AAMI Updates Standards for Manufacturers of Medtech Steam Sterilization Systems

The Association for the Advancement of Medical Instrumentation (AAMI) has revised its American National Standard that establishes safety and performance requirements for steam sterilization units used to process reusable medical devices in hospitals and other healthcare delivery organizations.

ANSI/AAMI ST8:2026; Hospital steam sterilizers provides minimum labeling, safety, performance, and testing requirements to help ensure a reasonable level of safety and efficacy in the steam sterilizers used in health care facilities such as hospitals, surgical centers, and dental offices.

Since its initial publication in 1983, ANSI/AAMI ST8 has been revised at appropriate intervals in response to scientific and technological developments. The newly published seventh edition of the standard now includes the most current safety and testing information based on current scientific consensus in the medical device field. Major changes in the 2026 edition of ST8 compared with previous editions of the standard are:

• Inclusion of requirements for moisture tension tests to be conducted separately from biological performance tests.
• Exclusion of drying times from the process of biological performance testing.
• Adoption of the term “immediate-use steam sterilization” (IUSS) rather than “flash sterilization.”
• Addition of requirements for the manufacturer’s instructions for use (IFUs) that accompany steam sterilizer units.

The standard includes extensive, detailed information on the design features and operational elements of steam sterilizers, including:

• Sterilizer design, construction, and safety.
• Process monitoring and control devices.
• Reference test methods and procedures for verification of conformance with ANSI/AAMI ST8.
• Details on conducting mechanical air removal and moisture retention tests.

The revised ANSI/AAMI ST8 was produced by AAMI’s Hospital Steam Sterilizers Working Group, which was staffed by volunteer experts from regulatory agencies, the medical device industry, and healthcare delivery organizations, including representatives from regional American hospital systems.

“The new edition of ANSI/AAMI ST8 provides critically needed updates to align the standard with current regulatory requirements and state-of-the-art for performance and safety for hospital steam sterilizers and affords manufacturers of these devices a solid foundation for innovation,” said Amanda Benedict, AAMI’s vice president of Sterilization.

The Association for the Advancement of Medical Instrumentation is a nonprofit organization founded in 1967. Having developed national and international consensus standards, AAMI has built a network of over 15,000 members across more than 70 countries. This diverse and engaged membership includes industry leaders, healthcare professionals, and government representatives working together to improve patient safety and healthcare outcomes.