ISO 11138-1:2017规定了用于灭菌过程验证和常规监测的生物指示剂（包括接种载体和悬浮液）及其成分的生产、标签、试验方法和性能特征的一般要求。 ISO 11138-1:2017规定了适用于ISO 11138所有部分的基本和通用要求。ISO 11138的相关部分提供了特定工艺的生物指示剂要求。 如果未提供具体的后续部分，则本文件适用。 注:国家或地区法规可适用。 ISO 11138-1:2017不适用于依赖于微生物物理去除的过程的微生物测试系统，例如过滤过程或物理和/或机械去除与微生物灭活相结合的过程，如使用清洗消毒器或管道冲洗和蒸汽。然而，本文件可包含与此类微生物测试系统相关的元素。

ISO 11138-1:2017 specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes. ISO 11138-1:2017 specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies. NOTE National or regional regulations can apply. ISO 11138-1:2017 does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.