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  • 11/30212473 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS EN ISO 10993-3 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-10-2014

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements for test strategies
    5 Genotoxicity tests
    6 Carcinogenicity tests
    7 Reproductive and developmental toxicity tests
    8 Test report
    Annex A (informative) - Rationale of test systems
    Annex B (informative) - Cell transformation test
            systems
    Annex C (normative) - Considerations for carcinogenicity
            studies performed as implantation studies
    Annex D (normative) - Guidance on selecting an
            appropriate sample preparation procedure in
            genotoxicity testing
    Annex E (informative) - Tests to evaluate genotoxicity
    Annex F (informative) - In vitro tests for embryotoxicity
    Bibliography
    Annex ZA (informative) - Relationship between this
             International Standard and the Essential
             Requirements of EU Directive 93/42/EC

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

    Comment Closes On
    Committee CH/194
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
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