AAMI TIR16:2009/(R)2013

Microbiological aspects of ethylene oxide sterilization

Association for the Advancement of Medical Instrumentation , 03/03/2010

Publisher: AAMI

File Format: PDF

$81.00$163.00

Description

Standard By:Association for the Advancement of Medical Instrumentation , 03/03/2010

Published:03/03/2010

Pages:33

ISBN(s):1570203741

File Size:1 file , 300 KB

Language:English

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

Addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. Does not address the various factors that can have an effect on the bioburden of the product and on the sterilization process. Provides additional guidance to ANSI/AAMI/ISO 11135-1:2007 and ANSI/AAMI/ISO TIR11135-2:2008 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.