Arlington, VA, March 26, 2025 (GLOBE NEWSWIRE) -- AAMI is pleased to announce that the FDA has amended its database of Recognized Consensus Standards, adding multiple AAMI documents in the agency’s latest round of updates announced in March 2025. This includes one new addition as well as three revised versions of sterility assurance and sterilization documents previously recognized by FDA in December of 2024.
The new entry to FDA’s database of Recognized Consensus Standards is AAMI TIR106:2024: Microbiological methods—Understanding and use of product bioburden data. Three of AAMI’s most notable sterilization guidance documents were also superseded by newer versions that were recently revised and updated by AAMI. These documents are:
- ANSI/AAMI ST58:2024, Chemical sterilization and high-level disinfection in health care facilities
- ANSI/AAMI ST24:2024, General purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
- AAMI TIR17:2024, Compatibility of materials subject to sterilization
AAMI welcomes the recognition of TIR106, but the inclusion of the updated editions of the other three documents is a major milestone. ST58, ST24, and TIR17 were all recently updated by AAMI, and FDA recognition is an important validation of the new editions’ usefulness for regulators, hospitals, and the medical device industry.
The most recent edition of ANSI/AAMI ST58 was comprehensively revised and reorganized in 2024. The document now includes information on new technologies and chemical sterilization modalities, including ethylene oxide (EO). Prior to 2024, ST24 had not been updated in more than two decades, and the most recent edition features FDA-cleared EO sterilization systems not included in the prior edition. Finally, the new edition of TIR17 includes completely overhauled materials compatibility tables per modality.
AAMI Vice President of Sterilization Amanda Benedict said, “FDA had previously included prior editions of AAMI ST58, ST24, and TIR17 in its database of Recognized Consensus Standards, but the recognition of the recently updated documents and the new recognition of TIR106 is a welcome validation of AAMI’s efforts to promote patient well-being through the production of regulatory-ready sterilization and sterility assurance standards and technical documents.”
All four guidance documents can be found on AAMI ARRAY. Questions about what these FDA approvals mean for AAMI or about the changes to the guidance documents discussed above? Contact the AAMI media team at dvisnovsky@aami.org.
