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 analyze it later on a
separate unit or record and analyze the ECG simultaneously. The type of storage media used is
irrelevant with regard to this standard, and b) systems that provide continuous analysis and only
partial or limited recording not allowing a full re-analysis of the ECG.