医用高频电刀电磁兼容的测试要求及结果判定  

Discussion on the Electromagnetic Compatibility Test Requirements and Results Determination of Medical High-frequency Electrotome

作　　者：李雅楠[1] 高山[1] 刘博[1] 

机构地区：[1]国家食品药品监督管理局天津医疗器械质量监督检验中心,天津300384

出　　处：《中国医疗设备》2014年第12期60-63,共4页China Medical Devices

基　　金：国家科技支撑计划课题(2012BAI22B04)

摘　　要：依据国家食品药品监督管理局对于医用电气设备强制实施YY0505-2012标准的要求,确定医用高频电刀产品在电磁兼容测试中的基本性能,以及典型的测试模式,对于测试中的关注点予以梳理,并通过实例说明对测试结果的判定。According to the requirements of China Food and Drug Administration, the YY0505-2012 standard must be implemented compulsively for medical electronic devices. The essential performance and typical test modes of high-frequency electrotome equipment should be confirmed during the test of the electromagnetic compatibility. Then the concerns during the test are summarized and the test results are determinated according to some examples.

关 键 词：电磁兼容 医用高频电刀 医用电气设备 机械手术刀 

分 类 号：TH777[机械工程—仪器科学与技术]