基于GB 9706.1-2007标准对医用电气设备的质量分析  

Quality Analysis of Medical Electrical Equipment Based on GB 9706.1-2007

作　　者：谭伟[1] 周平[1] 王志芳[1] 蒋用羽 TAN Wei;ZHOU Ping;WANG Zhifang;JIANG Yongyu(Department of Acive Medical Devices,Chongqing Medical Equiptment Quality Control Institue,Chongqing 401147,China)

机构地区：[1]重庆医疗器械质量检验中心有源室,重庆401147

出　　处：《中国医疗设备》2021年第2期144-147,151,共5页China Medical Devices

摘　　要：目的研究医疗器械生产企业在医用电气设备生产过程中进行质量控制的方法。方法通过分析2015至2019年重庆市辖区内生产领域医用电气设备的监督抽检情况,总结出不符合情况频率较高的项目、不符合原因及其存在的风险。结果提炼出存在的问题,建议生产企业落实整改,每年医用电气设备的不符合率总体有下降趋势。结论通过分析医用电气设备的不符合原因、总结存在的问题,提出可行的质量控制建议,有助于医疗器械产品的质量控制。Objective To study the method of quality control in medical electrical equipment manufacturing.Methods By analyzing the surveillance and random inspection of medical electrical equipment in production area of Chongqing city from 2015 to 2019,the items with high frequency of non-conformity,the causes of non-conformity and the existing risks were summarized.Results The existing problems were extracted,and it was suggested that the enterprises should carry out rectification and reform.The non-conformity rate of medical electrical equipment has been declining year by year.Conclusion Through the analysis of reasons for non-conformity of medical electrical equipment,summarize the existing problems,feasible quality control suggestions are put forward,which is helpful to the quality control of medical devices.

关 键 词：医用电气设备 质量控制 电气安全 标识 

分 类 号：R197.39[医药卫生—卫生事业管理]