IEC 60601-2-4:2002

Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators

Specifies requirements for the safety of cardiac defibrillators. The requirements are followed by specifications for the relevant tests.

Appareils électromédicaux - Partie 2-4: Règles particulières de sécurité pour les défibrillateurs cardiaques

Spécifie les exigences de sécurité relatives aux défibrillateurs cardiaques. Les exigences sont suivies par les modalités d'essai correspondantes.

General Information

• Status: Published
• Publication Date: 21-Aug-2002
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 08-Dec-2010

Relations

• Corrected By: IEC 60601-2-4:2002/COR1:2004 - Corrigendum 1 - Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators
• Effective Date: 05-Sep-2023
• Revised: IEC 60601-2-4:2010 - Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
60601-2-4
Second edition
2002-08
Medical electrical equipment –
Part 2-4:
Particular requirements for the safety
of cardiac defibrillators
Appareils électromédicaux –
Partie 2-4:
Règles particulières de sécurité
pour les défibrillateurs cardiaques

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
60601-2-4
Second edition
2002-08
Medical electrical equipment –
Part 2-4:
Particular requirements for the safety
of cardiac defibrillators
Appareils électromédicaux –
Partie 2-4:
Règles particulières de sécurité
pour les défibrillateurs cardiaques

 IEC 2002  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
XA
International Electrotechnical Commission
Международная Электротехническая Комиссия
For price, see current catalogue

– 2 – 60601-2-4  IEC:2002(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
*5 Classification .11
6 Identification, marking and documents.11
SECTION TWO – ENVIRONMENTAL CONDITIONS
10 Environmental conditions .16
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification .16
*17 Separation .16
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS.18
*20 Dielectric strength .19
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
*36 Electromagnetic compatibility (EMC) .21
SECTION SIX– PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
OTHER SAFETY HAZARDS
*42 Excessive temperatures .24
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility.24
46 Human errors.25
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION AGAINST
HAZARDOUS OUTPUT
*50 Accuracy of operating data .26
51 Protection against hazardous output.26

60601-2-4 © IEC:2002(E) – 3 –
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;

ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions .27

SECTION TEN – CONSTRUCTIONAL REQUIREMENTS

*56 Components and general assembly.27

57 MAINS PARTS, components and layout .29

SECTION 101 – ADDITIONAL REQUIREMENTS RELATING TO SAFETY

*101 Charging time.29
102 Internal electrical power source .32
*103 Endurance.34
*104 Synchronizer .35
*105 Recovery of the MONITOR/ECG INPUT after defibrillation .35
*106 Disturbance to the monitor from charging or internal discharging .36
Appendix L References – Publications mentioned in this Standard .43
Annex AA (informative) General guidance and rationale.44
Annex BB (informative) AUTOMATED EXTERNAL DEFIBRILLATORS: background and
rationale.54

– 4 – 60601-2-4  IEC:2002(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-4: Particular requirements for the safety of

cardiac defibrillators
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
with the IEC also participate in this preparation. The 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 the 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 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 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 60601-2-4 has been prepared by sub-committee 62D: Electro-
medical equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This second edition of IEC 60601-2-4 cancels and replaces the first edition published in 1983
of which it constitutes a technical revision.
The text of this standard is based on the following documents:

FDIS Report on voting
62D/455/FDIS 62D/460/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.
Annexes AA and BB are for information only.

60601-2-4 © IEC:2002(E) – 5 –
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: smaller type;

– test specifications, headings of subclauses and headings of items: 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

2007-08. At this date, the publication will be

• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
The contents of the corrigendum of April 2004 have been included in this copy.

– 6 – 60601-2-4  IEC:2002(E)
INTRODUCTION
This Particular Standard concerns the safety of CARDIAC DEFIBRILLATORS. It amends and

supplements IEC 60601-1 (second edition, 1988): Medical electrical equipment – Part 1:

General requirements for safety, including its amendments 1 (1991) and 2 (1995), hereinafter

referred to as the General Standard.

A first edition of this Particular Standard, based on the first edition (1977) of IEC 60601-1 was

published in 1983. The aim of this second edition is to bring this Particular Standard up to date

with reference to the publications and documents mentioned above through minor changes to

the technical content.
The requirements are followed by specifications for the relevant tests.
A rationale for the more important requirements, where appropriate, is given in Annex AA. It is
considered that a knowledge of the reasons for these requirements will not only facilitate the
proper application of this Particular 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.
Clauses and subclauses for which a corresponding rationale statement is given in Annex AA
are marked with an asterisk * before their number in the text.

60601-2-4 © IEC:2002(E) – 7 –
MEDICAL ELECTRICAL EQUIPMENT
Part 2: Particular requirements for the safety of

cardiac defibrillators
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 requirements for the safety of CARDIAC DEFIBRILLATORS as
defined in 2.1.101, hereinafter referred to as EQUIPMENT.
This Particular Standard does not apply to implantable defibrillators, remote control DEFIBRIL-
LATORS, external transcutaneous pacemakers, or separate stand alone CARDIAC MONITORS
(which are standardized by IEC 60601-2-27). Cardiac monitors which use separate ECG
monitoring electrodes are not within the scope of this standard unless they are used as the sole
basis for AED rhythm recognition detection or beat detection for synchronized cardioversion.
Defibrillation waveform technology is evolving rapidly. Published studies indicate that the
effectiveness of waveforms varies. The choice of a particular waveform including waveshape,
delivered energy, efficacy, and safety has been specifically excluded from the scope of this
standard.
However, due to the critical importance of the therapeutic waveform, comments have been
added to the rationale which address considerations in waveform selection.
1.2 Object
Replacement:
The object of this Particular Standard is to establish particular requirements for the safety of
CARDIAC DEFIBRILLATOR
...

IEC 60601-2-4
Edition 2.0 2002-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-4: Particular requirements for the safety of cardiac defibrillators

Appareils électromédicaux –
Partie 2-4: Règles particulières de sécurité pour les défibrillateurs cardiaques

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IEC 60601-2-4
Edition 2.0 2002-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-4: Particular requirements for the safety of cardiac defibrillators

Appareils électromédicaux –
Partie 2-4: Règles particulières de sécurité pour les défibrillateurs cardiaques

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XA
CODE PRIX
ICS 11.040.10 ISBN 2-8318-8208-7
– 2 – 60601-2-4 © CEI:2002
SOMMAIRE
AVANT-PROPOS .6

INTRODUCTION.10

SECTION UN – GÉNÉRALITÉS
1 Domaine d’application et objet .12
2 Terminologie et définitions .14
4 Exigences générales pour les essais.20
*5 Classification .20
6 Identification, marquage et documentation .22

SECTION DEUX – CONDITIONS D’ENVIRONNEMENT

10 Conditions d'environnement.32

SECTION TROIS – PROTECTION CONTRE LES RISQUES
DE CHOCS ELECTRIQUES
14 Exigences relatives à la classification .32
*17 Séparation .34
19 COURANTS DE FUITE permanents et COURANTS AUXILIAIRES PATIENT .36
* 20 Tension de tenue .38

SECTION QUATRE – PROTECTION CONTRE LES RISQUES MECANIQUES

SECTION CINQ – PROTECTION CONTRE LES RISQUES
DUS AUX RAYONNEMENTS NON DESIRES OU EXCESSIFS

*36 Compatibilité électromagnétique (CEM).44

SECTION SIX – PROTECTION CONTRE LES DANGERS D’ALLUMAGE
DE MÉLANGES ANESTHÉSIQUES INFLAMMABLES

SECTION SEPT – PROTECTION CONTRE LES TEMPÉRATURES EXCESSIVES
ET LES AUTRES RISQUES
*42 Températures excessives .48
44 Débordement, renversement, fuites, humidité, pénétration de liquides, nettoyage,
stérilisation, désinfection et compatibilité .50
46 Erreurs humaines .52

60601-2-4 © IEC:2002 – 3 –
CONTENTS
FOREWORD.7

INTRODUCTION.11

SECTION ONE – GENERAL
1 Scope and object .13
2 Terminology and definitions .15
4 General requirements for tests.21
*5 Classification.21
6 Identification, marking and documents .23

SECTION TWO – ENVIRONMENTAL CONDITIONS

10 Environmental conditions .33

SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification .33
*17 Separation .35
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS.37
*20 Dielectric strength.39

SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS

SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
*36 Electromagnetic compatibility (EMC) .45

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

SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
*42 Excessive temperatures.49
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility .51
46 Human errors.53

– 4 – 60601-2-4 © CEI:2002
SECTION HUIT – PRECISION DES CARACTERISTIQUES DE FONCTIONNEMENT ET

PROTECTION CONTRE LES CARACTÉRISTIQUES DE SORTIE DANGEREUSES

*50 Précision des caractéristiques de fonctionnement .54

51 Protection contre les caractéristiques de sortie dangereuses.54

SECTION NEUF – FONCTIONNEMENT ANORMAL ET CONDITIONS DE DÉFAUT;
ESSAIS D’ENVIRONNEMENT
52 Fonctionnement anormal et conditions de défaut .56

SECTION DIX – REGLES DE CONSTRUCTION

* 56 Composants et ensembles .56
57 PARTIES RELIEES AU RESEAU, composants et montage.60

SECTION 101 – EXIGENCES COMPLEMENTAIRES RELATIVES A LA SECURITE

* 101 Temps de charge .62
102 Source électrique interne .66
* 103 Endurance .72
*104 SYNCHRONISEUR .74
*105 Rétablissement du MONITEUR/de l'entrée ECG après une défibrillation.74
* 106 Perturbations du MONITEUR dues à la charge ou à la décharge interne .76

Annexe L Références – Publications mentionnées dans la présente norme.88
Annexe AA (informative) Guide général et justifications .90
Annexe BB (informative) DEFIBRILLATEURS EXTERNES AUTOMATIQUES: contexte et
justification . 112

60601-2-4 © IEC:2002 – 5 –
SECTION EIGHT – ACCURACY OF OPERATING DATA

AND PROTECTION AGAINST HAZARDOUS OUTPUT

*50 Accuracy of operating data.55

51 Protection against hazardous output .55

SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions.57

SECTION TEN – CONSTRUCTIONAL REQUIREMENTS

*56 Components and general assembly.57
57 MAINS PARTS, components and layout.61

SECTION 101 – ADDITIONAL REQUIREMENTS RELATING TO SAFETY

*101 Charging time .63
102 Internal electrical power source.67
*103 Endurance .73
*104 Synchronizer.75
*105 Recovery of the MONITOR/ECG INPUT after defibrillation.75
*106 Disturbance to the monitor from charging or internal discharging .77

Appendix L References – Publications mentioned in this Sta
...