摘要
将IEC61010-1第三版与我国现行国家标准GB 4793.1-2007(转化自IEC61010-1第二版)进行对比,并对其中与体外诊断设备有关的主要条款的变化情况进行分析。得出结论:IEC61010-1第三版的多个条款进行了技术上的修订,对体外诊断设备提出了新的要求。体外诊断设备制造商在设计和生产设备时,宜参考标准具体的条款内容,以保证产品符合新标准的要求,为未来新标准的发布实施做好准备。
This paper compared IEC61010-1 3rd edition with the current national standard GB4793.1-2007（transformed from IEC61010-1 2nd）, and analyzed the changed clauses related to IVD equipment. It concluded that IEC61010-1 3rd edition made technical revisions on multiple clauses, which expressed new requirements for IVD equipments. IVD equipment manufacturers should refer to detail clauses while designing and manufacturing products to meet the new requirements, and prepare for the publication and implementation of the new standard in advance.
作者
于晓慧
李庆雨
宋庆华
田佳
YU Xiao-hui;LI Qing-yu;SONG Qing-hua;TIAN Jia(Medical Equipment Department Shandong Quality Inspection Center for Medical Devices Shandong Jinan 250101;EMC Department Shandong Quality Inspection Center for Medical Devices Shandong Jinan 250101;Informatization Ofce Shandong Quality Inspection Center for Medical Devices Shandong Jinan 250101)
出处
《中国医疗器械信息》
2018年第15期1-2,54,共3页
China Medical Device Information
基金
国家重点研发计划
循环肿瘤细胞检测工作站及相应配套设备的集成研发(项目编号:2016YFC0106001)
