医疗器械生产企业质量管理体系规范 - 嘉兴高是灭菌技术有限公司.pdf

无菌医疗器械技术和质量 嘉兴高是灭菌技术有限公司 刘文一 主要讲解内容 一、无菌医疗器械简介 二、无菌医疗器械生产管理 三、无菌医疗器械质量管理相关标准 四、 微生物基本概念 五、 净化车间环境管理 六、 灭菌方法确认（环氧乙烷灭菌） 七、 包装和产品有效期 主要讲解内容 八、无菌检验技术 九、常见问题和回答 一、无菌医疗器械简介 无菌医疗器械是一大类比较特殊的产品。 ISO13485标准专门为其作出定义。 3.8 无菌医疗器械 sterile medical device 旨在满足无菌要求的医疗器械类别。 注：对医疗器械无菌的要求，可按国家或地区的法规或标准 执行。 一、无菌医疗器械简介 什么叫“无菌”,“sterile” 欧盟： EN 556-1：2001 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” - Part 1: Requirements for terminally sterilized medical devices 4 Requirements 4.1 For a terminally-sterilized medical device to be designated “STERILE”, the theoretical probability of there being a viable micro- organism present on/in the device shall be equal -6 to or less than 1x10 . -6 存在器械上的可视微生物的存活概率低于1x10 . 一、无菌医疗器械简介 4.2 Compliance shall be shown by the manufacturer or supplier through provision of documentation and records which demonstrate that the devices have been subjected to a validated sterilization process fulfilling 4.1. 制造商或者供应商 应通过灭菌确认的过程来证实。 一、无菌医疗器械简介 美国 ANSI/AAMI ST:41:1999 Ethylene oxide sterilization in health care facilities: Safety and effectiveness 2.80 sterile: State of being free from all living microorganisms. NOTE—In practice, sterility is usually described as a probability function, e.g., as the probability of a surviving microorganism being one in a million. 无菌没有存活微生物。实践中，百万分之一的存活概率。 一、无菌医疗器械简介 2.82 sterility assurance level (SAL): Probability of a viable microorganism being present on a product unit afte