• NF EN ISO 10993-1:2020

    Current The latest, up-to-date edition.

    Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

    Available format(s):  Hardcopy

    Language(s):  English - French

    Published date:  01-12-2020

    Publisher:  Association Francaise de Normalisation

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    This document specifies: —the general principles governing the biological evaluation of medical devices within a risk management process; —the general categorization of medical devices based on the nature and duration of their contact with the body; —the evaluation of existing relevant data from all sources; —the identification of gaps in the available data set on the basis of a risk analysis; —the identification of additional data sets necessary to analyse the biological safety of the medical device; —the assessment of the biological safety of the medical device.

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    Committee ISO/TC 94
    Document Type Standard
    Publisher Association Francaise de Normalisation
    Status Current
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