AAMI TIR20:2001

This AAMI technical information report (TIR) provides guidance to augment information andrequirements for parametric release provided in ANSI/AAMI/ISO 11135:1994, Medical devices?Validation and routine control of ethylene oxide (EO) sterilization. This TIR is intended to assistthose individuals using ANSI/AAMI/ISO 11135:1994 in understanding the steps necessary todevelop and validate an ethylene oxide sterilization process that meets the standard?srequirements for parametric release. This TIR also provides guidance for choosing theappropriate actions where alternatives are given. The guidance in this TIR is limited to thesections of the standard that specifically address parametric release.