AAMI TIR28:2009/(R)2013

Product adoption and process equivalency for ethylene oxide sterilization

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

Publisher: AAMI

File Format: PDF

$65.00$131.00


This AAMI technical information report (TIR) provides guidance for the adoption of a new ormodified product into an existing validated sterilization process and for the determination ofequivalency of a sterilization process as conducted in different equipment. Its guidance isintended to augment ANSI/AAMI/ISO 11135:1994, Medical devices?Validation and routinecontrol of ethylene oxide sterilization, and to expand on the areas of product adoption andprocess equivalency that are not addressed in ANSI/AAMI/ISO 11135:1994.

AAMI TIR28:2009/(R)2013 History

AAMI TIR28:2016/(R)2024

AAMI TIR28:2016/(R)2024

$74.00 $148.00

AAMI TIR28:2009/(R)2013

AAMI TIR28:2009/(R)2013

$65.00 $131.00

AAMI TIR28:2001

AAMI TIR28:2001

$44.00 $88.00

More AAMI Standards PDF

AAMI TIR23:1999/(R)2019

AAMI TIR23:1999/(R)2019

$113.00 $227.00

AAMI EQ56-99

AAMI EQ56-99

$49.00 $99.00

AAMI BIOT9

AAMI BIOT9

$82.00 $165.00

AAMI BIOT9-S

AAMI BIOT9-S

$198.00 $396.00