摘要
本文针对目前医用X射线管组件在注册检测中对电磁兼容性(Electromagnetic Compatibility,EMC)评价时存在的矛盾进行讨论,分析了X射线管组件的EMC检测方法的意义和其必要性。本文设计了两组对比试验,将某型号的X射线管组件分别安装在两套不同的医用X射线系统内,按照YY 0505-2012的要求分别进行EMC测试。结果表明X射线管组件的发射特性和抗扰特性相比整个医用X射线系统的电磁兼容性可忽略不计。该研究指出X射线管组件的电磁兼容性可在医用X射线系统的电磁兼容特性中考虑,无需单独进行评价。
This paper discussed the conflict problems about electromagnetic compatibility(EMC)of medical X-ray tube components in the registration.The purpose of this research was to analyze the significance and necessity of EMC detection method of X-ray tube components.In this paper two comparative experiments were designed.We installed one type of X-ray tube assembly in two different medical X-ray systems and carried out EMC test according to YY0505-2012.The results showed that the emission characteristics and the anti-disturbance characteristics of the X-ray tube components were negligible compared with the electromagnetic compatibility of the whole medical X-ray system.We suggest that the electromagnetic compatibility of the X ray tube component should be considered in the electromagnetic compatibility of the X-ray system and there is no necessary to consider the electromagnetic compatibility of the X ray tube component alone.
作者
李宁
苏宗文
王晨希
任海萍
LI Ning;SU Zong-wen;WANG Chen-xi;REN Hai-ping(Institute for Medical Devices Control, National Institutes for Food and Drug Control, Beijing 100050, China)
出处
《中国医疗设备》
2017年第8期24-27,32,共5页
China Medical Devices
基金
国家重点研发计划数字诊疗装备研发课题(2016YFC0103706)
关键词
X射线管组件
电磁兼容性
X射线系统
辐射发射
辐射抗扰
X ray tube components
electromagnetic compatibility
X-ray system
radiation emission
radiation immunity