1994L0009 — EN — 09.05.1994 — 000.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B DIRECTIVE94/9/ECOFTHEEUROPEANPARLIAMENTANDTHECOUNCIL
of23March1994
on the approximation of the laws of the Member States concerning equipment and protective
systemsintendedforuseinpotentiallyexplosiveatmospheres
(OJ L 100, 19.4.1994, p. 1)
Corrected by:
►C1Corrigendum, OJ L 21, 26.1.2000, p. 42 (94/9/EC)
►C2Corrigendum, OJ L 304, 5.12.2000, p. 19 (94/9/EC)
▼B
DIRECTIVE94/9/ECOFTHEEUROPEANPARLIAMENTAND
THECOUNCIL
of23March1994
ontheapproximationofthelawsoftheMemberStatesconcerning
equipment and protective systems intended for use in potentially
explosiveatmospheres
THE 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 animalsand 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 aregenerally electrical and non-electrical specifications having an effect onthe design and structure of equipment which can be used in potentiallyexplosive atmospheres;
Whereas the requirements to be met by such equipment differ from one
Member State to another in respect of their extent and differinginspection procedures; whereas these differences are, therefore, likely toraise 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 besatisfactorily achieved by the individual Member States; whereas thisDirective 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 Councilresolution 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 MemberStates; whereas that resolution provides that a very large number ofproducts be covered by a single Directive in order to avoid frequentamendments 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 explosiveatmospheres have made positive steps towards protection againstexplosions 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 Directivesis necessary since, more particularly, in an overall context, action mustbe taken to guard against the potential hazards arising from suchequipment. 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 and1994L0009 — EN — 09.05.1994 — 000.001 — 2
(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.
▼B
surface equipment; whereas it is, therefore, absolutely necessary to
cover by a single Directive protective equipment and systems fallingwithin both groups;
Whereas the two groups of equipment referred to above are used in a
large number of commercial and industrial sectors and possessconsiderable 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 equipmentand systems; whereas, in particular, the additional requirements areintended to take account of existing or potential hazards; whereasprotective equipment and systems will, therefore, embody at least one ofthose 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 equipmentand systems; whereas it is essential that manufacturers supply fullinformation; whereas specific, clear marking of said equipment, statingits 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 explosionhazards which derive from a given use and/or types and methods ofinstallation;
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 inorder to take account of both the technology obtaining at the time ofmanufacture 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 protectionagainst explosions — standards relating to the design, manufacture andtesting of equipment, compliance with which enables a product to bepresumed 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 EuropeanCommittee for Standardization (CEN) and the European Committeefor Electrotechnical Standardization (Cenelec) are recognized as thebodies 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 ofthis Directive, a harmonized standard is a technical specification(European Standard or harmonization document) adopted by one orother of those bodies, or by both, at the prompting of the Commissionpursuant 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 appropriatecontribution 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 toestablish procedures applying to the assessment of compliance with thebasic 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 immediateenvironment; whereas, therefore, each category of equipment confor-1994L0009 — EN — 09.05.1994 — 000.001 — 3
(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).
▼B
mity must be supplemented by an adequate procedure or a choice
between several equivalent procedures; whereas the procedures adoptedcomply 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 technicalharmonization Directives(
1);
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 theCommunity 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 orprohibit 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 controlprocedure;
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 explosiveatmospheres (76/117/EEC)(
2) and, on 15 February 1982, a Directive
concerning electrical equipment for use in potentially explosiveatmospheres in mines susceptible to fire damp (82/130/EEC)(
3);
whereas, from the outset of harmonization work, the conversion into
total harmonization of the optional and partial harmonization on whichthese Directives are based had been contemplated; whereas thisDirective fully covers the scope of the abovementioned Directives andwhereas, 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 nationalregulations in force at the date of adoption of this Directive to bemarketed and placed in service,
HAVE ADOPTED THIS DIRECTIVE:
CHAPTER I
Scope,placingonthemarketandfreedomofmovement
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 ofthis Directive.1994L0009 — EN — 09.05.1994 — 000.001 — 4
(1) OJ No L 220, 30. 8. 1993, p. 23.
(2) 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).
(3) OJ No L 59, 2. 3. 1982, p. 10.
▼B
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, ►C1control and
conversion of energy and/or the processing ◄of material and
which are capable of causing an explosion through their ownpotential sources of ignition.
(b)►
C1‘Protective systems’ means devices other than components of
the equipment defined above which are intended to halt incipient
explosions immediately and/or to limit the effective range of an
explosion and which are separately placed on the market for use asautonomous 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 ►
C2in
underground parts of mines, and in 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 onlyrarely 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,1994L0009 — EN — 09.05.1994 — 000.001 — 5
(1) OJ No L 399, 30. 12. 1989, p. 18.
▼B
— means of transport, i.e. vehicles and their trailers intended solely for
transporting passengers by air or by road, rail or water networks, aswell 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 explosiveatmosphere 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 systemsand devices referred to in Article 1 (2)to which this Directive applies may be placed on the market and put intoservice only if, when properly installed and maintained and used fortheir 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 theTreaty, such requirements as they may deem necessary to ensure thatpersons and, in particular, workers are protected when using theequipment, 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 inthe Directive.
3. At trade fairs, exhibitions, demonstrations, etc., Member States
shall not prevent the showing of equipment, protective systems, or thedevices referred to in Article 1 (2) which do not conform to theprovisions 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 havebeen brought into conformity by the manufacturer or his authorizedrepresentative 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, accountbeing 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 complywith this Directive.
2. Member States shall not prohibit, restrict or impede the placing on
the market of components which, ►
C1accompanied by a written
attestation of conformity as referred to in Article 8(3) ◄, are intended
to be incorporated into equipment or protective systems within themeaning of this Directive.
Article 5
1. Member States shall regard as conforming to all the provisions of
this Directive, including the relevant conformity assessment procedureslaid down in chapter II:
— equipment, protective systems, and devices referred to in Article 1
(2) accompanied by the EC declaration of conformity referred to inAnnex 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 parties1994L0009 — EN — 09.05.1994 — 000.001 — 6
▼B
concerned the existing national technical standards and specifications
regarded as important or relevant to the proper implementation of theessential 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 tocomply 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 andmonitoring 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 satisfythe relevant essential health and safety requirements referred to inArticle 3, the Commission or the Member State concerned shall bringthe 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 thisDirective 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 andchaired 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 itsopinion on the draft, within a time limit which the chairman may laydown according to the urgency of the matter, if necessary by taking avote.
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 theminutes.
The Commission shall take the utmost account of the opinion delivered
by the committee. It shall inform the committee of the manner in whichits 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.►
C2When 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 ►
C1shall take all appropriate
measures ◄to withdraw such equipment or protective systems from
the market, to prohibit the placing on the market, putting into service oruse thereof, or to restrict free movement thereof.1994L0009 — EN — 09.05.1994 — 000.001 — 7
▼B
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 informthe Member State which took the initiative and the other Member States.Where the Commission considers, after this consultation, that the actionis 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 inparagraph 1 is based on a shortcoming in the standards and where theMember State at the origin of the decision maintains its position, theCommission shall immediately inform the Committee in order to initiatethe procedures referred to in Article 6 (1).
3.►
C1Where equipment, a protective system or a device referred
to in Article 1(2) 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 theCommission 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
Conformityassessmentprocedures
Article 8
1. The procedures for assessing the conformity of equipment,
including where necessary the devices referred to in Article 1 (2), shallbe 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 CEtype-examination procedure (referred to in Annex III), in conjunc-
tion 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 orhis authorized representative established in the Communityshall, in order to affix the CE mark, follow the EC-typeexamination procedure (referred to in Annex III), in conjunctionwith:
— 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 inthe Community must, in order to affix the CE mark, follow the
procedure relating to internal control of production (referred to
in Annex VIII)
and1994L0009 — EN — 09.05.1994 — 000.001 — 8
▼B
communicate the dossier provided for in Annex VIII, paragraph
3, to a notified body, which shall acknowledge receipt of it assoon 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 theprocedure relating to internal control of production referred to nAnnex 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 inthe Community may also, in order to affix the CE marking, followthe 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 exceptionof the affixing of the CE marking. ►
C1A written attestation 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 themand stating their characteristics and how they must be incorporated intoequipment or protective systems to assist compliance with the essentialrequirements 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 (referredto 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 autho-
rities may, on a duly justified request, authorize the placing on themarket 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 toin the previous paragraphs have not been applied and the use of which isin 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 theofficial languages of the Member States in which those procedures arebeing applied or in a language accepted by the notified body.
7. (a)►
C1Where the equipment, protective systems and devices
referred to in Article 1(2) are ◄subject to other Community
Directives covering other aspects which also provide for theaffixing of the CE marking referred to in Article 10, that markingshall indicate ►
C1that the equipment, protective systems and
devices referred to in Article 1(2) 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 whicharrangements to apply, the CE marking shall indicate conformityonly 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►
C1accompanying the equipment, protective systems and
devices referred to in Article 1(2). ◄
Article 9
1. Member States shall notify the Commission and the other Member
States of the bodies which they have appointed to carry out theprocedures referred to in Article 8, together with the specific tasks which1994L0009 — EN — 09.05.1994 — 000.001 — 9
▼B
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. TheCommission 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 referredto in Annex XI. It shall immediately inform the Commission and the
other Member States accordingly.
CHAPTER III
CEconformitymarking
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
►C1indelibly to equipment, protective systems and devices referred to
in Article 1(2) ◄, supplementary to the provisions of point 1.0.5. of
Annex II.
3. The affixing of ►C1markings on the equipment, protective
systems or devices referred to in Article 1(2) ◄which are likely to
deceive third parties as to the meaning and form of the CE marking shallbe prohibited. Any other marking may be affixed to ►
C1the
equipment, protective systems or devices referred to in Article
1(2)◄, 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 ►C1bring
the product into conformity ◄as regards the provisions concerning
the CE marking and to end the infringement under the conditionsimposed 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 onthe market of the product in question or to ensure that it iswithdrawn from the market in accordance with the procedures laiddown in Article 7.
CHAPTER IV
Finalprovisions
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 whichit is based. Such a decision shall be notified forthwith to the partyconcerned, who shall at the same time be informed of the legal remediesavailable to him under the laws in force in the Member State concernedand of the time limits to which such remedies are subject.1994L0009 — EN — 09.05.1994 — 000.001 — 10
▼B
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 andof the notified bodies regarding reciprocal information and thedissemination 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 downin the Directives referred toin 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) forthe assessment of the conformity of electrical equipment placed on themarket 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 before1 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 MemberStates.
2. However, Member States shall allow the placing on the market and
the putting into service of equipment and protective systems conformingwith the national regulations in force in their territory at the date ofadoption of this Directive for the period until 30 June 2003.
Article 16
This Directive is addressed to the Member States.1994L0009 — EN — 09.05.1994 — 000.001 — 11
(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).
▼B
ANNEX I
CRITERIA DETERMINING THE CLASSIFICATIONOF EQUIPMENT-
GROUPSINTOCATEGORIES
1.Equipment-groupI
(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 2comprises 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-groupII
(a) Category 1 comprises equipment designed to be capable of functioning in
conformity with the operational parameters established by the manufac-
turer 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 2comprises equipment designed to be capable of functioning in
conformity with the operational parameters established by the manufac-
turer 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
►C1are likely to occur occasionally. ◄
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, 2.2.1994L0009 — EN — 09.05.1994 — 000.001 — 12
▼B
(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, 2.3.1994L0009 — EN — 09.05.1994 — 000.001 — 13
▼B
ANNEX II
ESSENTIALHEALTHANDSAFETYREQUIREMENTSRELATINGTO
THEDESIGNANDCONSTRUCTIONOFEQUIPMENTANDPROTEC-
TIVESYSTEMSINTENDEDFORUSEINPOTENTIALLYEXPLOSIVE
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 PROTEC-
TIVE SYSTEMS
1.0.Generalrequirements
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
followed by the
symbol of the equipment group and category,
— for equipment-group II, the letter ‘G’ (concerning explosive atmo-
spheres caused by gases, vapours or mists),
and/orthe letter ‘D’ (concerning explosive atmospheres caused by dust).1994L0009 — EN — 09.05.1994 — 000.001 — 14
▼B
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 tempera-
tures 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.Selectionofmaterials
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 and1994L0009 — EN — 09.05.1994 — 000.001 — 15
▼B
wear resistance, ►C1electrical conductivity, mechanical strength,
ageing resistance ◄and the effects of temperature variations.
1.2.DesignandConstruction
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 ►C1such a way that releases of 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 ►C1so as to limit releases 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 manufac-
tured 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 ►C1foreseeable conditions of overload do 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.1994L0009 — EN — 09.05.1994 — 000.001 — 16
▼B
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.Potentialignitionsources
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.Hazardsarisingfromexternaleffects
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.Requirementsinrespectofsafety-relateddevices
1.5.1. Safety devices must function ►C1independently of any measurement
and/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.
►C1The 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 on1994L0009 — EN — 09.05.1994 — 000.001 — 17
▼B
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.Integrationofsafetyrequirementsrelatingtothesystem
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 EQUIP-
MENT
2.0.RequirementsapplicabletoequipmentincategoryMofequipment-
groupI
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.1994L0009 — EN — 09.05.1994 — 000.001 — 18
▼B
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 awarning 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.Requirementsapplicabletoequipmentincategory1ofequipment-
groupII
2.1.1.►
C1Explosive atmospheres caused by gases, vapours or mists ◄
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.1994L0009 — EN — 09.05.1994 — 000.001 — 19
▼B
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.Requirementsforcategory2ofequipment-groupII
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.Requirementsapplicabletoequipmentincategory3ofequipment-
groupII
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.1994L0009 — EN — 09.05.1994 — 000.001 — 20
▼B
3. SUPPLEMENTARY REQUIREMENTS IN RESPECT OF PROTEC-
TIVE SYSTEMS
3.0.Generalrequirements
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 ►C1capable of being
positioned 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 fora period sufficient to avoid a dangerous situation.
3.0.4. Protective systems must not fail due to outside interference.
3.1.Planninganddesign
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 ►C1to best effect, with 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.1994L0009 — EN — 09.05.1994 — 000.001 — 21
▼B
ANNEX III
MODULEEC-TYPEEXAMINATION
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
provisionsof 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 ►
C1have not been 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.
►C1A list of the significant 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 all1994L0009 — EN — 09.05.1994 — 000.001 — 22
▼B
modifications to the approved equipment or protective system which must
receive further approval ►C1where such changes may affect
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.1994L0009 — EN — 09.05.1994 — 000.001 — 23
▼B
ANNEX IV
MODULE:PRODUCTIONQUALITYASSURANCE
1. This module describes the procedure whereby the manufacturer who satisfies
the obligations of point 2ensures 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 anddraw 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.Qualitysystem
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 require-
ments 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 documen-
tation 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 3.2or 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.1994L0009 — EN — 09.05.1994 — 000.001 — 24
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4.Surveillanceundertheresponsibilityofthenotifiedbody
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 shallprovide it with all necessary information, in particular
— the quality system documentation
— the quality records, ►
C1such 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. 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.1994L0009 — EN — 09.05.1994 — 000.001 — 25
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ANNEX V
MODULE:PRODUCTVERIFICATION
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 require-
ments 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.Verificationbyexaminationandtestingofeachpieceofequipment.
4.1. All equipment shall be individually examined and appropriate tests as set out
in the relevant standard(s) referred to in Article 5 ►C2or equivalent 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 require-
ments 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.1994L0009 — EN — 09.05.1994 — 000.001 — 26
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ANNEX VI
MODULE:CONFORMITYTOTYPE
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 ►C1and satisfies the
requirements of the Directive applicable to it. ◄The manufacturer or his
authorized representative established within the Community shall affix the CEmarking 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 ►
C1manufactured
equipment 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.1994L0009 — EN — 09.05.1994 — 000.001 — 27
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ANNEX VII
MODULE:PRODUCTQUALITYASSURANCE
1. This module describes the procedure whereby the manufacturer who satisfies
the obligations of Section 2ensures 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 beaccompanied 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.Qualitysystem
3.1. The manufacturer shall lodge an application for assessment of his quality
system►
C1for the equipment, 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 ►C1in the form of written policies,
procedures and instructions. ◄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 3.2or 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.Surveillanceundertheresponsibilityofthenotifiedbody
4.1. The purpose of surveillance is to ensure that the manufacturer duly fulfils the
obligations arising out of the approved quality system.1994L0009 — EN — 09.05.1994 — 000.001 — 28
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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.1994L0009 — EN — 09.05.1994 — 000.001 — 29
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ANNEX VIII
MODUL:INTERNALCONTROLOFPRODUCTION
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 ►C1that the
equipment satisfies the requirements ◄of the Directive applicable to it. The
manufacturer or his authorized representative established within the Commu-
nity shall affix the CE marking to each piece of equipment and draw up awritten 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 compo-
nents, 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 2and with the
requirements of the Directive applicable to such equipment.1994L0009 — EN — 09.05.1994 — 000.001 — 30
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ANNEX IX
MODULE:UNITVERIFICATION
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 2conforms 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.1994L0009 — EN — 09.05.1994 — 000.001 — 31
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ANNEX X
A.CEMarking
The CE conformity marking shall consist of the initials ‘CE’ taking the
following form:
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.ContentoftheECdeclarationofconformity
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 representa-
tive established within the Community.1994L0009 — EN — 09.05.1994 — 000.001 — 32
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ANNEX XI
MINIMUMCRITERIATOBETAKENINTOACCOUNTBYMEMBER
STATESFORTHENOTIFICATIONOFBODIES
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-visthe
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.1994L0009 — EN — 09.05.1994 — 000.001 — 33