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心室辅助装置电磁兼容性评价要点解析

张超 李澍 王权 苏宗文 任海萍

中国医疗设备2018,Vol.33Issue(9):6-9,18,5.
中国医疗设备2018,Vol.33Issue(9):6-9,18,5.DOI:10.3969/j.issn.1674-1633.2018.09.002

心室辅助装置电磁兼容性评价要点解析

Analysis of the EMC Issues in Ventricular Assist Devices

张超 1李澍 1王权 1苏宗文 1任海萍1

作者信息

  • 1. 中国食品药品检定研究院 医疗器械检定所,北京 102629
  • 折叠

摘要

Abstract

Currently, ventricular assist devices play an important role in replacing human heart function and in transition time during cardiac donor waiting. With the rapid development of consumer electronic equipment and personal wireless terminal equipment, the electromagnetic environment around us has become increasingly complex, and it is very important to make a reasonable and objective evaluation of the electromagnetic compatibility of the ventricular assist devices. In this study, we analyzed the key points of evaluation of ventricular assist devices from the three aspects (general electromagnetic compatibility requirements, special immunity of active implantable medical devices and instantaneous high power disturbance immunity) based on the environment and possible risk points of ventricular assist devices. The evaluation points of the electromagnetic compatibility of the equipment were given, and the key test parameters, such as the limit value, the level of conformity and the basic performance were defined. This paper provides supporting material for the design, inspection, evaluation and supervision of the ventricular assist device.

关键词

心室辅助装置/电磁兼容/电磁发射/电磁抗扰度/预期使用环境/风险分析

Key words

ventricular assist device/electromagnetic compatibility/electromagnetic emission/electromagnetic immunity/environments of intended use/risk analysis

分类

医药卫生

引用本文复制引用

张超,李澍,王权,苏宗文,任海萍..心室辅助装置电磁兼容性评价要点解析[J].中国医疗设备,2018,33(9):6-9,18,5.

基金项目

心室辅助装置相关电磁兼容测试方法学与检测规范研究(2016YFC0103202). (2016YFC0103202)

中国医疗设备

OACSTPCD

1674-1633

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