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AAMI TIR15:2009 (R2013) (AAMI TIR 15:2009 (R2013))

Physical aspects of ethyleneoxide sterilization

This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135û1:2007. 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..

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

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Document History
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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.