本文件为生物指示剂在灭菌过程的开发、验证和常规监测中应用结果的选择、使用和解释提供了指导。它不考虑那些仅仅依靠物理去除微生物的过程，例如过滤。不适用于使用洗涤器、消毒剂或管道冲洗、蒸汽等组合工艺。它没有规定选择和使用生物指示剂的要求，用于监测在大气压力下用于隔离物和室内生物净化过程的蒸发过氧化氢过程。不适用于液体浸泡灭菌工艺。

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.