ST - WG 02 - Radiation Sterilization Working Group
AAMI Staff Contact
Gigi Golriz
Description
The AAMI ST/WG 02 - Radiation Sterilization Working Group provides input into international standards developed by ISO/TC 198/WG 02 - Radiation sterilization, through the AAMI ST Committee which serves as the mirror committee and U.S. TAG to ISO/TC 198.
Related Groups
Related Documents
- AAMI TIR35: 2016, Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits
- AAMI TIR37: 2013, Sterilization of health care products - Radiation - Guidance on sterilization of human tissue-based products
- AAMI TIR40:2018 Sterilization of health care products—Radiation—Guidance on dose setting utilizing a Modified Method 2
- AAMI TIR43:2011, Ultrapure dialysate for hemodialysis and related therapies
- ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019, Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices, Amendment 2
- ANSI/AAMI/ISO 11137-03: 2017, Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects