浅谈医疗器械控制生物负载的重要性  

Discussion on the Importance of Medical Devices to Control Bioburden

作　　者：张悦[1] 沈以凌[1] 李梦媛[1] ZHANG Yue;SHEN Yi-ling;LI Meng-yuan(Beijing Research Center for Radiation Application（Beijing 100015)

机构地区：[1]北京市射线应用研究中心,北京100015

出　　处：《中国医疗器械信息》2018年第17期24-25,共2页China Medical Device Information

摘　　要：医疗器械上/内的微生物数量和种类在医疗器械设定灭菌参数和日常质量控制中具有重要意义。文章介绍了生物负载在医疗器械辐照灭菌确认过程和日常质量控制中的重要性。The number and type of microorganisms on and inside the medical devices play a very important role in setting sterilization parameters and daily quality control of medical devices. This paper introduces the importance of bioburden in the irradiation sterilization validation and daily quality control of medical devices.

关 键 词：医疗器械 生物负载 辐照灭菌确认 

分 类 号：R197.39[医药卫生—卫生事业管理]