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    I.S. EN ISO 10993-11:2018

    Current The latest, up-to-date edition.

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  04-10-2018

    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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    Abstract - (Show below) - (Hide below)

    This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

    General Product Information - (Show below) - (Hide below)

    Committee TC 194
    Document Type Standard
    Product Note This standard also referce to ISO 10993, ASTM F619-03, AAMI/ST72 The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document.
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes
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