基于标准YY0505-2012的监护类医疗器械患者耦合电缆传导抗扰度测试方法分析

射频场感应的传导骚扰抗扰度试验是医用电气设备的一项重要检验项目,基于YY 0505-2012对GB/T 17626.6中条款进行的修改和补充,本文旨在研究传导抗扰度试验中监护类医疗器械患者耦合电缆单根试验布置和成束试验布置的差异,为患者耦合电缆传导抗扰度试验探究可靠的试验布置方法。文中对传导骚扰抗扰度试验的标准和原理作了概述,分别对监护类医疗器械患者耦合电缆的单根试验布置和成束试验布置进行传导抗扰度测试,文中所选受试设备在两种测试布置状态下均出现不能通过测试的结果,测试现象存在差异。通过对两种试验布置结果进行分析和总结,综合考虑临床使用的风险性和试验结论的可靠性,本文建议监护类医疗器械的患者耦合电缆在传导抗扰度试验时两种试验布置均要进行测试,以确保患者耦合电缆在最不利的状态下试验。本文通过试验数据的分析和总结,为患者耦合电缆的传导抗扰度试验布置方法提供了规范性参考。

Analysis of the Immunity to Conducted Disturbances Test Method on Patient-Coupled Cables of Monitoring Medical Equipment Based on YY 0505-2012 Standard

The purpose of this paper was to research the difference between individual and bundled patient couple cables of monitoring equipment and explore a reliable test arrangement method for the patient couple cables for the immunity to conducted disturbances induced by radio-frequency fields test based on the amendments and additions proposed by YY 0505-2012 to the items in GB/T 17626.6.This paper summarized the standards and principles about immunity to conducted disturbances induced by radiofrequency fields test,and test the individual and bundled patient couple cables of monitoring equipment separately.The equipment under test selected in this paper could not pass the test under both types of test configurations.There were differences in the test phenomena.Through analysis and summary of two kinds of test results,considering the risk of clinical use and the reliability of the test results,this paper suggested that the patient couple cables need to test under both types of test configurations,to ensure that patient couple cables test under the most unfavorable conditions.This paper analyses and summarizes the test results,which can provide reference for the arrangement of immunity to conducted disturbances induced by radio-frequency fields test of patientcoupled cables.