IEC60601-1-2医用电气设备电磁兼容标准研究

Study on IEC 60601-1-2:the Standard of Electromagnetic Compatibility for Medical Electrical Equipment

研究了YY0505-2005标准与IEC60601-1-2第2.1版标准的差异,得出以下结论:两者在试验项目、试验方法等方面相同,在对分类、基本性能、风险分析的要求方面有较大差异,并对IEC60601-1-2第2.1版标准在我国转化实施提出了建议。

In this paper we did some comparisons between YY0505-2005 and IEC 60601-1-2 edition2.1, and concluded that they are identical in respects of testing items and methods, but significantly different in respects of classification, essential performance and risk analysis. Some suggestions about the transformation and implementation of edition 2.1 standards in our country were proposed.