ANSI/AAMI/ISO 11135:2014/A1:2018
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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
Amendment of
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
13-02-2020
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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