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    I.S. EN ISO 16061:2021

    Current The latest, up-to-date edition.

    Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  18-04-2021

    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 Intended performance
    5 Design attributes
    6 Selection of materials
    7 Design evaluation
    8 Manufacture
    9 Sterilization
    10 Packaging
    11 Information supplied by the manufacturer
    Annex A (informative) Examples of typical applications of instruments to be used in association with non-active surgical implants and materials found acceptable for instrument manufacture
    Bibliography

    Abstract - (Show below) - (Hide below)

    This document specifies the general requirements for instruments to be used in association with non-active surgical implants.

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

    Committee TC 150
    Document Type Standard
    Product Note 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 Current
    Supersedes
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