AAMI TIR14:2009

Contract sterilization using ethylene oxide

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

Publisher: AAMI

File Format: PDF

$61.00$123.00

Description

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

Published:03/17/2009

Pages:22

ISBN(s):1570203377

File Size:1 file , 350 KB

Language:English

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

This AAMI TIR provides additional guidance to augment ANSI/AAMI/IS0 11135-1:2007, both for medical devicemanufacturers that use contract sterilization facilities and for contract sterilization operations. This TIR addresses howANSI/AAMI/ISO 11135-1:2007applies to contract ethylene oxide (EO) sterilization operations for devices marketed inthe United States.EO contract sterilization guidance for health care providers is not specifically covered in this TIR.Additional guidance on ANSI/AAMI/ISO 11135-1:2007 can be found in ANSI/AAMI/ISO 11135-2:2008.