Sterilization Q&A
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Asked April 23rd, 2009
The following AAMI standards can assist you in performing the proper testing to evaluate the validity of your sterile barrier:
- ANSI/AAMI/ISO 11607-1:2006 - Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems, and packaging.
- ANSI/AAMI/ISO 11607-2:2006 - Packaging for terminally sterilized medical devices-Part 2: Validation requirements for forming, sealing, and assembly processes.
- AAMI TIR22:2007 - Guidance for ANSI/AAMI/ISO 11607-Packaging for terminally sterilized medical devices-Part 1 and Part 2:2006.
In addition, AAMI TIR 17:2008 provides guidance on performing accelerated aging studies, which you may also wish to perform while validating your packaging materials.
You can purchase all of these AAMI standards and TIRs at www.aami.org.



