摘要
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YY 0782-2010[1]标准中,专门针对心电图机分析性能提出了要求。心电图机分析性能涉及的检测内容多且复杂,心电图机检测人员往往理不出头绪。本文通过对标准条款的分析、对比、归纳、总结出心电图机分析性能的检测重点,并从心电图机的自动测量和自动解释两个方面,明确提出了检测采用的标准数据库、需要检测的项、检测的数据量、检测时的数据处理要求和检测结果合格的判定条件。
Particular requirements for safety, including essential performance, of recording and analyzing single channel and multichannel electrocardiographs YY 0782-2010 standard request for ECG analysis performance. The detection of ECG analysis performance requirements involved are many and complex, ECG detection personnel often reason no clue. Based on the ways of analysis, comparison, induction, conclusion for the standard terms,summing up the detection focus of ECG analysis performance. From automatic measurement and automatic interpretation of the ECG, clearly suggest the standard database of the detection, the items to be detected, the detection amount of data, the data processing requirement of the detection and the determination condition of the detection result.
出处
《中国医疗器械信息》
2016年第8期39-41,46,共4页
China Medical Device Information
