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    I.S. EN ISO 13485:2000

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)

    Available format(s):  Hardcopy, PDF

    Superseded date:  08-10-2018

    Language(s):  English

    Published date:  31-12-1999

    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 International Standard specifies, in conjunction with ISO 9001, the quality System requirements for the
    design/development, production and, when relevant, installation and servicing of medical devices.

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

    Committee TC 210
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
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