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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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 EN 60601-2-27.
IEC 60601-2-47 NOTE Harmonized as EN 60601-2-47.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cenelec.eu.

Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replacement in Annex ZA of EN 60601-1:2006:
IEC 60601-1-2 (mod) 2007 Medical electrical equipment - EN 60601-1-2 2007
Part 1-2: General requirements for basic
- -  + corrigendum Mar. 2010
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and tests
Addition to Annex ZA of EN 60601-1:2006:
IEC 60601-2-2 2009 Medical electrical equipment - EN 60601-2-2 2009
Part 2-2: Particular requirements for the
- -  + A11 2011
basic safety and essential performance
of high frequency surgical equipment and
high frequency surgical accessories

Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
IEC 60601-2-25 ®
Edition 2.0 2011-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-25: Particular requirements for the basic safety and essential performance
of electrocardiographs
Appareils électromédicaux –
Partie 2-25: Exigences particulières pour la sécurité de base et les performances
essentielles des électrocardiographes

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XD
ICS 11.040.55; 11.040.99 ISBN 978-2-88912-719-1

– 2 – 60601-2-25  IEC:2011
CONTENTS
FOREWORD . 5
INTRODUCTION . 7
201.1 Scope, object and related standards. 8
201.2 Normative references . 10
201.3 Terms and definitions . 10
201.4 General requirements . 12
201.5 General requirements for testing of ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 16
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 21
201.10 Protection against unwanted and excessive radiation HAZARDS . 21
201.11 Protection against excessive temperatures and other HAZARDS . 21
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 22
201.13 HAZARDOUS SITUATIONS and fault conditions . 37
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 37
201.15 Construction of ME EQUIPMENT . 37
201.16 ME SYSTEMS. 37
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 37
202     Electromagnetic compatibility – Requirements and tests . 38
Annexes . 43
Annex AA (informative) Particular guidance and rationale . 44
Annex BB (informative) ELECTRODES, their positions, identifications and colour codes . 51
Annex CC (informative) LEADS, their identification and colour codes (other than those
specified in 201.12.4.102) . 53
Annex DD (informative) Polarity of PATIENT LEADS (other than those specified in
201.12.4.102) . 54
Annex EE (informative) Additional marking of ELECTRODES . 55
Annex FF (informative) Definitions and rules for the measurement of
ELECTROCARDIOGRAMS . 56
Annex GG (informative) Calibration and test data sets . 61
Annex HH (informative) CTS test atlas . 63
Bibliography . 94
Index of defined terms used in this particular standard. 95

Figure 201.101 – ELECTRODE position according to Frank . 14
Figure 201.102 – Test of protection against the effects of defibrillation (differential

mode) (see 201.8.5.5.1) . 19
Figure 201.103 – Test of protection against the effects of defibrillation (common mode)
(see 201.8.5.5.1) . 20
Figure 201.104 – Application of the test voltage between LEAD WIRES to test the energy
delivered by the defibrillator . 21

60601-2-25  IEC:2011 – 3 –
Figure 201.105 – Test circuit for COMMON MODE REJECTION and NOISE level . 28
Figure 201.106 – General test circuit . 30
Figure 201.107 – Triangular waveforms for test E of Table 201.107 . 32
Figure 201.108 – Input impulse signal and ELECTROCARDIOGRAPH response . 32
Figure 201.109 – Circuit for test of linearity. 34
Figure 201.110 – Result of linearity test . 34
Figure 201.111 – Pacemaker overload test circuit . 36
Figure 202.101 – Set-up for radiated and conducted emission test . 39
Figure 202.102 – Set-up for radiated immunity test . 40
Figure 202.103 – Test circuit for HF surgery protection measurement . 42
Figure 202.104 – Test setup for HF surgery protection measurement. 43
Figure BB.1a – LEADS and colours for fetal ECG (see Table BB.2) . 52
Figure BB.1b – Positions of the ELECTRODES on the fetus for fetal ECG (see Table BB.2) . 52
Figure BB.2 – LEAD positions and colours for fetal scalp ECG (see Table BB.2) . 52
Figure FF.1 – Normal ELECTROCARDIOGRAM . 56
Figure FF.2 – Determination of global intervals (example) . 57
Figure FF.3 – Waveform durations, isoelectric segments .
...