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    I.S. EN ISO 10993-8:2000

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 8: SELECTION AND QUALIFICATION OF REFERENCE MATERIALS FOR BIOLOGICAL TESTS

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  01-02-2005

    Language(s):  English

    Published date:  01-12-2000

    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
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Use of certified reference materials or reference
       materials
    5 Characteristics of reference materials
    6 Use of reference materials as experimental controls
    Bibliography
    Annex ZA (normative) Normative references to international
             publications with their relevant European
             publications

    Abstract - (Show below) - (Hide below)

    Gives requirements on the use of reference materials or certified reference materials used to determine the biological response of a material.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Withdrawn

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO Guide 33:2015 Reference materials Good practice in using reference materials
    ISO Guide 35:2017 Reference materials Guidance for characterization and assessment of homogeneity and stability
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ISO Guide 30:2015 Reference materials Selected terms and definitions
    EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
    ISO Guide 31:2015 Reference materials — Contents of certificates, labels and accompanying documentation
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