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  • ANSI/AAMI/ISO 11135:2014/A1:2018

    Current The latest, up-to-date edition.

    Sterilization of healthcare 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

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  13-02-2020

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Abstract - (Show below) - (Hide below)

    Specifies the requirements for the release of product from a single batch for a sterilization process where there is only sufficient product, at most, for a single sterilization load, for example, during research and development of new product or for clinical trial product.

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    Committee WG 01
    Document Type Amendment
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
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