GB/T 18281.7-2024 Sterilization of health care products—Biological indicators—Part 7:Guidance for the selection,use and interpretation of results

Scope

This document provides guidelines for the selection, use, and interpretation of results of biological indicators in the development, validation, and routine monitoring of sterilization processes. This document is applicable to all biological indicators. This document does not consider processes that rely solely on physical methods to remove microorganisms, such as filtration. This document is not applicable to the use of various combination processes, such as cleaning and disinfecting sterilizers or flushing and steam sterilizing pipelines. This document does not specify requirements for the selection and use of biological indicators to monitor the vaporized hydrogen peroxide process for isolator and indoor biological decontamination at atmospheric pressure. This document is not applicable to liquid immersion sterilization processes.

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