EN 60601-2-25:2015

Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

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.

Medizinische elektrische Geräte - Teil 2-25: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektrokardiographen

Appareils électromédicaux - Partie 2-25: Exigences particulières pour la sécurité de base et les performances essentielles des électrocardiographes

La CEI 60601-2-25:2011 s'applique à la sécurité de base et aux performances essentielles des électrocardiographes, destinés de par leur nature ou comme partie intégrante d'un système électro-médical, à la production de rapports d'électrocardiographie à des fins de diagnostic. Les appareils destinés à être utilisés dans des conditions environnementales extrêmes ou non maîtrisées à l'extérieur d'un hôpital ou du cabinet d'un médecin, telles que dans des ambulances et dans un aéronef, doivent satisfaire à la présente norme particulière. Des normes supplémentaires peuvent s'appliquer pour ces environnements d'utilisation. Ne relèvent pas du domaine d'application de la présente norme particulière: a) la partie des appareils électro-médicaux qui fournit des boucles vecto-cardiographiques; b) les appareils électro-médicaux de surveillance électrocardiographique ambulatoire couverts par la CEI 60601-2-47, lorsqu'ils ne sont pas destinés à obtenir des rapports d'électrocardiographie à des fins de diagnostic; c) les moniteurs cardiaques couverts par la CEI 60601-2-27 lorsqu'ils ne sont pas destinés à obtenir des rapports d'électrocardiographie à des fins de diagnostic. Cette deuxième édition annule et remplace la première édition de la CEI 60601-2-25, parue en 1993, et la première édition de la CEI 60601-2-51, parue en 2003. La mise à jour des normes particulières afin de faire référence à la troisième édition de la norme générale a permis de fusionner les premières éditions de la CEI 60601-2-25 et de la CEI 60601-2-51 en une seule norme. Une remise en forme et des modifications techniques ont été effectuées. Cette deuxième édition de la CEI 60601-2-25 constitue une révision technique de ces deux normes.

Medicinska električna oprema - 2-25. del: Posebne zahteve za osnovno varnost in bistvene lastnosti elektrokardiografov

IEC 60601-2-25:2011 se uporablja za osnovno varnost in bistvene lastnosti elektrokardiografov, ki so kot samostojne enote ali del medicinskega električnega sistema namenjeni za izdelavo elektrokardiografskih izvidov. Oprema, ki je namenjena za uporabo v izrednih ali nenadzorovanih vremenskih razmerah zunaj bolnišnic ali zdravniških ordinacij (npr. v reševalnih vozilih ali zračnem prometu), mora biti v skladu s tem standardom. Za medicinsko električno opremo v takih okoljih se morda uporabljajo dodatni standardi. Področje uporabe tega standarda ne vključuje naslednjih naprav: a) del medicinske električne opreme, ki prikazuje vektorkardiografske zanke; b) elektrokardiografska medicinska električna oprema v reševalnih vozilih, ki jo obravnava IEC 60601-2-47 in ni namenjena za izdelavo elektrokardiografskih izvidov za namene diagnoze; c) srčni monitorji, ki jih obravnava IEC 60601-2-27 in niso namenjeni za izdelavo elektrokardiografskih izvidov za namene diagnoze. Ta druga izdaja preklicuje in nadomešča prvo izdajo standarda IEC 60601-2-25, objavljeno leta 1993, ter prvo izdajo standarda IEC 60601-2-51, objavljeno leta 2003. Ker so bili posamezni standardi posodobljeni tako, da se nanašajo na tretjo izdajo splošnega standarda, se je ponudila priložnost za združitev prvih izdaj standardov IEC 60601-2-25 in IEC 60601-2-51 v en standard. Izvedeno je bilo preoblikovanje in uvedene so bile tehnične spremembe. Ta druga izdaja standarda IEC 60601-2-25 tvori tehnično popravljeno izdajo obeh teh standardov.

General Information

• Status: Published
• Publication Date: 22-Oct-2015
• Withdrawal Date: 14-Sep-2018
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 23-Oct-2015
• Completion Date: 23-Oct-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-25:2015 - Medical electrical equipment - Part 2-25: Particular requirements for basic safety and essential performance of electrocardiographs

Relations

• Replaces: EN 60601-2-25:1995/A1:1999 - Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs
• Effective Date: 28-Jan-2023
• Replaces: EN 60601-2-25:1995 - Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs
• Effective Date: 28-Jan-2023
• Replaces: EN 60601-2-51:2003 - Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-25:2015
01-december-2015
1DGRPHãþD
SIST EN 60601-2-25:1998
SIST EN 60601-2-25:1998/A1:2002
SIST EN 60601-2-51:2004
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLHOHNWURNDUGLRJUDIRY
Medical electrical equipment - Part 2-25: Particular requirements for basic safety and
essential performance of electrocardiographs
Medizinische elektrische Geräte - Teil 2-25: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Elektrokardiographen
Appareils électromédicaux - Partie 2-25 : Règles particulières de sécurité de base et de
performances essentielles des électrocardiographes
Ta slovenski standard je istoveten z: EN 60601-2-25:2015
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 60601-2-25:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-25:2015

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SIST EN 60601-2-25:2015


EUROPEAN STANDARD EN 60601-2-25

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2015
ICS 11.040.55; 11.040.99 Supersedes EN 60601-2-25:1995, EN 60601-2-51:2003
English Version
Medical electrical equipment - Part 2-25: Particular requirements
for the basic safety and essential performance of
electrocardiographs
(IEC 60601-2-25:2011)
Appareils électromédicaux - Partie 2-25: Exigences Medizinische elektrische Geräte - Teil 2-25: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des électrocardiographes wesentlichen Leistungsmerkmale von Elektrokardiographen
(IEC 60601-2-25:2011) (IEC 60601-2-25:2011)
This European Standard was approved by CENELEC on 2015-09-15. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.


European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-2-25:2015 E

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SIST EN 60601-2-25:2015
EN 60601-2-25:2015
European foreword
The text of document 62D/944/FDIS, future edition 2 of IEC 60601-2-25, prepared by SC 62D
"Electromedical equipment", of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-25:2015.
The following dates are fixed:
(dop) 2016-06-15
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2018-09-15
• latest date by which the national standards conflicting with
the document have to be withdrawn

This document supersedes EN 60601-2-25:1995 and EN 60601-2-51:2003.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 60601-2-25:2011 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60601-2-27 NOTE Harmonized as
...