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    I.S. EN ISO 11607-1:2020

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

    Available format(s):  Hardcopy, PDF

    Superseded date:  13-03-2020

    Language(s):  English

    Published date:  23-01-2020

    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)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Materials, preformed sterile barrier systems and sterile barrier systems
    6 Design and development for packaging systems
    7 Usability evaluation for aseptic presentation
    8 Packaging system performance and stability
    9 Packaging system validation and changes
    10 Inspection immediately prior to aseptic presentation
    11 Information to be provided
    Annex A (informative) Guidance on medical packaging
    Annex B (informative) Standardized test methods, guides and procedures that can be used to demonstrate conformity with the requirements of this document
    Annex C (normative) Test method for resistance of impermeable materials to the passage of air
    Annex D (informative) Environmental aspects
    Annex E (informative) Draft guidance on ways to differentiate a sterile barrier system from protective packaging
    Bibliography

    Abstract - (Show below) - (Hide below)

    This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

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

    Committee TC 198
    Document Type Test Method
    Product Note The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
    Supersedes
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