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ANSI/AAMI/ISO 11138-5:2017

Sterilization of health care products—Biological indicators—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes American National Standard

Specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.


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Association for the Advancement of Medical Instrumentation [aami]


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