EN 60601-2-51:2003

Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

Establishes particular requirements, in addition to the requirements of EN 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; - analysing 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 analysing electrocardiographs.

Medizinische elektrische Geräte - Teil 2-51: Besondere Festlegungen für die Sicherheit, einschließlich wesentlicher Leistungsmerkmale von aufzeichnenden und interpretierenden Einkanal- und Mehrkanal-Elektrokardiographen

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.

Medicinska električna oprema - 2-51. del: Posebne varnostne zahteve, vključno z bistvenim delovanjem, za snemanje in analiziranje enokanalskih in večkanalskih elektrokardiografov (IEC 60601-2-51:2003)

General Information

• Status: Withdrawn
• Publication Date: 30-Jul-2003
• Withdrawal Date: 31-Mar-2006
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Sep-2018
• Completion Date: 15-Sep-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: 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)

Relations

• Replaced By: EN 60601-2-25:2015 - Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2004
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYHYNOMXþQR]
ELVWYHQLPGHORYDQMHP]DVQHPDQMHLQDQDOL]LUDQMHHQRNDQDOVNLKLQYHþNDQDOVNLK
HOHNWURNDUGLRJUDIRY,(&
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)
Medizinische elektrische Geräte - Teil 2-51: Besondere Festlegungen für die Sicherheit,
einschließlich wesentlicher Leistungsmerkmale von aufzeichnenden und
interpretierenden Einkanal- und Mehrkanal-Elektrokardiographen (IEC 60601-2-51:2003)
Appareils électromédicaux - Partie 2-51: Règles particulières de sécurité et
performances essentielles des électrocardiographes enregistreurs et analyseurs mono et
multi-canaux (CEI 60601-2-51:2003)
Ta slovenski standard je istoveten z: EN 60601-2-51:2003
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-51
NORME EUROPÉENNE
EUROPÄISCHE NORM July 2003
ICS 11.040.55
English version
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)
Appareils électromédicaux Medizinische elektrische Geräte
Partie 2-51: Règles particulières Teil 2-51: Besondere Festlegungen
de sécurité et performances essentielles für die Sicherheit, einschließlich
des électrocardiographes enregistreurs wesentlicher Leistungsmerkmale von
et analyseurs mono et multi-canaux aufzeichnenden und interpretierenden
(CEI 60601-2-51:2003) Einkanal- und Mehrkanal-
Elektrokardiographen
(IEC 60601-2-51:2003)
This European Standard was approved by CENELEC on 2003-04-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic,
Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2003 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 60601-2-51:2003 E
Foreword
The text of document 62D/469/FDIS, future edition 1 of IEC 60601-2-51, prepared by SC 62D,
Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to
the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-51 on 2003-04-01.

The following dates were fixed:

– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2004-02-01

– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2006-04-01

Annexes designated "normative" are part of the body of the standard.
Annexes designated "informative" are given for information only.
In this standard, annexes GG, HH, ZA and ZB are normative, annexes AA to FF and annex II are
informative.
Annexes ZA and ZB have been added by CENELEC.

In this particular standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– notes, explanations, advice, introductions, general statements, exceptions and references: small roman type;
– test specifications: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL
CAPITALS.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-51:2003 was approved by CENELEC as a European
Standard without any modification.
__________
- 3 - EN 60601-2-51:2003
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of any
of these publications apply to this European Standard only when incorporated in it by amendment or
revision. For undated references the latest edition of the publication referred to applies (including
amendments).
NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
Publication Year Title EN/HD Year
Addition to annex ZB of EN 60601-1:1990/A2:1995

IEC 60601-1 1988 Medical electrical equipment EN 60601-1 1990
Part 1: General requirements for safety + corr. July 1994
A1 1991 A1 1993
+ corr. July 1994
A2 1995 A2 1995
+ A13 1996
IEC 60601-1-4 1996 Medical electrical equipment EN 60601-1-4 1996
Part 1-4: General requirements for
safety - Collateral standard:
Programmable electrical medical
systems
IEC 60601-2-25 1993 Part 2-25: Particular requirements for EN 60601-2-25 1995
the safety of electrocardiographs
A1 1999 A1 1999
ENV 1064 1991 Medical Informatics - Standard - -
Communication Protocol - Computer-
Assisted Electrocardiopgraphy
Annex ZB
(normative)
Other international publications mentioned in this standard
with the references of the relevant European publications
Publication Year Title EN/HD Year
Addition to annex ZB of EN 60601-1:1990/A2:1995

AAMI EC11 1991 Diagnostic electrocardiographic devices- -

CSE working 1985 Recommendation for Measurement - -
group Standards in Quantitative
recommendation Electrocardiagraphy
European Heart Journal. 1985, 6,
p.815-825
IEEE Computer 1990 Computers in Cardiology: Proceedings - -
Society Press 1991
ISO 1000 1992 SI units and recommendations for the - -
use of their multiples and of certain
other units
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 differenc
...