前言:这是CAN/CSA-Z11135《医疗保健产品的灭菌——环氧乙烷——医疗器械灭菌过程的开发、验证和常规控制要求》的第一版，采用了同名ISO（国际标准化组织）标准11135（第二版，2014-07-15），但有加拿大的偏差。本标准取代了CAN/CSA-Z11135-1-09《医疗保健产品的灭菌-环氧乙烷-第1部分:医疗器械灭菌过程的开发、验证和常规控制要求》（采用ISO 11135-1:2007）和CAN/CSA-Z11135-2-09，医疗保健产品的灭菌.环氧乙烷.第2部分:ISO 11135-1（采用ISO/TS 11135-2:2008）的应用指南，已修订并浓缩成一个标准。范围:1.1包括本国际标准规定了工业和医疗保健设施环境下医疗器械环氧乙烷灭菌过程的开发、验证和常规控制要求，并承认两种应用之间的相似性和差异。 注1:相似之处包括对质量体系、员工培训和适当安全措施的共同需求。主要区别在于医疗设施独特的物理和组织条件，以及用于灭菌的可重复使用医疗设备的初始条件。注2:医疗保健设施与医疗器械制造商在加工区的物理设计、使用的设备以及具有足够培训水平和经验的人员的可用性方面有所不同。医疗设施的主要功能是提供患者护理；医疗器械后处理只是支持该功能的众多活动之一。注3:就医疗器械的初始条件而言，医疗器械制造商通常会对大量由原始材料生产的类似医疗器械进行消毒。另一方面，医疗保健机构必须处理和处理新的医疗设备和可重复使用的医疗设备，这些医疗设备具有不同的描述和不同的生物负载水平。 因此，他们还面临着消毒前清洁、评估、准备和包装医疗器械的额外挑战。在本国际标准中，针对医疗保健设施的替代方法和指南被确定为此类。注4:环氧乙烷气体及其混合物是有效的灭菌剂，主要用于不能进行湿热灭菌的热和/或湿敏医疗设备。注5:尽管本国际标准的范围仅限于医疗器械，但它规定了可适用于其他医疗保健产品的要求并提供了指导。1.2例外情况1。2.1本国际标准未规定海绵状脑病（如羊瘙痒病、牛海绵状脑病和克雅氏病）病原体灭活过程的开发、验证和常规控制要求。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本国际标准未详细说明将医疗器械指定为无菌医疗器械的规定要求。注:请注意将医疗器械指定为“无菌”的国家或地区要求。例如参见EN 556？1或ANSI/AAMI ST67。1.2.3本国际标准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:医疗器械灭菌过程的开发、验证和常规控制需要有效实施已定义和文件化的程序。这些程序通常被认为是质量管理体系的组成部分。本国际标准不要求在制造或再加工过程中建立完整的质量管理体系。必要的元素在文本中的适当位置进行了规范性引用（具体见第4条）。 请注意控制医疗器械生产或再加工所有阶段的质量管理体系标准（见ISO 13485）。提供医疗器械的国家和/或地区法规可能要求实施完整的质量管理体系，并由第三方对该体系进行评估。1.2.4本国际标准未规定与环氧乙烷灭菌设施的设计和运行相关的职业安全要求。注1:有关安全性的更多信息，请参见参考书目中的示例。国家或地区法规也可能存在。注2环氧乙烷有毒、易燃、易爆。需要注意的是，一些国家可能存在规定EO处理和使用场所安全要求的法规。1.2.5本国际标准不包括通过将环氧乙烷或含有环氧乙烷的混合物直接注入包装或柔性腔室进行灭菌。 注:这些类型的EO工艺见ISO 14937。1.2.6本国际标准不包括测定残留EO和/或其反应产物水平的分析方法。注1:更多信息见ISO 10993-7。注2:请注意，可能存在国家或地区法规，规定医疗器械上或医疗器械中EO残留水平的限制。

Preface:This is the first edition of CAN/CSA-Z11135,Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 11135 (second edition, 2014-07-15).This Standard replaces CAN/CSA-Z11135-1-09,Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices(adopted ISO 11135-1:2007), and CAN/CSA-Z11135-2-09,Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1(adopted ISO/TS 11135-2:2008), which have been revised and condensed into one Standard.Scope:1.1 InclusionsThis International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.NOTE 1 Among the similarities are the common need for quality systems, staff training, and proper safety measures. The major differences relate to the unique physical and organizational conditions in health care facilities, and to the initial condition of reusable medical devices being presented for sterilization.NOTE 2 Health care facilities differ from medical device manufacturers in the physical design of processing areas, in the equipment used, and in the availability of personnel with adequate levels of training and experience. The primary function of the health care facility is to provide patient care; medical device reprocessing is just one of a myriad of activities that are performed to support that function.NOTE 3 In terms of the initial condition of medical devices, medical device manufacturers generally sterilize large numbers of similar medical devices that have been produced from virgin material. Health care facilities, on the other hand, must handle and process both new medical devices and reusable medical devices of different descriptions and with varying levels of bioburden. They are therefore faced with the additional challenges of cleaning, evaluating, preparing and packaging a medical device prior to sterilization. In this International Standard, alternative approaches and guidance specific to health care facilities are identified as such.NOTE 4 EO gas and its mixtures are effective sterilants that are primarily used for heat- and/or moisture sensitive medical devices that cannot be moist heat sterilized.NOTE 5 Although the scope of this International Standard is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other health care products.1.2 Exclusions1.2.1This International Standard 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 22442-3.1.2.2This International Standard does not detail a specified requirement for designating a medical device as sterile. NOTE Attention is drawn to national or regional requirements for designating medical devices as "sterile". See for example EN 556?1 or ANSI/AAMI ST67.1.2.3This International Standard does not specify a quality management system for the control of all stages of production of medical devices.NOTE The effective implementation of defined and documented procedures is necessary for the development, validation and routine control of a sterilization process for medical devices. Such procedures are commonly considered to be elements of a quality management system. It is not a requirement of this International Standard to have a full quality management system during manufacture or reprocessing. The necessary elements are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. National and/or regional regulations for the provision of medical devices might require the implementation of a full quality management system and the assessment of that system by a third party.1.2.4This International Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations may also exist.NOTE 2 EO is toxic, flammable and explosive. Attention is drawn to the possible existence in some countries of regulations giving safety requirements for handling EO and for premises in which it is used.1.2.5This International Standard does not cover sterilization by injecting EO or mixtures containing EO directly into packages or a flexible chamber.NOTE See ISO 14937 for these types of EO processes.1.2.6This International Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products.NOTE 1 For further information see ISO 10993-7.NOTE 2 Attention is drawn to the possible existence of national or regional regulations specifying limits for the level of EO residues present on or in medical devices.