IEC 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

Establishes particular requirements, in addition to the requirements of IEC 60601-2-25, for the safety, including essential performance of recording and analysing single channel and multichannel electrocardiographs. These requirements shall apply particularly to - recording electrocardiographs; - electrocardiographs which are part of other medical electrical equipment, for example exercise testing systems, if this equipment is used to record ECGs for diagnostic purposes; - electrocardiographs which are used as output units for ECG data base management systems or electrocardiographs which are used as output units located at other places than the recording unit; - analyzing electrocardiographs, systems, and computing devices which by means of electronic data processing and pattern recognition derive measurements (e.g. intervals and amplitudes) and diagnostic statements from the ECG; - those parts of patient monitors or other specialised electrocardiographs that are capable of performing the functions of the analyzing electrocardiographs.

Appareils électromédicaux - Partie 2-51: Règles particulières de sécurité et performances essentielles des électrocardiographes enregistreurs et analyseurs mono et multi-canaux

Etablit des exigences particulières, en complément des exigences de la CEI 60601-2-25 concernant la sécurité et les performances essentielles des électrocardiographes enregistreurs et analyseurs mono et multi-canaux. Ces exigences doivent s'appliquer en particulier aux - électrocardiographes enregistreurs; - électrocardiographes intégrés à d'autres appareils électromédicaux, tels que les systèmes d'épreuve d'effort, si ces appareils servent à l'enregistrement d'ECG à des fins de diagnostic; - électrocardiographes utilisés en tant qu'unités de sortie par des systèmes de gestion de base de données d'ECG ou aux électrocardiographes utilisés en tant qu'unités de sortie à d'autres endroits que l'unité d'enregistrement; - électrocardiographes analyseurs, systèmes et équipements informatiques qui à l'aide d'un traitement informatique et d'imagerie calculent des mesures (telles que des intervalles et des amplitudes) et établissent des diagnostics à partir de l'ECG; - parties d'appareils de surveillance de patients ou autres électrocardiographes spéciaux capables de remplir les fonctions d'un électrocardiographe analyseur.

General Information

• Status: Replaced
• Publication Date: 26-Feb-2003
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 19-Oct-2011

Relations

• Replaced By: IEC 60601-2-25:2011 - Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
60601-2-51
First edition
2003-02
Medical electrical equipment –
Part 2-51:
Particular requirements for safety,
including essential performance,
of recording and analysing single channel
and multichannel electrocardiographs
Appareils électromédicaux –
Partie 2-51:
Règles particulières de sécurité et
performances essentielles des électrocardiographes
enregistreurs et analyseurs mono et multi-canaux
Reference number
Publication numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1.
Consolidated editions
The IEC is now publishing consolidated versions of its publications. For example,
edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the
base publication incorporating amendment 1 and the base publication incorporating
amendments 1 and 2.
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INTERNATIONAL IEC
STANDARD
60601-2-51
First edition
2003-02
Medical electrical equipment –
Part 2-51:
Particular requirements for safety,
including essential performance,
of recording and analysing single channel
and multichannel electrocardiographs
Appareils électromédicaux –
Partie 2-51:
Règles particulières de sécurité et
performances essentielles des électrocardiographes
enregistreurs et analyseurs mono et multi-canaux
 IEC 2003  Copyright - all rights reserved
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 the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: [phone] Telefax: [phone] E-mail: [e-mail]  Web: www.iec.ch
PRICE CODE
Commission Electrotechnique Internationale
XC
International Electrotechnical Commission
Международная Электротехническая Комиссия
For price, see current catalogue

– 2 – 60601-2-51 © IEC:2003(E)
CONTENTS
FOREWORD . 4
INTRODUCTION .6
SECTION ONE – GENERAL
1 Scope and object . 7
2 Terminology and definitions. 8
4 General requirements for tests .11
6 Identification, marking and documents.12
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data.14
50.101 Automated measurements on ECGs (for ANALYSING ELECTROCARDIOGRAPHS) .14
50.102 Automated ECG interpretation (for ANALYSING ELECTROCARDIOGRAPHS) .19
51 Protection against hazardous output.23
51.101 LEADS .23
51.102 Input circuit .27
51.103 CALIBRATION.28
51.104 SENSITIVITY.29
51.105 Reduction of the effects of unwanted external voltages .29
51.106 Base-line .30
51.107 Distortion.32
51.108 Printing, electronic storage and transmission .34
51.109 Use with cardiac pacemakers .36
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly .37
56.7 BATTERIES .37
Appendix L (normative) References – Publications mentioned in this standard .43
Annex AA (informative) General guidance and rationale.44
Annex BB (informative) ELECTRODES, their positions, identifications and colour codes.51
Annex CC (informative) LEADS and their identification (other than described in 51.101).53
Annex DD (informative) Polarity of PATIENT LEADS (other than those specified in 51.101) .55
Annex EE (informative) Additional marking of electrodes.56
Annex FF (informative) Noise .58

60601-2-51 © IEC:2003(E) – 3 –
Annex GG (normative) Definitions and rules for the measurement
of ELECTROCARDIOGRAMS.60
Annex HH (normative) Calibration and test data sets .66
Annex II (informative) CTS test atlas .69
Bibliography .81
INDEX OF DEFINED TERMS .82
Figure 101 – Electrode position according to Frank (see Table 101).38
Figure 102 – Polarity of patient leads (see 51.101.1).38
Figure 103 – Test of weighting networks and input impedance (see 51.101.2.2 and 51.102.1) . 38
Figure 104 – Test of common mode rejection (see 51.105.1 and 51.106.4) .39
Figure 105 – Triangular waveforms for test E of Table 114 (see 51.107.1.1.1).40
Figure 106 – Input impulse signal (dashed trace) and cardiograph response
(continuous trace) (see 51.107.1.1.2) .40
Figure 107 – Circuit for test of linearity (see 51.107.2) .41
Figure 108 – Result of linearity test (see 51.107.2) .41
Figure 109 – Test of rectangular coordinates (see 51.108.4.1) .42
Table 101 – ELECTRODES and NEUTRAL ELECTRODES, their position, identification and
colour code .13
Table 102 – Offset voltage for ST and T amplitude reference values if the signals are
fed through a first order high pass FILTER with a TIME CONSTANT of 3,2 s.16
Table 103 – Acceptable mean differences and standard deviations for global intervals
and Q-, R-, S-durations on calibration and analytical ECGs .17
Table 104 – Acceptable mean differences and standard deviations for global durations
and intervals for biological ECGs .18
Table 105 – Disclosed changes of measurements caused by NOISE on ECGs according
to Table HH.3.18
Table 106 – Tabulation of test results .19
Table 107 – Format for disclosure of accuracy measures for diagnostic
interpretative statements .22
Table 108 – Format for disclosure of accuracy measures for rhythm interpretative statements. 23
Table 109 – Connection of ELECTRODES for a particular LEAD.24
Table 110 – LEADS and their identification (nomenclature and definition).24
Table 111 – LEAD networks for Goldberger and Wilson LEADS.26
Table 112 – LEAD network for Frank LEADS.27
Table 113 – Test of input impedance – Positions of LEAD SELECTOR, connection of LEAD
ELECTRODES and peak to valley deflection in mm with S1 open.28
Table 114 – Frequency response.32
Table HH.1 – Calibration and analytical ECGs.66
Table HH.2 – Data set for testing of measurement and wave recognition accuracy of
biological data – 100 ECGs of the CSE-study. .67
Table HH.3 – Data set for testing NOISE stability.67

– 4 – 60601-2-51 © IEC:2003(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-51: Particular requirements for safety, including essential
performance, of recording and analysing single channel
and multichannel electrocardiographs
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. 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
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for Standardization (ISO) in accordance with conditions determined by agreement between the two
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2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an
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3) The documents produced have the form of recommendations for international use and are published in the form
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Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-51 has been prepared by subcommittee 62D: Electro-
medical equipment, of IEC technical committee 62: Electrical equipment in medical practice.
The text of this standard is based on the following documents:
FDIS Report on voting
62D/469/FDIS 62D/473/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
In this Particular Standard, the fol
...

IEC 60601-2-51
Edition 1.0 2003-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-51: Particular requirements for the safety, including essential
performance, of recording and analysing single channel and multichannel
electrocardiographs
Appareils électromédicaux –
Partie 2-51: Règles particulières de sécurité et performances essentielles des
électrocardiographes enregistreurs et analyseurs mono et multi-canaux

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IEC 60601-2-51
Edition 1.0 2003-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-51: Particular requirements for the safety, including essential
performance, of recording and analysing single channel and multichannel
electrocardiographs
Appareils électromédicaux –
Partie 2-51: Règles particulières de sécurité et performances essentielles des
électrocardiographes enregistreurs et analyseurs mono et multi-canaux

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XC
CODE PRIX
ICS 11.040.55 ISBN 2-8318-8311-3
– 2 – 60601-2-51 © CEI:2003
SOMMAIRE
AVANT-PROPOS .8
INTRODUCTION.12

SECTION UN – GÉNÉRALITÉS
1 Domaine d'application et objet .14
2 Terminologie et définitions .18
4 Exigences générales relatives aux essais .24
6 Identification, marquage et documents .24
SECTION DEUX – CONDITIONS D'ENVIRONNEMENT
SECTION TROIS – PROTECTION CONTRE LES RISQUES DE CHOCS ÉLECTRIQUES
SECTION QUATRE – PROTECTION CONTRE LES RISQUES MÉCANIQUES
SECTION CINQ – PROTECTION CONTRE LES RISQUES DUS AUX RAYONNEMENTS
NON DÉSIRÉS OU EXCESSIFS
SECTION SIX – PROTECTION CONTRE LES RISQUES D’IGNITION
DE MÉLANGES ANESTHÉSIQUES INFLAMMABLES
SECTION SEPT – PROTECTION CONTRE LES TEMPÉRATURES EXCESSIVES
ET LES AUTRES RISQUES
SECTION HUIT – PRÉCISION DES CARACTÉRISTIQUES DE FONCTIONNEMENT
ET PROTECTION CONTRE LES CARACTÉRISTIQUES DE SORTIE PRÉSENTANT
DES RISQUES
50 Précision des données de fonctionnement .30
50.101 Mesure automatisée d’ECG (pour les ELECTROCARDIOGRAPHES ANALYSEURS).30
50.102 Interprétation automatisée d’ECG (pour les ELECTROCARDIOGRAPHES
ANALYSEURS).40
51 Protection contre les caractéristiques de sortie présentant des risques.50
51.101 DERIVATIONS.50
51.102 Circuit d’entrée.56
51.103 CALIBRAGE.60
51.104 SENSIBILITE .60
51.105 Réduction des effets de tensions externes non désirées .62
51.106 Ligne de base.64
51.107 Distorsion.68
51.108 Impression, mémorisation électronique et transmission.72
51.109 Utilisation avec des stimulateurs cardiaques .76
SECTION NEUF – FONCTIONNEMENT ANORMAL ET CONDITIONS DE DÉFAUT;
ESSAIS D’ENVIRONNEMENT
60601-2-51 © IEC:2003 – 3 –
CONTENTS
FOREWORD.9
INTRODUCTION.13
SECTION ONE – GENERAL
1 Scope and object .15
2 Terminology and definitions .19
4 General requirements for tests.25
6 Identification, marking and documents .25
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data.31
50.101 Automated measurements on ECGs (for ANALYSING ELECTROCARDIOGRAPHS).31
50.102 Automated ECG interpretation (for ANALYSING ELECTROCARDIOGRAPHS).41
51 Protection against hazardous output .51
51.101 LEADS.51
51.102 Input circuit .57
51.103 CALIBRATION .61
51.104 SENSITIVITY .61
51.105 Reduction of the effects of unwanted external voltages.63
51.106 Base-line.65
51.107 Distortion .69
51.108 Printing, electronic storage and transmission.73
51.109 Use with cardiac pacemakers .77
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
– 4 – 60601-2-51 © CEI:2003
SECTION DIX – RÈGLES DE CONSTRUCTION
56 Composants et ensembles.78
56.7 BATTERIES .78

Appendice L (normative) Références – Publications mentionnées dans cette norme .90
Annexe AA (informative) Directives générales et justificatifs .92
Annexe BB (informative) ELECTRODES: positions, identification et codes de couleur . 108
Annexe CC (informative) DERIVATIONS et leur identification (autres que celles décrites
en 51.101) . 112
Annexe DD (informative) Polarité des DERIVATIONS PATIENTS (autres que celles décrites
en 51.101) . 116
Annexe EE (informative) Marquage supplémentaire d’ELECTRODES . 118
Annexe FF (informative) BRUIT. 122
Annexe GG (normative) Définitions et règles de mesure d’ELECTROCARDIOGRAMMES. 126
Annexe HH (normative) Jeu de données de calibrage et d’essai . 138
Annexe II (informative) Atlas d’essai CTS. 144

Bibliographie . 170

INDEX DES TERMES DÉFINIS . 172

Figure 101 – Position d’électrodes selon Frank (voir le tableau 101) .80
Figure 102 – Polarité des dérivations du patient (voir 51.101.1) .80
Figure 103 – Essai de pondération des systèmes et de l‘impédance d’entrée (voir
51.101.2.2 et 51.102.1) .80
Figure 104 – Essai de rejet de mode commun (voir 51.105.1 et 51.106.4).82
Figure 105 – Formes d’ondes triangulaires pour l’essai E du tableau 114 (voir
51.107.1.1.1).84
Figure 106 – Signal d’impulsion d’entrée (tracé en tirets) et réponse du cardiographe
(tracé continu) (voir 51.107.1.1.2).84
Figure 107 – Circuit d’essai de linéarité (voir 51.107.2).86
Figure 108 – Résultat de l
...