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ANSI/AAMI/ISO 11138-2:2017

Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes

Specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.

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Association for the Advancement of Medical Instrumentation [aami]

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