ISO 11138-8:2021

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ISO 11138-8:2021 is an international standard focused on the sterilization of health care products. Specifically, it outlines a method for validating a reduced incubation time for biological indicators used in sterilization process validation and routine monitoring. The standard describes how to determine if a biological indicator can be incubated for a shorter time than the standard 7-day period while still ensuring adequate detection of surviving microorganisms. This reduced incubation time procedure helps streamline the validation process and can be beneficial for medical device manufacturers and healthcare facilities