AAMI TIR28:2009

$59.00

Product adoption and process equivalency for ethylene oxide sterilizationAssociation for the Advancement of Medical Instrumentation / 17-Mar-2009 / 24 pages

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.

Keywords: adoption, equivalency, process equivalency, product adoption, product family




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