心电图机两个行业标准的对比研究

Comparative Study on Two ECG Standards

由于记录和分析型心电图机能够测量和解释心电数据,方便了医生后续的医疗诊断,因此近年来得到迅猛发展。此类心电图机的检测除了必须执行YY 1139—2013《心电诊断设备》标准外,还需执行YY 0782—2010《医用电气设备第2-51部分:记录和分析型单道和多道心电图机安全和基本性能专用要求》标准,这两个标准之间既有联系又有区别。该文通过对两个标准的分析、对比、归纳,总结出两个标准的相同及不同之处,同时对于两个标准的不同之处又从宏观和微观两个角度进行了详细地阐述,这有助于心电图机检测人员加深对标准条款的理解,提高心电图机的检测效率。

The recording and analyzing ECG is able to measure and interpret ECG data, which is convenient for doctors＇ subsequent medical diagnosis, so in recent years it has rapid development. This ECG must implement YY 1139- 2013 Diagnostic electrocardiographic devices standard, and YY 0782-2010 Medical electrical equipment-Part 2-51： Particular requirements for safety, including essential performance, of recording and analyzing single channel and multichannel of electrocardiographs standard. The two standards have links and differences. By analyzing, comparing, inducing two standards, this article sums up the links and differences of the two standards, describes the differences of the two standards between macro and micro point of views in detail, helps ECG testing personnel to deepen the understanding of the standard terms, and improve the detection efficiency of ECG.