AAMI TIR15:2016/(R)2024

AAMI TIR15:2016 provides additional guidance to augment ANSI/AAMI/ISO 11135:2014. 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.