IEC 60601-2-47:2001

Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems

Specifies the particular safety requirements for ambulatory electrocardiographic systems. Within the scope of this standard are systems of the following types: a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyse it later on a separate unit, or record and analyse the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard; b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG. The safety aspects of this standard apply to all types of systems falling in one of the above- mentioned categories.

Appareils électromédicaux - Partie 2-47: Règles particulières de sécurité et performances essentielles des systèmes d'électrocardiographie ambulatoires

Spécifie les exigences particulières de sécurité applicables aux systèmes électrocardiographiques ambulatoires. Les systèmes des types suivants relèvent du domaine d'application de la présente norme: a) systèmes qui assurent un enregistrement en continu et une analyse en continu de l'ECG permettant une nouvelle analyse globale donnant des résultats essentiellement similaires. Les systèmes peuvent d'abord enregistrer et mémoriser l'ECG, puis l'analyser ultérieurement sur une unité distincte, ou ils peuvent enregistrer et analyser l'ECG simultanément. Le type de support de stockage utilisé ne relève pas de la présente norme. b) systèmes qui assurent une analyse en continu et seulement un enregistrement partiel ou limité ne permettant pas de nouvelle analyse globale de l'ECG. Les aspects de sécurité de la présente norme s'appliquent à tous les types de systèmes appartenant à l'une des catégories mentionnées ci-dessus.

General Information

• Status: Published
• Publication Date: 09-Jul-2001
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 16-Feb-2012

Relations

• Revised: IEC 60601-2-47:2012 - Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
60601-2-47
First edition
2001-07
Medical electrical equipment –
Part 2-47:
Particular requirements for the safety,
including essential performance,
of ambulatory electrocardiographic systems
Appareils électromédicaux –
Partie 2-47:
Règles particulières de sécurité et performances essentielles
des systèmes d'électrocardiographie ambulatoires
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
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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
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INTERNATIONAL IEC
STANDARD
60601-2-47
First edition
2001-07
Medical electrical equipment –
Part 2-47:
Particular requirements for the safety,
including essential performance,
of ambulatory electrocardiographic systems
Appareils électromédicaux –
Partie 2-47:
Règles particulières de sécurité et performances essentielles
des systèmes d'électrocardiographie ambulatoires
 IEC 2001  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 Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
S
International Electrotechnical Commission
For price, see current catalogue

– 2 – 60601-2-47 © IEC:2001(E)
CONTENTS
FOREWORD.4
INTRODUCTION.6
SECTION ONE – GENERAL
1 Scope and object .7
2 Terminology and definitions.8
5 Classification.10
6 Identification, marking and documents.10
SECTION TWO – ENVIRONMENTAL CONDITIONS
10 Environmental conditions.11
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
20 Dielectric strength.12
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength.12
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE
RADIATION
36 Electromagnetic compatibility.13
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 .15
51 Protection against hazardous output .22
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly .29

60601-2-47 © IEC:2001(E) – 3 –
Appendix L (normative) References – Publications mentioned in this standard.35
Annex AA (informative) Guidance and rationale.36
Figure 101 – Test set-up for conductive emission test according 36.201.1. .30
Figure 102 – Test set-up for radiated emission and radiated immunity test according
to 36.201.1 and 36.202.2.31
Figure 103 – Test signal for input dynamic range test according to 51.5.1.32
Figure 104 – General test circuit for 51.5.32
Figure 105 – Test circuit for common mode rejection according to 51.5.3.33
Figure 106 – Test circuit for pacemaker pulse tolerance according to 51.5.11 .34
Table 101 – LEAD colour codes .10
Table 102 – Reporting requirements for standard analyser outputs .16
Table 103 – Reporting requirements for optional analyser outputs .16
Table 104 – Beat-by-beat matrix.19
Index of defined terms.44

– 4 – 60601-2-47 © IEC:2001(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-47: Particular requirements for the safety, including essential
performance, of ambulatory electrocardiographic systems
FOREWORD
1) The IEC (International Electrotechnical Commission) is a world-wide organisation for standardisation comprising
all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote
international co-operation on all questions concerning standardisation 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 organisations liaising
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for Standardisation (ISO) in accordance with conditions determined by agreement between the two
organisations.
2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an inter-
national consensus of opinion on the relevant subjects since each technical committee has representation from
all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
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 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 60601-2-47 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
The text of this standard is based upon the following documents:
FDIS Report on voting
62D/408/FDIS 62D/411/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.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.
Annex AA is for information only.

60601-2-47 © IEC:2001(E) – 5 –
In this Particular Standard the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type,
– notes, explanations, advice, introductions, general statements, exceptions and references: in smaller type,
– test specifications: in italic type,
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL
CAPITALS.
The committee has decided that the contents of this publication will remain unchanged until
2005. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
A bilingual edition of this publication may be issued at a later date.

– 6 – 60601-2-47 © IEC:2001(E)
INTRODUCTION
This Particular Standard concerns the safety of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS.
It amends and supplements IEC 60601-1 (second edition 1988): Medical electrical equipment –
Part 1: General requirements for safety, as amended by its amendment 1 (1991) and its
amendment 2 (1995), hereinafter referred to as the General Standard. The requirements of this
Particular Standard take priority over those of the General Standard.
A “General guidance and rationale” for the requirements of this Particular Standard is included
in annex AA.
It is considered that a knowledge of the reasons for these requirements will not only facilitate
the 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, this annex does not form part of the requirements of this Standard.
An asterisk (*) by a clause or subclause number indicates that some explanatory notes are
given in annex AA of this Particular Standard.

60601-2-47 © IEC:2001(E) – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-47: Particular requirements for the safety, including essential
performance, of ambulatory electrocardiographic systems
SECTION ONE – GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies except as follows:
1.1 Scope
Addition:
This Particular Standard specifies the particular safety requirements for AMBULATORY
ELECTROCARDIOGRAPHIC SYSTEMS, as defined in 2.101.
Within the scope of this standard are systems of the following types:
a) systems that provide continuous recording and continuous analysis of the ECG allowing full
re-analysis giving essentially similar results. The systems may first record and store the
ECG and analyse it later on a separate unit, or record and analyse the ECG simultaneously.
The type of storage media used is irrelevant with regard to this standard;
b) systems that provide continuous analysis and only partial or limited recording not allowing a
full re-analysis of the ECG.
The safety aspects of this standard apply to all types of systems falling in one of the above-
mentioned categories.
If the ambulatory electrocardiographic system offers automatic ECG analysis, minimal
performance requirements for measurement and analysis functions apply. Medical electrical
equipment covered by IEC 60601-2-25 and IEC 60601-2-27 are excluded from the scope of this
standard.
This standard does not apply to systems that do not continuously record and analyse the ECG
(for example, ‘intermittent event recorders’).
1.2 Object
Replacement:
The object of this Particular Standard is to establish particular requirements for the safety,
including essential performance, of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS.

– 8 – 60601-2-47 © IEC:2001(E)
1.3 Particular Standards
Addition:
This Particular Standard refers to IEC 60601-1 (1988): Medical electrical equipment – Part 1:
General requirements for safety, as amended by its amendment 1 (1991) and its amendment 2
(1995).
For brevity, IEC 60601-1 is referred to in this Particular Standard either as the General
Standard including its collateral standards or as the General Requirement(s).
The numbering of sections and subclauses of this Particular Standard corresponds to that of
the General Standard. Changes to the text of the General Standard are specified by the
following words:
‘Replacement’ means that the clause or subclause of the General 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.
‘Amendment’ means
...

IEC 60601-2-47
Edition 1.0 2001-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-47: Particular requirements for the safety, including essential
performance, of ambulatory electrocardiographic systems

Appareils électromédicaux –
Partie 2-47: Règles particulières de sécurité et performances essentielles des
systèmes d’électrocardiographie ambulatoires

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IEC 60601-2-47
Edition 1.0 2001-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-47: Particular requirements for the safety, including essential
performance, of ambulatory electrocardiographic systems

Appareils électromédicaux –
Partie 2-47: Règles particulières de sécurité et performances essentielles des
systèmes d’électrocardiographie ambulatoires

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
X
CODE PRIX
ICS 11.040.55 ISBN 2-8318-8583-3
– 2 – 60601-2-47 © CEI:2001
SOMMAIRE
AVANT-PROPOS .8
INTRODUCTION.12

SECTION UN – GÉNÉRALITÉS
1 Domaine d’application et objet .14
1.1 Domaine d'application.14
1.2 Objet.14
1.3 Normes Particulières .16
1.5 Normes Collatérales.16
*2 Terminologie et définitions .16
5 Classification.20
6 Identification, marquage et documentation .20
6.1 Marquage sur l’extérieur des APPAREILS ou des parties d’APPAREIL .20
6.8.2 Instructions d’utilisation.20

SECTION DEUX – CONDITIONS D'ENVIRONNEMENT
*10 Conditions d'environnement .22
10.2.1 Environnement.22

SECTION TROIS – PROTECTION CONTRE LES RISQUES DE CHOCS ÉLECTRIQUES
20 Tension de tenue .24
20.2 Exigences pour les APPAREILS comportant une PARTIE APPLIQUEE .24
20.3 Valeurs des tensions d'essai.24

SECTION QUATRE – PROTECTION CONTRE LES RISQUES MÉCANIQUES
21 Résistance mécanique.24

SECTION CINQ – PROTECTION CONTRE LES RISQUES DUS
AUX RAYONNEMENTS NON DÉSIRÉS OU EXCESSIFS
*36 COMPATIBILITE ELECTROMAGNETIQUE.26
36.201 Emissions .26
36.201.1 Emissions de fréquences radioélectriques .26
36.202 Immunité.26
*36.202.1 Décharge électrostatique .28
*36.202.2 Champs électromagnétiques à fréquences radioélectriques
rayonnés.28
36.202.6 Champs magnétiques .28

SECTION SIX – PROTECTION CONTRE LES RISQUES D’IGNITION
DE MÉLANGES ANESTHÉSIQUES INFLAMMABLES

SECTION SEPT – PROTECTION CONTRE LES TEMPÉRATURES EXCESSIVES
ET AUTRES RISQUES
60601-2-47 © IEC:2001 – 3 –
CONTENTS
FOREWORD.9
INTRODUCTION.13

SECTION ONE – GENERAL
1 Scope and object .15
1.1 Scope.15
1.2 Object.15
1.3 Particular Standards .17
1.5 Collateral Standards .17
*2 Terminology and definitions .17
5 Classification.21
6 Identification, marking and documents .21
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts .21
6.8.2 Instructions for use .21

SECTION TWO – ENVIRONMENTAL CONDITIONS
*10 Environmental conditions .23
10.2.1 Environment.23

SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
20 Dielectric strength.25
20.2 Particular requirements for EQUIPMENT with an APPLIED PART.25
20.3 Values of test voltages.25

SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength.25

SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
*36 ELECTROMAGNETIC COMPATIBILITY .27
36.201 Emissions .27
36.201.1 Radio frequency (RF) emissions.27
36.202 Immunity.27
*36.202.1 Electrostatic discharge .29
*36.202.2 Radiated radio-frequency electromagnetic fields.29
36.202.6 Magnetic fields.29

SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES

SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
– 4 – 60601-2-47 © CEI:2001
SECTION HUIT – PRÉCISION DES CARACTÉRISTIQUES DE FONCTIONNEMENT
ET PROTECTION CONTRE LES CARACTÉRISTIQUES DE SORTIE
PRÉSENTANT DES RISQUES
50 Précision des caractéristiques de fonctionnement .30
*50.101 Analyse automatisée.30
*50.101.1 Bases de données normalisées à utiliser pour évaluer les
analyses automatisées.30
*50.101.2 Exigences concernant les rapports de performance.30
*50.101.3 Rapport médical – exigences minimales .44
* 51 Protection contre les caractéristiques de sortie présentant des risques.46
*51.5 Sortie incorrecte .46
*51.5.1 Plage dynamique des entrées .46
*51.5.2 Impédance d'entrée.48
*51.5.3 Réjection de mode commun .50
*51.5.4 Précision du gain .52
*51.5.5 Stabilité du gain .52
*51.5.6 Etalonnage d'amplitude .52
*51.5.7 Bruit du système .52
*51.5.8 Diaphonie entre plusieurs voies.54
*51.5.9 Réponse en fréquence .54
*51.5.10 Dimension minimale des détails .
...