• EN ISO 10993-1:2009

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    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

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    Withdrawn date:  16-06-2020


    Published date:  15-10-2009

    Publisher:  Comite Europeen de Normalisation

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    Abstract - (Show below) - (Hide below)

    ISO 10993-1:2009 describes:the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of 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 CEN/TC 206
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Withdrawn
    Superseded By
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