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    I.S. EN 868-1:1997

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS

    Available format(s):  Hardcopy, PDF

    Superseded date:  03-07-2006

    Language(s):  English

    Published date:  01-01-1997

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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    Table of Contents - (Show below) - (Hide below)

    1 Scope
    2 Normative references
    3 Definitions
    4 Requirements
    5 Test methods
    6 Documentation
    7 Information
    Annex A (informative) Guidance on clause 4
    Annex B (informative) Microbial barrier evaluation scheme
    Annex C (informative) Air impermeability - Test methods
    Annex D (informative) Microbial barrier properties -
            Test methods for materials
    Annex E (informative) Microbial barrier properties -
            Test methods for permeable closures (filter assembly,
            tortuous path)
    Annex F (informative) Impermeability and continuity of seals
            formed by fusion or adhesion - Test methods
    Annex G (informative) Impermeability of seals not formed by
            fusion or adhesion - Test methods - Test procedure
            for rigid containers
    Annex H (informative) Bibliography
    Annex ZA (informative) Clauses of this European Standard
            addressing essential requirements or other provision
            of EU Directives

    Abstract - (Show below) - (Hide below)

    Gives the requirements and test methods for packaging materials and systems which are used for packaging of medical devices which are to be terminally sterilised; and which are intended to maintain sterility of the device.

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
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