计算机化心脏工作站标准的研究

摘要

目前我国还没有计算机化心脏工作站的国家及行业标准，质量监督检验部门对其检测只能参照心电图机、心电监护仪等仪器的标准进行，但部分项目无检验标准。通过分析临床对心脏工作站技术、安全等方面的要求，建立了计算机化心脏工作站标准，提出了仪器应该具备的技术指标及相应的试验方法和检验规则。尤其是建立了没有国家标准和行业标准的心音、搏动等心机械信号，心室晚电位等高频低幅信号，心电向量图等心电信号的技术要求和试验方法，并整合了现有的心电图机、心电监护仪等国家标准和行业标准。该研究可以为国家标准化职能部门制定计算机化心脏工作站标准提供参考。%To date there is no national and industry standard on computerized heart workstation, quality supervision and inspection department has to refer to standard of electrocardiograph or electro cardiac moniting equipment to inspect it. However, part of the inspection stil can not be carried out without relevant standard. In this study, we established standards on computerized heart workstation and put forward technical index, test method and inspection rule. Specialy, the standard is involved in cardiechema, pulsatewe and other mechanical signal, in VLP and other high-frequency low-amplitude singal, in VCG and other electrocardio signal. In addition, the standard has also integrated the existing industry and national standards on electrocardiograph and electro cardiac moniting equipment. In conclusion, this study can provide a reference for the national standardization departments to formulate a standard on computerized heart workstation.