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ANSI/AAMI/ISO 11138-1:2017

Sterilization of health care products—Biological indicators—Part 1: General requirements

Specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.


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Association for the Advancement of Medical Instrumentation [aami]


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