AAMI TIR16:2023
Microbiological aspects of ethylene oxide sterilization
- Standard No.
- AAMI TIR16:2023
- Release Date
- 2023
- Published By
- American National Standards Institute （ANSI)
- Latest
- AAMI TIR16:2023
- Scope
- Addresses various microbiological aspects of the development and validation of an ethylene oxide sterilization process. Does not address the various factors that can have an effect on the bioburden of the product and on the sterilization process. Provides additional guidance to ANSI/AAMI/ISO 11135:2014 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.
AAMI TIR16:2023 history
- 2023 AAMI TIR16:2023 Microbiological aspects of ethylene oxide sterilization
- 2017 AAMI TIR16:2017 Microbiological aspects of ethylene oxide sterilization
- 2009 AAMI TIR16:2009 Microbiological aspects of ethylene oxide sterilization
- 2000 AAMI TIR16:2000 Process development and performance qualification for ethylene oxide sterilization - Microbiological aspects
