IEC 60601-2-4:2010

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

IEC 60601-2-4:2010 establishes particular basic safety and essential performance requirements for cardiac defibrillators. This third edition cancels and replaces the second edition published in 2002. This edition constitutes a technical revision, revised to structurally align it with IEC 60601-1:2005 and to implement the decision of IEC SC 62A that the clause numbering structure of particular standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes.

Appareils électromédicaux - Partie 2-4: Exigences particulières pour la sécurité de base et les performances essentielles des défibrillateurs cardiaques

La CEI 60601-2-4:2010 établit des exigences particulières de sécurité de base et de performances essentielles pour les défibrillateurs cardiaques. Cette troisième édition annule et remplace la deuxième édition publiée en 2002. La présente édition constitue une révision technique dont la structure est alignée sur la CEI 60601-1:2005, et est destinée à mettre en oeuvre la décision du SC 62A de la CEI selon laquelle la structure de numérotation des articles des normes particulières rédigées selon la CEI 60601-1:2005 respecterait la forme spécifiée dans les directives ISO/CEI, partie 2:2004. Cette troisième édition est destinée à mettre à jour la présente norme particulière par rapport à la troisième édition de la norme générale par une nouvelle mise en forme et des modifications techniques.

General Information

• Status: Published
• Publication Date: 07-Dec-2010
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 19 - TC 62/SC 62D/MT 19
• Current Stage: PPUB - Publication issued
• Start Date: 15-Dec-2010
• Completion Date: 08-Dec-2010

Relations

• Amended By: IEC 60601-2-4:2010/AMD1:2018 - Amendment 1 - Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-4:2002 - Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators
• Effective Date: 05-Sep-2023
• Revises: 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

Standards Content (Sample)

IEC 60601-2-4 ®
Edition 3.0 2010-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-4: Particular requirements for the basic safety and essential performance
of cardiac defibrillators
Appareils électromédicaux –
Partie 2-4: Exigences particulières pour la sécurité de base et les performances
essentielles des défibrillateurs cardiaques

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.

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International Standards for all electrical, electronic and related technologies.

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IEC 60601-2-4 ®
Edition 3.0 2010-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-4: Particular requirements for the basic safety and essential performance
of cardiac defibrillators
Appareils électromédicaux –
Partie 2-4: Exigences particulières pour la sécurité de base et les performances
essentielles des défibrillateurs cardiaques

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XC
CODE PRIX
ICS 11.040.10 ISBN 978-2-88912-254-7
– 2 – 60601-2-4 Ó IEC:2010
CONTENTS
FOREW ORD . 4
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 11
201.5 General requirements for testing of ME EQUIPMENT. 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17
201.9 Protection against MECAHNICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 23
201.10 Protection against unwanted and excessive radiation HAZARDS . 23
201.11 Protection against excessive temperatures and other HAZARDS . 23
201.12 * Accuracy of controls and instruments and protection against hazardous
outputs . 25
201.13 HAZARDOUS SITUATIONS and fault conditions . 27
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 27
201.15 Construction of ME EQUIPMENT . 27
201.16 ME SYSTEMS . 32
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 32
201.101 * Charging time . 32
201.102 Internal electrical power source . 35
201.103 * Endurance . 36
201.104 * Synchronizer . 37
201.105 * Recovery of the MONITOR and/or ECG input after defibrillation . 37
201.106 * Disturbance to the MONITOR from charging or internal discharging . 41
201.107 * Requirements for RHYTHM RECOGNITION DETECTOR . 42
201.108 DEFIBRILLATOR ELECTRODES . 43
201.109 * External pacing (U.S.) . 45
202 * Electromagnetic compatibility – Requirements and tests . 49
Annexes . 52
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 53
Annex AA (informative) Particular guidance and rationale . 55
Annex BB (informative) Mapping between the elements of the second edition of
IEC 60601-2-4 and IEC 60601-2-4:2010 . 68
Bibliography . 73
Index of defined terms used in this particular standard . 74

Figure 201.101 – Dynamic test for limitation of energy from different parts of the
ME EQUIPMENT . 18
Figure 201.102 – Allowed current versus applied test voltage . 22
Figure 201.103 – Examples of cord anchorages that require testing . 31
Figure 201.104 – Test apparatus for flexible cords and their anchorages. 32

60601-2-4 Ó IEC:2010 – 3 –
Figure 201.105 – Arrangement for test of recovery after defibrillation . 39
Figure 201.106 – Arrangement of monitoring electrodes on sponge . 40
Figure 201.107 – Arrangement for recovery test after defibrillation . 40
Figure 201.108 – Arrangement for test of disturbance from charging and internal
discharging . 42
Figure 201.109 – Test circuit for offset instability/internal noise determination . 49
Figure 201.110 – Test circuit for DEFIBRILLATOR overload test of pacing output circuitry. 49

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 12
Table 201.102 – Rhythm recognition detector categories . 42
Table 201.C.101 – Marking on the outside of a CARDIAC DEFIBRILLATOR or its parts . 53
Table 201.C.102 – Marking of controls and instruments of a CARDIAC DEFIBRILLATOR . 53
Table 201.C.103 – ACCOMPANYING DOCUMENTS, general . 53
Table 201.C.104 – ACCOMPANYING DOCUMENTS, instructions for use . 54
Table 201.C.105 – ACCOMPANYING DOCUMENTS, technical description . 54
Table BB.1 – Mapping between the elements of the second edition of IEC 60601-2-4
and IEC 60601-2-4:2010 . 68

– 4 – 60601-2-4 Ó IEC:2010
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-4: Particular requirements for the basic safety
and essential performance of cardiac defibrillators

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
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...

IEC 60601-2-4 ®
Edition 3.1 2018-02
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-4: Particular requirements for the basic safety and essential performance
of cardiac defibrillators
Appareils électromédicaux –
Partie 2-4: Exigences particulières pour la sécurité de base et les performances
essentielles des défibrillateurs cardiaques

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 l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
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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.

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Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

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IEC 60601-2-4 ®
Edition 3.1 2018-02
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 2-4: Particular requirements for the basic safety and essential performance

of cardiac defibrillators
Appareils électromédicaux –
Partie 2-4: Exigences particulières pour la sécurité de base et les performances

essentielles des défibrillateurs cardiaques

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.10 ISBN 978-2-8322-5413-4

IEC 60601-2-4 ®
Edition 3.1 2018-02
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 2-4: Particular requirements for the basic safety and essential performance
of cardiac defibrillators
Appareils électromédicaux –
Partie 2-4: Exigences particulières pour la sécurité de base et les performances
essentielles des défibrillateurs cardiaques

– 2 – IEC 60601-2-4:2010+AMD1:2018 CSV
 IEC 2018
CONTENTS
FOREWORD . 4
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
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 . 17
201.9 Protection against MECAHNICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 24
201.10 Protection against unwanted and excessive radiation HAZARDS . 24
201.11 Protection against excessive temperatures and other HAZARDS . 24
201.12 * Accuracy of controls and instruments and protection against hazardous
outputs . 26
201.13 HAZARDOUS SITUATIONS and fault conditions . 28
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 28
201.15 Construction of ME EQUIPMENT . 28
201.16 ME SYSTEMS . 33
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 33
201.101 * Charging time . 33
201.102 INTERNAL ELECTRICAL POWER SOURCE . 36
201.103 * Endurance . 38
201.104 * SYNCHRONIZER . 38
201.105 * Recovery of the MONITOR and/or ECG input after defibrillation . 39
201.106 * Disturbance to the MONITOR from charging or internal discharging . 43
201.107 * Requirements for RHYTHM RECOGNITION DETECTOR . 44
201.108 DEFIBRILLATOR ELECTRODES . 45
201.109 * External pacing (U.S.) . 47
202 * Electromagnetic compatibility – Requirements and tests . 52
Annexes . 54
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 55
Annex AA (informative) Particular guidance and rationale . 57
Annex BB (informative) Mapping between the elements of the second edition of
IEC 60601-2-4 and IEC 60601-2-4:2010 . 73
Bibliography . 78
Index of defined terms used in this particular standard. 79

Figure 201.101 – Dynamic test for limitation of energy from different parts of the
ME EQUIPMENT . 19
Figure 201.102 – Allowed current versus applied test voltage . 23
Figure 201.103 – Examples of cord anchorages that require testing . 32
Figure 201.104 – Test apparatus for flexible cords and their anchorages . 33

 IEC 2018
Figure 201.105 – Arrangement for test of recovery after defibrillation . 41
Figure 201.106 – Arrangement of monitoring electrodes on sponge . 42
Figure 201.107 – Arrangement for recovery test after defibrillation . 42
Figure 201.108 – Arrangement for test of disturbance from charging and internal
discharging . 44
Figure 201.109 – Test circuit for offset instability/internal noise determination .
Figure 201.110 – Test circuit for DEFIBRILLATOR overload test of pacing output circuitry . 52
Figure AA.1 – Simulated PATIENT Load . 71

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 12
Table 201.102 – RHYTHM RECOGNITION DETECTOR CATegories . 44
Table 201.C.101 – Marking on the outside of a CARDIAC DEFIBRILLATOR or its parts. 55
Table 201.C.102 – Marking of controls and instruments of a CARDIAC DEFIBRILLATOR . 55
Table 201.C.103 – ACCOMPANYING DOCUMENTS, general . 55
Table 201.C.104 – ACCOMPANYING DOCUMENTS, instructions for use . 56
Table 201.C.105 – ACCOMPANYING DOCUMENTS, technical description . 56
Table BB.1 – Mapping between the elements of the second edition of IEC 60601-2-4
and IEC 60601-2-4:2010 . 73

– 4 – IEC 60601-2-4:2010+AMD1:2018 CSV
 IEC 2018
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-4: Particular requirements for the basic safety
and essential performance of cardiac defibrillators
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Comm
...