The Association for the Advancement of Medical Instrumentation has updated its American National Standard for hospital steam sterilizers, adding new safety, testing and labeling requirements for manufacturers.
The updated standard establishes minimum safety, performance, testing and labeling requirements for steam sterilization units used to process reusable medical devices in hospitals, surgical centers and dental offices, according to a July 14 news release. The standard has been revised periodically since its initial publication in 1983.
The new standard also introduces separate moisture tension testing requirements from biological performance testing, removes drying times from biological performance testing, adopts the term “immediate-use steam sterilization” in place of “flash sterilization,” and adds new requirements for manufacturers’ instructions for use accompanying steam sterilizer units.
AAMI said the revised standard reflects current scientific consensus and includes updated guidance on sterilizer design, process monitoring, safety and verification testing.
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