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  • ANSI/AAMI/ISO 10993-3:2014(R2023)

    Current The latest, up-to-date edition.

    Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  09-10-2023

    Publisher:  Association for the Advancement of Medical Instrumentation

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    This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices: — genotoxicity; — carcinogenicity; — reproductive and developmental toxicity.

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    Committee ISO/TC 194
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    Supersedes
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