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  • ISO/TR 10993-33:2015

    Current The latest, up-to-date edition.

    Biological evaluation of medical devices Part 33: Guidance on tests to evaluate genotoxicity Supplement to ISO 10993-3

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English

    Published date:  06-03-2015

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    There are differences between the views of regulatory bodies on the subject of genotoxicity testing. The purpose of this ISO/TR 10993-33: 2015 is to provide background information to facilitate the selection of tests and guidance on the performance of tests.

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    Document Type Technical Report
    Product Note THIS STANDARD ALSO REFERS TO OECD 471,OECD 473,OECD 474,OECD 475,OECD 476,OECD 477
    Publisher International Organization for Standardization
    Status Current

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

    ANSI/AAMI/ISO 10993-3:2014 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY, AND REPRODUCTIVE TOXICITY
    BS EN ISO 10993-3:2014 Biological evaluation of medical devices Tests for genotoxicity, carcinogenicity and reproductive toxicity
    17/30344601 DC : 0 BS EN ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
    I.S. EN ISO 10993-3:2014 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY (ISO 10993-3:2014)
    DIN EN ISO 10993-3:2015-02 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY (ISO 10993-3:2014)
    UNE-EN ISO 10993-3:2015 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
    ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    UNI EN ISO 10993-3 : 2015 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY
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