AAMI TIR28:2009/(R)2013

Product adoption and process equivalency for ethylene oxide sterilization

Association for the Advancement of Medical Instrumentation , 03/17/2009

Publisher: AAMI

File Format: PDF

$65.00$131.00

Description

Standard By:Association for the Advancement of Medical Instrumentation , 03/17/2009

Published:03/17/2009

Pages:24

File Size:1 file , 130 KB

Language:English

Note:This product is unavailable in Belarus, Russia, Ukraine

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.