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AAMI TIR15:2009

Physical aspects of ethylene oxide 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. Additional guidance on ANSI/AAMI/ISO 11135-1:2007 can be found in ANSI/AAMI/ISO 11135-2:2008.

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Association for the Advancement of Medical Instrumentation [aami]

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