ISO 11119-1:2017规定了生物指示剂的生产，标签，试验方法和性能特征的一般要求，包括接种的载体和悬浮液及其组分，用于灭菌过程的验证和常规监测。 ISO 11119-1:2017规定了适用于ISO 11138的所有部分的基本和共同要求。特定规定流程的生物指标要求在ISO 11138的相关部分提供。如果没有提供特定的后续部分，本文件适用。 注意国家或地区法规可以适用。 ISO 11119-1:2017不适用于依赖微生物物理去除的过程的微生物测试系统，例如，将物理和/或机械去除与微生物灭活相结合的过滤过程或过程，例如使用洗涤消毒器或管道的冲洗和蒸汽。然而，本文件可以包含与这些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.