医疗器械外部标记常见不合格项探讨  

Discussion on Common Non-conformities of External Marking of Medical Devices

作　　者：胡旭君[1] 赵嘉宁[1] 许于春[1] HU Xu-jun;ZHAO Jia-ning;XU Yu-chun(Guangdong Medical Devices Quality Surveillance and Test Institute （Guangdong Guangzhou 510663)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510663

出　　处：《中国医疗器械信息》2018年第9期1-3,共3页China Medical Device Information

摘　　要：随着国家食品药品监督管理总局对医疗器械抽查与执行力度的加大加严,市面上的医疗器械暴露出来越来越多的问题。根据近几年国家食品药品监督管理局及广东省食品药品监督管理局对医疗器械抽查结果的统计分析,医疗器械的外部标识不合格率一直牢牢占据着所有不合格项目中不合格率的榜首位置,占比将近50%。鉴于外部标记不合格现象的高频发生,文章主要讲解一些常见的外部标记不合格项目的注意事项及相关要求分析。As the CFDA has tightened up the inspection of medical devices, more and more problems have been exposed in the listed medical devices. According to the recent inspection results of medical devices that investigated by the CFDA and Guangdong FDA, The non-conforming rate of the external identification of medical devices has been firmly in the top spot of all unqualified items, accounting for nearly 50%. In view of the frequent occurrence of non-conformance of external markers, this paper mainly explains the considerations and reason analysis of some common external mark nonconforming items

关 键 词：熔断器 输入功率 应用部分 防除颤应用部分 电源开关 

分 类 号：R197.39[医药卫生—卫生事业管理]