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  • CSA ISO 10993-12 : 98(R2002)

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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

    Available format(s): 

    Withdrawn date:  29-02-2008

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Canadian Standards Association

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

    1 Scope
    2 Normative references
    3 Definitions
    4 Experimental controls
    5 Test material selection
    6 Test camp and reference material preparation
    7 Preparation of extracts of test materials
    8 Test report
    Annexes
    A Experimental, controls
    B Guidance for test material preparation
    C Guidance for extraction of samples
    D Bibliography

    Abstract - (Show below) - (Hide below)

    Gives guidance and requirements for preparing samples of medical devices for testing in biological systems.

    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    Status Withdrawn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 10993-16 : 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)

    ASTM F 563 : 2000 Standard Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563) (Withdrawn 2005)
    ASTM F 90 : 2014 : REDLINE Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
    ASTM F 136 : 2013 : REDLINE Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
    ISO/IEC Guide 25:1990 General requirements for the competence of calibration and testing laboratories
    ISO 9000-2:1997 Quality management and quality assurance standards — Part 2: Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003
    ISO Guide 30:2015 Reference materials Selected terms and definitions
    ISO 9000-4:1993 Quality management and quality assurance standards — Part 4: Guide to dependability programme management
    ASTM F 562 : 2013 : REDLINE Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
    ISO 9000-1:1994 Quality management and quality assurance standards — Part 1: Guidelines for selection and use
    ASTM F 648 : 2014 : REDLINE Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
    ISO 9000-3:1997 Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software
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