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


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.

AAMI ST67:2019 History

AAMI ST67:2019

AAMI ST67:2019

$74.00 $149.00

AAMI ST67:2011/(R)2017

AAMI ST67:2011/(R)2017

$70.00 $140.00

AAMI ST67:2003/(R)2008

AAMI ST67:2003/(R)2008

$44.00 $88.00

More AAMI Standards PDF

AAMI TIR34:2007

AAMI TIR34:2007

$82.00 $165.00

AAMI EC11:1991/(R)2007

AAMI EC11:1991/(R)2007

$40.00 $80.00

AAMI BF7:1989 (R2011)

AAMI BF7:1989 (R2011)

$49.00 $99.00

AAMI EC71:2001/(R)2013

AAMI EC71:2001/(R)2013

$40.00 $80.00