scope:

This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various factors that can have an effect on the bioburden of the product and on the sterilization process, nor does it specifically address parametric release. This TIR provides additional guidance to augment ANSI/AAMI/ISO 11135:1994, Medical devices-Validation and routine control of ethylene oxide sterilization (AAMI 1994) for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.

NOTE-If parametric release is being considered for the release of the product, the requirements in ANSI/AAMI/ISO 11135:1994 (AAMI 1994) for temperature parameters and monitoring should be followed. An AAMI TIR addressing parametric release is in preparation.

Although the information presented was developed for application to medical devices, the content of this guideline may also be applied to other relevant products or materials.