AAMI TIR28:2009/(R)2013 PDF

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Product adoption and process equivalency for ethylene oxide sterilization
standard by Association for the Advancement of Medical Instrumentation, 03/17/2009

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Category: AAMI

Description

This AAMI technical information report (TIR) provides guidance for the adoption of a new ormodified product into an existing validated sterilization process and for the determination ofequivalency of a sterilization process as conducted in different equipment. Its guidance isintended to augment ANSI/AAMI/ISO 11135:1994, Medical devices?Validation and routinecontrol of ethylene oxide sterilization, and to expand on the areas of product adoption andprocess equivalency that are not addressed in ANSI/AAMI/ISO 11135:1994.