June 17, 2024

Updated ethylene oxide sterilizer standard covers latest technology

Editor's Note 

The Association for the Advancement of Medical Instrumentation (AAMI) has updated its standard on ethylene oxide (EO) sterilizers for healthcare facilities, according to a June 12 press release. The first update in two decades, the fourth edition ANSI/AAMI ST24:2024 covers labeling, safety, performance, and testing requirements for general-purpose EO sterilizers with automatic controls. Updates also reflect the Environmental Protection Agency’s new Final Rule on EO.

Important updates include:

  • Labeling, performance, safety, and installation requirements for EO emission control systems.
  • Sterilizer construction, components, and accessories.
  • Sterilizer safety, including worker safety, thermal hazards, air filtration, and exposure monitoring.
  • Requirements for registration, labeling, container safety, shipping, and emissions related to sources of EO.
  • Test methods and procedures that can be used to demonstrate conformance with the standard.

According to the press release, the updated standard now includes EO sterilization systems cleared by the FDA since the publication of the last edition. It also de-emphasizes outdated EO tank and mixture-based systems.  

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