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    I.S. EN ISO 11137-1:2015&A2:2019

    Current The latest, up-to-date edition.

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137- 1:2006/Amd 2:2018)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  08-12-2019

    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 Quality management system elements
    5 Sterilizing agent characterization
    6 Process and equipment characterization
    7 Product definition
    8 Process definition
    9 Validation
    10 Routine monitoring and control
    11 Product release from sterilization
    12 Maintaining process effectiveness
    Annex A (informative) Guidance
    Bibliography

    Abstract - (Show below) - (Hide below)

    This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.

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

    Committee TC 198
    Document Type Standard
    Product Note THIS STANDARD ALSO REFERS-EN 556-1 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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