ISO-11135-2014-EO灭菌-医疗器械灭菌过程开发、确认和常规控制要求(中英文)

Sterilization of health-care products ̶E thyleneoxide̶Requirements for the development,validation and routine control of a sterilizationprocess for medical devices医疗保健产品灭菌——环氧乙烷——医疗器械灭菌过程开发、确认和常规控制要求1Scope范围1.1Inclusions 包含内容This 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. 本标准规定了医疗器械产品在工业与医疗保健机构的环氧乙烷灭菌过程的开发、验证和常规控制的要求，并承认这两个领域之间灭菌过程开发、确认的常规控制的异同。

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.注1．其中, 相同之处在于质量体系、人员培训及适当的安全措施的通用要求。

主要的区别涉及到医疗保健机构的独特的硬件环境和组织条件，以及供灭菌的可重复使用医疗器械的初始条件。

NOTE 2. Health care facilities differ from medical device manufacturers in the physical design of processing areas, in the equipment used, and in theavailability 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.注2．医疗器械制造商与医疗机构的主要不同点在于灭菌区域的硬件设计、所使用的设备，以及有技能和经充分培训的人员的可用性方面。

卫生保健机构的基本功能是为病人提供医疗保健;医疗器械的再处理仅是支持医疗保健功能的无数活动之一。

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.注3．就医疗器械的初始条件而言，医疗器械制造商通常灭菌大量的从原始材料开始生产的类似的医疗器械。

另一方面，卫生保健机构必须同时处理和加工有着不同生物负载水平的新的医疗器械和再次使用的医疗器械。

因此，医疗保健机构的灭菌产品面临着在灭菌前清洗、评估、准备和包装医疗器械的额外挑战。

在本标准，确定了针对医疗保健机构的灭菌过程开发、确认和控制的方法或指南。

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.注4. EO气体及其混合物是一种主要用于对湿热敏感而不能用湿热进行灭菌的医疗器械灭菌的有效的灭菌剂。

NOTE 5. Although the scope of this International Standard is limited to medical devices, it specifies requirements and provides guidance that can beapplicable to other health care products.注5 尽管本标准限定于医疗器械，但标准规定的要求和提供的指南同样适用于其他医疗保健产品。

1.2Exclusions 不适用1.2.1This 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.本标准没有对海绵状脑病的致病因子(如痒病、牛绵状脑病和克-雅病)的灭活过程的开发、确认和常规控制作出规定。

有些国家已有了处理可能受此类因子污染的材料的推荐资料。

NOTE， See ISO 22442-1, ISO 22442-2 and ISO 22442-3.注，见ISO 22442-1, ISO 22442-2 和 ISO 22442-31.2.2This International Standard does not detail a specified requirement for designating a medical device as sterile.本标准未详细论述确定医疗器械为无菌的规定要求。

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. 须注意国家和地区确定医疗器械‘无菌’的要求，见如EN556-1或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.本标准未对医疗器械生产各个阶段的控制的质量管理体系作出规定。

NOTE The effective implementation of defined and documented procedures is necessary for the development, validation and routine control of asterilization 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.建立医疗器械灭菌过程的开发、确认和常规控制的文件化的，并能有效实施的程序是必需的，这样的程序文件通常被认为是质量管理体系的要素。