all decks, be located aft of the level of the collision bulkhead and, as long as they are below the bulkhead deck, forward of the level of the aft-peak bulkhead, and

(b) be separated from the engine and boiler rooms in a gas-tight manner;

(c) be so arranged, that sight lines in accordance with Article 7.02 do not pass through them. 2.   Cupboards and rooms referred to in Article 11.13 and intended for the storage of flammable liquids shall be outside the passenger area. 3.   The number and width of the exits of passenger rooms shall comply with the following requirements:

(a) rooms or groups of rooms designed or arranged for 30 or more passengers or including berths for 12 or more passengers shall have at least two exits. On day trip vessels one of these two exits can be replaced by two emergency exits;

(b) if rooms are located below the bulkhead deck, one of the exits can be a watertight bulkhead door, according to Article 15.02(10), leading into an adjacent compartment from which the upper deck can be reached directly. The other exit shall lead directly or, if permitted in accordance with (a), as an emergency exit into the open air, or to the bulkhead deck. This requirement does not apply to individual cabins;

(c) exits according to (a) and (b) shall be suitably arranged and shall have a clear width of at least 0,80 m and also a clear height of at least 2,00 m. For doors of passenger cabins and other small rooms, the clear width can be reduced to 0,70 m;

(d) in the case of rooms or groups of rooms intended for more than 80 passengers the sum of the widths of all exits intended for passengers and which shall be used by them in an emergency shall be at least 0,01 m per passenger;

(e) if the total width of the exits is determined by the number of passengers, the width of each exit shall be at least 0,005 m per passenger;

(f) emergency exits shall have a shortest side at least 0,60 m long or a minimum diameter of 0,70 m. They shall open in the direction of escape and be marked on both sides;

(g) exits of rooms intended for use by persons with reduced mobility shall have a clear width of at least 0,90 m. Exits normally used for embarking and disembarking people with reduced mobility shall have a clear width of at least 1,50 m. 4.   Doors of passenger rooms shall comply with the following requirements:

(a) with the exception of doors leading to connecting corridors, they shall be capable of opening outwards or be constructed as sliding doors;

(b) cabin doors shall be made in such a way that they can also be unlocked from the outside at any time;

(c) powered doors shall open easily in the event of failure of the power supply to this mechanism;

(d) for doors intended for use by persons with reduced mobility, there shall be from the direction from which the door opens, a minimum clearance of 0,60 m between the inner edge of the doorframe on the lock side and an adjacent perpendicular wall. 5.   Connecting corridors shall comply with the following requirements:

(a) they shall have a clear width of at least 0,80 m or, if they lead to rooms used by more than 80 passengers, at least 0,01 m per passenger;

(b) their clear height shall be not less than 2,00 m;

(c) connecting corridors intended for use by persons with reduced mobility shall have a clear width of 1,30 m. Connecting corridors more than 1,50 m wide shall have handrails on either side;

(d) where a part of the vessel or a room intended for passengers is served by a single connecting corridor, the clear width thereof shall be at least 1,00 m;

(e) connecting corridors shall be free of steps;

(f) they shall lead only to open decks, rooms or staircases;

(g) dead ends in connecting corridors shall be not longer than two meters. 6.   In addition to the provisions of paragraph 5, escape routes shall also comply with the following requirements:

(a) stairways, exits and emergency exits shall be so disposed that, in the event of a fire in any given area, the other areas may be evacuated safely;

(b) the escape routes shall lead by the shortest route to evacuation areas according toparagraph 8;

(c) escape routes shall not lead through engine rooms or galleys;

(d) there shall be no rungs, ladders or the like installed at any point along the escape routes;

(e) doors to escape routes shall be constructed in such a way as not to reduce the minimum width of the escape route referred to in paragraph 5(a) or (d);

(f) escape routes and emergency exits shall be clearly signed. The signs shall be lit by the emergency lighting system. 7.   Escape routes and emergency exits shall have a suitable safety guidance system. 8.   For all persons on board, there shall be muster areas available which satisfy the following requirements:

(a) the total area of the muster areas in m2 shall correspond to at least the value produced by the following formulae:

Day trip vessels

:

AS = 0,35 · Fmax (m2)

Cabin vessels

:

AS = 0,45 · Fmax (m2)

In these formulae the following definition applies:

Fmax

maximum permitted number of passengers on board;

(b) each individual muster or evacuation area shall be larger than 10 m2;

(c) the muster areas shall be clear of furniture, whether movable or fixed;

(d) if movable furniture is located in a room in which muster areas are defined, it shall be secured appropriately to avoid slipping;

(e) life-saving appliances shall be easily accessible from the evacuation areas;

(f) it shall be possible to evacuate people safely from these evacuation areas, using either side of the vessel;

(g) the muster areas shall lie above the margin line;

(h) the muster and evacuation areas are to be shown as such in the safety plan and signposted on board the vessel;

(i) if fixed seats or benches are located in a room in which muster areas are defined the corresponding number of persons need not be taken into account when calculating the total area of muster areas according to (a). However, the number of persons for whom fixed seats or benches in a certain room are taken into account must not exceed the number of persons for whom muster areas are available in this room;

(j) the provisions of (d) and (i) shall also apply to free decks on which muster areas are defined;

(k) if collective life-saving appliances complying with Article 15.09( 5), are available on board, the number of persons for whom such appliances are available may be disregarded when calculating the total surface area of the muster areas referred to in (a);

(l) however, in all cases where reductions according to (i) to (k) are applied, the total area according to (a) shall be sufficient for at least 50 % of the maximum permitted number of passengers. 9.   Stairs and their landings in the passenger areas shall comply with the following requirements:

(a) they shall be constructed in accordance with European standard EN 13056: 2000;

(b) they shall have a clear width of at least 0,80 m or, if they lead to connecting corridors or areas used by more than 80 passengers, at least 0,01 m per passenger;

(c) they shall have a clear width of at least 1,00 m if they provide the only means of access to a room intended for passengers;

(d) where there is not at least one staircase on each side of the vessel in the same room, they shall lie in the safe area;

(e) in addition, stairs intended for use by persons with reduced mobility shall comply with the following requirements:

(aa)

The gradient of the stairs shall not exceed 38°;

(bb)

The stairs shall have a clear width of at least 0,90 m;

(cc) Spiral staircases are not allowed;

(dd) The stairs shall not run in a direction transverse to the vessel;

(ee)

The handrails of the stairs shall extend approximately 0,30 m beyond the top and bottom of the stairs without restricting traffic routes;

(ff)

Handrails, front sides of at least the first and the last step as well as the floor coverings at the ends of the stairs shall be colour highlighted.

Lifts intended for persons with reduced mobility, and lifting equipment, like stairlifts or lifting platforms, shall be constructed according to a relevant standard or a regulation of a Member State. 10.   Parts of the deck intended for passengers, and which are not enclosed, shall comply with the following requirements:

(a) they shall be surrounded by a fixed bulwark or guard rail at least 1,00 m high or a railing according to the European standard EN 711: 1995, construction type PF, PG or PZ. Bulwarks and railings of decks intended for use by persons with reduced mobility shall be at least 1,10 m high;

(b) openings and equipment for embarking or disembarking and also openings for loading or unloading shall be such that they can be secured and have a clear width of at least 1,00 m. Openings, used normally for the embarking or disembarking of persons with reduced mobility, shall have a clear width of at least 1,50 m;

(c) if the openings and equipment for embarking or disembarking cannot be observed from the wheelhouse, optical or electronic aids shall be provided;

(d) passengers sitting down shall not interrupt sight lines in accordance with Article 7.02. 11.   The parts of the vessel not intended for passengers, in particular access to the wheelhouse, to the winches and to the engine rooms, shall be such that they can be secured against unauthorised entry. At any such access, a symbol corresponding to Figure 1 in Appendix I shall be displayed in a prominent position. 12.   Gangways shall be constructed in accordance with European standard EN 14206: 2003. By way of derogation from Article 10.02( 2)(d), their length can be less than 4 m. 13.   Traffic areas intended for use by persons with reduced mobility shall have a clear width of 1,30 m and be free of doorsteps and sills more than 0,025 m high. Walls in traffic areas intended for use by persons with reduced mobility shall be equipped with handrails at a height of 0,90 m above the floor. 14.   Glass doors and walls in traffic areas and also window panes shall be manufactured from pre-stressed glass or laminated glass. They may also be made from a synthetic material, provided this is authorised for use in a fire-protection context.

Transparent doors and transparent walls extending as far as the floor in traffic areas shall be prominently marked. 15.   Superstructures or their roofs consisting completely of panoramic panes shall only be manufactured from materials which, in the event of an accident, reduce as much as possible the risks of injury to the persons on board. 16.   Potable water systems shall, at least, comply with the requirements of Article 12.05. 17.   There shall be toilets available for passengers. At least one toilet shall be fitted for use by persons with reduced mobility according to a relevant standard or a regulation of a Member State and shall be accessible from areas intended for use by persons with reduced mobility. 18.   Cabins without an opening window shall be connected to a ventilation system. 19.   By analogy, rooms in which crew members or shipboard personnel are accommodated shall comply with the provisions of this Article.
Article 15.07

Propulsion system

In addition to the main propulsion system, vessels shall be equipped with a second independent propulsion system so as to ensure that, in the event of a breakdown affecting the main propulsion system, the vessel can continue to make steerageway under its own power.

The second independent propulsion system shall be placed in a separate engine room. If both engine rooms have common partitions, these shall be built according to Article 15.11 (2).
Article 15.08

Safety devices and equipment 1.   All passenger vessels shall have internal communication facilities according to Article 7.08. Such facilities shall also be available in the operation rooms and, where there is no direct communication from the wheelhouse, in the access and evacuation areas for passengers as referred to in Article 15.06(8). 2.   All passenger areas shall be reachable via a loudspeaker system. The system shall be designed in such a way as to ensure that the information transmitted can be clearly distinguished from background noise. Loudspeakers are optional where direct communication between the wheelhouse and the passenger area is possible. 3.   The vessel shall be equipped with an alarm system. The system shall include:

(a) an alarm system enabling passengers, crew members and shipboard personnel to alert the vessel’s command and crew.

This alarm should be given only in areas assigned to the vessel’s command and to the crew; it should only be possible for the vessel’s command to stop the alarm. The alarm shall be capable of being triggered from at least the following places:

(aa)

in each cabin;

(bb)

in the corridors, lifts and stairwells, with the distance to the nearest trigger not exceeding 10 m and with at least one trigger per watertight compartment;

(cc) in lounges, dining rooms and similar recreation rooms;

(dd) in toilets, intended for use by persons with reduced mobility;

(ee)

in engine rooms, galleys and similar rooms where there is a fire risk;

(ff)

in the cold-storage rooms and other store rooms.

The alarm triggers shall be installed at a height above the floor of 0,85 m to 1,10 m;

(b) an alarm system enabling the vessel’s command to alert passengers.

This alarm shall be clearly and unmistakably audible in all rooms accessible to passengers. It shall be capable of being triggered from the wheelhouse and from a location that is permanently staffed;

(c) an alarm system enabling the vessel’s command to alert the crew and shipboard personnel.

The alarm system referred to in Article 7.09(1), shall also reach the recreation rooms for the shipboard personnel, the cold-storage rooms and other store rooms.

Alarm triggers shall be protected against unintentional use. 4.   Each watertight compartment shall be fitted with a bilge level alarm. 5.   Two motor-driven bilge pumps shall be provided. 6.   A permanently installed drainage system according to Article 8.08(4), shall be provided on board. 7.   Cold-storage room doors, even when locked, shall also be capable of being opened from the inside. 8.   Where CO2 bar-systems are situated in rooms below deck these rooms shall be fitted with an automatic ventilation system which turns itself on automatically when the door or hatch to the room is opened. The ventilation ducts shall run down to 0,05 m from the floor of this room. 9.   In addition to the first-aid kit according to Article 10.02(2)(f), further first-aid kits shall be provided in sufficient number. The first-aid kits and their storage shall comply with the requirements set out in Article 10.02(2)(f).
Article 15.09

Life-saving equipment 1.   In addition to the lifebuoys specified in Article 10.05(1), all parts of the deck intended for passengers and not enclosed shall be equipped with lifebuoys in accordance with the European standard EN 14144: 2003 on both sides of the vessel, positioned not more than 20 m apart.

Half of all the prescribed lifebuoys shall be fitted with a buoyant cord at least 30 m long with a diameter of 8 to 11 mm. The other half of the prescribed lifebuoys shall be fitted with a self-igniting, battery-powered light which will not be extinguished in water. 2.   In addition to the lifebuoys referred to in paragraph 1, the following equipment shall be available and ready for use:

(a) individual life-saving equipment according to Article 10.05(2), for shipboard personnel responsible for undertaking duties according to the safety rota;

(b) individual life-saving equipment according to European standard EN 395: 1998 or EN 396: 1998 for other shipboard personnel. 3.   Passenger vessels shall have appropriate equipment to enable persons to be transferred safely to shallow water, to the bank or to another craft. 4.   In addition to the life-saving equipment referred to in paragraphs 1 and 2, individual life-saving equipment according to European standard EN 395: 1998 or EN 396: 1998 shall be available for 100 % of the maximum permitted number of passengers.

Where individual life-saving equipment as referred to in the first paragraph is not also suitable for children, individual life-saving equipment according to European standard EN 395: 1998 for children weighing not more than 30 kg shall be available for 10 % of the maximum number of permitted passengers. 5.   The term ‘collective life-saving equipment’ covers ship’s boats according to Article 10.04, and life rafts.

Life rafts shall:

(a) bear a notice indicating their purpose and the number of persons for whom they are approved;

(b) offer adequate seating space for the permitted number of persons;

(c) provide a buoyancy of at least 750 N per person in fresh water;

(d) be provided with a rope linked to the passenger vessel to prevent them drifting away;

(e) be made of suitable materials and be resistant to oil, oil products and temperatures up to 50 °C;

(f) assume and maintain a stable trim and, in this respect, be fitted with appropriate devices enabling them to be grabbed by the indicated number of persons;

(g) be fluorescent orange in colour or have fluorescent surfaces, visible from all sides, of at least 100 cm2;

(h) be such that they can be released from their stowed position and put overboard quickly and safely by one person, or can float free from their stowed position;

(i) be provided with appropriate means of evacuation from the evacuation areas referred to in Article 15.06(8), onto the life rafts if the vertical distance between the deck of the evacuation areas and the plane of maximum draught is greater than 1 m. 6.   Additional collective life-saving appliances are items of life-saving equipment which ensure the buoyancy of several persons in the water. These shall:

(a) bear a notice indicating their purpose and the number of persons for whom they are approved;

(b) provide a buoyancy of at least 100 N per person in fresh water;

(c) be made of suitable materials and be resistant to oil, oil products and to temperatures of up to 50 °C;

(d) assume and maintain a stable trim and, in this respect, be fitted with appropriate devices enabling them to be grabbed by the indicated number of persons;

(e) be fluorescent orange in colour or have fluorescent surfaces, visible from all sides, of at least 100 cm2;

(f) be such that they can be released from their stowed position and put overboard quickly and safely by one person, or can float free from their stowed position. 7.   Inflatable collective life-saving appliances shall in addition:

(a) comprise at least two separate air compartments;

(b) inflate automatically or by manual command when launched;

(c) assume and maintain a stable trim irrespective of the load to be supported, even when only half the air compartments are inflated. 8.   The life-saving appliances shall be stowed on board in such a way that they can be reached easily and safely when required. Concealed storage places shall be clearly marked. 9.   Life-saving equipment shall be checked according to the manufacturer’s instructions. 10.   The ship’s boat shall be equipped with an engine and a searchlight. 11.   A suitable stretcher shall be available.
Article 15.10

Electrical Equipment 1.   Only electrical equipment shall be permitted for lighting. 2.   Article 9.16(3), shall also apply additionally for passageways and recreation rooms for passengers. 3.   For the following rooms and locations, adequate lighting and emergency lighting shall be provided:

(a) locations where life-saving equipment is stored and where such equipment is normally prepared for use;

(b) escape routes, access for passengers, including gangways, entrances and exits, connecting corridors, lifts and accommodation area companionways, cabin areas and accommodation areas;

(c) markings on the escape routes and emergency exits;

(d) in other areas intended for use by persons with reduced mobility;

(e) operation rooms, engine rooms, steering equipment rooms and their exits;

(f) wheelhouse;

(g) emergency power supply room;

(h) points at which extinguishers and fire extinguishing equipment controls are located;

(i) areas in which passengers, shipboard personnel and crew muster in the event of danger. 4.   There shall be an emergency power plant, consisting of an emergency power source and emergency switchboard, which, in the event of a failure of the supply to the following electrical equipment, can immediately take over as their replacement supply, where the equipment does not have its own power source:

(a) signal lights;

(b) audible warning devices;

(c) emergency lighting in accordance with paragraph 3;

(d) radiotelephone installations;

(e) alarm, loudspeaker and on-board message communications systems;

(f) searchlights according to Article 10.02(2)(i);

(g) fire alarm system;

(h) other safety equipment such as automatic pressurised sprinkler systems or fire extinguishing pumps;

(i) lifts and lifting equipment within the meaning of Article 15.06 (9), second sentence. 5.   The light fittings for the emergency lighting shall be marked as such. 6.   The emergency power plant shall be installed outside the main engine room, outside the rooms housing the power sources referred to in Article 9.02(1), and outside the room where the main switchboard is located; it shall be separated from these rooms by partitions according to Article 15.11(2).

Cables feeding the electrical installations in the event of an emergency shall be installed and routed in such a way as to maintain the continuity of supply of these installations in the event of fire or flooding. These cables shall never be routed through the main engine room, galleys or rooms where the main power source and its connected equipment is installed, except insofar as it is necessary to provide emergency equipment in such areas.

The emergency power plant shall be installed above the margin line. 7.   The following are admissible for use as an emergency power source:

(a) auxiliary generator sets with their own independent fuel supply and independent cooling system which, in the event of a power failure, turn on and take over the supply of power within 30 seconds automatically or, if they are located in the immediate vicinity of the wheelhouse or any other location permanently manned by crew members, can be turned on manually;, or

(b) accumulator batteries, which, in the event of a power failure, turn on automatically or, if they are located in the immediate vicinity of the wheelhouse or any other location permanently manned by crew members, can be turned on manually. They shall be capable of powering the abovementioned power consumers throughout the prescribed period without recharging and without an unacceptable voltage reduction. 8.   The projected operating period for the emergency power supply is to be defined according to the defined purpose of the passenger vessel. It shall not be less than 30 minutes. 9.   The insulation resistances and the earthing for electrical systems shall be tested on the occasion of inspections according to Article 2.09. 10.   The power sources according to Article 9.02(1), shall be independent of each other. 11.   A failure of the main or emergency power equipment shall not mutually affect the operational safety of the installations.
Article 15.11

Fire protection 1.   The suitability for fire protection of materials and components shall be established by an accredited test institution on the basis of appropriate test methods.

(a) The test institution shall satisfy:

(aa)

the Code for Fire Test Procedures; or

(bb)

European standard EN ISO/IEC 17025: 2000 concerning the general requirements for the competence of testing and calibration laboratories.

(b) The recognised test methods for determining the non-flammability of materials are:

(aa)

Annex 1, Part 1, of the Code for Fire Test Procedures; and

(bb)

the equivalent regulations of one of the Member States.

(c) The recognised test methods for determining that a material is flame-retardant are:

(aa)

the respective requirements laid down in Annex 1, Parts 5 (Surface flammability test), 6 (Test for the deck coverings), 7 (Test for hanging textiles and plastics), 8 (Test for upholstered furniture) and 9 (Test for components of bedding) of the Code for Fire Test Procedures; and

(bb)

the equivalent regulations of one of the Member States.

(d) The recognised test methods for determining fire resistance are:

(aa)

IMO Resolution A.754 (18); and

(bb)

the equivalent regulations of one of the Member States. 2.   Partitions between rooms shall be designed in accordance with the following tables:

Table for partitions between rooms, in which no pressurised sprinkler systems according to Article 10.03a are installed

Rooms

Control centres

Stairwells

Muster areas

Lounges

Engine rooms

Galleys

Store rooms

Control centres

–

A0

A0/B15 (6) A30

A60

A60

A60

Stairwells
–

A0

A30

A60

A60

A60

Muster areas

–

A30/B15 (7) A60

A60

A60

Lounges
-/B15 (8) A60

A60

A60

Engine rooms

A60/A0 (9) A60

A60

Galleys
A0

A60/B15 (10) Store rooms

–

Table for partitions between rooms, in which pressurised sprinkler systems according to Article 10.03a are installed

Rooms

Control centres

Stairwells

Muster areas

Lounges

Engine rooms

Galleys

Store rooms

Control centres

–

A0

A0/B15 (11) A0

A60

A60

A30

Stairwells
–

A0

A0

A60

A30

A0

Muster areas

–

A30/B15 (12) A60

A60

A60

Lounges
-/B0 (13) A60

A30

A0

Engine rooms

A60/A0 (14) A60

A60

Galleys
–

B15

Store rooms

–

(a) Type A partitions are bulkheads, walls and decks which satisfy the following requirements:

(aa)

They are made of steel or of another equivalent material;

(bb)

They are appropriately stiffened;

(cc) They are insulated with an approved non-combustible material such that the average temperature on the side facing away from the fire rises to not more than 140 °C above the initial temperature and at no point, including the gaps at the joints, does a temperature increase of more than 180 °C above the initial temperature occur within the following specified periods:

Type A60

60 minutes

Type A30

30 minutes

Type A0

0 minutes;

(dd) they are constructed in such a way as to prevent the transmission of smoke and flames until the end of the one-hour normal fire test;

(b) type B partitions are bulkheads, walls, decks, ceilings or facings that meet the following requirements:

(aa)

they are made of an approved non-combustible material. Furthermore, all materials used in the manufacture and assembly of partitions shall be non-combustible, except for the facing, which shall be at least flame retardant;

(bb)

they demonstrate an insulation value such that the average temperature on the side facing away from the fire rises to not more than 140 °C above the initial temperature and at no point, including the gaps at the joints, does a temperature increase of more than 225 °C above the initial temperature occur within the following specified periods:

Type B15

15 minutes

Type B0

0 minutes.

(cc) they are constructed in such a way as to prevent the transmission of flames until the end of the first half hour of the normal fire test;

(c) the inspection body may, in accordance with the Code for Fire Test Procedures, prescribe a test on a sample partition in order to ensure compliance with the above provisions on resistivity and temperature increase. 3.   Paints, lacquers and other surface treatment products as well as deck coverings used in rooms except engine rooms and store rooms shall be flame-retardant. Carpets, fabrics, curtains and other hanging textile materials as well as upholstered furniture and components of bedding shall be flame-retardant if the rooms in which they are located are not equipped with a pressurised sprinkler system according to Article 10.03a. 4.   Lounge ceilings and wall claddings, including their substructures, shall, where these lounges do not have a pressurised sprinkler system according to Article 10.03a, be manufactured from non-combustible materials with the exception of their surfaces, which shall be at least flame-retardant. 5.   Furniture and fittings in lounges which serve as muster areas shall, where the rooms do not have a pressurised sprinkler system according to Article 10.03a, be manufactured from non-combustible materials. 6.   Paints, lacquers and other materials used on exposed internal areas shall not produce excessive amounts of smoke or toxic substances. This shall be proven in accordance with the Code for Fire Test Procedures. 7.   Insulation materials in lounges shall be non-combustible. This does not apply to insulations used on coolant-carrying pipes. The surfaces of the insulation materials used on these pipes shall be at least flame-retardant. 8.   Doors in partitions according to paragraph 2 shall satisfy the following requirements:

(a) they shall satisfy the same requirements set out in paragraph 2 as the partitions themselves;

(b) they shall be self-closing in the case of doors in partition walls according toparagraph 10 or in the case of enclosures around engine rooms, galleys and stairwells;

(c) self-closing doors which remain open in normal operation shall be such that they can be closed from a location permanently manned by shipboard personnel or crew members; Once a door has been remotely closed, it shall be possible to reopen and close it safely on the spot;

(d) watertight doors according to Article 15.02 need not be insulated. 9.   Walls according to paragraph 2 shall be continuous from deck to deck or end at continuous ceilings, which satisfy the same requirements as referred to in paragraph 2. 10.   The following passenger areas shall be divided by vertical partitions as referred to in paragraph 2:

(a) passenger areas with a total surface area of more than 800 m2;

(b) passenger areas in which there are cabins, at intervals of not more than 40 m.

The vertical partitions shall be smoke-tight under normal operating conditions and shall be continuous from deck to deck. 11.   Hollows above ceilings, beneath floors and behind wall claddings shall be separated at intervals of not more than 14 m by non-combustible draught stops which, even in the event of fire, provide an effective fireproof seal. 12.   Stairs shall be made of steel or another equivalent non-combustible material. 13.   Internal stairs and lifts shall be encapsulated at all levels by walls according to paragraph 2. The following exceptions are permissible:

(a) a staircase connecting only two decks does not need to be encapsulated, if on one of the decks the staircase is enclosed according to paragraph 2;

(b) in a lounge, stairs need not be encapsulated if they are located entirely within the interior of this room, and

(aa)

if this room extends over only two decks, or

(bb)

if there is a pressurised sprinkler system according to Article 10.03a installed in this room on all decks, this room has a smoke extraction system according to paragraph 16 and the room has access on all decks to a stairwell. 14.   Ventilation systems and air supply systems shall satisfy the following requirements:

(a) they shall be designed in such a way as to ensure that they themselves do not cause the spread of fire and smoke;

(b) openings for air intake and extraction and air supply systems shall be such that they can be closed off;

(c) ventilation ducts shall be made from steel or an equivalent non-combustible material and be securely connected to each other and to the superstructure of the vessel;

(d) when ventilation ducts with a cross-section of more than 0,02 m2 are passed through partitions according to paragraph 2 of Type A or partitions according to paragraph 10, they shall be fitted with automatic fire dampers which can be operated from a location permanently manned by shipboard personnel or crew members;

(e) ventilation systems for galleys and engine rooms shall be separated from ventilation systems which supply other areas;

(f) air extraction ducts shall be provided with lockable openings for inspection and cleaning. These openings shall be located close to the fire dampers;

(g) built-in ventilators shall be such that they can be switched off from a central location outside the engine room. 15.   Galleys shall be fitted with ventilation systems and stoves with extractors. The air extraction ducts of the extractors shall satisfy the requirements according to paragraph 14 and, additionally, be fitted with manually operated fire dampers at the inlet openings. 16.   Control centres, stairwells and internal evacuation areas shall be fitted with natural or mechanical smoke extraction systems. Smoke extraction systems shall satisfy the following requirements:

(a) they shall offer sufficient capacity and reliability;

(b) they shall comply with the operating conditions for passenger vessels;

(c) if smoke extraction systems also serve as general ventilators for the rooms, this shall not hinder their function as smoke extraction systems in the event of a fire;

(d) smoke extraction systems shall have a manually operated triggering device;

(e) mechanical smoke extraction systems shall additionally be such that they can be operated from a location permanently manned by shipboard personnel or crew members;

(f) natural smoke extraction systems shall be fitted with an opening mechanism, operated either manually or by a power source inside the extraction system;

(g) manually operated triggering devices and opening mechanisms shall be accessible from inside or outside the room being protected. 17.   Lounges not constantly supervised by shipboard personnel or crew members, galleys, engine rooms and other rooms presenting a fire risk shall be connected to an appropriate fire alarm system. The existence of a fire and its exact whereabouts shall be automatically displayed at a location permanently manned by shipboard personnel or crew members.
Article 15.12

Fire-fighting 1.   In addition to the portable extinguishers according to Article 10.03, at least the following portable extinguishers shall be available on board:

(a) one portable extinguisher for every 120 m2 of gross floor area in passenger areas;

(b) one portable extinguisher per group of 10 cabins, rounded upwards;

(c) one portable extinguisher in each galley and in the vicinity of any room in which flammable liquids are stored or used. In galleys the extinguishing agent shall also be suitable for fighting fat fires.

These additional fire extinguishers shall meet the requirements laid down in Article 10.03, paragraph 2, and be installed and distributed on the vessel so that, in the event of a fire starting at any point and at any time, a fire extinguisher can be reached immediately. In every galley and also in hairdressing salons and perfumeries, there shall be a fire blanket to hand. 2.   Passenger vessels shall be provided with a hydrant system consisting of:

(a) two motor-driven fire extinguishing pumps of sufficient capacity, at least one of which is permanently installed;

(b) one fire extinguisher line with a sufficient number of hydrants with permanently connected fire hoses at least 20 m in length and fitted with a nozzle capable of producing both a mist and a jet of water and incorporating a shut-off facility. 3.   Hydrant systems shall be designed and dimensioned in such a way that:

(a) any point of the vessel can be reached from at least two hydrants in different places, each with a single hose length of not more than 20 m;

(b) the pressure at the hydrants is at least 300 kPa; and

(c) on all decks a water jet length of at least 6 m can be attained.

If a hydrant chest is provided, an ‘extinguisher hose’ symbol similar to that shown in Figure 5 in Appendix I, of at least 10 cm side length, shall be affixed to the outside of the chest. 4.   Hydrant valves with screw threads or cocks shall be such that they can be set so that each of the fire hoses can be separated and removed during operation of the fire extinguishing pumps. 5.   Fire extinguisher hoses in the internal area shall be rolled up on an axially connected reel. 6.   Materials for fire-fighting equipment shall either be heat-resistant or shall be suitably protected against failure to work when subjected to high temperatures. 7.   Pipes and hydrants shall be arranged in such a way that the possibility of freezing is avoided. 8.   The fire extinguishing pumps shall:

(a) be installed or housed in separate rooms;

(b) be such that they can be operated independently of each other;

(c) each be capable, on all decks, of maintaining the necessary pressure at the hydrants and achieving the requisite length of water jet;

(d) be installed forward of the aft bulkhead.

Fire extinguishing pumps may also be used for general purposes. 9.   Engine rooms shall be fitted with a permanently fitted fire extinguishing system according to Article 10.03b. 10.   On cabin vessels there shall be:

(a) two self-contained breathing apparatus sets corresponding to European standard EN 137: 1993 with full-face masks corresponding to European standard EN 136: 1998;

(b) two sets of equipment consisting of at least a protective suit, helmet, boots, gloves, axe, crowbar, torch and safety-line, and

(c) four smoke hoods.
Article 15.13

Safety organisation 1.   A safety rota shall be provided on board passenger vessels. The safety rota describes the duties of the crew and the shipboard personnel in the following eventualities:

(a) breakdown;

(b) fire on board;

(c) evacuation of passengers;

(d) person overboard.

Specific safety measures for persons with reduced mobility shall be taken into consideration.

The crew members and shipboard personnel designated in the safety rota should be assigned their various duties, depending on the posts they occupy. Special instructions to the crew shall ensure that, in the event of danger, all doors and openings in the watertight bulkheads referred to in Article 15.02 will be hermetically closed immediately. 2.   The safety rota includes a safety plan, in which at least the following are clearly and precisely designated:

(a) areas intended for use by persons with reduced mobility;

(b) escape routes, emergency exits and muster and evacuation areas as referred to in Article 15.06(8);

(c) life-saving equipment and ship’s boats;

(d) fire extinguishers and fire extinguishing and pressurised sprinkler systems;

(e) other safety equipment;

(f) the alarm system referred to in Article 15.08(3)(a);

(g) the alarm system referred to in Article 15.(3)(b) and (c);

(h) the bulkhead doors referred to in Article 15.02(5), and the position of their controls, as well as the other openings referred to in Article 15.02(9), (10) and (13), and Article 15.03(12);

(i) doors referred to in Article 15.11(8);

(j) fire dampers;

(k) fire alarm system;

(l) emergency power plant;

(m) ventilation system control units;

(n) shore connections;

(o) fuel line shut-offs;

(p) liquefied gas installations;

(q) public address systems;

(r) radiotelephone equipment;

(s) first-aid kits. 3.   The safety rota according to paragraph 1 and the safety plan according to paragraph 2 shall:

(a) be duly stamped by the inspection body, and

(b) be prominently displayed at an appropriate point on each deck. 4.   A code of conduct for passengers shall be posted up in each cabin and also a simplified safety plan containing only the information referred to in paragraph 2(a) to (f).

This code of conduct shall include at least:

(a) designation of emergencies

—

fire,

—

flooding,

—

general hazard;

(b) description of the various alarm signals;

(c) instructions concerning the following:

—

escape routes,

—

what to do,

—

need to keep calm;

(d) instructions concerning the following:

—

smoking,

—

use of fire and naked flame,

—

opening windows,

—

use of certain items of equipment.

These details shall be posted up in Dutch, English, French and German.
Article 15.14

Waste water collection and disposal facilities 1.   Passenger vessels shall be equipped with waste water collecting tanks or appropriate on-board sewage treatment systems. 2.   Waste water collection tanks shall have sufficient capacity. Tanks shall be fitted with a device to indicate their content level. There shall be on-board pumps and pipes for emptying the tanks, whereby waste water can be passed from both sides of the vessel. It shall be possible to pass waste water from other vessels through.

The pipes shall be fitted with a discharge connection according to European standard EN 1306: 1996. 

Article 15.15

Derogations for certain passenger vessels 1.   As an alternative to proving adequate stability after damage according to Article 15.03(7) to (13), passenger vessels with a length of not more than 25 m and authorised to carry up to a maximum of 50 passengers shall comply with the following criteria:

(a) after symmetrical flooding, the immersion of the vessel shall not exceed the margin line; and

(b) the metacentric height GMR shall not be less than 0,10 m.

The necessary residual buoyancy shall be assured through the appropriate choice of material used for the construction of the hull or by means of highly cellular foam floats, solidly attached to the hull. In the case of vessels with a length of more than 15 m, residual buoyancy can be ensured by a combination of floats and subdivision complying with the 1-compartment status according to in Article 15.03. 2.   For passenger vessels in accordance with paragraph1 the inspection body may permit minor derogations from the clear height required in Article 15.06(3)(c) and paragraph 5(b). The derogation shall not be more than 5 %. In the case of derogations the relevant parts shall be indicated by colour. 3.   By way of derogation from Article 15.03(9), passenger vessels not exceeding 45 m in length and authorised to carry up to a maximum of 250 passengers do not need to have two-compartment status. 4.   (Left void) 5.   The inspection body may waive the application of Article 10.04 in the case of passenger vessels authorised to carry up to a maximum of 250 passengers and with a length of not more than 25 m, provided they are equipped with a platform, accessible from each side of the vessel, directly above the waterline, so as to enable persons to be recovered safely from the water. Passenger vessels may be equipped with a comparable installation, subject to the following conditions:

(a) one person alone shall be able to operate the installation;

(b) mobile installations are allowed;

(c) the installations shall be outside the danger area of the propulsion systems; and

(d) effective communication shall be possible between the boatmaster and the person in charge of the installation. 6.   The inspection body may waive the application of Article 10.04 in the case of passenger vessels authorised to carry up to a maximum of 600 passengers and with a length of not more than 45 m, provided they are equipped with a platform according to paragraph 5, first sentence, or with an equivalent installation according to paragraph 5, second sentence. In addition, the passenger vessel shall have:

(a) a rudder propeller, a cycloidal propeller or a water jet as main propulsion, or

(b) a main propulsion system with two propulsion units, or

(c) a main propulsion system and a bow-thruster. 7.   By way of derogation from Article 15.02(9), passenger vessels not exceeding 45 m in length and authorised to carry at most a number of passengers corresponding to the length of the vessel in metres are allowed to have on board, in the passenger area, a manually controlled bulkhead door without remote control according to Article 15.02(5), if:

(a) the vessel has only one deck;

(b) this door is accessible directly from the deck and is not more than 10 m away from the deck;

(c) the lower edge of the door opening lies at least 30 cm above the floor of the passenger area, and

(d) each of the compartments divided by the door is fitted with a bilge level alarm. 8.   On passenger vessels in accordance with paragraph 7, by way of derogation from Article 15.06(6)(c), one escape route may lead through a galley, as long as there is a second escape route available. 9.   For passenger vessels with a length not exceeding 45 m the following shall not apply: Article 15.01( 2)(e), when the liquefied gas installations are fitted with appropriate alarm systems for CO concentrations posing a health risk and for potentially explosive mixtures of gas and air. 10.   The following provisions shall not apply to passenger vessels not exceeding 25 m in length:

(a) Article 15.04(1), last sentence;

(b) Article 15.06(6)(c), for the galleys, as long as a second escape route is available;

(c) Article 15.07. 11.   For cabin vessels not exceeding 45 m in length, Article 15.12(10), shall not apply, provided smoke-hoods in a number corresponding to the number of berths are readily accessible in each cabin.

CHAPTER 15aSPECIFIC REQUIREMENTS FOR PASSENGER SAILING VESSELS

Article 15a.01

Application of Part II

In addition to the provisions of Part II, the requirements in this Chapter shall apply to passenger sailing vessels.
Article 15a.02

Exceptions for certain passenger sailing vessels 1.   For passenger sailing vessels having an LWL not exceeding 45 m and a maximum permissible number of passengers not exceeding LWL in whole meters, the following provisions shall not apply:

(a) Article 3.03(7), provided that anchors are not transported in hawse pipes;

(b) Article 10.02(2)(d), with regard to length;

(c) Article 15.08(3)(a);

(d) Article 15.15(9)(a). 2.   By way of derogation from paragraph1, the number of passengers may be raised to 1,5 times the LWL in whole meters, if sails, rigging and deck fittings so permit.
Article 15a.03

Stability requirements for vessels under sail 1.   For the calculation of the heeling moment according to Article 15.03(3), the furled sails shall be taken into account when determining the centre of gravity of the vessel. 2.   Taking into consideration all load conditions according to Article 15.03(2), and using a standard arrangement of sails, the heeling moment caused by wind pressure shall not be so high as to exceed a heeling angle of 20°. At the same time

(a) a constant wind pressure of 0,07 kN/m2 shall be applied for the calculation,

(b) the residual safety clearance shall be at least 100 mm, and

(c) the residual freeboard shall not be negative. 3.   The righting lever of static stability shall

(a) reach its maximum value at a heeling angle of 25° or over,

(b) amount to at least 200 mm at a heeling angle of 30° or over,

(c) be positive at a heeling angle of up to 60°. 4.   The area under the righting lever curve shall not be less than

(a) 0,055 mrad up to 30°;

(b) 0,09 mrad up to 40° or at the angle at which an unprotected opening reaches the water surface and which is less than 40°.

Between

(c) 30° and 40°, or

(d) 30° and the angle at which an unprotected opening reaches the water surface and which is less than 40°,

this area shall not be less than 0,03 mrad.
Article 15a.04

Shipbuilding and mechanical requirements 1.   By way of derogation from Article 6.01(3), and Article 9.01(3), the equipment must be designed for permanent lists of up to 20°. 2.   By way of derogation from Article 15.06(5)(a) and Article 15.06(9)(b), the inspection body may, in the case of passenger sailing vessels not more than 25 m long, authorise a clear width of less than 800 mm for connecting corridors and companionways. However, the clear width shall be at least 600 mm. 3.   By way of derogation from Article 15.06(10)(a), the inspection body may, in specific cases, authorise the use of removable guard rails in areas where this is necessary for controlling the sails. 4.   Within the meaning of Article 15.07, sails rank as a main propulsion system. 5.   By way of derogation from Article 15.15(7)(c), the height of the lower edge of the door opening may be reduced to 200 mm above the floor of the passenger area. Once opened, the door shall close and lock automatically. 6.   If there is a possibility of the propeller idling while the vessel is under sail, any endangered parts of the propulsion system shall be protected against potential damage.
Article 15a.05

Rigging in general 1.   The parts of the rigging shall be arranged in such a way as to prevent unacceptable chafing. 2.   If a material other than wood is used or if special types of rigging are used, such a design shall guarantee equivalent levels of safety with the dimensions and strength values laid down in this Chapter. As evidence of the strength

(a) a strength calculation shall be carried out, or

(b) confirmation of sufficient strength shall have been obtained from an approved classification society, or

(c) dimensioning shall be based on the procedures set out in a recognised regulatory framework (e.g. Middendorf, Kusk-Jensen).

The evidence shall be presented to the inspection body.
Article 15a.06

Masts and spars in general 1.   All spars shall be made of high-quality material. 2.   Wood for masts shall:

(a) be free of knot concentrations;

(b) be free of sapwood within the required dimensions;

(c) as far as possible be straight-grained;

(d) contain as little as possible twisted growth. 3.   If the chosen timber is either pitch pine or Oregon pine of quality level ‘clear and better’ the diameters in the tables reproduced in Articles 15a.07 to 15a.12 can be reduced by 5 %. 4.   If the timbers used for masts, topmasts, yardarms, booms and bowsprits are not round in cross-section, such timbers must be of equivalent strength. 5.   Mast pedestals, mast trunks and fastenings on deck, on floor-plates and on stem or stern shall be constructed in such a way that they can either absorb the forces they are subjected to or transfer them to other connected parts of the structure. 6.   Depending on the stability of the vessel and the external forces it is subjected to and also the distribution of the available sail area, the inspection body may, on the basis of the dimensions laid down in Articles 15a.07 to 15a.12, allow reductions in the cross-sections of the spars and, where appropriate, of the rigging. Evidence shall be submitted in accordance with Article 15a.05(2). 7.   If the vessel’s period of oscillation/period of roll, in seconds, is less than three quarters of its breadth, in metres, the dimensions set out in Articles 15a.07 to 15a.12 shall be increased. Evidence shall be submitted in accordance with Article 15a.05(2). 8.   In the tables reproduced in Articles 15a.07 to 15a.12 and 15a.14, possible intermediate values shall be interpolated.
Article 15a.07

Special provisions for masts 1.   Wooden masts shall meet the following minimum requirements:

Length (*1)

(m) Diameter on deck

(cm) Diameter on the cross-tree

(cm) Diameter on the mast cap

(cm) 10

20

17

15

11

22

17

15

12

24

19

17

13

26

21

18

14

28

23

19

15

30

25

21

16

32

26

22

17

34

28

23

18

36

29

24

19

39

31

25

20

41

33

26

21

43

34

28

22

44

35

29

23

46

37

30

24

49

39

32

25

51

41

33

If a mast has two yards, the diameters shall be increased by at least 10 %.

If a mast has more than two yards, the diameters shall be increased by at least 15 %.

In the case of masts fitted through the deck, the diameter at the mast foot shall be at least 75 % of the diameter of the mast at deck level. 2.   Mast fittings, mast bands, cross-trees and mast caps shall be sufficiently strongly dimensioned and attached.
Article 15a.08

Special provisions for topmasts 1.   Wooden topmasts shall meet the following minimum requirements:

Length (*2)

(m) Diameter at the foot

(cm) Half-length diameter

(cm) Diameter at fitting (*3)

(cm) 4

8

7

6

5

10

9

7

6

13

11

8

7

14

13

10

8

16

15

11

9

18

16

13

10

20

18

15

11

23

20

16

12

25

22

17

13

26

24

18

14

28

25

20

15

31

27

21

If square sails are attached to a topmast, the dimensions set out in the table shall be increased by 10 %. 2.   The overlap between the topmast and the mast shall be at least 10 times the required foot diameter of the topmast.
Article 15a.09

Special provisions for bowsprits 1.   Wooden bowsprits shall meet the following minimum requirements:

Length (*4)

(m) Diameter at stem

(cm) Half-length diameter

(cm) 4

14,5

12,5

5

18

16

6

22

19

7

25

23

8

29

25

9

32

29

10

36

32

11

39

35

12

43

39 2.   The inboard section of the bowsprit shall have a length of at least four times the diameter of the bowsprit at the stem. 3.   The diameter of the bowsprit at its head shall be at least 60 % of the diameter of the bowsprit at the stem.
Article 15a.10

Special provisions for jib-booms 1.   Wooden jib-booms shall meet the following minimum requirements:

Length (*5) (m) 2

3

4

5

6

7

8

9

10

Diameter at the stem (cm) 7

10

14

17

21

24

28

31

35 2.   The diameter of the jib-boom at its head shall be at least 60 % of the diameter at the stem.
Article 15a.11

Special provisions for main booms 1.   Wooden main booms shall meet the following minimum requirements:

Length (*6) (m) 5

6

7

8

9

10

11

12

13

14

15

16

Diameter (cm) 14

15

16

17

18

20

21

23

24

25

26

27 2.   The diameter at the swivel pin shall be at least 72 % of the diameter specified in the table. 3.   The diameter at the clew shall be at least 85 % of the diameter specified in the table. 4.   Measured from the mast, the greatest diameter shall be at two thirds of the length. 5.   Where:

(a) there is an angle of less than 65° between the main boom and the after leech and the main sheet is attached to the end of the boom, or

(b) the attachment point of the sheet is not abreast of the clew,

the inspection body may, according to Article 15a.05(2), require a greater diameter. 6.   For sail areas of less than 50 m2, the inspection body may authorise reductions in the dimensions set out in the table.
Article 15a.12

Special provisions for gaffs 1.   Wooden gaffs shall meet the following minimum requirements:

Length (*7) (m) 4

5

6

7

8

9

10

Diameter (cm) 10

12

14

16

17

18

20 2.   The unsupported length of the gaff shall be not more than 75 %. 3.   The breaking strength of the crowfoot shall be at least equal to 1,2 times the breaking strength of the peak halyard. 4.   The top angle of the crowfoot shall be a maximum of 60°. 5.   If, by way of derogation from paragraph 4, the top angle of the crowfoot is greater than 60°, the tensile strength shall be adjusted to accommodate the forces that will then occur. 6.   For sail areas of less than 50 m2, the inspection body may authorise reductions in the dimensions set out in the table.
Article 15a.13

General provisions for standing and running rigging 1.   Standing and running rigging shall comply with the strength requirements set out in Articles 15a.14 and 15a.15. 2.   Wire cable connections may take the form of:

(a) splicings,

(b) compression sleeves, or

(c) sealing sleeves.

Splicings shall be marled and ends shall be whipped. 3.   Eye splices shall be provided with thimbles. 4.   Ropes shall be routed in such a way as not to obstruct entrances and companionways.
Article 15a.14

Special provisions for standing rigging 1.   Forestays and shrouds shall meet the following minimum requirements:

Mast length (*8) (m) 11

12

13

14

15

16

17

18

Tensile strength of the forestay (kN)

160

172

185

200

220

244

269

294

Tensile strength of the shrouds (kN)

355

415

450

485

525

540

630

720

Number of shroud cables and ropes per side

3

3

3

3

3

3

4

4 2.   Backstays, topmasts, flying jib-stays, jib-booms and bowsprit shrouds shall meet the following minimum requirements:

Mast length (*9) (m) <13

13-18

>18

Tensile strength of the backstay (kN)

89

119

159

Tensile strength of the topmast (kN)

89

119

159

Length of topmast (m) <6

6-8

>8

Tensile strength of the flying jib-stay (kN)

58

89

119

Length of jib-boom (m) <5

5-7

>7

Tensile strength of the bow sprit shrouds (kN)

58

89

119 3.   The preferred rope design shall be based on Rope Construction Method 6 x 7 FE in the strength class 1 550 N/mm2. Alternatively, at the same strength class, Construction Method 6 x 36 SE or 6 x 19 FE may be used. Because of the higher elasticity of Construction Method 6 x 19, the tensile strengths given in the table shall be increased by 10 %. Use of a different rope design shall be permitted provided it has comparable properties. 4.   If rigid rigging is used, the tensile strengths shown in the table shall be increased by 30 %. 5.   For rigging, only approved forks, round eyes and bolts may be used. 6.   Bolts, forks, round eyes and turnbuckles shall be capable of being properly secured. 7.   The tensile strength of the bobstay shall be at least 1,2 times the tensile strength of the respective jib-stay and flying jib-stay. 8.   For vessels with less than 30 m3 water displacement, the inspection body may permit the reductions in tensile strengths shown in the table set out below:

Water displacement divided by the number of masts (m3)

Reduction (%)

>20 to 30

20

10 to 20

35

< 10

60
Article 15a.15

Special provisions for running rigging 1.   For running rigging, fibre ropes or steel wire ropes shall be used. The minimum tensile strength and the diameter for running rigging shall, in relation to the sail area, meet the following minimum requirements:

Type of running rigging

Rope material

Sail area (m2)

Minimum tensile strength (KN)

Diameter of rope (mm) Staysail halyards

Steel wire

up to 35

20

6

> 35

38

8

Fibre (polypropylene-PP)

Rope diameter of at least 14 mm and one rope sheave for every 25 m2 or part thereof

Gaff sail halyards

Top sail halyards

Steel wire

up to 50

20

6

> 50 to 80

30

8

> 80 to 120

60

10

>120 to 160

80

12

Fibre (PP)

Rope diameter of at least 18 mm and one rope sheave for every 30 m2 or part thereof

Staysail sheets

Fibre (PP)

up to 40

14
> 40

18

For sail areas of more than 30 m2, the sheet shall take the form of a tackle or shall be capable of being operated by a winch

Gaff-/Top-sail sheets

Steel wire

< 100

60

10

100 to 150

85

12

> 150

116

14

For top sail sheets, elastic connection elements (fore runners) are necessary.

Fibre (PP)

Rope diameter of at least 18 mm and at least three rope sheaves. Where the sail area is greater than 60 m2, one rope sheave per 20 m2 2.   Running rigging forming part of the staying shall have a tensile strength which corresponds to that of the respective stay or shrouds. 3.   If materials other than those stated in paragraph 1 are used, the strength values given in the table inparagraph 1 shall be complied with.

Fibre ropes of polyethylene shall not be used.
Article 15a.16

Fittings and parts of the rigging 1.   If steel wire ropes or fibre ropes are used, the diameters of the rope sheaves (measured from centre of rope to centre of rope) shall meet the following minimum requirements:

Steel wire (mm) 6

7

8

9

10

11

12

Fibre (mm) 16

18

20

22

24

26

28

Rope sheave (mm) 100

110

120

130

145

155

165 2.   By way of derogation from paragraph 1, the diameter of the rope sheaves may be equal to six times the diameter of the steel wire, provided that the steel wire does not constantly run over sheaves. 3.   The tensile strength of the fittings (e.g. forks, round eyes, turnbuckles, eye-plates, bolts, rings and shackles) shall be compatible with the tensile strength of the standing or running rigging that is attached to them. 4.   The fastenings of stay and shroud futtocks shall be designed to take up the forces they are subjected to. 5.   Only one shackle, along with the relevant stay or shroud, may be attached to each eye. 6.   Blocks of halyards and topping lifts shall be securely fastened to the mast, and the revolving crowfeet used for this purpose shall be in good condition. 7.   Attachments of eye-bolts, cleats, belaying pins and fife-rails shall be designed to cope with the forces they are subjected to.
Article 15a.17

Sails 1.   It shall be ensured that sails can be taken in simply, swiftly and safely. 2.   The sail area shall be appropriate for the type of vessel and the water displacement.
Article 15a.18

Equipment 1.   Vessels that are fitted with a jib-boom or a bowsprit shall have a jib-net and an adequate number of appropriate holding and tensioning devices. 2.   The equipment according to paragraph 1 may be dispensed with if the jib-boom or bowsprit is equipped with a hand becket and a foot rope adequately dimensioned to allow for the attachment of a safety harness to be carried on board. 3.   For work on the rigging, a boatswain’s chair shall be provided.
Article 15a.19

Testing 1.   The rigging shall be tested by the inspection body every 2,5 years. As a minimum, the test shall cover the following:

(a) the sails, including leeches, clews and reef eyes;

(b) the state of the masts and spars;

(c) the state of the standing and running rigging together with cable wire connections;

(d) facilities for taking in the sail swiftly and safely;

(e) the secure fastening of blocks of halyards and topping lifts;

(f) the fastening of mast trunks and other fastening points for standing and running rigging that are attached to the vessel;

(g) the winches for operating the sails;

(h) other facilities fitted for the purposes of sailing, such as lee-boards and the fittings for operating them;

(i) the measures taken to prevent the chafing of the spars, the running and standing rigging and the sails;

(j) the equipment according to Article 15a.18. 2.   That part of the wooden mast passing through the deck and located below the deck shall be re-examined at intervals to be determined by the inspection body, but at the very least on the occasion of each periodical inspection according to Article 2.09. The mast shall be extracted for this purpose. 3.   A certificate of the last inspection carried out in accordance withparagraph 1 and issued, dated and signed by the inspection body, shall be carried on board.

CHAPTER 16SPECIFIC REQUIREMENTS APPLICABLE TO CRAFT INTENDED TO FORM PART OF A PUSHED OR TOWED CONVOY OR OF A SIDE-BY-SIDE FORMATION

Article 16.01

Craft suitable for pushing 1.   Craft which are to be used for pushing purposes shall incorporate a suitable pushing device. They shall be designed and equipped in such a way as to:

(a) enable crews easily and safely to cross over to the pushed craft with the coupling devices connected;

(b) enable them to occupy a fixed position in relation to the coupled craft;

(c) prevent relative movement between the craft themselves. 2.   If the craft are joined together with cables the pusher craft shall be equipped with at least two special winches or equivalent coupling devices for tensioning the cables. 3.   The coupling devices shall enable a rigid assembly to be formed with the pushed craft.

Where convoys consist of a pusher craft and a single pushed craft the coupling devices may permit controlled articulation. The necessary drive units shall easily absorb the forces to be transmitted and shall be capable of being controlled easily and safely. Articles 6.02 to 6.04 shall apply mutatis mutandis to such drive units. 4.   The collision bulkhead referred to in Article 3.03(1)(a), can be dispensed with for pushers.
Article 16.02

Craft suitable for being pushed 1.   The following shall not apply to lighters without steering system, accommodation, engine or boiler rooms:

(a) Chapters 5 to 7 and 12;

(b) Article 8.08(2) to (8), Article 10.02 and Article 10.05(1).

If steering systems, accommodation, engine or boiler rooms are present the relevant requirements of this Annex shall apply to them. 2.   In addition, ship-borne lighters whose length L does not exceed 40 m shall meet the following requirements:

(a) collision bulkheads referred to in Article 3.03(1), can be dispensed with if their front faces are able to bear a load at least 2,5 times that set for the collision bulkheads on inland waterway vessels with the same draught and built in accordance with the requirements of an approved classification society;

(b) by way of derogation from Article 8.08(1), compartments of the double bottom to which access is difficult do not have to be drainable unless their volume exceeds 5 % of the water displacement of the ship-borne lighter at the maximum authorised loaded draught. 3.   Craft intended for being pushed shall be fitted with coupling devices ensuring a safe connection to other craft.
Article 16.03

Craft suitable for propelling side-by-side formations

Craft intended to propel side-by-side formations shall be equipped with bollards or equivalent devices which, as a result of their number and arrangement, enable the formation to be coupled in a safe manner.
Article 16.04

Craft suitable for being propelled in convoys

Craft intended to be propelled in convoys shall be equipped with coupling devices, bollards or equivalent devices which, as a result of their number and arrangement, ensure a safe connection to other craft in the convoy.
Article 16.05

Craft suitable for towing 1.   Craft intended for towing shall meet the following requirements:

(a) the towing devices shall be arranged in such a way that their use does not compromise the safety of the craft, crew or cargo;

(b) tugging and towing craft shall be fitted with a tow hook which shall be capable of being released safely from the wheelhouse; this shall not apply if the design or other fittings prevent capsizing;

(c) towing devices shall consist of winches or a tow hook. The towing devices shall be located ahead of the propeller plane. This requirement shall not apply to craft that are steered by their propulsion units such as rudder propellers or cycloidal propellers;

(d) by way of derogation from the requirements of (c), for craft solely giving — in accordance with applicable navigational authority regulations of the Member States — towing assistance to motorised craft, a towing device such as a bollard or an equivalent device shall suffice. Point (b) shall apply mutatis mutandis;

(e) where the towing cables could snag on the stern of the vessel, deflector hoops with cable catchers shall be provided. 2.   Craft of length L exceeding 86 m shall not be authorised for towing downstream.
Article 16.06

Navigation tests on convoys 1.   In order to authorise a pusher or motor vessel to propel a rigid convoy, and to enter this on the Community certificate, the inspection body shall decide which formations are to be presented and shall conduct the navigation tests referred to in Article 5.02 with the convoy in the formation(s) applied for, which the inspection body regards to be the least favourable one(s). The requirements set out in Articles 5.02 to 5.10 shall be met by this convoy.

The inspection body shall check that the rigid connection of all craft in the convoy is maintained during the manoeuvres required by Chapter 5. 2.   If during the navigation tests referred to inparagraph 1 there are specific installations on board the craft that are being either pushed or propelled side-by-side, such as the steering system, propulsion units or manoeuvring equipment, or articulated couplings in order to meet the requirements set out in Articles 5.02 to 5.10, the following shall be entered on the Community certificate for the craft propelling the convoy: formation, position, name and official number of those craft which are fitted with the specific installations used.
Article 16.07

Entries on the Community certificate 1.   If a craft is intended to propel a convoy, or be propelled in a convoy, its compliance with the relevant requirements as set out in Articles 16.01 to 16.06 shall be entered on the Community certificate. 2.   The following information shall be entered on the Community certificate for the propelling craft:

(a) the convoys and formations that have been accepted;

(b) the types of coupling;

(c) the maximum coupling forces determined, and

(d) where appropriate, the minimum tensile strength of the coupling cables for the longitudinal connection and also the number of cable windings.

CHAPTER 17SPECIFIC REQUIREMENTS APPLICABLE TO FLOATING EQUIPMENT

Article 17.01

General

For construction and equipment of floating equipment Chapters 3, 7 to 14 and 16 shall apply. Floating equipment with its own means of propulsion shall also meet the requirements of Chapters 5 and 6. Propulsion units permitting only short-haul operation shall not constitute own means of propulsion.
Article 17.02

Derogations 1.   The inspection body may grant derogations from the following requirements:

(a) Article 3.03(1) and (2), shall apply mutatis mutandis;

(b) Article 7.02 shall apply mutatis mutandis;

(c) the maximum sound pressure levels prescribed by Article 12.02 (5), second sentence, may be exceeded while the floating equipment’s working gear is operating, provided that, during service, nobody sleeps on board at night;

(d) derogations may be granted from other requirements concerning structure, working gear or equipment provided that equal safety is ensured in each case. 2.   The inspection body may dispense with the application of the following requirements:

(a) Article 10.01(1), shall not apply if during operation of floating equipment that equipment can be securely anchored by means of a working anchor or piles. However, floating equipment with its own means of propulsion shall have at least one anchor meeting the requirements in Article 10.01 (1), where an empirical coefficient k is taken to be equal to 45, and the smallest height is taken for T;

(b) Article 12.02(1), second part of sentence, if the accommodation can be adequately lit by means of electricity. 3.   In addition, the following shall apply:

(a) for Article 8.08(2), second sentence, the bilge pump shall be motor driven;

(b) for Article 8.10(3), the noise may exceed 65 dB(A) at a lateral distance of 25 m from the ship’s side of any stationary floating equipment while its working gear is operating;

(c) for Article 10.03(1), at least one further portable extinguisher is required if working gear not permanently attached to the craft is placed on the deck;

(d) for Article 14.02(2), in addition to the liquefied-gas equipment for domestic use, there may also be other liquefied-gas facilities. Those facilities and their accessories shall meet the requirements of one of the Member States.
Article 17.03

Additional requirements 1.   Floating equipment on which persons are present during operation shall be fitted with a general alarm system. The alarm signal shall be clearly distinguishable from other signals and, within accommodation and at all work stations, shall produce a sound pressure level that is at least 5 dB(A) higher than the maximum local sound pressure level. It shall be possible to actuate the alarm system from the wheelhouse and the main work stations. 2.   Working equipment shall have sufficient strength to withstand the loads it is subjected to and shall meet the requirements of Directive 98/37/EC of the European Parliament and of the Council of 22 June 1998 on the approximation of the laws of the Member States relating to machinery (15); 3.   The stability (resistance to overbalancing) and strength of working equipment, and where appropriate its attachments, shall be such that it may withstand the forces resulting from the expected heel, trim and movement of the floating equipment. 4.   If loads are lifted by means of hoists the maximum authorised load deriving from stability and strength shall be prominently displayed on panels on deck and at the control stations. If the lifting capacity can be increased by connecting additional floats the values authorised both with and without these additional floats shall be clearly stated.
Article 17.04

Residual safety clearance 1.   For the purposes of this Chapter and by way of derogation from Article 1.01 of this Annex, residual safety clearance means the shortest vertical distance between surface of the water and the lowest part of the floating equipment beyond which it is no longer watertight, taking into account trim and heel resulting from the moments referred to in Article 17.07(4). 2.   The residual safety clearance is sufficient according to Article 17.07(1), for any spray-proof and weathertight aperture if it is at least 300 mm. 3.   At an aperture that is not spray-proof and weathertight the residual safety clearance shall be at least 400 mm.
Article 17.05

Residual freeboard 1.   For the purposes of this Chapter and by way of derogation from Article 1.01 of this Annex, residual freeboard means the smallest vertical distance between the surface of the water and the upper surface of the deck at its edge taking into account trim and heel resulting from the moments referred to in Article 17.07 (4). 2.   The residual freeboard is sufficient according to Article 17.07(1), if it is at least 300 mm. 3.   The residual freeboard may be reduced if it is proven that the requirements of Article 17.08 have been met. 4.   Where the shape of a float differs perceptibly from that of a pontoon, as in the case of a cylindrical float, or where the cross-section of a float has more than four sides, the inspection body may require or authorise a residual freeboard that differs from programme 2. This shall also apply to floating equipment consisting of several floats.
Article 17.06

Heeling test 1.   Confirmation of stability according to Articles 17.07 and 17.08 shall be based on a heeling test that has been carried out in a proper manner. 2.   If during a heeling test it is not possible to achieve adequate heeling angles, or if the heeling test causes unreasonable technical difficulties, this may be replaced by a calculation of the craft’s centre of gravity and weight. The result of the weight calculation shall be checked by measuring the draught, and the difference shall not exceed ± 5 %.
Article 17.07

Confirmation of stability 1.   It shall be confirmed that, when taking into account the loads applied during operation of the working gear and whilst under way, the residual freeboard and the residual safety clearance are sufficient. For that purpose the sum of the trim and heeling angles shall not exceed 10° and the bottom of the float shall not emerge. 2.   Confirmation of stability shall include the following data and documents:

(a) scale drawings of floats and working gear and the detailed data relating to these that are needed to confirm stability, such as content of the tanks, openings providing access to the inside of the vessel;

(b) hydrostatic data or curves;

(c) righting lever curves for static-stability to the extent required in accordance with paragraph 5 below or Article 17.08;

(d) description of the operating conditions together with the corresponding data concerning weight and centre of gravity, including its unladen state and the equipment situation as regards transport;

(e) calculation of the heeling, trimming and righting moments, with a specification of the trim and heeling angles and the corresponding residual freeboard and residual safety clearances;

(f) a compilation of the results of the calculation with a specification of the limits for operation and the maximum loads. 3.   Confirmation of stability shall be based on at least the following load assumptions:

(a) specific mass of the dredging products for dredgers:

—

sands and gravels: 1,5 t/m3,

—

very wet sands: 2,0 t/m3,

—

soil, on average: 1,8 t/m3,

—

mixture of sand and water in the ducts: 1,3 t/m3;

(b) for clamshell dredgers, the values given under point (a) shall be increased by 15 %;

(c) for hydraulic dredgers the maximum lifting power shall be considered.

4.1.   Confirmation of stability shall take account of the moments resulting from:

(a) load;

(b) asymmetric structure;

(c) wind pressure;

(d) turning whilst under way of self-propelled floating equipment;

(e) cross current, if necessary;

(f) ballast and provisions;

(g) deck loads and, where appropriate, cargo;

(h) free surfaces of liquids;

(i) inertia forces;

(j) other mechanical equipment.

The moments which may act simultaneously shall be added up.

4.2.   The moment caused by the wind pressure shall be calculated in accordance with the following formula:

where:

c

=

shape-dependent coefficient of resistance

For frameworks c = 1,2 and for solid-section beams c = 1,6. Both values take account of gusts of wind.

The whole area encompassed by the contour line of the framework shall be taken to be the surface area exposed to the wind.

pw

=

specific wind pressure; this shall uniformly be taken to be 0,25 kN/m2;

A

=

lateral plane above the plane of maximum draught in m2;

lw

=

distance from the centre of area of the lateral plane A from the plane of maximum draught, in m.

4.3.   In order to determine the moments due to turning whilst under way according toparagraph 4.1(d) for self-propelled floating equipment, the formula set out in Article 15.03 (6) shall be used.

4.4.   The moment resulting from cross current according to paragraph 4.1(e) shall be taken into account only for floating equipment which is anchored or moored across the current while operating.

4.5.   The least favourable extent of tank filling from the point of view of stability shall be determined and the corresponding moment introduced into the calculation when calculating the moments resulting from liquid ballast and liquid provisions according to paragraph 4.1(f).

4.6.   The moment resulting from inertia forces according to paragraph 4.1(i) shall be given due consideration if the movements of the load and the working gear are likely to affect stability. 5.   The righting moments for floats with vertical side walls may be calculated using the following formula
Ma = 10 · D · 

 · sinφ (kNm)

where:

=

metacentric height, in m;

φ

=

heeling angle in degrees.

That formula shall apply up to heeling angles of 10° or up to a heeling angle corresponding to immersion of the edge of the deck or emergence of the edge of the bottom; the smallest angle shall be decisive. The formula may be applied to slanting side walls up to heeling angles of 5°; the limit conditions set out in paragraphs 3 and 4 shall also apply.

If the particular shape of the float(s) does not permit such simplification the righting lever curves according to paragraph 2(c) shall be required.
Article 17.08

Confirmation of stability in the case of reduced residual freeboard

If a reduced residual freeboard according to Article 17.05(3), is used, it shall be proven for all operating conditions that:

(a) after correction for the free surfaces of liquids, the metacentric height is not less than 0,15 m;

(b) for heeling angles between 0 and 30°, there is a righting lever of at least

h = 0,30 – 0,28 · φn (m) φn being the heeling angle from which the righting lever curve displays negative values (range of stability); it shall not be less than 20° or 0,35 rad and shall not be introduced into the formula for more than 30° or 0,52 rad, taking the radian (rad) (1° = 0,01745 rad) for the unit of φ°;

(c) the sum of the trim and heeling angles does not exceed 10°;

(d) a residual safety clearance meeting the requirements in Article 17.04 remains;

(e) a residual freeboard of at least 0,05 m remains;

(f) for heeling angles between 0 and 30°, a residual righting lever of at least

h = 0,20 – 0,23 · φn (m) remains, where φn is the heeling angle from which the righting lever curve displays negative values; it shall not be introduced into the formula for more than 30° or 0,52 rad.

Residual righting lever means the maximum difference existing between 0° and 30° of heel between the righting lever curve and the heeling lever curve. If an opening towards the inside of the vessel is reached by the water at a heeling angle less than that corresponding to the maximum difference between the lever curves, the lever corresponding to that heeling angle shall be taken into account.
Article 17.09

Draught marks and draught scales

Draught marks and draught scales shall be affixed in accordance with Articles 4.04 and 4.06. 

Article 17.10

Floating equipment without confirmation of stability 1.   The application of Articles 17.04 to 17.08 may be dispensed with for floating equipment:

(a) whose working gear can in no way alter their heeling or trim, and

(b) where any displacement of the centre of gravity can be reasonably excluded. 2.   However,

(a) at maximum load the safety clearance shall be at least 300 mm and the freeboard at least 150 mm;

(b) for apertures which cannot be closed spray-proof and weathertight the safety clearance shall be at least 500 mm.

CHAPTER 18SPECIFIC REQUIREMENTS APPLICABLE TO WORKSITE CRAFT

Article 18.01

Operating conditions

Worksite craft designated as such in the Community certificate set out in Part I or II of Annex V may navigate outside worksites only when unladen. That restriction shall be entered on the Community certificate.

For this purpose worksite craft shall have a certificate issued by the competent authority indicating the duration of works and the geographical boundaries of the worksite in which the craft may be operated.
Article 18.02

Application of Part II

Unless otherwise specified in this Chapter the construction and equipment of worksite craft shall be in line with Chapters 3 to 14 of Part II.
Article 18.03

Derogations 1. (a) Article 3.03(1), shall apply mutatis mutandis;

(b) Chapters 5 and 6 shall apply mutatis mutandis where the craft is self-propelled;

(c) Article 10.02(2)(a) and (b), shall apply mutatis mutandis;

(d) the inspection body may grant exceptions to the other requirements concerning construction, arrangement and equipment provided that equivalent safety is proven in every case. 2.   The inspection body may dispense with the following provisions:

(a) Article 8.08 (2) to (8), if no crew is required;

(b) Article 10.01(1) and (3), if the worksite craft can be securely anchored by means of working anchors or piles. However, self-propelled worksite craft shall be equipped with at least one anchor meeting the requirements set out in Article 10.01(1), where coefficient k is taken to be 45 and T is taken to be the lowest height;

(c) Article 10.02(1)(c), if the worksite craft is not self-propelled.
Article 18.04

Safety clearance and freeboard 1.   If a worksite craft is used as a reclamation barge or a hopper barge the safety clearance outside the hold area shall be at least 300 mm and the freeboard at least 150 mm. The inspection body may permit a smaller freeboard if proof by calculation is provided that stability is sufficient for a cargo having a specific mass of 1,5 t/m3 and that no side of the deck reaches the water. The effect of liquefied cargo shall be taken into account. 2.   The provisions of Articles 4.01 and 4.02 shall apply mutatis mutandis to worksite craft not covered by paragraph 1. The inspection body may determine values departing from the above for safety clearance and freeboard.
Article 18.05

Ship’s boats

Worksite craft shall not be required to have a ship’s boat where:

(a) they are not self-propelled or

(b) a ship’s boat is available elsewhere on the worksite.

That derogation shall be entered on the Community certificate.

CHAPTER 19SPECIFIC REQUIREMENTS APPLICABLE TO HISTORIC VESSELS

(Left void)

CHAPTER 19aSPECIFIC REQUIREMENTS APPLICABLE TO CANAL BARGES

(Left void)

CHAPTER 19bSPECIFIC REQUIREMENTS APPLICABLE TO VESSELS NAVIGATING ON ZONE 4 WATERWAYS

Article 19b.01

Application of Chapter 4 1.   By way of derogation from Article 4.01(1) and (2), the safety clearance of doors and openings other than hold hatches for vessels navigating on Zone 4 waterways is reduced as follows:

(a) for openings which can be closed spray-proof and weathertight, to 150 mm;

(b) for openings which cannot be closed spray-proof and weathertight, to 200 mm. 2.   By way of derogation from Article 4.02, the minimum freeboard of vessels navigating on Zone 4 waterways is 0 mm, if the safety clearance according to paragraph 1 is respected.

CHAPTER 20SPECIFIC REQUIREMENTS APPLICABLE TO SEA-GOING VESSELS

(Left void)

CHAPTER 21SPECIFIC REQUIREMENTS APPLICABLE TO RECREATIONAL CRAFT

Article 21.01

General

Only Articles 21.02 and 21.03 shall apply to the construction and equipment of recreational craft.
Article 21.02

Application of Part II 1.   Recreational craft shall meet the following requirements:

(a) from Chapter 3:
Article 3.01, Article 3.02(1)(a) and 2, Article 3.03(1)(a) and (6), and Article 3.04(1);

(b) Chapter 5:

(c) from Chapter 6:
Article 6.01(1), and Article 6.08;

(d) from Chapter 7:
Article 7.01(1) and (2), Article 7.02, Article 7.03(1) and (2), Article 7.04(1), Article 7.05(2), Article 7.13 if there is a wheelhouse designed for radar navigation by one person;

(e) from Chapter 8:
Article 8.01(1) and (2), Article 8.02(1) and (2), Article 8.03(1) and (3), Article 8.04, Article 8.05(1) to (10) and (13), Article 8.08 (1), (2), (5), (7) and (10), Article 8.09(1), and Article 8.10;

(f) from Chapter 9:
Article 9.01(1), mutatis mutandis:

(g) from Chapter 10:
Article 10.01( 2), (3) and (5) to (14), Article 10.02(1)(a) to (c), and (2)(a) and (e) to (h), Article 10.03(1)(a), (b) and (d): however, there shall be at least two fire extinguishers on board; Article 10.03(2) to (6), Article 10.03a, Article 10.03b and Article 10.05;

(h) Chapter 13:

(i) Chapter 14. 2.   For recreational craft subject to Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of laws, regulations and administrative provisions of the Member States relating to recreational craft (16), first inspection and periodical inspections only extend to:

(a) Article 6.08, if there is a rate-of-turn indicator;

(b) Article 7.01(2), Article 7.02, Article 7.03(1), and Article 7.13, if there is a wheelhouse designed for radar navigation by one person;

(c) Article 8.01(2), Article 8.02(1), Article 8.03(3), Article 8.05(5), Article 8.08(2), and Article 8.10;

(d) Article 10.01(2), (3), (6) and (14), Article 10.02(1)(b) and (c), (2)(a) and (e) to (h), Article 10.03 (1)(b) and (d) and (2) to (6), and Article 10.07;

(e) Chapter 13;

(f) from Chapter 14:

(aa)

Article 14.12;

(bb)

Article 14.13; the acceptance test after putting into service of the liquefied gas installation shall be carried out in accordance with the requirements of Directive 94/25/EC, and an acceptance report shall be submitted to the inspection body;

(cc) Articles 14.14 and 14.15; the liquefied gas installation shall be in accordance with the requirements of Directive 94/25/EC;

(dd) Chapter 14 entirely, if the liquefied gas installation is fitted after placing on the market of the recreational craft.
Article 21.03

(Left void)

CHAPTER 22STABILITY OF VESSELS CARRYING CONTAINERS

Article 22.01

General 1.   The provisions of this Chapter shall apply to vessels carrying containers where stability documents are required according to the applicable navigational authority regulations in force in the Member States.

Stability documents shall be checked, or submitted elsewhere for checking, and duly stamped by an inspection body. 2.   Stability documents shall provide the boatmaster with comprehensible information on vessel stability for each loading condition.

Stability documents shall include at least the following:

(a) information on the permissible stability coefficients, the permissible 

 – values or the permissible heights for the centre of gravity of the cargo;

(b) data concerning spaces that can be filled with ballast water;

(c) forms for checking stability;

(d) instructions for use or an example of a calculation for use by the boatmaster. 3.   For vessels where it is optional whether containers are carried non-secured or secured, separate calculation methods shall be provided for confirmation of stability both for transport of non-secured and secured cargoes of containers. 4.   A cargo of containers shall only be considered to be secured if each individual container is firmly attached to the hull of the vessel by means of container guides or securing equipment and its position cannot alter during the voyage.
Article 22.02

Limit conditions and method of calculation for confirmation of stability for the transport of non-secured containers 1.   All methods of calculating vessel stability in the case of non-secured containers shall meet the following limit conditions:

(a) Metacentric height 

 shall be not less than 1,00 m.

(b) Under the joint action of the centrifugal force resulting from the vessel’s turning, wind pressure and the free surfaces of liquids the heeling angle shall not exceed 5° and the edge of the deck shall not be immersed.

(c) The heeling lever resulting from the centrifugal force caused by the vessel’s turning shall be determined in accordance with the following formula:

where:

cKZ

parameter (cKZ = 0,04) (s2/m);

v

the maximum speed of the vessel in relation to the water (m/s);

height of centre of gravity of the laden vessel above its base (m);

T’

draught of the laden vessel (m).

(d) The heeling lever resulting from the wind pressure shall be determined in accordance with the following formula:

where:

cKW

parameter (cKW = 0,025) (t/m2);

A’

lateral plane above the respective plane of draught with the vessel laden (m2);

D’

displacement of the laden vessel (t);

lW

height of the centre of gravity of the lateral plane A’ above the respective plane of draught (m);

T ‘

draught of the laden vessel (m).

(e) The heeling lever resulting from the free surfaces of rainwater and residual water within the hold or the double bottom shall be determined in accordance with the following formula:

where:

cKfO

parameter (cKfO = 0,015) (t/m2)

b

width of hold or section of the hold in question (m); (*10)

l

length of hold or section of the hold in question (m); (*10)

D’

displacement of the laden vessel (t).

(f) Half of the fuel and fresh water supply shall be taken into account for each load condition. 2.   The stability of a vessel carrying non-secured containers shall be considered to be sufficient if the effective 

 does not exceed the 

zul resulting from the following formulae. The 

zul shall be calculated for various displacements covering the entire range of draughts.

(a) No value less than 11,5 (11,5 = 1/tan5°) shall be taken for 

 .

(b) zul = 

 – 1,00 (m) The lowest value of 

zul in accordance with formula (a) or (b) shall be decisive.Within the formulae:

zul

maximum permissible height of the laden vessel’s centre of gravity above its base (m);

height of the metacentre above the base (m) in accordance with the approximation formula in paragraph 3;

F

respective effective freeboard at 1/2 L (m);

Z

parameter for the centrifugal force resulting from turning

v

maximum speed of the vessel in relation to the water (m/s);

Tm

respective average draught (m);

hKW

heeling lever resulting from lateral wind pressure according to paragraph 1(d) (m);

hKfO

sum of the heeling levers resulting from the free surfaces of liquids according to paragraph 1(e) (m). 3.   Approximation formula for 

Where no sheet of hydrostatic curves is available the value 

 for the calculation in accordance withparagraph 2 and Article 22.03 (2), may be determined by the following approximation formulae:

(a) for vessels in the shape of a pontoon

(b) for other vessels
Article 22.03

Limit conditions and method of calculation for confirmation of stability for the transport of secured containers 1.   All methods of calculating vessel stability in the case of secured containers shall meet the following limit conditions:

(a) metacentric height 

 shall be not less than 0,50 m;

(b) no hull opening shall be immersed by the joint action of the centrifugal force resulting from the turning of the vessel, the wind pressure and the free surfaces of liquids;

(c) the heeling levers resulting from the centrifugal force due to the vessel’s turning, the wind pressure and the free surfaces of liquids shall be determined in accordance with the formulae referred to in Article 22.02(1)(c) to (e);

(d) half of the fuel and fresh water supply shall be taken into account for each load condition. 2.   The stability of a vessel carrying secured containers shall be considered to be sufficient if the effective 

 does not exceed 

zul the resulting from the following formulae that has been calculated for various displacements covering the entire range of draughts.

(a) Text of image

No value less than 6,6 shall be taken for 

 andno value less than 0 for 

Text of image

 .

(b) zul = 

 – 0,50 (m) The lowest value for 

zul in accordance with formula (a) or (b) shall be decisive.Within these formulae, apart from the terms defined previously:

I

transverse moment of inertia of water line area at Tm (m4) (for the approximation formula see paragraph 3);

i

transverse moment of inertia of the water line area parallel to the base, at height

water displacement of the vessel at Tm (m3);

F’

ideal freeboard F’ = H’ — Tm (m) or 

, the lowest value shall be decisive;

a

the vertical distance between the lower edge of the opening that is first immersed in the event of heeling and the water line in the vessel’s upright position (m);

b

distance from that same opening from the centre of the vessel (m);

H’

ideal side height 

;

q

sum of the volumes of the deckhouses, hatches, trunk decks and other superstructures up to a maximum height of 1,0 m above H or up to the lowest aperture in the volume under consideration, the lowest value being decisive. Parts of volumes located within a range of 0,05 L from the extremities of the vessel shall not be taken into account (m3). 3.   Approximation formula for I

Where there is no sheet of hydrostatic curves available the value for the transverse moment of inertia I of the water line area may be calculated by the following approximation formulae:

(a) for vessels in the shape of a pontoon

Text of image

(b) for other vessels

Text of image
Article 22.04

Procedure for assessing stability on board

The procedure for assessing stability may be determined by the documents referred to in Article 22.01(2).

CHAPTER 22aSPECIFIC REQUIREMENTS APPLICABLE TO CRAFT LONGER THAN 110 M

Article 22a.01

Application of Part I

In addition to the requirements set out in Article 2.03(3), the inspection body which is subsequently to issue the Community certificate shall be informed by the owner or his representative before building of craft longer than 110 m, except sea-going ships, begins (building of a new vessel or extension of a vessel already in service). That inspection body shall conduct inspections during the building stage. It may dispense with inspections during the building stage if a certificate is produced before building begins to show that an approved classification society declares that it is to supervise that building.
Article 22a.02

Application of Part II

In addition to Part II, Articles 22a.03 to 22a.05 shall apply to craft that are longer than 110 m.
Article 22a.03

Strength

Sufficient hull strength in accordance with Article 3.02(1)(a) (longitudinal, lateral and local strength) shall be verified by a certificate issued by an approved classification society.
Article 22a.04

Buoyancy and stability 1.   Paragraphs 2 to 9 shall apply to craft that are longer than 110 m, with the exception of passenger vessels. 2.   The proof of sufficient stability, including stability after damage, shall be verified for the most unfavourable loading condition.

The basic values for the stability calculation, the vessel’s lightweight and the location of the centre of gravity, shall be determined:

—

either by means of a heeling experiment, or

—

by detailed mass and moment calculation, in which case the lightweight of the vessel shall be verified by checking the draught, with a tolerance limit of +/- 5 % between the mass determined by calculation and the displacement determined by the draught readings. 3.   The proof of buoyancy after damage shall be verified for the fully laden craft.

For this purpose, calculated proof of sufficient stability shall be established for the critical intermediate stages of flooding and for the final stage of flooding. Negative values of stability in intermediate stages of flooding may be accepted by the competent authority if sufficient stability in subsequent intermediate stages is verified. 4.   The following assumptions shall be taken into consideration for the damaged condition:

(a) Extent of side damage:

longitudinal extent

:

at least 0,10 L,

transverse extent

:

0,59 m,

vertical extent

:

from the base line upwards without limit;

(b) Extent of bottom damage:

longitudinal extent

:

at least 0,10 L,

transverse extent

:

3,00 m,

vertical extent

:

from the base 0,39 m upwards, the sump excepted.

(c) Any bulkheads within the damaged area shall be assumed damaged, which means that the subdivision shall be chosen so that the vessel remains afloat after the flooding of two or more adjacent compartments in the longitudinal direction.

For the main engine room only the one-compartment standard need be taken into account, i.e. the end bulkheads of the engine room shall be assumed as not damaged.

For bottom damage, adjacent athwartship compartments shall also be assumed as flooded.

(d) Permeability

Permeability shall be assumed to be 95 %.

By way of derogation from this assumption, the following permeability may be assumed:

—

engine and operation rooms:

85 %

—

double bottoms, fuel tanks, ballast tanks, etc. depending on whether, according to their function, they have to be assumed as full or empty for the vessel floating at the maximum permissible draught:

0 or 95 %.

If a calculation proves that the average permeability of any compartment is lower, the calculated value may be used.

(e) The lower edge of any non-watertight openings (e.g. doors, windows, access hatches) shall, at the final stage of flooding, be not less than 100 mm above the damaged waterline. 5.   The stability after damage shall be sufficient if, on the basis of the assumptions inparagraph 4:

(a) at the final stage of flooding a safety clearance of not less than 100 mm remains and the heeling angle of the craft does not exceed 5°; or

(b) calculations in accordance with the procedure for calculation of damaged stability specified in Part 9 of the ADNR produce a positive result. 6.   When cross- or down-flooding openings are provided for reduction of asymmetrical flooding, the time for equalisation shall not exceed 15 minutes, if during the intermediate stages of flooding sufficient damaged stability has been verified. 7.   If openings through which undamaged compartments may additionally become flooded are capable of being closed watertight, the closing appliances shall be marked according to their operating instructions. 8.   The proof by calculation in accordance with paragraphs 2 to 5 shall be considered to have been provided if damaged stability calculations in accordance with Part 9 of the ADNR, are produced with a positive result. 9.   Where necessary in order to meet the requirements in paragraphs 2 or 3, the plane of maximum draught shall be re-established.
Article 22a.05

Additional requirements 1.   Craft longer than 110 m shall:

(a) be fitted with a multi-propeller propulsion system, with at least two independent engines of equal power and a bow thruster that is controlled from the wheelhouse and is also effective when the craft is in an unladen state; or

have a single-propeller propulsion system and a bow thruster that is controlled from the wheelhouse with its own power supply and which is also effective when the craft is in an unladen state and makes it possible for the craft to proceed under its own power in the event of a breakdown of the main propulsion system;

(b) be fitted with a radar navigation system, together with a rate-of-turn indicator in accordance with Article 7.06(1);

(c) have a permanently-installed bilge pumping system in accordance with Article 8.08;

(d) meet the requirements of Article 23.09(1)(1). 2.   For craft, except passenger ships, with a length of more than 110 m, which in addition to paragraph 1

(a) are capable of being separated, in the event of an accident, in the middle third of the vessel without the use of heavy salvage equipment while the separated parts of the vessel shall remain afloat after separation;

(b) are provided with a certificate that shall be carried on board and which is issued by an approved classification society regarding the buoyancy, trim position and stability of the separate parts of the vessel, indicating the degree of loading above which buoyancy of the two parts is no longer ensured;

(c) are built as double-hull vessels in accordance with the ADNR, where for motor vessels sections 9.1.0.91 to 9.1.0.95, and for tank vessels sections 9.3.2.11.7 and 9.3.2.13 to 9.3.2.15 of Part 9 of the ADNR shall apply;

(d) are fitted with a multi-screw propulsion system in accordance withparagraph 1(a), first half sentence;

it shall be entered in item 52 of the Community certificate that they comply with all the requirements of points (a) to (d). 3.   For passenger vessels with a length of more than 110 m which in addition toparagraph 1

(a) are built or converted for their highest class under the supervision of an approved classification society, in which case compliance shall be confirmed by means of a certificate issued by the classification society while current class is not necessary;

(b) either

have a double bottom with a height of at least 600 mm and subdivision to ensure that, in the event of flooding of any two adjacent watertight compartments, the vessel does not immerse lower than the margin line and a residual safety clearance of 100 mm remains,

or

have a double bottom with a height of at least 600 mm and a double hull with a distance of at least 800 mm between the side wall of the vessel and the longitudinal bulkhead;

(c) be fitted with a multi-screw propulsion system with at least two independent engines of equal power and a bow thruster system which can be operated from the wheelhouse and which operates longitudinally as well as transversely;

(d) allow the stern anchor to be operated directly from the wheelhouse;

it shall be entered in item 52 of the Community certificate that they comply with all the requirements of points (a) to (d).
Article 22a.06

Application of Part IV in the event of conversion

The inspection body may apply Chapter 24 to craft converted to a length of more than 110 m only on the basis of specific recommendations by the Committee.

CHAPTER 22bSPECIFIC REQUIREMENTS APPLICABLE TO HIGH-SPEED VESSELS

Article 22b.01

General 1.   High-speed vessels shall not be constructed as cabin vessels. 2.   The following installations are prohibited on board high-speed vessels:

(a) appliances fitted with wick burners according to Article 13.02;

(b) vaporising oil burner stoves according to Articles 13.03 and 13.04;

(c) solid-fuel heating appliances according Article 13.07;

(d) liquefied gas installations according to Chapter 14. 

Article 22b.02

Application of Part I 1.   In addition to the provisions of Article 2.03, high-speed vessels shall be constructed and classified under the supervision and in accordance with the applicable rules of an approved classification society which has special rules for high-speed vessels. The class shall be maintained. 2.   By way of derogation from Article 2.06, Community certificates issued in accordance with the provisions of this Chapter shall be valid for a maximum of five years.
Article 22b.03

Application of Part II 1.   Notwithstanding paragraph 2 and Article 22b.02(2), Chapters 3 to 15 shall apply to high-speed vessels, with the exception of the following provisions:

(a) Article 3.04(6), second subparagraph;

(b) Article 8.08(2), second sentence;

(c) Article 11.02(4), second and third sentences;

(d) Article 12.02(4), second sentence;

(e) Article 15.06(3)(a), second sentence. 2.   By way of derogation from Article 15.02(9), and Article 15.15(7), all doors in watertight bulkheads shall be capable of being remote controlled. 3.   By way of derogation from Article 6.02(1), in case of failure or malfunctioning of the steering apparatus drive unit a second independent steering apparatus drive unit or a manually operated drive unit shall come into operation without time delay. 4.   In addition to the requirements of Part II, high-speed vessels shall meet the requirements of Articles 22b.04 to 22b.12. 

Article 22b.04

Seats and safety belts

Seats shall be available for the maximum number of passengers permitted on board. Seats shall be fitted with safety belts. Safety belts may be dispensed with where suitable impact protection is provided or where they are not required under Chapter 4, part 6, of the HSC Code 2000. 

Article 22b.05

Freeboard

By way of derogation from Articles 4.02 and 4.03, the freeboard shall be at least 500 mm.
Article 22b.06

Buoyancy, stability and subdivision

For high-speed vessels, proper documentation shall be provided for:

(a) buoyancy and stability characteristics adequate for safety where the craft is operated in the displacement mode, both when intact and when damaged;

(b) stability characteristics and stabilising systems ensuring the safety of the craft when used in the dynamic buoyancy phase and the transition phase;

(c) stability characteristics in the non-displacement and transitional modes adequate to transfer the craft safely to displacement mode in case of any system malfunction.
Article 22b.07

Wheelhouse 1.   Arrangement

(a) By way of derogation from Article 7.01(1), wheelhouses shall be arranged in such a way that the helmsman and a second member of the crew may at all times perform their tasks while the vessel is under way.

(b) The steering position shall be arranged so as to accommodate workstations for the persons mentioned in (a). The instruments for navigation, manoeuvring, monitoring and communication and other important operating controls shall be sufficiently close together to allow a second member of the crew as well as the helmsman to obtain the necessary information and to operate the controls and installations as necessary while seated. The following requirements shall apply in all cases:

(aa)

the steering position for the helmsman shall be arranged so as to allow radar navigation by one person.

(bb)

the second member of the crew shall have his own radar screen (slave) at his workstation and shall be able to intervene from his workstation to transmit information and control the propulsion of the vessel.

(c) The persons mentioned in (a) shall be able to operate the installations mentioned in (b) without any hindrance, including when safety belts are properly worn. 2.   Unobstructed view

(a) By way of derogation from Article 7.02(2), the area of obstructed view forward of the bow for the helmsman in a seated position shall not be more than one vessel length irrespective of the amount of cargo.

(b) By way of derogation from Article 7.02(3), the total arc of blind sectors from right ahead to 22,5° abaft the beam on either side shall not exceed 20°. Each individual blind sector shall not exceed 5°. The clear sector between two blind sectors shall not be less than 10°. 3.   Instruments

Instrument panels for operating and monitoring the installations mentioned in Article 22b.11 shall be in separate and clearly marked positions in the wheelhouse. This shall also apply, where appropriate, to controls for launching collective lifesaving equipment. 4.   Lighting

Red light shall be used for areas or pieces of equipment which shall be lit during use. 5.   Windows

Reflections shall be avoided. A means for avoiding dazzle by sunlight shall be provided. 6.   Surface materials

The use of reflective surface materials in the wheelhouse shall be avoided.
Article 22b.08

Additional equipment

High-speed craft shall have the following equipment:

(a) a radar installation and rate-of-turn indicator according to Article 7.06(1),

(b) readily accessible individual lifesaving equipment conforming to European Standard EN 395:1998 for the maximum number of persons permitted on board.
Article 22b.09

Closed areas 1.   General

Public spaces and accommodation and the equipment they contain shall be designed so that any person making proper use of those facilities will not suffer injury during a normal and emergency start or stop, or during manoeuvring in normal cruise and in failure or malfunction conditions. 2.   Communication

(a) For the purpose of informing passengers of safety measures, all passenger vessels shall be fitted with acoustic and visual installations visible and audible to everyone on board.

(b) The installations described under (a) shall enable the boatmaster to give instructions to passengers.

(c) Every passenger shall have access to instructions for emergency situations close to their seat, including a plan of the vessel showing all exits, escape routes, emergency equipment, lifesaving equipment and instructions for the use of lifejackets.
Article 22b.10

Exits and escape routes

Escape and evacuation routes shall satisfy the following requirements:

(a) there shall be easy, safe and quick access from the steering position to spaces and accommodation accessible to the public;

(b) escape routes leading to emergency exits shall be clearly and permanently marked;

(c) all exits shall be properly marked. The operation of the opening mechanism shall be obvious from the outside and the inside;

(d) the escape routes and emergency exits shall have a suitable safety guidance system;

(e) sufficient space for a member of the crew shall be left next to exits.
Article 22b.11

Fire protection and fire-fighting 1.   Corridors, rooms and accommodation accessible to the public and also galleys and engine rooms shall be connected to an appropriate fire alarm system. Any fire and its location shall be indicated automatically in a place permanently manned by crew. 2.   Engine rooms shall be equipped with a permanently installed fire-fighting system according to Article 10.03b. 3.   Rooms and accommodation accessible to the public and their escape routes shall be equipped with a pressurised water sprinkler system according to Article 10.03a. It shall be possible to drain the used water rapidly and directly to the outside.
Article 22b.12

Transitional provisions

High-speed vessels according to Article 1.01(22) which have a valid Community certificate on 31 March 2003 shall meet the following provisions of this Chapter:

(a) Articles 22b.01, 22b.04, 22b.08, 22b.09, 22b.10, 22b.11(1) when the Community certificate is renewed;

(b) on 1 April 2013,

Article 22b.07(1), (3), (4), (5) and (6);

(c) on 1 January 2023

all other provisions.

PART IIICHAPTER 23EQUIPMENT OF VESSELS WITH REGARD TO MANNING

Article 23.01

(Left void)
Article 23.02

(Left void)
Article 23.03

(Left void)
Article 23.04

(Left void)
Article 23.05

(Left void)
Article 23.06

(Left void)
Article 23.07

(Left void)
Article 23.08

(Left void)
Article 23.09

Vessels’ equipment 1.   For motor vessels, pushers, pushed convoys and passenger vessels, compliance with, or failure to comply with, the provisions of subparagraphs 1.1 or 1.2 shall be entered in item 47 of the Community certificate by the inspection body.

1.1   Standard S1

(a) The propulsion systems shall be arranged in such a way that speed can be changed and the direction of the propeller thrust reversed from the steering position.

It shall be possible for the auxiliary engines needed for operational purposes to be switched on or off from the steering position, unless this is done automatically or the engines run continuously during each voyage.

(b) In the danger areas of,

—

the temperature of the main-engine cooling water,

—

the lubricating-oil pressure for the main engines and transmissions,

—

the oil and air pressure of the main-engine reversing units, reversible transmissions or propellers,

—

the bilge levels in the main engine room,

there shall be monitoring by means of instruments which set off acoustic and visual signals in the wheelhouse in the event of malfunction. The acoustic alarm signals may be combined in one audible warning device. They may be switched off as soon as the malfunction has been acknowledged. The visual alarm signals may only be switched off when the malfunctions which set them off have been corrected.

(c) The fuel shall be supplied and the main engine cooled automatically.

(d) The steering system shall be able to be operated by one person, even in maximum draught, without requiring particular force.

(e) It shall be possible to give the visual and acoustic signals required under national or international navigational authority regulations, as appropriate, from the steering position.

(f) Where there is no direct communication between the steering position and the foresection, the aft, the accommodation and the engine rooms, a voice communication system shall be provided. For communication with the engine rooms, this may be in the form of an optical or acoustic signal.

(g) The required ship’s boat shall be capable of being released by one crew member alone and in an appropriate amount of time.

(h) There shall be a searchlight which can be operated from the steering position.

(i) The operation of cranks and similar revolving parts of lifting devices shall not require a force of more than 160 N.

(k) The towing winches entered in the Community certificate shall be motorised.

(l) The bilge and deck-wash pumps shall be motorised.

(m) The principal control units and monitoring instruments shall be ergonomically arranged.

(n) The equipment required under Article 6.01(1), shall be capable of being remotely operated from the steering position.

1.2   Standard S2

(a) For motor vessels operating seperately:
standard S1 and additionally equipped with a bow thruster which can be operated from the steering position;

(b) For motor vessels propelling in side-by-side formation:
standard S1 and additionally equipped with a bow thruster which can be operated from the steering position;

(c) For motor vessels propelling pushed convoys made up of the motor vessel itself and a craft in front:
standard S1 and additionally equipped with hydraulic or electrically operated coupling winches. This equipment is, however, not required if the foremost vehicle in the pushed convoy is equipped with a bow thruster which can be operated from the steering position of the pushing motor vessel;

(d) For pushers propelling a pushed convoy:
standard S1 and additionally equipped with hydraulic or electric coupling winches. This equipment is, however, not required if the foremost craft in the pushed convoy is equipped with a bow thruster which can be operated from the steering position of the pusher;

(e) For passenger vessels:
standard S1 and additionally equipped with a bow thruster which can be operated from the steering position. This equipment is, however, not required if the propulsion system and steering system of the passenger vessel guarantee equal manoeuvrability.
Article 23.10

(Left void)
Article 23.11

(Left void)
Article 23.12

(Left void)
Article 23.13

(Left void)
Article 23.14

(Left void)
Article 23.15

(Left void)

PART IVCHAPTER 24TRANSITIONAL AND FINAL PROVISIONS

Article 24.01

Applicability of transitional provisions to craft which are already in service 1.   The provisions of Articles 24.02 to 24.04 apply only to craft carrying on 30 December 2008 a valid vessel certificate according to the Rhine Vessel Inspection Regulation in force on 31 December 1994, or which were under construction or undergoing conversion on 31 December 1994. 2.   For craft not covered by paragraph 1, the provisions of Article 24.06 apply.
Article 24.02

Derogations for craft which are already in service 1.   Without prejudice to Articles 24.03 and 24.04, craft which do not fully comply with the provisions of this Directive must

(a) be adapted to comply with those provisions in accordance with the transitional provisions listed in the table below, and

(b) until their adaptation, comply with the Rhine Vessel Inspection Regulation in force on 31 December 1994. 2.   The following definitions apply in the table below:

—

                              ‘NRC’: the provision does not apply to craft which are already operating, unless the parts concerned are replaced or converted, i.e. the provision applies only to Newly-built craft and to the Replacement or Conversion of the parts or areas concerned. If existing parts are replaced by replacement parts using the same technology and of the same type, this does not constitute replacement (‘R’) within the meaning of the transitional provisions.

—

                              ‘Issue or renewal of the Community certificate’: the provision must be complied with the time of the next issue or renewal of the Community certificate after the date indicated.

Article and paragraph

Content

Deadline and comments
CHAPTER 3

3.03(1)(a) Situation of collision bulkhead

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 2

Accommodations

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

Safety equipment

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 4

Gastight separation of accommodations from engine rooms, boiler rooms and holds

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 5, second subparagraph

Monitoring of doors in aft-peak bulkheads

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 7

Anchors not protruding in foresections of vessels

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2041

3.04(3), second sentence

Insulation material used in engine rooms

NRC, at the latest on issue or renewal of the Community certificate

paragraph 3, third and fourth sentences

Openings and locking devices

NRC, at the latest on issue or renewal of the Community certificate

3.04(6) Exits of engine rooms

Engine rooms which were not considered as engine rooms according to Article 1.01 before 1995 must be equipped with a second exit at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035
CHAPTER 5

5.06(1), first sentence

Minimum speed

For craft laid down before 1996 at the latest on issue or renewal of the Community certificate after 1.1.2035
CHAPTER 6

6.01(1) Manoeuvrability required by Chapter 5

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 3

Permanent lists and ambient temperatures

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 7

Design of rudder stocks

For craft laid down before 1996: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

6.02(2) Single operation sufficient to operate second driving unit

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 3

Manoeuvrability required by Chapter 5 ensured by second drive unit/manual drive

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

6.03(1) Connection of other consumers to hydraulic steering apparatus drive unit

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 2

Separate hydraulic reservoirs

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

6.05(1) Wheel of manual drive not driven by powered drive unit

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

6.06(1) Two independent actuation systems

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

6.07(2)(a) Monitoring devices for level of hydraulic reservoir and service pressure

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 2(e) Monitoring of buffer devices

NRC, at the latest on issue or renewal of the Community certificate

6.08(1) Requirements for electrical equipment according to Article 9.20

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015
CHAPTER 7

7.02(3), second subparagraph

Unobstructed view in the helmsman’s usual axis of vision

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 5

Minimal light transmission

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

7.03(7) Shutdown of alarms

NRC, at the latest on issue or renewal of the Community certificate, unless the wheelhouse has been designed for radar navigation by one person

paragraph 8

Automatic switch to another power supply

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

7.04(1) Control of main engines and steering systems

NRC, at the latest on issue or renewal of the Community certificate

paragraph 2

Control of main engine

Unless wheelhouses have been designed for radar navigation by one person: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035 if the direction of motion can be achieved directly; 1.1.2010 for other engines

7.09

Alarm system

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

7.12 first paragraph

Retractable wheelhouses

NRC, at the latest on issue or renewal of the Community certificate

Non-hydraulic lowering system: at the latest on issue or renewal of the Community certificate after 1.1.2035

second and third paragraphs
NRC, at the latest on issue or renewal of the Community certificate
CHAPTER 8

8.01 (3) Only internal-combustion engines burning fuels having a flashpoint of more than 55°C

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

8.02(1) Securing of engines against unintentional starting

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 4

Automatic protection of engine parts

NRC, at the latest on issue or renewal of the Community certificate

8.03(2) Monitoring devices

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 3

Automatic protection against overspeed

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 5

Design of shaft bushings

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

8.05(1) Steel tanks for liquid fuels

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 2

Automatic closing of tank valves

NRC, at the latest on issue or renewal of the Community certificate

paragraph 3

No fuel tanks located forward of the collision bulkhead

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 4

No fuel tanks and their fittings above engines or exhaust pipes

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010. Until then, appropriate devices must ensure the safe evacuation of fuels.

paragraph 6, third to fifth sentences

Installation and measurements of breather pipes and connection pipes

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

8.05(7) Shutoff device to be operated from the deck

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 9, first sentence

Capacity-gauging devices to be legible up to maximum filling level

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 13

Filling level control not only for main engines but also other engines needed for safe operation of the vessel

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

8.08(8) Simple closing device not sufficient for connection of ballast spaces to drainage pipes for holds capable of carrying ballast

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 9

Gauging devices in hold bilges

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

8.09(2) Installations for the collection of oily water and used oil stores

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

8.10(3) Emission limit of 65 dB(A) for stationary vessels

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015
CHAPTER 8a

The transitional provisions on Chapter 8a of the Rhine Vessel Inspection Regulation apply

CHAPTER 9

9.01(1), second sentence

Relevant documents to be submitted to the inspection body

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 2, second indent

Switching diagrams for main, emergency and distribution switchboard to be kept on board

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 3

Ambient inside and deck temperatures

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

9.02(1) to (3) Electricity supply systems

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

9.05(4) Cross-section of the earthing conductors

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.11(4) Effective ventilation when accumulators are installed in a closed compartment, cabinet or chest

NRC, at the latest on issue or renewal of the Community certificate

9.12(2)(d) Switch-gear installations

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 3(b) Earth detection device capable of giving both visual and audible alarm

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

9.13

Emergency circuit breakers

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

9.14(3), second sentence

Prohibition of single-pole switches in laundries, bathrooms, washrooms and other rooms with wet facilities

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

9.15(2) Minimum cross-section of 1,5 mm2 per cable

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 9

Cables connected to retractable wheelhouses

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

9.16(3), second sentence

Second circuit

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.19

Alarm and safety systems for mechanical equipment

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.20

Electronic equipment

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

9.21

Electromagnetic compatibility

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035
CHAPTER 10

10.01

Anchor equipment

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

10.02(2)(a) Certificate for mooring and other cables

First cable to be replaced on the vessel: NRC, at the latest 1.1.2008

Second and third cables: 1.1.2013

10.03(1) European standard

For replacement, at the latest 1.1.2010

paragraph 2

Suitability for Class A, B and C fires

For replacement, at the latest 1.1.2010

paragraph 4

Relation of CO2 content and size of room

For replacement, at the latest 1.1.2010

10.03a

Permanently installed fire-fighting systems in accommodation spaces, wheelhouses and passenger spaces

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

10.03b

Permanently installed fire-fighting systems in engine rooms, boiler rooms and pump rooms

 (17) 10.04

Application of the European standard to dinghies

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

10.05(2) Inflatable life jackets

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010. Life jackets which have been on board on 30.9.2003 may be used until the issue or renewal of the Community certificate after 1.1.2010.  

CHAPTER 11

11.02(4) Equipment of outer edges of decks, side decks and work stations

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

11.04

Side decks

 (18) First issue or renewal of the Community certificate after 1.1.2035, when larger than 7,30 m

11.05 (1) Access to workplaces

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraphs. 2 and 3

Doors and accesses, exits and passageways where there is more than a 0,50 m difference in floor level

Issue or renewal of the Community certificate

paragraph 4

Stairs in working spaces which are manned continuously

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

11.06 (2) Exits and emergency exits

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

11.07(1), 2nd sentence

Ladders, steps and similar devices

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraphs 2 and 3
Issue or renewal of the Community certificate

11.10

Hatch covers

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

11.11

Winches

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

11.12(2) to (6) and (8) to (10) Cranes: manufacturer’s plate, maximum permissible loadings, protection devices, calculation test, inspection by experts, certificates on board

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

11.13

Storing of flammable liquids

NRC, at the latest on issue or renewal of the Community certificate
CHAPTER 12

12.01(1) Accommodation for the persons lodging habitually on board

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

12.02(3) Situation of floors

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 4

Living and sleeping quarters

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 6

Headroom in the accommodation

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 8

Free floor area of communal living quarters

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 9

Cubic capacity of rooms

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 10

Volume of airspace per person

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 11

Size of doors

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 12(a) and (b) Situation of stairs

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 13

Pipes carrying dangerous gases or liquids

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

12.03

Sanitary installations

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

12.04

Galleys

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

12.05

Potable water

NRC, at the latest on 31.12.2006

12.06

Heating and ventilation

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

12.07(1), second sentence

Other accommodation installations

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035
CHAPTER 15

15.01 (1)(d) Non-application of Article 9.14 (3) second sentence for rated voltages of over 50V

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 2(c) Prohibition of solid fuel heaters according to Article 13.07

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

The provision does not apply to craft with solid fuel engines (steam engines).

(e) Prohibition of liquefied gas devices according to Chapter 14

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.02(2) Number and position of bulkheads

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 5, second sentence

Margin line if no bulkhead deck

For passenger vessels which have been laid down before 1.1.1996, the requirement applies at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 10(c) Time for closure process

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 12

Optical warning system

NRC, at the latest on issue or renewal of the Community certificate

paragraph 15

Minimum height of double bottoms, width of wing voids

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.03 (1) to (6) Intact stability

NRC, and when the maximum number of passengers is raised, at the latest on issue or renewal of the Community certificate after 1.1.2045

Paragraphs 7 and 8

Damaged stability

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 9

Two-compartment status

NRC

paragraphs 10 to 13

Damaged stability

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.05( 2)(a) Number of passengers for whom the existence of an evacuation area according to Article 15.06(8) has been proven

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

(b) Number of passengers that has been taken into account for the stability calculation according to Article 15.03

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.06(1)(a) Passenger rooms on all decks aft of the collision bulkhead and forward of the level of the aft-peak bulkhead

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 3(c), first sentence

Clear height of exits

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

second sentence

Clear width of doors of passenger cabins and other small rooms

For the measurement of 0,7 m, NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045, applies

15.06(3)(f), first sentence

Size of emergency exits

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

(g) Exits of rooms intended for use by persons with reduced mobility

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 4(d) Doors intended for use by persons with reduced mobility

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 5

Requirements for connecting corridors

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 6(b) Escape routes to evacuation areas

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

(d) No rungs, ladders or the like installed along the escape routes

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 7

Suitable safety guidance system

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 8

Requirements for muster areas

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 9

Requirements for stairs and their landings in the passenger areas

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 10(a), first sentence

Railing according to European standard EN 711: 1995

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

second sentence

Height of bulwarks and railings of decks intended for use by persons with reduced mobility

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.06(10)(b), second sentence

Clear width of openings used normally for the embarking or disembarking of persons with reduced mobility

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 13

Traffic areas and walls in traffic areas intended for use by persons with reduced mobility

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 14, first sentence

Design of glass doors and walls in traffic areas and window panes

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 15

Requirements for superstructures or their roofs consisting completely of panoramic panes

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 16

Potable water systems in accordance with Article 12.05

NRC, at the latest on issue or renewal of the Community certificate after 31.12.2006

paragraph 17, second sentence

Requirements for toilets fitted for use by persons with reduced mobility

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 18

Ventilation system for cabins without an opening window

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 19

Requirements of Article 15.06 for rooms in which crew members or shipboard personnel are accommodated

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.07

Requirements for the propulsion system

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.08(2) Requirements for loudspeaker systems in passenger areas

For passenger vessels with LWL of less than 40 m or for not more than 75 persons the provision applies at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 3

Requirements for the alarm system

For day-trip vessels the provision applies at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 4

Bilge level alarm for each watertight compartment

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 5

Two motor-driven bilge pumps

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 6

Permanently installed bilge system

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 8

Ventilation system for CO2 bar-systems in rooms below deck

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

15.09(3) Appropriate transfer equipment

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

15.09(4) Individual life-saving equipment for children

Until the issue or renewal of the Community certificate after 1.1.2010 this equipment is considered an alternative to individual life-saving equipment

Life-saving equipment

For passenger vessels which were equipped with collective life-saving appliances according to Article 15.09(5) before 1.1.2005, these appliances are considered an alternative to individual life-saving equipment.

For passenger vessels which were equipped with collective life-saving appliances according to Article 15.09(6) before 1.1.2005, these are considered an alternative to individual life-saving equipment until the issue or renewal of the Community certificate after 1.1.2010. paragraph 5(b) and (c) Adequate seating space, buoyancy of at least 750 N

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

(f) Stable trim and appropriate grabbing devices

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

(i) Appropriate means of evacuation from evacuation areas on to life rafts

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 10

Ship’s boat equipped with engine and searchlight

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

15.10(2) Article 9.16(3) also applicable to passageways and recreation rooms for passengers

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 3

Adequate emergency lighting

Emergency lighting NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

15.10 (4) Emergency power plant

For day-trip vessels with LWL of 25 m or less, the provision applies at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

(f) Emergency supply for searchlights according to Article 10.02 (2)(i) NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

(i) Emergency supply for lifts and lifting equipment according to Article 15.06(9), second sentence

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 6

Requirements for the emergency power plant:
—

Partitions according to Article 15.11(2) NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

—

Installation of cables

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

—

Emergency power plant above the margin line

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

15.11

Fire protection
paragraph 1

Suitability for fire protection of materials and components

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 2

Design of partitions

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 3

Paints, lacquers and other surface treatment products as well as deck coverings used in rooms except engine rooms and store rooms shall be flame-retardant

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

paragraph 4

Lounge ceilings and wall claddings manufactured from non-combustible material

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 5

Furniture and fittings in muster areas manufactured from non-combustible material

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 6

Tested according to Code

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 7

Insulation materials in lounges

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 8

Requirements for doors in partitions

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 9

Walls

On cabin vessels without automatic pressurised-water spraying systems, ends of walls between cabins: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 10

Partitions

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.11(11) Draught stops

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 12, 2nd sentence

Stairs made of steel or another equivalent non-combustible material

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 13

Encapsulation of internal stairs

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 14

Ventilation systems and air supply systems

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 15

Ventilation systems in galleys and stoves with extractors

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 16

Control centres, stairwells, muster areas and smoke extraction systems

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 17

Fire alarm system

For day-trip vessels: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

15.12 (1) Portable extinguishers

Extinguisher and quenching material in galleys, hairdressing salons and perfumeries: NRC, at the latest on issue or renewal of the Community certificate

paragraph 2

Hydrant system

2nd fire extinguishing pump: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 3

Requirements for hydrant systems

Pressure and water jet length: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 6

Materials, protection against failure

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

15.12 (7) Avoidance of the possibility of freezing of pipes and hydrants

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 8(b) Independent operation of fire extinguishing pumps

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

(c) Water jet length on all decks

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

(d) Installation of fire extinguishing pumps

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 9

Fire extinguishing system in engine rooms

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.14(1) Waste water collection and disposal facilities

For cabin vessels with no more than 50 berths and for day-trip vessels: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 2

Requirements for waste water collection tanks

For cabin vessels with no more than 50 berths and for day-trip vessels with no more than 50 passengers: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.15 (1) Damage stability

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

paragraph 4

(Left void)
paragraph 5

Equipped with a ship’s boat, a platform or an equivalent installation

For passenger vessels licensed for a maximum of 250 passengers or 50 berths: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

15.15(6) Equipped with a ship’s boat, a platform or an equivalent installation

For passenger vessels licensed for a maximum of 250 passengers or 50 berths: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

paragraph 9(a) Alarm systems for liquefied gas installations

NRC, at the latest on renewal of the certificate according to Article 14.15

(b) Collective life-saving appliances according to Article 15.09(5) NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010
CHAPTER 16

16.01(2) Special winches or equivalent coupling devices

The requirement applies to craft licensed before 1.1.1995 for pushing without proper securing equipment, only at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035. 16.01(3), last sentence

Requirements for drive units

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035
CHAPTER 17

17.02(3) Additional requirements

The same transitional provisions as those indicated under the relevant article apply.

17.03(1) General alarm system

NRC, at the latest on issue or renewal of the Community certificate

paragraph 4

Maximum authorised load

NRC, at the latest on issue or renewal of the Community certificate

17.04(2) and (3) Residual safety clearance

NRC, at the latest on issue or renewal of the Community certificate

17.05(2) and (3) Residual freeboard

NRC, at the latest on issue or renewal of the Community certificate

17.06, 17.07 and 17.08

Heeling test and confirmation of stability

NRC, at the latest on issue or renewal of the Community certificate

17.09

Draught marks and draught scales

NRC, at the latest on issue or renewal of the Community certificate
CHAPTER 20
The transitional provisions on Chapter 20 of the Rhine Vessel Inspection Regulation apply

CHAPTER 21

21.01 to 21.02
The requirements apply to recreational craft built before 1.1.1995, only at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035. 

Article 24.03

Derogations for craft which were laid down on or before 1 April 1976 1.   In addition to the provisions of Article 24.02, the following provisions may be applied to craft which were laid down on or before 1 April 1976. The following definitions apply in the table below:

—

                              ‘RC’: The provision does not apply to craft which are already operating, unless the parts concerned are replaced or converted, i.e. the provision applies only to the Replacement or Conversion of the parts or areas concerned. If existing parts are replaced by replacement parts using the same technology and of the same type, this does not constitute replacement (‘R’) within the meaning of the transitional provisions.

—

                              ‘Issue or renewal of the Community certificate’: The provision must be complied with by the time of the next issue or renewal of the Community certificate after the date indicated.

Article and paragraph

Content

Deadline and comments
CHAPTER 3

3.03(1)(a) Situation of collision bulkhead

RC, at the latest on issue or renewal of the Community certificate after 1.1.2035

3.04(2) Common surfaces of bunkers and accommodation and passenger areas

RC, at the latest on issue or renewal of the Community certificate after 1.1.2035

paragraph 7

Maximum permissible sound pressure level

Issue or renewal of the Community certificate after 1.1.2015
CHAPTER 4

4.01(2), 4.02 and 4.03

Safety clearance, freeboard, minimum freeboard

Issue or renewal of the Community certificate after 1.1.2015
CHAPTER 7

7.01(2) Sound pressure generated by the vessel

RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

7.05(2) Monitoring of navigation lights

Issue or renewal of the Community certificate
CHAPTER 8

8.08 (3) and (4) Minimum pumping capacity and internal diameter of drainage pipes

Issue or renewal of the Community certificate after 1.1.2015

8.10(2) Noise generated by a vessel under way

RC, at the latest on issue or renewal of the Community certificate after 1.1.2015
CHAPTER 9

9.01

Requirements for electrical equipment

RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.03

Protection against physical contact, intrusion of solid objects and the ingress of water

RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.06

Maximum permissible voltages

RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.10

Generators and motors

RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.11(2) Installation of accumulators

RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.12

Switch-gear installations

RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.14

Installation fittings

RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.15

Cables

RC, at the latest on issue or renewal of the Community certificate after 1.1.2015

9.17

Navigation lights

RC, at the latest on issue or renewal of the Community certificate after 1.1.2015
CHAPTER 12

12.02(5) Noise and vibration in accommodations

Issue or renewal of the Community certificate after 1.1.2015
CHAPTER 15

15.02(5), (6), first sentence, (7) to (11) and (13) Margin line if no bulkhead deck

RC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.02(16) Watertight windows

RC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.04

Safety clearance, freeboard, immersion measures

RC, at the latest on issue or renewal of the Community certificate after 1.1.2045

15.05

Number of passengers

Issue or renewal of the Community certificate after 1.1.2015

15.10 (4), ( 6), (7), (8) and (11) Emergency power plant

RC, at the latest on issue or renewal of the Community certificate after 1.1.2045 2.   Article 15.11(3)(a), applies to day-trip vessels laid down on or before 1 April 1976 until the first issue or renewal of the Community certificate after 1.1.2045, with the proviso that only paints, varnishes, coatings and other materials used on surfaces facing escape routes and other materials for the surface treatment of panels must be fire-resistant and that smoke or toxic vapours may not develop to any dangerous extent. 3.   Article 15.11(12), applies to day-trip vessels laid down on or before 1 April 1976 until the first issue or renewal of the Community certificate after 1.1.2045, with the proviso that it is sufficient if, instead of stairs in the form of a load-bearing steel assembly, the stairs serving as an escape route are designed in such a way that they remain useable, in the event of a fire, for about the same time as stairs in the form of a load-bearing steel assembly.
Article 24.04

Other derogations 1.   For craft the minimum freeboard of which was determined in accordance with Article 4.04 of the Rhine Vessel Inspection Regulation as applicable on 31 March 1983, the inspection body may, at the request of the owner, determine the freeboard in accordance with Article 4.03 of the Rhine Vessel Inspection Regulation as applicable on 1 January 1995. 2.   Craft laid down before 1 July 1983 do not need to conform to Chapter 9, but must at least conform to Chapter 6 of the Rhine Vessel Inspection Regulation as applicable on 31 March 1983. 3.   Article 15.06(3)(a) to (e), and Article 15.12(3)(a), with regard to the rule concerning a single hose length apply only to craft laid down after 30 September 1984, and to conversions of the areas concerned, at the latest when the Community certificate is renewed after 1 January 2045. 4.   If it is difficult in practical terms to apply the provisions set out in this Chapter following the expiry of the transitional provisions, or if their application gives rise to unreasonably high costs, the inspection body may allow derogations from these provisions subject to recommendations by the Committee. These derogations must be entered in the Community certificate. 5.   Where this provision refers, with regard to equipment design requirements, to a European or an international standard, such equipment may, after any revision of the standard, continue to be used for a further 20 years following the revision of the standard.
Article 24.05

(Left void)
Article 24.06

Derogations for craft not covered by Article 24.01 1.   The following provisions apply:

(a) to craft for which a vessel certificate in accordance with the Rhine Vessel Inspection Regulation was issued for the first time between 1 January 1995 and 30 December 2008, provided they were not under construction or undergoing conversion on 31 December 1994;

(b) to craft which have obtained another traffic licence between 1 January 1995 and 30 December 2008. 2.   It must be proved that those craft comply with the Rhine Vessel Inspection Regulation as applicable on the date on which the vessel certificate or the other traffic licence is granted. 3.   The craft must be adapted to comply with provisions which enter into force following the first issue of the vessel certificate or other traffic licence in accordance with the transitional provisions set out in the table below. 4.   Article 24.04(4) and (5), apply MUTATIS MUTANDIS. 5.   The following definitions apply in the table below:

—

                              ‘NRC’: The provision does not apply to craft which are already operating, unless the parts concerned are replaced or converted, i.e. the provision applies only to Newly-built craft and to the Replacement or Conversion of the parts or areas concerned. If existing parts are replaced by replacement parts using the same technology and of the same type, this does not constitute replacement (‘R’) within the meaning of the transitional provisions.

—

                              ‘Issue or renewal of the Community certificate’: The provision must be complied with by the time of the next issue or renewal of the Community certificate after the date indicated.

Article and paragraph

Content

Deadline and comments

Valid for craft with vessel certificate or traffic licence before
CHAPTER 3

3.03( 7)

Anchors not protruding in foresections of vessels

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2041

1.10.1999

3.04 (3), second sentence

Insulation in engine rooms

NRC, at the latest on issue or renewal of the Community certificate

1.4.2003

paragraph 3, third and fourth sentences

Openings and closing devices

NRC, at the latest on issue or renewal of the Community certificate

1.10.2003
CHAPTER 8

8.02(4) Protection of engine parts

NRC, at the latest on issue or renewal of the Community certificate

1.4.2003

8.03(3) Protection against overspeed

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.4.2004

8.05(9), first sentence

Sounding devices must be readable up to the maximum filling level

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.4.1999

paragraph 13

Filling level control not only for main engines but also other engines needed for safe operation of the vessel

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

1.4.1999
CHAPTER 8a
The transitional provisions on Chapter 8a of the Rhine Vessel Inspection Regulation apply.
CHAPTER 10

10.02(2)(a) Certification of wire ropes and other ropes

The first rope replaced on the vessel: NRC, at the latest 1.1.2008. Second and third ropes: 1.1.2013. 1.4.2003

10.03(1) European standard

On replacement, at the latest 1.1.2010

1.4.2002

paragraph 2

Suitable for fire category A, B and C

On replacement, at the latest 1.1.2010

1.4.2002

10.03a

Permanently installed fire-fighting systems in cabins, wheelhouses and passenger areas

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2035

1.4.2002

10.03b

Permanently installed fire-fighting systems in engine rooms, boiler rooms and pump rooms

 (19) at the latest on issue or renewal of the Community certificate after 1.1.2035

1.4.2002

10.04

Application of the European standard to dinghies

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

1.10.2003

10.05 (2) Inflatable life-jackets

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010. Life jackets which have been on board on 30.9.2003 may be used until the issue or renewal of the Community certificate after 1.1.2010. 1.10.2003
CHAPTER 11

11.13

Storage of flammable liquids

NRC, at the latest on issue or renewal of the Community certificate

1.10.2002
CHAPTER 15

15.01(1)(c) Non-application of Article 8.06 (2), second sentence

NRC, at the latest on issue or renewal of the Community certificate

1.1.2006

(d) Non-application of Article 9.14(3), second sentence for rated voltages of over 50V

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

paragraph 2(b) Prohibition of vaporising oil-burner stoves according to Article 13.04

NRC, at the latest on issue or renewal of the Community certificate

1.1.2006

(c) Prohibition of solid fuel heaters according to Article 13.07

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

(e) Prohibition of liquefied gas devices according to Chapter 14

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

15.02(2) Number and position of bulkheads

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 5, second sentence

Margin line if no bulkhead deck

For passenger vessels laid down before 1.1.1996, the requirement applies at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 15

Minimum height of double bottoms, width of wing voids

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

15.03 (1) to (6) Intact stability

NRC, and when the maximum number of passengers is raised, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

15.03 (7) and (8) Damaged stability

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 9

2-compartment status

NRC

1.1.2007

paragraphs 10 to 13

Damaged stability

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

15.05(2)(a) Number of passengers for whom the existence of an evacuation area according to Article 15.06 section 8 has been proven

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

(b) Number of passengers that has been taken into account for the stability calculation according to Article 15.03

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

15.06 (1) Passenger rooms on all decks forward of the level of the aft-peak bulkhead

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 2

Cupboards and rooms referred to in Article 11.13 and intended for the storage of flammable liquids

NRC, at the latest on issue or renewal of the Community certificate

1.1.2006

paragraph 3(c), first sentence

Clear height of exits

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

second sentence

Clear width of doors of passenger cabins and other small rooms

For the measurement of 0,7 m, NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045, applies

1.1.2006

15.06(3)(f), first sentence

Size of emergency exits

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

(g) Exits intended for use by persons with reduced mobility

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 4(d) Doors intended for use by persons with reduced mobility

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 5

Requirements for connecting corridors

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 6(b) Escape routes to evacuation areas

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

(c) No escape routes through engine rooms and galleys

NRC, at the latest on issue or renewal of the Community certificate

1.1.2006

(d) No rungs, ladders or the like installed along the escape routes

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 7

Suitable safety guidance system

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 8

Requirements for muster areas

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 9(a) to (c), (e), and last sentence

Requirements for stairs and their landings in the passenger areas

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 10(a), first sentence

Railing according to European standard EN 711: 1995

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

second sentence

Height of bulwarks and railings of decks intended for use by persons with reduced mobility

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

(b), second sentence

Clear width of openings used for the embarking or disembarking of persons with reduced mobility

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 12

Gangways in accordance with European standard EN 14206: 2003

NRC, at the latest on issue or renewal of the Community certificate

1.1.2006

paragraph 13

Traffic areas and walls in traffic areas, intended for use by persons with reduced mobility

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 14, first sentence

Design of glass doors and walls in traffic areas and window panes

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 15

Requirements for superstructures or their roofs consisting completely of panoramic panes

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 16

Potable water systems according to Article 12.05

NRC, at the latest on issue or renewal of the Community certificate

1.1.2006

paragraph 17, second sentence

Requirements for toilets fitted for use by persons with reduced mobility

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 18

Ventilation system for cabins without an opening window

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

15.07

Requirements for the propulsion system

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2007

15.08(2) Requirements for loudspeaker systems in passenger areas

For passenger vessels with LWL of less than 40 m or for not more than 75 persons the provision applies at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

paragraph 3

Requirements for the alarm system

For day-trip vessels the provision applies at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

paragraph 3(c) Alarm system enabling the vessel’s command to alert the crew and shipboard personnel

For cabin vessels the provision applies at NRC, at the latest on issue or renewal of the Community certificate

1.1.2006

paragraph 4

Bilge level alarm for each watertight compartment

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

paragraph 5

Two motor-driven bilge pumps

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

paragraph 6

Permanently installed bilge system according to Article 8.06 section 4

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

1.1.2006

paragraph 7

Inside opening of cold-storage rooms

NRC, at the latest on issue or renewal of the Community certificate

1.1.2006

paragraph 8

Ventilation system for CO2 bar-systems in rooms below deck

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

paragraph 9

First-aid kits

NRC, at the latest on issue or renewal of the Community certificate

1.1.2006

15.09(1), first sentence

Lifebuoys

NRC, at the latest on issue or renewal of the Community certificate

1.1.2006

paragraph 2

Individual life-saving equipment

NRC, at the latest on issue or renewal of the Community certificate

1.1.2006

paragraph 3

Appropriate transfer equipment

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

15.09(4) Individual life-saving equipment according to European standard EN 395: 1998 or EN 396: 1998 available for 100% of passengers

NRC, at the latest on issue or renewal of the Community certificate

1.1.2006
Individual life-saving equipment for children

Until the issue or renewal of the Community certificate after 1.1.2010 this equipment is considered an alternative to individual life-saving equipment.

1.1.2006
Life-saving equipment

For passenger vessels which were equipped with collective life-saving appliances according to Article 15.09 section 5 before 1.1.2005, these appliances are considered an alternative to individual life-saving equipment.

For passenger vessels which were equipped with collective life-saving appliances according to Article 15.09 section 6 before 1.1.2005, these are considered an alternative to individual life-saving equipment until issue or renewal of the Community certificate after 1.1.2010. 1.1.2006

paragraph 5(b) and (c) Adequate seating space, buoyancy of at least 750 N

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

(f) Stable trim and appropriate grabbing devices

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

(i) Appropriate means of evacuation from the evacuation areas onto the life rafts

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

paragraph 9

Check on life-saving equipment according to the manufacturer’s instructions

NRC, at the latest on issue or renewal of the Community certificate

1.1.2006

paragraph 10

Ship’s boat equipped with engine and searchlight

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

paragraph 11

Stretcher

NRC, at the latest on issue or renewal of the Community certificate

1.1.2006
Electrical Equipment
1.1.2006

15.10(2) Article 9.16(3) also applicable to passageways and recreation rooms for passengers

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

1.1.2006

paragraph 3

Adequate emergency lighting

Emergency lighting NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

1.1.2006

paragraph 4

Emergency power plant

For day-trip vessels with LWL of 25 m or less, the provision applies at NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

1.1.2006

(f) Emergency supply for searchlights according to Article 10.02(2)(i

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

1.1.2006

(i) Emergency supply for lifts and lifting equipment according to Article 15.06(9), second sentence

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

1.1.2006

paragraph 6

Requirements for the emergency power plant:
1.1.2006

—

Partitions according to Article 15.11 (2) NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

1.1.2006

—

Installation of cables

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

1.1.2006

—

Emergency power plant above the margin line

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

1.1.2006

15.11

Fire protection
1.1.2007

paragraph 1

Suitability for fire protection of materials and components

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

15.11(2) Design of partitions

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 3

Paints, lacquers and other surface treatment products as well as deck coverings used in rooms except engine rooms and store rooms shall be flame-retardant

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2015

1.1.2006

paragraph 4

Lounge ceilings and wall claddings manufactured from non-combustible material

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 5

Furniture and fittings in muster areas manufactured from non-combustible material

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 6

Tested according to Code

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 7

Insulation materials in lounges non-combustible

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 8, (a), (b), (c), second sentence and (d) Requirements for doors in partitions

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 9

Walls

On cabin vessels without automatic pressurised-water spraying systems, ends of walls between cabins: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

paragraph 10

Partitions

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 12, second sentence

Stairs made of steel or another equivalent non-combustible material

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 13

Encapsulation of internal stairs by walls according to paragraph 2

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 14

Ventilation systems and air supply systems

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 15

Ventilation systems in galleys and stoves with extractors

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 16

Control centres, stairwells, muster areas and smoke extraction systems

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 17

Fire alarm system

For day-trip vessels: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

15.12(1) Portable extinguishers

Fire extinguisher and fire blanket in galleys, hairdressing salons and perfumeries: NRC, at the latest on issue or renewal of the Community certificate

1.1.2006

paragraph 2

Hydrant system

2nd fire extinguishing pump: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

paragraph 4

Hydrant valves

NRC, at the latest on issue or renewal of the Community certificate

1.1.2006

paragraph 5

Axially connected reel

NRC, at the latest on issue or renewal of the Community certificate

1.1.2006

paragraph 6

Materials, protection against failure

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

paragraph 7

Avoidance of the possibility of freezing of pipes and hydrants

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

paragraph 8(b) Independent operation of fire extinguishing pumps

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

(d) Installation of fire extinguishing pumps

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

paragraph 9

Fire extinguishing system in engine rooms

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

15.12( 9)

Fire extinguishing system in engine rooms made from steel or with equivalent properties

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045. The transitional period does not apply to passenger vessels which have been laid down after 31.12.1995, the hull of which is made of wood, aluminium or plastic and the engine rooms of which are not made of a material according to Article 3.04(3) and (4).

1.1.2006

15.13

Safety organisation

For day-trip vessels: NRC, at the latest on issue or renewal of the Community certificate

1.1.2006

15.14 (1) Waste water collection and disposal facilities

For cabin vessels with 50 or fewer berths, and for day-trip vessels: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 2

Requirements for waste water collection tanks

For cabin vessels with 50 or fewer berths, and for day-trip vessels with 50 or fewer passengers: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

15.15

Derogations for certain passenger vessels
1.1.2006

paragraph 1

Damage stability

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2045

1.1.2006

paragraph 4

(Left void)

paragraph 5

Equipped with a ship’s boat, a platform or an equivalent installation

For passenger vessels licensed for a maximum of 250 passengers or 50 berths: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

paragraph 6

Equipped with a ship’s boat, a platform or an equivalent installation

For passenger vessels licensed for a maximum of 250 passengers or 50 berths: NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006

15.15(9)(a) Alarm systems for liquefied gas installations

NRC, at the latest on renewal of the attestation according to Article 14.15

1.1.2006

(b) Collective life-saving appliances according to Article 15.09 section 5

NRC, at the latest on issue or renewal of the Community certificate after 1.1.2010

1.1.2006
Article 24.07

(Left void)

CHAPTER 24aADDITIONAL TRANSITIONAL PROVISIONS FOR CRAFT NOT NAVIGATING ON ZONE R WATERWAYS

Article 24a.01

Application of transitional provisions to craft already in service and validity of previous Community certificates 1.   The following provisions apply:

(a) to craft for which a Community certificate was issued for the first time before 30 December 2008; and

(b) to craft which obtained another traffic licence before 30 December 2008,

not navigating a Zone R waterway. 2.   It must be proved that those craft comply with the provisions of Chapters 1 to 12 of Annex II to Directive 82/714/EEC on the date on which the Community certificate or the other traffic licence is issued. 3.   Community certificates delivered before 30 December 2008 remain valid until the date of expiry indicated on the certificate. Article 2.09(2), remains applicable.
Article 24a.02

Derogations for craft already in service 1.   Without prejudice to Articles 24a.03 and 24a.04, craft which do not fully comply with the provisions of this Directive must be adapted to comply with provisions which enter into force after the first issue of their Community certificate or other traffic licence in accordance with the transitional provisions listed in the table below. 2.   The following definitions apply in the table below:

—

                              ‘NRC’: The provision does not apply to craft which are already operating, unless the parts concerned are replaced or converted, i.e. the provision applies only to Newly-built craft and to the Replacement or Conversion of the parts or areas concerned. If existing parts are replaced by replacement parts using the same technology and of the same type, this does not constitute replacement (‘R’) within the meaning of the transitional provisions.

—

                              ‘Issue or renewal of the Community certificate’: The provision must be complied with by the time of the issue or next renewal of the Community certificate after 30 December 2008. If the certificate expires between 30 December 2008 and the day before 30 December 2009, that requirement is, however, only mandatory from 30 December 2009. Article and paragraph

Content

Deadline and comments
CHAPTER 3

3.03(1)(a) Location of collision bulkhead

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

3.03(2) Accommodations

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

3.03(2) Safety equipment

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

3.03(4) Gastight separation

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

3.03(5), second paragraph

Monitoring of doors in the aft-peak bulkhead
3.03(7) Anchors not protruding in foresections of vessels

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

3.04(3), second sentence

Insulation in engine rooms

NRC, at the latest on issue or renewal of the Community certificate

3.04(3), third and fourth sentences

Openings and locking devices

NRC, at the latest on issue or renewal of the Community certificate

3.04(6) Exits from spaces classified as engine rooms as a result of this Directive

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049
CHAPTER 4

4.04

Draught marks

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024
CHAPTER 5

5.06(1), first sentence

Minimum speed

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049
CHAPTER 6

6.01(1) Manoeuvrability required by Chapter 5

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraph 3

Permanent lists and ambient temperatures

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

6.01(7) Design of rudder stocks

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

6.02(2) Placing in service of second drive unit by means of a single operation

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 3

Manoeuvrability required by Chapter 5 ensured by second drive unit/manual service

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

6.03(1) Connection of other power consumers to the hydraulic steering apparatus drive unit

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 2

Separate hydraulic reservoirs

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

6.05(1) Wheel of manual drive not driven by powered drive unit

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

6.06(1) Two independent actuation systems

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

6.07(2)(a) Monitoring devices for level of hydraulic reservoir and service pressure

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

(e) Monitoring of buffer devices

NRC, at the latest on issue or renewal of the Community certificate

6.08(1) Requirements for electronic equipment according to Article 9.20

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029
CHAPTER 7

7.02(2) to (7) Unobstructed view from the wheelhouse,except the following sections:

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

7.02(3), second paragraph

Unobstructed view in the sightline of the helmsman

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

paragraph 5

Minimal light transmission of glazing

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

7.03(7) Shutdown of alarms

NRC, at the latest on issue or renewal of the Community certificate

paragraph 8

Automatic switch to alternative power supply

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

7.04(1) Control of main engines and steering devices

NRC, at the latest on issue or renewal of the Community certificate

7.04(2) Control of main engines

If wheelhouses have not been designed for radar navigation by one person: NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049 if the direction of motion can be achieved directly; at the latest on issue or renewal of the Community certificate after 30 December 2024 for other engines

7.09

Alarm system

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

7.12 first paragraph

Retractable wheelhouses

NRC, at the latest on issue or renewal of the Community certificate. Without automatic retraction: NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

second and third paragraphs
NRC, at the latest on issue or renewal of the Community certificate
CHAPTER 8

8.01(3) Only internal-combustion engines burning fuels having a flashpoint of more than 55 °C

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

8.02(1) Securing of engines against unintentional starting

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 4

Protection of machinery parts

NRC, at the latest on issue or renewal of the Community certificate

8.03(2) Monitoring devices

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 3

Automatic protection against overspeed

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 5

Design of shaft bushings

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

8.05(1) Steel tanks for liquid fuels

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

8.05(2) Automatic closing of tank valves

NRC, at the latest on issue or renewal of the Community certificate

paragraph 3

No fuel tanks forward of the collision bulkhead

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 4

No fuel tanks and their fittings above engines or exhaust pipes

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024. Until then, appropriate devices must ensure the safe evacuation of fuels

paragraph 6 third to fifth sentences

Installation and measurements of breather pipes and connection pipes

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 7

Shutoff device to be operated from the deck

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

paragraph 9, first sentence

Capacity-gauging devices to be legible up to maximum filling level

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 13

Filling level control not only for main engines but also other engines needed for safe operation of the vessel

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

8.06

Storage of lubricating oil, pipes and accessories

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

8.07

Storage of oils used in power transmission systems, control and activating systems and heating systems, pipes and accessories

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

8.08( 8)

Simple closing device not sufficient for connection of ballast spaces to drainage pipes for holds capable of carrying ballast

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

8.08( 9)

Gauging devices in hold bilges

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

8.09(2) Installations for the collection of oily water and used oil stores

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

8.10(3) Emission limit of 65 dB(A) for stationary craft

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029
CHAPTER 9

9.01(1), second sentence

Relevant documents to be submitted to the inspection body

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

9.01(2), second indent

Switching diagrams for main, emergency and distribution switchboard to be kept on board

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 3

Ambient inside and deck temperatures

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

9.02(1) to (3) Electricity supply systems

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

9.03

Protection against physical contact, intrusion of solid objects and the ingress of water

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

9.05(4) Cross-section of the earthing conductors

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

9.11(4) Effective ventilation when accumulators are installed in a closed compartment, cabinet or chest

NRC, at the latest on issue or renewal of the Community certificate

9.12

Switch-gear installations

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

9.12 (3)(b) Earth detection device capable of giving both visual and audible alarm

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

9.13

Emergency circuit breakers

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

9.14

Installation fittings

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

9.14(3), second sentence

Prohibition of single-pole switches in laundries, bathrooms, washrooms and other rooms with wet facilities

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

9.15(2) Minimum cross-section of 1,5 mm2 per cable

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

paragraph 10

Cables connected to retractable wheelhouses

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

9.16(3), second sentence

Second circuit

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

9.19

Alarm and safety systems for mechanical equipment

NRC, at the latest on issue or renewal of the Community certificate 30 December 2029

9.20

Electronic equipment

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

9.21

Electromagnetic compatibility

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049
CHAPTER 10

10.01

Anchor equipment

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

10.02 (2)(a) Certificate for mooring and other cables

First cable to be replaced on the vessel: NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

Second and third cables: 30 December 2029

10.03(1) European standard

At replacement, at the latest 30 December 2024

paragraph 2

Suitability for Class A, B and C fires

At replacement, at the latest 30 December 2024

paragraph 4

Relation of CO2 content and size of room

At replacement, at the latest 30 December 2024

10.03a

Permanently installed fire-fighting systems in accommodation spaces, wheelhouses and passenger spaces

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

10.03b

Permanently installed fire-fighting systems in engine rooms, boiler rooms and pump rooms

CO2 fire-fighting systems permanently installed before 1 October 1985 may remain in use until the issue or renewal of the Community certificate after 30 December 2049 if they comply with the requirements of Article 13.03 of Annex II of Directive 82/714/EEC

10.04

Application of the European standard to dinghies

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

10.05(2) Inflatable life jackets

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

Life jackets which are on board on the day before 30 December 2008 can be used until renewal of the Community certificate after 30 December 2024
CHAPTER 11

11.02(4) Equipment of outer edges of decks, side decks and work stations

NRC, [at the latest on issue or renewal of the Community certificate after 30 December 2029

11.04

Side decks

First issue or renewal of the Community certificate (20) after 30 December 2049 where width exceeds 7,30 m

11.05(1) Access to workplaces

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraphs 2 and 3

Doors and accesses, exits and passageways where there is more than a 0,50 m difference in floor level

NRC, at the latest on issue or renewal of the Community certificate

paragraph 4

Stairs in working spaces which are manned continuously

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

11.06(2) Exits and emergency exits

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

11.07(1), second sentence

Ladders, steps and similar devices

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraphs 2 and 3
NRC, at the latest on issue or renewal of the Community certificate

11.10

Hatch covers

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

11.11

Winches

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2024

11.12(2) to (6) and (8) to (10) Cranes: manufacturer’s plate, maximum permissible loadings, protection devices, calculation test, inspection by experts, certificates on board

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

11.13

Storing of flammable liquids

NRC, at the latest on issue or renewal of the Community certificate
CHAPTER 12

12.01(1) Accommodation for the persons lodging habitually on board

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

12.02(3) Situation of floors

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraph 4

Living and sleeping quarters

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

12.02(5) Noise and vibration in accommodations

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

paragraph 6

Headroom in accommodations

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraph 8

Free floor area of communal living quarters

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraph 9

Cubic capacity of rooms

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraph 10

Volume of airspace per person

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraph 11

Size of doors

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraph 12(a) and (b) Situation of stairs

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraph 13

Pipes carrying dangerous gases or liquids

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

12.03

Sanitary installations

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

12.04

Galleys

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

12.05

Potable water

NRC, at the latest on issue or renewal of the Community certificate

12.06

Heating and ventilation

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

12.07 section 1, second sentence

Other accommodation installations

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049
CHAPTER 15
Passenger vessels

see Article 8 of this Directive
CHAPTER 15a
Passenger sailing vessels

see Article 8 of this Directive
CHAPTER 16

16.01(2) Special winches or equivalent coupling devices

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049

paragraph 3, last sentence

Requirements for drive units

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2049
CHAPTER 17
Floating equipment

see Article 8 of this Directive
CHAPTER 21
Recreational craft

see Article 8 of this Directive
CHAPTER 22b

22b.03

Second independent steering apparatus drive unit

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029
Article 24a.03

Derogations for craft which were laid down before 1 January 1985 1.   In addition to the provisions in Article 24a.02, craft which were laid down before 1 January 1985 may be exempted from the following provisions, under the conditions described in column 3 of the table below, provided the safety of the vessel and its crew is ensured in an appropriate manner. 2.   The following definitions apply in the table below:

—

                              ‘NRC’: The provision does not apply to craft which are already operating, unless the parts concerned are replaced or converted, i.e. the provision only applies to Newly-built craft and to the Replacement or Conversion of the parts or areas concerned. If existing parts are replaced by replacement parts using the same technology and of the same type, this does not constitute replacement (‘R’) within the meaning of these transitional provisions.

—

                              ‘Issue or renewal of the Community certificate’: The provision must be complied with by the time of the first issue or next renewal of the Community certificate after 30 December 2008. If the certificate expires between 30 December 2008 and the day before 30 December 2009, that requirement is, however, only mandatory from 30 December 2009. Article and paragraph

Content

Deadline and comments
CHAPTER 3

3.03(1) Watertight collision bulkheads

NRC

3.03(2) Accommodations, safety installations

NRC

3.03(5) Openings in watertight bulkheads

NRC

3.04(2) Surfaces of bunkers

NRC

3.04(7) Maximum permissible sound pressure level in engine rooms

NRC
CHAPTER 4

4.01

Safety clearance

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2019

4.02

Freeboard

NRC
CHAPTER 6

6.01(3) Requirements of steering system

NRC
CHAPTER 7

7.01(2) Maximum permissible sound pressure level in wheelhouse

NRC

7.05(2) Monitoring of navigation lights

NRC

7.12

Retractable wheelhouses

NRC
CHAPTER 8

8.01(3) Prohibition of certain liquid fuels

NRC

8.04

Engine exhaust system

NRC, at the latest on issue or renewal of the Community certificate

8.05(13) Alarm device for level of fuel filling

NRC

8.08(2) Equipment with bilge pumps

NRC

8.08(3) and (4) Diameter and minimum pumping capacity of bilge pumps

NRC

8.08(5) Self-priming bilge pumps

NRC

8.08(6) Equipment with strainers

NRC

8.08(7) Automatically closable fitting for aft peak

NRC

8.10(2) Noise emitted by craft

NRC
CHAPTER 9

9.01(2) Certificates for electrical equipment

NRC

9.01(3) Installation of electrical equipment

NRC

9.06

Maximum permissible voltages

NRC

9.10

Generators and motors

NRC

9.11(2) Accumulators

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

9.12(2) Switches, protective devices

NRC, at the latest on issue or renewal of the Community certificate after 30 December 2029

9.14(3) Simultaneous switching

NRC

9.15

Cables

NRC

9.16(3) Lighting in engine rooms

NRC

9.17(1) Switchboards for navigation lights

NRC

9.17(2) Power supply for navigation lights

NRC
CHAPTER 10

10.01(9) Anchor windlasses

NRC

10.04(1) Dinghies according to standard

NRC

10.05(1) Lifebuoys according to standard

NRC

10.05(2) Life jackets according to standard

NRC
CHAPTER 11

11.11(2) Safety of winches

NRC
CHAPTER 12

12.02(13) Pipes carrying dangerous gases or liquids

NRC
Article 24a.04

Other derogations

If it is difficult in practical terms to apply the provisions set out in this Chapter following the expiry of the transitional provisions, or if their application gives rise to unreasonably high costs, the inspection body may allow derogations from these provisions subject to recommendations by the Committee. These derogations must be entered in the Community certificate.
(1)  Where appliances release large amounts of heat: IP 12.

(2)  Where appliances or panels do not have this type of protection their location shall meet the conditions applying to that type of protection.

(3)  Electrical equipment of the certified safety type as in accordance with

(a) | European standards EN 50014: 1997; 50015: 1998; 50016: 2002; 50017: 1998; 50018: 2000; 50019: 2000 and 50020: 2002;or

(b) | IEC publication 60079 as of 1 October 2003.

(4)  Where that voltage comes from higher-voltage networks galvanic separation shall be used (safety transformer).

(5)  All of the poles of the secondary circuit shall be insulated from the earth.

(6)  Partitions between control centres and internal muster areas shall correspond to Type A0, but external muster areas only to Type B15.

(7)  Partitions between lounges and internal muster areas shall correspond to Type A 30, but external muster areas only to Type B15.

(8)  Partitions between cabins, partitions between cabins and corridors and vertical partitions separating lounges according to paragraph 10 shall comply with Type B15, for rooms fitted with pressurised sprinkler systems B0.

(9)  Partitions between engine rooms according to Articles 15.07 and 15.10(6), shall comply with Type A60; in other cases they shall comply with Type A0.

(10)  B15 is sufficient for partitions between galleys, on the one hand, and cold-storage rooms and food store rooms, on the other.

(11)  Partitions between control centres and internal muster areas shall correspond to Type A0, but external muster areas only to Type B15.

(12)  Partitions between lounges and internal muster areas shall correspond to Type A 30, but external muster areas only to Type B15.

(13)  Partitions between cabins, partitions between cabins and corridors and vertical partitions separating lounges according to paragraph 10 shall comply with Type B15, for rooms fitted with pressurised sprinkler systems B0.

(14)  Partitions between engine rooms according to Articles 15.07 and 15.10(6), shall comply with Type A60; in other cases they shall comply with Type A0.

(*1)  Distance from the cross-tree to the deck.

(*2)  Total length of the topmast, without the masthead.

(*3)  Diameter of the topmast at the level of the masthead fitting.

(*4)  Total length of the bowsprit.

(*5)  Total length of the jib-boom.

(*6)  Total length of the main boom.

(*7)  Total length of the gaff.

(*8)  Distance from the top or cross-tree to the deck.

(*9)  Distance from the top or cross-tree to the deck.

(15)  

            OJ L 207, 23.7.1998, p. 1. Directive as amended by Directive 98/79/EC (OJ L 331, 7.12.1998, p. 1).

(16)  

            OJ L 164, 30.6.1994, p. 15. Directive as last amended by Regulation (EC) No 1882/2003.

(*10)  The hold sections providing free surfaces that are exposed to water arise from the longitudinal and/or tranverse water-tight compartmentalisation that forms independent sections.

1. | Permanent CO2fire-fighting systems installed before 1 October 1980 may remain in use until the issue or renewal of the Community certificate after 1 January 2035, if they comply with the requirements of Article 7.03(5) of the Rhine Vessel Inspection Regulation in force on 1 April 1976.

2. | Permanent CO2fire-fighting systems installed between 1 April 1992 and 31 December 1994 may remain in use until the issue or renewal of the Community certificate after 1 January 2035, if they comply with the requirements of Article 7.03(5) of the Rhine Vessel Inspection Regulation in force on 31 December 1994.

3. | Recommendations of the CCNR issued between 1 April 1992 and 31 December 1994 with regard to Article 7.03(5) of the Rhine Vessel Inspection Regulation in force on 31 December 1994 remain valid until the issue or renewal of the Community certificate after 1 January 2035.

4. | Article 10.03b(2)(a) is only applicable until the issue or renewal of the Community certificate after 1 January 2035 if those installations have been installed in vessels laid down after 1 October 1992.

(18)  The provision applies to vessels laid down after 31.12.1994 and to vessels in service with the following proviso:The requirements of Article 11.04 must be complied with where the entire hold area is renewed.Where a conversion modifying the clear width of the side deck covers the entire length of the side decks,

(a) | Article 11.04 must be complied with, if the clear width of the side deck before the conversion to a height of 0,90 m, or if the clear width above that height is to be reduced,

(b) | the clear width of the side deck before the conversion to a height of 0,90 m, or the clear width above that height must not be lower than the measurements indicated in Article 11.04.

1. | Permanent CO2fire-fighting systems installed between 1 January 1995 and 31 March 2003 remain authorised until the issue or renewal of the Community certificate after 1 January 2035 if they comply with Article 10.03(5), of the Rhine Vessel Inspection Regulation as applicable on 31 March 2002.

2. | Recommendations of the Central Commission for Navigation on the Rhine issued between 1 January 1995 and 31 March 2002 regarding Article 10.03(5), of the Rhine Vessel Inspection Regulation as applicable on 31 March 2002 remain valid until the issue or renewal of the Community certificate after 1 January 2035.

3. | Article 10.05(2)(a), is applicable until the issue or renewal of the Community certificate after 1 January 2035 only if those systems have been installed in vessels laid down after 1 October 1992.

(20)  The provision applies to vessels laid down 2 years after the date of entry into force of this Directive and to vessels in service with the following proviso:The requirements of Article 11.04 must be complied with where the entire hold area is renewed.Where a conversion modifying the clear width of the side deck covers the entire length of the side decks,

(a) | Article 11.04 must be complied with if the clear width of the side deck before the conversion to a height of 0,90 m, or the clear width above that height is to be reduced,

(b) | the clear width of the side deck before the conversion, to a height of 0,90 m, or the clear width above that height must not be lower than the measurements indicated in Article 11.04.
Safety signsAppendix I

Figure 1No entry for unauthorised persons |  | Colour: red/white/black

Figure 2Fire, naked flame and smoking prohibited |  | Colour: red/white/black

Figure 3Fire extinguisher |  | Colour: red/white

Figure 4General danger warning |  | Colour: black/yellow

Figure 5Extinguisher hose |  | Colour: red/white

Figure 6Fire-fighting installation |  | Colour: red/white

Figure 7Wear acoustic protection device |  | Colour: blue/white

Figure 8First-aid kit |  | Colour: green/whiteThe symbols actually used may slightly differ from or be more detailed than the graphical representations in this Appendix, provided the meaning is not changed and differences and modifications do not render the meaning incomprehensible.
Appendix IIAdministrative instructions

1 | : | Requirements relating to the capacity for evasive action and turning

2 | : | Requirements concerning prescribed minimum speed, stopping capacity and capacity for going astern

3 | : | Requirements for coupling systems and coupling devices for craft pushing or being pushed in a rigid assembly

4 | : | Noise measurements

5 | : | Special reduced mass anchors

6 | : | Strength of watertight side-scuttles

7 | : | Requirements for automatic pressurised-water spraying systems

8 | : | Issue of the ship certificate

9 | : | Fuel tanks on floating craft

10 | : | Minimum hull thickness for barges

11 | : | Used-oil collection facilities

12 | : | Vessel movement under its own power

13 | : | Appropriate fire alarm system

14 | : | Proof of buoyancy, trim and stability of the separate parts of a vessel

15 | : | Equipment for vessels which are to be operated with a minimum crew

16 | : | Electric cables

17 | : | Wheelhouse visibility
ANNEX IIISUBJECTS FOR POSSIBLE ADDITIONAL TECHNICAL REQUIREMENTS APPLICABLE TO VESSELS ON INLAND WATERWAYS OF ZONES 1 AND 2Any additional technical requirements adopted by a Member State under Article 5(1) of this Directive for vessels operating on Zones 1 and/or 2 of that Member State’s territory are limited to the following subjects:
1. | Definitions—Necessary for understanding the additional requirements | — | Necessary for understanding the additional requirements

— | Necessary for understanding the additional requirements

2. | Stability—Structure reinforcement—Certificate/attestation by an approved Classification Society | — | Structure reinforcement | — | Certificate/attestation by an approved Classification Society

— | Structure reinforcement

— | Certificate/attestation by an approved Classification Society

3. | Safety clearance and freeboard—Freeboard—Safety clearance | — | Freeboard | — | Safety clearance

— | Freeboard

— | Safety clearance

4. | Watertightness of hull openings and superstructures—Superstructures—Doors—Windows and skylights—Hold hatches—Other openings (ventilation pipes, exhaust pipes, etc.) | — | Superstructures | — | Doors | — | Windows and skylights | — | Hold hatches | — | Other openings (ventilation pipes, exhaust pipes, etc.)

— | Superstructures

— | Doors

— | Windows and skylights

— | Hold hatches

— | Other openings (ventilation pipes, exhaust pipes, etc.)

5. | Equipment—Anchors and anchor chains—Navigation lights—Sound signals—Compass—Radar—Transmitting and receiving installations—Life-saving equipment—Availability of nautical charts | — | Anchors and anchor chains | — | Navigation lights | — | Sound signals | — | Compass | — | Radar | — | Transmitting and receiving installations | — | Life-saving equipment | — | Availability of nautical charts

— | Anchors and anchor chains

— | Navigation lights

— | Sound signals

— | Compass

— | Radar

— | Transmitting and receiving installations

— | Life-saving equipment

— | Availability of nautical charts

6. | Additional provisions for passenger vessels—Stability (wind strength, criteria)—Life-saving equipment—Freeboard—Safety clearance—Wheelhouse visibility | — | Stability (wind strength, criteria) | — | Life-saving equipment | — | Freeboard | — | Safety clearance | — | Wheelhouse visibility

— | Stability (wind strength, criteria)

— | Life-saving equipment

— | Freeboard

— | Safety clearance

— | Wheelhouse visibility

7. | Convoys and container transport—Pusher connection craft-lighter—Stability of craft or lighters carrying containers | — | Pusher connection craft-lighter | — | Stability of craft or lighters carrying containers

— | Pusher connection craft-lighter

— | Stability of craft or lighters carrying containers
ANNEX IVSUBJECTS FOR POSSIBLE REDUCTIONS OF THE TECHNICAL REQUIREMENTS APPLICABLE TO VESSELS ON INLAND WATERWAYS OF ZONES 3 AND 4Any reduced technical requirements allowed by a Member State under Article 5(7) of this Directive for vessels operating exclusively on Zone 3 or Zone 4 waterways on the territory of that Member State are restricted to the following subjects:
 | Zone 3—Anchor equipment, including length of anchor chains—(Forward) speed—Collective life-saving appliances—Two-compartment status—Wheelhouse visibility | — | Anchor equipment, including length of anchor chains | — | (Forward) speed | — | Collective life-saving appliances | — | Two-compartment status | — | Wheelhouse visibility

— | Anchor equipment, including length of anchor chains

— | (Forward) speed

— | Collective life-saving appliances

— | Two-compartment status

— | Wheelhouse visibility

 | Zone 4—Anchor equipment, including length of anchor chains—(Forward) speed—Life-saving appliances—Two-compartment status—Wheelhouse visibility—Second independent propulsion system | — | Anchor equipment, including length of anchor chains | — | (Forward) speed | — | Life-saving appliances | — | Two-compartment status | — | Wheelhouse visibility | — | Second independent propulsion system

— | Anchor equipment, including length of anchor chains

— | (Forward) speed

— | Life-saving appliances

— | Two-compartment status

— | Wheelhouse visibility

— | Second independent propulsion system
Part IANNEX VMODEL COMMUNITY INLAND NAVIGATION CERTIFICATESMODEL COMMUNITY INLAND NAVIGATION CERTIFICATE
(date)

(Place)

COMMUNITY INLAND NAVIGATION CERTIFICATE

(Reserved for State emblem)

NAME OF STATE

CERTIFICATE No

,

Seal

(Inspection body)

(Signature)

Remarks

The craft may be used for navigation by virtue of this certificate only while in the condition herein described.

In the event of major alterations or repairs, the craft must undergo a special inspection before any new voyage..

The owner of the craft, or his representative, must inform an inspection body of any change in the name or ownership of the craft, any remeasurement and any change in the official number, registration number or home port, and send it the inspection certificate for amendment.

Certificate No . of the inspection body 1. Name of craft 2. Type of craft 3. Official number 4. Name and address of owner 5. Place of registration and registration number 6. Home port 7. Year of construction 8. Name and location of shipyard 9. This certificate replaces Certificate No issued on by the

……………………………………. inspection body 10. The abovementioned craft,

subsequent to the inspection carried out on (*)

on presentation of the certificate issued on (*)

by the approved classification society

is acknowledged as fit to operate

on Community waterways in Zone(s) (*)

on the waterways in Zone(s) (*)

in (Names of States (*))

except for:

on the following waterways in :… (Name of the State (*))

at the maximum authorised draught and with the equipment and crew specified below. 11. The validity of this certificate expires on

(*)

Amendment to item(s):

New text:

(*)

This page has been replaced.

(date)

(Place)

,

Seal

Inspection body

(Signature)

(*) Delete as appropriate.
 1. push (*) 4. be propelled in a side-by-side formation (*)

1.1

in rigid formation (*) 5. tow (*)

1.2

with controlled articulation (*)

5.1

craft having no motive power of their own (*) 2. be pushed (*)

5.2

motorised craft (*)

2.1

in rigid formation (*)

5.3

upstream only (*)

2.2

at the head of a rigid formation (*) 6. be towed (*)

2.3

with controlled articulation (*)

6.1

as a motorised craft (*) 3. propel a side-by-side formation (*)

6.2

as a craft with no motive power of its own (*)

Certificate No . of the inspection body 12. The certificate number (1), official number (2), registration number (3) and measurement number (4) are affixed with the corresponding signs at the following locations on the craft 1. 2. 3. 4. 13. The maximum authorised draught is indicated on each side of the craft

by two — — draught marks (*).

by the upper measurement plates (*).

Two draught scales have been applied (*).

The rear measurement scales serve as draught scales: they have been supplemented for that purpose by figures indicating the draughts (*). 14. Without prejudice to the restrictions (*) mentioned in items 15 and 52, the craft is fit to

(*)

Amendment to item(s):

New text:

(*)

This page has been replaced.

(Place)

(date)

,

Seal

(Inspection body)

(Signature)

(*) Delete as appropriate.
 2. Couplings::

Type of coupling:

Number of couplings per side:

Number of coupling cables:

Length of each coupling cable: m

Tensile strength per longitudinal coupling: kN

Number of cable windings:

Tensile strength per coupling cable: kN

Certificate No . of the inspection body 15. Authorised formations 1. The craft is authorised to propel the following formations:

Formation figure

Restrictions resulting from chapters 5 and 16

Maximum dimensions.

Navigation direction and load status

Maximum wetted

Remarks:

m

upstream

downstream

section in m2

No

length

breadth

loaded t

empty

loaded t

empty

upstream

downstream

o. Stb.

17

16

15

14

13

12

11

10

9

8

7

6

5

4

1

2

3

Other formations

Key to symbols:

pusher

Self-propelled craft

lighter

(*)

Amendment to item(s):

New text:

(*)

This page has been replaced.

(date)

(Place)

,

Seal

(Inspection body)

(Signature)

(*) Delete as appropriate.

Certificate No . of the inspection body 16. Measurement certificate No of the Measurement Office dated

17 a.

17 b.

Length overall m

Length L m

18 a. Breadth overall m

18 b. Breadth B m 19. Maximum draught m 20. Freeboard cm 21. Dead weight/Displacement (*)

t/m3 (*) 22. Number of passengers: 23. Number of passenger berths: 24. Number of watertight compartments 25. Number of holds 26. Type of hatch cover 27. Number of main propulsion engines 28. Total power rating of main means of propulsion

kw 29. Number of main propellers 30. Number of bow windlasses 31. Number of stern windlasses

of which…………. powered

of which………… powered 32. Number of towing hooks 33. Number of towing winches

of which……………………… powered 34. Steering gear

Number of rudder blades on main rudder

Main rudder drive

manual (*)

electric (*)

electric/hydraulic (*)

hydraulic (*)

Other installations:: yes/no (*) Type:

Flanking rudder:

yes /no (*)

Flanking rudder drive:

manual (*)

electric (*)

electric/hydraulic (*)

hydraulic (*)

Bow rudder installation

sí/no (*)

bow rudder (*)

bow thruster (*)

other installation (*)

Remote control

yes /no (*)

Remote activation

yes /no (*) 35. Pumping equipment

Total calculated capacity

Number of power driven pumps

Flow rate

Number of pumps

l/min

l/min

(*)

Amendment to item(s):

New text:

(*)

This page has been replaced.

(date)

(Place)

,

Seal

(Inspection body)

(Signature)

(*) This page has been replaced.

Certificate No . of the inspection body 36. Number and position of closures referred to in Article 8.08(10) and (11) 37. Anchors

Number of bow anchors

Total mass of bow anchors

Number of stern anchors

Total mass of stern anchors

kg

kg 38. Anchor chains

Number of bow anchor chains

Length of each chain

Tensile strength of each chain

m

kN

Number of stern anchor chains

Length of each chain

Tensile strength of each chain

m

kN 39. Mooring cables

1st cable …………….. m long with a tensile strength of……………….. kN

2nd cable ……………… m long with a tensile strength of……………….. kN

3rd cable …………….. m long with a tensile strength of……………….. kN 40. Towing cables

with a length of m and a tensile strength of kN

with a length of m and a tensile strength of kN 41. Visual and audible signals

The lights, flags, balls, floats and audible warning devices used for signalling and to emit the visual and audible signals prescribed by the navigational authority regulations in force in the Member States are carried on board, as are the stand-alone emergency mooring lights prescribed by the navigational authority regulations in force in the Member States

(*)

Amendment to item(s):

New text:

(*)

This page has been replaced

(date)

(Place)

,

Seal

(Inspection body)

(Signature)

(*) Delete as appropriate.

Certificate No . of the inspection body 42. Other equipment

heaving line

Voice communication system

alternative two-way (*)

gangway with handrail

simultaneous two-way/telephone (*)

internal radio-telephone link (*)

gaff hook

Radio-telephone installation

vessel-to-vessel service

first-aid kit

nautical information service

vessel-port authority service

pair of binoculars

notice concerning rescue of persons overboard

fire-resistant receptacles

Cranes

in accordance with Article 11.12(9 (*)

other cranes with a useful load not exceeding 2 000 kg (*)

embarkation stairway/ladder (*) 43. Fire-fighting appliances

Number of portable extinguisher

Fixed sprinkler system(s) No. Number (*)

Other fixed fire-fighting system(s) No. Number (*)

Number of fire pumps

Number of hydrants

Number of hoses

The powered drainage pump replaces a fire pump

Yes/No (*) 44. Life-saving equipment

Number of lifebuoys

A life-jacket for each person regularly on board.

Other life-saving equipment on passenger vessels (*)

A ship’s boat with a set of oars, one mooring line and a baler (*)

Collective life-saving equipment on passenger vessels (*) 45. Special wheelhouse arrangements for radar navigation by one person:

The vessel has a wheelhouse designed for radar navigation by one person (*).

(*)

Amendment to item(s):

New text:

(*)

This page has been replaced.

(date)

(Place)

,

Seal

(Inspection body)

(Signature)

(*) Delete as appropriate.

Certificate No . of the inspection body 46. Operating modes meeting the requirements of national or international law concerning the crew (**) 47. Vessel equipment in accordance with Article 23.09

The vessel (complies) (*)/(does not comply) (*) with Article 23.09 (1)( (*)/(Article 23.09(1)(2) (*)

Space for entering the minimum crew meeting the requirements of national or international law (**)

Space for entering the operating modes according to item 46. 48. Space for entering the minimum crew for vessels that are not covered by general minimum crew prescriptions in national or international requirements (**)

Space for entering the operating modes (**)

Observations and special conditions:

(*)

Amendment to item(s):

New text:

(*)

This page has been replaced.

(date)

(Place)

,

Seal

(Inspection body)

(Signature)

(*) Delete as appropriate.

(**) Requirements of national or international law which a Member State may choose to apply, or have no requirements.

Certificate No . of the inspection body 49. Extension/confirmation (*) of certificate validity (*) Periodical/special (*) inspection

The Inspection Body inspected the vessel on (*).

A certificate dated from the approved classification society

was presented to the inspection body (*)

Reason for the inspection/certificate (*)

In view of the inspection result/certificate (*), the period of validity of the certificate is maintained/extended (*)

until

,

(Place)

(date)

Seal

(Inspection body)

(Signature)

(*) Delete as appropriate. 49. Extension/confirmation (*) of certificate validity (*) Periodical/special (*) inspection

The Inspection Body inspected the vessel on (*).

A certificate dated from the approved classification society

was presented to the inspection body (*)

Reason for the inspection/certificate (*)

In view of the inspection result/certificate (*), the period of validity of the certificate is maintained/extended (*)

until

,

(Place)

(date)

Seal

(Inspection body)

(Signature)

(*) Delete as appropriate. 49. Extension/confirmation (*) of certificate validity (*) Periodical/special (*) inspection

The Inspection Body inspected the vessel on (*).

A certificate dated from the approved classification society

was presented to the inspection body (*)

Reason for the inspection/certificate (*)

In view of the inspection result/certificate (*), the period of validity of the certificate is maintained/extended (*)

until

,

(Place)

(date)

Seal

(Inspection body)

(Signature)

(*) Delete as appropriate.

Certificate No . of the inspection body 49. Extension/confirmation (*) of certificate validity (*) Periodical/special (*) inspection

The Inspection Body inspected the vessel on (*).

A certificate dated from the approved classification society

was presented to the inspection body (*)

Reason for the inspection/certificate (*)

In view of the inspection result/certificate (*), the period of validity of the certificate is maintained/extended (*)

until

,

(Place)

(date)

Seal

(Inspection body)

(Signature)

(*) Delete as appropriate. 49. Extension/confirmation (*) of certificate validity (*) Periodical/special (*) inspection

The Inspection Body inspected the vessel on (*).

A certificate dated from the approved classification society

was presented to the inspection body (*)

Reason for the inspection/certificate (*)

In view of the inspection result/certificate (*), the period of validity of the certificate is maintained/extended (*)

until

,

(Place)

(date)

Seal

(Inspection body)

(Signature)

(*) Delete as appropriate. 49. Extension/confirmation (*) of certificate validity (*) Periodical/special (*) inspection

The Inspection Body inspected the vessel on (*).

A certificate dated from the approved classification society

was presented to the inspection body (*)

Reason for the inspection/certificate (*)

In view of the inspection result/certificate (*), the period of validity of the certificate is maintained/extended (*)

until

,

(Place)

(date)

Seal

(Inspection body)

(Signature)

(*) Delete as appropriate.

Certificate No . of the inspection body 50. Attestation relating to liquefied gas installation(s) The liquefied gas installation(s) on board the craft has/have been inspected by the authorised officer (*)

and according to his acceptance report dated ……………… (*) fulfil(s) the conditions laid down

The plant(s) include(s) the following gas-consuming appliances::

Plant

Serial No

Model

Make

Type

Position

This attestation is valid until

,

(Place)

(date)

Authorised officer (*)

(Inspection body)

(Signature)

Seal

(*)

Amendment to item(s):

New text:

(*)

This page has been replaced.

(date)

(Place)

,

(Inspection body)

(Signature)

Seal

(*) Delete as appropriate.

Certificate No . of the inspection body 51. Extension of the attestation relating to liquefied gas installation(s) The period covered by the attestation relating to liquefied gas installation(s) dated: is extended until

following the periodical inspection by the authorised officer

on presentation of the acceptance report dated

,

(Place)

(date)

Seal

(Inspection body)

(Signature) 51. Extension of the attestation relating to liquefied gas installation(s) The period covered by the attestation relating to liquefied gas installation(s) dated: is extended until

following the periodical inspection by the authorised officer

on presentation of the acceptance report dated

,

(Place)

(date)

Seal

(Inspection body)

(Signature) 51. Extension of the attestation relating to liquefied gas installation(s) The period covered by the attestation relating to liquefied gas installation(s) dated: is extended until

following the periodical inspection by the authorised officer

on presentation of the acceptance report dated

,

(Place)

(date)

Seal

(Inspection body)

(Signature)

Certificate No . of the inspection body 52. Annex to certificate No

(*)

Amendment(s) to item(s):

New text

(*)

This page has been replaced.

(date)

(Place)

,

Seal

(Inspection body)

(Signature)

(*) Delete as appropriate.

Continued on page (*)

End of inspection certificate (*)

Part IIMODEL SUPPLEMENTARY COMMUNITY INLAND NAVIGATION CERTIFICATE
Annex to inspection certificate for the Rhine No Page 1

SUPPLEMENTARY COMMUNITY INLAND NAVIGATION CERTIFICATE

(Reserved for State emblem)

NAME OF STATE

Name and address of the competent authority issuing the supplementary certificate 1. Name of vessel: 2. Official number: 3. Place of registration and registration number: 4. Country of registration and/or home port (1) 5. Having regard to the inspection certificate for the Rhine No

dated valid until 6. Having regard to the result of the inspection

on 7. the abovementioned vessel is deemed fit to operate on the Community waterways of Zone(s) de la Comunidad Europea. 8. This supplementary certificate expires on 9. Issued in, on 10. (Competent authority)

(Signature)

Seal

(1) Delete where inapplicable.

Page 2 Annex to inspection certificate for the Rhine No 11. Zone and / or waterways (1) 4

3

2

1

Freeboard

(cm) with hold closed

with hold open 12. Derogations from inspection certificate for the Rhine No 13. The entries concerning the number of crew members in the inspection certificate for the Rhine do not apply. 14. Having regard to inspection certificate for the Rhine No

dated valid until

Having regard to the result of the inspection

on

This supplementary certificate is extended/renewed (1) until

(Place)

(date)

Seal

(Competent authority)

(Signature)

(1) Delete where inapplicable.

Part IIIMODEL PROVISIONAL COMMUNITY INLAND NAVIGATION CERTIFICATE
Provisional Community certificate (*)/Provisional certificate of Approval (*) No …………….. 1. Name of craft 2. Type of craft 3. Official number 4. Name and domicile of owner 5. Length L/LWL (*) Number of passengers

Number of berths (*) 6. Space for information about the crew

6.1

Operating modes meeting the requirements of national or international law (**)

6.2

Vessel equipment in accordance with Article 23.09

The vessel (complies (*)/(does not comply (*)/with Article 23.09(1) (*)/(Article 23.09(1)(2) (*)

Space for entering the minimum crew meeting the requirements of national or international law (**)

Space for entering the operating modes according to 6.1

6.3. Space for entering the minimum crew for vessels that are not covered by general minimum crew prescriptions in national international requirements (**) 7. Liquefied gas installation(s) Attestation valid until 8. Special conditions 9. Carriage of dangerous goods, see separate box (*) 10. Validity

Provisional certificate (*)/provisional certificate of approval (*) valid until

for navigation (*)/for a single voyage (*) (Date)

The abovementioned craft is acknowledged as fit to operate

on Community waterways in Zone(s) (*)

on the waterways in Zone(s) (*)

in (Names of States (*))

except for

on the following waterways in (Name of State (*))
 11. ,

(Place)

(Date)

,

(Place)

(Date)

(Competent authority for provisional certificate of approval)

Signature

(Inspection body)

Signature

Seal

Seal

(*) Delete as appropriate.

(**) Requirements of national or international law which a Member State may choose to apply, or have no requirements 9. Carriage of dangerous goods

(Indicate whether the vessel meets the requirements of national and international law, if any)
ANNEX VIMODEL REGISTER OF COMMUNITY INLAND NAVIGATION CERTIFICATES
Competent authority/Inspection body

Register of Community inland navigation certificates

Year

(Left-hand page)

Community inland navigation certificate

Name of vessel

Official number of vessel

Owner

Vessel register

Type of vessel

No

Day

Month

Name

Address

Place

No

(Right-hand page)

Deadweight according to tonnage certificate or displacement (*)

Zones or stretch of inland waterway, where appropriate

Endorsements concerning supplementary or special inspections, withdrawal and annulment of the certificate

Community inland navigation certificate valid until

Other comments

Date of tonnage certificate

Tonnage mark

t/m3

from

to

(*) If no tonnage certificate is available, estimate the deadweight or displacement..
Part IANNEX VIICLASSIFICATION SOCIETIESCONTENTS

Part I: | Criteria for the approval of classification societies | 

Part II: | Procedure for the approval of classification societies | 

Part III: | List of approved classification societies | Criteria for the approval of classification societiesClassification societies seeking approval pursuant toArticle 10 of this Directive shall meet all the following criteria:
1. | the classification society shall be able to document extensive experience in assessing the design and construction of inland waterway vessels, including vessels for the carriage of dangerous goods. The classification society shall have comprehensive rules and regulations for the design, construction and periodic inspection of inland waterway vessels, including vessels for the carriage of dangerous goods, which shall be published at least in Dutch, English, French or German and shall be continuously updated and improved through research and development programmes. The rules and regulations must not conflict with the provisions of Community law or with international agreements in force;

2. | the classification society shall publish its register of vessels annually;

3. | the classification society shall not be controlled by shipowners or shipbuilders or by others engaged commercially in the design, manufacture, fitting-out, repair, operation or insurance of ships. The classification society shall not be dependent on a single commercial enterprise for its revenue;

4. | the headquarters of the classification society or a branch authorised to give a ruling and to act in all areas incumbent on it under the regulations governing inland waterway transport shall be located in one of the Member States;

5. | the classification society and its experts shall have a good reputation in inland waterway transport; the experts shall be able to provide proof of their professional abilities. They shall act on the responsibility of the classification society;

6. | the classification society shall have a significant technical, managerial, support, inspection and research staff, in proportion to the tasks and the vessels classified and catering also for developing capability and updating the regulations. It shall have inspectors in at least one Member State;

7. | the classification society shall be governed by a code of ethics;

8. | the classification society shall be managed and administered in such a way as to ensure the confidentiality of information required by a Member State;

9. | the classification society shall be prepared to provide relevant information to a Member State;

10. | the classification society’s management shall have defined and documented its policy and objectives for, and commitment to, quality and ensured that this policy is understood, implemented and maintained at all levels in the classification society;

11. | the classification society shall have prepared and implemented and shall maintain an effective internal quality system based on the relevant parts of internationally recognised quality standards and complying with the EN 45004 (inspection bodies) and EN 29001 standards, as interpreted by the IACS Quality System Certification Scheme Requirements. The quality system must be certified by an independent body of auditors recognised by the administration of the State in which the classification society has its headquarters or branch, as provided for in subparagraph 4, and which,inter alia, ensures that:(a)the classification society’s rules and regulations are established and maintained in a systematic manner;(b)the classification society’s rules and regulations are complied with;(c)the requirements of the statutory work for which the classification society is authorised are satisfied;(d)the responsibilities, powers and interrelation of personnel whose work affects the quality of the classification society’s services are defined and documented;(e)all work is carried out under controlled conditions;(f)a supervisory system is in place which monitors the actions and work carried out by surveyors and technical and administrative staff employed directly by the classification society;(g)the requirements of major statutory work for which the classification society is authorised are only carried out or directly supervised by its exclusive surveyors or by exclusive surveyors of other approved classification societies;(h)a system for qualification of surveyors and continuous updating of their knowledge is implemented;(i)records are maintained, demonstrating achievement of the required standards in the items covered by the services performed, as well as the effective operation of the quality system; and(j)a comprehensive system of planned and documented internal audits of quality-related activities exists in all locations. | (a) | the classification society’s rules and regulations are established and maintained in a systematic manner; | (b) | the classification society’s rules and regulations are complied with; | (c) | the requirements of the statutory work for which the classification society is authorised are satisfied; | (d) | the responsibilities, powers and interrelation of personnel whose work affects the quality of the classification society’s services are defined and documented; | (e) | all work is carried out under controlled conditions; | (f) | a supervisory system is in place which monitors the actions and work carried out by surveyors and technical and administrative staff employed directly by the classification society; | (g) | the requirements of major statutory work for which the classification society is authorised are only carried out or directly supervised by its exclusive surveyors or by exclusive surveyors of other approved classification societies; | (h) | a system for qualification of surveyors and continuous updating of their knowledge is implemented; | (i) | records are maintained, demonstrating achievement of the required standards in the items covered by the services performed, as well as the effective operation of the quality system; and | (j) | a comprehensive system of planned and documented internal audits of quality-related activities exists in all locations.

(a) | the classification society’s rules and regulations are established and maintained in a systematic manner;

(b) | the classification society’s rules and regulations are complied with;

(c) | the requirements of the statutory work for which the classification society is authorised are satisfied;

(d) | the responsibilities, powers and interrelation of personnel whose work affects the quality of the classification society’s services are defined and documented;

(e) | all work is carried out under controlled conditions;

(f) | a supervisory system is in place which monitors the actions and work carried out by surveyors and technical and administrative staff employed directly by the classification society;

(g) | the requirements of major statutory work for which the classification society is authorised are only carried out or directly supervised by its exclusive surveyors or by exclusive surveyors of other approved classification societies;

(h) | a system for qualification of surveyors and continuous updating of their knowledge is implemented;

(i) | records are maintained, demonstrating achievement of the required standards in the items covered by the services performed, as well as the effective operation of the quality system; and

(j) | a comprehensive system of planned and documented internal audits of quality-related activities exists in all locations.

12. | the quality system must be certified by an independent body of auditors recognised by the administration of the State in which the classification society has its headquarters or branch, as provided for in paragraph 4;

13. | the classification society shall undertake to bring its requirements into line with the appropriate European Union directives and to provide the Committee with all relevant information in good time;

14. | the classification society shall undertake periodically to consult with the classification societies already approved in order to guarantee the equivalence of their technical standards and of implementation thereof, and should allow participation in the development of its rules and regulations by representatives of a Member State and other parties concerned.Part IIProcedure for the approval of classification societiesA decision to approve a classification society pursuant to Article 10 of this Directive is to be taken by the Commission according to the procedure referred to in Article 19(2) of this Directive. In addition, the following procedure must be observed:
1. | an application for approval shall be submitted to the Commission by the representatives of the State in which the classification society has its headquarters or a branch authorised to give a ruling and act in all areas incumbent on it under the regulations governing inland waterway vessels. Furthermore, the representatives of this State shall send all information and documentation needed to check that the criteria for approval are met;

2. | any Committee member can demand a hearing with the classification society concerned or that further information or documentation be provided;

3. | approval shall be withdrawn in a similar way. Any Committee member can ask for approval to be withdrawn. The representatives of the State asking for the withdrawal shall submit the information and documentation supporting their application;

4. | when making its decisions, the Commission shall take account of decisions made by the Central Commission for Navigation on the Rhine regarding approval of the classification society concerned. Before approving a classification society which has not been approved by the Central Commission for Navigation on the Rhine, the Commission shall consult the Secretariat of the Central Commission;

5. | following each decision on approval of a classification society or the withdrawal of approval, the list of approved societies shall be amended;

6. | the Commission shall inform the classification societies concerned of the Commission’s decisions.Part IIIList of approved classification societiesOn the basis of the criteria set out in Parts I and II, the following classification societies are currently approved in accordance with Article 10 of this Directive:
1. | Bureau Veritas,

2. | Germanischer Lloyd,

3. | Lloyd’s Register of Shipping.Until their approval under Parts I and II, classification societies which are recognised and approved and authorised by a Member State in accordance with Council Directive 94/57/EC of 22 November 1994 on common rules and standards for ship inspection and survey organisations and for the relevant activities of maritime administrations(1)are currently approved in accordance with Article 10 of this Directive only in respect of vessels which operate exclusively on waterways of that Member State.
(1)  

            OJ L 319, 12.12.1994, p. 20. Directive as last amended by Directive 2002/84/EC of the European Parliament and of the Council (OJ L 324, 29.11.2002, p. 53).
ANNEX VIIIRULES OF PROCEDURE FOR THE CARRYING OUT OF INSPECTIONS

Article 1

If the authorities find upon inspection that the certificate carried on the vessel is invalid, or that the vessel does not satisfy the requirements set out in the certificate, but that such invalidity or failure to satisfy the requirements does not constitute a manifest danger, the owner of the vessel or his representative shall take all necessary measures to remedy the situation. The authority which issued the certificate or which last renewed it shall be informed within seven days.
Article 2

If, upon making the inspection referred to in Article 1, the authorities find that the certificate is not being carried or that the vessel constitutes a manifest danger, they may prevent the vessel from proceeding until the necessary steps have been taken to remedy the situation.

They may also prescribe measures which will enable the vessel to proceed safely, where appropriate on termination of its transport operations, to a place where it will be either inspected or repaired. The authority which issued or last renewed the certificate shall be informed within seven days.
Article 3

A Member State which has prevented a vessel from proceeding, or has notified the owner of its intention to do so if the defects found are not corrected, shall inform the authority in the Member State which issued or last renewed the certificate, within seven days, of the decision which it has taken or intends to take.
Article 4

Any decision to interrupt the passage of a vessel taken pursuant to measures adopted in implementation of this Directive shall state in detail the reasons on which it is based. It shall be notified without delay to the party concerned, who shall at the same time be informed of the appeal procedures available to him under the laws in force in the Member States and of their time limits.
PART IANNEX IXREQUIREMENTS APPLICABLE TO SIGNAL LIGHTS, RADAR INSTALLATIONS AND RATE-OF-TURN INDICATORSCONTENTS

Part I: | Requirements concerning the colour and intensity of lights and the approval of signal lanterns for inland waterway vessels | 

Part II: | Requirements concerning the conditions for testing and approval of signal lanterns for inland waterway vessels | 

Part III: | Minimum requirements and test conditions for radar installations used for navigation in inland waterway vessels | 

Part IV: | Minimum requirements and test conditions for rate-of-turn indicators used in inland waterway vessels | 

Part V: | Requirements for installation and performance tests for radar equipment and rate-of-turn indicators used in inland waterway vessels | 

Part VI: | Model list of test institutes, approved equipment and approved installation firms | REQUIREMENTS CONCERNING THE COLOUR AND INTENSITY OF LIGHTSAND THE APPROVAL OF SIGNAL LANTERNSFOR INLAND WATERWAY VESSELSCONTENTS

Chapter 1 | Definitions | 

Article 1.01. | Signal lanterns | 

1.02. | Signal lights | 

1.03. | Light sources | 

1.04. | Optic | 

1.05. | Filter | 

1.06. | Relation between IO, IBand t | 

Chapter 2 | Requirements for signal lights | 

Article 2.01. | Colour of signal lights | 

2.02. | Luminous intensity and range of signal lights | 

2.03. | Signal light dispersion | 

Chapter 3 | Requirements for signal lanterns | 

Article 3.01. | Technical requirements | 

Chapter 4 | Tests, approval and markings | 

Article 4.01. | Type tests | 

4.02. | Test procedure | 

4.03. | Approval certificate | 

4.04. | Spot checks | 

4.05. | Markings | 

Appendix | Model approval certificate for signal lanterns for inland waterway vessels | CHAPTER 1DEFINITIONS

Article 1.01

Signal lanterns 1.   ‘Lantern’ means a device for distributing the flux from an artificial light source; it also includes the components needed to filter, refract or reflect the light, and to hold or operate the light source. 2.   Lanterns intended to give signals on board a vessel are called signal lanterns.
Article 1.02

Signal lights 1. ‘Signal lights’ means the light signals emitted by signal lanterns. 2. ‘Masthead light’ means a white light, visible throughout a horizontal arc of 225° and projecting a uniform uninterrupted beam over 112° 30′ on each side, i.e. from the bow to 22° 30′ abaft the beam on each side. 3. ‘Side lights’ means a green light to starboard and a red light to port; each of these lights shall be visible throughout a horizontal arc of 112° 30′ and project a uniform uninterrupted beam, i.e. from the bow to 22° 30′ abaft the beam. 4. ‘Stern light’ means a white light, visible throughout a horizontal arc of 135° and projecting a uniform uninterrupted beam over a sector of 67° 30′ along each side from the stern. 5. ‘Yellow stern light’ means a yellow light, visible throughout a horizontal arc of 135° and projecting a uniform uninterrupted beam over a sector of 67° 30′ along each side from the stern. 6. ‘Light visible from all directions’ means a light visible throughout a horizontal arc of 360° and projecting a uniform uninterrupted beam. 7. (a) ‘Scintillating light’ means a light flashing at a rate of 40 to 60 light periods per minute.

(b) ‘Rapidly scintillating light’ means a light flashing at a rate of 100 to 120 light periods per minute.

A scintillating light is a series of regular light periods per unit time. 8. Signal lights are classified according to their luminous intensity as:

—

ordinary lights,

—

bright lights,

—

strong lights.
Article 1.03

Light sources

‘Light sources’ means electrical or non-electrical devices designed to produce light fluxes in signal lanterns.
Article 1.04

Optic 1. ‘Optic’ means a device comprising refracting, reflecting, or refracting and reflecting components, including their holders. The function of these components is to direct the rays from a light source in new specific directions. 2. ‘Coloured optic’ means an optic which modifies the colour and intensity of the light transmitted. 3. ‘Neutral optic’ means an optic which modifies the intensity of the light transmitted.
Article 1.05

Filter 1. ‘Coloured filter’ means a selective filter which modifies the colour and intensity of the light transmitted. 2. ‘Neutral filter’ means a non-selective component which modifies the intensity of the light transmitted.
Article 1.06

Relation between IO, IB and t

IO

means the photometric luminous intensity in candelas (cd) measured at normal voltage for electric lights.

IB

means the operational luminous intensity in candelas (cd).

t

means the range in kilometres (km).

Taking into account, for example, the ageing of the light source, the degree of dirtiness of the optic and variations in the voltage of the on-board grid, IB is taken as 25 % less than IO.

Consequently:
IB = 0,75 · IO

The relation between IB and t of signal lights is given by the following equation:
IB = 0,2 · t2 · q-t

The atmospheric transmission coefficient q is taken as 0,76, corresponding to a meteorological visibility of 14,3 km.

CHAPTER 2REQUIREMENTS FOR SIGNAL LIGHTS

Article 2.01

Colour of signal lights 1.   A five-colour signal system shall apply to the lights, comprising the following colours:

—

white,

—

red,

—

green,

—

yellow,

—

blue.

This system shall conform to the recommendations of the International Commission on Illumination, ‘Colours of Signal Lights’, IEC publication No 2.2. (TC-1.6) 1975. The colours shall apply to the light fluxes emitted by the signal lantern. 2.   The colour boundaries of signal lights shall be demarcated by the coordinates of the intersecting points of the chromatic diagram in IEC publication No 2.2 (TC-1.6) 1975 (see chromaticity diagram) as follows:

Colour of signal light

Coordinates of the intersecting points

White

x

0,310

0,443

0,500

0,500

0,453

0,310

y

0,283

0,382

0,382

0,440

0,440

0,348

Red

x

0,690

0,710

0,680

0,660

y

0,290

0,290

0,320

0,320

Green

x

0,009

0,284

0,207

0,013

y

0,720

0,520

0,397

0,494

Yellow

x

0,612

0,618

0,575

0,575

y

0,382

0,382

0,425

0,406

Blue

x

0,136

0,218

0,185

0,102

y

0,040

0,142

0,175

0,105

IEC chromaticity diagram

where

                                    2 930 K corresponds to the light of a vacuum filament lamp

                                    2 856 K corresponds to the light of a gas-filled filament lamp
Article 2.02

Intensity and range of the signal lights

The table set out below contains the permitted limits for IO, IB and t (daytime and nighttime use) according to the nature of the signal lights. The values indicated shall apply to the light flux emitted by the signal lanterns.

IO and IB are given in cd and t in km.

Maximum and minimum values

Nature of the signal lights

Colour of signal light

White

Green/red

Yellow

Blue

min.

max.

min.

max.

min.

max.

min.

max.

ordinary

IO

2.7

10.0

1.2

4.7

1.1

3.2

0.9

2.7

IB

2.0

7.5

0.9

3.5

0.8

2.4

0.7

2.0

t

2.3

3.7

1.7

2.8

1.6

2.5

1.5

2.3

bright

IO

12.0

33.0

6.7

27.0

4.8

20.0

6.7

27.0

IB

9.0

25.0

5.0

20.0

3.6

15.0

5.0

20.0

t

3.9

5.3

3.2

5.0

2.9

4.6

3.2

5.0

strong

IO

47.0

133.0

–

–

47.0

133.0

–

–

IB

35.0

100.0

–

–

35.0

100.0

–

–

t

5.9

8.0

–

–

5.9

8.0

–

–

However, for daytime use of the yellow scintillating lights a minimum luminous intensity (IO) of 900 cd shall apply.
Article 2.03

Signal light dispersion 1.   Horizontal dispersion of the luminous intensity

1.1. The luminous intensities indicated in Article 2.02 shall apply to all directions of the horizontal plane passing through the focus of the optic or the luminous centre of gravity of the correctly adjusted light source of a vertically positioned signal lantern.

1.2. For the masthead lights, stern lights and side lights, the luminous intensities prescribed shall be maintained throughout the horizontal arc within the sector prescribed at least up to within 5° of the limits.

As from 5° within the sector prescribed up to the limit, the luminous intensity may decrease by 50 %; it shall subsequently decrease gradually in such a way that, as from 5° beyond the limits of the sector, only a negligible amount of light remains.

1.3. The side lights shall have the prescribed luminous intensity in the direction parallel to the axis of the vessel forward. The intensities shall decrease practically to zero between 1° and 3° beyond the limits of the prescribed sector.

1.4. For bi-coloured or tri-coloured lanterns, the dispersion of the luminous intensity shall be uniform so that 3° on either side of the prescribed sector limits, the maximum permitted intensity is not exceeded and the minimum prescribed intensity is reached.

1.5. The horizontal dispersion of the luminous intensity of the lanterns shall be uniform throughout the sector, so that the minimum and maximum values observed for the photometric luminous intensity do not differ by more than a factor of 1,5. 2.   Vertical dispersion of the luminous intensity

In the event of heeling of up to ± 5° or ± 7,5° from the horizontal, the luminous intensity shall remain at least equal to 80 % in the first case, and 60 % in the second case, of the luminous intensity corresponding to 0° heeling, although it shall not exceed it by more than 1,2 times.

CHAPTER 3REQUIREMENTS FOR SIGNAL LANTERNS

Article 3.01

Technical requirements 1.   The construction of and materials of signal lanterns and light sources shall be such as to ensure their safety and durability. 2.   The components of the lanterns (for example, the cross braces) shall not impair the intensity, colours or dispersion of the light. 3.   It shall be possible to install the signal lanterns on board simply and in the correct position. 4.   It shall be easy to replace the light source.

CHAPTER 4TESTS, APPROVAL AND MARKINGS

Article 4.01

Type tests

The type test according to the ‘Conditions for testing and approval of signal lanterns in inland waterway vessels’ is intended to ascertain whether the signal lanterns and their light source meet these requirements.
Article 4.02

Test procedure 1.   An application for a type test shall be submitted to the competent testing authority, with at least two copies of the plans and two specimens of the lantern as well as the light sources required. 2.   If the test does not give rise to objections, one copy of the plans accompanying the application, with the approval entered on it, and one of the approved specimen lanterns shall be returned to the applicant. The second copy and second specimen lantern shall be kept by the testing authority. 3.   The manufacturer shall declare to the testing authority that all the components of the series-produced lantern conform to those of the type-tested lantern.
Article 4.03

Approval certificate 1.   If the type test shows that these requirements have been met, the signal lantern type shall be approved and an approval certificate based on the model in the Appendix and bearing the markings referred to in Article 4.05 shall be issued to the applicant. 2.   The holder of the approval certificate:

—

shall be authorised to affix the markings referred to in Article 4.05 to the various parts;

—

may undertake manufacture only in conformity with the plans approved by the testing authority and according to the technique used for the type-tested lanterns;

—

may modify the approved plans and lantern models only with the approval of the testing authority. The latter shall also decide whether the approval certificate issued only requires additions to be made to it or whether a new application for approval is needed.
Article 4.04

Spot checks 1.   The testing authority shall be empowered to take samples of signal lanterns from the production series for testing. 2.   If the test reveals serious shortcomings, the approval may be withdrawn.
Article 4.05

Markings 1.   Approved signal lanterns, optics and light sources shall be marked as indicated below:
 e. X. YY. nnn

where ‘
 e’ is the approval mark,

                        ‘X’ indicates the country of approval, where:

1

=

Germany

2

=

France

3

=

Italy

4

=

Netherlands

5

=

Sweden

6

=

Belgium

7

=

Hungary

8

=

Czech Republic

9

=

Spain

11

=

United Kingdom

12

=

Austria

13

=

Luxembourg

17

=

Finland

18

=

Denmark

20

=

Poland

21

=

Portugal

23

=

Greece

24

=

Ireland

26

=

Slovenia

27

=

Slovakia

29

=

Estonia

32

=

Latvia

36

=

Lithuania

49

=

Cyprus

50

=

Malta

                        ‘YY’ are the last two figures of the year of approval, and

                        ‘nnn’ is the approval number assigned by the testing authority. 2.   The markings shall be clearly legible and shall be indelibly affixed. 3.   Markings on the housing shall be such that the signal lantern does not need to be dismantled in order to find them on board. If the optic and housing are inseparable, a marking on the housing shall suffice. 4.   Only approved signal lanterns, optics and light sources may bear the markings indicated in paragraph 1 above. 5.   The testing authority shall immediately inform the Committee of the marking assigned.
Appendix

Text of image

MODEL APPROVAL CERTIFICATE FOR SIGNAL LANTERNS FOR INLAND WATERWAY VESSELS

The signal lantern

(Description of type, model, and trademark)

is authorised for use in inland waterway vessels within the scope of Directive 2006/87/EC of the European Parliament and of the Council of 12 December 2006 laying down technical requirements for inland waterway vessels and repealing Council Directive 82/714/EEC.

It has been assigned No e

The components of the lantern shall be marked in conformity with Article 4.05 of Part I of Annex IX to Directive 2006/87/EC.

The holder of the approval shall guarantee, in conformity with Article 4.03 of Part I of Annex IX of Directive 2006/87/EC, that manufacture is undertaken only in conformity with the plans approved by the testing authority and in accordance with the technique used for the type-tested lanterns. Modifications are permitted only with the approval of the testing authority.

Special comments

(Place)

(Date)

(Testing authority)

(Signature)

PART IIREQUIREMENTS CONCERNING THE CONDITIONS FOR TESTING AND APPROVAL OF SIGNAL LANTERNS FOR INLAND WATERWAY VESSELSCONTENTS

Chapter 1 | General provisions | 

Article 1.01 | Standard voltages | 

1.02 | Operating requirements | 

1.03 | Mounting | 

1.04 | Photometric requirements | 

1.05 | Components | 

1.06 | Maintenance | 

1.07 | Safety requirements | 

1.08 | Accessories | 

1.09 | Non-electric signal lanterns | 

1.10 | Double lanterns | 

Chapter 2 | Photometric and colorimetric requirements | 

Article 2.01 | Photometric requirements | 

2.02 | Colorimetric requirements | 

Chapter 3 | Manufacturing requirements | 

Article 3.01 | Electric lanterns | 

3.02 | Filters and optical glasses | 

3.03 | Electric light sources | 

Chapter 4 | Test and approval procedure | 

Article 4.01 | General rules of procedure | 

4.02 | Application | 

4.03 | Test | 

4.04 | Approval | 

4.05 | Cessation of validity of the approval | 

Appendix | Environment tests | 

1. | Test concerning protection against splashing water and dust | 

2. | Humid atmosphere test | 

3. | Cold test | 

4. | Heat test | 

5. | Vibration test | 

6. | Accelerated weather resistance test | 

7. | Salt water and weather-resistance test (sea-fog test) | CHAPTER 1GENERAL PROVISIONS

Article 1.01

Standard voltages

The standard voltages for signal lanterns for inland waterway vessels shall be 230 V, 115 V, 110 V, 24 V and 12 V. Wherever possible, 24 V appliances should be used.
Article 1.02

Operating requirements

The normal operation of signal lanterns and their accessories shall not be hindered by routine on-board operations. In particular, all the optical components used and major parts for mounting and adjusting them shall be so manufactured that their position, once established, cannot be modified during operation.
Article 1.03

Mounting

The parts for mounting signal lanterns on board shall be so made that, once they have been adjusted, the position of the lanterns, when fixed, cannot be modified during operation.
Article 1.04

Photometric requirements

Signal lanterns shall produce the prescribed dispersion of luminous intensity; the identifying colour of the light and the prescribed intensity shall be obtained as soon as the light is turned on.
Article 1.05

Components

Only components manufactured for the purpose shall be used in signal lanterns.
Article 1.06

Maintenance

The method of construction of signal lanterns and their accessories shall permit their regular maintenance and, if necessary, enable light sources to be changed easily, even in darkness.
Article 1.07

Safety requirements

Signal lanterns and their accessories shall be so manufactured and proportioned that they can be operated, controlled and monitored without danger to persons.
Article 1.08

Accessories

Lantern accessories shall be so designed and manufactured that their arrangement, mounting and connection shall not hinder the normal use and proper functioning of the lanterns.
Article 1.09

Non-electric signal lanterns

Non-electric lanterns shall be designed and manufactured in conformity with Articles 1.02 to 1.08 of this Chapter and so as to meet the requirements of Chapter 3. The requirements contained in Chapter 2 of these testing and approval conditions shall apply mutatis mutandis.
Article 1.10

Double lanterns

It shall be possible to use two lanterns mounted one above the other in one housing (double lantern) as a single lantern. Under no circumstances shall the two light sources of a double lantern be used simultaneously.

CHAPTER 2PHOTOMETRIC AND COLORIMETRIC REQUIREMENTS

Article 2.01

Photometric requirements 1.   The photometric specifications for signal lanterns are set out in Part I. 2.   The construction of signal lanterns shall guarantee that the light cannot be reflected or interrupted. The use of reflectors shall not be permitted. 3.   In the case of two-colour or three-colour lights, the projection of light of a colour beyond the sector limits prescribed for that colour shall be effectively prevented, including inside the glass. 4.   These requirements shall apply mutatis mutandis to non-electric lights.
Article 2.02

Colorimetric requirements 1.   The colorimetric specifications for signal lanterns are set out in Part I. 2.   The colour of the light emitted by signal lanterns shall be situated, for the temperature of the colour used by the light source, in the appropriate chromatic position established in Part I. 3.   The colour of signal lights shall come only from filters (optics, glasses) and optical glasses coloured throughout if the chromatic points of the transmitted light do not diverge by more than 0,01 from their coordinates in the IEC chromaticity diagram. Coloured bulbs shall not be permitted. 4.   The transparency of coloured glasses (filters) shall be such that, at the temperature of the light source colour used, the luminous intensity prescribed shall be reached. 5.   The reflection of the source light on the parts of the signal lantern shall not be selective, i.e. the trichromatic coordinates x and y of the source used in the signal lantern shall, at the temperature of the colour used, not deviate by more than 0,01 following reflection. 6.   Colourless glass shall not, at the temperature of the colour used, selectively influence the light emitted. Similarly, following an extensive operating period, the trichromatic coordinates x and y of the light source used in the signal lantern shall not deviate by more than 0,01, once the light has passed through the glass. 7.   The colour of the light of non-electric signal lanterns, at the temperature of the light source used, shall be located in the appropriate chromatic position established in Part I. 8.   The colour of the light from non-electric coloured signal lanterns shall come only from silicate glass, coloured throughout. For coloured non-electric lanterns, all the coloured silicate glass shall be such that at the colour temperature nearest the non-electric light source the prescribed luminous intensity shall be reached.

CHAPTER 3MANUFACTURING REQUIREMENTS

Article 3.01

Electric signal lanterns 1.   All the parts of the lanterns shall withstand the particular operational stresses resulting from movement of the vessel, vibrations, corrosion, temperature variations, impacts during loading and navigation in ice and other influences which may be exerted on board. 2.   The construction, the materials and the workmanship of the lantern shall guarantee stability and ensure that, after mechanical and thermal stresses and exposure to ultraviolet rays in accordance with these requirements, its performance is unchanged; in particular, the photometric and colorimetric properties shall be preserved. 3.   The components exposed to corrosion shall be made of corrosion-resistant materials or be provided with effective protection against corrosion. 4.   The materials used shall not be hygroscopic where this would be detrimental to the operation of the installations, appliances and accessories. 5.   The materials used shall be highly fire-resistant. 6.   The testing authority may grant exemptions concerning the properties of the materials used provided that safety is guaranteed by the manufacture. 7.   Signal lanterns shall be tested to ensure their suitability for use on board. The tests shall be divided between environmental and operating requirements. 8.   Environmental requirements:

(a) Type of environment

—

Type of climate:

X

Appliances intended for use in places exposed to weather conditions.

S

Appliances intended for submersion or for prolonged contact with salt water.

—

Types of vibration:

V

Appliances and devices intended for installation on masts and at other points particularly exposed to vibrations.

—

Types of ambient conditions:

Ambient conditions are divided into three types: 1. Normal ambient conditions:

These may regularly occur on board during a long period. 2. Extreme ambient conditions:

These may exceptionally occur on board in special cases. 3. Transport ambient conditions:

These may occur during transport and immobilisation other than during the operation of the installations, appliances and accessories.

Tests under normal ambient conditions are described as ‘normal ambient tests’, tests under extreme ambient conditions as ‘extreme ambient tests’ and tests under transport ambient conditions as ‘transport ambient tests’.

(b) Requirements

Signal lanterns and their accessories shall be suited to lengthy operation under the influence of the motion of the sea, and of the vibrations, humidity and temperature variations which must be expected on board ship.

Signal lanterns and their accessories shall, on exposure to the ambient conditions listed in the Appendix, meet the requirements of their class of environment, as defined in paragraph 8(a). 9.   Suitability for operation

(a) Power supply: during fluctuations in the voltages and frequencies of the supply current from their rated values (1) within the limits specified in the table set out below and oscillations of 5 % in the alternating supply voltage, signal lanterns and their accessories shall operate within the permitted tolerances for on-board operation applicable to them on the basis of the test and approval conditions. Theoretically, the supply voltage for the lanterns shall not deviate by more than ± 5 % from the rated voltage selected.

Supply

(Rated voltage)

Fluctuations in voltage and frequency of the supply current of lanterns and their accessories

Fluctuations in voltage

Fluctuations in frequency

Duration

Direct current of more than 48 V

± 10 %

± 5 %

continuous

and alternating current

± 20 %

± 10 %

max. 3 s

Direct current up to and including 48 V

± 10 %

–

continuous

Voltage peaks of up to ± 1 200 V with a rise time of between 2 and 10 μs and a maximum duration of 20 μs and the reversal of the supply voltage shall not cause damage to the signal lanterns and their accessories. After their occurrence, when safety devices may have cut in, the signal lanterns and their accessories shall operate within the permitted tolerances for on-board operation on the basis of the test and approval conditions.

(b) Electromagnetic compatibility: all reasonable and practical measures shall be taken to eliminate or reduce the reciprocal electromagnetic effects of lanterns and their accessories and of other installations and appliances forming part of the vessels’ equipment. 10.   Ambient conditions on board vessels

The normal, extreme and transport ambient conditions referred to in paragraph 8(a) are based on the proposed additions to IEC publications 92-101 and 92-504. Other values deviating from them are marked with *.
Normal

Extreme

Transport

Ambient conditions

(a)   Ambient air temperature:

Classes of climate:

– 25 to

– 25 to

– 25 to

Climate classes X and S according to paragraph 8(a) + 55 °C*

+ 55 °C*

+ 70 °C*

(b)   Ambient air humidity:

Constant temperature

+ 20 °C

+ 35 °C

+ 45 °C

Maximum relative humidity

95 %

75 %

65 %

Change of temperature

Possibly reaching dewpoint

(c)   Weather conditions on deck:

Sunlight

1 120  W/m2

Wind

50 m/s

Rainfall

15 mm/min

Speed of the water during movement (waves)

10 m/s

Water salinity

30 kg/m3

(d)   Magnetic field:

Magnetic field from any direction

80 A/m

(e)   Vibration:

Sinusoidal vibration from any direction

Class of vibration V according to paragraph 8(a) (severe stress, e.g. on masts)

Frequencies

2 to 10 Hz

2 to 13,2 Hz*

Range

± 1,6 mm

± 1,6 mm

Frequencies

10 to 100 Hz

13,2 to 100 Hz*

Range of acceleration

± 7 m/s2

± 11 m/s2 * 11.   Signal lanterns must pass the environment tests set out in the Appendix. 12.   Lantern components made of organic materials shall not be sensitive to ultraviolet radiation.

After testing for 720 hours in conformity with paragraph 6 of the Appendix, there shall be no deterioration in quality and the trichromatic coordinates x and y shall not deviate by more than 0,01 from those for transparent parts which have been exposed neither to radiation nor to water. 13.   The transparent parts and screens of the lanterns shall be so designed and manufactured that, given normal on-board requirements, extended operation with an excess voltage of 10 % and an ambient temperature of + 45 °C, they are not deformed, altered or destroyed. 14.   With extended operation and an excess voltage of 10 % and an ambient temperature of + 60 °C, lanterns shall remain intact on their holders when subjected to a force of 1 000 N (Newton) for eight hours. 15.   Lanterns shall be resistant to temporary submersion. During extended operation with an excess voltage of 10 % and an ambient temperature of + 45 °C, they shall not be affected by drenching with the contents of a receptacle containing 10 litres of water at a temperature of + 15 to + 20 °C. 16.   The durability of the materials used shall be ensured under operating conditions; in particular, the materials shall be capable of withstanding, during operation, their highest continuous use temperatures. 17.   If the lanterns include non-metallic components, their continuous use temperature under on-board conditions at an ambient temperature of + 45 °C shall be determined.

If the continuous use temperature of the non-metallic materials as so determined exceeds the maximum temperatures indicated in Tables X and XI in IEC publication 598, part 1, special examinations shall be carried out to determine the resistance to continuous mechanical, thermal and climatic stresses on these parts of the lanterns. 18.   For the non-deformability tests of parts at continuous use temperature, the lantern shall be placed in operating position in a slight constant air flow (v = approximately 0,5 m/s) in an ambient temperature of + 45 °C and under on-board conditions. While they are being brought to temperature, and once the operating temperature is reached, the non-metallic parts shall be subjected to a mechanical stress in keeping with their purpose or with possible manipulation thereof. The transparent parts of the lanterns of materials other than silicate glass shall be subjected to the action of a 5 mm x 6 mm metallic punch exerting a continuous force of 6,5 N (equivalent to finger pressure) half way between the upper and lower sides of the transparent part.

The part shall not suffer any permanent deformation as a result of such mechanical stresses. 19.   For the test of the resistance of the components to atmospheric agents, lanterns with non-metallic components exposed to the elements shall be placed in a climatic chamber, for 12 consecutive hours alternately in an atmosphere of 45 °C and 95 % relative humidity and an atmosphere of — 20 °C, and operated intermittently under on-board conditions, so that they are exposed to hot-humid and cold cycles and to changes from low to high temperatures for periods corresponding to their operating times.

The total duration of this test shall be at least 720 hours. The test shall not affect the operational capacity of the non-metallic parts of the lantern. 20.   The parts of lanterns within easy reach shall not, in an ambient temperature of + 45 °C, reach temperatures higher than + 70 °C when they are made of metal or + 85 °C if they are not made of metal. 21.   Lanterns shall be designed and manufactured according to accepted standards and comply, in particular, with IEC publication 598, part 1, ‘Ships, lights — General specifications and tests’. The requirements of the following paragraphs shall be met:

—

protection of connections ( 7.2),

—

protection against electric shocks ( 8.2),

—

insulation resistance and voltage stability ( 10.2 and 10.3),

—

ground and overhead lines ( 11.2),

—

durability and heating ( 12.1, tables X, XI and XII),

—

resistance to heat, fire and to stray currents ( 13.2, 13.3 and 13.4),

—

threaded connections ( 14.2, 14.3 and 14.4). 22.   Electric wiring shall normally have a cross-section of not less than 1,5 mm2. The wire used for the connection shall be at least of type HO 7 RN-F or equivalent. 23.   The type of lantern protection for explosion danger zones shall be established and certified for the purpose by the competent testing authorities. 24.   The method of manufacture of the lanterns shall make provision for: 1. ease of cleaning, including inside the lantern, and ease of changing the light source, even in darkness; 2. prevention of the accumulation of condensation; 3. use of durable elastic fittings only to ensure that demountable parts are leakproof; 4. ensuring that no light of any colour other than that provided for can escape from the lantern. 25.   All lanterns to be installed shall be accompanied by positioning and installation instructions indicating where the light is to be mounted, and the purpose and the type of interchangeable parts. It shall be possible to position movable lanterns easily and safely. 26.   The required mounts shall be such that, in its intended position, the horizontal plane of symmetry of the lantern is parallel to the water line of the vessel. 27.   The following marks shall be placed clearly and durably on each lantern, at a point remaining visible after installation on board: 1. the rated power of the source, in so far as different rated powers may give different ranges, 2. the type of lantern for sector lights, 3. the zero-direction reference, on sector lights, using a mark immediately above or below the transparent section, 4. the type of light, e.g. ‘strong’, 5. the trademark, 6. the place for the approval mark, for example .F.91.235. 

Article 3.02

Filters and optical glasses 1.   Filters (optics and glasses) and optical glasses may be made of organic glass (synthetic glass) or inorganic glass (silicate glass).

Filters and optical glasses of silicate glass shall be made of a glass at least of the class IV hydrolytic type referred to in ISO standard 719 guaranteeing durable resistance to water.

Filters and optical glasses of synthetic glass shall have a durable resistance to water comparable with those made of silicate glass.

Optical glasses shall be manufactured in glass with low internal stress. 2.   Filters and optical glasses shall as far as possible be free of blisters, bubbles and impurities. There shall be no surface defects such as unpolished (matt) sections, deep scratches, etc. 3.   Filters and optical glasses shall meet the requirements of Article 3.01. Their photometric and colorimetric properties shall not be affected by those conditions. 4.   The red and green optical glasses of the side lights shall not be interchangeable. 5.   In addition to the manufacturer’s mark, the approval number and the type description shall be legibly and durably marked on filters and optical glasses at a point remaining visible once they have been placed in the lanterns.

These markings shall not result in values below the minimum photometric and colorimetric requirements.
Article 3.03

Electric light sources 1.   Only filament lamps manufactured for the purpose shall be used in signal lanterns. They shall be available in the standard voltages. Exceptions may be permitted in special cases. 2.   It shall be possible to install filament lamps only in the intended position in signal lanterns. A maximum of two unequivocal positions shall be permitted in signal lanterns. Incorrect and intermediate positions shall not be possible. For the test, the less favourable position shall be selected. 3.   Filament lamps shall have no special features which adversely affect their efficiency, such as scratches or stains on the bulk or faulty positioning of the filament. 4.   The operating colour temperature of filament lamps shall not be less than 2 360 K. 5.   The mountings and lamp holders used shall meet the special requirements of the optical system and withstand the mechanical stresses of on-board operations. 6.   The cap of the filament lamp shall be strong and solidly attached to the bulk so that after operating for 100 hours at an excess voltage of 10 % it withstands uniform rotation with a moment of 25 kgcm. 7.   The trademark, the rated voltage and the power rating and/or the rated luminous intensity as well as the approval number shall be marked legibly and durably on the bulk or on the cap of filament lamps. 8.   Filament lamps shall meet the following tolerances:

(a) Filament lamps for the rated voltages of 230 V, 115 V, 110 V and 24 V

Text of image

Permissible deviation of the filament axis from the socket axis at a light-centre-length of 1,5 mm

Light-centre-length

Clear

Marktar

Socket position: L (2) Lamp socket e.g. P 28s

45 ± 2 mm (1) Rated voltage

V

Rated output

W

Max. power noted3)

W

Rated life

h

Test values measured3)

Body of lantern mm

Horizontal luminous intensity4)

cd

Colour temperature

K

b

mm

l

mm

24

40

43
45

2360

110 or 115

60

69

1 000 

to

to

230

65

69
65

2 856 

Comments 1. Light-centre-length tolerance of the 24 V/40 W lamp: ± 1,5 mm. 2. L: the broad lug of the P 28 S cap is on the left when the lamp is upright, seen against the direction of emission. 3. Before measurement of the values at the start of the test, filament lamps shall have already been in service at the rated voltage for 60 minutes. 4. These limits shall be respected in an area extending ± 10° on either side of the horizontal line passing through the median point of the body of the lantern when the lamp is rotated through 360° on its axis.

(b) Filament lamps for the rated voltages 24 V and 12 V

Text of image

Permissible deviation of the filament axis from the socket axis at a light-entre-length of 1 mm

light-centre-length

Clear

Lamp socket e.g. BAY 15d

Reference pin

35 ± 1 mm

Rated voltage

V

Rated output

W

Max. power noted (2) W

Rated life

h

Test values measured (2) Body of lantern

l mm

Horizontal luminous intensity (3) cd

Colour temperature K

12

10

18

1000

12 to 20

2 360  to 2 856 

9 to 13

24

9 to 17

12

25

26.5

30 to 48

9 to 13

24

(c) The filament lamps shall be marked on the cap with an indication of the corresponding sizes. If these marks are on the bulb, the operation of the lamp shall not be affected.

(d) If discharge lamps are used instead of filament lamps, the same requirements as for filament lamps shall be applicable.

CHAPTER 4TEST AND APPROVAL PROCEDURE

Article 4.01

General rules of procedure

Part I shall be applicable for the test and approval procedure.
Article 4.02

Application 1.   The following data and documents as well as samples of the lanterns and of their accessories, if any, shall be attached to the application for approval submitted by the manufacturer or his authorised representative:

(a) the type of light (e.g. strong);

(b) the trade name and the description of the lantern type, its light source and accessories if any;

(c) for electric signal lanterns, the on-board voltage supply required by the lanterns depending on their purpose;

(d) specifications of all characteristics and capacities;

(e) a brief technical description indicating the materials of which the sample lantern is made and a wiring diagram with a brief technical description if accessories of the lantern likely to influence operation are included;

(f) for sample lanterns and, where relevant, their accessories, two copies of:

(i) adjustment or mounting instructions with data concerning the light source and the mounting or holding device;

(ii) sketch with dimensions and type names and descriptions needed to identify the test sample and lanterns installed on board and their accessories, if any;

(iii) other documents such as drawings, lists of parts, wiring diagrams, operating instructions and photographs which concern or may concern all the important details referred to in Chapters 1 to 3 of these test and approval conditions, in so far as they are necessary for verifying the conformity of the lanterns to be manufactured with the test sample. The following data and drawings are particularly relevant:

—

a longitudinal section showing the details of the structure of the filter and the profile of the light source (filament lamp), as well as the positioning and the mount,

—

a cross-section of the lantern halfway up the filter showing details of the layout of the light source, filter, the optical glass, if any, and the horizontal dispersion angle for sector lights,

—

a view from the rear for sector lights, with details of the holder or mount,

—

a view of circular lights with details of the holder or mount;

(iv) data concerning dimensional tolerances in mass produced light sources, filters, optical glasses, mounting or holding devices and of the light source placed in the lantern in relation to the filter;

(v) data concerning the horizontal luminous intensity of mass-produced sources at the rated voltage;

(vi) data concerning mass-production tolerances for coloured glasses with regard to the colour and transparency of a standard illuminant A (2856 K) or the type of light from the intended light source. 2.   Two samples ready for use shall be supplied with the application, each with 10 light sources of each rated voltage and, where relevant, five coloured filters of each signal colour, together with the mounting or positioning device.

The specific additional accessories required for the approval tests shall also be made available on request. 3.   The sample shall correspond in all respects to the production models envisaged. It shall be fitted with all the accessories required for mounting and positioning it in the normal operating position in which it is to be used on board in accordance with its purpose. Some accessories may be omitted if the competent testing authority agrees. 4.   Additional samples, documents and data shall be supplied on request. 5.   The documents shall be submitted in the language of the country of the testing and approval authority. 6.   If an application for approval is submitted for an additional device, paragraphs 1 to 5 shall apply mutatis mutandis, on the understanding that the additional parts may be approved only in combination with the approved lanterns. 7.   Sector lights shall in principle be submitted as a complete set.
Article 4.03

Test 1.   For tests on a new or amended version of an approved lantern or accessory, it shall be ascertained whether the sample meets the requirements of these test and approval conditions and corresponds to the documents referred to in Article 4.02(1)(f). 2.   The approval test shall be based on the conditions occurring on board the vessels. The test shall cover all light sources, optical glasses and accessories which must be provided and which are intended for the signal lanterns. 3.   The photometric and colorimetric test shall be carried out at the rated voltage.

The evaluation of the lantern shall take into account the horizontal operating luminous intensity IB and the operating colour temperature. 4.   Parts or accessories shall be tested only with the type of lantern for which they are intended. 5.   Tests done by other competent authorities may be accepted as proof of conformity with the requirements of Chapter 3, provided that they have been confirmed as equivalent to the tests set out in the Appendix.
Article 4.04

Approval 1.   Approval of signal lanterns shall be based on Articles 4.01 to 4.05 of Part I. 2.   For lanterns and accessories which are or will be mass-produced, the approval may be issued to the applicant following a test at the applicant’s expense if the applicant guarantees that proper use will be made of the rights resulting from the approval. 3.   In the event of approval, the approval certificate referred to in Article 4.03 of Part I shall be issued for the corresponding lantern type and an approval marking in accordance with Article 4.05 of Part I shall be allocated.

The approval marking and the serial number shall be legibly and durably affixed to each lantern manufactured in accordance with the sample, at a point which remains fully visible after installation on board. Original markings and type descriptions shall be clearly legible and shall be indelibly affixed. Marks liable to be confused with approval markings shall not be affixed to lanterns. 4.   Approval may be granted for a limited period and subject to conditions. 5.   Modifications of an approved lantern and additions to approved lanterns shall be subject to the agreement of the testing authority. 6.   If approval of a lantern is withdrawn, the applicant shall be informed directly. 7.   One sample of each type of lantern approved shall be left with the testing authority which approved it.
Article 4.05

Cessation of validity of the approval 1.   The approval shall cease to be valid on the expiry of the prescribed period, or if it is revoked or withdrawn. 2.   The approval may be revoked if:

—

subsequently and conclusively, the conditions for its issue no longer exist,

—

the test and approval conditions are no longer met,

—

a lantern does not correspond to the approved sample,

—

the conditions imposed are not complied with, or

—

the holder of the approval proves unreliable.

It shall be withdrawn if the conditions laid down when it was issued have not been met. 3.   If manufacture of an approved signal lantern type is discontinued, the testing authority which issued the approval shall be informed immediately. 4.   Withdrawal or revocation of approval shall mean that use of the approval number allocated is prohibited. 5.   Once the approval ceases to be valid the certificate shall be submitted for annulment to the testing authority which issued it.
Appendix

Environment tests 1.   Test concerning protection against splashing water and dust

1.1. The type of lantern protection shall be guaranteed in accordance with classification IP 55 of the IEC publication — Part 598-1. The test concerning protection of the sample against splashing water and against dust, and the evaluation of the results, shall be carried out in conformity with IEC publication 529, classification IP 55. The first ‘5’ stands for protection against dust. This means: full dust-proof protection of live components and protection against harmful deposits of dust. The penetration of dust is not completely prevented.

The second ‘5’ stands for protection against splashing water. This means that a water jet aimed at the lantern from all directions shall have no damaging effect.

1.2. The protection of the sample against water is evaluated as follows: the protection is considered to be adequate if any water which has entered has no detrimental effect on operation of the sample.

No water deposits shall have formed on the insulating materials, if this means that minimum vanishing point values could not be achieved. Live components shall not be wetted and shall not be affected by any water accumulating inside the lantern. 2.   Humid atmosphere test

2.1.   Purpose and application

This test is to determine the action of humid heat and of humidity during a change of temperature, as described in Article 3.01(10)(b), during operation or during transport or storage, on nautical installations, appliances and instruments, given that they could experience surface humidity from condensation.

This condensation is similar in the case of non-enclosed components to the action of a dust deposit or of a hygroscopic salt film forming during operation.

The following specification is based on IEC publication 68, Part 2-30 in conjunction with Article 3.01(10)(a) and (b). Additional information can be found in the publication.

Components and groups of components submitted non-enclosed for approval as type models shall be tested in that non-enclosed state or, if this is not possible given the nature of the components, by providing them with the minimum protection devices which the applicant considers necessary for use on board.

2.2.   Execution 1. The test is conducted in a test chamber in which, if necessary by means of an air circulation device, the temperature and level of humidity are practically the same at all points. The movement of the air shall not noticeably cool the sample being tested, but should be sufficient to ensure that the prescribed values for air temperature and humidity are maintained in its immediate vicinity.

Condensate shall be continuously evacuated from the test chamber. No condensate shall drip on to the sample. Condensate may only be reused for humidification following reprocessing, in particular once chemicals from the sample have been eliminated. 2. The sample shall not be exposed to heat radiation from the heating of the chamber. 3. The sample shall have been out of service immediately prior to the test long enough for all its parts to be at ambient temperature. 4. The sample is placed in a test chamber at an ambient temperature of + 25 ± 10 °C corresponding to its normal use on board. 5. The chamber is closed. The air temperature is set at -25 ± 3 °C and the relative humidity at 45 to 75 % and those conditions are maintained until the sample has reached the same temperature. 6. The relative humidity of the air is raised to not less than 95 % in a maximum time of one hour, the air temperature remaining unchanged. This increase may take place during the last hour of temperature conditioning of the sample. 7. The air temperature in the chamber is increased progressively to +40 ± 2 °C over a period of 3 h ± 0,5 h. As the temperature rises, the relative humidity of the air is maintained at not less than 95 %, and at not less than 90 % during the last 15 minutes. During this temperature rise, the sample becomes damp. 8. The air temperature is maintained at + 40 ± 2 °C for a time period of 12 h ± 0,5 h measured from the start of phase 7, with a relative air humidity of 93 ± 3 %. During the first 15 and the last 15 minutes of the period during which the temperature is + 40 ± 2 °C, relative air humidity may be between 90 and 100 %. 9. The air temperature is reduced to + 25 ± 3 °C over a period of three to six hours. The relative humidity of the air must be constantly maintained at over 80 %. 10. The air temperature is maintained at + 25 ± 3 °C for a period of 24 hours from the start of phase 7, relative air humidity remaining constantly above 95 %. 11. Phase 7 is repeated. 12. Phase 8 is repeated. 13. Not earlier than 10 hours after the start of phase 12 the air conditioning equipment of the sample is switched on. When the climatic data indicated by the manufacturer for the sample have been obtained, the sample is put into operation in accordance with the manufacturer’s instructions and at the rated voltage of the on-board network, with a tolerance of ± 3 %. 14. After the time necessary to achieve normal operation in accordance with the manufacturer’s instructions has elapsed, the functions are checked and the operating data of importance for use on board recorded and noted. If the chamber needs to be opened for this purpose, it shall be reclosed as quickly as possible.

If more than 30 minutes are required to reach normal operation, this phase shall be extended sufficiently so that, once the operating state has been reached, at least 30 minutes are available to monitor the functions and measure the operating data. 15. Within a period of one to three hours, with the sample again in service, the air temperature is lowered to ambient temperature, with a tolerance of ± 3 °C, and the relative humidity of the air to under 75 %. 16. The chamber is opened and the sample exposed to the normal temperature and humidity of the ambient air. 17. After 3 hours, and when all humidity visible on the sample has evaporated, the functions of the sample are monitored again, and operating data of importance for use on board recorded and noted. 18. The sample is subjected to a visual inspection. The body of the lantern is opened and the interior examined for any effects of the climatic test and for residual condensate.

2.3.   Results to be obtained

2.3.1. The sample shall function normally under the conditions stipulated in phases 12 to 18. No deterioration shall be observed.

2.3.2. The operating data for phases 12 and 18 shall be within the tolerances permitted for the sample on the basis of these test and approval conditions.

2.3.3. There shall be no corrosion or no residual condensate inside the lantern which, as a result of the long-term action of high atmospheric humidity, might cause it to malfunction. 3.   Cold test

3.1.   Purpose

This test is to determine the action of cold during operation or during transport and storage, in accordance with Article 3.01(8) and (10). Additional information may be found in IEC publication 68, Part 3-1. 3.2.   Execution 1. The test is carried out in a test chamber in which, if necessary by means of an air circulation device, the temperature is practically the same at all points. The air humidity must be low enough to ensure that the sample is not wetted by condensation during any of the phases. 2. The sample is placed in a test chamber at an ambient temperature of + 25 ± 10 °C corresponding to its normal use on board. 3. The temperature in the chamber is lowered to — 25 ± 3 °C at a rate of not more than 45 °C/h. 4. The temperature in the chamber is maintained at — 25 ± 3 °C until the sample has reached temperature equilibrium, plus at least a further 2 hours. 5. The temperature in the chamber is raised to 0 ± 2 °C at a rate of not more than 45 °C/h.

For all samples referred to in Article 3.01(10)(a), the following also applies: 6. During the last hour of phase (4) in climate class X, the sample is put into operation in accordance with the manufacturer’s instructions, at the rated voltage of the on-board network, with a tolerance of ± 3 %. The heat sources contained in the sample must be in operation.

After the time necessary to achieve normal operation has elapsed, the functions are checked and the operating data of importance for use on board recorded and noted. 7. The temperature in the chamber is raised to ambient temperature at a rate of not more than 45oC/h. 8. Once the sample has reached temperature equilibrium, the chamber is opened. 9. The functions of the sample are checked again and the operating data of importance for use on board recorded and noted.

3.3.   Results to be obtained

The sample shall function normally under the conditions stipulated in phases 7, 8 and 9. No deterioration shall be observed.

The operating data for phases 7 and 9 shall be within the tolerances permitted for the sample on the basis of these test and approval conditions. 4.   Heat test

4.1.   Purpose and application

This test is to determine the action of heat during operation, transport and storage, in accordance with Article 3.01(8)(a) and (10)(a). The following specification is based on IEC publication 68, Part 2-2 in conjunction with Article 3.01(10)(a). Additional information can be found in the IEC publication.
Normal

Extreme

Environment tests

Climate classes X and S

+ 55 °C

+ 70 °C

Permissible tolerance ± 2 °C

The test under extreme ambient conditions shall, in principle, be performed first. If the operating data are within the tolerances applicable under normal ambient conditions, the normal ambient test may be dispensed with.

4.2.   Execution 1. The test is conducted in a test chamber in which, if necessary by means of an air circulation device, the temperature is practically the same at all points. The movement of the air shall not noticeably cool the sample being tested. The sample shall not be exposed to heat radiation from the heating of the chamber. The air humidity must be low enough to ensure that the sample is not wetted by condensation during any of the phases. 2. The sample is placed in a test chamber at a temperature of + 25 ± 10 °C corresponding to its normal use on board. The sample is put into operation in accordance with the manufacturer’s instructions at the rated voltage of the on-board network with a tolerance of ± 3 %.

After the time necessary to achieve normal operation has elapsed, the functions are checked and the operating data of importance for use on board recorded and noted. 3. The air temperature in the chamber is raised to the test temperature referred to in Article 3.01(10)(a) at a rate of not more than 45 °C/h. 4. The air temperature is maintained at the test temperature until the sample reaches temperature equilibrium plus a further two hours.

During the last two hours, the functions are checked again and the operating data recorded and noted. 5. The temperature is lowered to ambient temperature over a period of not less than one hour. The chamber is then opened.

After bringing the sample to ambient temperature, the functions are again checked and the operating data of importance for use on board recorded and noted.

4.3.   Results to be obtained

The sample shall function normally under the conditions stipulated in all phases of the test. No deterioration shall be observed. The operating data for phases (2), (4) and (5) shall be within the tolerances permitted for the sample for normal ambient environment tests on the basis of these test and approval conditions. 5.   Vibration test

5.1.   Purpose and application

This test is to determine the functional and structural effects of the vibrations referred to in Article 3.01(10)(e). Structural effects concern the performance of the mechanical components, particularly vibrations by resonance and stress on materials leading to fatigue without necessarily producing direct effects on operation or changes in operating data.

The functional effects directly concern the operation and operating data of the sample. They may be linked to structural effects.

The following specification is based on IEC publication 68, Part 2-6 in conjunction with Article 3.01(10)(e). Values deviating from those in the abovementioned provisions are indicated by *. Additional information may be found in IEC publication 68, Part 2-6. Test requirements:

The test shall be conducted with sinusoidal vibrations using the following frequencies with the amplitudes indicated:
Normal

Extreme

Environment tests

Vibration class V:

Frequencies

2 to 10 Hz

2 to 13,2 Hz*

Amplitude

± 1,6 mm

± 1,6 mm

Frequencies

10 to 100 Hz

13,2 to 100 Hz*

Acceleration amplitude

± 7 m/s2

± 11 m/s2

The test under extreme ambient conditions shall, in principle, be performed first. If the operating data are within the tolerances applicable under normal ambient conditions, the normal ambient test may be dispensed with.

Samples intended to be used with shock-absorbing devices shall be tested with those devices. If, in exceptional cases, it is not possible to test with the shock-absorbers intended for normal operation, the appliances shall be tested without shock-absorbers and the stress modified to take account of the action of the shock-absorber.

A test without shock-absorbers is also acceptable for the determination of characteristic frequencies.

The vibration test shall be conducted in three main directions perpendicular to each other. For samples which on account of their construction may be subject to special stresses from vibrations at an oblique angle to the main directions, the test shall also be performed in the directions of special sensitivity.

5.2.   Execution 1. Test apparatus

The test is conducted using a vibrating device known as a vibrating table, which enables the sample to be subjected to mechanical vibrations in accordance with the following conditions:

—

The basic movement shall be sinusoidal and such that the mounting points of the sample basically move in phase and along parallel lines.

—

The maximum amplitude of vibration of the lateral movement of any mounting point shall not exceed 25 % of the specified amplitude of the basic movement.

—

The relative importance of the spurious vibration, expressed by the formula

 (in %)

where a1 is the effective value of the acceleration produced by the frequency applied,

and where atot is the effective value of the total acceleration, including a1, measured in the frequencies < 5 000 Hz,

shall not exceed 25 % at the mounting point taken as the point of reference for measurement of the acceleration.

—

The vibration amplitude shall not differ from its theoretical value by more than:

—

± 15 % at the mounting point taken as the point of reference and

—

± 25 % at any other mounting point.

In order to determine the characteristic frequencies, it must be possible to adjust the vibration amplitude in small steps between zero and the theoretical value.

—

The vibration frequency shall not differ from its theoretical value by more than

± 0,05 Hz

for frequencies up to 0,25 Hz,

± 20%

for frequencies higher than 0,25 Hz and up to 5 Hz,

± 1Hz

for frequencies higher than 5 Hz and up to 50 Hz,

± 2%

for frequencies higher than 50 Hz,

In order to compare the characteristic frequencies, it must be possible to adjust them at the beginning and end of the vibration test to within:

± 0,05 Hz for frequencies up to 0,5 Hz,

± 10%

± 0,5 Hz for frequencies up to 5 Hz,

± 0,5 Hz for frequencies higher than 5 Hz and up to 100 Hz,

± 0,5% for frequencies higher than 100 Hz.

In order to scan the frequencies, it should be possible for the vibration frequency to vary continuously and exponentially in both directions between the lower and upper limits of the frequency ranges indicated in paragraph 5.1, with a scanning speed of 1 octave/minute ± 10 %.

In order to determine the characteristic frequencies, it must be possible to slow the speed of variation of the vibration frequency as desired.

—

The intensity of the magnetic field created by the vibration device in the vicinity of the sample should not exceed 20 kA/m. The testing authority may require lower permissible values for some samples. 2. First inspection, mounting and putting into service

The sample is inspected visually to verify that it is in impeccable condition as far as is apparent, and that the assembly is impeccable from the point of view of the construction of all the components and groups of components.

The sample is mounted on the vibrating table in accordance with the type of mount provided for on-board installation. Samples, the operation and performance of which under the influence of vibrations depend on their position in relation to the vertical, shall be tested in their normal operating position. The mounts and devices used for the mounting shall not noticeably modify the amplitude and the movements of the sample in the range of frequencies used in the test.

The sample is put into operation in accordance with the manufacturer’s instructions at the rated voltage of the on-board network with a tolerance of ± 3 %.

After the time necessary to achieve normal operation has elapsed, the functions are checked and the operating data of importance for use on board recorded and noted. 3. Preliminary inspection of performance when subjected to vibrations

This test phase shall be conducted for all samples. For samples which may be used for different purposes with varying vibratory effects, the test shall be conducted for all or some of the various uses.

A frequency cycle is effected with the vibrating table so that the frequency range indicated in paragraph 5.1, with its corresponding amplitudes, is covered from the lowest frequency to the highest and conversely, at a rate of one octave per minute. The sample is observed during this operation using the appropriate means of measurement and visually, if necessary using a stroboscope, to check thoroughly for any operating problems, modifications of operating data and mechanical phenomena such as vibrations by resonance and rattling noises occurring in specific frequencies. These frequencies are described as ‘characteristic’.

If necessary, in order to determine characteristic frequencies and vibration effects, the frequency variation is slowed down, stopped or reversed and the amplitude of the vibrations reduced. During the gradual modification of the operating data, it is necessary to wait until the final value is reached while maintaining the vibration frequency, although not more than five minutes.

During the frequency scan, at least the frequencies and operating data of importance for use on board are recorded, and all characteristic frequencies are noted, with their effects, for subsequent comparison during phase (7).

If the response of the sample to mechanical vibrations cannot be adequately determined during operation, an additional vibration response test shall be performed without connecting the sample.

If during the frequency scan the operational data noticeably exceed the permissible tolerances, the operation is unacceptably disrupted or if the structural resonance vibrations are likely to cause destruction should the vibration test be continued, the test may be interrupted. 4. Test of switching functions

This test phase shall be conducted for all samples where vibratory stress may influence switching functions, for example relays.

The sample is subjected to vibrations in the frequency ranges indicated in paragraph 5.1 with frequency variation steps in accordance with the E-12 series (4) and the corresponding amplitudes. At each frequency step, all switching functions which may be sensitive to vibration, if necessary including switching-on and switching-off, are carried out at least twice.

Switching functions may also be tested at frequencies occurring between the E-12 series values. 5. Extended test

This test phase shall be conducted for all samples. For samples which may be used for different purposes with varying vibratory effects, the first part of this phase (when the sample is in service) may be conducted several times, for all or some of the various uses.

When the sample is in service as described in phase (2) above, it is subjected to five cycles during which the frequency range indicated as stress producing in paragraph 5.1, with the corresponding amplitudes, is covered each time from the lowest to the highest frequency and conversely, at a rate of one octave per minute.

After the fifth cycle, the vibrating table may be stopped, the functions are tested and the operating data of importance for on-board use recorded and noted. 6. Fixed frequency extended test

This test phase shall be conducted if, on examining vibratory performance during phase (3) above, mechanical resonances are observed during the scan of the frequency range above 5 Hz, which are acceptable for extended use on board according to the manufacturer or his authorised representative, but for which the strength of the parts concerned cannot be taken for granted. In particular, this phase concerns appliances fitted with shock absorbers with a resonance frequency within the frequency range indicated in paragraph 5.1 and higher than 5 Hz.

When the sample is in service as described in phase 2 above, for each resonance frequency concerned, it is subjected for two hours to vibrations at the amplitude provided for in the extreme ambient test and at the corresponding frequency as referred to in paragraph 5.1, the direction of vibration being that which in normal use exerts the maximum stress on the parts in question. If necessary, the frequency applied must be rectified so that the resonance vibrations continue at not less than 70 % of their maximum amplitude, or the frequency must be made to vary continuously between two values 2 % below and 2 % above the resonance frequency initially observed, at a rate of at least 0,1 but not more than 1 octave per minute. During the vibratory stress, the functions of the sample are monitored until malfunctions begin to occur, as a result of mechanical parts becoming detached or displaced or of a break in the electrical connection or of a short-circuit.

Samples for which the execution of this test phase is relevant when switched off may be tested in that state, provided the mechanical stress on the parts concerned is not less than in normal use. 7. Final inspection of performance when subjected to vibration

This test phase must be effected as necessary.

The inspection of performance when subjected to vibrations referred to in phase 3 is repeated using the frequencies and amplitudes applied in that phase. The characteristic frequencies observed and the observed effects of vibration stress are compared with the results of phase 3 in order to determine any changes which occurred during the vibration test. 8. Conclusions of the inspection

Once the vibrating table has stopped and the time necessary to arrive at an operating state without vibratory stress has elapsed, the functions are tested and the operating data of importance for on-board use recorded and noted.

Lastly, the sample is inspected visually to verify that it is in impeccable condition.

5.3.   Results to be obtained

The sample and its components and groups of components should not show any mechanical resonance vibrations in the frequency ranges indicated in paragraph 5.1. When resonance vibrations of this type are unavoidable, construction measures must be taken to ensure that the sample, its components and groups of components suffer no damage.

During and following the vibration test, no perceptible effect of vibratory stress shall occur, and in particular no difference between the characteristic frequencies observed in phase 7 and the values determined in phase 3 and no damage or malfunction as a result of extended vibration shall be observed.

In the case of the normal ambient test, the operating data recorded in phases 3 to 8 shall remain within the tolerances permitted on the basis of these test and approval conditions.

During the switching functions test in phase 4, no switching malfunction or breakdown shall occur. 6.   Accelerated weather resistance test

6.1.   Purpose and application

The accelerated weather resistance test (simulation of exposure to the elements through exposure to radiation from xenon lamps with filters and by sprinkling) is conducted in accordance with Parts 2-3, 2-5 and 2-9 of IEC publication 68 plus the following additions:

According to this publication, the accelerated weather resistance test aims at simulating natural weather conditions by means of a test apparatus under specific reproducible conditions, so as to provoke rapid changes in the properties of the materials.

The accelerated test is carried out in a test apparatus with filtered radiation from xenon lamps and intermittent sprinkling. Following exposure to the elements, measured by the product of the intensity of radiation and its duration, the agreed properties of the samples are compared with those of samples of the same origin which have not been exposed to the elements. First to be specified are the properties crucial for practical use, such as colour, surface quality, shock resistance, tensile strength and solidity.

In order to compare the results with those of exposure to natural weather conditions, it is assumed that the alteration of properties by the elements is caused in particular by natural radiation and the simultaneous action of oxygen, water and heat on the materials.

For the accelerated test, particular account must be taken of the fact that the radiation in the appliance is very close to natural radiation (see the IEC publication). The radiation from the xenon lamp with a special filter simulates natural radiation.

Experience has shown that, under the test conditions indicated, there is a strong correlation between resistance to weather in the accelerated test and resistance to natural weather conditions. The accelerated test, which is independent of place, climate and season, has the advantage over natural weather conditions of being reproducible and of making it possible to shorten the duration of the test as it is independent of the alternation of day and night and of the seasons.

6.2.   Number of samples

For the weather-resistance test, unless otherwise agreed, an adequate number of samples is used. An adequate number of samples not subjected to weather conditions is required for the purposes of comparison.

6.3.   Preparation of samples

The samples are subjected to the tests in the state in which they are delivered, unless otherwise agreed. The samples to be used for comparison are kept in the dark at ambient temperature throughout the tests.

6.4.   Test apparatus

The test apparatus consists basically of a ventilated test chamber with the radiation source in the centre. Optical filters are placed round the radiation source. The sample mounts are rotated around the longitudinal axis of the system at the required distance from the source and the filters to reach the intensity of radiation prescribed in paragraph 6.4.1. The intensity of the radiation on any component of the total sample surfaces exposed shall not differ by more than ± 10 % from the arithmetical mean of radiation intensity on the various surfaces.

6.4.1.   Radiation source

A xenon lamp is used as the radiation source. The radiation flux shall be selected so that the intensity of radiation on the sample surface is 1 000 ± 20O W. m-2 in the 300 to 830 nm waveband (see paragraph 6.9 for the apparatus for measuring irradiation).

If air-cooled xenon lamps are used, the air already used containing ozone must not enter the test chamber and must be evacuated separately.

The experimental values show that the radiation flux from xenon lamps drops to 80 % of its initial value after approximately 1 500 hours of operation; after this period, the proportion of ultra-violet radiation is also reduced noticeably compared with other forms of radiation. The xenon lamp must therefore be replaced after this period (see also the data supplied by the xenon lamp manufacturer).

6.4.2.   Optical filters

Optical filters must be positioned between the radiation source and the sample mounts so that the filtered radiation from the xenon lamps is as close as possible to natural radiation (see IEC publication 68, Parts 2 to 9).

All glass filters must be cleaned regularly to avoid any undesirable decrease in radiation intensity. The filters must be replaced if the similarity to natural radiation can no longer be achieved.

With regard to appropriate optical filters, the data supplied by the manufacturer of the test apparatus must be complied with. On delivery of test apparatus, the manufacturer must guarantee that it meets the requirements set out in paragraph 6.4. 6.5.   Sprinkling and air humidifying device

The sample shall be wetted in such a way that the action is the same as that of natural rain and dew. The sample sprinkling device shall be so constructed that during sprinkling all the external surfaces of the samples are wetted. It must be controlled in such a way that the sprinkling/dry-period cycle prescribed in paragraph 6.10.3 is complied with. The air in the test chamber must be humidified so as to maintain the relative humidity prescribed in paragraph 6.10.3. The water used for sprinkling and for humidifying the air must be distilled water or fully desalinated water (conductivity < 5 μS/cm).

The tanks, pipes and sprayers for distilled or fully desalinated water must be of corrosion-resistant materials. The relative humidity of the air in the test chamber is measured using a hygrometer protected against sprinkling and direct radiation and is adjusted by means of the hygrometer.

When fully desalinated water or water in a closed circuit is used the risk exists (as in the varnish test) of the formation of a deposit on the surface of the samples or of wear on the surface by substances in suspension.

6.6.   Ventilation device

The temperature of the black panel prescribed in paragraph 6.10.2 is maintained in the test chamber by the circulation of clean, filtered, humidified and, if necessary, temperature-controlled air over the samples. The flow and speed of the air shall be selected so as to ensure uniform tempering of all external surfaces of the mounts of the samples in the system.

6.7.   Sample mounts

Any mounts in stainless steel enabling the samples to be mounted as set out in paragraph 6.10.1 may be used.

6.8.   Blackpanel thermometer

In order to measure the temperature of the black panel during the dry period of the cycle, a blackpanel thermometer is used. This thermometer consists of a stainless steel panel thermally insulated from its mounts, the same size as the sample mounts and 0,9 ± 0,1 mm thick. The two sides of the panel are covered with shiny black varnish which is highly weather-resistant and has a maximum reflecting power of 5 % at wave-lengths of more than 780 nm. The temperature of the panel is measured using a bimetallic thermometer the sensor of which is placed in the middle of the panel with a good thermal contact.

It is not advisable to leave the thermometer in the apparatus throughout the test referred to in paragraph 6.10. It is sufficient for it to be inserted into the test apparatus every 250 hours, for 30 minutes or so, and for the temperature of the black panel to be taken during the dry period.

6.9.   Irradiation measuring apparatus

Irradiation (unit of measurement: W. s m-2) is the product of the intensity of irradiation (unit: W. m-2) and duration of irradiation (unit: s). The irradiation of the surfaces of the sample in the test apparatus is measured with an appropriate irradiation measuring apparatus, adapted to the radiation function of the system consisting of the radiation source and the filter. The irradiation measuring apparatus shall be graduated or calibrated so that infra-red radiation over 830 nm is not taken into account.

The capacity of the irradiation measuring apparatus depends basically on whether its sensor is highly resistant to weather and to ageing and has adequate spectral sensitivity to natural radiation.

The irradiation measuring apparatus may include the following parts, for example:

(a) a silicon photo-electric cell as radiation sensor;

(b) an optical filter placed in front of the photo-electric cell; and

(c) a coulometer which measures the product (unit: C = A.s) of the intensity of the current produced in the photo-electric cell in proportion to radiation intensity (unit: A) and the duration of radiation (unit: s).

The scale of the irradiation measuring apparatus shall be calibrated. The calibration shall be checked after being used for a year and corrected if necessary.

The intensity of irradiation on the surface of samples depends on the distance from the radiation source. Sample surfaces shall therefore, as far as possible, be at the same distance from the source as the sensor of the irradiation measuring apparatus. If this is not possible, the irradiation reading on the measuring apparatus shall be multiplied by a correction factor.

6.10.   Execution

6.10.1. The samples are placed in mounts so that water cannot collect on the rear surface. The sample mounts must cause only the smallest possible amount of mechanical stress. In order to ensure irradiation and sprinkling are as evenly distributed as possible, the samples are rotated during the test at a rate of one to five revolutions per minute round the source-filter system and the sprinkling device. Normally, a single side of the sample is exposed to the weather conditions. Depending on the applicable provisions of the IEC publication, or as otherwise agreed, the front and back surfaces of a single sample may also be exposed. In this case, each surface is exposed to the same radiation and the same sprinkling.

The exposure of the front and back surfaces of a given sample to the same radiation and sprinkling may be produced by the periodic rotation of the sample. This can be done automatically using rotating appliances if the mount is in the form of an open frame.

6.10.2. The temperature of the black panel at the point where the samples are placed during the dry period is set and regulated in accordance with the IEC publications applicable to the equipment in question. Unless otherwise agreed, the average temperature of the black panel must be kept at + 45 °C. Average temperature of the black panel means the arithmetic mean of the black panel temperature reached at the end of the dry period. During the dry period, a local difference of ± 5 °C is permissible, and ± 3 °C in borderline cases.

In order to maintain the required temperature of the black panel and, when necessary, ensure radiation of equal intensity on the front and back surfaces of the sample (see paragraph 6.10.1), the samples may be turned automatically through 180° after each revolution. In this case, the blackpanel thermometer and the irradiation measuring apparatus shall be included in the rotation movement.

6.10.3. Samples installed in mounts and the sensor of the irradiation measuring apparatus referred to in paragraph 6.9 are evenly exposed to radiation and sprinkled according to the cycle defined below, which is repeated successively:

Sprinkling

:

3 minutes

Dry period:

:

17 minutes

The relative humidity of the air must be 60 to 80 % during the dry period.

6.11.   Test duration and procedure

The test follows procedure B in IEC publication 68, Part 2-9. The test duration is 720 hours, with the sprinkling cycle defined in paragraph 6.10.3. It is recommended that the weather-resistance test should be carried out with one and the same sample (in the case of a non-destructive test of the modification of the properties to be considered, such as the weather-resistance test, for example) or with several samples (in the case of a destructive test, as for shock-resistance, for example) at various degrees of irradiation, to be agreed upon. The development of the modification of the properties of a piece of equipment throughout the weather test can therefore be determined.

6.12.   Assessment

After the exposure to bad weather is completed, the sample is kept for at least 24 hours in darkness in an air temperature of +23 °C, a dew point of +12 °C, a relative air humidity of 50 %, an air circulation speed of 1 m/s and an atmospheric pressure of 860 to 1060 hPa. (The permissible difference may be ± 2 °C for the air temperature and ± 6 % for the relative humidity.)

These samples and those used for the comparison referred to in paragraphs 6.2 and 6.3 are inspected to determine properties in accordance with the requirements indicated in Article 2.01(1) and (2) and in Article 3.01(12). 7.   Salt water and weather-resistance test

(sea-fog test)

7.1.   Purpose and application

This test is to determine the action of salt water and a saline atmosphere during operation and during transport and storage in accordance with Article 3.01. It may be restricted to the sample or to specimens of the materials used.

The following specifications are based on IEC publication 68, Part 2-52. Additional information can be found in the publication.

7.2.   Execution

1

Test apparatus

The test is conducted in a test chamber using an atomiser and a saline solution meeting the following conditions:

—

the materials of the test chamber and the atomiser must not influence the corrosive action of the salt mist,

—

a fine, homogeneous, wet, thick mist must be diffused inside the test chamber; the distribution must not be affected by eddies or by the presence of the sample. The jet must not touch the sample directly. Drops forming on the inside of the chamber must not be able to fall on the sample;

—

the test chamber must be adequately ventilated and the ventilation outlet protected against sudden changes in the movement of the air, so as to prevent the formation of a strong air current in the chamber,

—

the saline solution used must consist, by mass, of 5 ± 1 parts of pure sodium chloride, with a maximum of 0,1 % sodium iodide and 0,3 % impurities, in the dry state, to 95 ± 1 parts of distilled or fully desalinated water. Its pH must be between 6,5 and 7,2 at a temperature of + 20 ± 2 °C and be kept within these limits during the operation. Solution once sprayed must not be reused,

—

the compressed air used for spraying must be free of impurities such as oil or dust and shall have a humidity level of at least 85 % in order to avoid blockage of the nozzle,

—

the mist diffused in the chamber must have a density such that, in a clean receptacle with an open horizontal surface area of 80 cm2, placed anywhere in the chamber, the average precipitation over the whole time is between 1.0 ml and 2.0 ml per hour. In order to monitor the density of the mist, at least two receptacles shall be placed in the chamber in such a way as not to be covered by the sample and not to receive drops of condensation. In order to calibrate the quantity of solution sprayed, the duration of spraying shall be at least eight hours,

the period of humidity between phases of spraying is spent in an air-conditioned chamber in which the air can be kept at a temperature of + 40 ± 2 °C and at a relative humidity of 93 ± 3 %. 2. Preliminary inspection

The sample is inspected visually to verify that it is in impeccable condition, and in particular that it is correctly assembled and that all openings close properly. External surfaces soiled with grease, oil or mud are cleaned. All controls and moving parts are manipulated and checked for proper operation. The mobility of all closures, covers and moving parts intended to be detached or moved during operation or maintenance must be inspected for mobility and correctly replaced.

The sample is put into operation in accordance with the manufacturer’s instructions at the rated voltage of the on-board network with a tolerance of ± 3 %.

After the time required to reach normal operation has elapsed, the functions are tested and the operating data of importance for on-board use and for assessing the action of the salt mist atmosphere are recorded and noted. The sample is then disconnected for exposure to spraying. 3. Spraying phase

The sample is put into the salt mist chamber and exposed to the salt mist for two hours at a temperature of +15 °C to +35 °C. 4. Humidity period

The sample is placed in the air-conditioned chamber so that the least possible amount of saline solution drips from it. It is kept in the air-conditioned chamber for seven days, at an air temperature of + 40 ± 2 °C and a relative humidity of 93 ± 3 %. It must not come into contact with any other sample or metal object. Several samples may be so arranged as to preclude any mutual influence. 5. Repetition of the test cycle

The test cycle, including phases 3 and 4, is repeated three times. 6. Subsequent treatment

Following the fourth test cycle, the sample is taken out of the air-conditioned chamber and immediately washed for five minutes in running tap water and rinsed in distilled or desalinated water. Drops adhering to the sample are removed by an air jet or shaken off.

The sample is exposed to the normal ambient atmosphere for at least three hours, and in any case long enough for any visible humidity to have evaporated, before being subjected to a final inspection. The sample is dried for an hour at + 55 ± 2 °C after rinsing. 7. Conclusions of the inspection

The external appearance of the sample is inspected visually. The nature and extent of deterioration from its initial state are recorded in the test report, with supporting photographs if necessary.

The sample is put into operation in accordance with the manufacturer’s instructions at the rated voltage of the on-board network with a tolerance of ± 3 %.

After the time required to reach normal operation has elapsed, the functions are tested and the operating data of importance for on-board use and for assessing the action of the salt mist atmosphere are recorded and noted.

All controls and moving parts are manipulated and checked for proper operation. The mobility of all closures, covers and moving parts intended to be detached or moved during operation or maintenance is checked.

7.3.   Results to be obtained

The sample must not show any change which could:

—

hinder its use and operation,

—

prevent to any considerable extent the detachment of closures and covers, or the movement of moving parts in so far as this is necessary for use or maintenance,

—

impair the waterproofness of the housing,

—

be expected to cause malfunctions in the long run.

The operating data recorded in phases 3 and 7 must remain within the tolerances laid down in these test and approval conditions.

PART IIIMINIMUM REQUIREMENTS AND TEST CONDITIONS FOR RADAR EQUIPMENT USED FOR NAVIGATION IN INLAND WATERWAY VESSELSCONTENTS

Chapter 1: | General | 

Article 1.01 | Scope | 

Article 1.02 | Purpose of the radar equipment | 

Article 1.03 | Approval testing | 

Article 1.04 | Application for approval testing | 

Article 1.05 | Type-approval | 

Article 1.06 | Marking of the equipment and approval number | 

Article 1.07 | Manufacturer’s declaration | 

Article 1.08 | Modifications to approved equipment | 

Chapter 2: | General minimum requirements for radar equipment | 

Article 2.01 | Construction, design | 

Article 2.02 | Spurious emissions and electromagnetic compatibility | 

Article 2.03 | Operation | 

Article 2.04 | Operating instructions | 

Article 2.05 | Installation and operating tests | 

Chapter 3: | Minimum operational requirements for radar equipment | 

Article 3.01 | Operational readiness of radar equipment | 

Article 3.02 | Resolution | 

Article 3.03 | Range scales | 

Article 3.04 | Variable range marker | 

Article 3.05 | Lubber line | 

Article 3.06 | Off-centring | 

Article 3.07 | Bearing scale | 

Article 3.08 | Bearing facilities | 

Article 3.09 | Facilities for reducing sea and rain clutter | 

Article 3.10 | Reduction of interference from other radar equipment | 

Article 3.11 | Compatibility with radar beacons | 

Article 3.12 | Gain control | 

Article 3.13 | Frequency tuning | 

Article 3.14 | Nautical orientation lines and information on the screen | 

Article 3.15 | System sensitivity | 

Article 3.16 | Target trail | 

Article 3.17 | Slave indicators | 

Chapter 4: | Minimum technical requirements for radar equipment | 

Article 4.01 | Operation | 

Article 4.02 | Display | 

Article 4.03 | Radar picture characteristics | 

Article 4.04 | Colour of the display | 

Article 4.05 | Picture refreshment rate and persistence | 

Article 4.06 | Display linearity | 

Article 4.07 | Accuracy of range and azimuthal measurements | 

Article 4.08 | Antenna characteristics and emission spectrum | 

Chapter 5 | Test conditions and test methods for radar equipment | 

Article 5.01 | Safety, load capacity and interference diffusion | 

Article 5.02 | Spurious emissions and electromagnetic compatibility | 

Article 5.03 | Test procedure | 

Article 5.04 | Antenna measurements | 

Appendix 1 | Angular resolution in ranges up to and including 1 200 m | 

Appendix 2 | Test field for determination of the resolution of radar equipment | CHAPTER 1GENERAL

Article 1.01

Scope

These provisions set out the minimum technical and operational requirements for radar equipment used for navigation in inland waterway vessels as well as the conditions for testing conformity with these minimum requirements. Inland ECDIS equipment that can be used in navigation mode counts as navigational radar equipment within the meaning of these provisions.
Article 1.02

Purpose of the radar equipment

The radar equipment shall facilitate the navigation of the vessel by providing an intelligible radar picture of its position in relation to buoys, shorelines and navigational structures, as well as permitting the reliable and timely recognition of other vessels and obstructions protruding above the water surface.
Article 1.03

Approval testing

Radar equipment may not be installed on board vessels until it has been established by means of a type test that the equipment meets the minimum requirements laid down in these provisions.
Article 1.04

Application for approval testing 1.   Applications for a type-test of radar equipment shall be submitted to a competent testing authority in one of the Member States.

The competent testing authorities shall be made known to the Committee. 2.   Each application shall be accompanied by the following documents:

(a) two copies of a detailed technical description;

(b) two complete sets of installation and service documents;

(c).

two copies of a detailed operator’s manual; and

(d) two copies of a summarised operator’s manual. 3.   By means of tests, the applicant shall establish or have it established that the radar equipment meets the minimum requirements of these provisions.

The results of the test and the measurement reports on the horizontal and vertical radiation pattern of the antenna shall be attached to the application.

These documents and the information obtained during testing shall be kept by the competent testing authority. 4.   For approval testing purposes, ‘applicant’ means any legal or natural person under whose name, trademark or any other form of identification the equipment submitted for testing is manufactured or marketed.
Article 1.05

Type-approval 1.   If the equipment passes the type test, the competent testing authority shall issue a certificate of conformity.

If the equipment fails to meet the minimum requirements, the applicant shall be notified in writing of the reasons for its rejection.

Approval shall be granted by the competent authority.

The competent authority shall inform the Committee of the equipment it has approved. 2.   Each testing authority shall be entitled to select equipment from the production series at any time for inspection.

If this inspection reveals defects in the equipment, type-approval may be withdrawn.

The type-approval shall be withdrawn by the authority that issued it. 3.   The type-approval shall be valid for a period of 10 years and may be renewed on request.
Article 1.06

Marking of the equipment and approval number 1.   Each component of the equipment shall be marked indelibly with the name of the manufacturer, the trade designation of the equipment, the type of equipment and the serial number. 2.   The approval number assigned by the competent authority shall be affixed indelibly to the display unit in such a way that it remains clearly visible after the equipment has been installed.

Composition of an approval number:

e-NN-NNN

(e

=

European Union

NN

=

code for the country of approval, where

1

=

Germany

2

=

France

3

=

Italy

4

=

Netherlands

5

=

Sweden

6

=

Belgium

7

=

Hungary

8

=

Czech Republic

9

=

Spain

11

=

United Kingdom

12

=

Austria

13

=

Luxembourg

17

=

Finland

18

=

Denmark

20

=

Poland

21

=

Portugal

23

=

Greece

24

=

Ireland

26

=

Slovenia

27

=

Slovakia

29

=

Estonia

32

=

Latvia

36

=

Lithuania

49

=

Cyprus

50

=

Malta

NNN

=

three-digit number, to be determined by the competent authority). 3.   The approval number shall be used only in conjunction with the associated approval.

It shall be the responsibility of the applicant to produce and affix the approval number. 4.   The competent authority shall immediately inform the Committee of the approval number assigned.
Article 1.07

Manufacturer’s declaration

Each unit of equipment shall be accompanied by a manufacturer’s declaration to the effect that it meets the prevailing minimum requirements and that is identical in every respect to the equipment submitted for testing.
Article 1.08

Modifications to approved equipment 1.   Any modification made to equipment already approved shall cause the type-approval to be withdrawn. Whenever modifications are planned, details shall be sent in writing to the competent testing authority. 2.   The competent testing authority shall decide whether the approval still applies or whether an inspection or new type-test is necessary.

If a new approval is granted, a new approval number shall be assigned.

CHAPTER 2GENERAL MINIMUM REQUIREMENTS FOR RADAR EQUIPMENT

Article 2.01

Construction, design 1.   Radar equipment shall be suitable for operation on board inland waterway vessels. 2.   The construction and design of the equipment shall be in accordance with the state of the art, both mechanically and electrically. 3.   In the absence of any specific provision in Annex II to this Directive or in these provisions, the requirements and test methods contained in IEC publication 945 ‘Marine Navigational Equipment General Requirements’ shall apply to power supply, safety, mutual interference of shipborne equipment, compass safe distance, resistance to climatic influences, mechanical strength, environmental influences, audible noise emission and equipment markings.

Additionally, the requirements of the ITU Radio Regulations shall apply. The equipment shall satisfy all requirements of these provisions for radar display ambient temperatures between 0 and 40 °C.
Article 2.02

Spurious emissions and electromagnetic compatibility 1.   In the frequency range of 30 to 2 000 MHz, the field strength of spurious emissions shall not exceed 500 μV/m.

In the frequency ranges of 156 to 165 MHz, 450 to 470 MHz and 1,53 to 1,544 GHz the field strength shall not exceed a value of 15 μV/m. These field strengths shall apply at a test distance of 3 metres from the equipment under test. 2.   The equipment shall satisfy the minimum requirements at electromagnetic field strengths of up to 15 V/m in the immediate vicinity of the equipment under test in the frequency range of 30 to 2 000 MHz.
Article 2.03

Operation 1.   The equipment shall not have more controls than are necessary for its correct operation.

The design, markings and manipulation of the controls shall be such as to permit their simple, unambiguous and fast operation. Their arrangement shall be such as to prevent operating mistakes as far as possible.

Controls not necessary for normal operation shall not be immediately accessible. 2.   All controls and indicators shall be provided with symbols and/or markings in English. Symbols shall meet the requirements of IMO Recommendation No A.278 (VIII) ‘Symbols for controls on marine navigational radar equipment’ or the requirements contained in IEC publication No 417; all numerals and letters shall be at least 4 mm high.

If it can be demonstrated that, for technical reasons, numerals and letters 4 mm high are not possible and if for the purposes of operation smaller numerals and letters are acceptable, a reduction to 3 mm shall be allowed. 3.   The equipment shall be designed in such a way that operating mistakes cannot cause its failure. 4.   Any functions over and above the minimum requirements, such as facilities for connection to other equipment, shall be provided in such a way that the equipment meets the minimum requirements under all conditions.
Article 2.04

Operating instructions 1.   A detailed operator’s manual shall be supplied with each unit. It shall be available in Dutch, English, French and German and shall contain at least the following information:

(a) activation and operation;

(b) maintenance and servicing;

(c) general safety instructions (health hazards, e.g. the influencing of pacemakers, etc. by electromagnetic radiation);

(d) instructions for correct technical installation. 2.   A summarised operator’s manual in a durable form shall be supplied with each unit.

It shall be available in Dutch, English, French and German.
Article 2.05

Installation and operating tests

Installation, replacement and operating tests shall be in accordance with the requirements of Part V.

CHAPTER 3MINIMUM OPERATIONAL REQUIREMENTS FOR RADAR EQUIPMENT

Article 3.01

Operational readiness of radar equipment 1.   From a cold start, radar equipment shall be fully operational within four minutes. After this period, it shall be possible to interrupt and activate transmission instantaneously. 2.   It shall be possible for a single person to operate the radar equipment and watch the display simultaneously.

If the control panel is a separate unit, it shall contain all controls used directly for radar navigation.

Cordless remote controls shall not be permitted. 3.   It shall be possible to read the display also when there is considerable ambient brightness. When necessary, appropriate vision aids shall be available and shall be attachable and removable simply and easily.

Vision aids shall be usable by wearers of spectacles.
Article 3.02

Resolution 1.   Angular resolution

Angular resolution is related to range scale and distance. The required minimum resolution for shorter ranges up to and including 1 200 m is shown in Appendix 1. Minimum resolution is understood to be the minimum azimuthal distance between two standard reflectors (see Article 5.03(2)) at which they are shown clearly separated on the radar picture. 2.   Minimum range and range resolution

At all distances between 15 and 1 200 m in range scales up to and including 1 200 m, standard reflectors located 15 m apart on the same bearing shall be shown clearly separated on the radar screen. 3.   Functions that can cause a deterioration of resolution shall not be switchable in range scales up to 2 000 m.
Article 3.03

Range scales 1.   The radar equipment shall be provided with the following sequentially-switchable range scales and circles:

Range scale 1

500 m one circle every 100 m

Range scale 2

800 m one circle every 200 m

Range scale 3

1 200  m one circle every 200 m

Range scale 4

1 600  m one circle every 400 m

Range scale 5

2 000  m one circle every 400 m 2.   Further sequentially-switchable range scales shall be permitted. 3.   The selected range scale, the distance between range circles and the distance of the variable range marker shall be indicated in metres or kilometres. 4.   The width of the range circles and the variable range marker shall, at the normal brightness setting, not exceed 2 mm. 5.   Subsector display and enlargements shall not be permitted.
Article 3.04

Variable range marker 1.   The radar equipment shall have a variable range marker. 2.   Within eight seconds, it shall be possible to set the range marker to any distance. 3.   The distance at which the variable range marker is set shall not change even after switchover to other range scales. 4.   The range shall be displayed as a three- or four-digit number.

The accuracy for ranges up to 2 000 m shall be within 10 metres. The radius of the range marker shall correspond to the digital display.
Article 3.05

Lubber line 1.   A lubber line shall extend from the position on the radar display that corresponds to the antenna position up to the edge of the radar screen. 2.   The width of the lubber line at the edge of the screen shall not be more than 0,5°. 3.   The radar unit shall have an adjusting device for correcting any azimuthal angular error in the antenna mounting. 4.   Following correction of the angular error and activation of the radar unit, the deviation of the lubber line from the keel line shall not exceed 0,5°.
Article 3.06

Off-centring 1.   To permit an extended forward view, off-centring of the radar picture shall be possible at all the range scales specified in Article 3.03(1).

Off-centring shall result exclusively in an extension of the forward view and shall be adjustable to at least 0,25, and at most 0,33, of the effective screen diameter. 2.   In the range with extended forward view, the range circles shall be extended and the variable range marker shall be adjustable and readable up to the maximum of the displayed range. 3.   A fixed forward extension of the range displayed in accordance with paragraph 1 is permitted provided that, for the central part of the picture, the effective diameter is not less than that specified in Article 4.03(1), and that the bearing scale is designed in such a way that a bearing can be taken in accordance with Article 3.08. In that case the off-centring facility referred to in paragraph 1 shall not be required.
Article 3.07

Bearing scale 1.   The radar equipment shall have a bearing scale at the edge of the screen. 2.   The bearing scale shall be divided into at least 72 parts each representing 5 degrees. The graduation marks representing 10 degrees must be clearly longer than those representing 5 degrees.

The 000 mark on the bearing scale shall be positioned in the middle of the upper edge of the screen. 3.   The bearing scale shall be marked in three-figure numbers from 000 to 360 degrees in a clockwise direction. Numbering shall be in Arabic numerals every 10 or every 30 degrees.

The figure 000 may be replaced by a clearly visible arrow.
Article 3.08

Bearing facilities 1.   Facilities for taking bearings of targets shall be allowed. 2.   If such facilities are provided, they shall be capable of taking a bearing of any target within approximately 5 seconds, with a maximum error of ± 1 degree. 3.   If an electronic bearing line is used, it shall:

(a) be clearly distinguishable from the lubber line;

(b) be displayed quasi-continuously;

(c) be freely rotatable through 360 degrees left and right;

(d) be at most 0,5 degrees wide at the edge of the screen;

(e) extend from origin up to the bearing scale;

(f) and complete a three- or four-figure decimal degree reading. 4.   If a mechanical bearing line is used, it shall:

(a) be freely rotatable through 360 degrees left and right;

(b) extend from the marked origin to the bearing scale;

(c) bear no further markings; and

(d) be designed in such a way that echo readings are not obscured unnecessarily.
Article 3.09

Facilities for reducing sea and rain clutter 1.   The radar equipment shall have facilities with manual controls for reducing clutter from sea and rain. 2.   The sea-clutter control (sensitivity time control — STC) shall, at its maximum setting, be effective up to a distance of approximately 1 200 m. 3.   The radar equipment shall not be provided with automatic facilities for reducing sea and rain clutter.
Article 3.10

Reduction of interference from other radar equipment 1.   There shall be a switchable facility for the reduction of interference caused by other radar equipment. 2.   The operation of this facility shall not suppress the display of useful targets.
Article 3.11

Compatibility with radar beacons

Signals from radar beacons in accordance with IMO resolution A.423 (XI) shall be displayed clearly with the rain clutter suppression (fast time constant — FTC) switched off.
Article 3.12

Gain control

The range of the gain control shall be such that, at minimum sea-clutter suppression setting, surface movement of the water is clearly visible and that powerful radar echoes with an echo area equivalent to 10 000 m2 may be cut out at any distance.
Article 3.13

Frequency tuning

The display unit shall be provided with a tuning indicator. The tuning scale shall have a length of at least 30 mm. The indicator shall function in all ranges, even without radar echoes. The indicator shall function equally well when the gain or suppression of close proximity echoes is activated.

A manual control to correct the tuning shall be available.
Article 3.14

Nautical orientation lines and information on the screen 1.   Only the lubber line, bearing lines and range circles may be superimposed on the radar screen. 2.   Apart from the radar picture and in addition to information on the operation of the radar equipment, only nautical information such as that listed below may be displayed:

(a) rate of turn;

(b) speed of the vessel;

(c) rudder position;

(d) water depth;

(e) compass course. 3.   All screen information besides the radar picture shall be displayed quasi-statically and the refreshing rate shall satisfy the operational requirements. 4.   The requirements regarding the display and accuracy of nautical information shall be the same as those applicable to the main equipment.
Article 3.15

System sensitivity

The system sensitivity shall be such that a standard reflector at a distance of 1 200 m appears clearly on the radar picture on every revolution of the antenna. In the case of a 1 m2 reflector at the same distance, the quotient of the number of antenna revolutions with radar echo during a specific period and the total number of antenna revolutions in that same period based on 100 revolutions (blip-scan rate) shall not be less than 0,8. 

Article 3.16

Target trail

Previous positions of targets shall be shown by means of a trail.

The representation of the target trail shall be quasi-continuous and the brightness shall be less than that of the associated target; the target trail and the radar picture shall have the same colour. The persistence of the trail shall be adjustable to operational requirements, but shall not last longer than 2 antenna revolutions.

The target trail shall not impair the radar picture.
Article 3.17

Slave indicators

Slave indicators shall comply with all requirements applicable to navigational radar equipment.

CHAPTER 4MINIMUM TECHNICAL REQUIREMENTS FOR RADAR EQUIPMENT

Article 4.01

Operation 1.   All controls shall be so arranged that during their operation no information is concealed from view and radar navigation remains unimpaired. 2.   Controls which can be used to switch off the equipment or, if activated, could lead to a malfunction must be protected against accidental operation. 3.   All controls and indicators shall be provided with a dazzle-free source of lighting appropriate for all ambient lighting conditions and adjustable down to zero by means of an independent control. 4.   The following functions must have their own controls with direct access:

(a) Stand-by/on;

(b) Range;

(c) Tuning;

(d) Gain;

(e) Seaclutter (STC);

(f) Rainclutter (FTC);

(g) Variable range marker (VRM);

(h) Cursor or electronic bearing line (EBL) (if fitted);

(i) Ship’s heading marker suppression (SHM).

If rotary controls are used for the abovementioned functions, concentric arrangement of the controls one above the other shall be prohibited. 5.   At least the controls for gain, sea clutter and rain clutter must be adjustable by means of a rotary control with an effect proportional to the angle of rotation. 6.   Adjustment of controls shall be such that movements to the right or upwards have a positive effect on the variable and movements to the left or downwards a negative effect. 7.   If push-buttons are used, it shall be possible to locate and operate them by touch. They shall also have clearly perceptible contact release. 8.   It must be possible to adjust the brightness of the following variables separately from zero to the value required for operational purposes:

(a) radar picture;

(b) fixed range circles;

(c) variable range circles;

(d) bearing scale;

(e) bearing line;

(f) nautical information as specified in Article 3.14(2). 9.   Provided that the difference in brightness of some of the displayed values is only slight and the fixed range circle, the variable range circle and the bearing line can be switched off independently of each other, there may be four brightness controls, one for each of the following groups of values:

(a) radar picture and lubber line;

(b) fixed range circles;

(c) variable range circles;

(d) bearing line and bearing scale and nautical information as specified in Article 3.14(2). 10.   The brightness of the lubber line shall be adjustable but shall not be reducible to zero. 11.   To switch off the lubber line, there shall be a control with automatic reset. 12.   From zero, the anti-clutter devices shall be continuously adjustable.
Article 4.02

Display 1.   ‘Radar picture’ means the scaled representation of radar echoes of the surroundings and their motion relative to the vessel on the display unit’s screen from one antenna revolution with the vessel’s keel line and the lubber line coinciding at all times. 2.   ‘Display unit’ means that part of the equipment that contains the screen. 3.   ‘Screen’ means the low-reflection part of the display unit on which either the radar picture alone, or the radar picture together with additional nautical information, is shown. 4.   ‘Effective diameter of the radar picture’ means the diameter of the largest completely circular radar picture which can be shown within the bearing scale. 5.   ‘Raster scan representation’ means the quasi-static representation of the radar picture from a complete revolution of the antenna, in the form of a television picture.
Article 4.03

Radar picture characteristics 1.   The effective diameter of the radar picture shall be not less than 270 mm. 2.   The diameter of the outer range circle in the range scales specified in Article 3.03 shall be at least 90 % of the effective radar picture diameter. 3.   For all range scales, the antenna position shall be visible in the radar picture.
Article 4.04

Colour of the display

The display colour shall be chosen on the basis of physiological factors. If various colours can be reproduced on the screen, the actual radar picture shall be monochrome. The reproduction of different colours shall not result in mixed colours, by superimposition, on any part of the screen.
Article 4.05

Picture refreshment rate and persistence 1.   The radar picture shown by the display shall be replaced by the up-to-date radar picture within 2,5 seconds. 2.   Each echo on the screen shall persist for at least the duration of one antenna revolution, but not longer than two antenna revolutions.

The persistence of the radar picture may be achieved in two fashions: either by a continuous display or by periodical picture refreshment. This periodical picture refreshment shall be effected at not less than 50 Hz. 3.   The difference in brightness between the writing of an echo and its afterglow during one antenna revolution shall be as small as possible.
Article 4.06

Display linearity 1.   The linearity error of the radar picture shall not exceed 5 %. 2.   In all ranges up to 2 000 m a fixed straight shore line at a distance of 30 m from the radar antenna shall be displayed as a straight continuous echo structure without observable distortions.
Article 4.07

Accuracy of range and azimuthal measurements 1.   The determination of the distance to a target by means of variable or fixed range circles shall be accurate to ± 10 m or ± 1,5 %, whichever is the larger. 2.   The angular value of the bearing of an object shall not differ by more than 1 degree from the real value.
Article 4.08

Antenna characteristics and emission spectrum 1.   The antenna drive system and the antenna shall be such as to allow correct operation at wind speeds of up to 100 km per hour. 2.   The antenna drive system shall have a safety switch by means of which the transmitter and the rotator drive can be switched off. 3.   The horizontal radiation pattern of the antenna, measured in one direction, shall meet the following requirements:

(a) – 3 dB, width of the main lobe: maximum 1,2 degrees;

(b) – 20 dB, width of the main lobe: maximum 3,0 degrees;

(c) side-lobe attenuation within ± 10 degrees around the main lobe: at least — 25 dB;

(d) side-lobe attenuation outside ± 10 degrees around the main lobe: at least — 32 dB. 4.   The vertical radiation pattern of the antenna, measured in one direction, shall meet the following requirements:

(a) – 3 dB, width of the main lobe: maximum 30 degrees;

(b) the maximum of the main lobe shall be in the horizontal axis;

(c) side-lobe attenuation: at least — 25 dB. 5.   The radiated high-frequency energy shall be horizontally polarised. 6.   The operating frequency of the equipment shall be in a range above 9 GHz which is allocated under prevailing ITU Radio Regulations to navigational radar equipment. 7.   The frequency spectrum of the high-frequency energy radiated by the antenna shall be in conformity with ITU Radio Regulations.

CHAPTER 5TEST CONDITIONS AND TEST METHODS FOR RADAR EQUIPMENT

Article 5.01

Safety, load capacity and interference diffusion

Power supply, safety, mutual interference of shipborne equipment, compass safe distance, resistance to climatic influences, mechanical strength, environmental impact and audible noise emission shall be tested in accordance with IEC publication 945 ‘Marine Navigational Equipment General Requirements’.
Article 5.02

Spurious emissions and electromagnetic compatibility 1.   Spurious emissions shall be measured in accordance with IEC publication 945 ‘Marine Navigational Equipment Interference’ in the frequency range of 30 to 2 000 MHz.

The requirements of Article 2.02(1) shall be met. 2.   The electromagnetic compatibility requirements of Article 2.02(2) shall be met.
Article 5.03

Test procedure 1.   The test field shown in Appendix 2 for the testing of radar equipment shall be arranged on a calm water surface at least 1,5 km long and 0,3 km wide, or on terrain with equivalent reflection properties. 2.   A standard reflector shall be a radar reflector which, at a wavelength of 3,2 cm, has an equivalent radar cross-section of 10 m2. The equivalent radar cross-section (sigma) of a three-axis radar reflector with triangular surfaces for a frequency of 9 GHz (3,2 cm) shall be calculated according to the following formula:

a

=

edge length in m

For a standard reflector with triangular surfaces, the edge length a = 0,222 m.

The dimensions of the reflectors used for the testing of range and discrimination at a wavelength of 3,2 cm shall also be used when the radar equipment under test has a wavelength other than 3,2 cm. 3.   Standard reflectors shall be set up at distances of 15 m, 30 m, 45 m, 60 m, 85 m, 300 m, 800 m, 1 170 m, 1 185 m and 1 200 m from the antenna position.

Beside the standard reflector at 85 m, standard reflectors shall be set up at a distance of 5 m on both sides, at right angles to the bearing line.

Beside the standard reflector at 300 m, a reflector with an equivalent radar cross-section of 300 m2 shall be set up at a distance of 18 m, at right angles to the bearing line.

Further reflectors with an equivalent radar cross-section of 1 m2 and 1 000 m2 shall be set up at an azimuthal angle to each other of at least 15 degrees, at the same distance of 300 m from the antenna.

Beside the standard reflector at 1 200 m, standard reflectors and a reflector with a radar cross-section of 1 m2 shall be set up at a distance of 30 m on both sides, at right angles to the bearing line. 4.   The radar equipment shall be adjusted to the best quality of picture. The gain must be adjusted in such a way that, in the area immediately beyond the range of operation of the anti-clutter control, noise can no longer be seen.

The sea-clutter suppression control (STC) shall be set at minimum, while the rain-clutter suppression control (FTC) shall be switched off.

All controls that influence picture quality shall be left unchanged for the duration of the test at a specific antenna height and be fixed in an appropriate way. 5.   The antenna shall be set up at any desired height between 5 and 10 m above the surface of the water or the ground. The reflectors shall be set up at such a height above the surface of the water or of the ground that their effective radar return corresponds to the value specified in paragraph 2. 6.   All reflectors set up within the selected range shall, at all distances up to and including 1 200 m, be shown on the screen simultaneously as clearly separated targets, regardless of the azimuthal position of the test field in relation to the lubber line.

Signals from radar beacons as described in Article 3.11 shall be displayed clearly.

All requirements specified in these provisions shall be met at any antenna height between 5 and 10 m, with only essential adjustments of the controls being authorised.
Article 5.04

Antenna measurements

The antenna characteristics shall be measured in accordance with IEC publication 936 ‘Shipborne Radar’.
Appendix 1

Angular resolution in ranges up to and including 1 200 m
Appendix 2

Test field for determination of the resolution of radar equipment

PART IVMINIMUM REQUIREMENTS AND TEST CONDITIONS FOR RATE-OF-TURN INDICATORS USED IN INLAND WATERWAY VESSELSCONTENTS

Chapter 1: | General | 

Article 1.01 | Scope | 

Article 1.02 | Purpose of the rate-of-turn indicator | 

Article 1.03 | Approval testing | 

Article 1.04 | Application for approval testing | 

Article 1.05 | Type-approval | 

Article 1.06 | Marking of the equipment and approval number | 

Article 1.07 | Manufacturer’s declaration | 

Article 1.08 | Modifications to approved equipment | 

Chapter 2: | General minimum requirements for rate-of-turn indicators | 

Article 2.01 | Construction, design | 

Article 2.02 | Spurious emissions and electromagnetic compatibility | 

Article 2.03 | Operation | 

Article 2.04 | Operating instructions | 

Article 2.05 | Installation and operating tests | 

Chapter 3: | Minimum operational requirements for rate-of-turn indicators | 

Article 3.01 | Operational readiness of the rate-of-turn indicator | 

Article 3.02 | Indication of the rate of turn | 

Article 3.03 | Measuring ranges | 

Article 3.04 | Accuracy of the indicated rate of turn | 

Article 3.05 | Sensitivity | 

Article 3.06 | Monitoring of operation | 

Article 3.07 | Insensitivity to other normal movements of the vessel | 

Article 3.08 | Insensitivity to magnetic fields | 

Article 3.09 | Slave indicators | 

Chapter 4: | Minimum technical requirements for rate-of-turn indicators | 

Article 4.01 | Operation | 

Article 4.02 | Damping devices | 

Article 4.03 | Connection of additional equipment | 

Chapter 5: | Test conditions and procedures for rate-of-turn indicators | 

Article 5.01 | Safety, load capacity and interference diffusion | 

Article 5.02 | Spurious emissions and electromagnetic compatibility | 

Article 5.03 | Test procedure | 

Appendix: | Maximum tolerances for indication errors of rate-of-turn indicators | CHAPTER 1GENERAL

Article 1.01

Scope

These provisions set out the minimum technical and operational requirements for rate-of-turn indicators used in inland waterway vessels, as well as the conditions for testing conformity with these minimum requirements.
Article 1.02

Purpose of the rate-of-turn indicator

The rate-of-turn indicator is intended to facilitate radar navigation, and to measure and indicate the rate of turn of the vessel to port or starboard.
Article 1.03

Approval testing

Rate-of-turn indicators may not be installed on board vessels until it has been established by means of a type test that they meet the minimum requirements laid down in these provisions.
Article 1.04

Application for approval testing 1.   Applications for a type-test of rate-of-turn indicators shall be submitted to a competent testing authority in one of the Member States.

The competent testing authorities shall be made known to the Committee. 2.   Each application shall be accompanied by the following documents:

(a) two copies of a detailed technical description;

(b) two complete sets of installation and service documents;

(c) two copies of an operator’s manual. 3.   By means of tests, the applicant shall establish or have it established that the radar equipment meets the minimum requirements of these provisions.

The results of the test and the measurement reports shall be attached to the application.

These documents and the information obtained during testing shall be kept by the competent testing authority. 4.   For approval testing purposes, ‘applicant’ means any legal or natural person under whose name, trademark or any other form of identification the equipment submitted for testing is manufactured or marketed.
Article 1.05

Type-approval 1.   If the equipment passes the type test, the competent testing authority shall issue a certificate of conformity.

If the equipment fails to meet the minimum requirements, the applicant shall be notified in writing of the reasons for its rejection.

Approval shall be granted by the competent authority.

The competent authority shall inform the Committee of the equipment it has approved. 2.   Each testing authority shall be entitled to select equipment from the production series at any time for inspection.

If this inspection reveals defects in the equipment, type-approval may be withdrawn.

The type-approval shall be withdrawn by the authority that issued it. 3.   The type-approval shall be valid for a period of 10 years and may be renewed on request.
Article 1.06

Marking of the equipment and approval number 1.   Each component of the equipment shall be marked indelibly with the name of the manufacturer, the trade designation of the equipment, the type of equipment and the serial number. 2.   The approval number assigned by the competent authority shall be affixed indelibly to the control unit in such a way that it remains clearly visible after the equipment has been installed.

Composition of an approval number:

e-NN-NNN

(e

=

European Union

NN

=

code for the country of approval, where

1

=

Germany

2

=

France

3

=

Italy

4

=

Netherlands

5

=

Sweden

6

=

Belgium

7

=

Hungary

8

=

Czech Republic

9

=

Spain

11

=

United Kingdom

12

=

Austria

13

=

Luxembourg

17

=

Finland

18

=

Denmark

20

=

Poland

21

=

Portugal

23

=

Greece

24

=

Ireland

26

=

Slovenia

27

=

Slovakia

29

=

Estonia

32

=

Latvia

36

=

Lithuania

49

=

Cyprus

50

=

Malta

NNN

=

three-digit number, to be determined by the competent authority). 3.   The approval number shall be used only in conjunction with the associated approval.

It shall be the responsibility of the applicant to produce and affix the approval number. 4.   The competent authority shall immediately inform the Committee of the approval number assigned.
Article 1.07

Manufacturer’s declaration

Each unit of equipment shall be accompanied by a manufacturer’s declaration to the effect that it meets the prevailing minimum requirements and that is identical in every respect to the equipment submitted for testing.
Article 1.08

Modifications to approved equipment 1.   Any modification made to equipment already approved shall cause the type-approval to be withdrawn.

Whenever modifications are planned, details shall be sent in writing to the competent testing authority. 2.   The competent testing authority shall decide whether the approval still applies or whether an inspection or new type-test is necessary. If a new approval is granted, a new approval number shall be assigned.

CHAPTER 2GENERAL MINIMUM REQUIREMENTS FOR RATE-OF-TURN INDICATORS

Article 2.01

Construction, design 1.   Rate-of-turn indicators shall be suitable for operation on board inland waterway vessels. 2.   The construction and design of the equipment shall be in accordance with the state of the art, both mechanically and electrically. 3.   In the absence of any specific provision in Annex II to this Directive or in these provisions, the requirements and test methods contained in IEC publication 945 ‘Marine Navigational Equipment General Requirements’ shall apply to power supply, safety, mutual interference of shipborne equipment, compass safe distance, resistance to climatic influences, mechanical strength, environmental influences, audible noise emission and equipment markings.

Additionally, the equipment shall satisfy all requirements of these provisions at ambient temperatures between 0 and 40 °C.
Article 2.02

Spurious emissions and electromagnetic compatibility 1.   In the frequency range of 30 to 2000 MHz, the field strength of spurious emissions shall not exceed 500 μV/m.

In the frequency ranges of 156 to 165 MHz, 450 to 470 MHz and 1,53 to 1,544 GHz the field strength shall not exceed a value of 15 μV/m. These field strengths shall apply at a test distance of 3 metres from the equipment under test. 2.   The equipment shall satisfy the minimum requirements at electromagnetic field strengths of up to 15 V/m in the immediate vicinity of the equipment under test in the frequency range of 30 to 2 000 MHz.
Article 2.03

Operation 1.   The equipment shall not have more controls than are necessary for its correct operation.

The design, markings and manipulation of the controls shall be such as to permit their simple, unambiguous and fast operation. Their arrangement shall be such as to prevent operating mistakes as far as possible.

Controls not necessary for normal operation shall not be immediately accessible. 2.   All controls and indicators shall be provided with symbols and/or markings in English. Symbols shall meet the requirements contained in IEC publication No 417. All numerals and letters shall be at least 4 mm high. If it can be demonstrated that, for technical reasons, numerals and letters 4 mm high are not possible and if for the purposes of operation smaller numerals and letters are acceptable, a reduction to 3 mm shall be allowed. 3.   The equipment shall be designed in such a way that operating mistakes cannot cause its failure. 4.   Any functions over and above the minimum requirements, such as facilities for connection to other equipment, shall be provided in such a way that the equipment meets the minimum requirements under all conditions.
Article 2.04

Operating instructions

A detailed operator’s manual shall be supplied with each unit. It shall be available in Dutch, English, French and German and shall contain at least the following information:

(a) activation and operation;

(b) maintenance and servicing;

(c) general safety instructions.
Article 2.05

Installation and operating tests 1.   Installation, replacement and operating tests shall be in accordance with the requirements of Part V. 2.   The direction of installation in relation to the keel line shall be indicated on the rate-of-turn indicator’s sensor unit. Installation instructions to ensure maximum insensitivity to other normal movements of the vessel shall be provided.

CHAPTER 3MINIMUM OPERATIONAL REQUIREMENTS FOR RATE-OF-TURN INDICATORS

Article 3.01

Operational readiness of the rate-of-turn indicator 1.   From a cold start, the rate-of-turn indicator shall be fully operational within four minutes and shall operate to within the required accuracy tolerances. 2.   A warning signal shall indicate that the indicator is switched on. It shall be possible to observe and operate the rate-of-turn indicator simultaneously. 3.   Cordless remote controls shall not be permitted.
Article 3.02

Indication of the rate of turn 1.   The rate of turn shall be indicated on a linear graduated scale having the zero point situated in the middle. It shall be possible to read the direction and extent of the rate of turn with the necessary accuracy. Needle indicators and bar-graphs shall be permitted. 2.   The indicator scale shall be at least 20 cm long and may be circular or rectilinear.

Rectilinear scales may be arranged horizontally only. 3.   Solely digital indicators shall not be permitted.
Article 3.03

Measuring ranges

Rate-of-turn indicators may be provided with one or more measuring ranges. The following measuring ranges are recommended:
30°/minute
60°/minute
90°/minute
180°/minute
300°/minute.
Article 3.04

Accuracy of the indicated rate of turn

The indicated rate of turn shall not differ by more than 2 % from the measurable maximum value or by more than 10 % from the actual value, whichever is the greater (see Appendix).
Article 3.05

Sensitivity

The operating threshold shall be less than or equal to a change in angular speed equivalent to l % of the indicated value.
Article 3.06

Monitoring of operation 1.   If the rate-of-turn indicator does not operate within the required accuracy range, this shall be indicated. 2.   If a gyroscope is used, any critical fall in the rate of rotation of the gyroscope shall be signalled by an indicator. A critical fall in the rate of rotation of the gyroscope is one which lowers accuracy by 10 %.
Article 3.07

Insensitivity to other normal movements of the vessel 1.   Rolling of the vessel of up to 10° at a rate of turn of up to 4° per second shall not give rise to measurement errors in excess of the stipulated tolerances. 2.   Impacts such as those that may occur during berthing shall not give rise to measurement errors in excess of the stipulated tolerances.
Article 3.08

Insensitivity to magnetic fields

The rate-of-turn indicator shall be insensitive to magnetic fields which typically occur on board the vessel.
Article 3.09

Slave indicators

Slave indicators shall comply with all requirements applicable to rate-of-turn indicators.

CHAPTER 4MINIMUM TECHNICAL REQUIREMENTS FOR RATE-OF-TURN INDICATORS

Article 4.01

Operation 1.   All controls shall be so arranged that during their operation no information is concealed from view and radar navigation remains unimpaired. 2.   All controls and indicators shall be provided with a dazzle-free source of lighting appropriate for all ambient lighting conditions and adjustable down to zero by means of an independent control. 3.   Adjustment of controls shall be such that movements to the right or upwards have a positive effect on the variable and movements to the left or downwards a negative effect. 4.   If push-buttons are used, it shall be possible to locate and operate them by touch. They shall also have clearly perceptible contact release.
Article 4.02

Damping devices 1.   The sensor system shall be damped for critical values. The damping constant (63 % of the limit value) shall not exceed 0,4 seconds. 2.   The indicator shall be damped for critical values.

Controls for increasing damping shall be permitted.

Under no circumstances may the damping constant exceed five seconds.
Article 4.03

Connection of additional equipment 1.   If the rate-of-turn indicator can be connected to slave indicators or similar equipment, the rate-of-turn indication shall remain usable as an electric signal.

The rate of turn shall continue to be indicated with galvanic earth insulation and the equivalent to an analogue voltage of 20 mV/degree ± 5 % and a maximum internal resistance of 100 ohms.

Polarity shall be positive when the vessel is turning to starboard and negative when it is turning to port.

The operating threshold shall not exceed 0,3°/minute.

Zero error shall not exceed 1°/minute at temperatures from 0 to 40°C.

With the indicator switched on and the sensor not exposed to the effects of movement, the spurious voltage at the output signal measured with a 10 Hz pass-band low-pass filter shall not exceed 10 mV.

The rate-of-turn signal shall be received without additional damping beyond the limits referred to in Article 4.02(1). 2.   An external alarm switch shall be provided. The switch shall be installed as a galvanic insulation break-switch for the indicator.

The external alarm shall be triggered by contact closure:

(a) if the rate-of-turn indicator is disconnected; or

(b) if the rate-of-turn indicator is not in operation; or

(c) if the operating control has reacted following an excessive error (Article 3.06).

CHAPTER 5TEST CONDITIONS AND PROCEDURES FOR RATE-OF-TURN INDICATORS

Article 5.01

Safety, load capacity and interference diffusion

Power supply, safety, mutual interference of shipborne equipment, compass safe distance, resistance to climatic influences, mechanical strength, environmental impact and audible noise emission shall be tested in accordance with IEC publication 945 ‘Marine Navigational Equipment General Requirements’.
Article 5.02

Spurious emissions and electromagnetic compatibility 1.   Spurious emissions shall be measured in accordance with IEC publication 945 ‘Marine Navigational Equipment Interference’ in the frequency range of 30 to 2 000 MHz.

The requirements of Article 2.02(1) shall be met. 2.   The electromagnetic compatibility requirements of Article 2.02(2) shall be met.
Article 5.03

Test procedure 1.   Rate-of-turn indicators shall be brought into operation and tested under nominal and boundary conditions. In this regard, the influence of the operating voltage and of the ambient temperature shall be tested as far as the prescribed limit value.

In addition, radio transmitters shall be used to set up the maximum magnetic fields in the vicinity of the indicators. 2.   Under the conditions described in paragraph 1, indicator errors shall remain within the tolerances indicated in the Appendix.

All other requirements shall be met.
Appendix

Maximum tolerances for indication errors of rate-of-turn indicators

Relative indication of the rate-of turn as a % of the limit values

Relative difference of the indicated value as a % of the measured value

PART VREQUIREMENTS FOR INSTALLATION AND PERFORMANCE TESTS FOR RADAR EQUIPMENT AND RATE-OF-TURN INDICATORS USED IN INLAND WATERWAY VESSELSCONTENTS

Article 1 | Scope | 

Article 2 | Approval of equipment | 

Article 3 | Approved specialised firms | 

Article 4 | Requirements for on-board power supply | 

Article 5 | Installation of the radar antenna | 

Article 6 | Installation of the display unit and the control unit | 

Article 7 | Installation of the rate-of-turn indicator | 

Article 8 | Installation of the position sensor | 

Article 9 | Installation and performance test | 

Article 10 | Installation and performance certificate | 

Appendix | Model installation and performance certificate for radar equipment and rate-of-turn indicators | 

Article 1

Scope

The purpose of these requirements is to ensure that in the interest of safety and orderly radar navigation on inland waterways in the Community, navigational radar equipment and rate-of-turn indicators are installed according to optimum technical and ergonomic standards and that installation is followed by a performance test. Inland ECDIS equipment that can be used in navigation mode counts as navigational radar equipment within the meaning of these provisions.
Article 2

Approval of equipment

For radar navigation on inland waterways in the Community, only equipment approved according to the applicable provisions of this Directive or of the Central Commission for Navigation on the Rhine and bearing an approval number shall be authorised for installation.
Article 3

Approved specialised firms 1.   The installation, replacement, repair or maintenance of radar equipment and rate-of-turn indicators shall be carried out only by specialised firms approved by the competent authority in accordance with Article 1. 2.   Approval may be granted by the competent authority for a limited period and may be withdrawn by the competent authority at any time if the conditions in Article 1 are no longer met. 3.   The competent authority shall immediately notify the Committee of the specialised firms which it has approved.
Article 4

Requirements for on-board power supply

All power supply leads for radar equipment and rate-of-turn indicators shall have their own separate safety devices and if possible be fail-safe.
Article 5

Installation of the radar antenna 1.   The radar antenna shall be installed as close as possible to the fore-and-aft-line. There shall be no obstruction in the vicinity of the antenna causing false echoes or unwanted shadows; if necessary, the antenna shall be mounted on the forecastle. The mounting and attachment of the radar antenna in its operational position shall be sufficiently stable to enable the radar equipment to perform within the required accuracy limits. 2.   After the angular error in the mounting has been corrected and the equipment has been switched on, the difference between lubber line and fore-and-aft-line shall not be greater than 1 degree.
Article 6

Installation of the display unit and the control unit 1.   The display unit and control unit shall be installed in the wheelhouse in such a way that the evaluation of the radar picture and the operation of the equipment present no difficulty. The azimuthal orientation of the radar picture shall be in accordance with the normal situation of the surroundings. Clamps and adjustable consoles are to be constructed in such a way that they can be locked in any position free of vibration. 2.   During radar navigation, artificial lighting shall not be reflected in the direction of the radar operator. 3.   When the control unit is not part of the display unit, it shall be located in a housing within 1 metre of the display unit. Cordless remote controls shall not be permitted. 4.   If slave indicators are installed, they shall satisfy the requirements which apply to navigational radar equipment.
Article 7

Installation of the rate-of-turn indicator 1.   The sensor system shall be installed as far as possible amidships, horizontal and aligned with the ship’s fore-and-aft-line. The installation site shall as far as possible be free of vibration and be liable to modest temperature variations. The indicator unit shall if possible be installed above the radar display. 2.   If slave indicators are installed, they shall satisfy the requirements which apply to rate-of-turn indicators.
Article 8

Installation of the position sensor

The position sensor (e.g. DGPS antenna) must be installed in such a way as to ensure that it operates with the greatest possible degree of accuracy and is not adversely affected by superstructures and transmitting equipment on board ship.
Article 9

Installation and performance test

Before the equipment is switched on for the first time after installation or after renewals or extensions of the ship’s survey certificate (except according to Article 2.09(2) of Annex II) as well as after each modification of the vessel likely to affect the operating conditions of the equipment, an installation and performance test shall be carried out by the competent authority or by a firm authorised in accordance with Article 3. For this purpose, the following conditions shall be fulfilled:

(a) the power supply shall have a separate safety device;

(b) the operating voltage shall be within the tolerance (Article 2.01 of Part III);

(c) the cabling and its installation shall satisfy the provisions of Annex II and, if necessary, the ADNR;

(d) the number of antenna revolutions shall reach at least 24 per minute;

(e) there shall be no obstruction in the vicinity of the antenna which impairs navigation;

(f) the safety switch of the antenna shall be in good working order;

(g) the arrangement of display units, rate-of-turn indicators and control units shall be ergonomic and user-friendly;

(h) the lubber line of the radar equipment shall not deviate from the ship’s fore-and-aft-line by more than 1 degree;

(i) the accuracy of the range and azimuthal displays shall satisfy the requirements (measurements using known targets);

(k) linearity in short ranges shall be correct (pushing and pulling);

(l) the displayed minimum range shall be 15 metres or less;

(m) the centre of the picture shall be visible and its diameter shall not exceed 1 mm;

(n) False echoes caused by reflections and unwanted shadows on the lubber line shall not occur or shall not impair the safety of navigation;

(o) Sea-clutter and rain-clutter suppressors (STC and FTC preset) and the associated controls shall perform correctly;

(p) the gain adjustment shall be in proper working order;

(q) focus and picture definition shall be correct;

(r) the ship’s turning direction shall be as indicated on the rate-of-turn indicator and the zero position at dead ahead shall be correct;

(s) the radar equipment shall not be sensitive to transmissions by the ship’s radio equipment or to interference from other on-board sources;

(t) the radar equipment and/or rate-of-turn indicator shall not interfere with other on-board equipment.

Furthermore, in the case of inland ECDIS equipment:

(u) the statistical positional error affecting the chart shall not exceed 2 m;

(v) the statistical phase angle error affecting the chart shall not exceed 1 degree.
Article 10

Installation and performance certificate

After successful completion of a test in accordance with Article 8, the competent authority or the approved firm shall issue a certificate based on the model in the Appendix. This certificate shall be kept permanently on board.

If the test conditions have not been met, a list of defects shall be drawn up. Any existing certificate shall be withdrawn or sent to the competent authority by the approved firm.
Appendix

Text of image

MODEL INSTALLATION AND PERFORMANCE CERTIFICATE FOR RADAR EQUIPMENT AND RATE-OF-TURN INDICATORS

Type/Name of vessel:

Official registration number of vessel:

Vessel’s owner

Name::

Address:

Telephone:

Radar appliances Number

Order No

Designation

Type

Approval No

Serial No

Rate-of-turn indicators Number

Order No

Designation

Type

Approval No

Serial No

This is to certify that the radar equipment and rate-of-turn indicator of the abovementioned vessel comply with the installation and performance test requirements for radar equipment and rate-of-turn indicators used in inland waterway vessels..

Approved firm

Name:

Address:

Telephone

Stamp

Place Date

Firma:

Autoridad competente

Name:

Address:

Telephone

PART VIMODEL LIST OF TEST INSTITUTES, APPROVED EQUIPMENT AND APPROVED INSTALLATION FIRMSas provided for in Part IV and Part V

A.   COMPETENT TESTING AUTHORITIESpursuant toArticle 1.04(1) of Part IB.   APPROVED RADAR EQUIPMENTpursuant to Article 1.06(4) of Part IV
No

Type

Manufacturer

Owner

Date and country of approval

Approval No

Doc. No.

C.   APPROVED RATE-OF-TURN INDICATORSpursuant to Article 1.06(4) of Part IV
No

Type

Manufacturer

Owner

Date and country of approval

Approval No

Doc. No.

D.   APPROVED SPECIALISED FIRMS FOR THE INSTALLATION OR REPLACEMENT OF RADAR EQUIPMENT AND RATE-OF-TURN INDICATORSpursuant to Article 3 of Part V
N.B.: The letters in column 4 refer to the designations in column 1 of points B (radar equipmnet) and C (rate-of-turn indicators).

Firm

Address

Approved types of equipment listed in column 1
(1)  The rated voltage and frequency are those indicated by the manufacturer.Ranges of voltage and/or frequency may also be indicated.

(2)  Before measurement of the values at the start of the test, filament lamps shall have already been in service at the rated voltage for 60 minutes.

(3)  These limits shall be respected in an area extending ± 30° on either side of the horizontal line passing through the median point of the body of the lantern when the lamp is rotated through 360° on its axis.

(4)  Fundamental values of the E-12 IEC series: 1,0; 1,2; 1,5; 1,8; 2,2; 2,7; 3,3; 3,9; 4,7; 5,6; 6,8; 8,2.

Pending: 32006L0070

                                January 16, 2026                            

4.8.2006
EN
Official Journal of the European Union
L 214/29

(1)
Directive 2005/60/EC requires institutions and persons covered to apply, on a risk-sensitive basis, enhanced customer due diligence measures in respect of transactions or business relationships with politically exposed persons residing in another Member State or in a third country. In the context of this risk analysis, it is appropriate for the resources of the institutions and persons covered to be focused in particular on products and transactions that are characterised by a high risk of money laundering. Politically exposed persons are understood to be persons entrusted with prominent public functions, their immediate family members or persons known to be close associates of such persons. In order to provide for a coherent application of the concept of politically exposed person, when determining the groups of persons covered, it is essential to take into consideration the social, political and economic differences between countries concerned.

(2)
Institutions and persons covered by Directive 2005/60/EC may fail to identify a customer as falling within one of the politically exposed person categories, despite having taken reasonable and adequate measures in this regard. In those circumstances, Member States, when exercising their powers in relation to the application of that Directive, should give due consideration to the need to ensure that those persons do not automatically incur liability for such failure. Member States should also consider facilitating compliance with that Directive by providing the necessary guidance to institutions and persons in this connection.

(3)
Public functions exercised at levels lower than national should normally not be considered prominent. However, where their political exposure is comparable to that of similar positions at national level, institutions and persons covered by this Directive should consider, on a risk-sensitive basis, whether persons exercising those public functions should be considered as politically exposed persons.

(4)
Where Directive 2005/60/EC requires institutions and persons covered to identify close associates of natural persons who are entrusted with prominent public functions, this requirement applies to the extent that the relation with the associate is publicly known or that the institution or person has reasons to believe that such relation exists. Thus it does not presuppose active research on the part of the institutions and persons covered by the Directive.

(5)
Persons falling under the concept of politically exposed persons should not be considered as such after they have ceased to exercise prominent public functions, subject to a minimum period.

(6)
Since the adaptation, on a risk-sensitive basis, of the general customer due diligence procedures to low-risk situations is the normal tool under Directive 2005/60/EC, and given the fact that simplified customer due diligence procedures require adequate checks and balances elsewhere in the system aiming at preventing money laundering and terrorist financing, the application of simplified customer due diligence procedures should be restricted to a limited number of cases. In these cases, the requirements for institutions and persons covered by that Directive do not disappear, and these are expected to,inter alia, conduct ongoing monitoring of the business relations, in order to be able to detect complex or unusually large transactions which have no apparent economic or visible lawful purpose.

(7)
Domestic public authorities are generally considered as low-risk customers within their own Member State and, in accordance with Directive 2005/60/EC, may be subject to simplified customer due diligence procedures. However, none of the Community institutions, bodies, offices or agencies, including the European Central Bank (ECB), directly qualify in the Directive for simplified customer due diligence under the ‘domestic public authority’ category or, in the case of the ECB, under the ‘credit and financial institution’ category. However, since these entities do not appear to present a high risk of money laundering or terrorist financing, they should be recognised as low-risk customers and benefit from the simplified customer due diligence procedures provided that appropriate criteria are fulfilled.

(8)
Furthermore, it should be possible to apply simplified customer due diligence procedures in the case of legal entities undertaking financial activities which do not fall under the definition of financial institution under Directive 2005/60/EC but which are subject to national legislation pursuant to that Directive and comply with requirements concerning sufficient transparency as to their identity and adequate control mechanisms, in particular enhanced supervision. This could be the case for undertakings providing general insurance services.

(9)
It should be possible to apply simplified customer due diligence procedures to products and related transactions in limited circumstances, for example where the benefits of the financial product in question cannot generally be realised for the benefit of third parties and those benefits are only realisable in the long term, such as some investment insurance policies or savings products, or where the financial product aims at financing physical assets in the form of leasing agreements in which the legal and beneficial title of the underlying asset remains with the leasing company or in the form of low value consumer credit, provided the transactions are carried out through bank accounts and are below an appropriate threshold. State controlled products which are generally addressed to specific categories of clients, such as savings products for the benefit of children, should benefit from simplified customer due diligence procedures even if not all the criteria are fulfilled. State control should be understood as an activity beyond normal supervision on financial markets and should not be construed as covering products, such as debt securities, issued directly by the State.

(10)
Before allowing use of simplified customer due diligence procedures, Member States should assess whether the customers or the products and related transactions represent a low-risk of money laundering or terrorist financing, notably by paying special attention to any activity of these customers or to any type of products or transactions which may be regarded as particularly likely, by their nature, to be used or abused for money laundering or terrorist financing purposes. In particular, any attempt by customers in relation to low-risk products to act anonymously or hide their identity should be considered as a risk factor and as potentially suspicious.

(11)
In certain circumstances, natural persons or legal entities may conduct financial activities on an occasional or very limited basis, as a complement to other non-financial activities, such as hotels that provide currency exchange services to their clients. Directive 2005/60/EC allows Member States to decide that financial activities of that kind fall outside its scope. The assessment of the occasional or very limited nature of the activity should be made by reference to quantitative thresholds in relation to the transactions and the turnover of the business concerned. These thresholds should be decided at national level, depending on the type of financial activity, in order to take account of differences between countries.

(12)
Moreover, a person engaging in a financial activity on an occasional or very limited basis should not provide a full range of financial services to the public but only those needed for improving the performance of its main business. When the main business of the person relates to an activity covered by Directive 2005/60/EC, the exemption for occasional or limited financial activities should not be granted, except in relation to traders in goods.

(13)
Some financial activities, such as money transmission or remittance services, are more likely to be used or abused for money laundering or terrorist financing purposes. It is therefore necessary to ensure that these or similar financial activities are not exempted from the scope of Directive 2005/60/EC.

(14)
Provision should be made for decisions pursuant to Article 2(2) of Directive 2005/60/EC to be withdrawn as quickly as possible if necessary.

(15)
Member States should ensure that the exemption decisions are not abused for money laundering or terrorist financing purposes. They notably should avoid adopting decisions under Article 2(2) of Directive 2005/60/EC in cases where monitoring or enforcement activities by national authorities present special difficulties as a result of overlapping competences between more than one Member State, such as the provision of financial services on board ships providing transport services between ports situated in different Member States.

(16)
The application of this Directive is without prejudice to the application of Council Regulation (EC) No 2580/2001 of 27 December 2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism(2)and Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with Usama bin Laden, the Al-Qaida network and the Taliban, and repealing Council Regulation (EC) No 467/2001 prohibiting the export of certain goods and services to Afghanistan, strengthening the flight ban and extending the freeze of funds and other financial resources in respect of the Taliban of Afghanistan(3).

(17)
The measures provided for in this Directive are in accordance with the opinion of the Committee on the Prevention of Money Laundering and Terrorist Financing,

1.
the technical aspects of the definition of politically exposed persons set out in Article 3(8) of that Directive;

2.
technical criteria for assessing whether situations represent a low risk of money laundering or terrorist financing as referred to in Article 11(2) and (5) of that Directive;

3.
technical criteria for assessing whether, in accordance with Article 2(2) of Directive 2005/60/EC, it is justified not to apply that Directive to certain legal or natural persons carrying out a financial activity on an occasional or very limited basis.

(a)
heads of State, heads of government, ministers and deputy or assistant ministers;

(b)
members of parliaments;

(c)
members of supreme courts, of constitutional courts or of other high-level judicial bodies whose decisions are not subject to further appeal, except in exceptional circumstances;

(d)
members of courts of auditors or of the boards of central banks;

(e)
ambassadors, chargés d'affaires and high-ranking officers in the armed forces;

(f)
members of the administrative, management or supervisory bodies of State-owned enterprises.

(a)
the spouse;

(b)
any partner considered by national law as equivalent to the spouse;

(c)
the children and their spouses or partners;

(d)
the parents.

(a)
any natural person who is known to have joint beneficial ownership of legal entities or legal arrangements, or any other close business relations, with a person referred to in paragraph 1;

(b)
any natural person who has sole beneficial ownership of a legal entity or legal arrangement which is known to have been set up for the benefit de facto of the person referred to in paragraph 1.

(a)
the customer has been entrusted with public functions pursuant to the Treaty on European Union, the Treaties on the Communities or Community secondary legislation;

(b)
the customer’s identity is publicly available, transparent and certain;

(c)
the activities of the customer, as well as its accounting practices, are transparent;

(d)
either the customer is accountable to a Community institution or to the authorities of a Member State, or appropriate check and balance procedures exist ensuring control of the customer’s activity.

(a)
the customer is an entity that undertakes financial activities outside the scope of Article 2 of Directive 2005/60/EC but to which national legislation has extended the obligations of that Directive pursuant to Article 4 thereof;

(b)
the identity of the customer is publicly available, transparent and certain;

(c)
the customer is subject to a mandatory licensing requirement under national law for the undertaking of financial activities and licensing may be refused if the competent authorities are not satisfied that the persons who effectively direct or will direct the business of such an entity, or its beneficial owner, are fit and proper persons;

(d)
the customer is subject to supervision, within the meaning of Article 37(3) of Directive 2005/60/EC, by competent authorities as regards compliance with the national legislation transposing that Directive and, where applicable, additional obligations under national legislation;

(e)
failure by the customer to comply with the obligations referred to in point (a) is subject to effective, proportionate and dissuasive sanctions including the possibility of appropriate administrative measures or the imposition of administrative sanctions.

(a)
the product has a written contractual base;

(b)
the related transactions are carried out through an account of the customer with a credit institution covered by Directive 2005/60/EC or a credit institution situated in a third country which imposes requirements equivalent to those laid down in that Directive;

(c)
the product or related transactions are not anonymous and their nature is such that it allows for the timely application of Article 7(c) of Directive 2005/60/EC;

(d)
the product is subject to a predetermined maximum threshold;

(e)
the benefits of the product or related transactions cannot be realised for the benefit of third parties, except in the case of death, disablement, survival to a predetermined advanced age, or similar events;

(f)
in the case of products or related transactions allowing for the investment of funds in financial assets or claims, including insurance or other kind of contingent claims:(i)the benefits of the product or related transactions are only realisable in the long term;(ii)the product or related transactions cannot be used as collateral;(iii)during the contractual relationship, no accelerated payments are made, no surrender clauses are used and no early termination takes place.
(i)
the benefits of the product or related transactions are only realisable in the long term;
(ii)
the product or related transactions cannot be used as collateral;
(iii)
during the contractual relationship, no accelerated payments are made, no surrender clauses are used and no early termination takes place.

(i)
the benefits of the product or related transactions are only realisable in the long term;

(ii)
the product or related transactions cannot be used as collateral;

(iii)
during the contractual relationship, no accelerated payments are made, no surrender clauses are used and no early termination takes place.

(i)
the benefits of the product or related transactions are only realisable in the long term;

(ii)
the product or related transactions cannot be used as collateral;

(iii)
during the contractual relationship, no accelerated payments are made, no surrender clauses are used and no early termination takes place.

(a)
the financial activity is limited in absolute terms;

(b)
the financial activity is limited on a transaction basis;

(c)
the financial activity is not the main activity;

(d)
the financial activity is ancillary and directly related to the main activity;

(e)
with the exception of the activity referred to in point (3)(e) of Article 2(1) of Directive 2005/60/EC, the main activity is not an activity mentioned in Article 2(1) of that Directive;

(f)
the financial activity is provided only to the customers of the main activity and is not generally offered to the public.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Directive 2005/60/EC of the European Parliament and of the Council of 26 October 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing(1), and in particular points (a), (b) and (d) of Article 40(1) thereof,

(1) Directive 2005/60/EC requires institutions and persons covered to apply, on a risk-sensitive basis, enhanced customer due diligence measures in respect of transactions or business relationships with politically exposed persons residing in another Member State or in a third country. In the context of this risk analysis, it is appropriate for the resources of the institutions and persons covered to be focused in particular on products and transactions that are characterised by a high risk of money laundering. Politically exposed persons are understood to be persons entrusted with prominent public functions, their immediate family members or persons known to be close associates of such persons. In order to provide for a coherent application of the concept of politically exposed person, when determining the groups of persons covered, it is essential to take into consideration the social, political and economic differences between countries concerned.

(2) Institutions and persons covered by Directive 2005/60/EC may fail to identify a customer as falling within one of the politically exposed person categories, despite having taken reasonable and adequate measures in this regard. In those circumstances, Member States, when exercising their powers in relation to the application of that Directive, should give due consideration to the need to ensure that those persons do not automatically incur liability for such failure. Member States should also consider facilitating compliance with that Directive by providing the necessary guidance to institutions and persons in this connection.

(3) Public functions exercised at levels lower than national should normally not be considered prominent. However, where their political exposure is comparable to that of similar positions at national level, institutions and persons covered by this Directive should consider, on a risk-sensitive basis, whether persons exercising those public functions should be considered as politically exposed persons.

(4) Where Directive 2005/60/EC requires institutions and persons covered to identify close associates of natural persons who are entrusted with prominent public functions, this requirement applies to the extent that the relation with the associate is publicly known or that the institution or person has reasons to believe that such relation exists. Thus it does not presuppose active research on the part of the institutions and persons covered by the Directive.

(5) Persons falling under the concept of politically exposed persons should not be considered as such after they have ceased to exercise prominent public functions, subject to a minimum period.

(6) Since the adaptation, on a risk-sensitive basis, of the general customer due diligence procedures to low-risk situations is the normal tool under Directive 2005/60/EC, and given the fact that simplified customer due diligence procedures require adequate checks and balances elsewhere in the system aiming at preventing money laundering and terrorist financing, the application of simplified customer due diligence procedures should be restricted to a limited number of cases. In these cases, the requirements for institutions and persons covered by that Directive do not disappear, and these are expected to,inter alia, conduct ongoing monitoring of the business relations, in order to be able to detect complex or unusually large transactions which have no apparent economic or visible lawful purpose.

(7) Domestic public authorities are generally considered as low-risk customers within their own Member State and, in accordance with Directive 2005/60/EC, may be subject to simplified customer due diligence procedures. However, none of the Community institutions, bodies, offices or agencies, including the European Central Bank (ECB), directly qualify in the Directive for simplified customer due diligence under the ‘domestic public authority’ category or, in the case of the ECB, under the ‘credit and financial institution’ category. However, since these entities do not appear to present a high risk of money laundering or terrorist financing, they should be recognised as low-risk customers and benefit from the simplified customer due diligence procedures provided that appropriate criteria are fulfilled.

(8) Furthermore, it should be possible to apply simplified customer due diligence procedures in the case of legal entities undertaking financial activities which do not fall under the definition of financial institution under Directive 2005/60/EC but which are subject to national legislation pursuant to that Directive and comply with requirements concerning sufficient transparency as to their identity and adequate control mechanisms, in particular enhanced supervision. This could be the case for undertakings providing general insurance services.

(9) It should be possible to apply simplified customer due diligence procedures to products and related transactions in limited circumstances, for example where the benefits of the financial product in question cannot generally be realised for the benefit of third parties and those benefits are only realisable in the long term, such as some investment insurance policies or savings products, or where the financial product aims at financing physical assets in the form of leasing agreements in which the legal and beneficial title of the underlying asset remains with the leasing company or in the form of low value consumer credit, provided the transactions are carried out through bank accounts and are below an appropriate threshold. State controlled products which are generally addressed to specific categories of clients, such as savings products for the benefit of children, should benefit from simplified customer due diligence procedures even if not all the criteria are fulfilled. State control should be understood as an activity beyond normal supervision on financial markets and should not be construed as covering products, such as debt securities, issued directly by the State.

(10) Before allowing use of simplified customer due diligence procedures, Member States should assess whether the customers or the products and related transactions represent a low-risk of money laundering or terrorist financing, notably by paying special attention to any activity of these customers or to any type of products or transactions which may be regarded as particularly likely, by their nature, to be used or abused for money laundering or terrorist financing purposes. In particular, any attempt by customers in relation to low-risk products to act anonymously or hide their identity should be considered as a risk factor and as potentially suspicious.

(11) In certain circumstances, natural persons or legal entities may conduct financial activities on an occasional or very limited basis, as a complement to other non-financial activities, such as hotels that provide currency exchange services to their clients. Directive 2005/60/EC allows Member States to decide that financial activities of that kind fall outside its scope. The assessment of the occasional or very limited nature of the activity should be made by reference to quantitative thresholds in relation to the transactions and the turnover of the business concerned. These thresholds should be decided at national level, depending on the type of financial activity, in order to take account of differences between countries.

(12) Moreover, a person engaging in a financial activity on an occasional or very limited basis should not provide a full range of financial services to the public but only those needed for improving the performance of its main business. When the main business of the person relates to an activity covered by Directive 2005/60/EC, the exemption for occasional or limited financial activities should not be granted, except in relation to traders in goods.

(13) Some financial activities, such as money transmission or remittance services, are more likely to be used or abused for money laundering or terrorist financing purposes. It is therefore necessary to ensure that these or similar financial activities are not exempted from the scope of Directive 2005/60/EC.

(14) Provision should be made for decisions pursuant to Article 2(2) of Directive 2005/60/EC to be withdrawn as quickly as possible if necessary.

(15) Member States should ensure that the exemption decisions are not abused for money laundering or terrorist financing purposes. They notably should avoid adopting decisions under Article 2(2) of Directive 2005/60/EC in cases where monitoring or enforcement activities by national authorities present special difficulties as a result of overlapping competences between more than one Member State, such as the provision of financial services on board ships providing transport services between ports situated in different Member States.

(16) The application of this Directive is without prejudice to the application of Council Regulation (EC) No 2580/2001 of 27 December 2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism(2)and Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with Usama bin Laden, the Al-Qaida network and the Taliban, and repealing Council Regulation (EC) No 467/2001 prohibiting the export of certain goods and services to Afghanistan, strengthening the flight ban and extending the freeze of funds and other financial resources in respect of the Taliban of Afghanistan(3).

(17) The measures provided for in this Directive are in accordance with the opinion of the Committee on the Prevention of Money Laundering and Terrorist Financing,

HAS ADOPTED THIS DIRECTIVE:
Subject-matter

Article 1

This Directive lays down implementing measures for Directive 2005/60/EC as regards the following:

1.

the technical aspects of the definition of politically exposed persons set out in Article 3(8) of that Directive;

2.

technical criteria for assessing whether situations represent a low risk of money laundering or terrorist financing as referred to in Article 11(2) and (5) of that Directive;

3.

technical criteria for assessing whether, in accordance with Article 2(2) of Directive 2005/60/EC, it is justified not to apply that Directive to certain legal or natural persons carrying out a financial activity on an occasional or very limited basis.
Politically exposed persons

Article 2

1.   For the purposes of Article 3(8) of Directive 2005/60/EC, ‘natural persons who are or have been entrusted with prominent public functions’ shall include the following:

(a)

heads of State, heads of government, ministers and deputy or assistant ministers;

(b)

members of parliaments;

(c)

members of supreme courts, of constitutional courts or of other high-level judicial bodies whose decisions are not subject to further appeal, except in exceptional circumstances;

(d)

members of courts of auditors or of the boards of central banks;

(e)

ambassadors, chargés d’affaires and high-ranking officers in the armed forces;

(f)

members of the administrative, management or supervisory bodies of State-owned enterprises.

None of the categories set out in points (a) to (f) of the first subparagraph shall be understood as covering middle ranking or more junior officials.

The categories set out in points (a) to (e) of the first subparagraph shall, where applicable, include positions at Community and international level.

2.   For the purposes of Article 3(8) of Directive 2005/60/EC, ‘immediate family members’ shall include the following:

(a)

the spouse;

(b)

any partner considered by national law as equivalent to the spouse;

(c)

the children and their spouses or partners;

(d)

the parents.

3.   For the purposes of Article 3(8) of Directive 2005/60/EC, ‘persons known to be close associates’ shall include the following:

(a)

any natural person who is known to have joint beneficial ownership of legal entities or legal arrangements, or any other close business relations, with a person referred to in paragraph 1;

(b)

any natural person who has sole beneficial ownership of a legal entity or legal arrangement which is known to have been set up for the benefit de facto of the person referred to in paragraph 1.

4.   Without prejudice to the application, on a risk-sensitive basis, of enhanced customer due diligence measures, where a person has ceased to be entrusted with a prominent public function within the meaning of paragraph 1 of this Article for a period of at least one year, institutions and persons referred to in Article 2(1) of Directive 2005/60/EC shall not be obliged to consider such a person as politically exposed.
Simplified customer due diligence

Article 3

1.   For the purposes of Article 11(2) of Directive 2005/60/EC, Member States may, subject to paragraph 4 of this Article, consider customers who are public authorities or public bodies and who fulfil all the following criteria as customers representing a low risk of money laundering or terrorist financing:

(a)

the customer has been entrusted with public functions pursuant to the Treaty on European Union, the Treaties on the Communities or Community secondary legislation;

(b)

the customer’s identity is publicly available, transparent and certain;

(c)

the activities of the customer, as well as its accounting practices, are transparent;

(d)

either the customer is accountable to a Community institution or to the authorities of a Member State, or appropriate check and balance procedures exist ensuring control of the customer’s activity.

2.   For the purposes of Article 11(2) of Directive 2005/60/EC, Member States may, subject to paragraph 4 of this Article, consider customers who are legal entities which do not enjoy the status of public authority or public body but which fulfil all the following criteria as customers representing a low risk of money laundering or terrorist financing:

(a)

the customer is an entity that undertakes financial activities outside the scope of Article 2 of Directive 2005/60/EC but to which national legislation has extended the obligations of that Directive pursuant to Article 4 thereof;

(b)

the identity of the customer is publicly available, transparent and certain;

(c)

the customer is subject to a mandatory licensing requirement under national law for the undertaking of financial activities and licensing may be refused if the competent authorities are not satisfied that the persons who effectively direct or will direct the business of such an entity, or its beneficial owner, are fit and proper persons;

(d)

the customer is subject to supervision, within the meaning of Article 37(3) of Directive 2005/60/EC, by competent authorities as regards compliance with the national legislation transposing that Directive and, where applicable, additional obligations under national legislation;

(e)

failure by the customer to comply with the obligations referred to in point (a) is subject to effective, proportionate and dissuasive sanctions including the possibility of appropriate administrative measures or the imposition of administrative sanctions.

Entity, as referred to in point (a) of the first subparagraph, shall include subsidiaries only in so far as the obligations of Directive 2005/60/EC have been extended to them on their own account.

For the purposes of point (c) of the first subparagraph, the activity conducted by the customer shall be supervised by competent authorities. Supervision is to be understood in this context as meaning the type of supervisory activity with the highest supervisory powers, including the possibility of conducting on-site inspections. Such inspections shall include the review of policies, procedures, books and records, and shall extend to sample testing.

3.   For the purposes of Article 11(5) of Directive 2005/60/EC, Member States may, subject to paragraph 4 of this Article, allow the institutions and persons covered by that Directive to consider products which fulfil all the following criteria, or transactions related to such products, as representing a low risk of money laundering or terrorist financing:

(a)

the product has a written contractual base;

(b)

the related transactions are carried out through an account of the customer with a credit institution covered by Directive 2005/60/EC or a credit institution situated in a third country which imposes requirements equivalent to those laid down in that Directive;

(c)

the product or related transactions are not anonymous and their nature is such that it allows for the timely application of Article 7(c) of Directive 2005/60/EC;

(d)

the product is subject to a predetermined maximum threshold;

(e)

the benefits of the product or related transactions cannot be realised for the benefit of third parties, except in the case of death, disablement, survival to a predetermined advanced age, or similar events;

(f)

in the case of products or related transactions allowing for the investment of funds in financial assets or claims, including insurance or other kind of contingent claims:

(i)

the benefits of the product or related transactions are only realisable in the long term;

(ii)

the product or related transactions cannot be used as collateral;

(iii)

during the contractual relationship, no accelerated payments are made, no surrender clauses are used and no early termination takes place.

For the purposes of point (d) of the first subparagraph, the thresholds established in Article 11(5)(a) of Directive 2005/60/EC shall apply in the case of insurance policies or savings products of similar nature. Without prejudice to the third subparagraph, in the other cases the maximum threshold shall be EUR 15 000. Member States may derogate from that threshold in the case of products which are related to the financing of physical assets and where the legal and beneficial title of the assets is not transferred to the customer until termination of the contractual relationship, provided that the threshold established by the Member State for the transactions related to this type of product, whether the transaction is carried out in a single operation or in several operations which appear to be linked, does not exceed EUR 15 000 per year.

Member States may derogate from the criteria set out in points (e) and (f) of the first subparagraph in the case of products the characteristics of which are determined by their relevant domestic public authorities for purposes of general interest, which benefit from specific advantages from the State in the form of direct grants or tax rebates, and the use of which is subject to control by those authorities, provided that the benefits of the product are realisable only in the long term and that the threshold established for the purposes of point (d) of the first subparagraph is sufficiently low. Where appropriate, that threshold may be set as a maximum annual amount.

4.   In assessing whether the customers or products and transactions referred to in paragraphs 1, 2 and 3 represent a low risk of money laundering or terrorist financing, Member States shall pay special attention to any activity of those customers or to any type of product or transaction which may be regarded as particularly likely, by its nature, to be used or abused for money laundering or terrorist financing purposes.

Member States shall not consider that customers or products and transactions referred to in paragraphs 1, 2 and 3 represent a low risk of money laundering or terrorist financing if there is information available to suggest that the risk of money laundering or terrorist financing may not be low.
Financial activity on an occasional or very limited basis

Article 4

1.   For the purposes of Article 2(2) of Directive 2005/60/EC, Member States may, subject to paragraph 2 of this Article, consider legal or natural persons who engage in a financial activity which fulfils all the following criteria as not falling within the scope of Article 3(1) or (2) of that Directive:

(a)

the financial activity is limited in absolute terms;

(b)

the financial activity is limited on a transaction basis;

(c)

the financial activity is not the main activity;

(d)

the financial activity is ancillary and directly related to the main activity;

(e)

with the exception of the activity referred to in point (3)(e) of Article 2(1) of Directive 2005/60/EC, the main activity is not an activity mentioned in Article 2(1) of that Directive;

(f)

the financial activity is provided only to the customers of the main activity and is not generally offered to the public.

For the purposes of point (a) of the first subparagraph, the total turnover of the financial activity may not exceed a threshold which must be sufficiently low. That threshold shall be established at national level, depending on the type of financial activity.

For the purposes of point (b) of the first subparagraph, Member States shall apply a maximum threshold per customer and single transaction, whether the transaction is carried out in a single operation or in several operations which appear to be linked. That threshold shall be established at national level, depending on the type of financial activity. It shall be sufficiently low in order to ensure that the types of transactions in question are an impractical and inefficient method for laundering money or for terrorist financing, and shall not exceed EUR 1 000.

For the purposes of point (c) of the first subparagraph, Member States shall require that the turnover of the financial activity does not exceed 5 % of the total turnover of the legal or natural person concerned.

2.   In assessing the risk of money laundering or terrorist financing occurring for the purposes of Article 2(2) of Directive 2005/60/EC, Member States shall pay special attention to any financial activity which is regarded as particularly likely, by its nature, to be used or abused for money laundering or terrorist financing purposes.

Member States shall not consider that the financial activities referred to in paragraph 1 represent a low risk of money laundering or terrorist financing if there is information available to suggest that the risk of money laundering or terrorist financing may not be low.

3.   Any decision pursuant to Article 2(2) of Directive 2005/60/EC shall state the reasons on which it is based. Member States shall provide for the possibility of withdrawing that decision should circumstances change.

4.   Member States shall establish risk-based monitoring activities or take any other adequate measures to ensure that the exemption granted by decisions pursuant to Article 2(2) of Directive 2005/60/EC is not abused by possible money launderers or financers of terrorism.
Transposition

Article 5

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 December 2007 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 6

This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.
Article 7

This Directive is addressed to the Member States.
THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Directive 2005/60/EC of the European Parliament and of the Council of 26 October 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing(1), and in particular points (a), (b) and (d) of Article 40(1) thereof,

(1) Directive 2005/60/EC requires institutions and persons covered to apply, on a risk-sensitive basis, enhanced customer due diligence measures in respect of transactions or business relationships with politically exposed persons residing in another Member State or in a third country. In the context of this risk analysis, it is appropriate for the resources of the institutions and persons covered to be focused in particular on products and transactions that are characterised by a high risk of money laundering. Politically exposed persons are understood to be persons entrusted with prominent public functions, their immediate family members or persons known to be close associates of such persons. In order to provide for a coherent application of the concept of politically exposed person, when determining the groups of persons covered, it is essential to take into consideration the social, political and economic differences between countries concerned.

(2) Institutions and persons covered by Directive 2005/60/EC may fail to identify a customer as falling within one of the politically exposed person categories, despite having taken reasonable and adequate measures in this regard. In those circumstances, Member States, when exercising their powers in relation to the application of that Directive, should give due consideration to the need to ensure that those persons do not automatically incur liability for such failure. Member States should also consider facilitating compliance with that Directive by providing the necessary guidance to institutions and persons in this connection.

(3) Public functions exercised at levels lower than national should normally not be considered prominent. However, where their political exposure is comparable to that of similar positions at national level, institutions and persons covered by this Directive should consider, on a risk-sensitive basis, whether persons exercising those public functions should be considered as politically exposed persons.

(4) Where Directive 2005/60/EC requires institutions and persons covered to identify close associates of natural persons who are entrusted with prominent public functions, this requirement applies to the extent that the relation with the associate is publicly known or that the institution or person has reasons to believe that such relation exists. Thus it does not presuppose active research on the part of the institutions and persons covered by the Directive.

(5) Persons falling under the concept of politically exposed persons should not be considered as such after they have ceased to exercise prominent public functions, subject to a minimum period.

(6) Since the adaptation, on a risk-sensitive basis, of the general customer due diligence procedures to low-risk situations is the normal tool under Directive 2005/60/EC, and given the fact that simplified customer due diligence procedures require adequate checks and balances elsewhere in the system aiming at preventing money laundering and terrorist financing, the application of simplified customer due diligence procedures should be restricted to a limited number of cases. In these cases, the requirements for institutions and persons covered by that Directive do not disappear, and these are expected to,inter alia, conduct ongoing monitoring of the business relations, in order to be able to detect complex or unusually large transactions which have no apparent economic or visible lawful purpose.

(7) Domestic public authorities are generally considered as low-risk customers within their own Member State and, in accordance with Directive 2005/60/EC, may be subject to simplified customer due diligence procedures. However, none of the Community institutions, bodies, offices or agencies, including the European Central Bank (ECB), directly qualify in the Directive for simplified customer due diligence under the ‘domestic public authority’ category or, in the case of the ECB, under the ‘credit and financial institution’ category. However, since these entities do not appear to present a high risk of money laundering or terrorist financing, they should be recognised as low-risk customers and benefit from the simplified customer due diligence procedures provided that appropriate criteria are fulfilled.

(8) Furthermore, it should be possible to apply simplified customer due diligence procedures in the case of legal entities undertaking financial activities which do not fall under the definition of financial institution under Directive 2005/60/EC but which are subject to national legislation pursuant to that Directive and comply with requirements concerning sufficient transparency as to their identity and adequate control mechanisms, in particular enhanced supervision. This could be the case for undertakings providing general insurance services.

(9) It should be possible to apply simplified customer due diligence procedures to products and related transactions in limited circumstances, for example where the benefits of the financial product in question cannot generally be realised for the benefit of third parties and those benefits are only realisable in the long term, such as some investment insurance policies or savings products, or where the financial product aims at financing physical assets in the form of leasing agreements in which the legal and beneficial title of the underlying asset remains with the leasing company or in the form of low value consumer credit, provided the transactions are carried out through bank accounts and are below an appropriate threshold. State controlled products which are generally addressed to specific categories of clients, such as savings products for the benefit of children, should benefit from simplified customer due diligence procedures even if not all the criteria are fulfilled. State control should be understood as an activity beyond normal supervision on financial markets and should not be construed as covering products, such as debt securities, issued directly by the State.

(10) Before allowing use of simplified customer due diligence procedures, Member States should assess whether the customers or the products and related transactions represent a low-risk of money laundering or terrorist financing, notably by paying special attention to any activity of these customers or to any type of products or transactions which may be regarded as particularly likely, by their nature, to be used or abused for money laundering or terrorist financing purposes. In particular, any attempt by customers in relation to low-risk products to act anonymously or hide their identity should be considered as a risk factor and as potentially suspicious.

(11) In certain circumstances, natural persons or legal entities may conduct financial activities on an occasional or very limited basis, as a complement to other non-financial activities, such as hotels that provide currency exchange services to their clients. Directive 2005/60/EC allows Member States to decide that financial activities of that kind fall outside its scope. The assessment of the occasional or very limited nature of the activity should be made by reference to quantitative thresholds in relation to the transactions and the turnover of the business concerned. These thresholds should be decided at national level, depending on the type of financial activity, in order to take account of differences between countries.

(12) Moreover, a person engaging in a financial activity on an occasional or very limited basis should not provide a full range of financial services to the public but only those needed for improving the performance of its main business. When the main business of the person relates to an activity covered by Directive 2005/60/EC, the exemption for occasional or limited financial activities should not be granted, except in relation to traders in goods.

(13) Some financial activities, such as money transmission or remittance services, are more likely to be used or abused for money laundering or terrorist financing purposes. It is therefore necessary to ensure that these or similar financial activities are not exempted from the scope of Directive 2005/60/EC.

(14) Provision should be made for decisions pursuant to Article 2(2) of Directive 2005/60/EC to be withdrawn as quickly as possible if necessary.

(15) Member States should ensure that the exemption decisions are not abused for money laundering or terrorist financing purposes. They notably should avoid adopting decisions under Article 2(2) of Directive 2005/60/EC in cases where monitoring or enforcement activities by national authorities present special difficulties as a result of overlapping competences between more than one Member State, such as the provision of financial services on board ships providing transport services between ports situated in different Member States.

(16) The application of this Directive is without prejudice to the application of Council Regulation (EC) No 2580/2001 of 27 December 2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism(2)and Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with Usama bin Laden, the Al-Qaida network and the Taliban, and repealing Council Regulation (EC) No 467/2001 prohibiting the export of certain goods and services to Afghanistan, strengthening the flight ban and extending the freeze of funds and other financial resources in respect of the Taliban of Afghanistan(3).

(17) The measures provided for in this Directive are in accordance with the opinion of the Committee on the Prevention of Money Laundering and Terrorist Financing,

HAS ADOPTED THIS DIRECTIVE:
Subject-matterThis Directive lays down implementing measures for Directive 2005/60/EC as regards the following:

1.

the technical aspects of the definition of politically exposed persons set out in Article 3(8) of that Directive;

2.

technical criteria for assessing whether situations represent a low risk of money laundering or terrorist financing as referred to in Article 11(2) and (5) of that Directive;

3.

technical criteria for assessing whether, in accordance with Article 2(2) of Directive 2005/60/EC, it is justified not to apply that Directive to certain legal or natural persons carrying out a financial activity on an occasional or very limited basis.
Politically exposed persons1.   For the purposes of Article 3(8) of Directive 2005/60/EC, ‘natural persons who are or have been entrusted with prominent public functions’ shall include the following:

(a)

heads of State, heads of government, ministers and deputy or assistant ministers;

(b)

members of parliaments;

(c)

members of supreme courts, of constitutional courts or of other high-level judicial bodies whose decisions are not subject to further appeal, except in exceptional circumstances;

(d)

members of courts of auditors or of the boards of central banks;

(e)

ambassadors, chargés d’affaires and high-ranking officers in the armed forces;

(f)

members of the administrative, management or supervisory bodies of State-owned enterprises.

None of the categories set out in points (a) to (f) of the first subparagraph shall be understood as covering middle ranking or more junior officials.

The categories set out in points (a) to (e) of the first subparagraph shall, where applicable, include positions at Community and international level.

2.   For the purposes of Article 3(8) of Directive 2005/60/EC, ‘immediate family members’ shall include the following:

(a)

the spouse;

(b)

any partner considered by national law as equivalent to the spouse;

(c)

the children and their spouses or partners;

(d)

the parents.

3.   For the purposes of Article 3(8) of Directive 2005/60/EC, ‘persons known to be close associates’ shall include the following:

(a)

any natural person who is known to have joint beneficial ownership of legal entities or legal arrangements, or any other close business relations, with a person referred to in paragraph 1;

(b)

any natural person who has sole beneficial ownership of a legal entity or legal arrangement which is known to have been set up for the benefit de facto of the person referred to in paragraph 1.

4.   Without prejudice to the application, on a risk-sensitive basis, of enhanced customer due diligence measures, where a person has ceased to be entrusted with a prominent public function within the meaning of paragraph 1 of this Article for a period of at least one year, institutions and persons referred to in Article 2(1) of Directive 2005/60/EC shall not be obliged to consider such a person as politically exposed.
Simplified customer due diligence1.   For the purposes of Article 11(2) of Directive 2005/60/EC, Member States may, subject to paragraph 4 of this Article, consider customers who are public authorities or public bodies and who fulfil all the following criteria as customers representing a low risk of money laundering or terrorist financing:

(a)

the customer has been entrusted with public functions pursuant to the Treaty on European Union, the Treaties on the Communities or Community secondary legislation;

(b)

the customer’s identity is publicly available, transparent and certain;

(c)

the activities of the customer, as well as its accounting practices, are transparent;

(d)

either the customer is accountable to a Community institution or to the authorities of a Member State, or appropriate check and balance procedures exist ensuring control of the customer’s activity.

2.   For the purposes of Article 11(2) of Directive 2005/60/EC, Member States may, subject to paragraph 4 of this Article, consider customers who are legal entities which do not enjoy the status of public authority or public body but which fulfil all the following criteria as customers representing a low risk of money laundering or terrorist financing:

(a)

the customer is an entity that undertakes financial activities outside the scope of Article 2 of Directive 2005/60/EC but to which national legislation has extended the obligations of that Directive pursuant to Article 4 thereof;

(b)

the identity of the customer is publicly available, transparent and certain;

(c)

the customer is subject to a mandatory licensing requirement under national law for the undertaking of financial activities and licensing may be refused if the competent authorities are not satisfied that the persons who effectively direct or will direct the business of such an entity, or its beneficial owner, are fit and proper persons;

(d)

the customer is subject to supervision, within the meaning of Article 37(3) of Directive 2005/60/EC, by competent authorities as regards compliance with the national legislation transposing that Directive and, where applicable, additional obligations under national legislation;

(e)

failure by the customer to comply with the obligations referred to in point (a) is subject to effective, proportionate and dissuasive sanctions including the possibility of appropriate administrative measures or the imposition of administrative sanctions.

Entity, as referred to in point (a) of the first subparagraph, shall include subsidiaries only in so far as the obligations of Directive 2005/60/EC have been extended to them on their own account.

For the purposes of point (c) of the first subparagraph, the activity conducted by the customer shall be supervised by competent authorities. Supervision is to be understood in this context as meaning the type of supervisory activity with the highest supervisory powers, including the possibility of conducting on-site inspections. Such inspections shall include the review of policies, procedures, books and records, and shall extend to sample testing.

3.   For the purposes of Article 11(5) of Directive 2005/60/EC, Member States may, subject to paragraph 4 of this Article, allow the institutions and persons covered by that Directive to consider products which fulfil all the following criteria, or transactions related to such products, as representing a low risk of money laundering or terrorist financing:

(a)

the product has a written contractual base;

(b)

the related transactions are carried out through an account of the customer with a credit institution covered by Directive 2005/60/EC or a credit institution situated in a third country which imposes requirements equivalent to those laid down in that Directive;

(c)

the product or related transactions are not anonymous and their nature is such that it allows for the timely application of Article 7(c) of Directive 2005/60/EC;

(d)

the product is subject to a predetermined maximum threshold;

(e)

the benefits of the product or related transactions cannot be realised for the benefit of third parties, except in the case of death, disablement, survival to a predetermined advanced age, or similar events;

(f)

in the case of products or related transactions allowing for the investment of funds in financial assets or claims, including insurance or other kind of contingent claims:

(i)

the benefits of the product or related transactions are only realisable in the long term;

(ii)

the product or related transactions cannot be used as collateral;

(iii)

during the contractual relationship, no accelerated payments are made, no surrender clauses are used and no early termination takes place.

For the purposes of point (d) of the first subparagraph, the thresholds established in Article 11(5)(a) of Directive 2005/60/EC shall apply in the case of insurance policies or savings products of similar nature. Without prejudice to the third subparagraph, in the other cases the maximum threshold shall be EUR 15 000. Member States may derogate from that threshold in the case of products which are related to the financing of physical assets and where the legal and beneficial title of the assets is not transferred to the customer until termination of the contractual relationship, provided that the threshold established by the Member State for the transactions related to this type of product, whether the transaction is carried out in a single operation or in several operations which appear to be linked, does not exceed EUR 15 000 per year.

Member States may derogate from the criteria set out in points (e) and (f) of the first subparagraph in the case of products the characteristics of which are determined by their relevant domestic public authorities for purposes of general interest, which benefit from specific advantages from the State in the form of direct grants or tax rebates, and the use of which is subject to control by those authorities, provided that the benefits of the product are realisable only in the long term and that the threshold established for the purposes of point (d) of the first subparagraph is sufficiently low. Where appropriate, that threshold may be set as a maximum annual amount.

4.   In assessing whether the customers or products and transactions referred to in paragraphs 1, 2 and 3 represent a low risk of money laundering or terrorist financing, Member States shall pay special attention to any activity of those customers or to any type of product or transaction which may be regarded as particularly likely, by its nature, to be used or abused for money laundering or terrorist financing purposes.

Member States shall not consider that customers or products and transactions referred to in paragraphs 1, 2 and 3 represent a low risk of money laundering or terrorist financing if there is information available to suggest that the risk of money laundering or terrorist financing may not be low.
Financial activity on an occasional or very limited basis1.   For the purposes of Article 2(2) of Directive 2005/60/EC, Member States may, subject to paragraph 2 of this Article, consider legal or natural persons who engage in a financial activity which fulfils all the following criteria as not falling within the scope of Article 3(1) or (2) of that Directive:

(a)

the financial activity is limited in absolute terms;

(b)

the financial activity is limited on a transaction basis;

(c)

the financial activity is not the main activity;

(d)

the financial activity is ancillary and directly related to the main activity;

(e)

with the exception of the activity referred to in point (3)(e) of Article 2(1) of Directive 2005/60/EC, the main activity is not an activity mentioned in Article 2(1) of that Directive;

(f)

the financial activity is provided only to the customers of the main activity and is not generally offered to the public.

For the purposes of point (a) of the first subparagraph, the total turnover of the financial activity may not exceed a threshold which must be sufficiently low. That threshold shall be established at national level, depending on the type of financial activity.

For the purposes of point (b) of the first subparagraph, Member States shall apply a maximum threshold per customer and single transaction, whether the transaction is carried out in a single operation or in several operations which appear to be linked. That threshold shall be established at national level, depending on the type of financial activity. It shall be sufficiently low in order to ensure that the types of transactions in question are an impractical and inefficient method for laundering money or for terrorist financing, and shall not exceed EUR 1 000.

For the purposes of point (c) of the first subparagraph, Member States shall require that the turnover of the financial activity does not exceed 5 % of the total turnover of the legal or natural person concerned.

2.   In assessing the risk of money laundering or terrorist financing occurring for the purposes of Article 2(2) of Directive 2005/60/EC, Member States shall pay special attention to any financial activity which is regarded as particularly likely, by its nature, to be used or abused for money laundering or terrorist financing purposes.

Member States shall not consider that the financial activities referred to in paragraph 1 represent a low risk of money laundering or terrorist financing if there is information available to suggest that the risk of money laundering or terrorist financing may not be low.

3.   Any decision pursuant to Article 2(2) of Directive 2005/60/EC shall state the reasons on which it is based. Member States shall provide for the possibility of withdrawing that decision should circumstances change.

4.   Member States shall establish risk-based monitoring activities or take any other adequate measures to ensure that the exemption granted by decisions pursuant to Article 2(2) of Directive 2005/60/EC is not abused by possible money launderers or financers of terrorism.
Transposition1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 December 2007 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States.

(i)	point (a) shall be replaced by the following:‘(a)“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’	‘(a)	“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’	—	diagnosis, prevention, monitoring, treatment or alleviation of disease,	—	diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,	—	investigation, replacement or modification of the anatomy or of a physiological process,	—	control of conception,
‘(a)	“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,—investigation, replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;’	—	diagnosis, prevention, monitoring, treatment or alleviation of disease,	—	diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,	—	investigation, replacement or modification of the anatomy or of a physiological process,	—	control of conception,
—	diagnosis, prevention, monitoring, treatment or alleviation of disease,
—	diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
—	investigation, replacement or modification of the anatomy or of a physiological process,
—	control of conception,

(ii)	points (d), (e) and (f) shall be replaced by the following:‘(d)“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;(e)“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;(f)“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’	‘(d)	“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;	(e)	“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;	(f)	“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’
‘(d)	“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;
(e)	“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;
(f)	“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’

(iii)	the following points shall be added:‘(j)“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;(k)“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;	‘(j)	“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;	(k)	“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;	—	clinical investigation(s) of the device concerned, or	—	clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or	—	published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
‘(j)	“authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;
(k)	“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned, or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;	—	clinical investigation(s) of the device concerned, or	—	clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or	—	published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
—	clinical investigation(s) of the device concerned, or
—	clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or
—	published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;

(f)	the following paragraph shall be added:‘6. This Directive shall not apply to:(a)medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;(b)human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a;(c)transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;(d)transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.’;	(a)	medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;	(b)	human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a;	(c)	transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;	(d)	transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.’;
(a)	medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;
(b)	human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a;
(c)	transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;
(d)	transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.’;

4.	in Article 4, paragraphs 1, 2 and 3 shall be replaced by the following:‘1. Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices complying with the provisions of this Directive and bearing the CE marking provided for in Article 12, which indicates that they have been the subject of an assessment of their conformity in accordance with Article 9.2. Member States shall not create any obstacles to:—devices intended for clinical investigations being made available to duly qualified medical practitioners or authorised persons for that purpose if they satisfy the conditions laid down in Article 10 and in Annex 6,—custom-made devices being placed on the market and put into service if they satisfy the conditions laid down in Annex 6 and are accompanied by the statement, which shall be available to the particular identified patient, referred to in that Annex.These devices shall not bear the CE marking.3. At trade fairs, exhibitions, demonstrations, etc., Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that a visible sign clearly indicates that such devices do not conform and cannot be marketed or put into service until they have been made to comply by the manufacturer or his authorised representative.’;	—	devices intended for clinical investigations being made available to duly qualified medical practitioners or authorised persons for that purpose if they satisfy the conditions laid down in Article 10 and in Annex 6,	—	custom-made devices being placed on the market and put into service if they satisfy the conditions laid down in Annex 6 and are accompanied by the statement, which shall be available to the particular identified patient, referred to in that Annex.
—	devices intended for clinical investigations being made available to duly qualified medical practitioners or authorised persons for that purpose if they satisfy the conditions laid down in Article 10 and in Annex 6,
—	custom-made devices being placed on the market and put into service if they satisfy the conditions laid down in Annex 6 and are accompanied by the statement, which shall be available to the particular identified patient, referred to in that Annex.

6.	Article 6 shall be amended as follows:(a)in paragraph 1 the reference ‘83/189/EEC’ shall be replaced by the reference‘98/34/EC(4)(4)Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37). Directive as last amended by the 2003 Act of Accession.’;"(b)paragraph 2 shall be replaced by the following:‘2. The Commission shall be assisted by a standing committee (hereinafter referred to as the Committee).3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.4. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.5. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;	(a)	in paragraph 1 the reference ‘83/189/EEC’ shall be replaced by the reference‘98/34/EC(4)(4)Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37). Directive as last amended by the 2003 Act of Accession.’;"	(b)	paragraph 2 shall be replaced by the following:‘2. The Commission shall be assisted by a standing committee (hereinafter referred to as the Committee).3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.4. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.5. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;
(a)	in paragraph 1 the reference ‘83/189/EEC’ shall be replaced by the reference‘98/34/EC(4)(4)Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37). Directive as last amended by the 2003 Act of Accession.’;"
(b)	paragraph 2 shall be replaced by the following:‘2. The Commission shall be assisted by a standing committee (hereinafter referred to as the Committee).3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.4. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.5. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;

7.	Article 8 shall be replaced by the following:‘Article 81. Member States shall take the necessary steps to ensure that information brought to their knowledge regarding the incidents mentioned below involving a device is recorded and evaluated in a centralised manner:(a)any malfunction of or deterioration in the characteristics and performances of a device, as well as any inadequacy in the labelling or in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;(b)any technical or medical reason in relation to the characteristics or performances of a device for the reasons referred to in point (a), leading to systematic recall of devices of the same type by the manufacturer.2. Where a Member State requires medical practitioners or the medical institutions to inform the competent authorities of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorised representative, is also informed of the incident.3. After carrying out an assessment, if possible together with the manufacturer or his authorised representative, Member States shall, without prejudice to Article 7, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise the recurrence of the incidents referred to in paragraph 1, including information on the underlying incidents.4. The measures necessary for the implementation of this Article shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).’;	(a)	any malfunction of or deterioration in the characteristics and performances of a device, as well as any inadequacy in the labelling or in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;	(b)	any technical or medical reason in relation to the characteristics or performances of a device for the reasons referred to in point (a), leading to systematic recall of devices of the same type by the manufacturer.
(a)	any malfunction of or deterioration in the characteristics and performances of a device, as well as any inadequacy in the labelling or in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(b)	any technical or medical reason in relation to the characteristics or performances of a device for the reasons referred to in point (a), leading to systematic recall of devices of the same type by the manufacturer.

8.	Article 9 shall be amended as follows:(a)paragraph 8 shall be replaced by the following:‘8. Decisions taken by the notified bodies in accordance with Annexes 2, 3 and 5 shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both Parties, for further periods of a maximum length of five years.’;(b)the following paragraph shall be added:‘10. The measures designed to amend non-essential elements of this Directive,inter aliaby supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex 1 Section 15 may be set out shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;	(a)	paragraph 8 shall be replaced by the following:‘8. Decisions taken by the notified bodies in accordance with Annexes 2, 3 and 5 shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both Parties, for further periods of a maximum length of five years.’;	(b)	the following paragraph shall be added:‘10. The measures designed to amend non-essential elements of this Directive,inter aliaby supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex 1 Section 15 may be set out shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;
(a)	paragraph 8 shall be replaced by the following:‘8. Decisions taken by the notified bodies in accordance with Annexes 2, 3 and 5 shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both Parties, for further periods of a maximum length of five years.’;
(b)	the following paragraph shall be added:‘10. The measures designed to amend non-essential elements of this Directive,inter aliaby supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex 1 Section 15 may be set out shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;

9.	Article 9a shall be replaced by the following:‘Article 9a1. A Member State shall submit a duly substantiated request to the Commission and ask it to take the necessary measures in the following situations:—that Member State considers that the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 9, by applying solely one of the given procedures chosen from among those referred to in Article 9,—that Member State considers that a decision is required as to whether a particular product or product group falls within the definition of Article 1(2)(a), (c), (d) or (e).Where measures are deemed necessary pursuant to the first subparagraph of this paragraph they shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).2. The Commission shall inform the Member States of the measures taken.’;	—	that Member State considers that the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 9, by applying solely one of the given procedures chosen from among those referred to in Article 9,	—	that Member State considers that a decision is required as to whether a particular product or product group falls within the definition of Article 1(2)(a), (c), (d) or (e).
—	that Member State considers that the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 9, by applying solely one of the given procedures chosen from among those referred to in Article 9,
—	that Member State considers that a decision is required as to whether a particular product or product group falls within the definition of Article 1(2)(a), (c), (d) or (e).

10.	Article 10 shall be amended as follows:(a)in paragraph 1, the word ‘his’ shall be replaced by the word ‘the’.(b)the second subparagraph of paragraph 2 shall be replaced by the following:‘Member States may, however, authorise manufacturers to start the clinical investigations in question before the expiry of the 60-day period, provided that the ethics committee concerned has issued a favourable opinion with respect to the investigation programme in question including its review of the clinical investigation plan.’;(c)paragraph 3 shall be replaced by the following:‘3. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.’;(d)the following paragraphs shall be added:‘4. The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in point 2.3.7 of Annex 7 at the disposal of the competent authorities.5. Clinical investigations shall be conducted in accordance with the provisions of Annex 7. The measures designed to amend non-essential elements of this Directive relating to the provisions on clinical investigation in Annex 7 shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;	(a)	in paragraph 1, the word ‘his’ shall be replaced by the word ‘the’.	(b)	the second subparagraph of paragraph 2 shall be replaced by the following:‘Member States may, however, authorise manufacturers to start the clinical investigations in question before the expiry of the 60-day period, provided that the ethics committee concerned has issued a favourable opinion with respect to the investigation programme in question including its review of the clinical investigation plan.’;	(c)	paragraph 3 shall be replaced by the following:‘3. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.’;	(d)	the following paragraphs shall be added:‘4. The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in point 2.3.7 of Annex 7 at the disposal of the competent authorities.5. Clinical investigations shall be conducted in accordance with the provisions of Annex 7. The measures designed to amend non-essential elements of this Directive relating to the provisions on clinical investigation in Annex 7 shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;
(a)	in paragraph 1, the word ‘his’ shall be replaced by the word ‘the’.
(b)	the second subparagraph of paragraph 2 shall be replaced by the following:‘Member States may, however, authorise manufacturers to start the clinical investigations in question before the expiry of the 60-day period, provided that the ethics committee concerned has issued a favourable opinion with respect to the investigation programme in question including its review of the clinical investigation plan.’;
(c)	paragraph 3 shall be replaced by the following:‘3. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.’;
(d)	the following paragraphs shall be added:‘4. The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in point 2.3.7 of Annex 7 at the disposal of the competent authorities.5. Clinical investigations shall be conducted in accordance with the provisions of Annex 7. The measures designed to amend non-essential elements of this Directive relating to the provisions on clinical investigation in Annex 7 shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;

11.	the following Articles shall be inserted:‘Article 10a1. Any manufacturer who, under his own name, places devices on the market in accordance with the procedure referred to in Article 9(2) shall inform the competent authorities of the Member State in which he has his registered place of business of the address of the registered place of business and the description of the devices concerned.Member States may request to be informed of all data allowing for the devices to be identified together with the label and the instructions for use when the devices are put into service within their territory.2. Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union.For devices referred to in the first subparagraph of paragraph 1 the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of all details as referred to in paragraph 1.3. The Member States shall on request inform the other Member States and the Commission of the details referred to in the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.Article 10b1. Regulatory data in accordance with this Directive shall be stored in a European databank accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well-informed basis.The databank shall contain the following:(a)data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures as laid down in Annexes 2 to 5;(b)data obtained in accordance with the vigilance procedure as defined in Article 8;(c)data relating to clinical investigations referred to in Article 10.2. Data shall be forwarded in a standardised format.3. The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in particular paragraph 1(c), shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).Article 10cWhere a Member State considers in relation to a given product or group of products that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed, such products should be withdrawn from the market, or their placing on the market and putting into service should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures.The Member State shall then inform the Commission and all the other Member States of the transitional measures, giving the reasons for its decision.The Commission shall, whenever possible, consult the interested Parties and the Member States. The Commission shall adopt its opinion, indicating whether the national measures are justified or not. The Commission shall inform all the Member States and the consulted interested Parties.When appropriate, the necessary measures designed to amend non-essential elements of this Directive, by supplementing it, relating to withdrawal from the market, prohibition of placing on the market and putting into service of a certain product or group of products or to restrictions or introduction of particular requirements therefor, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 6(5).’;	(a)	data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures as laid down in Annexes 2 to 5;	(b)	data obtained in accordance with the vigilance procedure as defined in Article 8;	(c)	data relating to clinical investigations referred to in Article 10.
(a)	data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures as laid down in Annexes 2 to 5;
(b)	data obtained in accordance with the vigilance procedure as defined in Article 8;
(c)	data relating to clinical investigations referred to in Article 10.

12.	Article 11 shall be amended as follows:(a)in paragraph 2, the following subparagraph shall be added: ‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex 8 to this Directive for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).’;(b)in paragraph 4, the words ‘agent established in the Community’ shall be replaced by the words ‘authorised representative’;(c)the following paragraphs shall be added:‘5. The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.6. Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or that a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer.In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof.The Member State shall inform the other Member States and the Commission.7. The notified body shall, on request, supply all relevant information and documents, including budgetary documents, required to enable the Member State to verify compliance with the criteria laid down in Annex 8.’;	(a)	in paragraph 2, the following subparagraph shall be added: ‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex 8 to this Directive for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).’;	(b)	in paragraph 4, the words ‘agent established in the Community’ shall be replaced by the words ‘authorised representative’;	(c)	the following paragraphs shall be added:‘5. The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.6. Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or that a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer.In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof.The Member State shall inform the other Member States and the Commission.7. The notified body shall, on request, supply all relevant information and documents, including budgetary documents, required to enable the Member State to verify compliance with the criteria laid down in Annex 8.’;
(a)	in paragraph 2, the following subparagraph shall be added: ‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex 8 to this Directive for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).’;
(b)	in paragraph 4, the words ‘agent established in the Community’ shall be replaced by the words ‘authorised representative’;
(c)	the following paragraphs shall be added:‘5. The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.6. Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or that a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer.In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof.The Member State shall inform the other Member States and the Commission.7. The notified body shall, on request, supply all relevant information and documents, including budgetary documents, required to enable the Member State to verify compliance with the criteria laid down in Annex 8.’;

13.	Article 13 shall be replaced by the following:‘Article 13Without prejudice to Article 7(a)where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of this Directive, the manufacturer or his authorised representative established within the Community shall be obliged to end the infringement under conditions imposed by the Member State;(b)where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the device in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 7.Those provisions shall also apply where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive.’;	(a)	where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of this Directive, the manufacturer or his authorised representative established within the Community shall be obliged to end the infringement under conditions imposed by the Member State;	(b)	where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the device in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 7.
(a)	where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of this Directive, the manufacturer or his authorised representative established within the Community shall be obliged to end the infringement under conditions imposed by the Member State;
(b)	where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the device in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 7.

14.	Article 14 shall be amended as follows:(a)the first paragraph shall be replaced by the following:‘Any decision taken pursuant to this Directive(a)to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;or(b)to withdraw devices from the marketshall state the exact grounds on which it is based. Such a decision shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.’;(b)in the second paragraph the words ‘established in the Community’ shall be deleted;	(a)	the first paragraph shall be replaced by the following:‘Any decision taken pursuant to this Directive(a)to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;or(b)to withdraw devices from the marketshall state the exact grounds on which it is based. Such a decision shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.’;	(a)	to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;or	(b)	to withdraw devices from the market	(b)	in the second paragraph the words ‘established in the Community’ shall be deleted;
(a)	the first paragraph shall be replaced by the following:‘Any decision taken pursuant to this Directive(a)to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;or(b)to withdraw devices from the marketshall state the exact grounds on which it is based. Such a decision shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.’;	(a)	to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;or	(b)	to withdraw devices from the market
(a)	to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;or
(b)	to withdraw devices from the market
(b)	in the second paragraph the words ‘established in the Community’ shall be deleted;

15.	Article 15 shall be replaced by the following:‘Article 151. Without prejudice to the existing national provisions and practices on medical confidentiality, Member States shall ensure that all the Parties involved in the application of this Directive are bound to observe confidentiality with regard to all information obtained in carrying out their tasks.This does not affect the obligations of Member States and notified bodies with regard to mutual information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law.2. The following information shall not be treated as confidential:(a)information on the registration of persons responsible for placing devices on the market in accordance with Article 10a;(b)information to users sent out by the manufacturer, authorised representative or distributor in relation to a measure in accordance with Article 8;(c)information contained in certificates issued, modified, supplemented, suspended or withdrawn.3. The measures designed to amend non-essential elements of this Directive,inter aliaby supplementing it, relating to the determination of the conditions under which information other than that referred to in paragraph 2, and in particular concerning any obligation for manufacturers to prepare and make available a summary of the information and data related to the device, may be made publicly available shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;	(a)	information on the registration of persons responsible for placing devices on the market in accordance with Article 10a;	(b)	information to users sent out by the manufacturer, authorised representative or distributor in relation to a measure in accordance with Article 8;	(c)	information contained in certificates issued, modified, supplemented, suspended or withdrawn.
(a)	information on the registration of persons responsible for placing devices on the market in accordance with Article 10a;
(b)	information to users sent out by the manufacturer, authorised representative or distributor in relation to a measure in accordance with Article 8;
(c)	information contained in certificates issued, modified, supplemented, suspended or withdrawn.

‘(k)	“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:—clinical investigation(s) of the device concerned; or—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;	—	clinical investigation(s) of the device concerned; or	—	clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or	—	published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
—	clinical investigation(s) of the device concerned; or
—	clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
—	published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

(c)	in paragraph 4:(i)the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;(ii)the words ‘that device must’ shall be replaced by the words ‘that device shall’;	(i)	the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;	(ii)	the words ‘that device must’ shall be replaced by the words ‘that device shall’;
(i)	the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;
(ii)	the words ‘that device must’ shall be replaced by the words ‘that device shall’;

(d)	in paragraph 4a:(i)the reference ‘89/381/EEC’ shall be replaced by the reference ‘2001/83/EC’;(ii)the words ‘that device must’ shall be replaced by the words ‘that device shall’;	(i)	the reference ‘89/381/EEC’ shall be replaced by the reference ‘2001/83/EC’;	(ii)	the words ‘that device must’ shall be replaced by the words ‘that device shall’;
(i)	the reference ‘89/381/EEC’ shall be replaced by the reference ‘2001/83/EC’;
(ii)	the words ‘that device must’ shall be replaced by the words ‘that device shall’;

(e)	paragraph 5 shall be amended as follows:(i)The introductory phrase shall be replaced by the following:‘This Directive shall not apply to:’;(ii)point (c) shall be replaced by the following:‘(c)medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;(iii)point (f) shall be replaced by the following:‘(f)transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;	(i)	The introductory phrase shall be replaced by the following:‘This Directive shall not apply to:’;	(ii)	point (c) shall be replaced by the following:‘(c)medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;	‘(c)	medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;	(iii)	point (f) shall be replaced by the following:‘(f)transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;	‘(f)	transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;
(i)	The introductory phrase shall be replaced by the following:‘This Directive shall not apply to:’;
(ii)	point (c) shall be replaced by the following:‘(c)medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;	‘(c)	medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;
‘(c)	medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;
(iii)	point (f) shall be replaced by the following:‘(f)transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;	‘(f)	transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;
‘(f)	transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;

3.	the second indent of Article 4(2) shall be replaced by the following:‘—custom-made devices being placed on the market and put into service if they meet the conditions laid down in Article 11 in combination with Annex VIII; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII, which shall be available to the particular patient identified by name, an acronym or a numerical code.’;	‘—	custom-made devices being placed on the market and put into service if they meet the conditions laid down in Article 11 in combination with Annex VIII; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII, which shall be available to the particular patient identified by name, an acronym or a numerical code.’;
‘—	custom-made devices being placed on the market and put into service if they meet the conditions laid down in Article 11 in combination with Annex VIII; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII, which shall be available to the particular patient identified by name, an acronym or a numerical code.’;

SECTION I

SECTION I

PART A

A. COMPANY LAW

Classification of waterways

Scope of application

Obligation to carry a certificate

Supplementary Community inland navigation certificates

Additional or reduced technical requirements for certain zones

Dangerous goods

Derogations

Issuance of Community inland navigation certificates

Competent authorities

Carrying out of technical inspections

Validity of Community inland navigation certificates

Replacement of Community inland navigation certificates

Renewal of Community inland navigation certificates

Extension of validity of Community inland navigation certificates

Issuance of new Community inland navigation certificates

Refusal to issue or renew, and withdrawal of, Community inland navigation certificates

Additional inspections

Recognition of navigability certificates of craft from third countries

Committee procedure

Adaptation of the annexes and recommendations on provisional certificates

Continued applicability of Directive 76/135/EEC

National additional or reduced requirements

Transposition

Penalties

Repeal of Directive 82/714/EEC

Entry into force

Addressees

CHAPTER 1

CONTENTS

Safety signs

Part I

Part I

PART I

Subject-matter

Politically exposed persons

Simplified customer due diligence

Financial activity on an occasional or very limited basis

Transposition

6.	In Article 8 paragraph 2 shall be replaced by the following:‘2. The Commission shall enter into consultation with the Parties concerned as soon as possible. Where, after such consultation, the Commission finds that:(a)the measures are justified:(i)it shall immediately so inform the Member State which took the measures and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the Parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the advisory procedure referred to in Article 6(2);(ii)when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);(b)the measures are unjustified, it shall immediately so inform the Member State which took the measures and the manufacturer or his authorised representative.’;	(a)	the measures are justified:(i)it shall immediately so inform the Member State which took the measures and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the Parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the advisory procedure referred to in Article 6(2);(ii)when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);	(i)	it shall immediately so inform the Member State which took the measures and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the Parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the advisory procedure referred to in Article 6(2);	(ii)	when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);	(b)	the measures are unjustified, it shall immediately so inform the Member State which took the measures and the manufacturer or his authorised representative.’;
(a)	the measures are justified:(i)it shall immediately so inform the Member State which took the measures and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the Parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the advisory procedure referred to in Article 6(2);(ii)when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);	(i)	it shall immediately so inform the Member State which took the measures and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the Parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the advisory procedure referred to in Article 6(2);	(ii)	when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);
(i)	it shall immediately so inform the Member State which took the measures and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the Parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the advisory procedure referred to in Article 6(2);
(ii)	when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);
(b)	the measures are unjustified, it shall immediately so inform the Member State which took the measures and the manufacturer or his authorised representative.’;

8.	Article 10 shall be amended as follows:(a)in paragraph 2, the words ‘established in the Community’ shall be deleted;(b)paragraph 3 shall be replaced by the following:‘3. After carrying out an assessment, if possible together with the manufacturer or his authorised representative, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise the recurrence of the incidents referred to in paragraph 1, including information on the underlying incidents.’;(c)the following paragraph shall be added:‘4. Any appropriate measures to adopt procedures to implement this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;	(a)	in paragraph 2, the words ‘established in the Community’ shall be deleted;	(b)	paragraph 3 shall be replaced by the following:‘3. After carrying out an assessment, if possible together with the manufacturer or his authorised representative, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise the recurrence of the incidents referred to in paragraph 1, including information on the underlying incidents.’;	(c)	the following paragraph shall be added:‘4. Any appropriate measures to adopt procedures to implement this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;
(a)	in paragraph 2, the words ‘established in the Community’ shall be deleted;
(b)	paragraph 3 shall be replaced by the following:‘3. After carrying out an assessment, if possible together with the manufacturer or his authorised representative, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise the recurrence of the incidents referred to in paragraph 1, including information on the underlying incidents.’;
(c)	the following paragraph shall be added:‘4. Any appropriate measures to adopt procedures to implement this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;

9.	Article 11 shall be amended as follows:(a)in paragraphs 8 and 9 the words ‘established in the Community’ shall be deleted;(b)in paragraph 11, the words ‘Annexes II and III’ shall be replaced by the words ‘Annexes II, III, V and VI’ and the words ‘for further periods of five years’ shall be replaced by the words ‘for further periods of a maximum length of five years’;(c)the following paragraph shall be added:‘14. The measures designed to amend non-essential elements of this Directive, by supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex I Section 13.1 may be set out, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;	(a)	in paragraphs 8 and 9 the words ‘established in the Community’ shall be deleted;	(b)	in paragraph 11, the words ‘Annexes II and III’ shall be replaced by the words ‘Annexes II, III, V and VI’ and the words ‘for further periods of five years’ shall be replaced by the words ‘for further periods of a maximum length of five years’;	(c)	the following paragraph shall be added:‘14. The measures designed to amend non-essential elements of this Directive, by supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex I Section 13.1 may be set out, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;
(a)	in paragraphs 8 and 9 the words ‘established in the Community’ shall be deleted;
(b)	in paragraph 11, the words ‘Annexes II and III’ shall be replaced by the words ‘Annexes II, III, V and VI’ and the words ‘for further periods of five years’ shall be replaced by the words ‘for further periods of a maximum length of five years’;
(c)	the following paragraph shall be added:‘14. The measures designed to amend non-essential elements of this Directive, by supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex I Section 13.1 may be set out, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;

10.	Article 12 shall be amended as follows:(a)the title shall be replaced by ‘Particular procedure for systems and procedure packs and procedure for sterilisation’;(b)paragraph 3 shall be replaced by the following:‘3. Any natural or legal person who sterilises, for the purpose of placing on the market, systems or procedure packs referred to in paragraph 2 or other CE-marked medical devices designed by their manufacturers to be sterilised before use, shall, at his choice, follow one of the procedures referred to in Annex II or V. The application of the abovementioned Annexes and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged. The person shall draw up a declaration stating that sterilisation has been carried out in accordance with the manufacturer's instructions.’;(c)in paragraph 4, the third sentence shall be replaced by the following:‘The declarations referred to in paragraphs 2 and 3 shall be kept at the disposal of the competent authorities for a period of five years.’;	(a)	the title shall be replaced by ‘Particular procedure for systems and procedure packs and procedure for sterilisation’;	(b)	paragraph 3 shall be replaced by the following:‘3. Any natural or legal person who sterilises, for the purpose of placing on the market, systems or procedure packs referred to in paragraph 2 or other CE-marked medical devices designed by their manufacturers to be sterilised before use, shall, at his choice, follow one of the procedures referred to in Annex II or V. The application of the abovementioned Annexes and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged. The person shall draw up a declaration stating that sterilisation has been carried out in accordance with the manufacturer's instructions.’;	(c)	in paragraph 4, the third sentence shall be replaced by the following:‘The declarations referred to in paragraphs 2 and 3 shall be kept at the disposal of the competent authorities for a period of five years.’;
(a)	the title shall be replaced by ‘Particular procedure for systems and procedure packs and procedure for sterilisation’;
(b)	paragraph 3 shall be replaced by the following:‘3. Any natural or legal person who sterilises, for the purpose of placing on the market, systems or procedure packs referred to in paragraph 2 or other CE-marked medical devices designed by their manufacturers to be sterilised before use, shall, at his choice, follow one of the procedures referred to in Annex II or V. The application of the abovementioned Annexes and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged. The person shall draw up a declaration stating that sterilisation has been carried out in accordance with the manufacturer's instructions.’;
(c)	in paragraph 4, the third sentence shall be replaced by the following:‘The declarations referred to in paragraphs 2 and 3 shall be kept at the disposal of the competent authorities for a period of five years.’;

12.	Article 13 shall be replaced by the following:‘Article 13Decisions with regard to classification and derogation clause1. A Member State shall submit a duly substantiated request to the Commission and ask it to take the necessary measures in the following situations:(a)that Member State considers that the application of the classification rules set out in Annex IX requires a decision with regard to the classification of a given device or category of devices;(b)that Member State considers that a given device or family of devices should, by way of derogation from the provisions of Annex IX, be classified in another class;(c)that Member State considers that the conformity of a device or family of devices should, by way of derogation from Article 11, be established by applying solely one of the given procedures chosen from among those referred to in Article 11;(d)that Member State considers that a decision is required as to whether a particular product or product group falls within one of the definitions in Article 1(2)(a) to (e).The measures referred to in the first subparagraph of this paragraph shall, as appropriate, be adopted in accordance with the procedure referred to in Article 7(2).2. The Commission shall inform the Member States of the measures taken.’;	(a)	that Member State considers that the application of the classification rules set out in Annex IX requires a decision with regard to the classification of a given device or category of devices;	(b)	that Member State considers that a given device or family of devices should, by way of derogation from the provisions of Annex IX, be classified in another class;	(c)	that Member State considers that the conformity of a device or family of devices should, by way of derogation from Article 11, be established by applying solely one of the given procedures chosen from among those referred to in Article 11;	(d)	that Member State considers that a decision is required as to whether a particular product or product group falls within one of the definitions in Article 1(2)(a) to (e).
(a)	that Member State considers that the application of the classification rules set out in Annex IX requires a decision with regard to the classification of a given device or category of devices;
(b)	that Member State considers that a given device or family of devices should, by way of derogation from the provisions of Annex IX, be classified in another class;
(c)	that Member State considers that the conformity of a device or family of devices should, by way of derogation from Article 11, be established by applying solely one of the given procedures chosen from among those referred to in Article 11;
(d)	that Member State considers that a decision is required as to whether a particular product or product group falls within one of the definitions in Article 1(2)(a) to (e).

13.	Article 14 shall be amended as follows:(a)in the second subparagraph of paragraph 1, the words ‘Classes IIb and III’ shall be replaced by the words ‘Classes IIa, IIb and III’;(b)paragraph 2 shall be replaced by the following:‘2. Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union. For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.’;(c)paragraph 3 shall be replaced by the following:‘3. The Member States shall on request inform the other Member States and the Commission of the details referred to in the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.’;	(a)	in the second subparagraph of paragraph 1, the words ‘Classes IIb and III’ shall be replaced by the words ‘Classes IIa, IIb and III’;	(b)	paragraph 2 shall be replaced by the following:‘2. Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union. For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.’;	(c)	paragraph 3 shall be replaced by the following:‘3. The Member States shall on request inform the other Member States and the Commission of the details referred to in the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.’;
(a)	in the second subparagraph of paragraph 1, the words ‘Classes IIb and III’ shall be replaced by the words ‘Classes IIa, IIb and III’;
(b)	paragraph 2 shall be replaced by the following:‘2. Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union. For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.’;
(c)	paragraph 3 shall be replaced by the following:‘3. The Member States shall on request inform the other Member States and the Commission of the details referred to in the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.’;

(a)	the second subparagraph of paragraph 1 shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;(ii)the following point shall be added:‘(d)data relating to clinical investigations referred to in Article 15;’;	(i)	point (a) shall be replaced by the following:‘(a)data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;	‘(a)	data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;	(ii)	the following point shall be added:‘(d)data relating to clinical investigations referred to in Article 15;’;	‘(d)	data relating to clinical investigations referred to in Article 15;’;
(i)	point (a) shall be replaced by the following:‘(a)data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;	‘(a)	data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;
‘(a)	data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;
(ii)	the following point shall be added:‘(d)data relating to clinical investigations referred to in Article 15;’;	‘(d)	data relating to clinical investigations referred to in Article 15;’;
‘(d)	data relating to clinical investigations referred to in Article 15;’;

16.	Article 15 shall be amended as follows:(a)paragraphs 1, 2 and 3 shall be replaced by the following:‘1. In the case of devices intended for clinical investigations, the manufacturer or the authorised representative, established in the Community, shall follow the procedure referred to in Annex VIII and notify the competent authorities of the Member States in which the investigations are to be conducted by means of the statement mentioned in Section 2.2 of Annex VIII.2. In the case of devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of 60 days after notification, unless the competent authorities have notified him within that period of a decision to the contrary based on considerations of public health or public policy.Member States may however authorise manufacturers to commence the relevant clinical investigations before the expiry of the period of 60 days, insofar as the relevant ethics committee has issued a favourable opinion on the programme of investigation in question, including its review of the clinical investigation plan.3. In the case of devices other than those referred to in paragraph 2, Member States may authorise manufacturers to commence clinical investigations immediately after the date of notification, provided that the ethics committee concerned has issued a favourable opinion on the programme of investigation in question including its review of the clinical investigation plan.’;(b)paragraphs 5, 6 and 7 shall be replaced by the following:‘5. The clinical investigations must be conducted in accordance with the provisions of Annex X. The measures designed to amend non-essential elements of this Directive, inter alia by supplementing it, relating to the provisions on clinical investigation in Annex X shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).6. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.7. The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in Section 2.3.7 of Annex X at the disposal of the competent authorities.’;	(a)	paragraphs 1, 2 and 3 shall be replaced by the following:‘1. In the case of devices intended for clinical investigations, the manufacturer or the authorised representative, established in the Community, shall follow the procedure referred to in Annex VIII and notify the competent authorities of the Member States in which the investigations are to be conducted by means of the statement mentioned in Section 2.2 of Annex VIII.2. In the case of devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of 60 days after notification, unless the competent authorities have notified him within that period of a decision to the contrary based on considerations of public health or public policy.Member States may however authorise manufacturers to commence the relevant clinical investigations before the expiry of the period of 60 days, insofar as the relevant ethics committee has issued a favourable opinion on the programme of investigation in question, including its review of the clinical investigation plan.3. In the case of devices other than those referred to in paragraph 2, Member States may authorise manufacturers to commence clinical investigations immediately after the date of notification, provided that the ethics committee concerned has issued a favourable opinion on the programme of investigation in question including its review of the clinical investigation plan.’;	(b)	paragraphs 5, 6 and 7 shall be replaced by the following:‘5. The clinical investigations must be conducted in accordance with the provisions of Annex X. The measures designed to amend non-essential elements of this Directive, inter alia by supplementing it, relating to the provisions on clinical investigation in Annex X shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).6. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.7. The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in Section 2.3.7 of Annex X at the disposal of the competent authorities.’;
(a)	paragraphs 1, 2 and 3 shall be replaced by the following:‘1. In the case of devices intended for clinical investigations, the manufacturer or the authorised representative, established in the Community, shall follow the procedure referred to in Annex VIII and notify the competent authorities of the Member States in which the investigations are to be conducted by means of the statement mentioned in Section 2.2 of Annex VIII.2. In the case of devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of 60 days after notification, unless the competent authorities have notified him within that period of a decision to the contrary based on considerations of public health or public policy.Member States may however authorise manufacturers to commence the relevant clinical investigations before the expiry of the period of 60 days, insofar as the relevant ethics committee has issued a favourable opinion on the programme of investigation in question, including its review of the clinical investigation plan.3. In the case of devices other than those referred to in paragraph 2, Member States may authorise manufacturers to commence clinical investigations immediately after the date of notification, provided that the ethics committee concerned has issued a favourable opinion on the programme of investigation in question including its review of the clinical investigation plan.’;
(b)	paragraphs 5, 6 and 7 shall be replaced by the following:‘5. The clinical investigations must be conducted in accordance with the provisions of Annex X. The measures designed to amend non-essential elements of this Directive, inter alia by supplementing it, relating to the provisions on clinical investigation in Annex X shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).6. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.7. The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in Section 2.3.7 of Annex X at the disposal of the competent authorities.’;

17.	Article 16 shall be amended as follows:(a)the following subparagraph shall be added to paragraph 2:‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex XI for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;(b)in paragraph 4, the words ‘established in the Community’ shall be deleted;(c)paragraph 5 shall be replaced by the following:‘5. The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.’;	(a)	the following subparagraph shall be added to paragraph 2:‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex XI for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;	(b)	in paragraph 4, the words ‘established in the Community’ shall be deleted;	(c)	paragraph 5 shall be replaced by the following:‘5. The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.’;
(a)	the following subparagraph shall be added to paragraph 2:‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex XI for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;
(b)	in paragraph 4, the words ‘established in the Community’ shall be deleted;
(c)	paragraph 5 shall be replaced by the following:‘5. The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.’;

18.	in Article 18 point (a) shall be replaced by the following:‘(a)where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of the Directive, the manufacturer or his authorised representative shall be obliged to end the infringement under conditions imposed by the Member State;’;	‘(a)	where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of the Directive, the manufacturer or his authorised representative shall be obliged to end the infringement under conditions imposed by the Member State;’;
‘(a)	where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of the Directive, the manufacturer or his authorised representative shall be obliged to end the infringement under conditions imposed by the Member State;’;