Avis juridique important

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31994L0009

Directive 94/9/EC of the European Parliament and 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

Official Journal L 100 , 19/04/1994 P. 0001 - 0029 Finnish special edition: Chapter 13 Volume 26 P. 0003  Swedish special edition: Chapter 13 Volume 26 P. 0003

DIRECTIVE 94/9/EC OF THE EUROPEAN  PARLIAMENT AND 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 atmospheresTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 100a  thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure referred to in Article 189b of the Treaty establishing the  European Community, Whereas it is the duty of Member States to protect, on their territory, the safety and health of  persons and, where appropriate, domestic animals and property and, in particular, that of workers,  especially against the hazards resulting from the use of equipment and systems providing protection  against potentially explosive atmospheres; Whereas mandatory provisions within the Member States determine the level of safety to be achieved  by protective equipment and systems intended for use in potentially explosive atmospheres; whereas  these are generally electrical and non-electrical specifications having an effect on the design and  structure of equipment which can be used in potentially explosive atmospheres; Whereas the requirements to be met by such equipment differ from one Member State to another in  respect of their extent and differing inspection procedures; whereas these differences are,  therefore, likely to raise barriers to trade within the Community; Whereas harmonization of national legislation is the only way in which to remove these barriers to  free trade; whereas this objective cannot be satisfactorily achieved by the individual Member  States; whereas this Directive merely lays down the requirements vital to freedom of movement for  the equipment to which it applies; Whereas the regulations intended to remove technical barriers to trade are required to follow the  new approach provided for in the Council resolution of 7 May 1985 (3), which requires a definition  of the essential requirements regarding safety and other requirements of society without reducing  existing, justified levels of protection within the Member States; whereas that resolution provides  that a very large number of products be covered by a single Directive in order to avoid frequent  amendments and the proliferation of Directives; Whereas the existing Directives on the approximation of the laws of the Member States to electrical  equipment for use in potentially explosive atmospheres have made positive steps towards protection  against explosions via measures linked with the structure of the equipment at issue and which have  helped to remove barriers to trade in this area; whereas, in parallel, a revision and expansion of  the existing Directives is necessary since, more particularly, in an overall context, action must  be taken to guard against the potential hazards arising from such equipment. This implies in  particular that measures intended to guarantee effective protection of users and third parties must  already be contemplated at the design and manufacturing states; Whereas the form taken by the hazard, the protective measures and the test methods are often very  similar, if not identical, for both mining and surface equipment; whereas it is, therefore,  absolutely necessary to cover by a single Directive protective equipment and systems falling within  both groups; Whereas the two groups of equipment referred to above are used in a large number of commercial and  industrial sectors and possess considerable economic significance; Whereas compliance with the basic safety and health requirements is essential in order to ensure  the safety of protective equipment and systems; whereas those requirements have been subdivided  into general and additional requirements which must be met by protective equipment and systems;  whereas, in particular, the additional requirements are intended to take account of existing or  potential hazards; whereas protective equipment and systems will, therefore, embody at least one of  those requirements where this is necessary for their proper functioning or is to apply to their  intended use; whereas the notion of intended use is of prime importance for the explosion-proofing  of protective equipment and systems; whereas it is essential that manufacturers supply full  information; whereas specific, clear marking of said equipment, stating its use in a potentially  explosive atmosphere, is also necessary; Whereas the intention is to prepare a Directive on operations in potentially explosive atmospheres  which is based on Article 118a; whereas that additional Directive will, in particular, aim at  explosion hazards which derive from a given use and/or types and methods of installation; Whereas compliance with essential health and safety requirements is imperative if the safety of  equipment is to be ensured; whereas judgment will have to be exercised in the implementation of  those requirements in order to take account of both the technology obtaining at the time of  manufacture and overriding technical and economic requirements; Whereas, therefore, this Directive sets out essential requirements only; whereas, in order to  facilitate the task of proving compliance with the essential requirements, harmonized European  standards are necessary, more especially with regard to the non-electrical aspects of protection  against explosions - standards relating to the design, manufacture and testing of equipment,  compliance with which enables a product to be presumed to meet such essential requirements; whereas  harmonized European standards are drawn up by private bodies and must retain their non-mandatory  status; whereas, for this purpose, the European Committee for Standardization (CEN) and the  European Committee for Electrotechnical Standardization (Cenelec) are recognized as the bodies  competent to adopt harmonized standards which follow the general guidelines for cooperation between  the Commission and those two bodies, signed on 13 November 1984; whereas, for the purposes of this  Directive, a harmonized standard is a technical specification (European Standard or harmonization  document) adopted by one or other of those bodies, or by both, at the prompting of the Commission  pursuant to Council Directive 83/189/EEC of the 28 March 1983 providing for a procedure governing  the provision of information on technical standards and regulations (1) and pursuant to the general  guidelines referred to above; Whereas the legislative framework should be improved in order to ensure that employers and workers  make an effective and appropriate contribution towards the standardization process; whereas this  should be completed by the time this Directive is implemented; Whereas, in view of the nature of the risks involved in the use of equipment in potentially  explosive atmospheres it is necessary to establish procedures applying to the assessment of  compliance with the basic requirements of the Directives; whereas these procedures must be devised  in the light of the level of risk which may be inherent in equipment and/or against which systems  must protect the immediate environment; whereas, therefore, each category of equipment conformity  must be supplemented by an adequate procedure or a choice between several equivalent procedures;  whereas the procedures adopted comply fully with Council Decision 93/465/EEC of 22 July 1993  concerning the modules for the various phases of the conformity assessment procedures which are  intended to be used in the technical harmonization Directives (2); Whereas the Council has provided for the affixing of the CE marking by either the manufacturer or  his authorized representative within the Community; whereas that marking means that the product  complies with all the basic requirements and assessment procedures provided for by the Community  law applying to that product; Whereas it is appropriate that the Member States, as provided for by Article 100a of the Treaty,  may take temporary measures to limit or prohibit the placing on the market and the use of equipment  and protective systems in cases where they present a particular risk to the safety of persons and,  where appropriate, domestic animals or property, provided that the measures are subject to a  Community control procedure; Whereas the recipients of any decision taken as part of this Directive must be aware of the reasons  behind that decision and the means of appeal open to them; Whereas, on 18 December 1985, the Council adopted a framework Directive on electrical equipment for  use in potentially explosive atmospheres (76/117/EEC) (3) and, on 15 February 1982, a Directive  concerning electrical equipment for use in potentially explosive atmospheres in mines susceptible  to fire damp (82/130/EEC) (4); whereas, from the outset of harmonization work, the conversion into  total harmonization of the optional and partial harmonization on which these Directives are based  had been contemplated; whereas this Directive fully covers the scope of the abovementioned  Directives and whereas, therefore, these Directives must be repealed; Whereas the internal market incorporates an area without internal frontiers within which the free  movement of goods, persons, services and capital is assured; Whereas it is necessary to provide for a transitional arrangement enabling equipment manufactured  in compliance with the national regulations in force at the date of adoption of this Directive to  be marketed and placed in service, HAVE ADOPTED THIS DIRECTIVE: CHAPTER I Scope, placing on the market and freedom of movement Article 1 1. This Directive applies to equipment and protective systems intended for use in potentially  explosive atmospheres. 2. Safety devices, controlling devices and regulating devices intended for use outside potentially  explosive atmospheres but required for or contributing to the safe functioning of equipment and  protective systems with respect to the risks of explosion are also covered by the scope of this  Directive. 3. For the purposes of this Directive, the following definitions shall apply: Equipment and protective systems intended for use in potentially explosive atmospheres (a) 'Equipment' means machines, apparatus, fixed or mobile devices, control components and  instrumentation thereof and detection or prevention systems which, separately or jointly, are  intended for the generation, transfer, storage, measurement, control and conversion of energy for  the processing of material and which are capable of causing an explosion through their own  potential sources of ignition. (b) 'Protective systems' means design units which are intended to halt incipient explosions  immediately and/or to limit the effective range of explosion flames and explosion pressures.  Protective systems may be integrated into equipment or separately placed on the market for use as  autonomous systems. (c) 'Components' means any item essential to the safe functioning of equipment and protective  systems but with no autonomous function. Explosive atmospheres 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. Potentially explosive atmosphere An atmosphere which could become explosive due to local and operational conditions. Equipment groups and categories Equipment group I applies to equipment intended for use in underground parts of mines, and to those  parts of surface installations of such mines, liable to be endangered by firedamp and/or  combustible dust. Equipment group II applies to equipment intended for use in other places liable to be endangered by  explosive atmospheres. The categories of equipment defining the required levels of protection are described in Annex I. Equipment and protective systems may be designed for a particular explosive atmosphere. In this  case, they must be marked accordingly. Intended use The use of equipment, protective systems, and devices referred to in Article 1 (2) in accordance  with the equipment group and category and with all the information supplied by the manufacturer  which is required for the safe functioning of equipment, protective systems and devices. 4. The following are excluded from the scope of this Directive: - medical devices intended for use in a medical environment, - equipment and protective systems where the explosion hazard results exclusively from the presence  of explosive substances or unstable chemical substances, - equipment intended for use in domestic and non-commercial environments where potentially  explosive atmospheres may only rarely be created, solely as a result of the accidental leakage of  fuel gas, - personal protective equipment covered by Directive 89/686/EEC (1), - seagoing vessels and mobile offshore units together with equipment on board such vessels or  units, - means of transport, i.e. vehicles and their trailers intended solely for transporting passengers  by air or by road, rail or water networks, as well as means of transport in so far as such means  are designed for transporting goods by air, by public road or rail networks or by water. Vehicles  intended for use in a potentially explosive atmosphere shall not be excluded, - the equipment covered by Article 223 (1) (b) of the Treaty. Article 2 1. Member States shall take all appropriate measures to ensure that the equipment, protective  systems and devices referred to in Article 1 (2) to which this Directive applies may be placed on  the market and put into service only if, when properly installed and maintained and used for their  intended purpose, they do not endanger the health and safety of persons and, where appropriate,  domestic animals or property. 2. The provisions of this Directive shall not affect Member States' entitlement to lay down, in due  observance of the provisions of the Treaty, such requirements as they may deem necessary to ensure  that persons and, in particular, workers are protected when using the equipment, protective  systems, and devices referred to in Article 1 (2) in question provided that this does not mean that  such equipment, protective systems, or devices are modified in a way not specified in the  Directive. 3. At trade fairs, exhibitions, demonstrations, etc., Member States shall not prevent the showing  of equipment, protective systems, or the devices referred to in Article 1 (2) which do not conform  to the provisions of this Directive, provided that a visible sign clearly indicates that such  equipment, protective systems, and devices referred to in Article 1 (2) do not conform and that  they are not for sale until they have been brought into conformity by the manufacturer or his  authorized representative established in the Community. During demonstrations, adequate safety  measures shall be taken to ensure the protection of persons. Article 3 Equipment, protective systems, and the devices referred to in Article 1 (2) to which this Directive  applies must meet the essential health and safety requirements set out in Annex II which apply to  them, account being taken of their intended use. Article 4 1. Member States shall not prohibit, restrict or impede the placing on the market and putting into  service in their territory of equipment, protective systems, or devices referred to in Article 1  (2) which comply with this Directive. 2. Member States shall not prohibit, restrict or impede the placing on the market of components  which, accompanied by a certificate of conformity as referred to in Article 8 (3), are intended to  be incorporated into equipment or protective systems within the meaning of this Directive. Article 5 1. Member States shall regard as conforming to all the provisions of this Directive, including the  relevant conformity assessment procedures laid down in chapter II: - equipment, protective systems, and devices referred to in Article 1 (2) accompanied by the EC  declaration of conformity referred to in Annex X and bearing the CE marking provided for in Article  10, - the components referred to in Article 4 (2), accompanied by the certificate of conformity  referred to in Article 8 (3). In the absence of harmonized standards, Member States shall take any steps which they deem  necessary to bring to the attention of the parties concerned the existing national technical  standards and specifications regarded as important or relevant to the proper implementation of the  essential health and safety requirements in Annex II. 2. Where a national standard transposing a harmonized standard, the reference for which has been  published in the Official Journal of the European Communities, covers one or more of the essential  health and safety requirements, the equipment, protective system, device referred to in Article 1  (2), or the component referred to in Article 4 (2), constructed in accordance with that standard  shall be presumed to comply with the relevant essential health and safety requirements. Member States shall publish the references of national standards transposing harmonized standards. 3. Member States shall ensure that appropriate measures are taken to enable the social partners to  influence the process of preparing and monitoring the harmonized standards at national level. Article 6 1. Where a Member State or the Commission considers that the harmonized standards referred to in  Article 5 (2) do not entirely satisfy the relevant essential health and safety requirements  referred to in Article 3, the Commission or the Member State concerned shall bring the matter  before the Committee set up under Directive 83/189/EEC, hereinafter referred to as 'the Committee',  giving reasons therefor. The Committee shall deliver an opinion without delay. Upon receipt of the Committee's opinion, the Commission shall inform the Member States whether or  not it is necessary to withdraw those standards from the published information referred to in  Article 5 (2). 2. The Commission may adopt any appropriate measure with a view to ensuring the practical  application in a uniform manner of this Directive in accordance with the procedure laid down in  paragraph 3. 3. The Commission shall be assisted by a Standing Committee, consisting of representatives  appointed by the Member States and chaired by a representative of the Commission. The Standing Committee shall draw up its own rules of procedure. The representative of the Commission shall submit to the Committee a draft of the measures to be  taken. The Committee shall deliver its opinion on the draft, within a time limit which the chairman  may lay down according to the urgency of the matter, if necessary by taking a vote. The opinion shall be recorded in the minutes; in addition, each Member State shall have the right  to ask to have its position recorded in the minutes. The Commission shall take the utmost account of the opinion delivered by the committee. It shall  inform the committee of the manner in which its opinion has been taken into account. 4. The Standing Committee may furthermore examine any question relating to the application of this  Directive and raised by its chairman either on the latter's initiative, or at the request of a  Member State. Article 7 1. Whee a Member State ascertains that equipment, protective systems or devices referred to in  Article 1 (2) bearing the CE conformity marking and used in accordance with their intended use are  liable to endanger the safety of persons and, where appropriate, domestic animals or property, it  shall take all appropriate meaures to withdraw such equipment or protective systems from the  market, to prohibit the placing on the market, putting into service or use thereof, or to restrict  free movement thereof. The Member State shall immediately inform the Commission of any such measure, indicating the  reasons for its decision and, in particular, whether non-conformity is due to: (a) failure to satisfy the essential requirements referred to in Article 3; (b) incorrect application of the standards referred to in Article 5 (2); (c) shortcomings in the standards referred to in Article 5 (2). 2. The Commission shall enter into consultation with the parties concerned without delay. Where the  Commission considers, after this consultation, that the measure is justified, it shall immediately  so inform the Member State which took the initiative and the other Member States. Where the  Commission considers, after this consultation, that the action is unjustified, it shall immediately  so inform the Member State which took the initiative and the manufacturer or his authorized  representative established within the Community. Where the decision referred to in paragraph 1 is  based on a shortcoming in the standards and where the Member State at the origin of the decision  maintains its position, the Commission shall immediately inform the Committee in order to initiate  the procedures referred to in Article 6 (1). 3. Where equipment or a protective system which does not comply bears the CE conformity marking,  the competent Member State shall take appropriate action against the person(s) having affixed the  marking and shall so inform the Commission and the other Member States. 4. The Commission shall ensure that the Member States are kept informed of the progress and outcome  of this procedure. CHAPTER II Conformity assessment procedures Article 8 1. The procedures for assessing the conformity of equipment, including where necessary the devices  referred to in Article 1 (2), shall be as follows: (a) equipment-group I and II, equipment-category M 1 and 1 The manufacturer or his authorized representative established in the Community must, in order to  affix the CE marking, follow the CE type-examination procedure (referred to in Annex III), in  conjunction with: - the procedure relating to production quality assurance (referred to in Annex IV), or - the procedure relating to product verification (referred to in Annex V); (b) Equipment-group I and II, equipment-category M 2 and 2 (i) In the case of internal combustion engines and electrical equipment in these groups and  categories, the manufacturer or his authorized representative established in the Community shall,  in order to affix the CE mark, follow the EC-type examination procedure (referred to in Annex III),  in conjunction with: - the procedure relating to conformity to type referred to in Annex VI, or - the procedure relating to product quality assurance referred to in Annex VII; (ii) in the case of other equipment in these groups and categories, the manufacturer or his  authorized representative established in the Community must, in order to affix the CE mark, follow  the procedure relating to internal control of production (referred to in Annex VIII) and communicate the dossier provided for in Annex VIII, paragraph 3, to a notified body, which shall  acknowledge receipt of it as soon as possible and shall retain it. (c) equipment-group II, equipment-category 3 The manufacturer or his authorized representative established in the Community must, in order to  affix the CE marking, follow the procedure relating to internal control of production referred to n  Annex VIII; (d) equipment-groups I and II In addition to the procedures referred to in paragraph 1(a), (b) and (c), the manufacturer or his  authorized representative established in the Community may also, in order to affix the CE marking,  follow the procedure relating to CE unit verification (referred to in Annex IX). 2. The provisions of 1(a) or 1(d) above shall be used for conformity assessment of autonomous  protective systems. 3. The procedures referred to in paragraph 1 shall be applied in respect of components as referred  to in Article 4 (2), with the exception of the affixing of the CE marking. A certificate shall be  issued by the manufacturer or his authorized representative established in the Community, declaring  the conformity of the components with the provisions of this Directive which apply to them and  stating their characteristics and how they must be incorporated into equipment or protective  systems to assist compliance with the essential requirements applicable to finished equipment or  protective systems. 4. In addition, the manufacturer or his authorized representative established in the Community may,  in order to affix the CE marking, follow the procedure relating to internal control of production  (referred to in Annex VIII) with regard to the safety aspects referred to in point 1.2.7 of Annex  II. 5. Notwithstanding the previous paragraphs, the competent authorities may, on a duly justified  request, authorize the placing on the market and putting into service on the territory of the  Member State concerned of the equipment, protective systems and individual devices referred to in  Article 1 (2) in respect of which the procedures referred to in the previous paragraphs have not  been applied and the use of which is in the interests of protection. 6. Documents and correspondence relating to the procedures referred to in the abovementioned  paragraphs shall be drawn up in one of the official languages of the Member States in which those  procedures are being applied or in a language accepted by the notified body. 7. (a) Where the equipment and protective systems are subject to other Community Directives  covering other aspects which also provide for the affixing of the CE marking referred to in Article  10, that marking shall indicate that the equipment and protective systems are also presumed to  conform with the provisions of those other Directives. (b) However, where one or more of those Directives allow the manufacturer, during a transitional  period, to choose which arrangements to apply, the CE marking shall indicate conformity only with  the Directives applied by the manufacturer. In this case, particulars of the said Directives, as  published in the Official Journal of the European Communities, must be given in the documents,  notices or instructions required by the Directives and accompanying the equipment and protective  systems. Article 9 1. Member States shall notify the Commission and the other Member States of the bodies which they  have appointed to carry out the procedures referred to in Article 8, together with the specific  tasks which these bodies have been appointed to carry out and the identification numbers assigned  to them beforehand by the Commission. The Commission shall publish in the Official Journal of the European Communities a list of the  notified bodies, with their identification numbers and the tasks for which they have been notified.  The Commission shall ensure that this list is kept up to date. 2. Member States shall apply the criteria laid down in Annex XI in assessing the bodies to be  indicated in such notification. Bodies meeting the assessment criteria laid down in the relative  harmonized standards shall be presumed to fulfil those criteria. 3. A Member State which has approved a body must withdraw its notification if it finds that the  body no longer meets the criteria referred to in Annex XI. It shall immediately inform the  Commission and the other Member States accordingly. CHAPTER III CE conformity marking Article 10 1. The CE conformity marking shall consist of the initials 'CE'. The form of the marking to be used  is shown in Annex X. The CE marking shall be followed by the identification number of the notified  body where such body is involved in the production control stage. 2. The CE marking shall be affixed distinctly, visibly, legibly and indelibly to equipment and  protective systems, supplementary to the provisions of point 1.0.5. of Annex II. 3. The affixing of markings on the equipment or protective systems which are likely to deceive  third parties as to the meaning and form of the CE marking shall be prohibited. Any other marking  may be affixed to the equipment or protective systems, provided that the visibility and legibility  of the CE marking is not thereby reduced. Article 11 Without prejudice to Article 7: (a) where a Member State establishes that the CE marking has been incorrectly affixed, the  manufacturer or his authorized representative established within the Community shall be obliged to  make the product conform as regards the provisions concerning the CE marking and to end the  infringement under the conditions imposed by the Member State; (b) in the event of continuing non-conformity, the Member State must take all appropriate measures  to restrict or prohibit the placing on the market of the product in question or to ensure that it  is withdrawn from the market in accordance with the procedures laid down in Article 7. CHAPTER IV Final provisions Article 12 Any decision taken pursuant to this Directive which restricts or prohibits the placing on the  market and/or the putting into service or requires the withdrawal from the market of equipment, a  protective system, or a device referred to in Article 1 (2) shall state the exact grounds on which  it is based. Such a decision shall be notified forthwith to the party concerned, who shall at the  same time be informed of the legal remedies available to him under the laws in force in the Member  State concerned and of the time limits to which such remedies are subject. Article 13 Member States shall ensure that all the parties involved in the application of the Directive are  bound to observe confidentiality in respect of all information obtained in the performance of  carrying out their tasks. This does not affect the obligations of the Member States and of the  notified bodies regarding reciprocal information and the dissemination of warnings. Article 14 1. Directive 76/117/EEC, Directive 79/196/EEC (1) and Directive 82/130/EEC shall be repealed as  from 1 July 2003. 2. EC certificates of conformity to the harmonized standards obtained in accordance with the  procedures laid down in the Directives referred to in paragraph 1 shall continue to be valid until  30 June 2003 unless they expire before that date. Their validity shall continue to be limited to  the harmonized standards indicated in the aforementioned Directives. 3. Member States shall take the necessary action to ensure that the notified bodies which are  responsible pursuant to Article 8 (1) to (4) for the assessment of the conformity of electrical  equipment placed on the market before 1 July 2003 take account of the results of tests and  verifications already carried out under the Directives referred to in paragraph 1. Article 15 1. Member States shall adopt and publish the laws, regulations and administrative provisions  necessary to comply with this Directive before 1 September 1995. They shall forthwith inform the  Commission thereof. The Member States shall apply these measures with effect from 1 March 1996. When Member States adopt the measures referred to in the first subparagraph, they shall contain a  reference to this Directive or shall be accompanied by such reference at the time of their official  publication. The methods of making such reference shall be laid down by Member States. 2. However, Member States shall allow the placing on the market and the putting into service of  equipment and protective systems conforming with the national regulations in force in their  territory at the date of adoption of this Directive for the period until 30 June 2003. Article 16 This Directive is addressed to the Member States. Done at Brussels, 23 March 1994. For the European Parliament The President E. KLEPSCH For the Council The President TH. PANGALOS (1) OJ No C 46, 20. 2. 1992, p. 19. (2) OJ No C 106, 27. 4. 1992, p. 9. (3) OJ No C 136, 4. 6. 1985, p. 1. (1) OJ No L 109, 26. 4. 1983, p. 8. Directive as last amended by Directive 88/182/EEC (OJ No L 81,  26. 3. 1988, p. 75). (2) OJ No L 220, 30. 8. 1993, p. 23. (3) OJ No L 24, 31. 1. 1976, p. 45. Directive as last amended by Directive 90/487/EEC (OJ No L 270,  2. 10. 1990, p. 23). (4) OJ No L 59, 2. 3. 1982, p. 10. (1) OJ No L 399, 30. 12. 1989, p. 18. (1) OJ No L 43, 20. 2. 1979, p. 20. Directive as last amended by Directive 90/487/EEC (OJ No L 270,  2. 10. 1990, p. 23).  ANNEX I CRITERIA DETERMINING THE CLASSIFICATION OF EQUIPMENT-GROUPS INTO CATEGORIES 1.  Equipment-group I (a) Category M 1 comprises equipment designed and, where necessary, equipped with additional  special means of protection to be capable of functioning in conformity with the operational  parameters established by the manufacturer and ensuring a very high level of protection. Equipment in this category is intended for use in underground parts of mines as well as those parts  of surface installations of such mines endangered by firedamp and/or combustible dust. Equipment in this category is required to remain functional, even in the event of rare incidents  relating to equipment, with an explosive atmosphere present, and is characterized by means of  protection such that: - either, in the event of failure of one means of protection, at least an independent second means  provides the requisite level of protection, - or the requisite level of protection is assured in the event of two faults occurring  independently of each other. Equipment in this category must comply with the supplementary requirements referred to in Annex II,  2.0.1. (b) Category M 2 comprises equipment designed to be capable of functioning in conformity with the  operational parameters established by the manufacturer and ensuring a high level of protection. Equipment in this category is intended for use in underground parts of mines as well as those parts  of surface installations of such mines likely to be endangered by firedamp and/or combustible  dust. This equipment is intended to be de-energized in the event of an explosive atmosphere. The means of protection relating to equipment in this category assure the requisite level of  protection during normal operation and also in the case of more severe operating conditions, in  particular those arising from rough handling and changing environmental conditions. Equipment in this category must comply with the supplementary requirements referred to in Annex II,  2.0.2. 2. Equipment-group II (a) Category 1 comprises equipment designed to be capable of functioning in conformity with the  operational parameters established by the manufacturer and ensuring a very high level of  protection. Equipment in this category is intended for use in areas in which explosive atmospheres caused by  mixtures of air and gases, vapours or mists or by air/dust mixtures are present continuously, for  long periods or frequently. Equipment in this category must ensure the requisite level of protection, even in the event of rare  incidents relating to equipment, and is characterized by means of protection such that: - either, in the event of failure of one means of protection, at least an independent second means  provides the requisite level of protection, - or the requisite level of protection is assured in the event of two faults occurring  independently of each other. Equipment in this category must comply with the supplementary requirements referred to in Annex II,  2.1. (b) Category 2 comprises equipment designed to be capable of functioning in conformity with the  operational parameters established by the manufacturer and of ensuring a high level of protection. Equipment in this category is intended for use in areas in which explosive atmospheres caused by  gases, vapours, mists or air/dust mixtures are likely to occur. The means of protection relating to equipment in this category ensure the requisite level of  protection, even in the event of frequently occurring disturbances or equipment faults which  normally have to be taken into account. Equipment in this category must comply with the supplementary requirements referred to in Annex II,  2.2. (c) Category 3 comprises equipment designed to be capable of functioning in conformity with the  operating parameters established by the manufacturer and ensuring a normal level of protection. Equipment in this category is intended for use in areas in which explosive atmospheres caused by  gases, vapours, mists, or air/dust mixtures are unlikely to occur or, if they do occur, are likely  to do so only infrequently and for a short period only. Equipment in this category ensures the requisite level of protection during normal operation. Equipment in this category must comply with the supplementary requirements referred to in Annex II,  2.3.  ANNEX II ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATING TO THE DESIGN AND  CONSTRUCTION OF EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE  ATMOSPHERES Preliminary observations A. Technological knowledge, which can change rapidly, must be taken into account as far as possible  and be utilized immediately. B. For the devices referred to in Article 1 (2), the essential requirements shall apply only in so  far as they are necessary for the safe and reliable functioning and operation of those devices with  respect to the risks of explosion. 1. COMMON REQUIREMENTS FOR EQUIPMENT AND PROTECTIVE SYSTEMS 1.0. General requirements 1.0.1. Principles of integrated explosion safety Equipment and protective systems intended for use in potentially explosive atmospheres must be  designed from the point of view of integrated explosion safety. In this connection, the manufacturer must take measures: - above all, if possible, to prevent the formation of explosive atmospheres which may be produced  or released by equipment and by protective systems themselves, - to prevent the ignition of explosive atmospheres, taking into account the nature of every  electrical and non-electrical source of ignition, - should an explosion nevertheless occur which could directly or indirectly endanger persons and,  as the case may be, domestic animals or property, to halt it immediately and/or to limit the range  of explosion flames and explosion pressures to a sufficient level of safety. 1.0.2. Equipment and protective systems must be designed and manufactured after due analysis of  possible operating faults in order as far as possible to preclude dangerous situations. Any misuse which can reasonably be anticipated must be taken into account. 1.0.3. Special checking and maintenance conditions Equipment and protective systems subject to special checking and maintenance conditions must be  designed and constructed with such conditions in mind. 1.0.4. Surrounding area conditions Equipment and protective systems must be so designed and constructed as to be capable of coping  with actual or foreseeable surrounding area conditions. 1.0.5. Marking All equipment and protective systems must be marked legibly and indelibly with the following  minimum particulars; - name and address of the manufacturer, - CE marking (see Annex X, point A), - designation of series or type, - serial number, if any, - year of construction, - the specific marking of explosion protection >REFERENCE TO A GRAPHIC>followed by the symbol of  the equipment group and category, - for equipment-group II, the letter 'G' (concerning explosive atmospheres caused by gases, vapours  or mists), and/or the letter 'D' (concerning explosive atmospheres caused by dust). Furthermore, where necessary, they must also be marked with all information essential to their safe  use. 1.0.6. Instructions (a) All equipment and protective systems must be accompanied by instructions, including at least  the following particulars: - a recapitulation of the information with which the equipment or protective system is marked,  except for the serial number (see 1.0.5.), together with any appropriate additional information to  facilitate maintenance (e.g. address of the importer, repairer, etc.); - instructions for safe: - putting into service, - use, - assembling and dismantling, - maintenance (servicing and emergency repair), - installation, - adjustment; - where necessary, an indication of the danger areas in front of pressure-relief devices; - where necessary, training instructions; - details which allow a decision to be taken beyond any doubt as to whether an item of equipment in  a specific category or a protective system can be used safely in the intended area under the  expected operating conditions; - electrical and pressure parameters, maximum surface temperatures and other limit values; - where necessary, special conditions of use, including particulars of possible misuse which  experience has shown might occur; - where necessary, the essential chracteristics of tools which may be fitted to the equipment or  protective system. (b) The instructions must be drawn up in one of the Community languages by the manufacturer or his  authorized representative established in the Community. On being put into service, all equipment and protective systems must be accompanied by a  translation of the instructions in the language or languages of the country in which the equipment  or protective system is to be used and by the instructions in the original language. This translation must be made by either the manufacturer or his authorized representative  established in the Community or the person introducing the equipment or protective system into the  language area in question. By way of derogation from this requirement, the maintenance instructions for use by the specialist  personnel employed by the manufacturer or his authorized representative established in the  Community may be drawn up in a single Community language understood by that personnel. (c) The instructions must contain the drawings and diagrams necessary for the putting into service,  maintenance, inspection, checking of correct operation and, where appropriate, repair of the  equipment or protective system, together with all useful instructions, in particular with regard to  safety. (d) Literature describing the equipment or protective system must not contradict the instructions  with regard to safety aspects. 1.1. Selection of materials 1.1.1. The materials used for the construction of equipment and protective systems must not trigger  off an explosion, taking into account foreseeable operational stresses. 1.1.2. Within the limits of the operating conditions laid down by the manufacturer, it must not be  possible for a reaction to take place between the materials used and the constituents of the  potentially explosive atmosphere which could impair explosion protection. 1.1.3. Materials must be so selected that predictable changes in their characteristics and their  compatibility in combination with other materials will not lead to a reduction in the protection  afforded; in particular, due account must be taken of the material's corrosion and wear resistance,  electrical conductivity, impact strength, ageing resistance and the effects of temperature  variations. 1.2. Design and Construction 1.2.1. Equipment and protective systems must be designed and constructed with due regard to  technological knowledge of explosion protection so that they can be safely operated throughout  their foreseeable lifetime. 1.2.2. Components to be incorporated into or used as replacements in equipment and protective  systems must be so designed and constructed that they function safely for their intended purpose of  explosion protection when they are installed in accordance with the manufacturer's instructions.1.2.3. Enclosed structures and prevention of leaks Equipment which may release flammable gases or dusts must wherever possible employ enclosed  structures only. If equipment contains openings or non-tight joints, these must as far as possible be designed in  such a way that developing gases or dusts cannot give rise to explosive atmospheres outside the  equipment. Points where materials are introduced or drawn off must, as far as possible, be designed and  equipped so as to limit escapes of flammable materials during filling or draining. 1.2.4. Dust deposits Equipment and protective systems which are intended to be used in areas exposed to dust must be so  designed that deposit dust on their surfaces is not ignited. In general, dust deposits must be limited where possible. Equipment and protective systems must be  easily cleanable. The surface temperatures of equipment parts must be kept well below the glow temperature of the  deposit dust. The thickness of deposit dust must be taken into consideration and, if appropriate, means must be  taken to limit the temperature in order to prevent a heat build up. 1.2.5. Additional means of protection Equipment and protective systems which may be exposed to certain types of external stresses must be  equipped, where necessary, with additional means of protection. Equipment must withstand relevant stresses, without adverse effect on explosion protection. 1.2.6. Safe opening If equipment and protective systems are in a housing or a locked container forming part of the  explosion protection itself, it must be possible to open such housing or container only with a  special tool or by means of appropriate protection measures. 1.2.7. Protection against other hazards Equipment and protective systems must be so designed and manufactured as to: (a) avoid physical injury or other harm which might be caused by direct or indirect contact; (b) assure that surface temperatures of accessible parts or radiation which would cause a danger,  are not produced; (c) eliminate non-electrical dangers which are revealed by experience; (d) assure that foreseeable conditions of overload shall not give rise to dangerous situations. Where, for equipment and protective systems, the risks referred to in this paragraph are wholly or  partly covered by other Community Directives, this Directive shall not apply or shall cease to  apply in the case of such equipment and protective systems and of such risks upon application of  those specific Directives. 1.2.8. Overloading of equipment Dangerous overloading of equipment must be prevented at the design stage by means of integrated  measurement, regulation and control devices, such as over-current cut-off switches, temperature  limiters, differential pressure switches, flowmeters, time-lag relays, overspeed monitors and/or  similar types of monitoring devices. 1.2.9. Flameproof enclosure systems If parts which can ignite an explosive atmosphere are placed in an enclosure, measures must be  taken to ensure that the enclosure withstands the pressure developed during an internal explosion  of an explosive mixture and prevents the transmission of the explosion to the explosive atmosphere  surrounding the enclosure. 1.3. Potential ignition sources 1.3.1. Hazards arising from different ignition sources Potential ignition sources such as sparks, flames, electric arcs, high surface temperatures,  acoustic energy, optical radiation, electromagnetic waves and other ignition sources must not  occur. 1.3.2. Hazards arising from static electricity Electrostatic charges capable of resulting in dangerous discharges must be prevented by means of  appropriate measures. 1.3.3. Hazards arising from stray electric and leakage currents Stray electric and leakage currents in conductive equipment parts which could result in, for  example, the occurrence of dangerous corrosion, overheating of surfaces or sparks capable of  provoking an ignition must be prevented. 1.3.4. Hazards arising from overheating Overheating caused by friction or impacts occurring, for example, between materials and parts in  contact with each other while rotating or through the intrusion of foreign bodies must, as far as  possible, be prevented at the design stage. 1.3.5. Hazards arising from pressure compensation operations Equipment and protective systems must be so designed or fitted with integrated measuring, control  and regulation devices that pressure compensations arising from them do not generate shock waves or  compressions which may cause ignition. 1.4. Hazards arising from external effects 1.4.1. Equipment and protective systems must be so designed and constructed as to be capable of  performing their intended function in full safety, even in changing environmental conditions and in  the presence of extraneous voltages, humidity, vibrations, contamination and other external  effects, taking into account the limits of the operating conditions established by the  manufacturer. 1.4.2. Equipment parts used must be appropriate to the intended mechanical and thermal stresses and  capable of withstanding attack by existing or foreseeable aggressive substances. 1.5. Requirements in respect of safety-related devices 1.5.1. Safety devices must function independently of any measurement or control devices required  for operation. As far as possible, failure of a safety device must be detected sufficiently rapidly by appropriate  technical means to ensure that there is only very little likelihood that dangerous situations will  occur. For electrical circuits the fail-safe principle is to be applied in general. Safety-related switching must in general directly actuate the relevant control devices without  intermediate software command. 1.5.2. In the event of a safety device failure, equipment and/or protective systems shall, wherever  possible, be secured. 1.5.3. Emergency stop controls of safety devices must, as far as possible, be fitted with restart  lockouts. A new start command may take effect on normal operation only after the restart lockouts  have been intentionally reset. 1.5.4. Control and display units Where control and display units are used, they must be designed in accordance with ergonomic  principles in order to achieve the highest possible level of operating safety with regard to the  risk of explosion. 1.5.5. Requirements in respect of devices with a measuring function for explosion protection. In so far as they relate to equipment used in explosive atmospheres, devices with a measuring  function must be designed and constructed so that they can cope with foreseeable operating  requirements and special conditions of use. 1.5.6. Where necessary, it must be possible to check the reading accuracy and serviceability of  devices with a measuring function. 1.5.7. The design of devices with a measuring function must incorporate a safety factor which  ensures that the alarm threshold lies far enough outside the explosion and/or ignition limits of  the atmospheres to be registered, taking into account, in particular, the operating conditions of  the installation and possible aberrations in the measuring system. 1.5.8. Risks arising from software In the design of software-controlled equipment, protective systems and safety devices, special  account must be taken of the risks arising from faults in the programme. 1.6. Integration of safety requirements relating to the system 1.6.1. 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. 1.6.2. When the emergency shutdown system is actuated, accumulated energy must be dispersed as  quickly and as safely as possible or isolated so that it no longer constitutes a hazard. This does not apply to electrochemically-stored energy. 1.6.3. Hazards arising from power failure Where equipment and protective systems can give rise to a spread of additional risks in the event  of a power failure, it must be possible to maintain them in a safe state of operation independently  of the rest of the installation. 1.6.4. Hazards arising from connections Equipment and protective systems must be fitted with suitable cable and conduit entries. When equipment and protective systems are intended for use in combination with other equipment and  protective systems, the interface must be safe. 1.6.5. Placing of warning devices as parts of equipment Where equipment or protective systems are fitted with detection or alarm devices for monitoring the  occurrence of explosive atmospheres, the necessary instructions must be provided to enable them to  be provided at the appropriate places. 2. SUPPLEMENTARY REQUIREMENTS IN RESPECT OF EQUIPMENT 2.0. Requirements applicable to equipment in category M of equipment-group I 2.0.1. Requirements applicable to equipment in category M 1 of equipment-group I 2.0.1.1. Equipment must be so designed and constructed that sources of ignition do not become  active, even in the event of rare incidents relating to equipment. Equipment must be equipped with means of protection such that: - either, in the event of failure of one means of protection, at least an independent second means  provides the requisite level of protection, - or, the requisite level of protection is ensured in the event of two faults occurring  independently of each other. Where necessary, this equipment must be equipped with additional special means of protection. It must remain functional with an explosive atmosphere present. 2.0.1.2. Where necessary, equipment must be so constructed that no dust can penetrate it. 2.0.1.3. The surface temperatures of equipment parts must be kept clearly below the ignition  temperature of the foreseeable air/dust mixtures in order to prevent the ignition of suspended  dust. 2.0.1.4. Equipment must be so designed that the opening of equipment parts which may be sources of  ignition is possible only under non-active or intrinsically safe conditions. Where it is not  possible to render equipment non-active, the manufacturer must affix a warning label to the opening  part of the equipment. If necessary, equipment must be fitted with appropriate additional interlocking systems. 2.0.2. Requirements applicable to equipment in category M 2 of equipment-group I 2.0.2.1. Equipment must be equipped with means of protection ensuring that sources of ignition do  not become active during normal operation, even under more severe operating conditions, in  particular those arising from rough handling and changing environmental conditions. The equipment is intended to be de-energized in the event of an explosive atmosphere. 2.0.2.2. Equipment must be so designed that the opening of equipment parts which may be sources of  ignition is possible only under non-active conditions or via appropriate interlocking systems.  Where it is not possible to render equipment non-active, the manufacturer must affix a warning  label to the opening part of the equipment. 2.0.2.3. The requirements regarding explosion hazards arising from dust applicable to category M 1  must be applied. 2.1. Requirements applicable to equipment in category 1 of equipment-group II 2.1.1. Explosive atmospheres caused by gases, vapours or hazes 2.1.1.1. Equipment must be so designed and constructed that sources of ignition do not become  active, even in event of rare incidents relating to equipment. It must be equipped with means of protection such that: - either, in the event of failure of one means of protection, at least an independent second means  provides the requisite level of protection, - or, the requisite level of protection is ensured in the event of two faults occurring  independently of each other. 2.1.1.2. For equipment with surfaces which may heat up, measures must be taken to ensure that the  stated maximum surface temperatures are not exceeded even in the most unfavourable circumstances. Temperature rises caused by heat build-ups and chemical reactions must also be taken into account. 2.1.1.3. Equipment must be so designed that the opening of equipment parts which might be sources  of ignition is possible only under non-active or intrinsically safe conditions. Where it is not  possible to render equipment non-active, the manufacturer must affix a warning label to the opening  part of the equipment. If necessary, equipment must be fitted with appropriate additional interlocking systems. 2.1.2. Explosive atmospheres caused by air/dust mixtures 2.1.2.1. Equipment must be so designed and constructed that ignition of air/dust mixtures does not  occur even in the event of rare incidents relating to equipment. It must be equipped with means of protection such that - either, in the event of failure of one means of protection, at least an independent second means  provides the requisite level of protection, - or, the requisite level of protection is ensured in the event of two faults occurring  independently of each other. 2.1.2.2. Where necessary, equipment must be so designed that dust can enter or escape from the  equipment only at specifically designated points. This requirement must also be met by cable entries and connecting pieces. 2.1.2.3. The surface temperatures of equipment parts must be kept well below the ignition  temperature of the foreseeable air/dust mixtures in order to prevent the ignition of suspended  dust. 2.1.2.4. With regard to the safe opening of equipment parts, requirement 2.1.1.3 applies. 2.2. Requirements for category 2 of equipment-group II 2.2.1. Explosive atmospheres caused by gases, vapours or mists 2.2.1.1. Equipment must be so designed and constructed as to prevent ignition sources arising, even  in the event of frequently occurring disturbances or equipment operating faults, which normally  have to be taken into account. 2.2.1.2. Equipment parts must be so designed and constructed that their stated surface temperatures  are not exceeded, even in the case of risks arising from abnormal situations anticipated by the  manufacturer. 2.2.1.3. Equipment must be so designed that the opening of equipment parts which might be sources  of ignition is possible only under non-active conditions or via appropriate interlocking systems.  Where it is not possible to render equipment non-active, the manufacturer must affix a warning  label to the opening part of the equipment. 2.2.2. Explosive atmospheres caused by air/dust mixtures 2.2.2.1. Equipment must be designed and constructed so that ignition of air/dust mixtures is  prevented, even in the event of frequently occurring disturbances or equipment operating faults  which normally have to be taken into account. 2.2.2.2. With regard to surface temperatures, requirement 2.1.2.3 applies. 2.2.2.3. With regard to protection against dust, requirement 2.1.2.2 applies. 2.2.2.4. With regard to the safe opening of equipment parts, requirement 2.2.1.3 applies. 2.3. Requirements applicable to equipment in category 3 of equipment-group II 2.3.1. Explosive atmospheres caused by gases, vapours or mists 2.3.1.1. Equipment must be so designed and constructed as to prevent foreseeable ignition sources  which can occur during normal operation. 2.3.1.2. Surface temperatures must not exceed the stated maximum surface temperatures under  intended operating conditions. Higher temperatures in exceptional circumstances may be allowed only  if the manufacturer adopts special additional protective measures. 2.3.2. Explosive atmospheres caused by air/dust mixtures 2.3.2.1. Equipment must be so designed and constructed that air/dust mixtures cannot be ignited by  foreseeable ignition sources likely to exist during normal operation. 2.3.2.2. With regard to surface temperatures, requirement 2.1.2.3 applies. 2.3.2.3. Equipment, including cable entries and connecting pieces, must be so constructed that,  taking into account the size of its particles, dust can neither develop explosive mixtures with air  nor form dangerous accumulations inside the equipment.3. SUPPLEMENTARY REQUIREMENTS IN RESPECT OF PROTECTIVE SYSTEMS 3.0. General requirements 3.0.1. Protective systems must be dimensioned in such a way as to reduce the effects of an  explosion to a sufficient level of safety. 3.0.2. Protective systems must be designed and capable of being positional in such a way that  explosions are prevented from spreading through dangerous chain reactions or flashover and  incipient explosions do not become detonations. 3.0.3. In the event of a power failure, protective systems must retain their capacity to function  for a period sufficient to avoid a dangerous situation. 3.0.4. Protective systems must not fail due to outside interference. 3.1. Planning and design 3.1.1. Characteristics of materials With regard to the characteristics of materials, the maximum pressure and temperature to be taken  into consideration at the planning stage are the expected pressure during an explosion occurring  under extreme operating conditions and the anticipated heating effect of the flame. 3.1.2. Protective systems designed to resist or contain explosions must be capable of withstanding  the shock wave produced without losing system integrity. 3.1.3. Accessories connected to protective systems must be capable of withstanding the expected  maximum explosion pressure without losing their capacity to function. 3.1.4. The reactions caused by pressure in peripheral equipment and connected pipe-work must be  taken into consideration in the planning and design of protective systems. 3.1.5. Pressure-relief systems If it is likely that stresses on protective systems will exceed their structural strength,  provision must be made in the design for suitable pressure-relief devices which do not endanger  persons in the vicinity. 3.1.6. Explosion suppression systems Explosion suppression systems must be so planned and designed that they react to an incipient  explosion at the earliest possible stage in the event of an incident and counteract it to best  effect, which due regard to the maximum rate of pressure increase and the maximum explosion  pressure. 3.1.7. Explosion decoupling systems Decoupling systems intended to disconnect specific equipment as swiftly as possible in the event of  incipient explosions by means of appropriate devices must be planned and designed so as to remain  proof against the transmission of internal ignition and to retain their mechanical strength under  operating conditions. 3.1.8. Protective systems must be capable of being integrated into a circuit with a suitable alarm  threshold so that, if necessary, there is cessation of product feed and output and shutdown of  equipment parts which can no longer function safely.  ANNEX III MODULE EC-TYPE EXAMINATION 1. This module describes that part of the  procedure by which a notified body ascertains and attests that a specimen representative of the  production envisaged meets the relevant applicable provisions of the Directive. 2. The application for the EC-type examination shall be lodged by the manufacturer or his  authorized representative established within the Community with a notified body of his choice. The application shall include: - the name and address of the manufacturer and, if the application is lodged by the authorized  representative, his name and address in addition; - a written declaration that the same application has not been lodged with any other notified  body; - the technical documentation, as described in point 3. The applicant shall place at the disposal of the notified body a specimen representative of the  production envisaged and hereinafter called 'type'. The notified body may request further specimens  if needed for carrying out the test programme. 3. The technical documentation shall enable the conformity of the product with the requirements of  the Directive to be assessed. It shall, to the extent necessary for such assessment, cover the  design, manufacture and operation of the product and shall to that extent contain: - a general type-description; - design and manufacturing drawings and layouts of components, sub-assemblies, circuits, etc.; - descriptions and explanations necessary for the understanding of said drawings and layouts 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 of the Directive where the standards  referred to in Article 5 have not been applied; - results of design calculations made, examinations carried out, etc.; - test reports. 4. The notified body shall: 4.1. examine the technical documentation, verify that the type has been manufactured in conformity  with the technical documentation and identify the elements which have been designed in accordance  with the relevant provisions of the standards referred to in Article 5, as well as the components  which have been designed without applying the relevant provisions of those standards; 4.2. perform or have performed the appropriate examinations and necessary tests to check whether  the solutions adopted by the manufacturer meet the essential requirements of the Directive where  the standards referred to in Article 5 have not ben applied; 4.3. perform or have performed the appropriate examinations and necessary tests to check whether  these have actually been applied, where the manufacturer has chosen to apply the relevant  standards; 4.4. agree with the applicant the location where the examinations and necessary tests shall be  carried out. 5. Where the type meets the provisions of the Directive, the notified body shall issue an  EC-type-examination certificate to the applicant. The certificate shall contain the name and  address of the manufacturer, conclusions of the examination and the necessary data for  identification of the approved type. A list of the relevant parts of the technical documentation shall be annexed to the certificate and  a copy kept by the notified body. If the manufacturer or his authorized representative established in the Community is denied a type  certification, the notified body shall provide detailed reasons for such denial. Provision shall be made for an appeals procedure. 6. The applicant shall inform the notified body which holds the technical documentation concerning  the EC-type-examination certificate of all modifications to the approved equipment or protective  system which must receive further approval where such changes may effect conformity with the  essential requirements or with the prescribed conditions for use of the product. This further  approval is given in the form of an addition to the original EC-type-examination certificate. 7. Each notified body shall communicate to the other notified bodies the relevant information  concerning the EC-type-examination certificates and additions issued and withdrawn. 8. The other notified bodies may receive copies of the EC-type-examination certificates and/or  their additions. The annexes to the certificates shall be kept at the disposal of the other  notified bodies. 9. The manufacturer or his authorized representative established in the Community shall keep with  the technical documentation copies of EC-type-examination certificates and their additions for a  period ending at least 10 years after the last equipment or protective system was manufactured. Where neither the manufacturer nor his authorized representative is established within the  Community, the obligation to keep the technical documentation available shall be the responsibility  of the person who places the product on the Community market.  ANNEX IV MODULE: PRODUCTION QUALITY ASSURANCE 1. This module describes the procedure  whereby the manufacturer who satisfies the obligations of point 2 ensures and declares that the  products concerned are in conformity with the type as described in the EC-type-examination  certificate and satisfy the requirements of the Directive which apply to them. The manufacturer, or  his authorized representative established in the Community, shall affix the CE marking to each  piece of equipment and draw up a written declaration of conformity. The CE marking shall be  accompanied by the identification number of the notified body responsible for EC monitoring, as  specified in Section 4. 2. The manufacturer shall operate an approved quality system for production, final equipment  inspection and testing as specified in Section 3 and shall be subject to monitoring as specified in  Section 4. 3. Quality system 3.1. The manufacturer shall lodge an application for assessment of his quality system with a  notified body of his choice, for the equipment concerned. The application shall include: - all relevant information for the product category envisaged; - the documentation concerning the quality system; - technical documentation on the approved type and a copy of the EC-type-examination certificate. 3.2. The quality system shall ensure compliance of the equipment with the type as described in the  EC-type-examination certificate and with the requirements of the Directive which apply to them. 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 must permit a consistent interpretation of quality programmes, plans,  manuals and records. It shall contain, in particular, an adequate description of - the quality objectives and the organizational structure, responsibilities and powers of the  management with regard to equipment quality; - the manufacturing, quality control and quality assurance techniques, processes and systematic  actions which will be used; - the examinations and tests which will be carried out before, during and after manufacture and the  frequency with which they will be carried out; - the quality records, such as inspection reports and test data, calibration data, reports on the  qualifications of the personnel concerned, etc.; - the means to monitor the achievement of the required equipment quality and 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 Section 3.2. It shall presume conformity with these requirements in  respect of quality systems which implement the relevant harmonized standard. The auditing team  shall have at least one member with experience of evaluation in the equipment technology concerned.  The evaluation procedure shall include an inspection visit to the manufacturer's premises. The  decision shall be notified to the manufacturer. The notification shall contain the conclusions of  the examination 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 uphold the system so that it remains adequate and efficient. The manufacturer or his authorized representative shall inform the notified body which has approved  the quality system of any intended updating of the quality system. The notified body shall evaluate the modifications proposed and decide whether the amended quality  system will still satisfy the requirements referred to in Section 3.2 or whether a re-assessment is  required. It shall notify its decision to the manufacturer. 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 inspection purposes, allow the notified body access to the  manufacture, inspection, testing and storage premises and shall provide it with all necessary  information, in particular - the quality system documentation - the quality records, such as inspection reports and text data, calibration data, reports on the  qualifications of the personnel concerned, etc. 4.3. The notified body shall periodically carry out audits to ensure that the manufacturer  maintains and applies the quality system and shall provide an audit report to the manufacturer. 4.4. Furthermore, the notified body may pay unexpected visits to the manufacturer. During such  visits, the notified body may carry out tests, or arrange for tests to be carried out, to check  that the quality system is functioning correctly, if necessary. The notified body shall provide the  manufacturer with a visit report and, if a test has taken place, with a test report. 5. The manufacturer shall, for a period ending at least 10 years after the last piece of equipment  was manufactured, keep at the disposal of the national authorities: - the documentation referred to in the second indent of Section 3.1; - the updating referred to in the second paragraph of Section 3.4; - the decisions and reports from the notified body which are referred to in Section 3.4, last  paragraph, Section 4.3 and Secton 4.4. 6. Each notified body shall apprise the other notified bodies of the relevant information  concerning the quality system approvals issued and withdrawn.  ANNEX V MODULE: PRODUCT VERIFICATION 1. This module describes the procedure whereby a  manufacturer or his authorized representative established within the Community checks and attests  that the equipment subject to the provisions of point 3 are in conformity with the type as  described in the EC-type-examination certificate and satisfy the relevant requirements of the  Directive. 2. The manufacturer shall take all measures necessary to ensure that the manufacturing process  guarantees conformity of the equipment with the type as described in the EC-type-examination  certificate and with the requirements of the Directive which apply to them. The manufacturer or his  authorized representative established in the Community shall affix the CE marking to each piece of  equipment and shall draw up a declaration of conformity. 3. The notified body shall carry out the appropriate examinations and tests in order to check the  conformity of the equipment, protective system or device referred to in Article 1 (2), with the  relevant requirements of the Directive, by examining and testing every product as specified in  Section 4. The manufacturer or his authorized representative shall keep a copy of the declaration of  conformity for a period ending at least 10 years after the last piece of equipment was  manufactured. 4. Verification by examination and testing of each piece of equipment. 4.1. All equipment shall be individually examined and appropriate tests as set out in the relevant  standard(s) referred to in Article 5 or equipment tests shall be carried out in order to verify  their conformity with the type as described in the EC-type-examination certificate and the relevant  requirements of the Directive. 4.2. The notified body shall affix or have affixed its identification number to each approved item  of equipment and shall draw up a written certificate of conformity relating to the tests carried  out. 4.3. The manufacturer or his authorized representative shall ensure that he is able to supply the  notified body's certificates of conformity on request.  ANNEX VI MODULE: CONFORMITY TO TYPE 1. This module describes that part of the procedure  whereby the manufacturer or his authorized representative established within the Community ensures  and declares that the equipment in question is in conformity with the type as described in the  EC-type-examination certificate and satisfy the requirements of the Directive applicable to them.  The manufacturer or his authorized representative established within the Community shall affix the  CE marking to each piece of equipment and draw up a written declaration of conformity. 2. The manufacturer shall take all measures necessary to ensure that the manufacturing process  assures compliance of the manufactured equipment or protective systems with the type as described  in the EC-type-examination certificate and with the relevant requirements of the Directive. 3. The manufacturer or his authorized representative shall keep a copy of the declaration of  conformity for a period ending at least 10 years after the last piece of equipment was  manufactured. Where neither the manufacturer nor his authorized representative is established  within the Community, the obligation to keep the technical documentation available shall be the  responsibility of the person who places the equipment or protective system on the Community  market. For each piece of equipment manufactured, tests relating to the anti-explosive protection aspects  of the product shall be carried out by the manufacturer or on his behalf. The tests shall be  carried out under the responsibility of a notified body, chosen by the manufacturer. On the responsibility of the notified body, the manufacturer shall affix the former's  identification number during the manufacturing process.  ANNEX V MODULE: PRODUCT VERIFICATION 1. This module describes the procedure whereby a  manufacturer or his authorized representative established within the Community checks and attests  that the equipment subject to the provisions of point 3 are in conformity with the type as  described in the EC-type-examination certificate and satisfy the relevant requirements of the  Directive. 2. The manufacturer shall take all measures necessary to ensure that the manufacturing process  guarantees conformity of the equipment with the type as described in the EC-type-examination  certificate and with the requirements of the Directive which apply to them. The manufacturer or his  authorized representative established in the Community shall affix the CE marking to each piece of  equipment and shall draw up a declaration of conformity. 3. The notified body shall carry out the appropriate examinations and tests in order to check the  conformity of the equipment, protective system or device referred to in Article 1 (2), with the  relevant requirements of the Directive, by examining and testing every product as specified in  Section 4. The manufacturer or his authorized representative shall keep a copy of the declaration of  conformity for a period ending at least 10 years after the last piece of equipment was  manufactured. 4. Verification by examination and testing of each piece of equipment. 4.1. All equipment shall be individually examined and appropriate tests as set out in the relevant  standard(s) referred to in Article 5 or equipment tests shall be carried out in order to verify  their conformity with the type as described in the EC-type-examination certificate and the relevant  requirements of the Directive. 4.2. The notified body shall affix or have affixed its identification number to each approved item  of equipment and shall draw up a written certificate of conformity relating to the tests carried  out. 4.3. The manufacturer or his authorized representative shall ensure that he is able to supply the  notified body's certificates of conformity on request.  ANNEX VI MODULE: CONFORMITY TO TYPE 1. This module describes that part of the procedure  whereby the manufacturer or his authorized representative established within the Community ensures  and declares that the equipment in question is in conformity with the type as described in the  EC-type-examination certificate and satisfy the requirements of the Directive applicable to them.  The manufacturer or his authorized representative established within the Community shall affix the  CE marking to each piece of equipment and draw up a written declaration of conformity. 2. The manufacturer shall take all measures necessary to ensure that the manufacturing process  assures compliance of the manufactured equipment or protective systems with the type as described  in the EC-type-examination certificate and with the relevant requirements of the Directive. 3. The manufacturer or his authorized representative shall keep a copy of the declaration of  conformity for a period ending at least 10 years after the last piece of equipment was  manufactured. Where neither the manufacturer nor his authorized representative is established  within the Community, the obligation to keep the technical documentation available shall be the  responsibility of the person who places the equipment or protective system on the Community  market. For each piece of equipment manufactured, tests relating to the anti-explosive protection aspects  of the product shall be carried out by the manufacturer or on his behalf. The tests shall be  carried out under the responsibility of a notified body, chosen by the manufacturer. On the responsibility of the notified body, the manufacturer shall affix the former's  identification number during the manufacturing process.  ANNEX VII MODULE: PRODUCT QUALITY ASSURANCE 1. This module describes the procedure  whereby the manufacturer who satisfies the obligations of Section 2 ensures and declares that the  equipment is in conformity with the type as described in the EC-type-examination certificate. The  manufacturer or his authorized representative established within the Community shall affix the CE  marking to each product and draw up a written declaration of conformity. The CE marking shall be  accompanied by the identification number of the notified body responsible for surveillance as  specified in Section 4. 2. The manufacturer shall operate an approved quality system for the final inspection and testing  of equipment as specified in Section 3 below and shall be subject to surveillance as specified in  Section 4 below. 3. Quality system 3.1. The manufacturer shall lodge an application for assessment of his quality system for the  equipment and protective systems, with a notified body of his choice. The application shall include: - all relevant information for the product category envisaged; - documentation on the quality system; - technical documentation on the approved type and a copy of the EC-type-examination certificate. 3.2. Under the quality system, each piece of equipment shall be examined and appropriate tests as  set out in the relevant standard(s) referred to in Article 5 or equivalent tests shall be carried  out in order to ensure its conformity with the relevant requirements of the 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 instruments. This  quality system documentation must permit a consistent interpretation of the quality programmes,  plans, manuals and records. It shall contain, in particular, an adequate description of: - the quality objectives and the organizational structure, responsibilities and powers of the  management with regard to product quality; - the examinations and tests which will be carried out after manufacture; - the means to monitor the effective operation of the quality system; - quality records, such as inspection reports and test data, calibration data, reports on the  qualifications of the personnel concerned, etc. 3.3. The notified body shall assess the quality system to determine whether it satisfies the  requirements referred to in Section 3.2. It shall presume conformity with these requirements in  respect of quality systems which implement the relevant harmonized standard. The auditing team shall have at least one member experienced as an assessor in the product  technology concerned. The assessment procedure shall include an assessment visit to the  manufacturer's premises. The decision shall be notified to the manufacturer. The notification shall contain the conclusions  of the examination and the reasoned assessment decision. 3.4. The manufacturer shall undertake to discharge the obligations arising from the quality system  as approved and to maintain it in an appropriate and efficient manner. The manufacturer or his authorized representative shall inform the notified body which has approved  the quality system of any intended updating of the quality system. The notified body shall evaluate the modifications proposed and decide whether the modified quality  system will still satisfy the requirements referred to in Section 3.2 or whether a re-assessment is  required. It shall notify its decision to the manufacturer. 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 ensure that the manufacturer duly fulfils the obligations  arising out of the approved quality system. 4.2. The manufacturer shall for inspection purposes allow the notified body access to the  inspection, testing and storage premises and shall provide it with all necessary information, in  particular: - quality system documentation; - technical documentation; - quality records, such as inspection reports and test data, calibration data, reports on the  qualifications of the personnel concerned, etc. 4.3. The notified body shall periodically carry out audits to ensure that the manufacturer  maintains and applies the quality system and shall provide an audit report to the manufacturer. 4.4. Furthermore, the notified body may pay unexpected visits to the manufacturer. At the time of  such visits, the notified body may carry out tests or arrange for tests to be carried out in order  to check the proper functioning of the quality system, where necessary; it shall provide the  manufacturer with a visit report and, if a test has been carried out, with a test report. 5. The manufacturer shall, for a period ending at least 10 years after the last piece of equipment  was manufactured, keep at the disposal of the national authorities: - the documentation referred to in the third indent of Section 3.1; - the updating referred to in the second paragraph of Section 3.4; - the decisions and reports from the notified body which are referred to in Section 3.4, last  paragraph, Section 4.3 and Section 4.4. 6. Each notified body shall forward to the other notified bodies the relevant information  concerning the quality system approvals issued and withdrawn.  ANNEX VIII MODUL: INTERNAL CONTROL OF PRODUCTION 1. This module describes the procedure  whereby the manufacturer or his authorized representative established within the Community, who  carries out the obligations laid down in Section 2, ensures and declares that the equipment satisfy  the requirements of the Directive applicable to it. The manufacturer or his authorized  representative established within the Community shall affix the CE marking to each piece of  equipment and draw up a written declaration of conformity. 2. The manufacturer shall establish the technical documentation described in Section 3 and he or  his authorized representative established within the Community shall keep it at the disposal of the  relevant national authorities for inspection purposes for a period ending at least 10 years after  the last piece of equipment was manufactured. Where neither the manufacturer nor his authorized representative is established within the  Community, the obligation to keep the technical documentation available shall be the responsibility  of the person who places the equipment on the Community market. 3. Technical documentation shall enable the conformity of the equipment with the relevant  requirements of the Directive to be assessed. It shall, to the extent necessary for such  assessment, cover the design, manufacture and operation of the product. It shall contain: - a general description of the equipment, - conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits,  etc., - descriptions and explanations necessary for the understanding of said drawings and schemes and  the operation of the equipment, - a list of the standards applied in full or in part, and descriptions of the solutions adopted to  meet the safety aspects of the Directive where the standards have not been applied, - results of design calculations made, examinations carried out, etc., - test reports. 4. The manufacturer or his authorized representative shall keep a copy of the declaration of  conformity with the technical documentation. 5. The manufacturer shall take all measures necessary to ensure that the manufacturing process  guarantees compliance of the manufactured equipment with the technical documentation referred to in  Section 2 and with the requirements of the Directive applicable to such equipment.  ANNEX IX MODULE: UNIT VERIFICATION 1. This module describes the procedure whereby the  manufacturer ensures and declares that the equipment or protective system which has been issued  with the certificate referred to in Section 2 conforms to the requirements of the Directive which  are applicable to it. The manufacturer or his authorized representative in the Community shall  affix the CE marking to the equipment or protective system and draw up a declaration of  conformity. 2. The notified body shall examine the individual equipment or protective system and carry out the  appropriate tests as set out in the relevant standard(s) referred to in Article 5, or equivalent  tests, to ensure its conformity with the relevant requirements of the Directive. The notified body shall affix, or cause to be affixed, its identification number on the approved  equipment or protective system and shall draw up a certificate of conformity concerning the tests  carried out. 3. The aim of the technical documentation is to enable conformity with the requirements of the  Directive to be assessed and the design, manufacture and operation of the equipment or protective  system to be understood. The documentation shall contain: - a general description of the product; - conceptual design and manufacturing drawings and layouts of components, sub-assemblies, circuits,  etc.; - descriptions and explanations necessary for the understanding of said drawings and layouts and  the operation of the equipment or protective system; - 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 the Directive where the standards  referred to in Article 5 have not been applied; - results of design calculations made, examinations carried out, etc.; - test reports.  ANNEX X A. CE Marking The CE conformity marking shall consist of the initials 'CE' taking the following form: >REFERENCE TO A GRAPHIC>If the marking is reduced or enlarged, the proportions given in the above  graduated drawing must be respected. The various components of the CE marking must have substantially the same vertical dimension, which  may not be less than 5 mm. This minimum dimension may be waived for small-scale equipment, protective systems or devices  referred to in Article 1 (2). B. Content of the EC declaration of conformity The EC declaration of conformity must contain the following elements: - the name or identification mark and the address of the manufacturer or his authorized  representative established within the Community; - a description of the equipment, protective system, or device referred to in Article 1 (2); - all relevant provisions fulfilled by the equipment, protective system, or device referred to in  Article 1 (2); - where appropriate, the name, identification number and address of the notified body and the  number of the EC-type-examination certificate; - where appropriate, reference to the harmonized standards; - where appropriate, the standards and technical specifications which have been used; - where appropriate, references to other Community Directives which have been applied; - identification of the signatory who has been empowered to enter into commitments on behalf of the  manufacturer or his authorized representative established within the Community.  ANNEX XI MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER STATES FOR THE NOTIFICATION  OF BODIES 1. The body, its director and the staff responsible for carrying out the verification  tests shall not be the designer, manufacturer, supplier or installer of equipment, protective  systems, or devices referred to in Article 1 (2) which they inspect, nor the authorized  representative of any of these parties. They shall become involved neither directly nor as  authorized representatives in the design, construction, marketing or maintenance of the equipment,  protective systems or devices referred to in Article 1 (2) in question. This does not preclude the  possibility of exchanges of technical information between the manufacturer and the body. 2. The body and its inspection staff shall carry out the verification tests with the highest degree  of professional integrity and technical competence and shall be free from all pressures and  inducements, particularly financial, which may influence their judgement or the results of the  inspection, especially from persons or groups of persons with an interest in the result of  verifications. 3. The body shall have at its disposal the necessary staff and possess the necessary facilities to  enable it to perform properly the administrative and technical tasks connected with verification;  it shall also have access to the equipment required for special verification. 4. The staff responsible for inspection shall have: - sound technical and professional training; - satisfactory knowledge of the requirements of the tests which they carry out and adequate  experience of such tests; - the ability to draw up the certificates, records and reports required to authenticate the  performance of the tests. 5. The impartiality of inspection staff shall be guaranteed. Their remuneration shall not depend on  the number of tests carried out or on the results of such tests. 6. The body shall take out liability insurance unless its liability is assumed by the State in  accordance with national law or the Member State itself is directly responsible for the tests. 7. The staff of the body shall be bound to observe professional secrecy with regard to all  information gained in carrying out its tasks (except vis-à-vis the competent administrative  authorities of the State in which its activities are carried out) under this Directive or any  provision of national law giving effect to it.