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    89 686 Eec

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    hadi
    The Personal Protective Equipment Directive (89/686/EEC) establishes requirements for personal protective equipment (PPE) in the European Union. It divides PPE into three categories based on complexity, with Category I being simple designs that manufacturers can self-certify and Category III being complex designs that require certification by a Notified Body. To bear the CE marking, manufacturers must demonstrate compliance with health and safety standards and undergo certification procedures that range from self-certification for Category I to quality control systems verified by a Notified Body for Categories II and III. The directive aims to harmonize PPE standards across EU member states.

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    89 686 Eec

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    hadi
    79 views5 pages
    The Personal Protective Equipment Directive (89/686/EEC) establishes requirements for personal protective equipment (PPE) in the European Union. It divides PPE into three categories based on complexity, with Category I being simple designs that manufacturers can self-certify and Category III being complex designs that require certification by a Notified Body. To bear the CE marking, manufacturers must demonstrate compliance with health and safety standards and undergo certification procedures that range from self-certification for Category I to quality control systems verified by a Notified Body for Categories II and III. The directive aims to harmonize PPE standards across EU member states.

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    89-686-EEC

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    The Personal Protective Equipment Directive (89/686/EEC) establishes requirements for personal protective equipment (PPE) in the European Union. It divides PPE into three categories based on complexity, with Category I being simple designs that manufacturers can self-certify and Category III being complex designs that require certification by a Notified Body. To bear the CE marking, manufacturers must demonstrate compliance with health and safety standards and undergo certification procedures that range from self-certification for Category I to quality control systems verified by a Notified Body for Categories II and III. The directive aims to harmonize PPE standards across EU member states.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    79 views5 pages

    89 686 Eec

    Uploaded by

    hadi
    The Personal Protective Equipment Directive (89/686/EEC) establishes requirements for personal protective equipment (PPE) in the European Union. It divides PPE into three categories based on complexity, with Category I being simple designs that manufacturers can self-certify and Category III being complex designs that require certification by a Notified Body. To bear the CE marking, manufacturers must demonstrate compliance with health and safety standards and undergo certification procedures that range from self-certification for Category I to quality control systems verified by a Notified Body for Categories II and III. The directive aims to harmonize PPE standards across EU member states.

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    PERSONAL PROTECTIVE EQUIPMENT

    DIRECTIVE
    ( 89/686/EEC )

    General
    Information

    APPENDIX : THE PERSONAL PROTECTIVE EQUIPMENT DIRECTIVE (89/686/EEC)


    G.1 Background
    G.1.1 The Personal Protective Equipment (PPE) Directive (89/686/EEC) was adopted on 21 December
    1989 and became Community Law on 1st July 1992. However, the Commission approved a transition
    period extended to 20th June 1995 whereby all types of PPE can continue to comply with
    National
    Regulations. After this date, all Personal Protective Equipment placed on the market in EU
    Member
    States
    must comply with directive 89/686/EEC and carry the CE Marking.
    S.I. No. 272 of 1993 European Communities (Personal Protective Equipment) Regulations 1993
    gives effect in Ireland to Directive 89/686/EEC.
    G.2 Scope
    G.2.1 Personal Protective Equipment covered by this directive is divided into 3 categories : Category I
    - 'Simple' design P.P.E. - e.g. gardening gloves, sun glasses.
    Category II
    - 'Intermediate' design P.P.E. e.g. cycle helmets, high visibility clothing.
    Category III - 'Complex' design P.P.E. - e.g. Firemen's helmets, respiratory Protective
    Equipment.
    Category 0 is sometimes used as a reference to P.P.E. not covered by this Directive.
    G.2.2 The following PPE is not covered by this directive : a. PPE designed and manufactured specifically for use by the armed forces or in the maintenance
    of law and order (helmets, shields, etc.).
    b. PPE for self-defence (aerosol canisters, personal deterrent weapons, etc.).
    c. PPE designed and manufactured for private use against :
    - adverse atmospheric conditions (headgear, seasonal clothing, footwear, umbrellas, etc.)
    - damp and water (dish-washing gloves, etc.),
    - heat (gloves, etc.)
    d. PPE intended for the protection or rescue of persons on vessels or aircraft, not worn all the
    time.
    G. 3 CE Marking
    G 3.1 The processes for obtaining the CE Mark vary from the relatively simple procedure for Category I through
    to increasingly more detailed procedures for Categories II and III.
    G 3.1.1 Category I
    In this category, the manufacturer can take responsibility for ensuring that the product complies with the
    P.P.E Directive and can attach the CE Marking. This Category is sometimes referred to as 'selfcertification'. In this case the manufacturer does not require the services of a Notified Body.
    To attach the CE Marking the Manufacturer must, according to the Directive, :(a) Ensure that his product complies with the Basic Health and Safety Requirements (Annex ii)
    (b) Assemble technical documentation (Article 8 and annex iii)
    (c) Draw up a Declaration of Production Conformity (Article 12 and Annex vi )
    (d) Affix the CE Marking (Article 13 and Annex iv)

    The right to use the CE Marking may be obtained via Module A according to Conformity Assessment Procedures
    in Community Legislation.
    G 3.1.2 Category II
    In this category to attach the CE Marking the Manufacturer must, according to the
    Directive, : (a) Ensure either (i) the product complies with harmonised European Standards or (ii) the
    product complies with verified technical specifications.
    (b) Assemble technical documentation for submission to the Notified Body (Article 8 and
    Annex (iii)).
    (c) Make application for EC Type examination to the Notified Body (Article 10).
    If satisfied, the Notified Body draws up an EC Type Examination Certificate and notifies the
    manufacturer to this effect.
    The Manufacturer then : (d) Draws up a Declaration of Production Conformity (Article 12 and Annex vi).
    (e) Affixes CE marking (article 13 and Annex iv).
    CE Marking may be authorised via Module B according to Conformity Assessment Procedures in
    Community Legislation.
    G 3.1.3 Category III
    To attach the CE Marking, the Manufacturer must, according to the Directive, carry out similar procedures
    (a) to (e) as for Category II, with the additional procedure for checking of PPE Manufacture (Article 11A
    or 11B).
    In Article 11A - "EC quality control system for the final product II - the Manufacturer requests a Notified
    Body to ensure that the P.P.E. conforms with the EC Type Examination Certificate by checking random
    production samples at least once a year. The Notified Body then issues the manufacturer with a test report.
    In Article 11B - "System for ensuring EC quality of production by means of monitoring" - the manufacturer
    has his quality control system approved by a Notified Body (A system conforming to
    EN 29003 would be suitable).
    CE Marking may be authorised, where article 11A is used, using Modules B and C and where Article 11B
    is used, using Modules B and E, according to Community Assessment Procedures in Community
    Legislation.

    G.4 Further Information


    G.4.1 The main initial requirement relating to this Directive is to determine the category to which an item of PPE is
    designated. This information may be obtained from the General Quality Standards Department of N.S.A.I.

    Flowchart : Personal Protective Equipment Directive ( 89/686/EEC )

    Simple Design PPE

    Conform with
    basic health and
    safety
    requirements
    ( Annex II )
    Manufacturer

    ' Intermediate' Design PPE


    Category II

    Conform with
    harmonised
    European
    Standards

    Conform with
    other verified
    technical
    specification

    Manufacturer

    Manufacturer

    Complex Design PPE


    Category III

    Conform with
    Harmonised
    European
    Standards
    Manufacturer

    Conform with
    other verified
    technical
    specification
    Manufacturer

    Technical
    documentation
    (Article 8 )
    ( Module A )

    Technical
    documentation
    (Article 8 )
    ( Module B )

    Technical
    documentation
    (Article 8 )
    ( Module B )

    Manufacturer

    Manufacturer

    Manufacturer

    EC type-examination
    ( Article 10 )
    ( Module B )

    EC type-examination
    ( Article 10 )
    ( Module B )

    Approved Body

    Declaration of
    production
    conformity
    (Article 12 )
    ( Module A )

    Declaration of
    production
    conformity
    (Article 12 )
    ( Module C )

    Manufacturer

    Manufacturer

    Affix CE marking
    ( Article 13 )
    ( Module A )

    Affix CE marking
    ( Article 13 )
    ( Module C )

    Manufacturer

    Manufacturer

    Approved Body

    Declaration of
    production
    conformity
    (Article 12 )
    ( Module see below )
    Manufacturer

    Affix CE marking
    ( Article 13 )
    ( Module see below )
    Manufacturer

    EC quality
    control
    system for the
    final product
    (Article 11.A)
    ( Module C &
    supplementary
    requests

    System for
    ensuring EC
    quality of
    production by
    means of
    monitoring
    (Article 11.B)
    ( Module E. )

    Manufactured &
    Approved Body

    Manufactured &
    Approved Body

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