FDA Recognizes Newly Revised AAMI Sterilization, Ethylene Oxide Guidance
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 ...
Medical Design & Outsourcing9 天
Steris reaches deal to settle ethylene oxide cases in Illinois
Steris said its Isomedix subsidiary will pay up to $48.15 million to resolve litigation around an EtO sterilization facility ...
Mena FN8 天
FDA Recognizes Newly Revised AAMI Sterilization, Ethylene Oxide Guidance
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 ...
AZoM on MSN1 个月
What FIFRA Means for Commercial Sterilizers using Ethylene Oxide
As of January 14, 2025, FIFRA now regulates the exposure of workers to Ethylene Oxide in commercial sterilizers and other related facilities. Image Credit: Picarro Under FIFRA, the EPA reviews and ...
Morningstar8 天
FDA Recognizes Newly Revised AAMI Sterilization, Ethylene Oxide Guidance
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 ...