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IEC 60601-2-47 Document Information:
Title
Medical electrical equipment – Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
Appareils électromédicaux – Partie 2-47: Règles particulières de sécurité et performances essentielles des systèmes d'électrocardiographie ambulatoires
International Electrotechnical Commission
Publication Date:
Jul 1, 2001
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).
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