Sterilization of health care products. Biological indicators - Method for validation of a reduced incubation time for a biological indicator

Sterilization of health care products. Biological indicators - Method for validation of a reduced incubation time for a biological indicator

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1   Scope

1.1   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.

NOTE For biological indicators used for EO sterilization, the stated RIT is applicable to 100 % EO processes or processes that use EO blends, regardless of the product load.