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. This TIR provides additional guidance to ANSI/AAMI/ISO 11135:2014 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.

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.

Products that have been used in a healthcare setting and are being presented for resterilization in accordance with the manufacturer's instructions (see ANSI/AAMI/ISO 17664) are a special case. There is the potential for such products to possess a wide range of contaminating microorganisms and residual inorganic and/or organic contamination in spite of the application of a cleaning process. Hence, it is important to pay particular attention to the validation and control of the cleaning and disinfection processes used during reprocessing. Healthcare facilities are encouraged to review AAMI ST35, TIR30, and TIR34 for additional information on handling reusable or non-sterile devices requiring sterilization processing.