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


AAMI TIR15:2009 (AAMI TIR 15:2009)

Physical aspects of ethylene oxide sterilization

This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135-1:2007. This TIR addresses some of the physical aspects of ethylene oxide (EO) sterilization and provides guidance on sterilization equipment, considerations for preconditioning, how to calculate relative humidity, EO concentration, and flammability, as well as guidance on the use of statistics for process equivalence. Additional guidance on ANSI/AAMI/ISO 11135-1:2007 can be found in ANSI/AAMI/ISO 11135-2:2008.

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

Others Also Bought

Product adoption and process equivalence for ethylene oxide sterilization
Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devi ...
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and ...
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.