IEC 60601-2-47:2006 Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
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 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.
This standard does not apply to systems that do not continuously record and analyse the ECG
(for example, ‘intermittent event recorders’).
IEC 60601-2-47:2006 history
2012IEC 60601-2-47:2012 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
2006IEC 60601-2-47:2006 Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
2001IEC 60601-2-47:2001 Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems