摘要
为配合医用电气设备电气安全通用标准IEC 60601-1第三版的整体转换进度,该文对目前国际上的两种版本与我国现行版本的差异进行了比较,并对IEC 60601系列标准引用情况进行了分析,进而对两种版本的转换利弊进行了探讨,最终给出了适合我国国情的转换第3版标准的修订建议。
In order to coordinate with the overall conversion progress of IEC 60601-1,the third edition of the General Standard for Electrical Safety of Medical Electrical Equipment,this paper compares the differences between the two editions in the world and the current edition in China,and analyses the quotation of IEC 60601 series standards,and then discusses the advantages and disadvantages of the conversion of the two editions.Finally,some suggestions for revision of the third edition of the standard are given,which is suitable for China's national conditions.
作者
何骏
高中
蒋岁
HE Jun;GAO Zhong;JIANG Sui(Shanghai Testing and Inspection Institute for Medical Devices,Shanghai,201318)
出处
《中国医疗器械杂志》
2019年第6期436-438,共3页
Chinese Journal of Medical Instrumentation