摘要
生产企业作为标准执行的主体,本文将对标准GB9706.4-2009《医用电气设备第2-2部分:高频手术设备安全专用要求》和标准YY1057-2016《医用脚踏开关通用技术条件》在高频手术设备中脚踏开关的应用展开安全性条款讨论,供相关生产企业参考。
Manufacturing enterprise as the standard implementation of the main body,this will be the standard GB9706.4-2009medical electrical equipment-Part2-2:Particular requirements for the safety of high frequency surgical equipment application and YY1057-2016technical conditions medical pedal switch pedal switch in high frequency surgical equipment launch safety items discussed,for reference to the relevant production enterprises.
作者
甄辉
王越
ZHEN Hui;WANG Yue(Zhejiang Center for Medical Device Evaluation (Zhejiang Hangzhou 310012))
出处
《中国医疗器械信息》
2017年第18期17-19,共3页
China Medical Device Information
关键词
高频手术设备
脚踏开关
安全性条款
high frequency surgical equipment
foot switch
safety clause
