EN 60601-2-4:2003

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

Specifies requirements for the safety of cardiac defibrillators.

Medizinische elektrische Geräte - Teil 2-4: Besondere Festlegungen für die Sicherheit von Defibrillatoren

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

Medicinska električna oprema - 2-4. del: Posebne varnostne zahteve za srčne defibrilatorje (IEC 60601-2-4:2002)

General Information

• Status: Withdrawn
• Publication Date: 30-Jan-2003
• Withdrawal Date: 30-Sep-2005
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation 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: 12-Jan-2014
• Completion Date: 12-Jan-2014
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to 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 60601-2-4:2003 - Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators (IEC 60601-2-4:2002)

Relations

• Replaces: HD 395.2.4 S1:1988 - Medical electrical equipment - Part 2: Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors
• Effective Date: 28-Jan-2023
• Replaced By: EN 60601-2-4:2011 - Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2003
1DGRPHãþD
SIST HD 395.2.4 S1:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]DVUþQH
GHILEULODWRUMH,(&
Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac
defibrillators (IEC 60601-2-4:2002)
Medizinische elektrische Geräte - Teil 2-4: Besondere Festlegungen für die Sicherheit
von Defibrillatoren (IEC 60601-2-4:2002)
Appareils électromédicaux - Partie 2-4: Règles particulières de sécurité pour les
défibrillateurs cardiaques (CEI 60601-2-4:2002)
Ta slovenski standard je istoveten z: EN 60601-2-4:2003
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-4
NORME EUROPÉENNE
EUROPÄISCHE NORM January 2003

ICS 11.040.10 Supersedes HD 395.2.4 S1:1988

English version
Medical electrical equipment
Part 2-4: Particular requirements for the safety of cardiac defibrillators
(IEC 60601-2-4:2002)
Appareils électromédicaux Medizinische elektrische Geräte
Partie 2-4: Règles particulières de Teil 2-4: Besondere Festlegungen für die
sécurité pour les défibrillateurs cardiaques Sicherheit von Defibrillatoren
(CEI 60601-2-4:2002) (IEC 60601-2-4:2002)

This European Standard was approved by CENELEC on 2002-10-01. 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, 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 60601-2-4:2003 E
Foreword
The text of document 62D/455/FDIS, future edition 2 of IEC 60601-2-4, prepared by the Technical
Committee CENELEC TC 62, Electrical equipment in medical practice, was submitted to the
IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-4 on 2002-10-01.

This European Standard supersedes HD 395.2.4 S1:1988.

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) 2003-08-01

– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2005-10-01

In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– explanations, advice, notes, general statements and exceptions: smaller roman type;
– test specifications: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL
CAPITALS.
Annexes designated "normative" are part of the body of the standard.
Annexes designated "informative" are given for information only.
In this standard, annex ZA is normative and annexes AA, BB and ZB are informative.
Annexes ZA and ZB have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-4:2002 was approved by CENELEC as a European
Standard without any modification.
__________
- 3 - EN 60601-2-4:2003
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
1)
IEC 60300-3-9 - Dependability management - -
Part 3: Application guide –
Section 9: Risk analysis of technological
systems
1)
2)
IEC 60651 - Sound level meters EN 60651 1994

1) 2)
IEC 61000-4-2 - Electromagnetic compatibility (EMC) EN 61000-4-2 1995
Part 4-2: Testing and measurement
techniques - Electrostatic discharge
immunity test
1) 2)
IEC 61000-4-3 - Part 4-3: Testing and measurement EN 61000-4-3 2002
techniques - Radiated, radio-frequency,
electromagnetic field immunity test

1) 2)
IEC 61000-4-4 - Part 4-4: Testing and measurement EN 61000-4-4 1995
techniques - Electrical fast
transient/burst immunity test
1) 2)
IEC 61000-4-5 - Part 4-5: Testing and measurement EN 61000-4-5 1995
techniques - Surge immunity test

1) 2)
IEC 61000-4-6 - Part 4-6: Testing and measurement EN 61000-4-6 1996
techniques - Immunity to conducted
disturbances, induced by radio-
frequency fields
1) 2)
IEC 61000-4-8 - Part 4-8: Testing and measurement EN 61000-4-8 1993
techniques - Power frequency magnetic
field immunity test
1)
Undated reference.
2)
Valid edition at date of issue.

Annex ZB
(informative)
Other international publications mentioned in this standard
with the references of the European publications
Publication Year Title EN/HD Year

1) 2)
IEC 60601-2-27 - Medical electrical equipment EN 60601-2-27 1994
Part 2: Particular requirements for the
safety of electrocardiographic
monitoring equipment
1)
Undated reference.
2)
Valid edition at date of issue.

NORME CEI
INTERNATIONALE
IEC
60601-2-4
INTERNATIONAL
Deuxième édition
STANDARD
Second edition
2002-08
Appareils électromédicaux –
Partie 2-4:
Règles particulières de sécurité
pour les défibrillateurs cardiaques

Medical electrical equipment –
Part 2-4:
Particular requirements for the safety
of cardiac defibrillators
 IEC 2005 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
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électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
microfilms, sans l'accord écrit de l'éditeur. the publisher.
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Telephone: [phone] Telefax: [phone] E-mail: [e-mail] Web: www.iec.ch
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For price, see current catalogue

60601-2-4  IEC:2005 – 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

60601-2-4  IEC:2005 – 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 Standard.89
Annex AA (informative) General guidance and rationale.91
Annex BB (informative) AUTOMATED EXTERNAL DEFIBRILLATORS: background and
rationale. 113

60601-2-4  IEC:2005 – 7 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-4: Particular requirements for the safety of
cardiac defibrillators
FOREWORD
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