EVS-EN 60601-2-47:2003

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.