AAMI TIR28:2016/(R)2024

Product adoption and process equivalency for ethylene oxide sterilization

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

Publisher: AAMI

File Format: PDF

$74.00$148.00

Description

Standard By:Association for the Advancement of Medical Instrumentation , 11/18/2016

Published:11/18/2016

Pages:22

ISBN(s):9781570206542

File Size:1 file , 360 KB

Language:English

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

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.