scope:

This AAMI Technical Information Report (TIR) provides guidance to augment ANSI/AAMI/ISO 10993-7, Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals. This TIR is intended to assist those individuals using ANSI/AAMI/ISO 10993-7 in understanding the steps necessary to evaluate an ethylene oxide-sterilized device according to the standard and to help those individuals choose appropriate actions where alternatives are given. This TIR also provides limited guidance for the application of other parts of the ANSI/AAMI/ISO 10993 series of standards to the biological evaluation of ethylene oxide-sterilized medical devices.