Most recent
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.
Content Provider
Association for the Advancement of Medical Instrumentation [aami]