IEC 60601-2-47:2001 PDF

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 recorders').

IEC 60601-2-47:2001 history

2012 IEC 60601-2-47:2012 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
2006 IEC 60601-2-47:2006 Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
2001 IEC 60601-2-47:2001 Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems