AAMI ST67:2019

Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"

Association for the Advancement of Medical Instrumentation , 07/29/2019

Publisher: AAMI

File Format: PDF

$74.00$149.00

Description

Standard By:Association for the Advancement of Medical Instrumentation , 07/29/2019

Published:07/29/2019

Pages:41

ISBN(s):9781570207273

File Size:1 file , 680 KB

Language:English

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

This standard establishes requirements, guidance and a risk framework for identification of acceptable approach(es) for assurance of sterility and for selection of alternative SAL(s) or aseptic processing for health care product that cannot be terminally sterilized to achieve an SAL value of 10^-6.