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AAMI TIR28:2016

M00011035

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AAMI TIR28:2016 Product adoption and process equivalency for ethylene oxide sterilization

standard by Association for the Advancement of Medical Instrumentation, 11/18/2016

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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.