ANSI/AAMI/ISO 11138-8:2023
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Sterilization of health care products—Biological indicators—Part 8: Method for validation of a reduced incubation item for a biological indicator
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08-24-2023
This document specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7-day reference incubation time specified in 7.3.2 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes.
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