This standard specifies the basic safety and essential performances for ambulatory electrocardiographic systems (medical electrical equipment). 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.
This standard amends DIN EN 60601-1 (VDE 0750-1):2007-07.

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