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IEC 60601-2-47 Ambulatory Electrocardiographic Monitors Testing

Medical electrical equipment – Part 2-47: the basic safety and essential performance of ambulatory electrocardiographic systems

IEC 60601-2-47 Scope:

IEC 60601 2 47 and EN 60601 2 47 testing applies to the basic safety and essential performance of ambulatory electrocardiographic systems, hereafter referred to as medical equipment systems

Hazards inherent in the intended physiological function of medical electronic equipment or medical equipment systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

Within the scope of IEC 60601-2-47 are systems of the following types:

  • 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 EN 60601-2-47;

  • Systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG.

The safety aspects of IEC 60601-2-47 testing apply to all types of systems falling in one of the abovementioned 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.

IEC 60601-2-47 does not apply to systems that do not continuously record and analyze the ECG (for example, ‘intermittent event recorders’).

Keystone Compliance assists manufacturers with IEC 60601-2-47 and EN 60601-2-47 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-47 test lab needs.