关于医用电气设备连接到独立电源的考核  

Test Method for Medical Equipment Connected to a Separate Power Supply

作　　者：许于春[1] 陈雪君 肖海鹏 胡旭君 XU Yu-chun;CHEN Xue-jun;XIAO Hai-peng;HU Xu-jun(Guang dong Medical Devices Quality Surveillance and Test Institute,Guangdong Guangzhou 510663;Center for Industrial Analysis and Testing,Guangdong Academy of Sciences,Guangdong Guangzhou 510400)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510663 [2]广东省科学院工业分析检测中心,广东广州510400

出　　处：《中国医疗器械信息》2024年第7期21-24,共4页China Medical Device Information

摘　　要：国标GB9706.1-2020已于2023年5月1日正式实施,标志着全国有源医疗器械的通用标准正式踏入3.0版本。这个标准对包括类似医用电子、呼吸麻醉机等有源医疗器械行业的冲击是巨大,包括生产企业、咨询公司、检验实验室、审评中心在内的相关机构或单位均避免不了这个标准的洗礼。在GB 9706.1-2020标准中,首次提到了“连接到独立电源”的概念。这一概念的提出,正式替换了旧版标准中的“特定电源”的概念,“连接到独立电源”的概念更加合理地描述了此类连接的一系列要求。文章意在“连接到独立电源”的相关要求进行分析,为研究、学习和执行新标准的生产企业、咨询公司、检验实验室、审评中心等公司或机构人员在标准分析检测中提供参考意见。The national standard GB 9706.1-2020 has been officially implemented on May 1,2023,marking that the national general standard for active medical devices has officially entered version 3.0.The impact of this standard on the entire active medical device industry is enormous,including production enterprises,consulting companies,testing laboratories,evaluation centers and other relevant institutions or units can not avoid the baptism of this standard.The concept of“connected to an independent power source”was first mentioned in GB 9706.1-2020,which officially replaced the concept of“specific power supply”in the old version of the standard.The concept of“connected to an independent power supply”more reasonably describes a series of requirements for such connections.The purpose of this article is to analyze the relevant requirements of“connecting to an independent power supply”,and to provide reference opinions for the production enterprises,consulting companies,testing laboratories,review centers and other companies or institutions who research,learn and implement the new standard in the standard analysis and testing.

关 键 词：独立电源 特定电源 供电网 医用电气设备 医用电气系统 

分 类 号：TH772[机械工程—仪器科学与技术]