Standards Working Group
ST/WG 07 - Packaging Working Group
AAMI Staff Contact
The AAMI ST/WG 07 - Packaging Working Group provides input into international standards developed by ISO/TC 198/WG 07 – Packaging, through the AAMI ST Committee which is the mirror committee and U.S. TAG to ISO/TC 198.
- AAMI/ISO TIR16775: 2014, Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
- ANSI/AAMI/ISO 11607-01: 2019, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging
- ANSI/AAMI/ISO 11607-02: 2019, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes