医用电气设备应用部分超温要求的分析  

Analysis About the Temperature Requirements for Applied Parts of Medical Electrical Equipment

作　　者：张文忠[1] ZHANG Wen-zhong(Guangdong Medical Device Quality Supervision and Inspection Institute,Guangdong Shenzhen 518000)

机构地区：[1]广东省医疗器械质量监督检验所,广东深圳518000

出　　处：《中国医疗器械信息》2020年第23期17-18,30,共3页China Medical Device Information

基　　金：单孔腔镜手术机器人系统研发及产业化(项目编号:192019082511500012)。

摘　　要：对GB9706.1-2007中有关应用部分温升限制要求进行说明,通过分析超声诊断设备及医用脉搏血氧仪专用标准特殊要求,介绍低温烫伤的机制,讨论医用电气设备应用部分超温危害。通过查阅新版GB9706.1-2020有关要求,确定标准发展的趋势,建议制造商在设计,第三方机构在检测,医护人员在使用过程中,对应用部分的低温烫伤的风险予以关注。This paper clarifies the temperature requirements of applied part in GB9706.1-2007,analyses the special temperature requirements of ultrasonic diagnostic equipment and pulse oximeter,introduces the mechanism of moderate temperature burns and discusses the over-temperature hazards concerning applied part of medical electrical equipment.Considering the new requirements in the IEC 60601-1 third edition,it is recommended that more attentions should be paid to the risk of moderate temperature burns in the processes of R&D,test and normal use.

关 键 词：应用部分 低温烫伤 超声换能器 医用脉搏血氧仪 

分 类 号：TH772[机械工程—仪器科学与技术]