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

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
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Summary

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. Annex 2

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2014
Page Count 0
Themes Sterilization—Industrial
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