本文件为在灭菌过程的开发、验证和常规监测中使用生物指示剂时选择、使用和解释结果提供了指导。 它不考虑那些仅依靠物理去除微生物的过程，例如过滤。 它不适用于使用清洗消毒器或管道冲洗和蒸汽的组合工艺。 它没有规定选择和使用生物指示剂的要求，这些指示剂用于监测隔离器和室温常压下生物去污过程的汽化过氧化氢过程。 不适用于液体浸泡灭菌过程。

This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes. It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration. It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines. It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure. It is not applicable to liquid immersion sterilization processes.