scope:

Addition:

This Particular Standard specifies the particular safety requirements for AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS, as defined in 2.101.

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.

If the ambulatory electrocardiographic system offers automatic ECG analysis, minimal performance requirements for measurement and analysis functions apply. Medical electrical equipment covered by IEC 60601-2-25 and IEC 60601-2-27 are excluded from the scope of this standard.

This standard does not apply to systems that do not continuously record and analyse the ECG (for example,  'intermittent event recorder's).