Dir 1989-686 Usefulfacts 1356
Dir 1989-686 Usefulfacts 1356
Dir 1989-686 Usefulfacts 1356
Ares(2014)77941 - 15/01/2014
DIRECTIVE 89/686/EEC
1
TABLE OF CONTENTS
PAGE
PART 1 : QUESTIONS/ANSWERS.................................................................................. 9
PART 3 : STANDARDISATION..................................................................................... 33
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3
FOREWORD
The present document brings together useful information to enable a better implementation of
the Personal Protective Equipment (PPE) Directive 89/686/EEC as amended(1).. It is addressed
to all parties who may be concerned by the Directive.
This document is an updated version of the 1997 edition, prepared by the Commission
services, based on the information available in October 1999. It accepts no responsibilities for
any inaccuracies or omissions which may occur in this document. In order to improve the
following updates, any identified omissions or amendments should be forwarded to the
address below.
The information in this publication is subject to continuous modifications, and it has been
decided to publish an update on an annual basis. It has also been decided only to publish it in
English, to ensure prompt availability. One section is available in all official EU languages,
and can be obtained by completing the request form on page 7.
______________________
(1) Directive 89/686/EEC of 21.12.89 (OJ L 399 of 30.12.89, p.18) as amended by Directives 93/68/EEC of
22.07.93 (OJ L 220 of 30.08.93, p. 1); 93/95/EEC of 29.10.93 (OJ L 276 of 09.11.93, p.11) and 96/58/EC
of 03.09.96 (OJ L 236 of 18.09.96, p.44).
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5
If you require further information in other languages for Part 1 or the subsequent update of
this document please copy or complete the form below and send via fax or letter to the
following address;
European Commission
DG ENTREPRISE /G/3, SC15 - 3/168
Rue de la Loi, 200
B-1049 BRUSSELS
BELGIUM
Fax: : +32 2 296 62 73
Internet address : [email protected]
"---------------------------------------------------------------------------------------------------------------
FR - DE - NL - IT - DA - ES - PT - EL - FI – SV
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PART 1
QUESTIONS/ANSWERS
This document includes all the questions presented to the Working Group that have received
an agreed answer.
The opinions expressed should therefore be considered as an important guidance. However,
they have been provided at different times and it should be taken into consideration that the
situation may have evolved.
These questions/answers are available in all official EU languages : if you would like to
receive other language versions, please complete the form on page 7, and specify the
language version required.
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9
Implementation of Council Directive 89/686/EEC of
21 December 1989 in relation to Personal Protective Equipment
(PPE), as amended by Directives 93/95/EEC, 93/68/EEC and
96/58/EC
Answers given by the Commission, after consulting the Committee set up by the Directive, to
questions relating to the implementation of the Directive.
Note : The missing questions have either been deleted or modified and given a new number.
A. 1 As a general rule, the clothes used by motorcyclists (which includes gloves, boots, shoes, etc.)
are for private use against the weather: rain, heat and cold.
They are therefore excluded from the scope of the PPE Directive (89/686/EEC)
(Annex I, point 3).
However, if the manufacturer specifically claims, or implies in sales literature or advertising,
that because of particular additional features (e.g. elbow pads, knee pads and the like) this
clothing offers special protection, these additional features alone shall be classed as PPE and
must therefore comply with the provisions of the Directive.
The manufacturer of the clothing must provide the information specified in Directive
89/686/EEC in the literature accompanying the clothing. If the protective devices are
detachable, the manufacturer must also give information on the correct way of attaching,
fixing and detaching them.
If the manufacturer claims, or implies in sales literature or advertising, that the whole garment
provides special protection in addition to that provided by individual protectors, the whole
garment must comply with all the essential requirements of Directive 89/686/EEC.
Notes:
(1) The same argument applies to clothing designed for sports for which specific clothing
already exists.
(2) Helmets designed to protect against shocks should always be classed as PPE, except
for helmets for riders of two- or three-wheeled motor vehicles, which are specifically
excluded from the Directive (Annex I, point 5).
A. 2 Unlike helmets and visors, which are not covered by the Directive, motorcyclists' goggles are
covered by the Directive, and are classed under category II.
10
Q. 3 What is the certification category for swimming and/or diving goggles and masks?
A. 3 Category I.
Q. 5 What is the certification category for shoes protecting against static electricity?
A. 5 Because of the potential risk of explosion, shoes designed and manufactured to protect
against static electricity are category II items of PPE.
A. 6 Clogs are destined to protect against wet and cool temperatures, normally for private use.
They shall not be considered as PPE.
Q. 7 Are the PPE designed and manufactured for the firefighters PPE or are they excluded
from the directive because used for military or police purposes ?
A. 7 The firefighters are never considered as “armed or police forces”; the equipment they use are
PPE with regard to the directive. Depending on their nature, they have to be considered as
category II or III.
Note : this answer is very general and excludes all exceptions; for instance, the equipment used
by the firefighters from Paris or by the sailors firefighters from Marseille have to be conform
with the directive 89/686/EEC, even if both bodies belong directly to the French Ministry of
Defense.
[See also the answer given by Mr. Bangemann on behalf of the Commission the 1st of July
1996 to the written question E-1173/96 of Mr. Gerhard Schmid].
A. 8 If plano sunglasses are used for other type of protection (chock protection, lasers, heat...) the
assembly, i.e. glasses + frame, should follow the procedures indicated in the directive for the
corresponding category of risk involved.
Q. 9 If an optometrist or optician assembles a frame and plano lenses and if he or she tints
the lenses to create a pain of sunglasses, which procedure must he or she follow ?
A. 9 After glasses are tinted, the assembly is considered as a pair of sunglasses; If the protection
provided is against sunlight, the assembly is considered in category I.
11
Q. 10 If an optometrist or optician creates a pair of plano sunglasses using a non-cE marked
frame and/or non CE-marked lenses provided by the patient, which procedure must
he or she follow ?
A. 10 The assembler must make an EC declaration of conformity (Annex VI of the PPE directive).
Since the assembly is sunglasses, it shall be in category I.
Q. 11. In the case of PPE consisting of a combination of several items, what is the notified
body responsible for conducting the EC type-examination required to check?
A. 11. The notified body must check that all the essential health and safety requirements have been
correctly applied for those items covered by categories II and III and for the whole
combination. For this purpose, it does not need to repeat the tests already carried out by a
notified body or tests recognised by a notified body. Moreover, with regard to Articles 11A
and 11B, it is not required to test performance except for those parts directly covered by
category III.
Q. 12 What view should be taken of lumbar supports and arm supports used to protect the
back or joints when carrying out strenuous tasks?
A. 12 These items are for medical use and so do not come under the Directive.
Q. 13 How can the ambiguity between respirators (face masks) worn for comfort and
protective respirators be removed?
A. 13 Protective respirators (face masks), however they are described, which are intended to
protect the wearer are covered by the Directive on PPE and must therefore meet all the
essential health and safety requirements set out in the Directive which apply to them.
A. 14 No. The Directive stipulates that such equipment must be attached to a reliable anchorage
point. Emergency and other parachutes, hang-gliders, etc., are not PPE.
Q. 15 Are crampons, ropes and other equipment used to get out of the water after falling
though ice PPE?
A. 15 This equipment is designed to protect the user from drowning in the event of falling through
ice. It is category II.
12
Q. 16 Should bullet-proof clothes or jackets for security guards be regarded as PPE?
A. 16 These are items of protective clothing and therefore category II PPE. They are not covered
by the exclusion relating to the armed forces or forces of law and order. Only bullet-proof
clothing and jackets specifically designed for the said forces are excluded from the scope of
the Directive.
Q. 21 Should the notified body carrying out EC type-examination verify the information
drawn up by the manufacturer and supplied with the equipment?
A. 21 Article 10(4) does not specifically mention verification of the information drawn up by the
manufacturer and supplied with the equipment. EC type-examination comprises examination
of the technical file (which does not include the information supplied with the equipment,
see Annex III) and of the model (type).
However, when examining the model submitted for EC type-examination, the notified body
must check that the model can be used safely in accordance with its intended purpose. To
do so, the body must check the information referred to in Annex II, point 1.4, which
includes instructions for installation, use, etc.
The information supplied with the equipment must be submitted to the notified body
together with the technical file and the model of the equipment.
A. 23 If the equipment is worn before the accident which prompts the rescue, it is PPE and covered
by the Directive. If the rescuer places it on the person requiring rescue after the accident
occurs, it is not.
For instance, a wet suit worn continuously to prevent hypothermia in the event of falling into
water is PPE. A sling used to rescue an unconscious person from an inaccessible spot is not.
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PART 2
This section resulted from the work of the PPE Working Party, set up under the 98/37/EC
Committee. Their work involves clarifying the PPE certification categories set out in Article 8
of the relevant Council Directives(1) relating to Personal Protective Equipment.
The reader's attention is drawn to the fact that only the texts of the Directive and its
transpositions into Member States' laws have legal force. In case of doubt, it is therefore
necessary to refer to Community texts published in the Official Journal, as well as their
transpositions into National Law.
The explanations given in this document may be updated or changed, if this is thought
necessary, taking into account experiences gained since its application.
______________________
(1) Directive 89/686/EEC of 21.12.89 (OJ L 399 of 30.12.89, p.18) as amended by Directives 93/68/EEC of
22.07.93 (OJ L 220 of 30.08.93, p. 1); 93/95/EEC of 29.10.93 (OJ L 276 of 09.11.93, p.11) and 96/58/EC
of 03.09.96 (OJ L 236 of 18.09.96, p.44).
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Explanatory Remarks
Annex 1 reproduces the provisions of the Directive; however, the paragraphs have been renumbered
for ease of reference.
The conformity assessment procedures for the certification categories used in this document are as
follows:
(b) certification category II - declaration of conformity by the manufacturer after a notified body
has drawn up an EC type-examination certificate for a PPE model
(Article 8, paragraph 2)
(c) certification category III - declaration of conformity by the manufacturer after a notified body
has drawn up an EC type-examination certificate for a PPE model
and after a notified body (either the same one that drew up the EC
type-examination certificate or another one) has carried out the
quality control of the PPE manufactured (Article 8, paragraph 4).
Important remark:
Whatever its certification category (I, II or III) a PPE must meet all the essential health and safety
requirements applicable to it. The manufacturer must take account of the latter when designing and
manufacturing the PPE.
The notified body responsible for carrying out the EC type-examination (certification categories II
and III) must:
- in the case of a single PPE, verify that all the essential health and safety requirements applicable
have been complied with,
- in the case of a PPE constituted by several devices, verify, taking into account tests which may
already have been carried out on some of those devices (avoiding duplication of tests already
carried out by a notified body or tests recognised by a notified body), that all the essential health
and safety requirements have been complied with, and carry out additional tests called for as a
result of the combination of devices.
For the purpose of applying Articles 11A and 11B, the notified body responsible for checking the
manufacture of PPE in certification category III should check performance specifically relating to
certification category III (e.g. respiratory protective equipment providing protection against solid
aerosols, and equipment providing protection against electrical risks).
These provisions apply both to single PPE and PPE constituted by several protection devices.
15
TYPE OF PERSONAL PROTECTIVE EQUIPMENT Certification Reason
category
Except:
2.2 Eye protectors and filters designed and manufactured for use III 3.3.4
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 be characterised by the presence of
infra-red radiation, flames or the projection of large amounts
of molten material.
2.3 Eye protectors and filters designed and manufactured to III 3.3.3
provide protection against ionising radiation.
2.4 Eye protectors and filters designed and manufactured to III 3.3.7
provide protection against electrical risks.
N.B. : Where corrective spectacles provide protection other than protection against sunlight
(e.g. against impact, abrasive projections, etc.), they are classified as personal protective
equipment of the category corresponding to the hazard in question solely in respect of their
protective features.
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TYPE OF PERSONAL PROTECTIVE EQUIPMENT Certification Reason
category
N.B. When using this table concerning equipment for protection against falls from a height, one
should be aware that some opinion divergence exists between the Member States about the
categorisation of some equipment. In case of difficulties, please contact the representative of
the Member States.
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TYPE OF PERSONAL PROTECTIVE EQUIPMENT Certification Reason
category
Except:
4.2 Helmets designed and manufactured for use in high- III 3.3.4
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 be characterised by the presence of infra-red
radiation, flames or the projection of large amounts of molten
material.
4.6 Helmets designed and manufactured specifically for use by the 0 2.1
armed forces or in the maintenance of law and order.
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TYPE OF PERSONAL PROTECTIVE EQUIPMENT Certification Reason
category
Except:
19
TYPE OF PERSONAL PROTECTIVE EQUIPMENT Certification Reason
category
6. PROTECTIVE CLOTHING
Except:
1 The manufacturer shall indicate the products against which protection is provided, and the time for which such
protection lasts.
20
TYPE OF PERSONAL PROTECTIVE EQUIPMENT Certification Reason
category
21
TYPE OF PERSONAL PROTECTIVE EQUIPMENT Certification Reason
category
2 The manufacturer must indicate the principal protective properties of the equipment, as well as the period
during which it may be used or an indication allowing the user safely to identify when the effectiveness of the
equipment has expired.
3 Where such masks are intended to protect the wearer against microbial and viral infections, etc. they are in
certification category III (personal protection rather than medical use).
22
TYPE OF PERSONAL PROTECTIVE EQUIPMENT Certification Reason
category
Except:
4 The manufacturer shall indicate the products gainst which protection is provided, and the time for which such
protection lasts.
23
TYPE OF PERSONAL PROTECTIVE EQUIPMENT Certification Reason
category
8.10 Some shoes, in particular sports shoes, contain components 0 they are not
intended to absorb shock when walking, running, etc. or to PPE
ensure a good grip or stability(5). These components are to be
regarded as being intended to increase comfort.
5 This category includes in particular football and rugby boots and spiked running shoes.
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TYPE OF PERSONAL PROTECTIVE EQUIPMENT Certification Reason
category
Except:
6 This includes all garments protecting the hand or part of the hand, including gloves, fingerless gloves, mittens,
garments protecting the fingers only or the palm only, etc.
7 The manufacturer shall indicate the products against which protection is provided and the time for which such
protection lasts.
25
TYPE OF PERSONAL PROTECTIVE EQUIPMENT Certification Reason
category
9.9 Gloves and finger guards for medical use in the patient's 0 medical use
environment.
26
TYPE OF PERSONAL PROTECTIVE EQUIPMENT Certification Reason
category
Except:
0 2.4
10.2 Life-buoys and life-jackets for emergency use by ship and
aircraft passengers(8).
8 The terms "ship" and "aircraft" refer exclusively to those carrying passengers and to seagoing vessels subject to
the international conventions of the IMO.
Pleasure craft (motor boats and sailing boats), fishing boats, working boats, etc., are not included in this
category.
27
TYPE OF PERSONAL PROTECTIVE EQUIPMENT Certification Reason
category
11.1 For the record: equipment for protection against electrical III 3.3.7
risks is included in the above tables.
Except:
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ANNEX 1
PPE shall mean any device or appliance designed to be worn or held by an individual for
protection against one or more health and safety hazards.
1.1 a unit constituted by several devices or appliances which have been integrally
combined by the manufacturer for the protection of an individual against one or more
potentially simultaneous risks (Article 1(2)(a));
1.3 interchangeable PPE components which are essential to its satisfactory functioning
and used exclusively for such equipment (Article 1(2)(c)).
1.4 Any system placed on the market in conjunction with PPE for its connection to
another external, additional device shall be regarded as an integral part of that
equipment even if the system is not intended to be worn or held permanently by the
user for the entire period of risk exposure (Article 1(3)).
2. PPE excluded from the scope of the PPE Directive, referred to in this document as
category 0
2.0 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
(Article 1(4) first indent).
2.1 PPE designed and manufactured specifically for use by the armed forces or in the
maintenance of law and order (helmets, shields, etc.) (Annex I, item 1).
2.2 PPE for self-defence (aerosol canisters, personal deterrent weapons, etc.) (Annex I,
item 2).
2.4 PPE intended for the protection or rescue of persons on vessels or aircraft, not worn
all the time (Annex I, item 4).
2.5 Helmets and visors intended for users of two- or three-wheeled vehicles (Annex I,
item 5; added by Directive 93/95/EEC).
29
3. Categorisation
3.1 PPE classified as category I for which the manufacturer, or his authorised
representative established in the Community, must draw up, without intervention of a
notified body, an EC declaration of conformity (Article 8(3)).
PPE models of simple design where the designer assumes the user can himself assess
the level of protection provided against the minimal risks concerned the effects of
which, when they are gradual, can be safely identified by the user in good time.
This category shall cover exclusively PPE intended to protect the wearer
against:
3.1.1 mechanical action whose effects are superficial (gardening gloves, thimbles,
etc.),
3.1.2 cleaning materials of weak action and easily reversible effects (gloves
affording protection against diluted detergent solutions, etc.),
3.1.3 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.),
3.1.5 minor impacts and vibrations which do not affect vital areas of the body and
whose effects cannot cause irreversible lesions (light anti-scalping helmets,
gloves, light footwear, etc.),
3.2 PPE classified as category II for which the manufacturer, or his authorised
representative established in the Community, must draw up an EC declaration of
conformity after a notified body has issued an EC type-examination certificate (Article
8(2)).
3.3 PPE classified as category III for which the manufacturer, or his authorised
representative established in the Community, must draw up an EC declaration of
conformity after a notified body has issued an EC type-examination certificate and
after a notified body has checked the manufacturing process (Article 8(4)(a)).
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 in sufficient time.
30
This category shall cover exclusively:
3.3.1 filtering respiratory devices for protection against solid and liquid aerosols or
irritant, dangerous, toxic or radio toxic gases,
3.3.2 respiratory protection devices providing full insulation from the atmosphere,
including those for use in diving,
3.3.3 PPE providing only limited protection against chemical attack or against
ionising radiation,
3.3.7 PPE against electrical risks and dangerous voltages or that used as insulation
in high-tension work.
31
PART 3
STANDARDISATION
PAGE
- 3.1 - Harmonised standards which give a presumption of conformity
with the PPE Directive ................................ ................................ ................................ ....
................................ ................................ ................................ ................................ ...... 34
- 3.2 - European standards relating to the PPE Directive but not (yet) published...................
................................ ................................ ................................ ................................ ...... 49
- 3.3 - Draft European standards relating to the PPE Directive ................................ ...............
................................ ................................ ................................ ................................ ................. 51
- 3.4 - European standards relating to the PPE field but not the Directive..............................
................................ ................................ ................................ ................................ ................. 59
Harmonised standards and European standards are inserted in the national collection of each
Member bodies of CEN and CENELEC; their texts exist in different languages.
Draft European standards are normally available in French, English and German.
The list of harmonised standards can be found at the following internet address :
http://europa.eu.int/comm/dg03/directs/dg3b/newapproa/eurstd/harmstds/index.html.
To obtain the text of these documents, contact the Member Bodies of CEN, CENELEC (listed
in part 5 of this document) or the standardisation body of your country outside the territory
of CEN/CENELEC members.
32
3.1. HARMONISED STANDARDS WHICH GIVE PRESUMPTION OF CONFORMITY
WITH THE PPE DIRECTIVE
Attention must be drawn to the fact that conformity with several harmonised standards does
not confer the presumption of conformity with all the Directive, unless these standards cover
all the essential requirements applicable to the PPE.
33
REFERENCE YEAR OF TITLE PUBLICATION IN
RATIFICATIO OJEC
N
34
REFERENCE YEAR OF TITLE PUBLICATION IN
RATIFICATIO OJEC
N
35
REFERENCE YEAR OF TITLE PUBLICATION IN
RATIFICATIO OJEC
N
36
REFERENCE YEAR OF TITLE PUBLICATION IN
RATIFICATIO OJEC
N
37
REFERENCE YEAR OF TITLE PUBLICATION IN
RATIFICATIO OJEC
N
38
REFERENCE YEAR OF TITLE PUBLICATION IN
RATIFICATIO OJEC
N
39
REFERENCE YEAR OF TITLE PUBLICATION IN
RATIFICATIO OJEC
N
40
REFERENCE YEAR OF TITLE PUBLICATION IN
RATIFICATIO OJEC
N
41
REFERENCE YEAR OF TITLE PUBLICATION IN
RATIFICATIO OJEC
N
44
REFERENCE YEAR OF TITLE PUBLICATION IN
RATIFICATIO OJEC
N
45
REFERENCE YEAR OF TITLE PUBLICATION IN
RATIFICATIO OJEC
N
46
REFERENCE YEAR OF TITLE PUBLICATION IN
RATIFICATIO OJEC
N
47
3.2. EUROPEAN STANDARDS RELATING TO THE PPE DIRECTIVE BUT NOT
(YET) PUBLISHED
We would like to draw your attention to the fact that the use of the following indicated
standards does not provide a presumption of conformity : these standards may be used
as guidance by manufacturers.
48
REFERENCE YEAR OF TITLE
RATIFICATION
49
3.3. DRAFT EUROPEAN STANDARDS RELATING TO THE PPE DIRECTIVE
This list provides information on draft standards under preparation in the framework of the
PPE Directive. These standards are at the stage of public enquiry or - if having passed this
stage - still having to be formally adopted as EN standards.
We draw your attention to the fact that the above indicated draft standards can be subject to
substantial modification before their adoption. The manufacturers may consider them as
general guidelines, having in mind that the solutions proposed by these draft standards may
be abandoned or refused at a later stage of the adoption procedure.
The recourse to the draft standards should therefore be carried out with extreme caution.
50
REFERENCE TITLE DATE
51
REFERENCE TITLE DATE
EN 355/prA1 Personal protective equipment against falls from a height - Aug. 1997
Energy absorbers
prEN 358 rev Personal protective equipment for work positioning and Jul. 1999
prevention or falls from a height - Belts for work
positioning and restraints and work positioning landyards
EN 360/prA1 Personal protective equipment against falls from a height - Aug. 1997
Retractable type fall arresters
EN 361/prA1 Personal protective equipment against falls from a height - Aug. 1997
Full body harnesses
EN 362/prA1 Personal protective equipment against falls from a height - Aug. 1997
Connectors
EN 363/prA1 Personal protective equipment against falls from a height - Aug. 1997
Fall arrest systems
prEN 374-1 rev Protective gloves against chemicals and micro-organisms Feb. 1998
- Part 1 : Terminology and performance requirements
prEN 374-2 rev Protective gloves against chemicals and micro-organisms Feb. 1998
- Part 2 : Determination of resistance to penetration
prEN 374-3 rev Protective gloves against chemicals and micro-organisms Feb. 1998
- Part 3 : Determination of resistance to permeation by
chemicals
prEN 381-4 Protective clothing for users of hand-held chain saws - Aug. 1998
Part 4: Test method for chainsaw protective gloves
prEN 381-7 Protective clothing for users of hand-held chain saws - Aug. 1998
Part 7: Requirements for chain saw protective gloves
prEN 388 Protective gloves against mechanical risks Jun. 1998
EN 397/prA1 Industrial safety helmets May 1998
prEN 402 rev Respiratory protective devices for escape - Self-contained Dec. 1998
open-circuit compressed air breathing apparatus with full
face mask or mouthpiece assembly - Requirements,
testing, marking
prEN 405 rev Respiratory protective devices - Valved filtering half Aug. 1997
masks to protect against gases or gases and particles -
Requirements, testing, marking
prEN 420 rev General requirements for gloves Apr. 1998
prEN 466-2 Protective clothing - Protection against liquid chemicals - Aug. 1996
Part 2 : Performance requirements for chemical protective
clothing with liquid tight connections between different
parts of the clothing for emergency teams (Type 3
Equipment)
prEN 469 rev Protective clothing for firefighters - Requirements and test Nov. 1998
methods for protective clothing for firefighting
52
REFERENCE TITLE DATE
prEN 943-1 Protective clothing for use against liquid and gaseous Oct. 1997
chemicals, including liquid aerosols and solid particles -
Performance requirements for ventilated and non-
ventilated "gas-tight" (Type 1) and "non-gas-tight" (Type
2) protective clothing
prEN 943-2 Protective clothing for use against liquid and gaseous Aug. 1996
chemicals, including liquid aerosols and solid particles -
Part 2 : Performance requirements "gas-tight" (Type 1)
chemical protective suits for emergency teams ( ET )
EN 966/prA1 Helmets for airborne sports Jul. 1998
prEN 1082-2 Protective clothing - Gloves and arm guards protecting May 1999
against cuts and stabs by hand knives - Part 2 : Gloves
and arm guards made of material other than chain mail
prEN 1082-3 Protective clothing - Gloves and arm guards protecting Jan. 1999
against cuts and stabs by hand knives - Part 3 : Impact
cut test for fabric, leather and other material
EN 1146/prA2 Respiratory protective devices for self-rescue - Self- Dec. 1998
contained open-circuit compressed air breathing
apparatus incorporating a hood (compressed air escape
apparatus with hood) - Requirements, testing, marking
prEN 1511 Protective clothing - Protection against liquid chemicals - Aug. 1997
Performance requirements for limited use chemical
protective clothing with liquid-tight connections between
different parts of the clothing (Limited use type 3
Equipment)
prEN 1512 Protective clothing - Protection against liquid chemicals - Aug. 1997
Performance requirements for limited use chemical
protective clothing with spray-tight connections between
different parts of the clothing (Limited use type 4
Equipment)
prEN 1513 Protective clothing - Protection against liquid chemicals - Aug. 1997
Performance requirements for limited use garments
providing chemical protection to parts of the body (Limited
use partial body protective equipment)
prEN 1621-2 Motorcyclists'protective clothing against mechanical Feb. 1999
impact - Part 2 : Requirements and test methods for back
protectrs
prEN 1835 Respiratory protective devices - Light duty compressed air Dec. 1998
line breathing apparatus incorporating helmet or hood -
Requirements, testing, marking
prEN ISO 4869-4 Acoustics - Hearing protectors - Part 4 : Method for the Aug. 1999
measurement of effective sound for level dependent
sound restoration earmuffs
53
REFERENCE TITLE DATE
prEN ISO 6529 Protective clothing - Protection against chemicals - Jun. 1998
Determination of resistance of protective clothing
materials to permeation by liquids and gases (revision of
6529:1998)
prEN ISO 6942 Protective clothing - Protection against heat and fire - May 1998
Methods of test : Evaluation of materials and material
assemblies when exposed toa source of radiant heat
(ISO/DIS 6942:1997)
prEN ISO 11610 Protective clothing - Glossary of terms and definitions Nov. 1997
(ISO/DIS 11610:1997)
prEN ISO 11611 Protective clothing for use in welding and allied processes Apr. 1999
(Revision of EN 470-1:1995)
prEN ISO 12402-1 Personal floatation devices - Part 1 : Class A (SOLAS Jan. 1999
lifejackets), safety requirements
prEN ISO 12402-2 Personal floatation devices - Part 2 : Class B (offshore Jan. 1999
lifejackets, extreme conditions - 275N), safety
requirements
prEN ISO 12402-3 Personal floatation devices - Part 3 : Class C (offshore Jan. 1999
lifejackets - 150N), safety requirements
prEN ISO 12402-4 Personal floatation devices - Part 4 : Class D (inland/close Jan. 1999
to shore lifejackets - 100N), safety requirements
prEN ISO 12402-5 Personal floatation devices - Part 5 : Class E (buoyancy Jan. 1999
aids - 50N), safety requirements
prEN ISO 12402-6 Personal floatation devices - Part 6 : Class F (special Jan. 1999
purpose devices) - Additional, specific safety
requirements
prEN ISO 12402-7 Personal floatation devices - Part 7 : Materials and Jan. 1999
components, safety requirements and test methods
prEN ISO 12402-8 Personal floatation devices - Part 8 : Additional items, Jan. 1999
safety requirements and test methods
prEN ISO 12402-9 Personal floatation devices - Part 9 : Test methods for Jan. 1999
classes A to F
prEN 12477 Protective gloves for welders Feb. 1999
prEN 12492 Mountaineering equipment - Climbers safety helmets - Aug. 1996
Safety requirements and test methods
prEN 12628 Diving accessories - Combined buoyancy and rescue Oct. 1996
devices - Functional and safety requirements, test
methods
prEN 12841 Personal protective equipment for prevention or falls from Apr. 1997
a height - Work positioning systems - Rope adjustment
devices
54
REFERENCE TITLE DATE
prEN 13034 Protective clothing against liquid chemicals - Performance Sep. 1997
requirements for chemical protective suits offering limited
protective performance against liquid chemicals (type 6
equipment)
prEN 13061 Protective clothing - Shin guards for soccer players - Oct. 1997
Requirements and test methods
prEN 13087-1 Protective helmets - Test methods - Part 1 : Conditions Sep. 1999
and conditioning
prEN 13087-2 Protective helmets - Test methods - Part 2 : Shock Sep. 1999
absorption
prEN 13087-3 Protective helmets - Test methods - Part 3 : Resistance to Sep. 1999
penetration
prEN 13087-4 Protective helmets - Test methods - Part 4 : Retention Jul. 1998
system effectiveness
prEN 13087-5 Protective helmets - Test methods - Part 5 : Retention Jul. 1998
system strength
prEN 13087-6 Protective helmets - Test methods - Part 6 : Field of vision Mar. 1998
prEN 13087-7 Protective helmets - Test methods - Part 7 : Flame Mar. 1998
resistance
prEN 13087-8 Protective helmets - Test methods - Part 8 : Electrical Apr. 1998
properties
prEN 13087-9 Protective helmets - Test methods - Part 9 : Mechanical May 1998
rigidity
prEN 13087-10 Protective helmets - Test methods - Part 10 : Resistance Apr. 1998
to radiant heat
prEN 13105 Respiratoty protective devices - Full face mask connected Dec. 1997
with head protection for use as a part of a respiratory
device by firefighters - Requirements, testing, marking
prEn 13138-1 Buoyant aids for swimming instruction - Part 1 : Buoyant Jan. 1998
aids to be worn - Safety requirements and test methods
prEn 13138-2 Buoyant aids for swimming instruction - Part 2 : Aug. 1998
Requirements and test methods for buoyant aids to be
held
prEN 13158 Protective clothing - Protective jackets, body and shoulder Apr. 1999
protectors for horse riders - Requirements and test
methods
prEN 13178 Personal eye protection - Eye protectors and face-shields Jan. 1999
for snow mobile users
prEN 13274-1 Respiratory protective devices - Methods of test - Part 1 : Jun. 1998
Determination of inward leakage and total inward leakage
prEN 13274-2 Respiratory protective devices - Methods of test - Part 2 : Jun. 1998
Practical performance tests
55
REFERENCE TITLE DATE
prEN 13274-3 Respiratory protective devices - Methods of test - Part 3 : Jun. 1998
Determination of breathing resistance
prEN 13274-4 Respiratory protective devices - Methods of test - Part 4 : Jun. 1998
Determination of resistance to flame and flammabilty
prEN 13274-5 Respiratory protective devices - Methods of test - Part 5 : Jun. 1998
Climatic conditions
prEN 13277-1 Protective equipment for martial arts - Part 1 : General Jul. 1999
requirements and test methods
prEN 13277-2 Protective equipment for martial arts - Part 2 : Additional Jul. 1999
requirements and test methods for instep protectors, shin
protectors and forearm protectors
prEN 13277-3 Protective equipment for martial arts - Part 3 : Additional Jul. 1999
requirements and test methods for trunk protectors
prEN 13277-4 Protective equipment for martial arts - Part 4 : Additional Jul. 1999
requirements and test methods for head protectors
prEN 13277-5 Protective equipment for martial arts - Part 5 : Additional Jul. 1999
requirements and test methods for genital protectors and
abdominal protectors
prEN 13287 Safety, protective and occupational footwear for Jul. 1998
professional use - test method and specifications for the
determination of slip resistance
prEN 13319 Diving accessories - Depth gauges and combined depth Sep. 1999
and time measuring devices - Functional and safety
requirements, tests methods
prEN 13356 High visibility accessories for non-professional use - Test Oct. 1998
methods ands requirements
prEN 13406-1 Ergonomic requirements for work with visual display Jan. 1998
based on flat panels - Part 1 : Introduction (ISO/DIS
13406-1:1998
prEN 13484 Helmets for users of luges Jan. 1999
prEN ISO 13506 Protective clothing against heat and flame - Test method Oct. 1998
for complete garments - Prediction of burn injury using an
instrumented manikin (ISO/DIS 13506:1998)
prEN 13567 Protective clothing - Hand, arm, abdomen, leg, genital and Apr. 1999
face protectors for fencers - Requirements and test
methods
prEN 13982-1 Protective clothing for use against solid particulate Aug. 1999
chemicals - Peformance requirements for chemical
protective clothing providing protection to the full body
against solid particulate chemicals (type 5 clothing)
prEN ISO 13995 Protective clothing - Mechanical properties - Test method Jun. 1998
for the determination of resistance to puncture and
dynamic tearung of materials (ISO/DIS 13995:1998)
56
REFERENCE TITLE DATE
57
3.4. EUROPEAN STANDARDS RELATING TO THE PPE FIELD BUT NOT TO THE
PPE DIRECTIVE
We would like to draw your attention to the fact that the use of the above indicated standards
does not provide a presumption of conformity : these standards may be used as guidance by
manufacturers of personal protective equipment.
58
REFERENCE YEAR OF TITLE
RATIFICATION
59
REFERENCE YEAR OF TITLE
RATIFICATION
60
61
PART 4
This section contains “fiches”, or information sheets, which have been established by the
European Co-ordination of Notified Bodies for Personal Protective Equipment in order to
assist these bodies in their task of product verification, in accordance with the terms of the
Directive.
These information sheets have been discussed by the Member States, who did not raise major
comments on them.
All parties should be aware of their existence; however, they shall keep in mind that they can
use them only as general reference.
The key addresses of the European Co-ordination and Cooperation between notified bodies
for personal protective equipment are also given at the start of this section.
62
European Coordination and Cooperation Between Notified Bodies for Personal
Protective Equipment (PPE)
Horizontal Committee and Vertical Group Information
63
Vertical Group 5 Vertical Group 9
"Protective Clothing, Hand and Arm "Protective Clothing for Motorcycle Riders"
Protection"
Chairperson: Ch. Meyer, RICOTEST
Chairperson: J. Bahima Via Einaudi 6-8
I.N.S.H.T./C.N.M.P. I - 37010 Sandra/VR
Autovia de San Pablo, Km. 4 phone: +39/45/759 5266
Apartado de Correos 615 fax: +39/45/759 6236
E - 41080 Sevilla e-mail: [email protected]
phone: +34/5/451 41 11
fax: +34/5/467 27 97
e-mail: [email protected]
Vertical Group 8
"Lifejackets"
Chairperson: J. Matthews
Fleetwood Testing Laboratory
Fleetwood Nautical Campus
GB - Broadwater Fleetwood
Lancashire FY7 8JZ
phone: +44/1253/779 123
fax: +44/1253/773 014
64
Recommendation for Use Sheets
Approval Approval
Number Revision Key Words Horizontal Standing
Committee Committee
00.001 01 declaration of conformity 24/06/94 01/07/96
00.002 03 technical file, control and test facilities 31/05/96 03/06/97
00.003 01 EC type examination certificate, withdrawal 24/06/94 01/07/96
00.005 03 EC type examination certificate 31/05/96 03/06/97
00.006 03 sub-contracting, accreditation, acceptance of test results, 31/05/96 03/06/97
competence of laboratories
00.007 03 retention, technical file, samples, liability 31/05/96 03/06/97
00.008 01 user information, availability 24/06/94 01/07/96
00.010 01 user information, conformity assessment 24/06/94 01/07/96
00.011 01 technical file 24/06/94 01/07/96
00.012 03 EC type examination, application 31/05/96 03/06/97
00.013 02 EC type examination certificate, withdrawal, extension, 31/05/96 01/07/96
refusal
00.014 01 certification, modified model 24/06/94 01/07/96
00.015 01 limited series, individual items of PPE 24/06/94 01/07/96
00.016 03 EC type examination procedure, harmonised standards 31/05/96 03/06/97
00.017 01 test reports 24/06/94 01/07/96
00.018 03 standards, deficiencies 31/05/96 03/06/97
00.019 01 user information 24/06/94 01/07/96
00.020 01 testing of materials 24/06/94 01/07/96
00.021 01 EC type examination certificate, modification of products 24/06/94 01/07/96
00.022 01 identification of test samples 24/06/94 01/07/96
00.023 02 Article 11 A, quality control, manufacturer 31/05/96 01/07/96
00.024 02 Article 11 A, quality control, checks 31/05/96 01/07/96
00.025 02 Article 11 A, quality control, application of CE marking 31/05/96 01/07/96
00.026 02 Article 11 A, quality control, time interval 31/05/96 01/07/96
00.028 01 EC type examination certificate, validity 24/06/94 20/05/95
00.029 01 CE marking, categories 24/06/94 20/05/95
00.030 03 Article 11 A, necessary checks 27/05/98 20/04/98
00.031 01 Article 11 A and B, withdrawal of certificates 02/06/95 01/07/96
00.032 01 manufacturer, authorized representative 02/06/95 01/07/96
00.036 03 period of obsolescence 27/05/98 20/04/98
00.038 03 components from different manufacturers 27/05/98 20/04/98
00.046 04 marking, standard reference, testing according to PrEN 26/05/99 21/06/99
00.048 03 Article 11 A, sampling 11 A procedures 04/06/97 20/04/98
00.052 03 test reports, designation of materials 04/06/97 20/04/98
00.058 03 test reports, materials 04/06/97 20/04/98
00.061 03 slip resistance, type examination certificate 18/11/97
00.064 03 type examination for category I PPE 04/06/97 20/04/98
65
Approval Approval
Number Revision Key Words Horizontal Standing
Committee Committee
00.068 04 revision of standard, validity, EC type examination 26/05/99 21/06/99
certificate
00.074 04 Article 11 A, change of certificate 04/06/97 20/04/98
00.075 04 distribution, type examination certificate 04/06/97 20/04/98
00.077 03 information to users 04/06/97 20/04/98
00.080 02 production plant 18/11/97
00.081 03 Article 1 and 2 (c), interchangeable components, EC type 27/05/99 21/06/99
examination
00.084 03 Article 11 B, Quality Assurance System, Supervision 27/05/98 20/04/98
00.085 03 Article 11 B, Quality Assurance System, Article 11B 1 (b) 05/01/98 20/04/98
00.086 03 Article 11 B, Quality Assurance System, Audit, 05/01/98 20/04/98
Composition of Auditing Team
00.087 03 Article 11 B, Quality Assurance System 05/01/98 20/04/98
00.088 03 Article 11 B, Quality Assurance System, Supervision, 05/01/98 20/04/98
Frequency of Audits
00.089 03 Article 11 B, (c) 05/01/98 20/04/98
00.090 03 Article 11 A and B, 11.B (b) / 11.A.3 05/01/98 20/04/98
00.092 02 Article 1.4 (I) and Annex II, notified body reference, 26/05/99 21/06/99
information supplied by the manufacturer
00.093 02 element, CE marking 27/05/99 21/06/99
00.094 02 harmonised standards, essential requirements, EC type 27/05/99 21/06/99
examination
66
CNB/P/00.001
CO-ORDINATION OF NOTIFIED BODIES
Revision 01
PPE-Directive 89/686/EEC + amendments Language : E
Question :
Which purpose does the declaration of conformity of the manufacturer serve?
Is it to be presented with each delivery of a PPE?
Solution :
The declaration of conformity has to be drawn up by the manufacturer to certify that the PPE placed on the market is in
conformity with the directive; it is the basis for CE marking.
The general opinion is that the declaration of conformity is to be issued by the manufacturer only once and has to be kept
with the documentation of the manufacturer.
This documentation has to be presented to the authorities on request.
Sent for information to : ¨ members of the VG¨ other(s) VG þ HC (2) ¨TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
67
CNB/P/00.002
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
Which minimal requirements are to be established for the control and test equipment of the manufacturer?
Some notified bodies consider the verification of the manufacturer's control and test equipment a part of the type
examination, others argue that this is not necessary, since article 10.4 (a) of the directive refers to the manufacturer's
technical file, which according to annex III does not include the description of the control and test facilities.
Solution :
The requirements must be seen in connection with the technical file mentioned in the directive which must describe the
control and testing. The notified body must be convinced that the system described is sufficient.
The verification of the control and test equipment of the manufacturer is required only in relation to quality control
according to article 11 B.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
68
CNB/P/00.003
CO-ORDINATION OF NOTIFIED BODIES
Revision 01
PPE-Directive 89/686/EEC + amendments Language : E
Question :
On which basis can a valid EC type examination certificate be withdrawn?
Solution :
An EC type examination certificate has to be withdrawn as soon as the notified body gets knowledge of any circumstances
indicating that the tested model of the PPE does no longer meet the requirements of the directive for reasons which had not
been known at the time when the certificate was issued.
It is recommended to note on the document that the certificate is the property of the notified body.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
69
CNB/P/00.005
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
Is it possible to issue certificates for one and the same product to different applicants (such as manufacturer and commission
agent)?
Solution :
There can only be one type examination certificate for each single named product.
It was, however, acknowledged that several declarations of conformity can be issued on the basis of this type examination
certificate.
Sent for information to : ¨ members of the VG ¨other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5
70
CNB/P/00.006
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question : Is it possible for a certification body to accept test data obtained by other than accredited laboratories?
Are test reports from authorities outside the Community acceptable for the purpose of CE marking?
If this is so, what is the minimum criteria to be used in judging their competency and how should they be monitored?
What quality control methods should be applied to sub-contracting laboratories?
Can the notified body use test reports on materials, items or components carried out by other specialised laboratories?
Can the notified body use reports on tests carried out by the manufacturer or the applicant?
Solution :
Under all circumstances, the notified body takes on the responsibility for test results/test reports it accepts as the basis for
certification.
Therefore, it should generally be recommended to use test results from accredited test laboratories only.
As this will not always be possible, other sources of testing have to be used. Sub-contracting laboratories should meet the
requirements according to EN 45 001, if this is not the case, the notified body has to ensure by other means that the test
results are reliable.
The notified body itself will have to specify the conditions for the acceptance of other test laboratories to carry out the tests.
In all cases, a sub-contracting laboratory must satisfy condition (3) of Annex V of the directive.
Quality control measures for sub-contracting test laboratories are important, the notified body itself is responsible for
deciding how to proceed with this.
Sent for information to : ¨members of the VG ¨other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
71
CNB/P/00.007
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
For how long must the EC type examination files, reference samples and tested items be stored?
Solution :
The directive specifies that the technical file will have to be held at the disposal of the authorities for 10 years following the
placing on the market of the PPE.
Some more information on the required retention of the technical file is given in EN 45 000.
In addition, the specifications of the product liability directive (85/374/EEC) should be taken into consideration.
Sent for information to : ¨members of the VG ¨other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
72
CNB/P/00.008
CO-ORDINATION OF NOTIFIED BODIES
Revision 01
PPE-Directive 89/686/EEC + amendments Language : E
Question :
Questions have been raised concerning the user information to be supplied by the manufacturer, especially with regard to
protective gloves.
Some notified bodies seem to interpret the directive and prEN 420 (protective gloves) to mean that it is sufficient, if the user
information is available on request, whereas other notified bodies require the user information to be supplied with each item
of PPE.
Solution :
The user information should be supplied with each item of PPE (the smallest commercial package available) as it is believed
that this is the spirit of the directive and provides the information where and when it is most needed.
Sent for information to : ¨members of the VG ¨other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
73
CNB/P/00.010
CO-ORDINATION OF NOTIFIED BODIES
Revision 01
PPE-Directive 89/686/EEC + amendments Language : E
Question :
Notified bodies that carry out certification procedures for foreign manufacturers have to decide what language version of the
user information will be checked in the framework of conformity assessment.
Solution :
The notified body can choose which languages it does accept for testing. Any translation is the responsibility of the
manufacturer / authorized representative. It would be useful, however, to note in the test report which language version was
checked.
Sent for information to : ¨members of the VG ¨other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
74
CNB/P/00.011
CO-ORDINATION OF NOTIFIED BODIES
Revision 01
PPE-Directive 89/686/EEC + amendments Language : E
Question :
What does the manufacturing technical file have to contain?
Solution :
A complete list of the information to be included in the technical file is laid down in annex III of the directive.
Sent for information to : ¨members of the VG ¨other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
75
CNB/P/00.012
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
How can it be assured that the manufacturer has not presented the same file to two or even several notified bodies?
How can it be assured that the manufacturer does not re-submit a file having been the subject of a previous EC type
examination certificate refusal decision?
Solution :
The manufacturer will be asked for a written confirmation that he has not submitted the same file to another notified body
and that the model presented for examination has not been the subject of any previous EC type certificate refusal decision.
For the future, an information system is considered useful. The Commission will be asked whether the directive provides a
legal basis for the establishment of such a system.
Sent for information to : ¨ members of the VG ¨other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
76
CNB/P/00.013
CO-ORDINATION OF NOTIFIED BODIES
Revision 02
PPE-Directive 89/686/EEC + amendments Language : E
Question :
How should:
- the EC type examination certificate
- the withdrawal of an EC type examination certificate
- an EC type certificate extension
- an EC type examination certificate refusal
be written?
Solution :
The general points to be included in the documents are laid down in the directive, the notified bodies being free to decide on
the form of presentation.
For future discussions on the possiblility of a harmonization of certificates, the notified bodies are asked to send samples of
their forms to the secretariat.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
77
CNB/P/00.014
CO-ORDINATION OF NOTIFIED BODIES
Revision 01
PPE-Directive 89/686/EEC + amendments Language : E
Question :
What is the procedure to be applied to the examination of variants of a PPE?
Which criteria should be taken into account for the certificate?
Solution :
The notified body is free to decide whether it will grant extensions to existing certificates or it prefers issuing a new
certificate for the variant to be certified.
A PPE is considered as a variant of a reference PPE only if it differs on points which have no noticeable influence on the
expected performances. The variants can correspond to differences relating in particular to dimensions, shape, nature of
constituent materials, colour, assembly methods, manufacturing processes etc.
It will be useful to consider in the vertical groups what criteria allow for acceptance of a modified model, e.g. modifications
with regard to accessories, colours, types of glues, an additional size, etc. which do not change the essential functions of
protection.
It is the responsibility of the notified body to evaluate for each individual case if a given PPE can effectively be considered as
a variant. In case of doubt, it will carry out any check, measurement or test considered to be useful.
In every case and for each of the variants, the applicant will provide the notified body with a detailed description indicating
the differences in comparison with the reference model and the number of examples of these variants required for
complementary checks and tests.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
78
CNB/P/00.015
CO-ORDINATION OF NOTIFIED BODIES
Revision 01
PPE-Directive 89/686/EEC + amendments Language : E
Question :
What is the EC type examination procedure for limited series and PPE manufactured singly?
Solution :
In the logic of the EC directives, the model of the PPE (prototype) has to be submitted to an EC type examination before
serial production starts.
Sent for information to :¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
79
CNB/P/00.016
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
What is the procedure to be applied to the EC type examination in the absence of test methods provided by the appropriate
harmonized European standards?
Solution :
The notified body has to decide what will be the basis for testing against the requirements of the directive.
The manufacturer has to set the specification for the product and ask for certification against this specification. Under
normal circumstances, the specifications of the manufacturer will remain strictly confidential.
The notified body is responsible for assessing whether or not the specification meets the applicable requirements of annex II
and determining whether or not the submitted PPE does comply with the requirements.
It is recommended to refer to existing standards (national or ISO (international)) whenever possible.
If this is not possible, the notified body should identify the objectives to be reached in testing for conformity with the
requirements and specify test procedures appropriate for the EC type examination.
The proposed method may be discussed with the notified bodies if this is necessary. If there is a general interest in a
harmonization of the test procedure, the subject should be brought into the European standardization committee responsible.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
80
CNB/P/00.017
CO-ORDINATION OF NOTIFIED BODIES
Revision 01
PPE-Directive 89/686/EEC + amendments Language : E
Question :
presentation of test reports
Solution :
It was generally agreed that no harmonized format is necessary for the presentation of test reports.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
81
CNB/P/00.018
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
What action should be taken if deficiencies or mistakes in standards are detected?
Solution :
Deficiencies and mistakes in standards always have to be discussed in the relevant CEN/TC or WG. Therefore, as soon as
any such mistake is recognized, the appropriate body has to be informed and asked to take action for a possible revision of
the standard as soon as possible.
In addition to that, the problem should be discussed within the vertical group so that a general approach to the problem is
laid down and the notifed bodies can agree how to proceed with the testing before a revision of the standard is published.
The relevant TC or WG should be informed of any such interim solution.
If the problem is of general interest, the Horizontal Committee should be informed so that the subject can be discussed at
Horizontal Committee level and, if necessary, with the relevant CEN authorities.
The European Commission will receive lists of the existing Recommendation for Use sheets for information.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
82
CNB/P/00.019
CO-ORDINATION OF NOTIFIED BODIES
Revision 01
PPE-Directive 89/686/EEC + amendments Language : E
Question :
On which point should the verification on the information/instruction notice provided by the certificate applicant be focused?
Solution :
Within the EC type examination framework, the notified body ensures that the information/instruction notice from the
manufacturer or applicant covers all the items of article 1.4 of annex II of directive 89/686/EEC modified and that it is
presented in an accurate and understandable way.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
83
CNB/P/00.020
CO-ORDINATION OF NOTIFIED BODIES
Revision 01
PPE-Directive 89/686/EEC + amendments Language : E
Question :
Is it permissible to carry out tests on materials, parts or components identical to those comprising the PPE instead of
carrying out tests on the PPE itself? If so, what are the conditions to be met for type approval and for production control?
Solution :
It is possible to carry out tests on materials described in the standards with the sample taken either on the PPE itself or on a
sample of the material if the manufacturer attests (in writing) that it is strictly identical to that used in the construction to the
PPE and if the notified body can confirm the identity by examination of the reference PPE and the samples supplied. This
procedure should be limited to a specific case as, for example, when referring to high cost PPE produced in small quantities.
The applicant has to supply one example of the PPE submitted to EC type examination so that the notified body can check
that the materials or items put forward for testing are indeed identical to those composing the PPE.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
84
CNB/P/00.021
CO-ORDINATION OF NOTIFIED BODIES
Revision 01
PPE-Directive 89/686/EEC + amendments Language : E
Question :
What should the manufacturer or his authorized representative established in the Community do in the case of a
modification to a PPE model having been the subject of an EC type examination certificate?
Solution :
The directive does not explicitly provide for the case of modification of a PPE model having been the subject of an EC type
examination certificate.
The manufacturer or his authorized representative established in the Community has to inform the notified body that
delivered the EC type examination certificate of any intended modification of the PPE.
The notified body then has to decide whether the modification does or does not require new type examination procedures.
If the modification only involves minor changes not affecting the safety characteristics of the product, the notified body
informs the applicant that the EC type examination certificate will continue to be valid for the modified mode. It may then
either deliver a type examination certificate extension or a new certificate.
If the modification consists of major changes to the product, the notified body has to inform the manufacturer or the
authorized representative that the certificate cannot be transferred to the modified model. If the manufacturer intends to keep
the modifications, he will be required to make a new official request for an EC type examination.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
85
CNB/P/00.022
CO-ORDINATION OF NOTIFIED BODIES
Revision 01
PPE-Directive 89/686/EEC + amendments Language : E
Question :
What are the measures to be taken for the identification of tested models for any subsequent controlling inspection or
expertises?
Solution :
There must be no ambiguity regarding the identification of the PPE having been submitted as a type (model) to a notified
body for EC type examination.
PPE placed on the market are the subject of the tested type declaration of conformity.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
86
CNB/P/00.023
CO-ORDINATION OF NOTIFIED BODIES
Revision 02
PPE-Directive 89/686/EEC + amendments Language : E
Question :
Article 11 A of the directive refers to "a manufacturer", but who is "a manufacturer"?
Solution :
Agreement that the manufacturer in this context must at least carry out the final assembly of the PPE. This is necessary due
to the responsibility to ensure homogeneity of production, which can only be achieved through controlling the
manufacturing process.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
87
CNB/P/00.024
CO-ORDINATION OF NOTIFIED BODIES
Revision 02
PPE-Directive 89/686/EEC + amendments Language : E
Question :
At what frequency should the required "necessary checks" (as referred to in article 11 A) be carried out?
Solution :
A minimum of one per year, the year starting from the date of issue of the certificate.
Sent for information to ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
88
CNB/P/00.025
CO-ORDINATION OF NOTIFIED BODIES
Revision 02
PPE-Directive 89/686/EEC + amendments Language : E
Question :
Should the checks referred to in article 11 A.2 be carried out before the application of the CE marking or afterwards?
Solution :
As a minimum the manufacturer must have entered into a formal agreement with a notified body for assessment against 11
A. This is explicit in article 12 of the directive, whereby the EC declaration is drawn up before the application of the CE
marking and part of the declaration states which body is/will be supervising the 11 A procedure.
The amending directive covering the application of the CE marking requires the number of the notified body responsible for
administering article 11 to be added to the marking. It would appear sensible for notified bodies to have checked a
company's control procedure before agreeing to its number being marked on the product.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
89
CNB/P/00.026
CO-ORDINATION OF NOTIFIED BODIES
Revision 02
PPE-Directive 89/686/EEC + amendments Language : E
Question :
What does "random" mean (in article 11 A.2)?
Solution :
For on-site assessments the interval between visits to be varied, and for remote sampling selection without the
manufacturer's advance knowledge. Where samples are to be selected from distributors, warehouses etc. it may be necessary
to arrange visits directly with the people concerned.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
90
CNB/P/00.028
CO-ORDINATION OF NOTIFIED BODIES
Revision 01
PPE-Directive 89/686/EEC + amendments Language : E
Question :
Is it possible to limit the period of validity of certificates?
Solution :
The directive does not provide for a time limit concerning "EC" type certification. Therefore notified bodies cannot limit the
duration of certificates even on a voluntary basis. Manufacturers are under an obligation to put on the market PPE with a
high level of safety. The notified bodies should keep the manufacturer to whom they have provided an EC type certificate
informed on any major evolutions of the state of the art.
In this case, the manufacturer should make suggested modifications. In extreme cases, if the notified body estimates that the
PPE already put on the market does not comply with the essential requirements of the directive, it may then inform Member
State Authorities, and the latter can apply the safeguard clause.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
91
CNB/P/00.029
CO-ORDINATION OF NOTIFIED BODIES
Revision 01
PPE-Directive 89/686/EEC + amendments Language : E
Question :
CE marking according to the directive 93/68/EEC does not provide for a clear distinction between categories I and II. Is it
possible to amend the provisions on CE marking so as to include a distinction, as this is considered to be helpful to the user?
Solution :
At the moment there is no intention to change the situation by another amending text.
Sent for information to : ¨ members of the VG ¨other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
92
CNB/P/00.030
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
What are the necessary checks required under article 11 A.2?
Solution :
Each certified model to be selected by the notified body at least once per year. The notified body has an obligation to sample
and test products that adequately represent the products within the family / group of products.
The selected sample(s) must be checked for compliance with the type described in the EC type approval certificate and the
relevant basic requirements of the directive.
That means, the compliance with 11 A is checked by every model tested once a year, no assessment of the manufacturing
process.
Sent for information to : ¨members of the VG ¨other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
93
CNB/P/00.031
CO-ORDINATION OF NOTIFIED BODIES
Revision 01
PPE-Directive 89/686/EEC + amendments Language : E
Question :
What procedure should be followed in the event of failures during 11 A and 11 B examinations?
Solution :
In the event of failures in 11 A and 11 B examinations, the notified body concerned has to decide in each individual case,
taking into account the reasons that lead to the failure and the risks involved.
In serious cases (danger of life) the notified body should proceed to withdraw the certificate; in that case the Member State
giving notification will have to be informed.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
94
CNB/P/00.032
CO-ORDINATION OF NOTIFIED BODIES
Revision 01
PPE-Directive 89/686/EEC + amendments Language : E
Question :
The directive always refers to the manufacturer or his authorized representative established in the Community. Can
manufacturers worldwide act equivalent to companies in the Communnity?
Solution :
The PPE group of the Standing Committee 89/392/EEC stated that the directive 89/686/EEC does not distinguish between
the manufacturer's location inside or outside the EEA. Only (authorized) representatives need to be based in the EEA.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
95
CNB/P/00.036
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
There are a few items of PPE for which a definitive life can be stated. In general, the time for which an item of PPE can be
used is dependent upon many and varied effects; for example storage, maintenance, conditions and frequency of use, etc.
This presents a problem for manufacturers required to state a period and for notified bodies in assessing whether or not this
requirement is complied with.
A practical solution is required which satisfies the spirit of the Directive and supplies the necessary information to the user.
Recommended solution :
All relevant information on the period of obsolescence and/or instructions to enable the user to assess and inspect the item to
determine whether or not the item can continue to be used.
Individual vertical groups may define more detailed specifications for different types of PPE.
(see annex II, 2.4)
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
96
CNB/P/00.038
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
Should a notified body agree to issue an EC Type Examination for a product submitted by manufacturer "A" which includes
interchangeable components produced by a manufacturer "B" where the product requires to be tested as a complete device?
for example:
a) filters for an air powered device
b) chemical protective clothing without a hood and/or boots
c) helmet mounted ear muffs
Recommended solution :
A notified body is responsible for reviewing the Technical Documentation for compliance with the relevant requirements of
the Directive. Provided the client's documentation submitted covers all the applicable requirements the notified body may
perform or arrange for the necessary tests to be carried out and if found satisfactory issue an EC Type Examination
Certificate.
Note: It is the manufacturer "A"'s responsibility to monitor that each subsequent product is in conformance with that tested
for the EC Type Examination and that the product manufactured by "B" remains the same and compatible with his
tested product.
Sent for information to :¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þSC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
97
CNB/P/00.046
CO-ORDINATION OF NOTIFIED BODIES
Revision 04
PPE-Directive 89/686/EEC + amendments Language : E
Question :
If only a prEN is available at the time of EC type approval, can the product be marked with the standard number „EN ...“?
Where the EC type examination is issued against a prEN, can EN be marked on the product, once the standard is ratified?
Recommended solution :
Marking with a standard reference is not mandatory by the directive.
Where a manufacturer decides to mark a standard or prEN on his product, the following principles apply:
As long as no final standard exists or the final standard is not identical with the prEN, the marking cannot be "EN ...".
If the ratified EN is identical to the prEN, then „EN ...“ may be marked on the product.
Where the ratified EN is not identical to the prEN, then „EN ...“ cannot be marked on the product.
Marking with a prEN is not recommended. However, where a manufacturer decides to mark with the prEN used for the EC
type examination then it should be fully identified by year and/or issue.
Sent for information to :¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þSC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
98
CNB/P/00.048
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
What sampling procedures are possible for 11 A procedures for small series of PPE, e.g. 10 PPE manufactured per year,
especially if the tests are destructive tests?
Recommended solution :
If the 11A option is taken, sufficient testing must be undertaken by the notified body. It is up to the notified body to decide
how sampling could be done.
If the manufacturer does not want to follow the 11A route, the only option is the quality system route 11B.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
99
CNB/P/00.052
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
In test reports, materials are often only referred to by a single, mostly commercial reference name. In many cases, however,
this name covers a variety of materials different by structure and weight (for fabrics) or by origin and thickness (for leather).
Is it possible to have a uniform and clear "finger print designation" of materials in test reports in order to make an
evaluation easier?
For this purpose, we propose to use the elements as given below:
- aramid twill 2/1 - 270 g/m²
-Recommended
cow split 1.3 - 1.5
solution : mm.
A unique reference number or name identifying the material must be the same in the technical file and in the test report.
The technical file should contain a documentation of the material, i. e. a sample or a proper identification.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
100
CNB/P/00.058
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
How old can test reports be when they are used for type examination?
Recommended solution :
This is the responsibility of the notified body.
The general view is that there should be no time limit for previous tests.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
101
CNB/P/00.061
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
Does slip resistance have to be considered an essential requirement for safety, protective and occupational footwear?
Recommended solution :
Slip resistance is a general feature of safety, protective and occupational footwear.
Notified bodies have to carry out slip resistance testing, unless the manufacturer clearly claims in his product specification
and in the user information that the footwear does not meet this requirement.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
102
CNB/P/00.064
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
Could PPE which do not belong to categories II or III be submitted to an EC type examination on a voluntary basis?
Recommended solution :
Only PPE belonging to categories II or III can be submitted to an EC type examination procedure leading to the issue of an
EC type examination certificate.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
103
CNB/P/00.068
CO-ORDINATION OF NOTIFIED BODIES
Revision 04
PPE-Directive 89/686/EEC + amendments Language : E
Question :
When a new version of an EN standard is published, are manufacturers obliged to get their products tested to the
new/revised version or can they continue to sell their product(s)?
Recommended solution :
Current certificates remain valid. However, manufacturers have a responsibility to keep abreast of changes and to modify
their products in the light of these changes to continue to supply safe products, which may necessitate the issue of a new
certificate.
(see also 00.028, rev. 01)
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
104
CNB/P/00.074
CO-ORDINATION OF NOTIFIED BODIES
Revision 04
PPE-Directive 89/686/EEC + amendments Language : E
Question :
When controls carried out in accordance with article 11A give performance level classification figures, for example, lower
than those stated in the EC type examination certification, should the original EC type examination certificate be changed?
Recommended solution :
The EC type examination certificate cannot be altered, only withdrawn and a new one be issued to cover the new lower
performance levels. The product in this case has to get a new identification.
The procedure set out in the Directive should be followed. (Reference Article 11A, para 4 & 5)
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
105
CNB/P/00.075
CO-ORDINATION OF NOTIFIED BODIES
Revision 04
PPE-Directive 89/686/EEC + amendments Language : E
Question :
How should files concerning PPE likely to have several product identifications be processed?
Recommended solution :
There are two acceptable situations.
1) The original manufacturer or his authorised representative remains responsible for placingthe equipment on the
market
The manufacturer is the certificate holder, and established the declarations of conformity.
The technical construction file indicates the different forms of product identification and markings as well as the trade
name of the distributors. The various versions of the instruction handbook are subject to EC type-examination (with the
exception of direct translations into foreign languages).
2) The distributor or importer, acting as a manufacturer, is responsible for placing the equipment on the market
Being responsible for placing the equipment on the market, the distributor / importer must request an EC type
examination.
The certificate or the extension to the certificate is established in the trade name of whoever is responsible for placing the
equipment on the market. He, in turn, established the declarations of conformity in his name.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
106
CNB/P/00.077
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
What is the responsibility of the notified body in checking the information to users?
Recommended solution :
The notified body shall verify that the equipment can be used in complete safety for its intended purpose (directive, article 10
(4) b). In order to do this, the notified body shall check that the claims of the manufacturer on the area and limits of
protection of the product are in line with the technical specification used and with the relevant essential safety requirements.
One of the essential safety requirements in clause 1.4 „information supplied by the manufacturer“ is intended to contain all
relevant information needed for the selection and use. The notified body must check that this information is given according
to clause 1.4 and that it does not contain misleading statements and obvious mistakes concerning the protection provided.
The manufacturer has the final responsibility for the accuracy of the content.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
107
CNB/P/00.080
CO-ORDINATION OF NOTIFIED BODIES
Revision 02
PPE-Directive 89/686/EEC + amendments Language : E
Question :
Do certificates only cover PPE made at the production plant(s) specified either on the certificate or associated documents? If
no, is the certificate holder free to sub-contract production to any alternative plant, without reference to the Notified Body,
and apply the CE marking on the basis of the original certificate and declaration?
Recommended solution :
The Type Examination certificate is linked directly to the production plant(s) specified at the time of application.
- Only products made at the specified site(s) are covered by the certificate and these can be CE marked following the
drawing up of the necessary declaration.
- If alternative production plants are to be used, the Notified Body who issued the original certification must be
informed. The N.B. decides, in agreement with the manufacturer, what level of verification testing, if any, is required
before amending the certificate and/or the technical file.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
108
CNB/P/00.081
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
Should interchangeable components be submitted to an EC type examination?
Recommended solution :
Yes, an EC type examination certificate can be issued in accordance with Article 1;2 c.
The notified body shall carry out sufficient evaluation and/or testing to verify their suitability for the stated equipment in its
final assembly.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
109
CNB/P/00.084
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
What premises should be included in the supervision according to article 11 B (b), (c), (d)?
Recommended solution :
1) Inspection during and after the certification process must include the premises where the product is tested, inspected and
stored. This may be
− the manufacturing plant of an EEA manufacturer
− the manufacturing plant of a manufacturer outside the EEA with the latter wishing to be visited
− an importer holding the design authority of products manufactured abroad according to his instructions and
having installed an ISO 9003 system
− an importer without design authority buying from a manufacturer (with a recognised QA-system) abroad and
having installed an ISO 9003 system
An importer buying from (different) foreign non-EEA manufacturers without recognised QA-system and installing an
ISO 9003 system is not acceptable.
See also 00.085 rev. 02
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
110
CNB/P/00.085
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
What Quality Assurance System, with respect to EN ISO 9001, 9002, 9003, must the manufacturer establish?
Recommended solution :
It is generally accepted that under the terms of article 11B 1 (b) the manufacturer could establish a QA-system according to
ISO 9001, 9002 or 9003, with ISO 9003 representing the very minimum. In any case, additional product-related aspects are
to be considered by the notified body.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
111
CNB/P/00.086
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
How should the auditing team be composed?
Recommended solution :
1) At least one member of the auditing team must have experience and knowledge of the product technology
concerned.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
112
CNB/P/00.087
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
Must existing certificates relating to QA-Systems (ISO 9001/9002/9003) be accepted by a notified body?
Recommended solution :
No; but the notified body is able to take into account existing certificates relating to QA-systems (ISO 9001/9002/9003) if it
is convinced of the qualification of the certification body (accreditation, mutual recognition and others). In all cases the
notified body must add product and regulation-related aspects.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
113
CNB/P/00.088
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
What frequency of audits is necessary to fulfil the obligation arising from Article 11 B (2) of Directive 89/686/EEC?
Recommended solution :
A supervision frequency of at least once a year.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
114
CNB/P/00.089
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
When must ISO 9001/2/3: 1994 be used as the harmonised standard?
Recommended solution :
The certification and procedures, of notified bodies and manufacturers, which reference ISO 9001/2/3, must reference the
1994 version by the end of 1998, at the latest.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
115
CNB/P/00.090
CO-ORDINATION OF NOTIFIED BODIES
Revision 03
PPE-Directive 89/686/EEC + amendments Language : E
Question :
Must the "appropriate tests" be as specified in the product standard or product specification?
Recommended solution :
The manufacturer's routine/regular inspections and tests can be alternatives, providing that the manufacturer can prove there
is sufficient correlation. Where this is the case, the test/inspection programme against the product standard/specification can
be less frequent.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
116
CNB/P/00.092
CO-ORDINATION OF NOTIFIED BODIES
Revision 02
PPE-Directive 89/686/EEC + amendments Language : E
Question :
1. Has information on the notified body who certifies a PPE product to be included in the user information?
2. What is the correct interpretation of the PPE Directive as amended?
Recommended solution :
1. Yes. Reference 93/68/EEC (Article 7, para. 7) which amends section 1.4 requiring „the name, address and
identification number of the notified body involved in the design stage of the PPE;“
2. The details to be included in the manufacturer’s user information must be that of the notified body responsible for the
issue of the EC type examination.
It should be noted that in some cases more than one notified body may be involved, i. e. combined PPE. In such cases
the information supplied would be for each notified body involved.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
117
CNB/P/00.093
CO-ORDINATION OF NOTIFIED BODIES
Revision 02
PPE-Directive 89/686/EEC + amendments Language : E
Question :
May an element (e. g. attachment element, steel toe cap) which is not sold to the end user be CE marked?
Recommended solution :
No, these elements are items that are supplied to a manufacturer for the manufacture of PPE.
Note: Certain items may be CE marked under another directive.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
118
CNB/P/00.094
CO-ORDINATION OF NOTIFIED BODIES
Revision 02
PPE-Directive 89/686/EEC + amendments Language : E
Question :
When carrying out an EC type examination, what is the responsibility of the notified body when the applicable product
harmonised standard does not address all the relevant Health and Safety Requirements?
Recommended solution :
Where a relevant product harmonised standard does not address all the relevant Health and Safety Requirements the
manufacturer must identify those not addressed in the standard and also state how these are dealt with in his Technical File.
The notified body is responsible for confirming that all the relevant Health and Safety Requirements have been identified,
listed and adequately dealt with when carrying out their review, inspection and testing for the EC Type Examination.
Note 1: A product harmonised standard gives a presumption of conformity with those Basic Health and Safety
Requirements which it identifies for the product and addresses.
Note 2: It must be remembered that the Directive is the law and must be complied with whilst standards are one means by
which a manufacturer may demonstrate his compliance with the Directive’s requirements.
Sent for information to : ¨ members of the VG ¨ other(s) VG þ HC (2) ¨ TC (3) þ SC (4) ¨ other (5)
(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified
(2) HC = horizontal committee (4) EEC Standing Committee 89/392
119
PART 5
NOTIFIED BODIES
This section should provide the list (updated at the date of publication) of all
bodies notified by the Authorities of the Member States and of the EEA States
within the framework of the PPE Directive.
Please bear in mind that that these bodies are notified only in the field of activity /
products specified.
At this time, the services of the Commission in charge of the maintenance of this
list can not provide a complete and accurate document.
DG ENTREPRISE
Rue de la Loi, 200
B-1049 BRUSSELS
BELGIUM
120
121
PART 6
USEFUL ADDRESSES
6.1. Representatives of Member States responsible for the implementation of the Directive
89/686/EEC, as modified.
a) CEN
b) CENELEC
c) ETSI
d) National Committees of
- CEN
- CENELEC
e) Technical Committees of European Standardisation Bodies
a) Worker Associations
b) Manufacturers Federations
c) Co-ordination of Notified Bodies
122
6.1. REPRESENTATIVES OF MEMBER STATES RESPONSIBLE FOR THE
IMPLEMENTATION OF THE 89/686/EEC DIRECTIVE
PPE
123
A Mr. Lentsch Wolfgang TEL: +43 1 711 00 5831
Bundesministerium für Wirtschaftliche Angelegenheiten FAX: +43 1 714 27 18
- Abteilung III/3
E mail: wolfgang.lentsch
Stubenring 1
@bmwa.gv.at
A-1011 Wien
P Mrs. Monteiro Maria De Fatima TEL.: +351 1 294 81 37
Instituto Português da Qualidade FAX : +351 1 294 81 32
Ministerio da Industria e Energia
Rua C à AV. dos Três Vales
P-2825 Monte Da Caparica
S Mr. Birgitta Carlsson TEL : +46 8 730 94 83
National Board of Occupational FAX : +46 8 730 19 67
Safety and Health
E mail: birgitta.carlsson
S - 171 84 Solna
@arbsky.se
UK Mr. Iain Nicol TEL : +44 171 215 1408
Department of Trade and Industry (STRD) FAX : +44 171 215 1529
151 Buckingham Palace Road E mail: [email protected]
GB-London SW1W 9SS
NOR Mr. Per Arne Larsen TEL : +47 22 957 182
Directorate of Labour Inspection FAX : +47 22 460 988
P.O. Box 8103 Dep.
E mail: per.arne.larsen
N - 0032 Oslo
@arbeidstilsynet.dep.no
IS Mr. Olafur Hauksson TEL : +354 5 672 500
Occupational Safety and Health Administration FAX : +354 5 674 086
Bíldshöfda 16
IS - 112 Reykjavik
124
6.2. EUROPEAN COMMISSION SERVICES
b) DG ENTRERPISE/G/2 : Standardisation
Mr. Didier HERBERT (Head of Unit)
ENTR/G/2 - SC15 2/135
200, rue de la Loi
B - 1049 Brussels
Tel. : +32 2 299 00 87
Fax : +32 2 296 70 19
125
6.3. EUROPEAN ORGANIZATIONS
IN CHARGE OF STANDARDISATION
a) CEN
Central Secretariat
36, rue de Stassart
B - 1050 Brussels
Tel. : +32 2 550 08 11
Fax : +32 2 550 08 19
E-mail : [email protected]
URL : http://www.cenorm.be/
b) CENELEC
Central Secretariat
35, rue de Stassart
B - 1050 Brussels
Tel. : +32 2 519 68 71
Fax : +32 2 519 69 19
E-mail : [email protected]
URL : http://www.cenelec.be/
c) ETSI
ETSI Secretariat
Postal address
F - 06921 Sophia Antipolis Cedex
Tel. : +33 4 92 94 42 00
Fax : +33 4 93 65 47 16
E-mail : [email protected]
URL : http://www.etsi.org/
126
d) National Committees Members of CEN and CENELEC
CEN
127
S Standardiseringen i Sverige (SIS) Tel : +46 8 610 30 00
PO Box 6455 Fax : +46 8 30 77 57
S - 11381 Stockholm
UK British Standards Institution (BSI) Tel.: +44 181 996 90 00
389 Chiswick High Road Fax : +44 181 996 74 00
GB-London W4 4AL
NOR Norges Standardiseringsforbund (NSF) Tel.: +47 22 04 92 00
P.O. Box 353 Skoyen Fax : +47 22 04 92 11
N - 0212 Oslo
IS Icelandic Council for Standardisation (STRI) Tel.: +354 52 07 150
Holtagörðum Fax : +354 52 07 171
IS-104 Reykjavík
CH Schweizerische Normen-Vereinigung (SNV) Tel.: +41 1 254 54 54
Mühlebachstraße 54 Fax : +41 1 254 54 75
CH - 8008 Zürich
CZ Czech Standards Institute (CSNI) Tel. : +42 2 218 02 173
Biskupsky dvúr 5 Fax : +42 2 232 43 73
CZ - 113 47 Praha 1
128
CENELEC
129
NL Nederlands Elektrotechnisch Comité (NEC) Tel: + 31 15 269 03 90
Kalfjeslaan 2 Fax: + 31 15 269 01
Postbus 5059
NL - 2600 GB Delft http://www.nni.nl
A Österreichischer Verband für Elektrotechnik (ÖVE) Tel: + 43 1 587 63 73
Eschenbachgasse 9 Fax: + 43 1 586 74 08
A - 1010 Wien E-mail: [email protected]
P Instituto Português da Qualidade (IPQ) Tel: + 351 1 294 81 00
Rua C à Av. dos Très Vales Fax: + 351 1 294 81 12
P - 2825 Monte de Caparica
http://www.ipq.pt
S Svenska Elektriska Kommissionen (SEK) Tel: + 46 84 44 14 00
Kistagången 19 Fax: + 46 84 44 14 30
Box 1284
S - 164 28 Kista Stockholm http://www.sekom.se
UK British Electrotechnical Committee (BEC) Tel: + 44 181 996 90 00
British Standards Institution (BSI) Fax: + 44 181 996 77 99
389 Chiswick High Road
GB - London W4 4AL http://www.bsi.org.uk
NOR Norges Elektroteknisk Komite (NEK) Tel: + 47 22 52 69 50
Harbitzalléen 2A, Skøyen Fax: + 47 22 52 69 61
Postboks 280
N - 0212 Oslo http://www.standard.no
IS The Icelandic Council for Standardization (STRI) Tel: + 354 5707 150
Technological Institute of Iceland Fax: + 354 5707 111
Keldnaholt
IS - 112 Reykjavik http://www.stri.is
http://www.sev.ch
130
e) Technical Committees of European Standardisation Bodies responsible for
Standardisation in the field of PPE
CEN
CENELEC
131
6.4. OTHER ADDRESSES
a) Workers Associations
b) Manufacturers Federations
132
b.1 MEMBER ORGANIZATIONS OF ESF
133
UK SEA TEL : +44 171 329 09 50
Sir John Lyon House,5 High Timber Str./Upper FAX : +44 171 329 42 18
Thames Str.
UK-LONDON EC4V 3PA
NOR B.P.V.-Bransjeforeningen for Personlig Verneutstyr TEL : +47 66 90 44 99
c/o Arthur Gurholt A/S
B.P. 96
N-1392 VETTRE
CH VSU-Verband schweizerischer TEL : +41 61 927 64 14
Unfallverhütungsfirmen FAX : +41 61 927 65 50
Haus des Gewerbes, Altmarktstrasse 96
CH-4410 LIESTAL
134
135
PART 7
NATIONAL IMPLEMENTATION MEASURES
This section provides information from Member States illustrating the measures
which have been taken at national levels to implement the Personal Protective
Equipment (PPE) Directive.
The information contained in this section has been summarised from the CELEX
database, which is produced and managed by the Office for Official Publication of
the European Communities (EUR-OP). This section also includes any relevant
updates forwarded to DGIII by Member States, prior to August 1999.
136
NATIONAL PROVISIONS COMMUNICATED BY
THE MEMBER STATES CONCERNING:
Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the
Member States relating to personal protective equipment, as amended by :
Belgium
Denmark
137
2. Bekendtgørelse nr. 508 af 22/06/1995 om cykelhjelme og andre personlige værnemidler.
Trafikmin.,4.kt.,j.nr. 1994-4402-16. Lovtidende A hæfte 98 udgivet den 30/06/1995 s.2543.
OBEK.
3. Bekendtgørelse nr. 186 af 14/03/1994 om ændring af bekendtgørelse om brug af personlige
værnemidler. Arbejdsmin., Arbejdstilsynet, j.nr. 1993-852-148. Lovtidende A 1994 hæfte nr. 38
udgivet den 22/03/1994 s. 865. ABEK
4. Arbejdsministeriets lovbekendtgørelse nr. 184 af 22/03/1995. Bekendtgørelse af lov om
arbejdsmiljø, Arbejdsmin. 3.kt., j.nr. 1992-2100-20. Lovtidende A hæfte 41 udgivet den
31/03/1995 s. 960. ALOV.
5. Lov nr. 364 af 18/05/1994 om produktsikkerhed. Industri- og samordningsmin. j.nr. 90-334-24.
Lovtidende A 1994 hæfte nr. 73 udgivet den 19/05/1994 s. 1686. TLOV
6. Bekendtgørelse nr. 901 af 11/11/1992 om anvendelse af personlige værnemidler på havanlæg.
Energistyrelsen, j.nr. 4012. Lovtidende A 1992 hæfte nr. 154 udgivet den 20/11/1992 s. 4156.
EBEK
7. Teknisk forskrift nr. 7 af 15/12/1992 om sikkerhed og sundhed for arbejde i skibe. Meddelelser
fra Søfartsstyrelsen Nr.2, 1993. 11/01/1993, 6. Årgang
8. Trafikministeriets bekendtgørelse nr. 509 af 22/06/1995 om styrthjelme. Trafikmin.,4.kt., j.nr.
1994-4402-16. Lovtidende A hæfte 98 udgivet den 30/06/1995 s.2555. OBEK.
9. Bekendtgørelse nr. 646 af 18/12/1985 af Lov om arbejdsmiljø. Arbejdsmin. 3. kt. j.nr. 3201-6.
Lovtidende A 1985 hæfte nr. 89 udgivet den 07/01/1986 s. 2036
10. Bekendtgørelse nr. 561 af 24/06/1994 om indretning af tekniske hjælpemidler. Arbejdstilsynet
j.nr. 1994-29-46. Hæfte nr. 107 udgivet den 01/07/1994 s. 3039. ABEK
11. Bekendtgørelse nr. 669 af 07/08/1995 om ændring af bekendtgørelse om indretning af tekniske
hjælpemidler. Dir. f. Arbejdstilsyn., j.nr. 1995-20-32. Lovtidende A hæfte 127 udgivet den
15/08/1995 s.3530. ABEK.
12. Bekendtgørelse nr. 1273 af 18/12/1996 om sikkerhedskrav m.v. til personlige værnemidler.
Arbejdsmin., Arbejdstilsynet, j.nr. 1996-140-54. Lovtidende A 1996 hæfte nr. 204 udgivet den
10/12/1997 s. 7416. ABEK
Germany
138
Greece
1. Arrêté ministériel numéro 4373/1205 du 11/03/1993, FEK B numéro 187 du 23/03/1993 Page
2411-2425
2. Décision ministérielle numéro 8881/94 du 03/06/1994, FEK A numéro 450 du 16/06/1994
Page 3965.
3. Décision ministérielle numéro 94649/8682/93 du 25/08/1994, FEK B numéro 688 du
13/09/1994 Page 6367
4. Décret présidentiel numéro 18/96 du 18/01/1996, FEK A numéro 12 du 18/01/1996 Page 113.
5. Décision ministérielle numéro 5261/190/97 du 11/10/1997, FEK B numéro 113 du 26/02/97
page 1205
Spain
1. Real Decreto número 1407/92 de 20/11/1992, por el que se regula las condiciones para la
comercialización y libre circulación intracomunitaria de los equipos de protección individual,
Boletín Oficial del Estado número 311 de 28/12/1992 Página 44120 (Marginal 28644)
2. Corrección de erratas del Real Decreto número 1407/92 de 20/11/1992, por el que se regula
las condiciones para la comercialización y libre circulación intracomunitaria de los equipos de
protección individual, Boletín Oficial del Estado número 47 de 24/02/1993 Página 44120
(Marginal 5139)
3. Real Decreto número 159/95 de 03/02/1995, por el que se modifica el Real Decreto 1407/92,
de 20 de noviembre, que regula las condiciones para la comercialización y libre circulación
intracomunitaria de los equipos de protección individual, Boletín Oficial del Estado número 57
de 08/03/1995 Página 7691
4. Corrección de erratas del Real Decreto número 159/95 de 03/02/1995, por el que se modifica
el Real Decreto 1407/92, de 20 de noviembre, por el que se regulan las condiciones para la
comercialización y libre circulación intracomunitaria de los equipos de protección individual,
Boletín Oficial del Estado número 69 de 22/03/1995 Página 8894 (Marginal 7057)
5. Orden de 16/05/1994, por la que se modifica el período transitorio establecido en el Real
Decreto 1407/92, de 20 de noviembre, por el que se regulan las condiciones para la
comercialización y libre circulación intracomunitaria de los equipos de protección individual,
Boletín Oficial del Estado número 130 de 01/06/1994 Página 17150 (Marginal 12437)
6. Orden de 20/02/1997, por la que se modifica el anexo del Real Decreto 159/95, de 3 de
febrero, que modificó a su vez el Real Decreto 1407/92, de 20 de noviembre, relativo a las
condiciones para la comercialización y libre circulación intracomunitaria de los equipos de
protección individual, Boletín Oficial del Estado número 56 de 06/03/1997 Página 7381
(Marginal 4842).
France
139
4. Décret Numéro 92-766 du 29/07/1992 définissant les procédures de certification de conformité
et diverses modalités du contrôle de conformité des équipements de travail et moyen de
protection et modifiant le Code du travail (Deuxième partie: Conseil d'Etat), Journal Officiel
du 07/08/1992 Page 10690 (Articles R. 233-83-3 et R. 233-83-4 du code du travail).
5. Décret Numéro 92-768 du 29/07/1992 relatif aux règles techniques et aux procédures de
certification de conformité applicables aux équipements de protection individuelle visés à
l'article R.233-83-3 du Code du travail et modifiant le Code du travail (Deuxième partie:
Décrets en Conseil d'Etat), Journal Officiel du 07/08/1992 Page 10714 (Articles R. 233-49 à
R. 233-63, R. 233-66 à R. 233-76-1 et R. 233-78 à R. 233-81-2 du code du travail).
6. Décret Numéro 94-689 du 05/08/1994 relatif à la prévention des risques résultant de l'usage
des équipements de protection individuelle pour la pratique sportive ou de loisirs, Journal
Officiel du 12/08/1994 Page 11820 (Articles R. 233-151, l’annexe II et articles R.233-152 à
R.233-154 du code du travail)
7. Décret Numéro 96-725 du 14/08/1996 relatif aux règles techniques et aux procédures de
certification de conformité applicables aux équipements de travail et moyens de protection
soumis à l'article L.233-5 du Code du travail, modifiant le Code du travail (deuxième partie :
Décrets en Conseil d'Etat) et portant transposition de diverses directives européennes, Journal
Officiel du 18/08/1996 Page 12746.
8. Arrêté du 07/02/1997 relatif au marquage CE des équipements de travail er des équipements
de protection individuelle, abrogeant et remplaçant l'arrêté du 18/12/1992 modifié relatif au
marquage CE des équipements de travail, des moyens de protection et des équipements de
protection individuelle, Journal Officiel du 28/02/1997 Page 3245.
Ireland
Italy
1. Decreto legislativo del 04/12/1992 n. 475, attuazione della direttiva 89/686/CEE del Consiglio
del 21 dicembre 1989, in materia di ravvicinamento delle legislazioni degli Stati membri
relative ai dispositivi di protezione individuale, Supplemento ordinario n. 128 alla Gazzetta
Ufficiale - Serie generale - del 09/12/1992 n. 289 pag. 5
2. Decreto ministeriale del 10/05/1996, disposizioni transitorie concernenti le caratteristiche ed i
requisiti delle cinture di salvataggio da utilizzare esclusivamente sulle unità da diporto,
Gazzetta Ufficiale - Serie generale - dell'11/05/1996 n. 109 pag. 19
3. Decreto legislativo del 02/01/1997 n. 10, attuazione delle direttive 93/68/CEE, 93/95/CEE e
96/58/CE relative ai dispositivi di protezione individuale, Gazzetta Ufficiale - Serie generale -
del 30/01/1997 n. 24 pag. 4.
Luxembourg
140
3. Règlement grand-ducal du 08/12/1996 complétant le règlement grand-ducal du 10/08/1992
relatif aux équipements de protection individuelle (EPI), Mémorial Grand-Ducal A Numéro 96
du 31/12/1996 Page 2922
4. Règlement grand-ducal du 17/08/1997 portant 2ème complément au règlement grand-ducal du
10/08/1992 relatif aux équipements de protection individuelle, Mémorial Grand-Ducal A
Numéro 66 du 05/09/1997 Page 2077.
Netherlands
Norway
Austria
141
6. NÖ Bauordnung 1976, Landesgesetzblatt für Niederösterreich, Nr. 8200-12 (10.Novelle)
7. Bauordnung für Wien, Landesgesetzblatt für Wien, Nr. 42/1992
8. Verordnung über Konformitätsbewertungsverfahren bei der Zulassung von Endgeräten
(Konformitätsbewertungsverordnung), Bundesgesetzblatt für die Republik Österreich, Nr.
791/1994 ausgegeben am 30/09/1994
9. Landesgesetz vom 07/05/1997, mit dem das O.ö. Straßengesetz 1991 geändert wird (O.ö.
Straßengesetz-Novelle 1997), Landesgesetzblatt für das Oberösterreich, Nr. 82/1992,
ausgegeben am 23/07/1997 Seite 265
10. NÖ Bautechnikverordnung 1997 (NÖ btv 1997), Landesgesetzblatt für Niederösterreich, Nr.
8200/7-0, ausgegeben am 24/10/1997
11. Sicherheitsverordnung , Bundesgesetzblatt für die Republik Österreich, Nr. 596/1994.
12. Verordnung des Bundesministers für wirtschaftliche Angelegenheiten, zur Änderung der PSA-
Sicherheitsverordnung, Bundesgesetzblatt für die Republik Österreich, Nr. 740/1996
Ausgegeben am 20/12/1996.
Portugal
1. Decreto-Lei n.° 128/93 de 22/04/1993. Transpõe para a ordem jurídica interna a Directiva
89/686/CEE, de 21 de Dezembro, relativa aos equipamentos de protecção individual, Diário da
República I Série A n.° 94 de 22/04/1993 Página 1965
2. Portaria n.° 1131/93 de 04/11/1993. Estabelece as exigência essenciais relativas à saúde e
segurança aplicáveis aos equipamentos de protecção individual (EPI), Diário da República I
Série B n.° 258 de 04/11/1993 Página 6189
3. Decreto-Lei n.° 139/95 de 14/06/1995. Altera diversa legislação no âmbito dos requisitos de
segurança e identificação a que devem obedecer o fabrico e comercialização de determinados
produtos e equipamentos, Diário da República I Série A n.° 136 de 14/06/1995 Página 3834
4. Portaria n.° 109/96 de 10/04/1996. Altera os anexos I, II, IV e V da Portaria n.° 1131/93, de 4
de Novembro [estabelece as exigências essenciais relativas à saúde e segurança aplicáveis aos
equipamentos de protecção individual (EPI)], Diário da República I Série B n.° 85 de
10/04/1996 Página 762
5. Portaria n.° 695/97 de 19/08/1997. Altera os anexos I e V da Portaria n.° 1131/93, de 4 de
Novembro (fixa os requisitos essenciais de segurança e saúde a que devem obedecer o fabrico
e comercialização de equipamentos de protecção individual (EPI)), Diário da República I Série
B n.° 190 de 19/08/1997 Página 4273
Finland
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7. Laki työsuojelun valvonnasta ja muutoksenhausta työsuojeluasioissa/Lag om tillsynen över
arbetarskyddet och om sökande av ändring i arbetarskyddsärenden (131/1973),
muutos/ändring (145/1993), (510/1993)
8. Asetus työsuojelun valvonnasta/Förordning om tillsynen över arbetarskyddet (954/1973).
Sweden
United Kingdom
1. The Personal Protective Equipment (EC Directive) Regulations 1992, Statutory Instruments
number 3139 of 1992
2. The Personal Protective Equipment (EC Directive) (Amendment) Regulations 1994, Statutory
Instruments number 2326 of 1994.
3. The Personal Protective Equipment (EC Directive)(Amendment) Regulations 1993, Statutory
Instruments number 3074 of 1993.
4. The Personal Protective Equipment (EC Directive) (Amendment) Regulations 1996, Statutory
Instruments number 3039 of 1996.
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