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    I.S. EN ISO 10993-1:2020

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    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-11)

    Available format(s):  Hardcopy, PDF

    Superseded date:  21-04-2021

    Language(s):  English

    Published date:  06-01-2021

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General principles applying to biological evaluation of medical devices
    5 Categorization of medical devices
    6 Biological evaluation process
    7 Interpretation of biological evaluation data and overall biological risk assessment
    Annex A (informative) Endpoints to be addressed in a biological risk assessment
    Annex B (informative) Guidance on the conduct of biological evaluation within a risk management process
    Annex C (informative) Suggested procedure for literature review
    Bibliography

    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 CEN/TC 206
    Document Type Standard
    Product Note This standard is also refer as ISO/TR 10993-19 The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
    Supersedes
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