• UNI EN ISO 10993-1:2021

    Current The latest, up-to-date edition.

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

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    Published date:  08-04-2021

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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    Abstract - (Show below) - (Hide below)

    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 CT 44
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Current
    Supersedes
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