Machinery directive 2006/42/CE - Functional safety & ATEX directive 2014/34/EU

ANNEX II

 

A. MINIMUM REQUIREMENTS FOR IMPROVING THE SAFETY AND HEALTH PROTECTION OF WORKERS POTENTIALLY AT RISK FROM EXPLOSIVE ATMOSPHERES

Preliminary note

The obligations laid down in this Annex apply to:

- places classified as hazardous in accordance with Annex I whenever required by the features of workplaces, workstations, the equipment or substances used or the danger caused by the activity related to the risks from explosive atmospheres,

- equipment in non-hazardous places which is required for, or helps to ensure, the safe operation of equipment located in hazardous places.

1. Organisational measures

1.1. Training of workers

The employer must provide those working in places where explosive atmospheres may occur with sufficient and appropriate training with regard to explosion protection.

1.2. Written instructions and permits to work

Where required by the explosion protection document:

- work in hazardous places must be carried out in accordance with written instructions issued by the employer,

- a system of permits to work must be applied for carrying out both hazardous activities and activities which may interact with other work to cause hazards.

Permits to work must be issued by a person with responsibility for this function prior to the commencement of work.

2. Explosion protection measures

2.1. Any escape and/or release, whether or not intentional, of flammable gases, vapours, mists or combustible dusts which may give rise to explosion hazards must be suitably diverted or removed to a safe place or, if that is not practicable, safely contained or rendered safe by some other suitable method.

2.2. If an explosive atmosphere contains several types of flammable and/or combustible gases, vapours, mists or dusts, protective measures shall be appropriate to the greatest potential risk.

2.3. Prevention of ignition hazards in accordance with Article 3 must also take account of electrostatic discharges, where workers or the working environment act as charge carrier or charge producer. Workers must be provided with appropriate working clothes consisting of materials which do not give rise to electrostatic discharges that can ignite explosive atmospheres.

2.4. Plant, equipment, protective systems and any associated connecting devices must only be brought into service if the explosion protection document indicates that they can be safely used in an explosive atmosphere. This applies also to work equipment and associated connecting devices which are not regarded as equipment or protective systems within the meaning of Directive 94/9/EC if their incorporation into an installation can in itself give rise to an ignition hazard. Necessary measures must be taken to prevent confusion between connecting devices.

2.5. All necessary measures must be taken to ensure that the workplace, work equipment and any associated connecting device made available to workers have been designed, constructed, assembled and installed, and are maintained and operated, in such a way as to minimise the risks of an explosion and, if an explosion does occur, to control or minimise its propagation within that workplace and/or work equipment. For such workplaces appropriate measures must be taken to minimise the risks to workers from the physical effects of an explosion.

2.6. Where necessary, workers must be given optical and/or acoustic warnings and withdrawn before the explosion conditions are reached.

2.7. Where required by the explosion protection document, escape facilities must be provided and maintained to ensure that, in the event of danger, workers can leave endangered places promptly and safely.

2.8. Before a workplace containing places where explosive atmospheres may occur is used for the first time, its overall explosion safety must be verified. Any conditions necessary for ensuring explosion protection must be maintained.

Such verification must be carried out by persons competent in the field of explosion protection as a result of their experience and/or professional training.

2.9. Where the risk assessment shows it is necessary:

- it must be possible, where power failure can give rise to the spread of additional risks, to maintain equipment and protective systems in a safe state of operation independently of the rest of the installation in the event of power failure,

- manual override must be possible in order to shut down the equipment and protective systems incorporated within automatic processes which deviate from the intended operating conditions, provided that this does not compromise safety. Only workers competent to do so may take such action,

- on operation of the emergency shutdown, accumulated energy must be dissipated as quickly and as safely as possible or isolated so that it no longer constitutes a hazard.

B. CRITERIA FOR THE SELECTION OF EQUIPMENT AND PROTECTIVE SYSTEMS

If the explosion protection document based on a risk assessment does not state otherwise, equipment and protective systems for all places in which explosive atmospheres may occur must be selected on the basis of the categories set out in Directive 94/9/EC.

In particular, the following categories of equipment must be used in the zones indicated, provided they are suitable for gases, vapours or mists and/or dusts as appropriate:

- in zone 0 or zone 20, category 1 equipment,

- in zone 1 or zone 21, category 1 or 2 equipment,

- in zone 2 or zone 22, category 1, 2 or 3 equipment.

ANNEX I

 

CLASSIFICATION OF PLACES WHERE EXPLOSIVE ATMOSPHERES MAY OCCUR

Preliminary note

The following system of classification must be applied to places where precautions in accordance with Articles 3, 4, 7 and 8 are taken.

1. Places where explosive atmospheres may occur

A place in which an explosive atmosphere may occur in such quantities as to require special precautions to protect the health and safey of the workers concerned is deemed to be hazardous within the meaning of this Directive.

A place in which an explosive atmosphere is not expected to occur in such quantities as to require special precautions is deemed to be non-hazardous within the meaning of this Directive.

Flammable and/or combustible substances are considered as materials which may form an explosive atmosphere unless an investigation of their properties has shown that in mixtures with air they are incapable of independently propagating an explosion.

2. Classification of hazardous places

Hazardous places are classified in terms of zones on the basis of the frequency and duration of the occurrence of an explosive atmosphere.

The extent of the measures to be taken in accordance with Annex II, Part A, is determined by this classification.

Zone 0

A place in which an explosive atmosphere consisting of a mixture with air of flammable substances in the form of gas, vapour or mist is present continuously or for long periods or frequently.

Zone 1

A place in which an explosive atmosphere consisting of a mixture with air or flammable substances in the form of gas, vapour or mist is likely to occur in normal operation occasionally.

Zone 2

A place in which an explosive atmosphere consisting of a mixture with air of flammable substances in the form of gas, vapour or mist is not likely to occur in normal operation but, if it does occur, will persist for a short period only.

Zone 20

A place in which an explosive atmosphere in the form of a cloud of combustable dust in air is present continously, or for long periods or frequently.

Zone 21

A place in which an explosive atmosphere in the form of a cloud of combustible dust in air is likely to occur in normal operation occasionally.

Zone 22

A place in which an explosive atmosphere in the form of a cloud of combustible dust in air is not likely to occur in normal operation but, if it does occur, will persist for a short period only.

Notes:

1. Layers, deposits and heaps of combustible dust must be considered as any other source which can form an explosive atmosphere.

2. "Normal operation" means the situation when installations are used within their design parameters.

SECTION I

GENERAL PROVISIONS

Article 1

Object and scope

1. This Directive, which is the 15th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC, lays down minimum requirements for the safety and health protection of workers potentially at risk from explosive atmospheres as defined in Article 2.

2. This Directive shall not apply to:

(a) areas used directly for and during the medical treatment of patients;

(b) the use of appliances burning gaseous fuels in accordance with Directive 90/396/EEC(7);

(c) the manufacture, handling, use, storage and transport of explosives or chemically unstable substances;

(d) mineral-extracting industries covered by Directive 92/91/EEC(8) or Directive 92/104/EEC(9);

(e) the use of means of transport by land, water and air, to which the pertinent provisions of the international agreements (e.g. ADNR, ADR, ICAO, IMO, RID), and the Community Directives giving effect to those agreements, apply. Means of transport intended for use in a potentially explosive atmosphere shall not be excluded.

3. The provisions of Directive 89/391/EEC and the relevant individual Directives are fully applicable to the domain referred to in paragraph 1, without prejudice to more restrictive and/or specific provisions contained in this Directive.

 

Article 2

Definition

For the purposes of this Directive, "explosive atmosphere" means a mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapours, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture.

 

SECTION II

OBLIGATIONS OF THE EMPLOYER

Article 3

Prevention of and protection against explosions

With a view to preventing, within the meaning of Article 6(2) of Directive 89/391/EEC, and providing protection against explosions, the employer shall take technical and/or organisational measures appropriate to the nature of the operation, in order of priority and in accordance with the following basic principles:

- the prevention of the formation of explosive atmospheres, or where the nature of the activity does not allow that,

- the avoidance of the ignition of explosive atmospheres, and

- the mitigation of the detrimental effects of an explosion so as to ensure the health and safety of workers.

These measures shall where necessary be combined and/or supplemented with measures against the propagation of explosions and shall be reviewed regularly and, in any event, whenever significant changes occur.

 

Article 4

Assessment of explosion risks

1. In carrying out the obligations laid down in Articles 6(3) and 9(1) of Directive 89/391/EEC the employer shall assess the specific risks arising from explosive atmospheres, taking account at least of:

- the likelihood that explosive atmospheres will occur and their persistence,

- the likelihood that ignition sources, including electrostatic discharges, will be present and become active and effective,

- the installations, substances used, processes, and their possible interactions,

- the scale of the anticipated effects.

Explosion risks shall be assessed overall.

2. Places which are or can be connected via openings to places in which explosive atmospheres may occur shall be taken into account in assessing explosion risks.

 

Article 5

General obligations

To ensure the safety and health of workers, and in accordance with the basic principles of risk assessment and those laid down in Article 3, the employer shall take the necessary measures so that:

- where explosive atmospheres may arise in such quantities as to endanger the health and safety of workers or others, the working environment is such that work can be performed safely,

- in working environments where explosive atmospheres may arise in such quantities as to endanger the safety and health of workers, appropriate supervision during the presence of workers is ensured in accordance with the risk assessment by the use of appropriate technical means.

 

Article 6

Duty of coordination

Where workers from several undertakings are present at the same workplace, each employer shall be responsible for all matters coming under his control.

Without prejudice to the individual responsibility of each employer as provided for in Directive 89/391/EEC, the employer responsible for the workplace in accordance with national law and/or practice shall coordinate the implementation of all the measures concerning workers' health and safety and shall state, in the explosion protection document referred to in Article 8, the aim of that coordination and the measures and procedures for implementing it.

 

Article 7

Places where explosive atmospheres may occur

1. The employer shall classify places where explosive atmospheres may occur into zones in accordance with Annex I.

2. The employer shall ensure that the minimum requirements laid down in Annex II are applied to places covered by paragraph 1.

3. Where necessary, places where explosive atmospheres may occur in such quantities as to endanger the health and safety of workers shall be marked with signs at their points of entry in accordance with Annex III.

 

Article 8

Explosion protection document

In carrying out the obligations laid down in Article 4, the employer shall ensure that a document, hereinafter referred to as the "explosion protection document", is drawn up and kept up to date.

The explosion protection document shall demonstrate in particular:

- that the explosion risks have been determined and assessed,

- that adequate measures will be taken to attain the aims of this Directive,

- those places which have been classified into zones in accordance with Annex I,

- those places where the minimum requirements set out in Annex II will apply,

- that the workplace and work equipment, including warning devices, are designed, operated and maintained with due regard for safety,

- that in accordance with Council Directive 89/655/EEC(10), arrangements have been made for the safe use of work equipment.

The explosion protection document shall be drawn up prior to the commencement of work and be revised when the workplace, work equipment or organisation of the work undergoes significant changes, extensions or conversions.

The employer may combine existing explosion risk assessments, documents or other equivalent reports produced under other Community acts.

 

Article 9

Special requirements for work equipment and workplaces

1. Work equipment for use in places where explosive atmospheres may occur which is already in use or is made available in the undertaking or establishment for the first time before 30 June 2003 shall comply from that date with the minimum requirements laid down in Annex II, Part A, if no other Community Directive is applicable or is so only partially.

2. Work equipment for use in places where explosive atmospheres may occur which is made available in the undertaking or establishment for the first time after 30 June 2003 shall comply with the minimum requirements laid down in Annex II, Parts A and B.

3. Workplaces which contain places where explosive atmospheres may occur and which are used for the first time after 30 June 2003 shall comply with minimum requirements set out in this Directive.

4. Where workplaces which contain places where explosive atmospheres may occur are already in use before 30 June 2003, they shall comply with the minimum requirements set out in this Directive no later than three years after that date.

5. If, after 30 June 2003, any modification, extension or restructuring is undertaken in workplaces containing places where explosive atmospheres may occur, the employer shall take the necessary steps to ensure that these comply with the minimum requirements set out in this Directive.

 

SECTION III

MISCELLANEOUS PROVISIONS

Article 10

Adjustments to the annexes

Purely technical adjustments to the annexes made necessary by:

- the adoption of Directives on technical harmonisation and standardisation in the field of explosion protection, and/or

- technical progress, changes in international regulations or specifications, and new findings on the prevention of and protection against explosions,

shall be adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC.

 

Article 11

Guide of good practice

The Commission shall draw up practical guidelines in a guide of good practice of a non-binding nature. This guide shall address the topics referred to in Articles 3, 4, 5, 6, 7 and 8, Annex I and Annex II, Part A.

The Commission shall first consult the Advisory Committee on Safety, Hygiene and Health Protection at Work in accordance with Council Decision 74/325/EEC(11).

In the context of the application of this Directive, Member States shall take the greatest possible account of the abovementioned guide in drawing up their national policies for the protection of the health and safety of workers

 

Article 12

Information to undertakings

Member States shall, on request, endeavour to make relevant information available to employers in accordance with Article 11, with particular reference to the guide of good practice

 

Article 13

Final provisions

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 June 2003. 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 provisions of domestic law which they have already adopted or adopt in the field governed by this Directive.

3. Member States shall report to the Commission every five years on the practical implementation of the provisions of this Directive, indicating the points of view of employers and workers. The Commission shall inform thereof the European Parliament, the Council, the Economic and Social Committee and the Advisory Committee on Safety, Hygiene and Health Protection at Work.

 

Article 14

This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.

 

Article 15

This Directive is addressed to the Member States.

 

Done at Brussels, 16 December 1999.

 

For the European Parliament

The President

N. FONTAINE

 

For the Council

The President

K. HEMILÄ

 

(1) OJ C 332, 9.12.1995, p. 10 and OJ C 184, 17.6.1997, p. 1.

(2) OJ C 153, 28.5.1996, p. 35.

(3) Opinion of the European Parliament of 20 June 1996 (OJ C 198, 8.7.1996, p. 160) confirmed on 4 May 1999 (OJ C 279, 1.10.1999, p 55), Council Common Position of 22 December 1998 (OJ C 55, 25.2.1999, p. 45), Decision of the European Parliament of 6 May 1999 (OJ C 279, 1.10.1999, p. 386). Decision of the European Parliament of 2 December 1999 and Council Decision of 6 December 1999.

(4) OJ L 183, 29.6.1989, p. 1.

(5) OJ L 100, 19.4.1994, p. 1.

(6) OJ L 245, 26.8.1992, p. 23.

(7) OJ L 196, 26.7.1990, p. 15. Directive as amended by Directive 93/68/EEC (OJ L 220, 30.8.1993, p. 1).

(8) OJ L 348, 28.11.1992, p. 9.

(9) OJ L 404, 31.12.1992, p. 10.

(10) OJ L 393, 30.12.1989, p. 13. Directive as amended by Directive 95/63/EC (OJ L 335, 30.12.1995, p. 28).

(11) OJ L 185, 9.7.1974, p. 15. Decision as last amended by the 1994 Act of Accession.

Directive 1999/92/EC of the European Parliament and of the Council of 16 December 1999 on minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres (15th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) 

Official Journal L 023 , 28/01/2000 P. 0057 - 0064

DIRECTIVE 1999/92/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 1999 on minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres (15th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)

 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 137 thereof,

Having regard to the proposal from the Commission(1), submitted after consultation with the Advisory Committee on Safety, Hygiene and Health Protection at Work and the Safety and Health Commission for the Mining and Other Extractive Industries,

Having regard to the opinion of the Economic and Social Committee(2),

After consulting the Committee of the Regions,

Acting in accordance with the procedure referred to in Article 251 of the Treaty, in the light of the joint text approved by the Conciliation Committee on 21 October 1999(3),

Whereas:

(1) Article 137 of the Treaty provides that the Council may adopt, by means of Directives, minimum requirements for encouraging improvements, especially in the working environment, to guarantee a better level of protection of the health and safety of workers;

(2) Under the terms of that Article, those Directives are to avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings;

(3) The improvement of occupational safety, hygiene and health is an objective which should not be subordinated to purely economic considerations;

(4) Compliance with the minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres is essential if workers' safety and health protection is to be ensured;

(5) This Directive is an individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(4); therefore, the provisions of the said Directive, in particular those relating to worker information, to the consultation and participation of workers and to the training of workers, are also fully applicable to cases in which workers are potentially at risk from explosive atmospheres, without prejudice to more restrictive or specific provisions contained in this Directive;

(6) This Directive constitutes a practical step towards the achievement of the social dimension of the internal market;

(7) Directive 94/9/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres(5) states that it is intended to prepare an additional Directive based on Article 137 of the Treaty covering, in particular, explosion hazards which derive from a given use and/or types and methods of installation of equipment;

(8) Explosion protection is of particular importance to safety; whereas explosions endanger the lives and health of workers as a result of the uncontrolled effects of flame and pressure, the presence of noxious reaction products and consumption of the oxygen in the ambient air which workers need to breathe;

(9) The establishment of a coherent strategy for the prevention of explosions requires that organisational measures complement the technical measures taken at the workplace; Directive 89/391/EEC requires the employer to be in possession of an assessment of the risks to workers' health and safety at work; this requirement is to be regarded as being specified by this Directive in that it provides that the employer is to draw up an explosion protection document, or set of documents, which satisfies the minimum requirements laid down in this Directive and is to keep it up to date; the explosion protection document includes the identification of the hazards, the evaluation of risks and the definition of the specific measures to be taken to safeguard the health and safety of workers at risk from explosive atmospheres, in accordance with Article 9 of Directive 89/391/EEC; the explosion protection document may be part of the assessment of the risks to health and safety at work required by Article 9 of Directive 89/391/EEC;

(10) An assessment of explosion risks may be required under other Community acts; whereas, in order to avoid unnecessary duplication of work, the employer should be allowed, in accordance with national practice, to combine documents, parts of documents or other equivalent reports produced under other Community acts to form a single "safety report";

(11) The prevention of the formation of explosive atmospheres also includes the application of the substitution principle;

(12) Coordination should take place when workers from several undertakings are present at the same workplace;

(13) Preventive measures must be supplemented if necessary by additional measures which become effective when ignition has taken place; maximum safety can be achieved by combining preventive measures with other additional measures limiting the detrimental effects of explosions on workers;

(14) Council Directive 92/58/EEC of 24 June 1992 on the minimum requirements for the provision of safety and/or health signs at work (ninth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(6) is fully applicable, in particular to places immediately contiguous to hazardous areas, where smoking, crosscutting, welding and other activities introducing flames or sparks may interact with the hazardous area;

(15) Directive 94/9/EC divides the equipment and protective systems which it covers into equipment groups and categories; this Directive provides for a classification by the employer of the places where explosive atmospheres may occur in terms of zones and determines which equipment and protective systems groups and categories should be used in each zone,

HAVE ADOPTED THIS DIRECTIVE:

 

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ANNEX XI

PART A : Repealed Directive with list of the successive amendments thereto

(referred to in Article 43)

Directive 94/9/EC of the European Parliament and of the Council (OJ L 100, 19.4.1994, p. 1).
Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).	Only point 8 of Annex I
Regulation (EU) No 1025/2012 of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).	Only point (c) of Article 26(1)

PART B : Time limits for transposition into national law and dates of application

(referred to in Article 43)

Directive	Time limit for transposition	Date of application
94/9/EC	1 September 1995	1 March 1996

ANNEX X : EU DECLARATION OF CONFORMITY (No XXXX) (1)

1.            Product model/product (product, type, batch or serial number):

2.            Name and address of the manufacturer and, where applicable, his authorised representative:

3.            This declaration of conformity is issued under the sole responsibility of the manufacturer.

4.            Object of the declaration (identification of product allowing traceability; it may, where necessary for the identification of the product, include an image):

5.            The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:

6.            References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared:

7.            Where applicable, the notified body … (name, number) performed … (description of intervention) and issued the certificate:

8.            Additional information:

Signed for and on behalf of:

(place and date of issue):

(name, function) (signature):

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(1)  It is optional for the manufacturer to assign a number to the declaration of conformity.

ANNEX IX : MODULE G:   CONFORMITY BASED ON UNIT VERIFICATION

1.   Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 5, and ensures and declares on his sole responsibility that the product concerned, which has been subject to the provisions of point 4, is in conformity with the requirements of this Directive that apply to it.

2.   Technical documentation

2.1.        The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point 4. The documentation shall make it possible to assess the product’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain at least the following elements:

(a)          a general description of the product,

(b)          conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

(c)          descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,

(d)          a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

(e)          results of design calculations made, examinations carried out, etc., and

(f)           test reports.

 

2.2.        The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the product has been placed on the market.

3.   Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with the applicable requirements of this Directive.

4.   Verification

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standards and/or equivalent tests set out in other relevant technical specifications, to check the conformity of the product with the applicable requirements of this Directive, or have them carried out. In the absence of such a harmonised standard the notified body concerned shall decide on the appropriate tests to be carried out.

The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved product, or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the product has been placed on the market.

5.   CE marking, EU declaration of conformity and attestation of conformity

5.1.        The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 4, the latter’s identification number to each product other than a component that satisfies the applicable requirements of this Directive.

5.2.        The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for 10 years after the product, other than a component has been placed on the market. The EU declaration of conformity shall identify such product for which it has been drawn up.

A copy of the EU declaration of conformity shall accompany every product, other than a component.

5.3.        The manufacturer shall draw up a written attestation of conformity and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

6.   Authorised representative

The manufacturer’s obligations set out in points 2.2 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

ANNEX VIII : MODULE A:   INTERNAL PRODUCTION CONTROL

1.   Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the products concerned satisfy the requirements of this Directive that apply to them.

2.   Technical documentation

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the product’s conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s).

The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain at least the following elements:

(a)          a general description of the product,

(b)          conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.

(c)          descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,

(d)          a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

(e)          results of design calculations made, examinations carried out, etc., and

(f)           test reports.

3.   Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation referred to in point 2 and with the requirements of this Directive that apply to them.

4.   CE marking, EU declaration of conformity and attestation of conformity

4.1.        The manufacturer shall affix the CE marking to each individual product other than a component that satisfies the applicable requirements of this Directive.

4.2.        The manufacturer shall draw up a written EU declaration of conformity for a product model other than a component and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product, other than a component, has been placed on the market. The EU declaration of conformity shall identify such product model for which it has been drawn up.

A copy of the EU declaration of conformity shall accompany every product other than a component.

4.3.        The manufacturer shall draw up a written attestation of conformity for each component model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

5.   Authorised representative

The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

ANNEX VII : MODULE E:   CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE

1.   Conformity to type based on product quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.

2.   Manufacturing

The manufacturer shall operate an approved quality system for final product inspection and testing of the products concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.

3.   Quality system

3.1.        The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned.

The application shall include:

(a)          the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

(b)          a written declaration that the same application has not been lodged with any other notified body,

(c)          all relevant information for the product category envisaged,

(d)          the documentation concerning the quality system, and

(e)          the technical documentation of the approved type and a copy of the EU-type examination certificate.

 

3.2.        The quality system shall ensure compliance of the products with the type described in the EU-type examination certificate and with the applicable requirements of this Directive.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

(a)          the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,

(b)          the examinations and tests that will be carried out after manufacture,

(c)          the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.,

(d)          the means of monitoring the effective operation of the quality system.

 

3.3.        The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 3.1(e) in order to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

3.4.        The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

3.5.        The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

4.   Surveillance under the responsibility of the notified body

4.1.        The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2.        The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

(a)          the quality system documentation,

(b)          the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

 

4.3.        The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

4.4.        In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

5.   CE marking, EU declaration of conformity and attestation of conformity

5.1.        The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual product other than a component that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.

5.2.        The manufacturer shall draw up a written EU declaration of conformity for each product model, other than a component and keep it at the disposal of the national authorities for 10 years after the product other than a component has been placed on the market. The EU declaration of conformity shall identify such product model for which it has been drawn up.

A copy of the EU declaration of conformity shall accompany every product other than a component.

5.3.        The manufacturer shall draw up a written attestation of conformity for each component model and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

6.   The manufacturer shall, for a period ending 10 years after the product has been placed on the market, keep at the disposal of the national authorities:

(a)          the documentation referred to in point 3.1,

(b)          the information relating to the change referred to in point 3.5, as approved,

(c)          the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.

7.   Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.

8.   Authorised representative

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.