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| 基于GB 9706.1-2007标准对医用电气设备的质量分析 | |
| 引用本文： | 谭伟,周平,王志芳,蒋用羽. 基于GB 9706.1-2007标准对医用电气设备的质量分析[J]. 中国医疗设备, 2021, 0(2): 144-147,151 |
| 作者姓名： | 谭伟 周平 王志芳 蒋用羽 |
| 作者单位： | 重庆医疗器械质量检验中心有源室 |
| 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... |
| 关 键 词： | 医用电气设备 质量控制 电气安全 标识 |
Quality Analysis of Medical Electrical Equipment Based on GB 9706.1-2007 |
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| TAN Wei,ZHOU Ping,WANG Zhifang,JIANG Yongyu. Quality Analysis of Medical Electrical Equipment Based on GB 9706.1-2007[J]. Chinese medical equipment, 2021, 0(2): 144-147,151 | |
| Authors: | TAN Wei ZHOU Ping WANG Zhifang JIANG Yongyu |
| Affiliation: | (Department of Acive Medical Devices,Chongqing Medical Equiptment Quality Control Institue,Chongqing 401147,China) |
| Abstract: | 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. |
| Keywords: | medical electrical equipment quality control electrical safety marking |
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