AAMI ST34-91

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Guideline for the Use of Ethylene Oxide and Steam Biological Indicators in Industrial Sterilization Processes

Association for the Advancement of Medical Instrumentation , 06/18/1991

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This guideline provides the essential elements for the use of biological indicators (BIs) to develop and monitor industrial steam and ethylene oxide (EO) sterilization processes. This guideline addresses sterilization equipment, BI selection, appropriate use of BIs for qualification/validation, routine monitoring, and revalidation of sterilization processes.