IEC 60601-2-47 Medical Electrical Equipment - Special Requirements for Basic Safety and Basic Performance of Ambulatory Electrocardiographic Systems

IEC 60601-2-47 deals with the basic safety and basic performance of ambulatory electrocardiographic systems. It replaces and supplements the general standard IEC 60601-1. The requirements of this particular standard take precedence over the requirements of the general standard.

The following types of systems are covered by this standard:

• Systems that provide continuous recording and continuous analysis of the ECG, allowing for full reanalysis with essentially similar results;
• Systems that provide only partial or limited recording that provide continuous analysis and do not allow for complete reanalysis of the ECG;

The safety aspects of this standard apply to all types of systems that fall into one of the above-mentioned categories. If the Ambulatory electrocardiographic system offers automatic ECG analysis, minimum performance requirements for measurement and analysis functions apply.

Medical electrical equipment within the scope of IEC 60601-2-25 and IEC 60601-2-27 is outside the scope of this standard. This standard does not apply to systems that do not continuously record and analyze the ECG.

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