AAMI TIR15:2009/(R)2013 PDF

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Physical aspects of ethylene oxide sterilization
standard by Association for the Advancement of Medical Instrumentation, 09/03/2009

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Category: AAMI

Description

This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135-1:2007. This TIR addresses some of thephysical aspects of ethylene oxide (EO) sterilization and provides guidance on sterilization equipment, considerations forpreconditioning, how to calculate relative humidity, EO concentration, and flammability, as well as guidance on the use ofstatistics for process equivalence.