AAMI TIR14:2016/(R)2024

Contract sterilization using ethylene oxide

Association for the Advancement of Medical Instrumentation , 06/05/2016

Publisher: AAMI

File Format: PDF

$74.00$148.00

Description

Standard By:Association for the Advancement of Medical Instrumentation , 06/05/2016

Published:06/05/2016

Pages:19

ISBN(s):1570206139

File Size:1 file , 390 KB

Language:English

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

This technical information report provides additional guidance to augment the ANSI/AAMI/IS0 11135 series both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. It addresses how ANSI/AAMI/ISO 11135:2014 applies to ethylene oxide sterilization operations for devices marketed in the United States. Ethylene oxide sterilization guidance for health care facilities is not specifically covered.