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  • CSA ISO 10993-10 : 0

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 10: TESTS FOR IRRITATION AND SENSITIZATION

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  23-09-2008

    Language(s):  English

    Published date: 

    Publisher:  Canadian Standards Association

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

    1 Scope
    2 Normative references
    3 Definitions
    4 General principles, step-wise approach
    5 Irritation tests
       5.1 Factors to be considered in design and
           selection of tests
       5.2 Skin irritation test
       5.3 Ocular irritation test
       5.4 Intracutaneous (intradermal) reactivity test
    6 Sensitization tests
       6.1 Factors to be considered in design and
           selection of tests
       6.2 Maximization sensitization test
       6.3 Closed patch sensitization test
    Annexes
    A Preparation of materials for testing
    B Method for extraction of materials for biological
       tests
    C Animals and husbandry
    D Additional irritation tests
    E Background information
    F Bibliography

    Abstract - (Show below) - (Hide below)

    Describes test methods for potential evaluation of devices used to produce sensitization or irritation.

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

    Document Type Standard
    Publisher Canadian Standards Association
    Status Withdrawn

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

    CSA ISO 10993-13 : 0 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
    CSA ISO 10993-16 : 0 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
    CSA ISO 10993-9 : 0 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS

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

    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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