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  • DIN EN 868-1:1997-05

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 1: GENERAL REQUIREMENTS AND TEST METHODS

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-07-2006

    Language(s):  English

    Published date:  12-01-2013

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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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)

    This standard is included in DIN Handbook 263. Defines requirements and methods of test for packaging materials and systems for medical devices for terminal sterilization and for maintenance of sterility of the device.

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

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    DIN 58946-6:2002-04 STERILIZATION - STEAM STERILIZERS - PART 6: OPERATING OF LARGE STERILIZERS IN HEALTH CARE FACILITIES
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