ISO 11135-2014中.pdf

ISO 11135-2014 Sterilization of health-care products ̶ Ethylene oxide ̶Requirements for the development, validation and routine control of a sterilization process 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 1 Scope范围 1.1 Inclusions 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 the 1 ISO 11135-2014 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. 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, medica