1989L0686 — EN — 08.10.1996 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCIL DIRECTIVE
of 21December 1 989
on the approximation of the laws of the Member States relating to personal protective equipment
(89/686/EEC)
(OJ L 399, 30.12.1989, p. 18)
Amended by:
Official Journal
Nopage date
►M1Council Directive 93/68/EEC of 22 July 1993 L 220 1 30.8.1993
►M2Council Directive 93/95/EEC of 29 October 1993 L 276 11 9.11.1993
►M3Directive 96/58/EC of the European Parliament and the Council of 3
September 1996 L 236 44 18.9.1996
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COUNCIL DIRECTIVE
of 21December 1 989
on the approximation of the laws of the Member States relating to
personal protective equipment
(89/686/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission(1),
In cooperation with the European Parliament(2),
Having regard to the opinion of the Economic and Social Committee(3),
Whereas it is necessary to adopt measures with the aim of progressively
establishing the internal market over a period expiring on 31 December1992; whereas the internal market comprises an area without internalfrontiers in which the free movement of goods, persons, services andcapital is guaranteed;
Whereas various Member States have, over recent years, adopted provi-
sions covering numerous items of personal protective equipment with aview in particular tosafeguarding public health, impro ving safety atwork and ensuring user protection;
Whereas these national provisions are often very detailed as regards the
requirements relating tothe design, manufacture, quality level, testingand certification of personal protective equipment with a view to theprotection of individuals against injury and illness;
Whereas, in particular, the national provisions relating to safety at work
make the use of personal protective equipment compulsory; whereasmany requirements oblige employers to make appropriate personalprotective equipment available to their staff in the absence or inade-quacy of priority public protection measures;
Whereas national provisions relating to personal protective equipment
differ significantly from one Member State to another; whereas theymay thus constitute a barrier to trade with direct consequences for thecreation and operation of the common market;
Whereas it is necessary to harmonize these different national provisions
in order to ensure the free movement of these products, without in anyway reducing the valid levels of protection already required in theMember States, and to provide for any necessary increase therein;
Whereas the provisions governing the design and manufacture of
personal protective equipment laid down in this Directive which arefundamental, in particular, toattempts toensure a safer wo rking envir-onment are without prejudice to provisions relating to the use of suchequipment and the organization of the health and safety of workers atthe workplace;
Whereas this Directive defines only the basic requirements to be satis-
fied by personal protective equipment; whereas, in order to facilitateproof of conformity with those basic requirements, it is essential thatharmonized European standards be available relating, in particular, tothe design and manufacture of, and the specifications and test methodsapplicable to, personal protective equipment, since compliance there-with confers on these products a presumption of conformity with theabovementioned basic requirements; whereas such harmonized Euro-pean standards are drawn up by private bodies and must retain the status
(1) OJ NoC 141, 30. 5. 1988, p. 14.
(2) OJ NoC 12, 16. 1. 1989, p. 109,
OJ NoC 304, 4. 12. 1989, p. 29.
(3) OJ NoC 337, 31. 12. 1988, p. 37.
1989L0686 — EN — 08.10.1996 — 001.001 — 3
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of non-mandatory texts; whereas, to this end, the European Committee
for Standardization (CEN) and the European Committee for Electro-technical Standardization (Cenelec) are the competent bodies whichhave been authorized to adopt harmonized standards in accordance withthe general guidelines governing cooperation between the Commissionand those two institutions ratified on 13 November 1984; whereas, forthe purposes of this Directive, a harmonized standard is a textcontaining technical specifications (a European standard or a harmon-ization document) which has been adopted by one or both of theabovementioned bodies at the instigation of the Commission in accord-ance with Council Directive 83/189/EEC of 28 March 1983 layingdown a procedure for the provision of information in the field oftechnical standards and regulations(
1), as amended by Directive 88/
182/EEC (2), and pursuant to the abovementioned general guidelines;
Whereas, pending the adoption of harmonized standards, which will be
very numerous because of the broad scope of application and thepreparation of which within the deadline set for the creation of theinternal market will involve a great deal of work, it would be advisableto maintain, on a transitional basis and subject to the requirements ofthe Treaty, the status quo as regards conformity with existing nationalstandards for personal protective equipment not covered by a harmon-ized standard at the date of adoption of this Directive;
Whereas, given the general and horizontal nature of the role played by
the Standing Committee set up pursuant to Article 5 of Directive83/189/EEC in Community standardization policy and, more particu-larly, its part in the preparation of standardization applications and theoperation of the existing European standardization agreements, thisStanding Committee is especially suited to the task of assisting theCommission in monitoring the conformity of harmonized standardsthroughout the Community;
Whereas compliance with these technical requirements must be moni-
tored in order to ensure adequate user and third-party protection;whereas existing monitoring procedures may differ appreciably fromone Member State to another; whereas, in order to avoid numerouschecks which merely impede the free movement of personal protectiveequipment, provision should be made for the mutual recognition ofinspections conducted by the Member States; whereas, in order tofacilitate such recognition, it is necessary, in particular, to lay downharmonized Community procedures and to harmonize the criteria to betaken into account in selecting the bodies responsible for examination,monitoring and verification;
Whereas the legislative framework should be improved so that both
sides of industry will make an effective and appropriate contribution tothe process of standardization,
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
SCOPE, PLACING ON THE MARKET AND FREE MOVEMENT
Article 1
1. This Directive applies to personal protective equipment, herein-
after referred toas ‘PPE'.
It lays down the conditions governing its placing on the market and free
movement within the Community and the basic safety requirementswhich PPE must satisfy in order to ensure the health protection andsafety of users.
(1) OJ NoL 109, 26. 4. 1983, p. 8.
(2) OJ NoL 81, 26. 3. 1988, p. 75.
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2. For the purposes of this Directive, PPE shall mean any device orappliance designed to be worn or held by an individual for protectionagainst one or more health and safety hazards.
PPE shall alsoco ver:
(a) a unit constituted by several devices or appliances which have been
integrally combined by the manufacturer for the protection of anindividual against one or more potentially simultaneous risks;
(b) a protective device or appliance combined, separably or insepar-
ably, with personal non-protective equipment worn or held by anindividual for the execution of a specific activity;
(c) interchangeable PPE components which are essential to its satisfac-
tory functioning and used exclusively for such equipment.
3. Any system placed on the market in conjunction with PPE for its
connection to another external, additional device shall be regarded as anintegral part of that equipment even if the system is not intended to beworn or held permanently by the user for the entire period of riskexposure.
4. This Directive does not apply to:
— PPE covered by another directive designed to achieve the same
objectives as this Directive with regard to placing on the market,free movement of goods and safety,
— the PPE classes specified in the list of excluded products in Annex I,
independently of the reason for exclusion mentioned in the firstindent.
Article 2
1. Member States shall take all appropriate measures to ensure that
the PPE referred toin Article 1 may be placed o n the market andbrought into service only if it preserves the health and ensures the safetyof users without prejudice to the health or safety of other individuals,domestic animals or goods, when properly maintained and used for itsintended purpose.
2. This Directive shall be without prejudice to the right of Member
States to lay down — in conformity with the Treaty — any require-ments which they consider necessary to ensure user protection, providedthat this does not give rise to modifications to PPE which could result inits non-conformity with the provisions of this Directive.
3. Member States shall not prevent the presentation at trade fairs,
exhibitions and the like of PPE which is not in conformity with theprovisions of this Directive, provided that an appropriate notice isdisplayed drawing attention to this fact and the prohibition on itsacquisition and/or use for any purpose whatsoever until it has beenbrought into conformity by the manufacturer or his representative estab-lished in the Community.
Article 3
The PPE referred toin Article 1 must satisfy the basic health and safety
requirements laid down in Annex II.
Article 4
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1. Member States may not prohibit, restrict or hinder the placing onthe market of PPE or PPE components which comply with the provi-sions of this Directive and which bear the CE marking attesting theirconformity to all the provisions of this Directive, including the certi-fication procedures in Chapter II.
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2. Member States shall not prohibit, restrict or impede the placing onthe market of PPE components which do not bear the ►
M1CE
marking ◄, and which are intended to be incorporated in PPE,
provided that they are not essential to its satisfactory functioning.
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Article 5
1. Member States shall regard as in conformity with the basic
requirements referred toin Article 3 the PPE referred toin Article 8 (3)bearing the ►
M1CE marking ◄with respect towhich the manufac-
turer is able to produce, on demand, the declaration of conformityreferred toin Article 12.
2. Member States shall presume that the PPE referred toin Article 8
(2) satisfies the basic requirements referred toin Article 3 if it bears the►
M1CE marking ◄with respect towhich the manufacturer is able
to produce, on demand, not only the declaration referred to in Article 12but also the certificate issued by the body of which notification has beengiven in accordance with Article 9 attesting to their conformity to therelevant national standards, transposing the harmonized standards,assessed at the EC type examination level in accordance with the firstindent of Article 10 (4) (a) and (b).
Where a manufacturer has not applied or has only partly applied the
harmonized standards or where there are no such standards the certifi-cate issued by the body of which notification has been given must statethe conformity to the basic requirements in accordance with the secondindent of Article 10 (4) (a) and (b).
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4. The Commission shall publish the references of the harmonizedstandards in the Official Journal of the European Communities .
Member States shall publish the references of the national standards
transposing the harmonized standards.
5. Member States shall ensure that by 30 June 1991 appropriate steps
are taken to enable both sides of industry to have an influence atnational level on the process of formulating the harmonized standardsand keeping them under review.
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6. (a) Where the PPE is subject to other Directives concerning other
aspects and which also provide for the affixing of the CEmarking, the latter shall indicate that the PPE is alsopresumed toconform to the provisions of the other Directives.
(b) However, where one or more of these Directives allow the
manufacturer, during a transitional period, to choose whicharrangements to apply, the CE marking shall indicate conformityto the provisions only of those Directives applied by the manu-facturer. In this case, particulars of the Directives applied, aspublished in the Official Journal of the European Communities ,
must be given in the documents, notices or instructions requiredby the Directives and accompanying such PPE.
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Article 6
1. Should a Member State or the Commission consider that the
harmonized standards referred to in Article 5 do not completely satisfythe relevant basic requirements referred to in Article 3, the Commissionor the Member State concerned shall refer the matter to the committeecreated pursuant toDirective 83/189/EEC (
1), setting out its reasons.
The committee shall deliver an opinion without delay.
In the light of the committee’s opinion, the Commission shall notify
Member States of whether or not it is necessary to withdraw thestandards concerned from publications made pursuant to Article 5.
(1) OJ NoL 109, 26. 4. 1983, p. 8.
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2. The Standing Committee set up by Article 6 (2) of Directive
89/392/EEC (1) may be apprised, in accordance with the procedure
described below, of any matter to which the implementation and prac-tical application of this Directive give rise.
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.
Article 7
1. If a Member State discovers that PPE bearing the ►
M1CE
marking ◄and used in accordance with its intended purpose could
compromise the safety of individuals, domestic animals or property, itshall take all necessary measures to remove that equipment from themarket and prohibit the marketing or free movement thereof.
The Member State concerned shall immediately inform the Commission
of such action, indicating the reasons for its decision and, in particular,stating whether non-conformity is due to:
(a) failure toco mply with the basic requirements referred toin Article
3;
(b) the unsatisfactory application of the standards referred to in Article
5;
(c) a shortcoming in the standards referred to in Article 5.
2. The Commission shall initiate discussions with the parties
concerned as soon as possible. If, after such consultation, the Commis-sion decides that the action taken was justified, it shall immediatelyinform the Member State concerned and all the other Member States tothat effect. If, after such consultation, the Commission decides that theaction taken was not justified, it shall immediately inform the MemberState concerned and the manufacturer or his authorized representativeestablished in the Community to that effect. If the decision referred to inparagraph 1 is in response to a shortcoming in the standards, theCommission shall refer the matter to the Committee referred to inArticle 6 (1) if the Member State co ncerned intends toadhere toitsdecision and shall initiate the procedure referred to in Article 6 (2).
3. If PPE which is not in conformity with the relevant requirements
bears the ►
M1CE marking ◄, the Member State concerned shall
take the appropriate measures with regard to those responsible foraffixing the mark and shall inform the Commission and the otherMember States accordingly.
4. The Commission shall ensure that the Member States are kept
informed of the progress and results of the procedure provided for inthis Article.
(1) OJ NoL 183, 29. 6. 1989, p. 9.
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CHAPTER II
CERTIFICATION PROCEDURES
Article 8
1. Before placing a PPE model on the market, the manufacturer or
his authorized representative established in the Community shallassemble the technical documentation referred to in Annex III so thatthis can, if necessary, be submitted to the competent authorities.
2. Prior to the series production of PPE other than those referred to
in paragraph 3, the manufacturer or his authorized representative estab-lished in the Community shall submit a model for EC type-examinationas referred toin Article 10.
3. EC type-examination shall not be required in the case of PPE
models of simple design where the designer assumes the user canhimself assess the level of protection provided against the minimal risksconcerned the effects of which, when they are gradual, can be safelyidentified by the user in good time.
This category shall cover exclusively PPE intended to protect the
wearer against:
— mechanical action whose effects are superficial (gardening gloves,
thimbles, etc.),
— cleaning materials of weak action and easily reversible effects
(gloves affording protection against diluted detergent solutions,etc.),
— risks encountered in the handling of hot components which do not
expose the user to a temperature exceeding 50 °C or to dangerous
impacts (gloves, aprons for professional use, etc.),
— atmospheric agents of a neither exceptional nor extreme nature
(headgear, seasonal clothing, footwear, etc.),
— minor impacts and vibrations which do not affect vital areas of the
body and whose effects cannot cause irreversible lesions (lightanti-scalping helmets, gloves, light footwear, etc.),
— sunlight (sunglasses).
4. Production of PPE shall be subject:
(a) according to the manufacturer’s choice, to one of the two proced-
ures referred to in Article 11 in the case of PPE of complex designintended to protect against mortal danger or against dangers thatmay seriously and irreversibly harm the health, the immediateeffects of which the designer assumes the user cannot identify insufficient time. This category shall cover exclusively:
— filtering respiratory devices for protection against solid and
liquid aerosols or irritant, dangerous, toxic or radiotoxic gases,
— respiratory protection devices providing full insulation from the
atmosphere, including those for use in diving,
— PPE providing only limited protection against chemical attack
or against ionizing radiation,
— emergency equipment for use in high-temperature environments
the effects of which are comparable to those of an air tempera-ture of 100 °C or more and which may or may not be character-
ized by the presence of infra-red radiation, flames or the projec-tion of large amounts of molten material,
— emergency equipment for use in low-temperature environments
the effects of which are comparable to those of an air tempera-ture of -50 °C or less,
— PPE to protect against falls from a height,— PPE against electrical risks and dangerous voltages or that used
as insulation in high-tension work,
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(b) the EC declaration of conformity referred to in Article 12 for all
PPE.
Article 9
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1. Member States shall notify the Commission and the other MemberStates of the bodies which they have appointed to carry out the proced-ures referred toin Article 8 to gether with the specific tasks which thesebodies have been appointed to carry out and the identification numbersassigned to them beforehand by the Commission.
The Commission shall publish in the Official Journal of the European
Communities a list of the notified bodies and their identification
numbers and the tasks for which they have been notified. The Commis-sion shall ensure that this list is kept up to date.
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2. Member States shall apply the criteria laid down in Annex V inassessing the bodies to be indicated in such notification. Bodies meetingthe assessment criteria laid down in the relevant harmonized standardsshall be presumed tofulfil tho se criteria.
3. A Member State shall withdraw its approval from such a body if it
establishes that the latter nolo nger satisfies the criteria referred toinAnnex V. It shall inform the Commission and the other Member Statesof its action forthwith.
EC TYPE-EXAMINATION
Article 10
1. EC type-examination is the procedure whereby the approved
inspection body establishes and certifies that the PPE model in questionsatisfies the relevant provisions of this Directive.
2. Application for EC type-examination shall be made by the manu-
facturer or his authorized representative to a single approved inspectionbody in respect of the model in question. The authorized representativeshall be established in the Community.
3. The application shall comprise:
— the name and address of the manufacturer or his authorized repres-
entative and of the PPE production plant in question,
— the manufacturer’s technical file referred toin Annex III.
It shall be accompanied by the appropriate number of specimens of the
model to be approved.
4. The inspection body of which notification has been given shall
conduct the EC type-examination in accordance with the undermen-tioned procedures:
(a) Examination of the manufacturer’s technical file
— It shall examine the manufacturer’s technical file toestablish its
suitability with respect tothe harmo nized standards referred toin Article 5.
— Where a manufacturer has not applied, or has only partly
applied, the harmonized standards or where there are no suchstandards, the body of which notification has been given mustcheck the suitability of the technical specifications used by themanufacturer with respect tothe basic requirements befo reexamining the manufacturer’s technical file toestablish its suit-ability with respect tothese technical specificatio ns.
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(b) Examination of the model
— When examining the model, the inspection body shall verify
that it has been produced in accordance with the manufacturer’stechnical file and can be used in complete safety for its intendedpurpose.
— It shall conduct the necessary examinations and tests to establish
the conformity of the model with the harmonized standards.
— Where a manufacturer has not applied or has only partly applied
the harmonized standards or where there are no such standardsthe body of which notification has been given shall conduct thenecessary examinations and tests to establish the conformity ofthe model with the technical specifications used by the manu-facturer, subject totheir being suitable with respect tothesebasic requirements.
5. If the model satisfies the relevant provisions, the inspection body
shall draw up an EC type-examination certificate and shall notify theapplicant to this effect. This certificate shall reproduce the findings ofthe examination, indicate any conditions attaching to its issue andincorporate the descriptions and drawings necessary for the identifica-tion of the approved model.
The Commission, the other approved inspection bodies and the other
Member States may obtain a copy of the certificate and, in response to areasoned request, a copy of the manufacturer’s technical file and thereports of the examinations and tests conducted.
The file shall be held at the disposal of the competent authorities for 10
years following the placing of the PPE on the market.
6. Any inspection body which refuses to issue an EC type-exam-
ination certificate shall inform the other approved inspection bodies ofthis fact. An inspection body withdrawing an EC type-examinationcertificate shall inform the Member State which approved it, to thiseffect. That Member State shall then inform the other Member Statesand the Commission, setting out the reasons for the decision.
CHECKING OF PPE MANUFACTURED
Article 11
A.‘EC' quality control system for the final product
1. A manufacturer shall take all steps necessary toensure that the
manufacturing process, including the final inspection of PPE and tests,ensures the homogeneity of production and the conformity of PPE withthe type described in the EC type-approval certificate and with therelevant basic requirements of this Directive.
2. A body of which notification has been given, chosen by a manu-
facturer, shall carry out the necessary checks. Those checks shall becarried out at random, normally at intervals of at least one year.
3. An adequate sample of PPE taken by the body of which noti-
fication has been given shall be examined and appropriate tests definedin the harmonized standards or necessary to show conformity to thebasic requirements of this Directive shall be carried out to check theconformity of PPE.
4. Where a body is not the body that issued the relevant EC type-
approval certificate it shall contact the body of which notification hasbeen given in the event of difficulties in connection with the assessmentof the conformity of samples.
5. The body of which notification has been given shall provide the
manufacturer with a test report. If the report concludes that productionis not homogeneous or that the PPE examined do not conform to thetype described in the EC type-approval certificate or the relevant basicrequirements, the body shall take measures appropriate to the nature of
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the fault or faults recorded and inform the Member State which gavenotification thereof accordingly.
6. The manufacturer must be able to present, on request, the report of
the body of which notification has been given.
B.System for ensuring EC quality of production by means of
monitoring
1.The system
(a) Under this procedure the manufacturer submits an application for
the approval of his quality-control system to a body of whichnotification has been given, of his choice.
That application shall include:
— all the information relating to the category of PPE concerned,
including, where appropriate, documentation relating to themodel approved,
— documentation on the quality-control system,— the undertaking to maintain the obligations arising from the
quality-control system and to maintain its adequacy and effi-ciency.
(b) Under the quality-control system, each PPE shall be examined and
the appropriate tests referred to in Section A paragraph 3 shall becarried out to check their conformity to the relevant basic require-ments of this Directive.
The documentation on the quality-control system shall in particular
include an adequate description of:
— the quality objectives, the organization chart, the responsibilities
of executives and their powers in respect of product quality,
— the checks and tests which must be carried out after manufac-
ture,
— the means to be employed to check the efficient operation of the
quality-control system.
(c) The body shall assess the quality-control system to determine
whether it satisfies the provisions referred to in paragraph 1 (b). Itshall assume that quality-control systems applying the relevantharmonized standard satisfy those provisions.
The body carrying out audits shall make all necessary objective
evaluations of the components of the quality-control system andshall check in particular whether the system ensures conformity ofPPE manufactured with the approved model.
The decision shall be communicated to the manufacturer. It shall
include the conclusions of the check and the reasoned assessmentdecision.
(d) The manufacturer shall inform the body which approved the
quality-control system of any plan to alter the quality-controlsystem.
The body shall examine the proposed changes and decide whether
the altered quality-control system satisfies the relevant provisions. Itshall communicate its decision to the manufacturer. The communi-cation shall include the conclusions of the check and the reasonedassessment decision.
2.Supervision
(a) The purpose of supervision is to ensure that a manufacturer
correctly fulfils the obligations arising from the approved quality-control system.
(b) The manufacturer shall authorize the body to have access, for
purposes of inspection, to PPE inspection, testing and storage sitesand shall provide the body with all requisite information, in partic-ular:
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documentation on the quality-control system,
technical documentation,quality control manuals.
(c) The body shall periodically carry out audits to ensure that the
manufacturer is maintaining and applying the approved quality-control system and shall provide the manufacturer with a copy ofthe audit report.
(d) In addition, the body may make unannounced visits to the manufac-
turer. In the course of such visits the body shall provide the manu-facturer with a report of the visit and, if appropriate, with an auditreport.
(e) The manufacturer must be able to present, on request, the report of
the body of which notification has been given.
EC DECLARATION OF PRODUCTION CONFORMITY
Article 12
►
M1The EC declaration of conformity is the procedure whereby the
manufacturer or his authorized representative established within theCommunity: ◄
1. draws up a declaration using the form laid down in Annex VI
certifying that the PPE placed on the market are in conformity withthe provisions of this Directive with a view to its submission to thecompetent authorities;
2. affixes the ►
M1CE marking ◄of conformity provided for by
Article 13 toeach PPE.
CHAPTER III
►M1CE MARKING ◄
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Article 13
1. The CE conformity marking shall consist of the initials ‘CE'inthe
form shown in the specimen in Annex IV. In the event of the involve-ment of a notified body in the production control phase as indicated inArticle 11, its identification number shall be added.
2. The CE marking must be affixed toeach piece o f manufactured
PPE soas tobe visible, legible and indelible thro ugho ut the expectedlife of the PPE; however, if this is not possible in view of the character-istics of the product, the CE marking may be affixed to the packaging.
3. The affixing of markings on the PPE which are likely to deceive
third parties as to the meaning and form of the CE marking shall beprohibited. Any other marking may be affixed to the PPE or its pack-aging provided that the visibility and legibility of the CE marking is notthereby reduced.
4. Without prejudice to Article 7:
(a) where a Member State establishes that the CE marking has been
affixed unduly, the manufacturer or his authorized representativeestablished within the Community shall be obliged to make theproduct conform as regards the provisions concerning the CEmarking and to end the infringement under the conditions imposedby the Member State;
(b) where non-conformity continues, the Member State must take all
appropriate measures to restrict or prohibit the placing on themarket of the product in question or to ensure that it is withdrawnfrom the market in accordance with the procedures laid down inArticle 7.
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CHAPTER IV
FINAL PROVISIONS
Article 14
Any decision taken in implementation of this Directive and leading to
restrictions on the marketing of PPE shall be accompanied by a detailedexplanation of the grounds on which it is based. The interested partyshall be notified of the decision without delay and informed of thepossibilities for appeal under the legislation in force in the MemberState concerned and of the deadlines for lodging such appeals.
Article 15
The Commission shall take the necessary steps to ensure that data
concerning all the relevant decisions in connection with the manage-ment of this Directive are made available.
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Article 16
1. Before 31 December 1991, Member States shall adopt and publish
the laws, regulations and administrative provisions necessary in order tocomply with this Directive. They shall forthwith inform the Commis-sion thereof.
They shall apply the measures in question with effect from 1 July 1992.2. Furthermore, Member States shall allow, for the period until 30
June 1995, the placing on the market and putting into service on PPE inconformity with the national regulations in force in their territory on 30June 1992.
3. Member States shall communicate to the Commission the texts of
the provisions of national law which they adopt in the field governed bythis Directive.
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Article 17
This Directive is addressed tothe Member States.
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ANNEX I
EXHAUSTIVE LIST OF PPE CLASSES NOT COVERED BY THIS
DIRECTIVE
1. PPE designed and manufactured specifically for use by the armed forces or in
the maintenance of law and order (helmets, shields, etc.).
2. PPE for self-defence (aerosol canisters, personal deterrent weapons, etc.).3. PPE designed and manufactured for private use against:
— adverse atmospheric conditions (headgear, seasonal clothing, footwear,
umbrellas, etc.),
— damp and water (dish-washing gloves, etc.),— heat (gloves etc.).
4. PPE intended for the protection or rescue of persons on vessels or aircraft, not
worn all the time.
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5. Helmets and visors intended for users of two- or three-wheeled motor
vehicles.
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ANNEX II
BASIC HEALTH AND SAFETY REQUIREMENTS
1. GENERAL REQUIREMENTS APPLICABLE TO ALL PPE
PPE must provide adequate protection against all risks encountered.
1.1.Design principles
1.1.1. Ergonomics
PPE must be sodesigned and manufactured that in the fo reseeable
conditions of use for which it is intended the user can perform therisk-related activity normally whilst enjoying appropriate protection ofthe highest possible level.
1.1.2. Levels and classes of protection
1.1.2.1.Highest level of protection possible
The optimum level of protection to be taken into account in the design is
that beyond which the constraints imposed by the wearing of the PPEwould prevent its effective use during the period of exposure to the riskor normal performance of the activity.
1.1.2.2.Classes of protection appropriate to different levels of
risk
Where differing foreseeable conditions of use are such that several
levels of the same risk can be distinguished, appropriate classes ofprotection must be taken into account in the design of the PPE.
1.2.Innocuousness of PPE
1.2.1. Absence of risks and other ‘inherent'nuisance factors
PPE must be sodesigned and manufactured as topreclude risks and
other nuisance factors under foreseeable conditions of use.
1.2.1.1.Suitable constituent materials
PPE materials and parts, including any of their decomposition products,
must not adversely affect user hygiene or health.
1.2.1.2.Satisfactory surface condition of all PPE parts in contact
with the user
Any PPE part in contact or in potential contact with the user when such
equipment is worn must be free of roughness, sharp edges, projectionsand the like which could cause excessive irritation or injuries.
1.2.1.3.Maximum permissible user impediment
Any inpediment caused by PPE tomo vements tobe made, po stures to
be adopted and sensory perception must be minimized; nor must PPEcause movements which endanger the user or other persons.
1.3.Comfort and efficiency
1.3.1. Adaptation of PPE to user morphology
PPE must be sodesigned and manufactured as tofacilitate co rrect
positioning on the user and to remain in place for the foreseeable periodof use, bearing in mind ambient factors, movements to be made andpostures to be adopted. For this purpose, it must be possible to optimizePPE adaptation to user morphology by all appropriate means, such asadequate adjustment and attachment systems or the provision of anadequate size range.
1.3.2. Lightness and design strength
PPE must be as light as possible without prejudicing design strength and
efficiency.
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Apart from the specific additional requirements which they must satisfy
in order to provide adequate protection against the risks in question (see3), PPE must be capable of withstanding the effects of ambientphenomena inherent under the foreseeable conditions of use.
1.3.3. Compatibilityof different classes or ty pes of PPE designed for simulta-
neous use
If the same manufacturer markets several PPE models of different
classes or types in order to ensure the simultaneous protection of adja-cent parts of the body against combined risks, these must be compatible.
1.4.Information supplied by the manufacturer
In addition to the name and address of the manufacturer and/or his
authorized representative established in the Community, the notes thatmust be drawn up by the former and supplied when PPE is placed on themarket must contain all relevant information on:
(a) storage, use, cleaning, maintenance, servicing and disinfection.
Cleaning, maintenance or disinfectant products recommended bymanufacturers must have no adverse effect on PPE or users whenapplied in accordance with the relevant instructions;
(b) performance as recorded during technical tests to check the levels or
classes of protection provided by the PPE in question;
(c) suitable PPE accessories and the characteristics of appropriate spare
parts;
(d) the classes of protection appropriate to different levels of risk and
the corresponding limits of use;
(e) the obsolescence deadline or period of obsolescence of PPE or
certain of its components;
(f) the type of packaging suitable for transport;
(g) the significance of any markings (see 2.12).
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(h) where appropriate, the references of the Directives applied in
accordance with Article 5 (6) (b);
(i) the name, address and identification number of the notified body
involved in the design stage of the PPE.
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These notes, which must be precise and comprehensible, must be
provided at least in the official language(s) of the Member State ofdestination.
2. ADDITIONAL REQUIREMENTS COMMON TO SEVERAL
CLASSES OR TYPES OF PPE
2.1.PPE incorporating adjustment systems
If PPE incorporates adjustment systems, the latter must be so designed
and manufactured as not to become incorrectly adjusted without theuser’s knowledge under the foreseeable conditions of use.
2.2.PPE ‘enclosing' the parts of the body to be protected
As far as possible, PPE ‘enclosing'the parts of the body to be protected
must be sufficiently ventilated to limit perspiration resulting from use; ifthis is not the case, it must if possible be equipped with devices whichabsorb perspiration.
2.3.PPE for the face, eyes and respiratory tracts
Any restriction of the user’s field of vision or sight by PPE for the face,
eyes or respiratory tract must be minimized.
The degree of optical neutrality of the vision systems of these PPE
classes must be compatible with the type of relatively meticulous and/orprolonged activities of the user.
If necessary, they must be treated or provided with facilities to prevent
moisture formation.
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PPE models intended for users requiring sight correction must be
compatible with the wearing of spectacles or contact lenses.
2.4.PPE subject to ageing
If it is known that the design performances of new PPE may be signifi-
cantly affected by ageing, the date of manufacture and/or, if possible,the date of obsolescence, must be indelibly inscribed on every PPE itemor interchangeable component placed on the market in such a way as topreclude any misinterpretation; this information must also be indeliblyinscribed on the packaging.
If a manufacturer is unable togive an undertaking with regard tothe
useful life of PPE, his notes must provide all the information necessaryto enable the purchaser or user to establish a reasonable obsolescencedate, bearing in mind the quality level of the model and the effectiveconditions of storage, use, cleaning, servicing and maintenance.
Where appreciable and rapid deterioration in PPE performance is likely
to be caused by ageing resulting from the periodic use of a cleaningprocess recommended by the manufacturer, the latter must, if possible,affix a mark to each item of PPE placed on the market indicating themaximum number of cleaning operations that may be carried out beforethe equipment needs tobe inspected o r discarded; failing that, themanufacturer must give this information in his notes.
2.5.PPE which may be caught up during use
Where the foreseeable conditions of use include in particular the risk of
the PPE being caught up by a moving object thereby creating a dangerfor the user, the PPE must possess an appropriate resistance thresholdabove which a constituent part will break and eliminate the danger.
2.6.PPE for use in explosive atmospheres
PPE intended for use in explosive atmospheres must be so designed and
manufactured that it cannot be the source of an electric, electrostatic orimpact-induced arc or spark likely to cause an explosive mixture toignite.
2.7.PPE intended for emergency use or rapid installation and/or
removal
These PPE classes must be sodesigned and manufactured as tomini-
mize the time required for attachment and (or) removal.
Any integral systems permitting correct positioning on, or removal from,
the user must be susceptible of rapid and easy operation.
2.8.PPE for use in very dangerous situations
The information notes supplied by the manufacturer together with PPE
for use in the very dangerous situations referred to in Article 8 (4) (a)must include, in particular, data intended for the exclusive use ofco mpetent trained individuals whoare qualified tointerpret them andensure their application by the user.
They must also describe the procedure to be adopted in order to verify
that PPE is correctly adjusted and functional when worn by the user.
If PPE incorporates an alarm which is activated in the absence of the
level of protection normally provided, this must be so designed andaccommodated as to be perceived by the user in the conditions of usefor which the PPE is marketed.
2.9.PPE incorporating components which can be adjusted or removed
by the user
Any PPE components which can be adjusted or removed by the user for
the purpose of replacement must be so designed and manufactured as tofacilitate adjustment, attachment and removal without tools.
2.10.PPE for connection to another, external complementary device
If PPE incorporates a system permitting connection to another, comple-
mentary, device, the attachment mechanism must be sodesigned andmanufactured as to enable it to be mounted only on appropriate equip-ment.
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2.11.PPE incorporating a fluid circulation system
If PPE incorporates a fluid circulation system, the latter must be so
chosen, or designed, and incorporated as to permit adequate fluidrenewal in the vicinity of the entire part of the body to be protected,irrespective of user gestures, posture or movement under the foreseeableconditions of use.
2.12.PPE bearing one or more identification or recognition marks
directly or indirectly relating to health and safety
The identification or recognition marks directly or indirectly relating to
health and safety affixed to these types or classes of PPE must prefer-ably take the form of harmonized pictograms or ideograms and mustremain perfectly legible throughout the foreseeable useful life of thePPE. In addition, these marks must be complete, precise and comprehen-sible soas toprevent any misinterpretatio n; in particular, when suchmarks incorporate words or sentences, the latter must appear in theofficial language(s) of the Member State where the equipment is to beused.
If PPE (or a PPE component) is too small to allow all or part of the
necessary marking to be affixed, the relevant information must bementioned on the packing and in the manufacturer’s notes.
2.13.PPE in the form of clothing capable of signalling the user’s presence
visually
PPE in the form of clothing intended for foreseeable conditions of use in
which the user’s presence must be visibly and individually signalledmust have one (or more) judiciously positioned means of or devices foremitting direct or reflected visible radiation of appropriate luminousintensity and photometric and colorimetric properties.
2.14.‘Multi-risk' PPE
All PPE designed to protect the user against several potentially simulta-
neo us risks must be sodesigned and manufactured as tosatisfy, inparticular, the basic requirements specific to each of those risks (see 3).
3. ADDITIONAL REQUIREMENTS SPECIFIC TO PARTICULAR
RISKS
3.1.Protection against mechanical impact
3.1.1. Impact caused byfalling or projecting objects and collision of parts of
the bodywith an obstacle
Suitable PPE for this type of risk must be sufficiently shock-absorbent
to prevent injury resulting, in particular, from the crushing or penetra-tion of the protected part, at least up to an impact-energy level abovewhich the excessive dimensions or mass of the absorbing device wouldpreclude effective use of the PPE for the foreseeable period of wear.
3.1.2. Falls
3.1.2.1.Prevention of falls due to slipping
The outsoles for footwear designed to prevent slipping must be so
designed, manufactured or equipped with added elements as to ensuresatisfactory adhesion by grip and friction having regard to the nature orstate of the surface.
3.1.2.2.Prevention of falls from a height
PPE designed to prevent falls from a height or their effects must
incorporate a body harness and an attachment system which can beconnected to a reliable anchorage point. It must be designed so thatunder the foreseeable conditions of use the vertical drop of the user isminimized to prevent collision with obstacles and the braking force doesnot, however, attain the threshold value at which physical injury or thetearing or rupture of any PPE component which might cause the user tofall can be expected too ccur.
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It must alsoensure that after braking the user is maintained in a co rrect
position in which he may await help if necessary.
The manufacturer’s notes must specify in particular all relevant informa-
tion relating to:
— the characteristics required for the reliable anchorage point and the
necessary minimum clearance below the user,
— the proper way of putting on the body harness and of connecting the
attachment system to the reliable anchorage point.
3.1.3. Mechanical vibration
PPE designed to prevent the effects of mechanical vibrations must be
capable of ensuring adequate attenuation of harmful vibration compo-nents for the part of the body at risk.
Under no circumstances must the effective value of the accelerations
transmitted to the user by those vibrations exceed the limit valuesrecommended in the light of the maximum foreseeable daily exposure ofthe part of the body at risk.
3.2.Protection against (static) compression of part of the body
PPE designed to protect part of the body against (static) compressive
stress must be sufficiently capable of attenuating its effects to preventserious injury or chronic complaints.
3.3.Protection against physical injury (abrasion, perforation, cuts, bites)
PPE constituent materials and other components designed to protect all
or part of the body against superficial injury caused by machinery, suchas abrasion, perforation, cuts or bites, must be so chosen or designed andincorporated as to ensure that these PPE classes provide sufficientresistance to abrasion, perforation and gashing (see also 3. 1) under theforeseeable conditions of use.
3.4.Prevention of drowning (lifejackets, armbands and lifesaving suits)
PPE designed to prevent drowning must be capable of returning to the
surface as quickly as possible, without danger to his health, a user whomay be exhausted or unconscious after falling into a liquid medium, andof keeping him afloat in a position which permits breathing whileawaiting help.
PPE may be wholly or partially inherently buoyant or may be inflated
either by gas which can be manually or automatically released or orally.
Under the foreseeable conditions of use:
— PPE must, without prejudice to its satisfactory operation, be capable
of withstanding the effects of impact with the liquid medium and theenvironmental factors inherent in that medium,
— inflatable PPE must be capable of inflating rapidly and fully.
Where particular foreseeable conditions of use so require, certain types
of PPE must also satisfy one or more of the following additionalrequirements:
— it must have all the inflation devices referred to in the second
subparagraph, and/or a light or sound-signalling device,
— it must have a device for hitching and attaching the body so that the
user may be lifted out of the liquid medium,
— it must be suitable for prolonged use throughout the period of
activity exposing the user, possibly dressed, to the risk of falling intothe liquid medium or requiring his immersion in it.
3.4.1. Buoyancy aids
Clothing which will ensure an effective degree of buoyancy, depending
on its foreseeable use, which is safe when worn and which affordspositive support in water. In foreseeable conditions of use, this PPEmust not restrict the user’s freedom of movement but must enable him,in particular, to swim or take action to escape from danger or rescueother persons.
3.5.Protection against the harmful effects of noise
PPE designed to prevent the harmful effects of noise must be capable of
attenuating the latter tosuch an extent that the equivalent so und levelsperceived by the user dono t under any circumstances exceed the daily
1989L0686 — EN — 08.10.1996 — 001.001 — 19
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limit values laid down by Council Directive 86/188/EEC (1)of1 2M a y
1986 on the protection of workers from the risks related to exposure tonoise at work.
All PPE must bear labelling indicating the noise attenuation level and
the value of the comfort index provided by the PPE; should this not bepossible, the labelling must be fixed to the packaging.
3.6.Protection against heat and/or fire
PPE designed to protect all or part of the body against the effects of heat
and/or fire must possess thermal insulation capacity and mechanicalstrength appropriate to foreseeable conditions of use.
3.6.1. PPE constituent materials and other components
Constituent materials and other components suitable for protection
against radiant and convective heat must possess an appropriate coeffi-cient of transmission of incident heat flux and be sufficiently incombust-ible to preclude any risk of spontaneous ignition under the foreseeableconditions of use.
Where the outside of these materials and components must be reflective,
its reflective power must be appropriate to the intensity of the heat fluxdue toradiatio n in the infra-red range.
Materials and other components of equipment intended for brief use in
high-temperature environments and of PPE which may be splashed byhot products such as large quantities of molten material must alsopossess sufficient thermal capacity to retain most of the stored heat untilafter the user has left the danger area and removed his PPE.
PPE materials and other components which may be splashed by large
amounts of hot products must also possess sufficient mechanical-impactabsorbency (see 3.1).
PPE materials and other components which may accidentally come into
contact with flame and those used in the manufacture of fire-fightingequipment must also possess a degree of non-flammability corre-sponding to the risk class associated with the foreseeable conditions ofuse. They must not melt when exposed to flames nor contribute to flamepropagation.
3.6.2. Complete PPE readyfor use
Under the foreseeable conditions of use:
1. the quantity of heat transmitted by PPE to the user must be suffi-
ciently low to prevent the heat accumulated during wear in the partof the body at risk from attaining, under any circumstances, the painor health impairment threshold;
2. PPE must if necessary prevent liquid or steam penetration and must
not cause burns resulting from contact between its protective integu-ment and the user.
If PPE incorporates refrigeration devices for the absorption of incident
heat by means of liquid evaporation or solid sublimation, their designmust be such that any volatile substances released are dischargedbeyond the outer protective integument and not towards the user.
If PPE incorporates a breathing device, the latter must adequately fulfil
the protective function assigned to it under the foreseeable conditions ofuse.
The manufacturer’s notes accompanying each PPE model intended for
brief use in high-temperature environments must in particular provide allrelevant data for the determination of the maximum permissible userexposure to the heat transmitted by the equipment when used in accord-ance with its intended purpose.
3.7.Protection against cold
PPE designed to protect all or part of the body against the effects of cold
must possess thermal insulating capacity and mechanical strength appro-priate to the foreseeable conditions of use for which it is marketed.
(1) OJ NoL 137, 24. 5. 1986, p. 28.
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3.7.1. PPE constituent materials and other components
Constituent materials and other components suitable for protection
against cold must possess a coefficient of transmission of incidentthermal flux as low as required under the foreseeable conditions of use.Flexible materials and other components of PPE intended for use in alow-temperature environment must retain the degree of flexibilityrequired for the necessary gestures and postures.
PPE materials and other components which may be splashed by large
amounts of cold products must also possess sufficient mechanical-impact absorbency (see 3.1).
3.7.2. Complete PPE readyfor use
Under the foreseeable conditions of use:
1. the flux transmitted by PPE tothe user must be sufficiently lo w to
prevent the cold accumulated during wear at any point on the part ofthe body being protected, including the tips of fingers and toes in thecase of hands or feet, from attaining, under any circumstances, thepain or health-impairment threshold;
2. PPE must as far as possible prevent the penetration of such liquids as
rain water and must not cause injuries resulting from contact betweenits cold protective integument and the user.
If PPE incorporates a breathing device, this must adequately fulfil the
protective function assigned to it under the foreseeable conditions ofuse.
The manufacturer’s notes accompanying each PPE model intended for
brief use in low-temperature environments must provide all relevant dataconcerning the maximum permissible user exposure to the cold trans-mitted by the equipment.
3.8.Protection against electric shock
PPE designed to protect all or part of the body against the effects of
electric current must be sufficiently insulated against the voltages towhich the user is likely to be exposed under the most unfavourableforeseeable conditions.
To this end, the constituent materials and other components of these
PPE classes must be so chosen or designed and incorporated as toensure that the leakage current measured through the protective integu-ment under test conditions at voltages correlated with those likely to beencountered in situis minimized and, at all events, below a maximum
conventional permissible value which correlates with the tolerancethreshold.
Together with their packaging, PPE types intended exclusively for use
during work or activities in electrical installations which are or may beunder tension must bear markings indicating, in particular, their protec-tion class and (or) corresponding operating voltage, their serial numberand their date of manufacture; a space must also be provided outside theprotective integument of such PPE for the subsequent inscription of thedate of entry into service and those of the periodic tests or inspections tobe conducted.
The manufacturer’s notes must indicate, in particular, the exclusive use
for which these PPE types are intended and the nature and frequency ofthe dielectric tests towhich they are tobe subjected during their usefullife.
3.9.Radiation protection
3.9.1. Non-ionizing radiation
PPE designed to prevent acute or chronic eye-damage from sources of
non-ionizing radiation must be capable of absorbing or reflecting themajority of the energy radiated in the harmful wavelengths withoutunduly affecting the transmission of the innocuous part of the visiblespectrum, the perception of contrasts and the ability to distinguishcolours where required by the foreseeable conditions of use.
Tothis end, pro tective glasses must be sodesigned and manufactured as
to possess, for each harmful wave, a spectral transmission factor suchthat the radiant-energy illumination density capable of reaching theuser’s eye through the filter is minimized and, under no circumstances,exceeds the maximum permissible exposure value.
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Furthermore, the glasses must not deteriorate or lose their properties as a
result of the effects of radiation emitted under the foreseeable conditonsof use and all marketed specimens must bear the protection-factornumber corresponding to the spectral distribution curve of their trans-mission factor.
Glasses suitable for radiation sources of the same type must be classified
in the ascending order of their protection factors and the manufacturer’snotes must indicate, in particular, the transmission curves which make itpossible to select the most appropriate PPE bearing in mind suchinherent factors of the effective conditions of use as distance to sourceand the spectral distribution of the energy radiated at that distance.
The relevant protection-factor number must be marked on all specimens
of filtering glasses by the manufacturer.
3.9.2. Ionizing radiation
3.9.2.1. Pro tection against external radioactive contamination
PPE constituent materials and other components designed to protect all
or part of the body against radioactive dust, gases, liquids or mixturesthereof must be so chosen or designed and incorporated as to ensure thatthis equipment effectively prevents the penetration of the contaminantsunder the foreseeable conditions of use.
Depending on the nature or condition of these contaminants, the neces-
sary leak-tightness can be provided by the impermeability of the protec-tive integument and/or by any other appropriate means, such as ventila-tion and pressurization systems designed to prevent the back-scatteringof these contaminants.
Any decontamination measures to which PPE is subject must not preju-
dice its possible re-use during the foreseeable useful life of these classesof equipment.
3.9.2.2.Limited protection against external irradiation
PPE intended to provide complete user protection against external irra-
diation or, failing this, adequate attenuation thereof, must be designed tocounter only weak electron (e. g. beta) or weak photon (e. g. X, gamma)radiation.
The constituent materials and other components of these PPE classes
must be so chosen or designed and incorporated as to provide the degreeof user protection required by the foreseeable conditions of use withoutleading to an increase in exposure time as a result of the impedance ofuser gestures, posture or movement (see 1.3.2).
PPE must bear a mark indicating the type and thickness of the constit-
uent material(s) suitable for the foreseeable conditions of use.
3.10.Protection against dangerous substances and infective agents
3.10.1. Respiratoryprotection
PPE intended for the protection of the respiratory tract must make it
possible to supply the user with breathable air when the latter is exposedto a polluted atmosphere and/or an atmosphere having inadequateoxygen concentration.
The breathable air supplied tothe user by the PPE must be o btained by
appropriate means, for example after filtration of the polluted airthrough the protective device or appliance or by a piped supply from anunpolluted source.
The constituent materials and other components of these PPE classes
must be so chosen or designed and incorporated as to ensure appropriateuser respiration and respiratory hygiene for the period of wearconcerned under the foreseeable conditions of use.
The leak-tightness of the facepiece and the pressure drop on inspiration
and, in the case of the filtering devices, purification capacity must besuch as to keep contaminant penetration from a polluted atmosphere lowenough not to be prejudicial to the health or hygiene of the user.
The PPE must bear the manufacturer’s identification mark and details of
the specific characteristics of that type of equipment which, in conjunc-tion with the instructions for use, will enable a trained and qualified userto employ the PPE correctly.
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The manufacturer’s notes must also in the case of filtering devices,
indicate the deadline for the storage of filters as new and kept in theiroriginal packaging.
3.10.2. Protection against cutaneous and ocular contact
PPE intended to prevent the surface contact of all or part of the body
with dangerous substances and infective agents must be capable ofpreventing the penetration or diffusion of such substances through theprotective integument under the foreseeable conditions of use for whichthe PPE is placed on the market.
To this end, the constituent materials and other components of these
PPE classes must be so chosen, or designed and incorporated as toensure, as far as possible, complete leak-tightness, which will allowwhere necessary prolonged daily use or, failing this, limited leak-tight-ness necessitating a restriction of the period of wear.
Where, by virtue of their nature and the foreseeable conditions of their
use, certain dangerous substances or infective agents possess high pene-trative power which limits the duration of the protection provided by thePPE in question, the latter must be subjected to standard tests with aview to their classification on the basis of effeciency. PPE which isconsidered to be in conformity with the test specifications must bear amark indicating, in particular, the names or, failing this, the codes of thesubstances used in the tests and the corresponding standard period ofprotection. The manufacturer’s notes must also contain, in particular, anexplanation of the codes (if necessary), a detailed description of thestandard tests and all appropriate information for the determination ofthe maximum permissible period of wear under the different foreseeableconditions of use.
3.11.Safety devices for diving equipment
1. Breathing equipment
The breathing equipment must make it possible to supply the user
with a breathable gaseous mixture, under foreseeable conditions ofuse and taking account in particular of the maximum depth ofimmersion.
2. Where the foreseeable conditions of use so require, the equipment
must comprise:
(a) a suit which protects the user against the pressure resulting from
the depth of immersion (see 3.2) and/or against cold (see 3.7);
(b) an alarm designed to give the user prompt warning of an
approaching failure in the supply of breathable gaseous mixture(see 2.8);
(c) a life-saving suit enabling the user toreturn tothe surface (see
3.4.1).
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ANNEX III
TECHNICAL DOCUMENTATION SUPPLIED BY THE MANUFAC-
TURER
The documentation referred to in Article 8 (1) must comprise all relevant data on
the means used by the manufacturer toensure that a PPE co mplies with the basicrequirements relating toit.
In the case of PPE models referred to in Article 8 (2), the documentation must
comprise in particular:
1. the manufacturer’s technical file consisting of:
(a) overall and detailed plans of the PPE accompanied, where appropriate, by
calculation notes and the results of prototype tests in so far as necessaryfor the verification of compliance with the basic requirements;
(b) an exhaustive list of the basic safety requirements and of the harmonized
standards or other technical specifications referred to in Articles 3 and 5,taken into account in the design of the model;
2. a description of the control and test facilities to be used in the manufacturer’s
plant to check compliance of production PPE with the harmonized standardsor other technical specifications and to maintain quality level;
3. a copy of the information notice referred to in Annex II, 1.4.
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ANNEX IV
CE CONFORMITY MARKING AND INFORMATION
— The CE conformity marking shall consist of the initials ‘CE' taking the
following form:
— If the CE 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 minimumdimension may be waived for small-scale PPE.
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ANNEX V
CONDITIONS TO BE FULFILLED BY THE BODIES OF WHICH NOTI-
FICATION HAS BEEN GIVEN
(Article 9 (2))
The bodies designated by the Member States must fulfil the following minimum
conditions:
1. availability of personnel and of the necessary means and equipment;2. technical competence and professional integrity of personnel;3. independence, in carrying out the tests, preparing the reports, issuing the
certificates and performing the surveillance provided for in the Directive, ofstaff and technical personnel in relation to all circles, groups or personsdirectly or indirectly concerned with PPE;
4. maintenance of professional secrecy by personnel;5. subscription of a civil liability insurance unless that liability is covered by the
State under national law.
Fulfilment of the conditions under 1 and 2 shall be verified at intervals by the
competent authorities of the Member States.
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ANNEX VI