Study on IEC 60601-1-2: the standard of electromagnetic compatibility for medical electrical equipment / 中国医疗器械杂志

ABSTRACT

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.