关于怎样理解高频手术设备专用安全标准GB9706.4条款50.2的一点意见

How to understand the item 50.2 in IEC60601-2-2:1998

如何准确理解、全面执行国家关于医疗设备安全的标准 ,既关系到医疗设备用户的安全,又关系到生产厂商的优胜劣汰。本文试图对GB9706.4 -1999中条款50.2的内容作一些探讨 ,希望能既有利于对高频手术设备之安全风险的防范 。

How to carry out the item 50.2 in IEC60601-2-2:1998 is one of the sticking points about the safety for consumers using the medical electrical equipment and the subsistence for the manufactures. The author of the paper tries to discuss the problem and argue with The Central of Quality Inspect for Medical Equipment in Shanhai.