Specifies the basic safety and essential performance of ambulatory electrocardiographic (ECG) 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.