X射线高频高压发生器产品技术审评概要研究  

Research on X-Ray High-Frequency High-Voltage Generator Product Technical Review Summary

作　　者：陈卓 王康 许嘉驿 CHEN Zhuo;WANG Kang;XU Jia-yi(Center for Certification and Evaluation,Guangdong Drug Administration,Guangdong Guangzhou 510080)

机构地区：[1]广东省药品监督管理局审评认证中心,广东广州510080

出　　处：《中国医疗器械信息》2020年第9期1-2,5,共3页China Medical Device Information

摘　　要：X射线高频高压发生器装配于诊断X射线机,为X射线管组件提供电能,以发出X射线。X射线高频高压发生器为诊断X射线机的核心部件,文章针对该产品申报注册中常见问题,进行归纳和分析,为医疗器械注册相关人员提供技术参考。The X-Ray high-frequency high-voltage generator is equipped with a diagnostic X-Ray machine to provide electrical energy to the X-Ray tube assembly to emit X-rays.Among them,the X-Ray high-frequency high-voltage generator is the core component of the diagnostic X-Ray machine.It summarizes and analyzes the common problems in the application for registration of the product,and provides technical reference for medical device registration related personnel.

关 键 词：医疗器械 X射线高频高压发生器 审评要求 

分 类 号：TH774[机械工程—仪器科学与技术]