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    I.S. EN ISO 17664-1:2021

    Current The latest, up-to-date edition.

    Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semicritical medical devices (ISO 17664-1:2021)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  19-09-2021

    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 Validation of the processes identified in the information provided by the medical
    device manufacturer
    5 Risk analysis
    6 Information to be provided by the medical device manufacturer
    7 Presentation of the information
    Annex A (informative) Commonly utilized processing methods
    Annex B (informative) Example of processing instructions for reusable medical devices
    Annex C (informative) Classification of medical device
    Annex D (informative) Additional guidance on information to be provided by the medical
    device manufacturer
    Bibliography

    Abstract - (Show below) - (Hide below)

    This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.

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

    Committee TC 198
    Document Type Standard
    Product Note This standard is also refer to AAMI/TIR 30 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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