标准摘要
[中文适用范围]： 本文件为用于灭菌过程的开发、验证和常规监测时生物指示剂应用结果的选择、使用和解释提供指导。 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等的组合工艺。 它没有规定用于监测大气压下隔离器和房间生物净化过程的汽化过氧化氢过程的生物指示剂的选择和使用要求。 不适用于液浸灭菌工艺。 [外文原描述]： 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.
英文名称Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results