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ANSI/AAMI/ISO 11135:2014/A1:2018

Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E - Single batch release

Amendment 1 - This amendment 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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Association for the Advancement of Medical Instrumentation [aami]

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