BS EN 60601-2-47:2015 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

BS EN 60601-2-47:2015

Medical electrical equipment. Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

Status : Current, Under review   Published : June 2015

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IEC 60601-2-47:2012 concerns the basic safety and essential performance of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS. It amends and supplements the general standard IEC 60601-1 (third edition 2005). The requirements of this particular standard take priority over those of the general standard. 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.


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'). This second edition cancels and replaces the first edition published in 2001. It constitutes a technical revision. This edition was revised to align structurally with the 2005 edition of IEC 60601-1.




Standard NumberBS EN 60601-2-47:2015
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
StatusCurrent, Under review
Publication Date30 June 2015
Normative References(Required to achieve compliance to this standard)EN 60601-1-2:2007, IEC 60601-1-2:2007
Informative References(Provided for Information)IEC 60601-2-25, EN 60601-2-27, EN 60601-2-25, IEC 60601-2-27, 93/42/EEC
ReplacesBS EN 60601-2-47:2001, IEC 60601-2-47:2001
International RelationshipsEN 60601-2-47:2015,EN 60745-2-15:2006,IEC 60601-2-47:2012
Draft Superseded By09/30169322 DC
DescriptorsElectrical medical equipment, Electronic equipment and components, Performance, Safety engineering, Safety measures, Electrical equipment, Medical equipment, Measuring instruments, Electrical safety, Electrocardiographs
ICS11.040.55
Title in FrenchAppareils électromédicaux. Exigences particulières pour la sécurité de base et les performances essentielles des systèmes d'électrocardiographie ambulatoires
Title in GermanMedizinische elektrische Geräte. Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von ambulanten elektrokardiographischen Systemen
CommitteeCH/62/4
ISBN978 0 580 59726 8
PublisherBSI
FormatA4
DeliveryYes
Pages72
File Size1.678 MB
Price£274.00


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