SIST EN 60601-2-25:2015

Medical electrical equipment - Part 2-25: Particular requirements for 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 : Règles particulières de sécurité de base et de 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: 09-Nov-2015
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 05-Nov-2015
• Due Date: 10-Jan-2016
• Completion Date: 10-Nov-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: EN 60601-2-25:2015 - Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

Relations

• Replaces: SIST EN 60601-2-51:2004 - Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs (IEC 60601-2-51:2003)
• Effective Date: 01-Dec-2015
• Replaces: SIST EN 60601-2-25:1998/A1:2002 - Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs (IEC 60601-2-25:1993/A1:1999)
• Effective Date: 01-Dec-2015
• Replaces: SIST EN 60601-2-25:1998 - Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs (IEC 60601-2-25:1993)
• Effective Date: 01-Dec-2015

Overview

EN 60601-2-25:2015 (adoption of IEC 60601-2-25:2011) is the particular standard for the basic safety and essential performance of electrocardiographs (ECGs). It applies to standalone electrocardiographs and ECGs as part of a medical electrical system intended to produce diagnostic electrocardiogram reports. This edition merges earlier EN/IEC parts (including IEC 60601-2-51) and updates requirements to align with the third edition of the general IEC 60601 series.

Key topics and requirements

• Scope and exclusions: Covers diagnostic ECG equipment, including use in ambulances and air transport (extreme/uncontrolled environments), while excluding vectorcardiography loops and certain ambulatory ECG/cardiac monitor devices covered by IEC 60601-2-47 and IEC 60601-2-27 when not intended for diagnostic ECG reports.
• Essential performance: Defines essential performance criteria for reliable ECG acquisition and reporting (see Table 201.101).
• Safety protections: Requirements for protection against electrical, mechanical, thermal and radiation hazards, including specific tests for defibrillation protection and patient safety during abnormal conditions.
• Electrodes, leads and polarity: Standardized electrode positions, lead nomenclature, identification and colour codes (annexes and tables) to ensure consistent clinical use and interoperability.
• Signal integrity and accuracy: Test methods for frequency response, linearity, noise, common-mode rejection, pacemaker pulse display and waveform fidelity to ensure clinically accurate ECG interpretation.
• Electromagnetic compatibility (EMC): References collateral standard IEC 60601-1-2 for EMC tests and immunity/emission limits.
• Documentation and marking: Requirements for identification, labelling, instructions for use, and test/validation documentation (including calibration and test data sets).
• Annexes and test datasets: Informative annexes provide rationale, electrode/lead guidance, calibration ECGs, CTS test atlas and recommended test procedures.

Applications and who uses it

• Medical device manufacturers: Design, development and verification of diagnostic electrocardiographs to meet safety and performance expectations.
• Test laboratories & conformity assessors: Type testing, EMC testing and certification against EN/IEC 60601-2-25 requirements.
• Clinical engineers and hospitals: Procurement specifications, acceptance testing and maintenance criteria for ECG systems used in hospitals, ambulances and transport environments.
• Regulatory and quality teams: Demonstrating conformity with EU Directive essential requirements (see Annex ZZ) and supporting CE marking for ECG devices.

Related standards

• EN/IEC 60601-1 - General requirements for basic safety and essential performance
• IEC 60601-1-2 - Electromagnetic compatibility (EMC) for medical electrical equipment
• IEC 60601-2-47 - Ambulatory electrocardiographic devices (where applicable)
• IEC 60601-2-27 - Cardiac monitors (where applicable)

EN 60601-2-25:2015 is essential reading when specifying, testing or certifying diagnostic ECG equipment to ensure patient safety, signal accuracy and regulatory compliance. Keywords: electrocardiograph standard, ECG safety, IEC 60601-2-25, medical electrical equipment, ECG performance, defibrillation protection, electrodes and leads.

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 . 58
Figure FF.4 – QRS complex with small R-wave(s) (see Figure FF.5, FF.6) . 59
Figure FF.5 – Detail of small accepted R-wave . 60
Figure FF.6 – Detail of small rejected R-wave . 60
Figure HH.1 – Nomenclature of calibration ECGS . 66
Figure HH.2 – Nomenclature of analytical ECGs . 69

Table 201.101 – ESSENTIAL PERFORMANCE requirements . 12
Table 201.102 – ELECTRODES, their position, identification and colour code . 14
Table 201.103 – Protection against the effect of defibrillation (test conditions) . 18
Table 201.104 – Acceptable mean differences and standard deviations for global
intervals and Q-, R-, S-durations on calibration and analytical ECGS . 23
Table 201.105 – Acceptable mean differences and standard deviations for global
durations and intervals for biological ECGs . 23
Table 201.106 – LEADS and their identification (nomenclature and definition) . 25
Table 201.107 – Frequency response . 31
Table 201.108 – PATIENT ELECTRODE connection for pacemaker pulse display test . 37
Table AA.1 – ELECTRODE positions and electrical strength requirements . 46
Table BB.1 – ELECTRODES, their positions, identifications and colour codes (other than
described in 201.7.4.101, Table 201.106) . 51
Table BB.2 – Other ELECTRODE-positions, identifications and colour codes not covered
by this particular standard . 51
Table DD.1 – ELECTRODE polarities . 54
Table EE.1 – Recommended identification and colour code for a 14-wire PATIENT CABLE . 55
Table GG.1 – CALIBRATION and analytical ECGS . 61
Table GG.2 – Data set for testing of measurement and wave recognition accuracy of
biological data – 100 selected ECGS of the CSE-study with their numbering in the CSE
database, to be used in 201.12.1.101.3.2 . 62
Table HH.1 – Naming of signals (calibration ECGS) . 67

– 4 – 60601-2-25  IEC:2011
Table HH.2 – Naming of signals (analytical ECGs) . 68

60601-2-25  IEC:2011 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

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

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-25 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
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. This second edition of
IEC 60601-2-25 constitutes a technical revision of both those standards.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/944/FDIS 62D/957/RVD
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.

– 6 – 60601-2-25  IEC:2011
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
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– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
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The committee has decided that the contents of this publication will remain unchanged until
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related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
60601-2-25  IEC:2011 – 7 –
INTRODUCTION
This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ELECTROCARDIOGRAPHIC EQUIPMENT. It amends and supplements IEC 60601-1 (third edition,
2005): Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance, hereinafter referred to as the general standard.
This particular standard now includes the contents of the particular standard IEC 60601-2-51:
Medical electrical equipment – Part 2-51: Particular requirements for the safety, including
essential performance, of recording and analysing single channel and multichannel
electrocardiographs.
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.
The requirements of this particular standard take priority over those of the general standard.
A “General guidance and rationale” for the more important requirements of this particular
standard is included in Annex AA. Knowledge of the reasons for these requirements will not
only facilitate proper application of the standard but will, in due course, expedite any revision
necessitated by changes in clinical practice or as a result of developments in technology.
However, Annex AA does not form part of the requirements of this standard.

– 8 – 60601-2-25  IEC:2011
MEDICAL ELECTRICAL EQUIPMENT –

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

201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ELECTROCARDIOGRAPHS as defined in 201.3.63 intended by themselves or as a part of an
ME SYSTEM, for the production of ECG REPORTS for diagnostic purposes, hereinafter referred to
as ME EQUIPMENT.
Not included within the scope of this particular standard are:
a) the part of ME EQUIPMENT that provides vectorcardiographic loops;
b) ambulatory electrocardiographic ME EQUIPMENT covered by IEC 60601-2-47 where not
intended for obtaining ECG REPORTS for diagnostic purposes;
c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining ECG
REPORTS for diagnostic purposes.
NOTE 1 For example. ME EQUIPMENT includes:
a) direct-writing ELECTROCARDIOGRAPHS;
b) other ME EQUIPMENT that produce ECG REPORTS for diagnostic purposes, e.g. patient monitors, defibrillators, exercise
testing devices;
c) ELECTROCARDIOGRAPHS having a display that is remote from the PATIENT (e.g. via phone lines, networks or storage media).
These ME EQUIPMENT or ME SYSTEMS are within the scope of this particular standard excluding transmission media.
NOTE 2 ME EQUIPMENT that provide selection between diagnostic and monitoring functions shall meet the
requirements of the appropriate standard when configured for that function.
ME 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
ME EQUIPMENT for those environments of use.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular requirements for BASIC SAFETY
and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHS as defined in 201.3.63.
201.1.3 Collateral standards
Addition:
—————————
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.

60601-2-25  IEC:2011 – 9 –
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2 applies as modified in Clause 202. IEC 60601-1-3, IEC 60601-1-8 and
IEC 60601-1-10 do not apply. All other published collateral standards in the IEC 60601-1
series apply as published
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard,
etc.). The changes to the text of the general standard are specified by the use of the following
words:
“Replacement” means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
“Addition” means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
“Amendment” means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, etc.
The term “this standard” is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.

– 10 – 60601-2-25  IEC:2011
201.2 Normative references
NOTE Informative references are listed in the bibliography beginning on page 94.
Clause 2 of the general standard applies, except as follows:
Replacement:
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
Addition:
IEC 60601-2-2:2009, Medical electrical equipment – Part 2-2: Particular requirements for the
basic safety and essential performance of high frequency surgical equipment and high
frequency surgical accessories
201.3 Terms and definitions
For the purpose of this document, the terms and definitions given in IEC 60601-1:2005 apply,
except as follows:
201.3.63
MEDICAL ELECTRICAL EQUIPMENT
Replacement:
ELECTROCARDIOGRAPH
ME EQUIPMENT
equipment and associated LEAD WIRES and ELECTRODES intended for the production of ECG
REPORTS for diagnostic purposes
Addition:
201.3.201
CENTRAL TERMINAL ACCORDING TO WILSON
CT
average potential of the R (RA), L (LA) and F (LL) ELECTRODES
201.3.202
CHANNEL
hardware and/or software selection of a particular electrocardiographic LEAD for purposes of
display, recording, or transmission
201.3.203
DC OFFSET VOLTAGE
d.c. voltage appearing on ELECTRODES with respect to the NEUTRAL ELECTRODE resulting from
ELECTRODE-skin voltages
201.3.204
COMMON MODE REJECTION
ability of the ELECTROCARDIOGRAPH including the PATIENT CABLE and ELECTRODES, high
frequency FILTERS, protection networks, LEAD networks, amplifier input, etc., to discriminate
between signals with differences between amplifier inputs (differential signal) and signals
common to amplifier inputs (common signal), in the presence of ELECTRODE impedance
imbalance
60601-2-25  IEC:2011 – 11 –
201.3.205
ECG REPORT
a prensentation (e.g. a hard copy print-out or a display) of an ELECTROCARDIOGRAM with
associated data such as the date and time that ELECTROCARDIOGRAM was acquired, PATIENT
identification etc.
201.3.206
EFFECTIVE RECORDING WIDTH
width of the paper recording within which the signal of a CHANNEL can be recorded according
to this particular standard
201.3.207
ELECTROCARDIOGRAM
ECG
graphical presentation of one or more LEADS over time
201.3.208
ELECTRODE
sensor in contact with a specified part of the body that is used to detect electrical activity
201.3.209
FILTER
means, realized in hardware, firmware or software, to attenuate unwanted components in the
signal being recorded, e.g. muscle action voltages in an ECG signal
201.3.210
GAIN
ratio of the amplitude of the output signal to the amplitude of the input signal
NOTE GAIN is expressed in mm/mV.
201.3.211
LEAD
ELECTRODES
voltage between
201.3.212
LEAD WIRE
cable connected between ELECTRODE and either a PATIENT CABLE or the ME EQUIPMENT
201.3.213
NEUTRAL ELECTRODE
reference point for differential amplifiers and/or interference suppression circuits, not intended
to be used to calculate any LEAD
201.3.214
NOISE
unwanted signals of any frequency present in the ELECTROCARDIOGRAM
201.3.215
NORMAL GAIN
GAIN of 10 mm/mV
201.3.216
PATIENT CABLE
multiwire cable used to connect the LEAD WIRES to the ELECTROCARDIOGRAPH

– 12 – 60601-2-25  IEC:2011
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Addition:
201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements
Table 201.101 identifies essential performance requirements for electrocardiographs and the
subclauses in which they are found.
Table 201.101 – ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Defibrillation protection 201.8.5.5.1
ESSENTIAL PERFORMANCE of ME EQUIPMENT 201.12.1.101
FILTERS (including line frequency interfeerence FILTERS) 201.12.4.105.3
Electrostatic discharge 202.6.2.2.1
Electric fast transients and bursts 202.6.2.4.1
Conducted disturbances 202.6.2.6.1
Electrosurgery interference 202.6.2.101
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.3 * Ambient temperature, humidity, atmospheric pressure
Addition:
aa) Tests are performed within a relative humidity range of 25 % to 95 % (without
condensation).
201.5.4 Other conditions
Addition:
aa) Unless otherwise stated, tests shall be carried out with the ACCESSORIES and the
recording materials specified by the MANUFACTURER.
bb) For ME EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE, if the test result is
affected by the INTERNAL ELECTRICAL POWER SOURCE voltage, then the test shall be
performed using the least favourable INTERNAL ELECTRICAL POWER SOURCE voltage
specified by the MANUFACTURER. If necessary for the purpose of conducting the test, an
external battery or d.c. power supply may be used to provide the necessary test voltage.
cc) The values used in test circuits, unless otherwise specified, shall have at least an
accuracy as given below:
– resistors: ±1 %;
– capacitors: ±10 %;
– inductors: ±10 %;
– test voltages: ±1 %
60601-2-25  IEC:2011 – 13 –
201.5.8 * Sequence of tests
Amendment:
Tests called for in 201.8.5.5.1 of this particular standard shall be carried out prior to the
LEAKAGE CURRENT and dielectric strength tests of clauses B.20 and B.22 of Annex B of the
general standard.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.2 Protection against electric shock
Replacement of the last paragraph:
APPLIED PARTS shall be classified as TYPE CF APPLIED PARTS (see 7.2.10 and 8.3 of the general
standard). APPLIED PARTS shall be classified as DEFIBRILLATION-PROOF APPLIED PARTS (see
8.5.5 of the general standard).
201.6.6 Mode of operation
Replacement:
ME EQUIPMENT shall be classified for CONTINUOUS OPERATION.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.4 Making of controls and instruments
Additional subclause:
ATIENT CABLE and PATIENT CABLE to ME EQUIPMENT connector
201.7.4.101 * P
In order to minimize the possibility of incorrect connections, the PATIENT CABLE shall be
ELECTRODE identifier and/or colour code)
permanently marked with one of the identifiers (
specified in Table 201.102;
Detachable LEAD WIRES shall be permanently marked on both ends with the identifiers
(ELECTRODE identifier and/or colour code) specified in Table 201.102. For addditional
markings, see Annex BB.
The PATIENT CABLE to ME EQUIPMENT connector shall be constructed or marked so that the
OPERATOR can identify the ME EQUIPMENT to which the PATIENT CABLE should be connected.

– 14 – 60601-2-25  IEC:2011
Table 201.102 – ELECTRODES, their position, identification and colour code
LEAD- CODE 1 (usually European) CODE 2 (usually American) Position on body surface
System
ELECTRODE Colour code ELECTRODE Colour code
identifier identifier
R Red RA White Right arm
Limb L Yellow LA Black Left arm
F Green LL Red Left leg
C White V Brown Single movable chest ELECTRODE
C1 White/red V1 Brown/red Fourth intercostal space at right border
of sternum
C2 White/yellow V2 Brown/yellow Fourth intercostal space at left border
of sternum
Chest
C3 White/green V3 Brown/green Fifth rib between C2 and C4
according
to Wilson C4 White/brown V4 Brown/blue Fifth intercostal space on left
midclavicular line
C5 White/black V5 Brown/orange Left anterior axillary line at the
horizontal level of C4
C6 White/violet V6 Brown/violet Left midaxillary line at the horizontal
level of C4
a
I Light blue/red I Orange/red At the right midaxillary line
a
E Light blue/yellow E Orange/yellow At the front midline
Position
C Light blue/green C Orange/green Between front midline and left
according midaxillary line at an angle of 45
a
to Frank degrees
(see
a
A Light blue/brown A Orange/brown At the left midaxillary line
Figure
a
201.101)
M Light blue/black M Orange/black At the back midline
H Light blue/violet H Orange/violet On the back of the neck
F Green F Red On the left leg
N or RF Black RL Green Right leg (neutral)
NOTE Additional recommendations are given in Annex BB and Annex EE.
a
Located at the transverse level of the ventricles, if known, or otherwise at the fifth intercostal space.

IEC  2246/11
Figure 201.101 – ELECTRODE position according to Frank

60601-2-25  IEC:2011 – 15 –
201.7.9.2 Instructions for use
Additional subclause:
201.7.9.2.101 Additional instructions for use
a) Advice shall be given on the following:
1) the INTENDED USE of the ELECTROCARDIOGRAPH including the environment of use. This
disclosure shall include all the attributes of INTENDED USE such as, but not limited to,
the following:
i) diagnostic application(s) for which the ELECTROCARDIOGRAPH is intended (e.g.:
screening for cardiac abnormalities in the general population, detecting acute
myocardial ischemia and infarction in chest pain PATIENTS, etc.);
ii) population(s) for whom the ELECTROCARDIOGRAPH is intended (e.g.: adults,
children, infants, neonates, etc. – specify the age limits of the targeted
population where applicable);
iii) location(s) for which the ELECTROCARDIOGRAPH is intended (e.g.: hospital,
general physician’s office, out-of-hospital locations such as ambulance, home-
care, etc.).
If the ELECTROCARDIOGRAPH has more than one INTENDED USE with different attributes,
all the INTENDED USES and associated attributes shall be disclosed;
2) instructions for connecting a POTENTIAL EQUALIZATION CONDUCTOR, if applicable;
3) that conductive parts of ELECTRODES and associated connectors for TYPE BF or CF
APPLIED PARTS, including the NEUTRAL ELECTRODE, should not contact any other
conductive parts including earth;
4) the specification (and type number, if necessary) of the PATIENT CABLE which needs
to be used to provide protection against the effect of the discharge of a cardiac
defibrillator and against high-frequency burns;
5) precautions to take when using a defibrillator on a PATIENT; a description of how the
discharge of a defibrillator affects the ME EQUIPMENT; a warning that defibrillator
protection requires use of MANUFACTURER specified ACCESSORIES including
ELECTRODES, LEAD WIRES and PATIENT CABLES. The specification (or type-number) of
such ACCESSORIES (see 201.8.5.5.1) shall be disclosed;
6) advice to the clinical OPERATOR regarding whether the ELECTROCARDIOGRAPH
incorporates a means to protect the PATIENT against burns when used with HIGH-
FREQUENCY (HF) SURGICAL EQUIPMENT. Advice shall be given regarding the location of
ELECTRODES, LEAD WIRES, etc. to reduce the hazards of burns in the event of a defect
in the HF SURGICAL EQUIPMENT’S NEUTRAL ELECTRODE connection;
7) the choice and application of specified PATIENT CABLES and LEAD WIRES; the choice
and application of ELECTRODES;
8) caution to the OPERATOR regarding summation of LEAKAGE CURRENTS when several
items of ME EQUIPMENT are interconnected.;
9) whether the ELECTROCARDIOGRAPH is suitable for DIRECT CARDIAC APPLICATION;
10) how to identify whether the ELECTROCARDIOGRAPH is inoperable (see 201.12.4.101);
11) precautions regarding any HAZARD that may be caused by the operation of a cardiac
pacemaker or other electrical stimulators with the ELECTROCARDIOGRAPH.
12) where relevant, a statement that the ME EQUIPMENT is protected against malfunction
caused by electrosurgery;
13) INTERNALLY POWERED ME EQUIPMENT: the minimum operating time of the
ME EQUIPMENT shall be disclosed, provided that the battery is new and fully charged.
If rechargeable batteries are used, the MANUFACTURER shall disclose the battery
charge time from depletion to 90 % charge in NORMAL USE and battery conditioning, if
applicable. Specific advice shall be given on how to determine when the battery
needs to be replaced. In addition, the battery charging procedure shall also be
disclosed;
– 16 – 60601-2-25  IEC:2011
14) * advice regarding testing of the ELECTROCARDIOGRAPH and ACCESSORIES on a daily
basis (by the clinical OPERATOR) and on a scheduled basis (as a service activity);
15) simple fault finding methods for troubleshooting problems by which the clinical
OPERATOR can
...