摘要
基于2023年~2024年江苏省第二类、第三类医用电气设备在注册核查中的电气安全缺陷项统计数据及典型缺陷项举例,分析问题、查找原因,结合法规和标准要求,提炼出有针对性的、可操作的电气安全检查要点及相应整改措施。从人、机、料、法、环等五个方面梳理出医用电气设备在注册核查中的电气安全缺陷项,总结电气安全现场检查的建议关注点,为医用电气设备的质量管理体系检查工作提供借鉴。
Based on statistical data and typical examples of electrical safety defects identified during the registration review of Class II and Class III medical electrical equipment in Jiangsu Province from 2023 to 2024,this study analyzes issues,identifies root causes,and extracts targeted,actionable electrical safety inspection points and corresponding corrective measures in compliance with regulatory and standard requirements.By systematically categorizing electrical safety defects identified during registration reviews across five dimensions—personnel,equipment,materials,methods,and environment—the study summarizes critical focus areas for on-site electrical safety inspections.The findings provide practical references for enhancing quality management system(QMS)inspections of medical electrical equipment.
作者
杜华月
李嘉宁
宋化昂
毛以时
黎萍
崔佳
DU Hua-yue;LI Jia-ning;SONG Hua-ang;MAO Yi-shi;LI Ping(CUI Jia Certer for Inspection of JSMPA,Jiangsu Nanjing 210019)
出处
《中国医疗器械信息》
2025年第9期11-13,71,共4页
China Medical Device Information
基金
2022年度药品监管科学研究计划项目(项目名称:基于GB 9706.1-2020的医用电气设备对电击危险的防护现场检查要点研究,项目编号:202229)。
关键词
医用电气设备
电气安全
质量管理体系
缺陷项
现场检查
medical electrical equipment
electrical safety
quality management system
defect items
on-site inspection
