AAMI TIR28:2016/(R)2024
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Product adoption and process equivalency for ethylene oxide sterilization
Association for the Advancement of Medical Instrumentation , 11/18/2016
Pages: 22
This technical information report provides guidance for the adoption of new or modified products into an existing validated sterilization process and for the determination of equivalence of a sterilization process as conducted with different equipment. Guidance is intended to augment the ANSI/AAMI/ISO 11135 series in the areas of product adoption and process equivalence.
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