BS EN ISO 11138-1:2017规定了生产、标签、试验方法和性能的一般要求 生物指示剂的特性，包括接种载体和悬浮液，以及它们的 组件，用于灭菌过程的验证和常规监控。本文件规定了适用于ISO 11138所有部分的基本和通用要求。 相关文件中提供了特定工艺的生物指示剂要求 ISO 11138的部分内容。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。本文件不适用于依赖物理去除的工艺的微生物测试系统 指微生物，例如过滤过程或物理和/或机械结合的过程 通过微生物灭活去除，如使用洗衣机消毒器或冲洗和蒸汽 管道。然而，本文件可能包含与此类微生物测试相关的元素 系统。交叉引用:ISO 11135ISO 11737-1:2006ISO 14937ISO 17665-1ISO 18472ISO 8601ISO/TS 11139:2006ISO 11140-1ISO 13485ISO 14161:2009ISO 15223-1ISO 80000IEC 60027购买本文件时提供的所有当前修订版均包含在购买本文件中。

BS EN 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.This document 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.This document 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.Cross References:ISO 11135ISO 11737-1:2006ISO 14937ISO 17665-1ISO 18472ISO 8601ISO/TS 11139:2006ISO 11140-1ISO 13485ISO 14161:2009ISO 15223-1ISO 80000IEC 60027All current amendments available at time of purchase are included with the purchase of this document.