IEC 60601-2-25:2011

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

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by
any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or
IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de la CEI ou du Comité national de la CEI du pays du demandeur.
Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette
publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.

IEC Central Office
3, rue de Varembé
CH-1211 Geneva 20
Switzerland
Email: inmail@iec.ch
Web: www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
 Catalogue of IEC publications: www.iec.ch/searchpub
The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,…).
It also gives information on projects, withdrawn and replaced publications.
 IEC Just Published: www.iec.ch/online_news/justpub
Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available
on-line and also by email.
 Electropedia: www.electropedia.org
The world's leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions
in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical
Vocabulary online.
 Customer Service Centre: www.iec.ch/webstore/custserv
If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service
Centre FAQ or contact us:
Email: csc@iec.ch
Tel.: +41 22 919 02 11
Fax: +41 22 919 03 00
A propos de la CEI
La Commission Electrotechnique Internationale (CEI) est la première organisation mondiale qui élabore et publie des
normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.
 Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm
Le Catalogue en-ligne de la CEI vous permet d’effectuer des recherches en utilisant différents critères (numéro de référence,
texte, comité d’études,…). Il donne aussi des informations sur les projets et les publications retirées ou remplacées.
 Just Published CEI: www.iec.ch/online_news/justpub
Restez informé sur les nouvelles publications de la CEI. Just Published détaille deux fois par mois les nouvelles
publications parues. Disponible en-ligne et aussi par email.
 Electropedia: www.electropedia.org
Le premier dictionnaire en ligne au monde de termes électroniques et électriques. Il contient plus de 20 000 termes et
définitions en anglais et en français, ainsi que les termes équivalents dans les langues additionnelles. Egalement appelé
Vocabulaire Electrotechnique International en ligne.
 Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm
Si vous désirez nous donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du
Service clients ou contactez-nous:
Email: csc@iec.ch
Tél.: +41 22 919 02 11
Fax: +41 22 919 03 00
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
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
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
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
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 locate problems if the ME EQUIPMENT appears to be functioning
incorrectly.
NOTE This relates to simple OPERATOR difficulties, not to technical malfunctions.
b) MANUFACTURER shall disclose the following in the ACCOMPANYING DOCUMENTS:
1) whether the isoelectric segments within the QRS are included in or excluded from the
ACCOMPANYING DOCUMENTS shall specifically explain whether
Q-, R- or S-waves. The
isoelectric parts (I-wave) after global QRS-onset or before global QRS-offset (K-
wave) are included in the duration measurement of the respective adjacent
waveform;
2) whether the ELECTROCARDIOGRAPH has to be be configured with specific FILTER
settings to pass the distortion test, and the effect of these FILTER settings have on
ECG signal distortion as required in 201.12.4.107.1.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
201.8.3 Classification of APPLIED PARTS
Replacement of items a), b), and c):
The APPLIED PART shall be a TYPE CF APPLIED PART.
201.8.5 Separation of parts
201.8.5.2.3 PATIENT leads
Addition:
Any detachable ELECTRODE connector of a LEAD WIRE shall, when separated from the
ELECTRODE, have an air clearance between connector pins and a flat surface of at least
0,5 mm.
Compliance is checked by inspection.
201.8.5.5.1 * Defibrillation protection
Addition:
Protection against the effects of defibrillation shall be provided for ME EQUIPMENT.
For defibrillator testing the ME EQUIPMENT is operated using the PATIENT CABLES as specified
by the MANUFACTURER.
The following requirements and tests apply in addition to the requirements and tests as
specified in 8.5.5.1 of the general standard.
• Common mode test
Addition:
Within 5 s after exposure to the defibrillation voltage, the ME EQUIPMENT shall resume normal
operation in the previous operating mode, without loss of any OPERATOR settings or stored

60601-2-25  IEC:2011 – 17 –
data, and shall continue to perform its intended function as specified in the ACCOMPANYING
DOCUMENTS.
Compliance is checked according to Figure 201.103.
For ME EQUIPMENT of CLASS I, apply the test voltage between all LEAD WIRES, including the
NEUTRAL ELECTRODE, connected together and the FUNCTIONAL EARTH TERMINAL. Energize the
ME EQUIPMENT for these tests.
In the case of ME EQUIPMENT of CLASS II and ME EQUIPMENT with an INTERNAL ELECTRICAL
POWER SOURCE, apply the test voltage between all LEAD WIRES, including the NEUTRAL
ELECTRODE, connected together and the FUNCTIONAL EARTH TERMINAL and/or metal foil in close
contact with the ENCLOSURE. Energize the ME EQUIPMENT for these tests.
ECG MONITORING EQUIPMENT having an INTERNAL ELECTRICAL POWER SOURCE, which is
rechargeab
...