1989L0686 — EN — 20.11.2003 — 002.003 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

COUNCIL DIRECTIVE►Bof 21 December 1989
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

►M1
►M2
►M3
►M4

Council Directive 93/68/EEC of 22 July 1993
Council Directive 93/95/EEC of 29 October 1993
Directive 96/58/EC of the European Parliament and the Council of 3
September 1996
Regulation (EC) No 1882/2003 of the European Parliament and of theCouncil of 29 September 2003

Corrected by:►C1

Corrigendum, OJ L 328, 14.12.2010, p. 36 (89/686/EEC)

No

page

date

L 220
L 276
L 236

1
11
44

30.8.1993
9.11.1993
18.9.1996

L 284

1

31.10.2003

1989L0686 — EN — 20.11.2003 — 002.003 — 2▼B
COUNCIL DIRECTIVE
of 21 December 1989
on the approximation of the laws of the Member States relating topersonal 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 December
1992; whereas the internal market comprises an area without internal
frontiers in which the free movement of goods, persons, services andcapital is guaranteed;
Whereas various Member States have, over recent years, adopted
provisions covering numerous items of personal protective equipmentwith a view in particular to safeguarding public health, improving safety
at work and ensuring user protection;
Whereas these national provisions are often very detailed as regards therequirements relating to the design, manufacture, quality level, testing
and 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; whereas
many requirements oblige employers to make appropriate personal
protective equipment available to their staff in the absence or inad­equacy of priority public protection measures;
Whereas national provisions relating to personal protective equipment
differ significantly from one Member State to another; whereas they
may 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 any
way reducing the valid levels of protection already required in theMember States, and to provide for any necessary increase therein;(1) OJ No C 141, 30.5.1988, p. 14.
(2) OJ No C 12, 16.1.1989, p. 109,
OJ No C 304, 4.12.1989, p. 29.
(3) OJ No C 337, 31.12.1988, p. 37.

1989L0686 — EN — 20.11.2003 — 002.003 — 3▼B
Whereas the provisions governing the design and manufacture of
personal protective equipment laid down in this Directive which are
fundamental, in particular, to attempts to ensure a safer working
environment are without prejudice to provisions relating to the use ofsuch equipment and the organization of the health and safety of workers
at the workplace;
Whereas this Directive defines only the basic requirements to besatisfied by personal protective equipment; whereas, in order to facilitate
proof of conformity with those basic requirements, it is essential that
harmonized European standards be available relating, in particular, tothe design and manufacture of, and the specifications and test methods
applicable to, personal protective equipment, since compliance therewith
confers on these products a presumption of conformity with the above­
mentioned basic requirements; whereas such harmonized European
standards are drawn up by private bodies and must retain the status
of non-mandatory texts; whereas, to this end, the European
Committee for Standardization (CEN) and the European Committee
for Electrotechnical Standardization (Cenelec) are the competentbodies which have been authorized to adopt harmonized standards inaccordance with the general guidelines governing cooperation between
the Commission and those two institutions ratified on 13 November
1984; whereas, for the purposes of this Directive, a harmonized
standard is a text containing technical specifications (a European
standard or a harmonization document) which has been adopted by
one or both of the abovementioned bodies at the instigation of theCommission in accordance with Council Directive 83/189/EEC of 28
March 1983 laying down a procedure for the provision of informationin the field of technical 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 bevery numerous because of the broad scope of application and the prep­
aration of which within the deadline set for the creation of the internalmarket will involve a great deal of work, it would be advisable tomaintain, on a transitional basis and subject to the requirements of
the Treaty, the status quo as regards conformity with existing national
standards for personal protective equipment not covered by aharmonized 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 Directive
83/189/EEC in Community standardization policy and, moreparticularly, its part in the preparation of standardization applications
and the operation of the existing European standardization agreements,
this Standing Committee is especially suited to the task of assisting theCommission in monitoring the conformity of harmonized standards
throughout the Community;
Whereas compliance with these technical requirements must be
monitored 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 numerous
checks which merely impede the free movement of personal protective
equipment, provision should be made for the mutual recognition of
inspections conducted by the Member States; whereas, in order tofacilitate such recognition, it is necessary, in particular, to lay down
harmonized Community procedures and to harmonize the criteria to
be taken into account in selecting the bodies responsible for exam­
ination, monitoring and verification;(1) OJ No L 109, 26.4.1983, p. 8.
(2) OJ No L 81, 26.3.1988, p. 75.

1989L0686 — EN — 20.11.2003 — 002.003 — 4▼B
Whereas the legislative framework should be improved so that bothsides of industry will make an effective and appropriate contribution
to the process of standardization,

HAS ADOPTED THIS DIRECTIVE:

CHAPTER ISCOPE, PLACING ON THE MARKET AND FREE MOVEMENT

Article 1
1.
This Directive applies to personal protective equipment, here­
inafter referred to as ‘PPE’.
It lays down the conditions governing its placing on the market and freemovement within the Community and the basic safety requirements
which PPE must satisfy in order to ensure the health protection andsafety of users.
2.
For the purposes of this Directive, PPE shall mean any device orappliance designed to be worn or held by an individual for protection
against one or more health and safety hazards.
PPE shall also cover:(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 inseparably,with personal non-protective equipment worn or held by an indi­vidual for the execution of a specific activity;(c) interchangeable PPE components which are essential to its satis­
factory 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 risk
exposure.
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 to in Article 1 may be placed on the market andbrought into service only if it preserves the health and ensures thesafety of users without prejudice to the health or safety of other indi­viduals, domestic animals or goods, when properly maintained and used
for its intended purpose.

1989L0686 — EN — 20.11.2003 — 002.003 — 5▼B
2.
This Directive shall be without prejudice to the right of Member
States to lay down — in conformity with the Treaty — any
requirements which they consider necessary to ensure user protection,
provided that this does not give rise to modifications to PPE which
could result in its 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 its
acquisition and/or use for any purpose whatsoever until it has beenbrought into conformity by the manufacturer or his representative estab­lished in the Community.

Article 3
The PPE referred to in Article 1 must satisfy the basic health and safety
requirements laid down in Annex II.

Article 4▼M1
1.
Member States may not prohibit, restrict or hinder the placing on
the market of PPE or PPE components which comply with theprovisions of this Directive and which bear the CE marking attesting
their conformity to all the provisions of this Directive, including thecertification procedures in Chapter II.

▼B
2.
Member States shall not prohibit, restrict or impede the placing on
the market of PPE components which do not bear the ►M1 CE
marking ◄, and which are intended to be incorporated in PPE,
provided that they are not essential to its satisfactory functioning.

Article 51.
Member States shall regard as in conformity with the basic
requirements referred to in Article 3 the PPE referred to in Article 8(3) bearing the ►M1 CE marking ◄ with respect to which the manu­
facturer is able to produce, on demand, the declaration of conformity
referred to in Article 12.

2.
Member States shall presume that the PPE referred to in Article 8(2) satisfies the basic requirements referred to in Article 3 if it bears the►M1 CE marking ◄ with respect to which the manufacturer is able toproduce, on demand, not only the declaration referred to in Article 12
but also the certificate issued by the body of which notification has been
given 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).

1989L0686 — EN — 20.11.2003 — 002.003 — 6▼B
Where a manufacturer has not applied or has only partly applied theharmonized standards or where there are no such standards thecertificate issued by the body of which notification has been given
must state the conformity to the basic requirements in accordancewith the second indent of Article 10 (4) (a) and (b).

▼M2__________▼B
4.
The Commission shall publish the references of the harmonized
standards 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 standards
and keeping them under review.

▼M1
6. (a) Where the PPE is subject to other Directives concerning otheraspects and which also provide for the affixing of the CE
marking, the latter shall indicate that the PPE is alsopresumed to conform 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
conformity to the provisions only of those Directives appliedby the manufacturer. In this case, particulars of the Directives
applied, as published in the Official Journal of the European
Communities, must be given in the documents, notices or
instructions required by the Directives and accompanying such
PPE.

▼B
Article 6
1.
Should a Member State or the Commission consider that theharmonized standards referred to in Article 5 do not completely
satisfy the relevant basic requirements referred to in Article 3, theCommission or the Member State concerned shall refer the matter tothe committee created pursuant to Directive 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 No L 109, 26.4.1983, p. 8.

1989L0686 — EN — 20.11.2003 — 002.003 — 7▼M4
2.
The Commission shall be assisted by the Standing Committee, set
up by Article 6(2) of Directive 98/37/EC (1), hereinafter referred to as‘the Committee’.
It may be apprised, in accordance with the procedure referred to in thisparagraph, of any matter to which the implementation and practicalapplication of this Directive give rise.
Where reference is made to this paragraph, Articles 3 and 7 of Decision
1999/468/EC (2) shall apply, having regard to the provisions of Article 8
thereof.
The Committee shall adopt its rules of procedure.
▼B
Article 7
1.
If a Member State discovers that PPE bearing the ►M1 CE
marking ◄ and used in accordance with its intended purpose could
compromise the safety of individuals, domestic animals or property, it
shall 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 Commissionof such action, indicating the reasons for its decision and, in particular,
stating whether non-conformity is due to:(a) failure to comply with the basic requirements referred to in
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, theCommission decides that the action taken was justified, it shallimmediately inform the Member State concerned and all the otherMember States to that effect. If, after such consultation, the Commission
decides that the action taken was not justified, it shall immediately
inform the Member State concerned and the manufacturer or his auth­orized representative established in the Community to that effect. If thedecision referred to in paragraph 1 is in response to a shortcoming inthe standards, the Commission shall refer the matter to the Committee
referred to in Article 6 (1) if the Member State concerned intends toadhere to its decision 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 ►M1 CE marking ◄, the Member State concerned shalltake the appropriate measures with regard to those responsible for
affixing 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 L 207, 23.7.1998, p. 1. Directive as amended by Directive 98/79/EC (OJ
L 331, 7.12.1998, p. 1).
(2) Council Decision 1999/468/EC of 28 June 1999 laying down the proceduresfor the exercise of implementing powers conferred on the Commission (OJ
L 184, 17.7.1999, p. 23).

1989L0686 — EN — 20.11.2003 — 002.003 — 8▼B
CHAPTER IICERTIFICATION 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 that
this can, if necessary, be submitted to the competent authorities.
2.
Prior to the series production of PPE other than those referred toin paragraph 3, the manufacturer or his authorized representative estab­lished in the Community shall submit a model for EC type-examination
as referred to in Article 10.
3.
EC type-examination shall not be required in the case of PPEmodels of simple design where the designer assumes the user canhimself assess the level of protection provided against the minimalrisks concerned the effects of which, when they are gradual, can besafely identified 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 proceduresreferred to in Article 11 in the case of PPE of complex design
intended to protect against mortal danger or against dangers that
may seriously and irreversibly harm the health, the immediate
effects of which the designer assumes the user cannot identify insufficient time. This category shall cover exclusively:— filtering respiratory devices for protection against solid andliquid aerosols or irritant, dangerous, toxic or radiotoxic gases,— respiratory protection devices providing full insulation from theatmosphere, including those for use in diving,— PPE providing only limited protection against chemical attack oragainst ionizing radiation,

1989L0686 — EN — 20.11.2003 — 002.003 — 9▼B— emergency equipment for use in high-temperature environments
the effects of which are comparable to those of an air
temperature of 100 °C or more and which may or may not becharacterized by the presence of infra-red radiation, flames or
the projection 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
temperature 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,▼M2__________▼B(b) the EC declaration of conformity referred to in Article 12 for all
PPE.
Article 9▼M1
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
which these bodies have been appointed to carry out and the identifi­
cation 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 and their identification
numbers and the tasks for which they have been notified. The
Commission shall ensure that this list is kept up to date.
▼B
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 standards
shall be presumed to fulfil those criteria.
3.
A Member State shall withdraw its approval from such a body if it
establishes that the latter no longer satisfies the criteria referred to in
Annex V. It shall inform the Commission and the other Member Statesof its action forthwith.

EC TYPE-EXAMINATION

Article 101.
EC type-examination is the procedure whereby the approved
inspection body establishes and certifies that the PPE model inquestion satisfies 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 inspection
body in respect of the model in question. The authorized representative
shall be established in the Community.

1989L0686 — EN — 20.11.2003 — 002.003 — 10
▼B
3.

The application shall comprise:— the name and address of the manufacturer or his authorized repre­
sentative and of the PPE production plant in question,— the manufacturer's technical file referred to in Annex III.
It shall be accompanied by the appropriate number of specimens of themodel to be approved.
4.
The inspection body of which notification has been given shallconduct 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 to establish its
suitability with respect to the harmonized 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 must
check the suitability of the technical specifications used by the
manufacturer with respect to the basic requirements before
examining the manufacturer's technical file to establish its suit­ability with respect to these technical specifications.
(b) Examination of the model— When examining the model, the inspection body shall verify
that it has been produced in accordance with the manufacturer's
technical file and can be used in complete safety for its intended
purpose.
— 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 standards
the 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 to their being suitable with respect to thesebasic requirements.
5.
If the model satisfies the relevant provisions, the inspection bodyshall 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 and incor­
porate the descriptions and drawings necessary for the identification of
the approved model.
The Commission, the other approved inspection bodies and the otherMember 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.

1989L0686 — EN — 20.11.2003 — 002.003 — 11
▼B6.
Any inspection body which refuses to issue an EC
type-examination certificate shall inform the other approved inspection
bodies of this fact. An inspection body withdrawing an EC
type-examination certificate shall inform the Member State whichapproved it, to this effect. That Member State shall then inform theother Member States and the Commission, setting out the reasons forthe decision.

CHECKING OF PPE MANUFACTURED

Article 11
A. ‘EC’ quality control system for the final product1.
A manufacturer shall take all steps necessary to ensure 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 be
carried out at random, normally at intervals of at least one year.
3.
An adequate sample of PPE taken by the body of which notifi­
cation has been given shall be examined and appropriate tests defined in
the harmonized standards or necessary to show conformity to the basic
requirements of this Directive shall be carried out to check the
conformity 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
has been given in the event of difficulties in connection with theassessment of 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 production
is not homogeneous or that the PPE examined do not conform to thetype described in the EC type-approval certificate or the relevant basic
requirements, the body shall take measures appropriate to the nature of
the fault or faults recorded and inform the Member State which gave
notification thereof accordingly.
6.
The manufacturer must be able to present, on request, the report ofthe 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 which
notification 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,

1989L0686 — EN — 20.11.2003 — 002.003 — 12▼B
— the undertaking to maintain the obligations arising from thequality-control system and to maintain its adequacy and effi­
ciency.
(b) Under the quality-control system, each PPE shall be examined andthe appropriate tests referred to in Section A paragraph 3 shall be
carried out to check their conformity to the relevant basic
requirements of this Directive.
The documentation on the quality-control system shall in particularinclude 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 manu­
facture,— the means to be employed to check the efficient operation of thequality-control system.
(c) The body shall assess the quality-control system to determine
whether it satisfies the provisions referred to in paragraph 1 (b).
It shall assume that quality-control systems applying the relevant
harmonized 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 of
PPE manufactured with the approved model.
The decision shall be communicated to the manufacturer. It shall
include the conclusions of the check and the reasoned assessment
decision.
(d) The manufacturer shall inform the body which approved thequality-control system of any plan to alter the quality-control
system.
The body shall examine the proposed changes and decide whether
the altered quality-control system satisfies the relevant provisions. It
shall communicate its decision to the manufacturer. The communi­
cation shall include the conclusions of the check and the reasoned
assessment 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, forpurposes of inspection, to PPE inspection, testing and storagesites and shall provide the body with all requisite information, inparticular:— documentation on the quality-control system,— technical documentation,— quality control manuals.
(c) The body shall periodically carry out audits to ensure that the manu­
facturer is maintaining and applying the approved quality-control
system and shall provide the manufacturer with a copy of theaudit report.

1989L0686 — EN — 20.11.2003 — 002.003 — 13
▼B(d) In addition, the body may make unannounced visits to the manu­
facturer. In the course of such visits the body shall provide the
manufacturer with a report of the visit and, if appropriate, with anaudit report.
(e) The manufacturer must be able to present, on request, the report ofthe body of which notification has been given.

EC DECLARATION OF PRODUCTION CONFORMITY

Article 12▼M1
The EC declaration of conformity is the procedure whereby the manu­
facturer or his authorized representative established within theCommunity:▼B
1. draws up a declaration using the form laid down in Annex VI
certifying that the PPE placed on the market are in conformity
with the provisions of this Directive with a view to its submission
to the competent authorities;
2. affixes the ►M1 CE marking ◄ of conformity provided for by
Article 13 to each PPE.
CHAPTER III▼M1

CE MARKING

Article 13
1.
The CE conformity marking shall consist of the initials ‘CE’in theform shown in the specimen in Annex IV. In the event of theinvolvement of a notified body in the production control phase as
indicated in Article 11, its identification number shall be added.
2.
The CE marking must be affixed to each piece of manufactured
PPE so as to be visible, legible and indelible throughout the expected
life of the PPE; however, if this is not possible in view of the char­acteristics 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 be
prohibited. Any other marking may be affixed to the PPE or its
packaging provided that the visibility and legibility of the CE
marking is not thereby 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 representative
established within the Community shall be obliged to make theproduct conform as regards the provisions concerning the CE
marking and to end the infringement under the conditions
imposed by the Member State;

1989L0686 — EN — 20.11.2003 — 002.003 — 14
▼M1(b) where non-conformity continues, the Member State must take allappropriate measures to restrict or prohibit the placing on themarket of the product in question or to ensure that it iswithdrawn from the market in accordance with the procedures
laid down in Article 7.
▼B
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 detailed
explanation of the grounds on which it is based. The interested party
shall be notified of the decision without delay and informed of thepossibilities for appeal under the legislation in force in the Member
State 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 managementof this Directive are made available.
▼M2
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 Commission
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 in
conformity with the national regulations in force in their territory on 30
June 1992.
3.
Member States shall communicate to the Commission the texts ofthe provisions of national law which they adopt in the field governed bythis Directive.
▼B
Article 17This Directive is addressed to the Member States.

1989L0686 — EN — 20.11.2003 — 002.003 — 15
▼B
ANNEX IEXHAUSTIVE LIST OF PPE CLASSES NOT COVERED BY THISDIRECTIVE
1.

PPE designed and manufactured specifically for use by the armed forces orin 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:▼C1— atmospheric conditions
umbrellas, etc.),(headgear,

seasonal

clothing,

footwear,▼B— 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.

5.

Helmets and visors intended for users of two- or three-wheeled motor
vehicles.

▼M21989L0686 — EN — 20.11.2003 — 002.003 — 16
▼B
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 so designed and manufactured that in the foreseeableconditions of use for which it is intended the user can perform therisk-related activity normally whilst enjoying appropriate protection of
the highest possible level.

1.1.2.

Levels and classes of protection

1.1.2.1. H i g h e s t l e v e l o f p r o t e c t i o n p o s s i b l e
The optimum level of protection to be taken into account in the designis that beyond which the constraints imposed by the wearing of the PPE
would prevent its effective use during the period of exposure to the risk
or normal performance of the activity.

1.1.2.2. C l a s s e s o f p r o t e c t i o nlevels of risk

appropriate

todifferent

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 so designed and manufactured as to preclude risks andother nuisance factors under foreseeable conditions of use.

1.2.1.1. S u i t a b l e c o n s t i t u e n t m a t e r i a l s
PPE materials and parts, including any of their decomposition products,
must not adversely affect user hygiene or health.

1.2.1.2. S a t i s f a c t o r y s u r f a c e c o n d i t i o n o f a l l P P E p a r t s i ncontact 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, projections
and the like which could cause excessive irritation or injuries.

1.2.1.3. M a x i m u m p e r m i s s i b l e u s e r i m p e d i m e n t
Any inpediment caused by PPE to movements to be made, postures tobe adopted and sensory perception must be minimized; nor must PPE
cause movements which endanger the user or other persons.

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1.3.

Comfort and efficiency

1.3.1.

Adaptation of PPE to user morphology
PPE must be so designed and manufactured as to facilitate correct
positioning on the user and to remain in place for the foreseeable
period of use, bearing in mind ambient factors, movements to bemade and postures to be adopted. For this purpose, it must be
possible to optimize PPE adaptation to user morphology by all appro­
priate means, such as adequate adjustment and attachment systems or
the provision of an adequate size range.

1.3.2.

Lightness and design strength
PPE must be as light as possible without prejudicing design strength andefficiency.
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.

Compatibility of different classes or types of PPE designed for simul­
taneous use
If the same manufacturer markets several PPE models of different
classes or types in order to ensure the simultaneous protection of
adjacent parts of the body against combined risks, these must becompatible.

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
the market 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 orclasses of protection provided by the PPE in question;(c) suitable PPE accessories and the characteristics of appropriate spareparts;(d) the classes of protection appropriate to different levels of risk andthe 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).

▼M1(h) where appropriate, the references of the Directives applied inaccordance 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.

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2.

ADDITIONAL REQUIREMENTS
CLASSES OR TYPES OF PPECOMMON

2.1.

PPE incorporating adjustment systems

TO

SEVERAL

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 protectedmust be sufficiently ventilated to limit perspiration resulting from use; if
this is not the case, it must if possible be equipped with devices which
absorb 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 PPEclasses must be compatible with the type of relatively meticulous
and/or prolonged activities of the user.

If necessary, they must be treated or provided with facilities to prevent
moisture formation.

PPE models intended for users requiring sight correction must becompatible 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 besignificantly affected by ageing, the date of manufacture and/or, if
possible, the date of obsolescence, must be indelibly inscribed on
every PPE item or interchangeable component placed on the market
in such a way as to preclude any misinterpretation; this informationmust also be indelibly inscribed on the packaging.

If a manufacturer is unable to give an undertaking with regard to theuseful life of PPE, his notes must provide all the information necessary
to enable the purchaser or user to establish a reasonable obsolescencedate, bearing in mind the quality level of the model and the effective
conditions 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 cleaning
process recommended by the manufacturer, the latter must, if possible,
affix a mark to each item of PPE placed on the market indicating the
maximum number of cleaning operations that may be carried out before
the equipment needs to be inspected or discarded; failing that, the manu­
facturer 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 danger
for the user, the PPE must possess an appropriate resistance threshold
above which a constituent part will break and eliminate the danger.

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2.6.

PPE for use in explosive atmospheres
PPE intended for use in explosive atmospheres must be so designed andmanufactured that it cannot be the source of an electric, electrostatic or
impact-induced arc or spark likely to cause an explosive mixture to
ignite.

2.7.

PPE intended for emergency use or rapid installation and/or
removal
These PPE classes must be so designed and manufactured as tominimize 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 ofcompetent trained individuals who are qualified to interpret 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 thelevel of protection normally provided, this must be so designed andaccommodated as to be perceived by the user in the conditions of use
for which the PPE is marketed.

2.9.

PPE incorporating components which can be adjusted or removedby the user
Any PPE components which can be adjusted or removed by the user forthe 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 so designed andmanufactured as to enable it to be mounted only on appropriate
equipment.

2.11.

PPE incorporating a fluid circulation system
If PPE incorporates a fluid circulation system, the latter must be sochosen, or designed, and incorporated as to permit adequate fluid
renewal 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.

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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 tohealth and safety affixed to these types or classes of PPE must
preferably take the form of harmonized pictograms or ideograms andmust remain perfectly legible throughout the foreseeable useful life of
the PPE. In addition, these marks must be complete, precise andcomprehensible so as to prevent any misinterpretation; in particular,when such marks incorporate words or sentences, the latter must
appear in the official language(s) of the Member State where theequipment is to be used.

If PPE (or a PPE component) is too small to allow all or part of thenecessary marking to be affixed, the relevant information must be
mentioned 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 luminous
intensity and photometric and colorimetric properties.

2.14.

‘Multi-risk’ PPE
All PPE designed to protect the user against several potentially simul­
taneous risks must be so designed and manufactured as to satisfy, 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 by falling or projecting objects and collision of parts ofthe body with an obstacle
Suitable PPE for this type of risk must be sufficiently shock-absorbent
to prevent injury resulting, in particular, from the crushing or
penetration of the protected part, at least up to an impact-energy level
above which the excessive dimensions or mass of the absorbing device
would preclude effective use of the PPE for the foreseeable period ofwear.

3.1.2.

Falls

3.1.2.1. P r e v e n t i o n o f f a l l s d u e t o s l i p p i n g
The outsoles for footwear designed to prevent slipping must be sodesigned, manufactured or equipped with added elements as to ensuresatisfactory adhesion by grip and friction having regard to the nature orstate of the surface.

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3.1.2.2. P r e v e n t i o n o f f a l l s f r o m a h e i g h t
PPE designed to prevent falls from a height or their effects must incor­
porate a body harness and an attachment system which can beconnected to a reliable anchorage point. It must be designed so that
under the foreseeable conditions of use the vertical drop of the user isminimized to prevent collision with obstacles and the braking force does
not, however, attain the threshold value at which physical injury or the
tearing or rupture of any PPE component which might cause the user tofall can be expected to occur.

It must also ensure that after braking the user is maintained in a correct
position in which he may await help if necessary.

The manufacturer's notes must specify in particular all relevant
information relating to:— the characteristics required for the reliable anchorage point and thenecessary minimum clearance below the user,— the proper way of putting on the body harness and of connecting theattachment 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
components for the part of the body at risk.

Under no circumstances must the effective value of the accelerationstransmitted to the user by those vibrations exceed the limit values
recommended in the light of the maximum foreseeable daily exposureof the 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 prevent
serious injury or chronic complaints.

3.3.

Protection against physical injury (abrasion, perforation, cuts, bites)
PPE constituent materials and other components designed to protect allor part of the body against superficial injury caused by machinery, suchas abrasion, perforation, cuts or bites, must be so chosen or designed
and incorporated 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 thesurface as quickly as possible, without danger to his health, a user who
may be exhausted or unconscious after falling into a liquid medium, andof keeping him afloat in a position which permits breathing while
awaiting 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.

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Under the foreseeable conditions of use:
— PPE must, without prejudice to its satisfactory operation, be capableof 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 typesof PPE must also satisfy one or more of the following additional
requirements:— 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 theuser 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
into the 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 affords
positive support in water. In foreseeable conditions of use, this PPE
must not restrict the user's freedom of movement but must enable
him, in particular, to swim or take action to escape from danger or
rescue other persons.

3.5.

Protection against the harmful effects of noise
PPE designed to prevent the harmful effects of noise must be capable ofattenuating the latter to such an extent that the equivalent sound levels
perceived by the user do not under any circumstances exceed the daily
limit values laid down by Council Directive 86/188/EEC of 12 May
1986 on the protection of workers from the risks related to exposure tonoise at work (1).
All PPE must bear labelling indicating the noise attenuation level andthe value of the comfort index provided by the PPE; should this not be
possible, 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 ofheat 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 coef­
ficient of transmission of incident heat flux and be sufficiently incom­bustible to preclude any risk of spontaneous ignition under the fore­
seeable conditions of use.

(1) OJ No L 137, 24.5.1986, p. 28.

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Where the outside of these materials and components must be reflective,
its reflective power must be appropriate to the intensity of the heat flux
due to radiation in the infra-red range.
Materials and other components of equipment intended for brief use inhigh-temperature environments and of PPE which may be splashed by
hot products such as large quantities of molten material must also
possess sufficient thermal capacity to retain most of the stored heat
until after 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-impact
absorbency (see 3.1).
PPE materials and other components which may accidentally come into
contact with flame and those used in the manufacture of fire-fighting
equipment must also possess a degree of non-flammability corre­
sponding to the risk class associated with the foreseeable conditionsof use. They must not melt when exposed to flames nor contribute toflame propagation.

3.6.2.

Complete PPE ready for use
Under the foreseeable conditions of use:
1. the quantity of heat transmitted by PPE to the user must be
sufficiently low to prevent the heat accumulated during wear in
the part of the body at risk from attaining, under any circumstances,the pain or health impairment threshold;
2. PPE must if necessary prevent liquid or steam penetration and must
not cause burns resulting from contact between its protective
integument and the user.
If PPE incorporates refrigeration devices for the absorption of incident
heat by means of liquid evaporation or solid sublimation, their design
must be such that any volatile substances released are discharged
beyond 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 forbrief use in high-temperature environments must in particular provide all
relevant data for the determination of the maximum permissible user
exposure to the heat transmitted by the equipment when used inaccordance with its intended purpose.

3.7.

Protection against cold
PPE designed to protect all or part of the body against the effects ofcold must possess thermal insulating capacity and mechanical strength
appropriate to the foreseeable conditions of use for which it is marketed.

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 incident
thermal flux as low as required under the foreseeable conditions ofuse. Flexible materials and other components of PPE intended for use
in a low-temperature environment must retain the degree of flexibility
required for the necessary gestures and postures.

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PPE materials and other components which may be splashed by large
amounts of cold products must also possess sufficientmechanical-impact absorbency (see 3.1).

3.7.2.

Complete PPE ready for use
Under the foreseeable conditions of use:
1. the flux transmitted by PPE to the user must be sufficiently low toprevent the cold accumulated during wear at any point on the partof the body being protected, including the tips of fingers and toes in
the case of hands or feet, from attaining, under any circumstances,the pain 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
between its cold protective integument and the user.
If PPE incorporates a breathing device, this must adequately fulfil theprotective function assigned to it under the foreseeable conditions ofuse.
The manufacturer's notes accompanying each PPE model intended forbrief use in low-temperature environments must provide all relevant data
concerning the maximum permissible user exposure to the cold trans­mitted by the equipment.

3.8.

Protection against electric shock
PPE designed to protect all or part of the body against the effects ofelectric current must be sufficiently insulated against the voltages towhich the user is likely to be exposed under the most unfavourable
foreseeable 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
integument under test conditions at voltages correlated with thoselikely to be encountered in situ is minimized and, at all events, below
a maximum conventional permissible value which correlates with thetolerance threshold.
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, theirprotection class and (or) corresponding operating voltage, their serial
number and their date of manufacture; a space must also be provided
outside the protective integument of such PPE for the subsequent
inscription of the date of entry into service and those of the periodic
tests or inspections to be 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 to which they are to be subjected during their useful
life.

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 the
majority of the energy radiated in the harmful wavelengths without
unduly affecting the transmission of the innocuous part of the visible
spectrum, the perception of contrasts and the ability to distinguishcolours where required by the foreseeable conditions of use.

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To this end, protective glasses must be so designed 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.
Furthermore, the glasses must not deteriorate or lose their properties as aresult of the effects of radiation emitted under the foreseeable conditonsof use and all marketed specimens must bear the protection-factor
number corresponding to the spectral distribution curve of their trans­mission factor.
Glasses suitable for radiation sources of the same type must be clas­sified in the ascending order of their protection factors and the manu­
facturer's notes must indicate, in particular, the transmission curves
which make it possible to select the most appropriate PPE bearing in
mind such inherent factors of the effective conditions of use as distanceto source and the spectral distribution of the energy radiated at that
distance.
The relevant protection-factor number must be marked on all specimensof filtering glasses by the manufacturer.
3.9.2.

Ionizing radiation

3.9.2.1. P r o t e c t i o n a g a i n s t e x t e r n a l r a d i o a c t i v e c o n t a m i ­nationPPE constituent materials and other components designed to protect allor part of the body against radioactive dust, gases, liquids or mixtures
thereof must be so chosen or designed and incorporated as to ensure that
this equipment effectively prevents the penetration of the contaminants
under the foreseeable conditions of use.
Depending on the nature or condition of these contaminants, thenecessary leak-tightness can be provided by the impermeability of theprotective integument and/or by any other appropriate means, such as
ventilation and pressurization systems designed to prevent the
back-scattering of these contaminants.
Any decontamination measures to which PPE is subject must notprejudice its possible re-use during the foreseeable useful life of theseclasses of equipment.
3.9.2.2. L i m i t e d p r o t e c t i o n a g a i n s t e x t e r n a l i r r a d i a t i o n
PPE intended to provide complete user protection against external
irradiation or, failing this, adequate attenuation thereof, must be
designed to counter 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 degree of user protection required by the foreseeable conditions ofuse without leading to an increase in exposure time as a result of the
impedance of user gestures, posture or movement (see 1.3.2).
PPE must bear a mark indicating the type and thickness of theconstituent material(s) suitable for the foreseeable conditions of use.
3.10.

Protection against dangerous substances and infective agents

3.10.1. Respiratory protection
PPE intended for the protection of the respiratory tract must make itpossible to supply the user with breathable air when the latter is exposed
to a polluted atmosphere and/or an atmosphere having inadequate
oxygen concentration.

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The breathable air supplied to the user by the PPE must be obtained byappropriate means, for example after filtration of the polluted air
through the protective device or appliance or by a piped supply froman unpolluted source.

The constituent materials and other components of these PPE classes
must be so chosen or designed and incorporated as to ensure appropriate
user respiration and respiratory hygiene for the period of wear
concerned 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 be
such as to keep contaminant penetration from a polluted atmosphere low
enough 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
conjunction with the instructions for use, will enable a trained andqualified user to employ the PPE correctly.

The manufacturer's notes must also in the case of filtering devices,
indicate the deadline for the storage of filters as new and kept intheir original packaging.

3.10.2. Protection against cutaneous and ocular contact
PPE intended to prevent the surface contact of all or part of the bodywith 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 which
the 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 allow
where necessary prolonged daily use or, failing this, limited
leak-tightness necessitating a restriction of the period of wear.

Where, by virtue of their nature and the foreseeable conditions of theiruse, certain dangerous substances or infective agents possess highpenetrative power which limits the duration of the protection provided
by the PPE in question, the latter must be subjected to standard tests
with a view to their classification on the basis of effeciency. PPE whichis considered 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, an
explanation of the codes (if necessary), a detailed description of thestandard tests and all appropriate information for the determination of
the 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.

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2. Where the foreseeable conditions of use so require, the equipment
must comprise:(a) a suit which protects the user against the pressure resulting fromthe 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 to return to the surface (see3.4.1).

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ANNEX IIITECHNICALDOCUMENTATION
SUPPLIEDMANUFACTURER

BY

THE

The documentation referred to in Article 8 (1) must comprise all relevant data on
the means used by the manufacturer to ensure that a PPE complies with the basic
requirements relating to it.
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 necessary
for 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 standards
or 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 thefollowing 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 samevertical dimension, which may not be less than 5 mm. This minimum
dimension may be waived for small-scale PPE.

▼M3__________

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ANNEX VCONDITIONS TO BE FULFILLED BY THE BODIES OF WHICHNOTIFICATION 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 thecertificates and performing the surveillance provided for in the Directive, ofstaff and technical personnel in relation to all circles, groups or persons
directly 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 theState under national law.
Fulfilment of the conditions under 1 and 2 shall be verified at intervals by thecompetent authorities of the Member States.

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ANNEX VI