IEC 60601-2-47:2001 ED1

Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems IEC 60601-2-47:2001 ED1

Publication date:   Jul 10, 2001

Scope

Specifies the particular safety requirements for ambulatory electrocardiographic systems.

Within the scope of this standard are systems of the following types:

a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyse it later on a separate unit, or record and analyse the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard;

b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG.

The safety aspects of this standard apply to all types of systems falling in one of the above- mentioned categories.