• NBN EN 868-5 : 2009

    Current The latest, up-to-date edition.

    PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS

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    Language(s): 

    Published date:  12-01-2013

    Publisher:  Belgian Standards

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 Requirements
    Annex A (normative) Method for the determination of
                          resistance to the sterilisation
                          process
    Annex B (normative) Method for the determination of
                          pinholes in plastic laminate
    Annex C (normative) Method for the determination of
                          peel characteristics of paper/
                          plastic laminate products
    Annex D (normative) Method for the determination of
                          the strength of the heat seal
                          joint for pouches and reel
                          material
    Annex E (normative) Method for the determination of
                          fibre orientation
    Annex F (informative) Dimensions and tolerances
    Annex G (informative) Bibliography

    Abstract - (Show below) - (Hide below)

    Gives examples of requirements and test procedures for heat and self-sealable pouches and reels made from paper which complies with EN 868-3 and plastic film. Defined are those suitable for use as packaging for medical devices which are to be terminally sterilized.

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    Document Type Standard
    Publisher Belgian Standards
    Status Current
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