• I.S. EN ISO 11135:2014&A1:2019/LC:2019

    Current The latest, up-to-date edition.

    Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)

    Publisher:  National Standards Authority of Ireland


    Available Formats:  PDF - English, Hardcopy - English
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    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.

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