范围:本文件为在灭菌的开发、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指导 过程。 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冲洗和消毒器的组合工艺 蒸汽管道。 它没有规定用于监测的生物指示剂的选择和使用要求 隔离器的汽化过氧化氢工艺和实验室生物净化工艺 大气压。 不适用于液体浸泡灭菌过程。交叉引用:ISO/IEC指南2ISO 18472ISO 11737（所有部分）ISO 14937ISO 20857ISO 11135ISO 9001ISO 11138（所有部分）ISO 13485ANSI/AAMI ST79EN 1422EN 285ISO/IEC 17025ISO 17665-1ISO 19011ISO/IEC 17011ISO 11139:2018购买本文件时提供的所有当前修订版均包括在内。

Scope: 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.Cross References:ISO/IEC Guide 2ISO 18472ISO 11737 (all parts)ISO 14937ISO 20857ISO 11135ISO 9001ISO 11138 (all parts)ISO 13485ANSI/AAMI ST79EN 1422EN 285ISO/IEC 17025ISO 17665-1ISO 19011ISO/IEC 17011ISO 11139:2018All current amendments available at time of purchase are included with the purchase of this document.