BS EN 60601-2-25:2015 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of electrocardiographs
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BS EN 60601-2-25:2015

Medical electrical equipment. Particular requirements for the basic safety and essential performance of electrocardiographs

Status : Current, Under review   Published : November 2015



IEC 60601-2-25:2011 applies to the basic safety and essential performance of electrocardiographs intended by themselves or as a part of a medical electrical system, for the production of electrocardiogram reports for diagnostic purposes. The equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to Medical electrical equipment for those environments of use. Not included within the scope of this particular standard are:

a) the part of Medical electrical equipment that provides vectorcardiographic loops;

b) ambulatory electrocardiographic medical electrical equipment covered by IEC 60601-2-47 where not intended for obtaining electrocardiogram reports for diagnostic purposes;

c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining electrocardiographic reports for diagnostic purposes.

This second edition cancels and replaces the first edition of IEC 60601-2-25, published in 1993 and the first edition of IEC 60601-2-51, published in 2003. Updating the particular standards to refer to the third edition of the general standard provided the opportunity to merge the first editions of IEC 60601-2-25 and IEC 60601-2-51 into one standard. Reformatting and technical changes were both made. This second edition of IEC 60601-2-25 constitutes a technical revision of both those standards.

Standard NumberBS EN 60601-2-25:2015
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of electrocardiographs
StatusCurrent, Under review
Publication Date30 November 2015
Normative References(Required to achieve compliance to this standard)IEC 60601-2-2:2009, EN 60601-2-2:2009+A11:2011, IEC 60601-1-2:2007, EN 60601-1-2:2007/Corrigendum 1:2010, EN 60601-2-2:2009, EN 60601-1-2:2007
Informative References(Provided for Information)IEC 60601-2-27, EN 60601-2-27, IEC 60601-2-47, 93/42/EEC, EN 60601-2-47
ReplacesBS EN 60601-2-25:1996, IEC 60601-2-25:1993, BS EN 60601-2-51:2003
International RelationshipsEN 60601-2-25:2015,EN 62150-1:2005,IEC 60601-2-25:2011
Draft Superseded By09/30168887 DC
DescriptorsInstructions for use, Protected electrical equipment, Defibrillators, Response time, Electrical equipment, Symbols, Safety engineering, Performance testing, Test equipment, Accuracy, Circuits, Ultraviolet radiation, Safety measures, Electronic equipment and components, Performance, Medical equipment, Environment (working), Electrical testing, Testing conditions, Leakage currents, Electrocardiographs, Marking, Electrical safety, Electrical medical equipment
Title in FrenchAppareils électromédicaux. Exigences particulières pour la sécurité de base et les performances essentielles des électrocardiographes
Title in GermanMedizinische elektrische Geräte. Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektrokardiographen
ISBN978 0 580 59597 4
File Size3.252 MB

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