Customer Service:
Mon - Fri: 8:30 am - 6 pm EST


AAMI TIR14:2016

Contract sterilization using ethylene oxide

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.

Content Provider
Association for the Advancement of Medical Instrumentation [aami]

Others Also Bought

Microbiological aspects of ethylene oxide sterilization
Physical aspects of ethylene oxide sterilization
Product adoption and process equivalence for ethylene oxide sterilization
Document History
Included in Packages
This standard is not included in any packages.
Amendments & Corrections
We have no amendments or corrections for this standard.

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.