CE Marking (CE Mark) for Equipment and protective systems intended for use in potentially explosive atmospheres: EU Council Directive of 23 March 1994 (94/9/EC) & Annex I, II, ... XI

Brief Introduction of
Directive 94/9/EC
Equipment and Protective Systems for
Use in Potentially Explosive Atmospheres
& Annex I, II, ... XI

Official Journal L 100 , 19/04/1994 P. 0001 - 0029

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.

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

Article 6

Article 7

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

CHAPTER III
CE conformity marking

Article 10
Article 11

CHAPTER IV
Final provisions

Article 12
Article 13
Article 14
Article 15
Article 16

ANNEX I
CRITERIA DETERMINING THE CLASSIFICATION OF EQUIPMENT-GROUPS INTO CATEGORIES

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

1. COMMON REQUIREMENTS FOR EQUIPMENT AND PROTECTIVE SYSTEMS
2. SUPPLEMENTARY REQUIREMENTS IN RESPECT OF EQUIPMENT
3. SUPPLEMENTARY REQUIREMENTS IN RESPECT OF PROTECTIVE SYSTEMS

ANNEX III
MODULE EC-TYPE EXAMINATION

ANNEX IV
MODULE: PRODUCTION QUALITY ASSURANCE

ANNEX V
MODULE: PRODUCT VERIFICATION

ANNEX VI
MODULE: CONFORMITY TO TYPE

ANNEX V
MODULE: PRODUCT VERIFICATION

ANNEX VI
MODULE: CONFORMITY TO TYPE

ANNEX VII
MODULE: PRODUCT QUALITY ASSURANCE

ANNEX VIII
MODUL: INTERNAL CONTROL OF PRODUCTION

ANNEX IX
MODULE: UNIT VERIFICATION

ANNEX X

A. CE Marking
B. Content of the EC declaration of conformity

ANNEX XI
MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER STATES FOR THE NOTIFICATION OF BODIES

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