1.1夹杂物 1.1.1本文件规定了使用低温蒸汽和甲醛混合物作为杀菌剂并在环境压力下运行的医疗器械低温蒸汽和甲醛（LTSF）灭菌过程的开发、验证和常规控制要求。 注:尽管本文件的范围仅限于医疗设备，但它规定了适用于其他产品和设备的要求并提供了指导。 1.1.2本文件适用于工艺开发商、灭菌设备制造商、待灭菌医疗器械制造商以及负责医疗器械灭菌的组织（见ISO 14937:2009，表E.1）。 1.2除外责任 1.2.1本文件未规定海绵状脑病病原体灭活过程的开发、验证和常规控制要求，如羊瘙痒病、牛海绵状脑病和克雅氏病- 雅各布病。对于可能被这些制剂污染的材料的处理，特定国家已经提出了具体的建议。 注:参见ISO 22442-1、ISO 22442-2和ISO 22442-3。 1.2.2本文件未规定将医疗器械指定为“无菌”的要求。EN 556-1中给出了此类要求。 1.2.3本文件未规定用于控制医疗器械生产所有阶段的质量管理体系。 注:本文件不要求在制造或再加工过程中建立完整的质量管理体系，但此类体系所需的要素在文本中的适当位置进行了规范性引用。请注意质量管理体系标准（见ISO 13485），该标准控制医疗器械生产或再加工的所有阶段，包括灭菌过程。 ISO 14937:2009的E.4中给出了进一步的指导。 1.2.4本文件未规定与LTSF灭菌设施的设计和运行相关的职业安全要求。 注1:IEC 61010？2？040规定了灭菌器的安全要求。 注2:还应注意一些国家存在规定安全要求的法规。 1.2.5本文件不包括测定甲醛和/或其反应产物含量或残留量的分析方法。 注1:请注意EN 14180。 注2:值得注意的是，一些国家可能存在规定医疗器械和产品甲醛残留水平限值的法定法规。 1.2.6本文件不包括灭菌前可能需要的准备措施，如清洁、消毒和包装。 注:对于可再加工医疗器械，这些器械的制造商可以提供有关准备措施的信息（见ISO 17664）。

1.1 Inclusions 1.1.1 This document specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure. NOTE Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other products and equipment. 1.1.2 This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices (see ISO 14937:2009, Table E.1). 1.2 Exclusions 1.2.1 This document does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE See ISO 22442？1, ISO 22442？2 and ISO 22442？3. 1.2.2 This document does not specify requirements for designating a medical device as "STERILE". Such requirements are given in EN 556？1. 1.2.3 This document does not specify a quality management system for the control of all stages of production of medical devices. NOTE It is not a requirement of this document to have a complete quality management system during manufacture or reprocessing, but those elements of such a system that are required are normatively referenced at appropriate places in the text. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices including the sterilization process. Further guidance is given in E.4 of ISO 14937:2009. 1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of LTSF sterilization facilities. NOTE 1 Safety requirements for sterilizers are specified in IEC 61010？2？040. NOTE 2 Attention is also drawn to the existence in some countries of regulations stipulating safety requirements. 1.2.5 This document does not cover analytical methods for determining levels or residues of formaldehyde and/or its reaction products. NOTE 1 Attention is drawn to EN 14180. NOTE 2 Attention is drawn to the possible existence in some countries of statutory regulations specifying limits for the level of formaldehyde residues on medical devices and products. 1.2.6 This document does not cover preparatory measures that might be necessary before sterilization such as cleaning, disinfection and packing. NOTE For reprocessable medical devices, the manufacturer(s) of these devices can supply information on the preparatory measures (see ISO 17664).