[医药卫生]无菌医疗器械管理培训.pdf

无菌医疗器械生产质量管理 嘉兴高是灭菌技术有限公司 刘文一 126.com 主要讲解内容 一、无菌医疗器械简介 二、无菌产品生产管理 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 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 to or less than 1x10-6. -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 after sterilization. NOTES— 1. SAL is normally expressed as 10-[n]. 2. A SAL of 10-6 means that there is less than or equal to one chance in a million that a single viable microorganism is present