心电图机的电磁兼容检测及整改技术研究  

The Research on Electromagnetic Compatibility Testing and Rectification Technology of Electrocardiograph

作　　者：仝盛 孟志平 Tong Sheng;Meng Zhiping(Beijing Institute of Medical Device Testing,Beijing 101111,China)

机构地区：[1]北京市医疗器械检验研究院,北京101111

出　　处：《医疗装备》2024年第3期27-30,33,共5页Medical Equipment

摘　　要：该研究结合心电图机产品结构和工作原理,依据国家标准对注册阶段和临床使用的心电图机进行电磁兼容性测试,分析出现的问题。结果显示,心电图机的辐射发射试验有可能超过标准限值,电快速脉冲群试验等抗扰度试验易受到电磁干扰,采集的图像可能影响正常临床诊断,需要进行整改。因此,在心电图机研发生产过程中需要进行数字信号的采集处理,重视电磁兼容性。In this study,with the combination of the structure and working principle of electrocardiographs,according to national standards,electrocardiographs used during registration and clinical use were subjected to electromagnetic compatibility testing,and the problems that arise were analyzed.The results showed that the electrocardiograph may exceed the standard limit when it is used for radiation emission,and it is vulnerable to electromagnetic interference when it is used for immunity tests such as electric rapid pulse group test.The collected images may affect normal clinical diagnosis,so it needs to be corrected.Therefore,during the operation of the electrocardiogram machine,it is necessary to collect and process digital signals,and pay attention to electromagnetic compatibility.

关 键 词：心电图机 电磁兼容 标准 检测 整改 

分 类 号：R318.6[医药卫生—生物医学工程]