浅谈射频消融导管的电磁兼容性测试和评估  

Discussion on the Electromagnetic Compatibility Testing and Evaluation of Radio Frequency Ablation Catheter

作　　者：王玉姬[1] 杨建刚[2] 

机构地区：[1]国家食品药品监督管理总局医疗器械技术审评中心,北京市100044 [2]天津市医疗器械质量监督检验中心,天津市300384

出　　处：《中国医疗器械杂志》2014年第6期430-432,共3页Chinese Journal of Medical Instrumentation

基　　金：国家科技支撑计划课题(2012BAI22B04)

摘　　要：随着YY 0505-2012标准的发布实施,射频消融导管的电磁兼容测试和评估的项目亟待研究。该文根据相关标准的要求,浅谈了射频消融导管在单独申请注册时,通过其预期用途和结构特征,利用电磁兼容学的知识分析出应实施的测试项目和评估重点。With the enforcement of YY 0505-2012, the testing items and evaluation points of radio frequency ablation catheter in electromagnetic compatibility field should be studied and discussed. Based on the requirements of relevant standards, this paper discusses on the testing items that should be applied and the evaluation points that should be focused on by analyzing the intended use and the structure of radio frequency ablation catheter, when it intends to apply registration individually with the basic knowledge of electromagnetic compatibility field,

关 键 词：射频消融导管 电磁兼容性 测试 评估 

分 类 号：TN98[电子电信—信息与通信工程]