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  • CSA ISO 10993-1 : 2001

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 1: EVALUATION AND TESTING

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  28-02-2006

    Language(s):  English

    Published date:  31-12-2000

    Publisher:  Canadian Standards Association

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

    1 Scope
    2 Definitions
    3 General principles applying to biological
       evaluation of medical devices
    4 Categorization of medical devices
    5 Testing
    6 Selection of biological evaluation test
    7 Assurance of test methods
    Annexes
    A Rationale
    B Flow chart to aid in systematic approach to
       biological evaluation of medical devices
    C Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies general principles governing the biological evaluation of medical devices, categorization of devices based on the nature and duration of their contact with the body and the selection of appropriate tests.

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

    Document Type Standard
    Publisher Canadian Standards Association
    Status Withdrawn
    Supersedes

    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
    CSA Z314.10 : 2003 SELECTION, USE, MAINTENANCE AND LAUNDERING OF REUSABLE TEXTILE WRAPPERS, SURGICAL GOWNS AND DRAPES FOR HEALTH FACILITIES
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