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ANSI/AAMI/ISO 11138-4:2017

Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes

Provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators, and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C.


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Association for the Advancement of Medical Instrumentation [aami]


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