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
• Start Date: 08-Dec-2010
• Completion Date: 13-Feb-2026

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

Overview

IEC 60601-2-4:2002 is the IEC Particular Standard that defines safety requirements and test specifications for cardiac defibrillators - medical electrical equipment intended to defibrillate the heart using external or internal electrodes. It supplements and modifies the general safety rules of IEC 60601-1 and is the authoritative reference for functional and electrical safety, performance testing and risk reduction for external and automated external defibrillators (AEDs). The standard does not cover implantable defibrillators, remote-control defibrillators, external transcutaneous pacemakers, or separate stand‑alone cardiac monitors except where they form the sole basis for AED rhythm recognition.

Key topics and technical requirements

The standard addresses particular requirements (with accompanying test specifications) including:

• Electrical safety and patient protection
  • Continuous leakage currents and patient auxiliary currents
  • Dielectric strength and separation requirements between circuits and patient connections
• Energy storage, charging and discharge
  • Charging circuit and charging time requirements
  • Discharge circuit, discharge control and internal discharge circuits
  • Endurance of energy storage devices
• Functional safety and outputs
  • Protection against hazardous output and accuracy of operating data
  • Synchronizer functionality for synchronized cardioversion
  • Recovery of monitor/ECG input after defibrillation and disturbance limits during charging/discharge
• Environmental, mechanical and thermal protection
  • Environmental conditions, ingress of liquids, overflow/spillage, excessive temperature limits
• Electromagnetic compatibility (EMC)
  • EMC requirements and tests to reduce interference with monitoring and other equipment
• Hazard management
  • Abnormal operation, fault conditions and human error mitigation
• Construction and components
  • Requirements for components, mains parts and layout, plus related test protocols
• Documentation and labeling
  • Identification, marking and user documentation requirements

The standard includes informative annexes (e.g., Annex AA rationale and Annex BB on AED background) to explain intent and aid application.

Practical applications

IEC 60601-2-4 is used to:

• Guide design and development of external defibrillators and AEDs to meet internationally accepted safety criteria
• Define test protocols for product verification and conformity assessment
• Support regulatory submissions, CE marking and compliance testing
• Inform clinical engineering, procurement and hospital safety assessments

Who should use this standard

• Medical device manufacturers and design engineers (defibrillator and AED developers)
• Compliance and regulatory affairs professionals
• Test laboratories and certification bodies
• Clinical engineers, hospital procurement and risk managers
• Standards writers and technical consultants in medical device safety

Related standards

• IEC 60601-1 (General requirements for safety)
• IEC 60601-1-2 (EMC)
• IEC 60601-1-1 (Medical electrical systems)
• IEC 60601-1-4 (Programmable electrical medical systems)

Keywords: IEC 60601-2-4, cardiac defibrillators, AED standard, medical electrical equipment safety, defibrillator testing, IEC 60601-1.

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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thus ensuring that the content reflects current technology. Information relating to
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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 DEFIBRILLATORS as defined in 2.1.101.
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 amendment 2
(1995).
For brevity, Part 1 is referred to in this Particular Standard either as the “General Standard” or
as the “General Requirement(s)”.

– 8 – 60601-2-4  IEC:2002(E)
The numbering of sections, clauses and subclauses of this Particular Standard corresponds

with that of the General Standard. The changes to the text of the General Standard are

specified by the use of 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 that the clause or subclause of the General Standard is amended as

indicated by the text of this Particular Standard.
Subclauses or figures which are additional to those of the General Standard are numbered
starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb),
etc.
The term “this Standard” is used to make reference to the General Standard and this Particular
Standard taken together.
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause of the General Standard, although possibly not relevant, applies
without modification.
Where it is intended that any part of the General Standard, although possibly relevant, is not to
be applied, a statement to that effect is given in this Particular Standard.
The requirements of this Particular Standard take priority over those of the General Standard.
1.5 Collateral Standards
Addition:
The following Collateral Standards apply:
IEC 60601-1-1:2000, Medical electrical equipment – Part 1-1: General requirements for safety
– Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-2:2001, Medical electrical equipment – Part 1-2: General requirements for safety
– Collateral standard: Electromagnetic compatibility – Requirements and tests

IEC 60601-1-4:1996, Medical electrical equipment – Part 1: General requirements for safety –
4. Collateral Standard: Programmable electrical medical systems
2 Terminology and definitions
This clause of the General Standard applies except as follows:
Additional definitions:
2.1.101
CARDIAC DEFIBRILLATOR
MEDICAL ELECTRICAL EQUIPMENT intended to defibrillate the heart by an electrical pulse via
electrodes applied either to the PATIENT's skin (external electrodes) or to the exposed heart
(internal electrodes). May be referred to as DEFIBRILLATOR or EQUIPMENT
NOTE Such EQUIPMENT may also include other monitoring or therapeutic functions.

60601-2-4 © IEC:2002(E) – 9 –
2.1.102
MONITOR
part of a DEFIBRILLATOR providing a visual display of the electrical activity of the PATIENT’s heart

NOTE The term is used within this Particular Standard to distinguish such a MONITOR from one which forms a

separate EQUIPMENT in its own right even in cases where the separate stand-alone monitor is able to provide

synchronization signals to the DEFIBRILLATOR, used as basis for AED rhythm recognition detection or providing
control signals to the DEFIBRILLATOR.

2.1.103
CHARGING CIRCUIT
circuit within the DEFIBRILLATOR intended for charging the ENERGY STORAGE DEVICE. This circuit

includes all parts conductively connected to the ENERGY STORAGE DEVICE during the charging

period
2.1.104
DEFIBRILLATOR ELECTRODES
electrodes intended to deliver an electrical pulse to the PATIENT for the purpose of cardiac
defibrillation
NOTE DEFIBRILLATOR ELECTRODES may also provide other monitoring (e.g. ECG acquisition) or therapeutic (e.g.
transcutaneous pacing) functions and may be disposable or reusable.
2.1.105
DISCHARGE CIRCUIT
circuit within the DEFIBRILLATOR which connects the ENERGY STORAGE DEVICE to the
DEFIBRILLATOR ELECTRODES. This circuit includes all switching connections between that device
and the DEFIBRILLATOR ELECTRODES
2.1.106
DISCHARGE CONTROL CIRCUIT
circuit including the manually operated discharge controls and all parts conductively connected
to them
2.1.107
INTERNAL DISCHARGE CIRCUIT
circuit within the DEFIBRILLATOR which discharges the ENERGY STORAGE DEVICE without
energizing the DEFIBRILLATOR ELECTRODES
2.1.108
SYNCHRONIZER
device allowing the DEFIBRILLATOR discharge to be synchronized with a specific phase of the
cardiac cycle
2.1.109
AUTOMATED EXTERNAL DEFIBRILLATOR (AED)
a DEFIBRILLATOR that, once activated by the OPERATOR, analyses the ECG obtained from
electrodes placed on the chest surface, identifies shockable cardiac rhythms, and automatically
operates the DEFIBRILLATOR when a shockable rhythm is detected, hereinafter referred to as an
AED
NOTE AEDs may provide varying levels of automation and be referred to by various terms. See Annex BB.
2.1.110
ENERGY STORAGE DEVICE
the component (for example a capacitor) that is charged with the energy necessary to deliver
an electrical defibrillation pulse to the PATIENT

– 10 – 60601-2-4  IEC:2002(E)

2.1.111
SEPARATE MONITORING ELECTRODES

electrodes applied to the PATIENT for the purpose of monitoring the PATIENT. These electrodes

are not used to apply defibrillation pulses to the PATIENT

2.1.112
RHYTHM RECOGNITION DETECTOR (RRD)

a system that analyzes the ECG and identifies whether a cardiac rhythm is shockable. The

algorithm in an AED is designed for sensitivity and specificity for the detection of arrythmias for

which a defibrillation shock is clinically indicated. May be referred to as RRD

2.12.101
DELIVERED ENERGY
energy which is delivered through the DEFIBRILLATOR ELECTRODES and dissipated in the PATIENT
or in a resistance of specified value
2.12.102
STAND-BY
mode of operation in which the EQUIPMENT is operational except that the ENERGY STORAGE
DEVICE is not yet charged
2.12.103
STORED ENERGY
energy which is stored in the DEFIBRILLATOR ENERGY STORAGE DEVICE
2.12.104
DUMMY COMPONENT
test replacement for moulded components like transformers, semiconductors etc. The DUMMY
COMPONENT has a geometry equal to that of the component it will replace during the test. The
moulded volume does not incorporate parts of the original components (ex-semiconductor dye,
transformer cores and windings). The DUMMY COMPONENT makes it possible to test creepage,
clearance and dielectric strength with the correct geometry without exceeding the internal
maximum voltage of the part being replaced
2.12.105
ENERGY METER / DEFIBRILLATOR TESTER
an INSTRUMENT capable of measuring the energy output from a CARDIAC DEFIBRILLATOR while
generating a simulated ECG output to the CARDIAC DEFIBRILLATOR
2.12.106
SELECTED ENERGY
energy which the defibrillator is intended to deliver, as determined by the setting of a manual

control or by an automatic protocol
2.12.107
FREQUENT USE
term used to describe a DEFIBRILLATOR designed to endure more than 2 500 discharges (see
103)
2.12.108
INFREQUENT USE
term used to describe a DEFIBRILLATOR designed to endure less than 2 500 discharges (see
103)
2.12.109
MANUAL DEFIBRILLATOR
DEFIBRILLATOR capable of being manually operated by the OPERATOR for selection of energy,
charging and discharging
60601-2-4 © IEC:2002(E) – 11 –

4 General requirements for tests

This clause of the General Standard applies except as follows:

*4.5 Ambient temperature, humidity, atmospheric pressure

Additional item:
aa)The test required in 102.2 and 102.3 shall be performed at an ambient temperature of

0 °C ± 2 °C.
4.6 Other conditions
Additional item:
aa) Unless otherwise specified in this Standard all tests apply to all kinds of defibrillator types
(manual, AED`s, infrequent use and frequent use defibrillators)
4.11 Sequence
Addition:
The endurance test required in Clause 103 shall be performed after the test for excessive
temperatures (see Clause C.20 of the General Standard).
The tests required in Clauses 101, 102, 104, 105 and 106 shall be performed after test C.35 of
Appendix C of the General Standard.
*5 Classification
This clause of the General Standard applies except as follows:
5.2 According to the degree of protection against electric shock:
Amendment:
Delete TYPE B APPLIED PART.
6 Identification, marking and documents

This clause of the General Standard applies except as follows:
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
*j) Power input
Replacement (paragraph beginning "If the rating of EQUIPMENT includes .".):
The RATED power input of mains operated EQUIPMENT shall be the maximum value attained by
averaging the power input over any period of 2 s.

– 12 – 60601-2-4  IEC:2002(E)

Additional items:
*aa) Concise operating instructions

Instructions for defibrillating, and where relevant, monitoring a PATIENT’S ECG, shall be

provided by means of either clearly legible markings, or clearly understandable auditory

commands.
Compliance shall be checked by either of the following tests:

Markings shall be clearly legible to a person of normal vision from a distance of 1 m in an

ambient illumination of 100 lux. The observer shall have a visual acuity of not less than 20/40

or corrected to not less than 20/40 as determined by a standard eye chart or by other
appropriate means, such as the Titmus Vision Test Series.
Auditory commands shall be clearly understandable to a person of normal hearing from a
distance of 1 m in an ambient white noise (defined as flat ±10 % over the range 100 Hz to
10 kHz) level of 65 dB, as measured with a Type 2 A-weighted sound level meter (see
IEC 60651).
*bb) Internally powered EQUIPMENT
INTERNALLY POWERED EQUIPMENT and any separate battery charger shall be marked with brief
instructions for, as appropriate, the re-charging or replacement of the battery.
In the case of such EQUIPMENT also capable of connection to the SUPPLY MAINS or to a separate
battery charger, the EQUIPMENT shall be marked to indicate any limitations of operation when
the EQUIPMENT is connected to the SUPPLY MAINS or to the battery charger. Such instructions
shall include the case of a discharged or missing battery.
cc) Disposable DEFIBRILLATOR electrodes
The labeling accompanying the electrode package shall include, at a minimum, the following
information:
1) symbols (in accordance with ISO 15223) or a statement indicating the date the electrodes
will expire (e.g., "use before ____") and the lot number or the date of manufacture;
2) appropriate cautions and warnings, including limits on duration of electrode application and
a caution that the unit package shall not be opened until immediately prior to use, if
applicable;
3) appropriate instructions for use, including procedures for skin preparation;
4) instructions concerning storage requirements, if applicable.

6.3 Marking of controls and INSTRUMENTS
Additional items:
*aa) The DEFIBRILLATOR shall be provided with a control for selection of the SELECTED ENERGY,
unless the EQUIPMENT provides an automatic protocol for the SELECTED ENERGY.
The SELECTED ENERGY (including any means for selection in a programming mode/menu)
or the relevant indicating means shall be expressed as the nominal DELIVERED ENERGY in
joules to a resistive load of 50 Ω.
The DEFIBRILLATOR shall give a clear indication of when the SELECTED ENERGY has been
reached.
Compliance shall be checked by inspection.

60601-2-4 © IEC:2002(E) – 13 –

6.8 Accompanying documents
6.8.2 Instructions for use
* items e), f), g), and h)
Replacement:
e) through h)
e) full details of the charging procedure for any rechargeable battery;

f) advice on the periodic replacement of any primary or rechargeable battery;
g) the number of maximum energy discharges (in the case of AEDs, the number of
preprogrammed discharges) which are available from a new and fully charged battery at
20 °C ambient temperature;
h) for EQUIPMENT also capable of connection to the SUPPLY MAINS or to a separate battery
charger, information on any limitations of operation when such a connection is made. This
information shall include the case of a discharged or missing battery.
Additional item:
aa) Supplementary instructions for use
The instructions for use shall additionally contain the following:
*1) a warning not to touch the PATIENT during defibrillation;
*2) a description of the correct type and method of handling the DEFIBRILLATOR ELECTRODES in
use as well as a prominent warning that DEFIBRILLATOR ELECTRODES shall be kept well
clear of other electrodes or metal parts in contact with the PATIENT. The OPERATOR shall
be advised that other MEDICAL ELECTRICAL EQUIPMENT which has no DEFIBRILLATION-PROOF
applied parts shall be disconnected from the PATIENT during defibrillation;
3) advice for the OPERATOR to avoid contact between parts of the PATIENT’s body such as
exposed skin of head or limbs, conductive fluids such as gel, blood or saline and metal
objects such as a bed frame or a stretcher which may provide unwanted pathways for the
defibrillating current;.
*4) any environmental limitations regarding storing the EQUIPMENT (e.g. in a car or an
ambulance under severe climatic conditions) immediately prior to use;
5) where means are provided for monitoring via SEPARATE MONITORING ELECTRODES,
instructions for the placement of these electrodes;
*6) a recommendation calling the OPERATOR’S attention to the need for periodic maintenance

of the EQUIPMENT irrespective of usage, especially:
− cleaning of any reusable DEFIBRILLATOR ELECTRODES and the insulating parts of the
handles;
− sterilization procedures for any reusable DEFIBRILLATOR ELECTRODES or handles,
including recommended sterilization methods and maximum sterilization cycles, if
applicable;
− cleaning of any reusable monitoring electrodes;
− inspection of the packaging of any disposable DEFIBRILLATOR ELECTRODES and any
disposable monitoring electrodes to ensure integrity of any seals and validity of any
expiry date;
− inspection of cables and electrode handles for possible defects;
− functional checks;
− charging of the ENERGY STORAGE DEVICE, if it is of a type requiring periodic charging
(e.g. electrolytic or polyvinylidene fluoride (PVDF) capacitors);

– 14 – 60601-2-4  IEC:2002(E)

*7) information on the time for charging the fully discharged ENERGY STORAGE DEVICE, when

the DEFIBRILLATOR is set to maximum energy,

a) with RATED MAINS VOLTAGE and, for an INTERNALLY POWERED DEFIBRILLATOR, with a

new fully charged battery;
b) as a), but for a MAINS VOLTAGE of 90 % of the RATED value and for an INTERNALLY
POWERED DEFIBRILLATOR after 15 maximum energy discharges FOR FREQUENT USE

DEFIBRILLATOR or 6 discharges for INFREQUENT USE DEFIBRILLATOR;

c) as b) but measured from initially switching power on to charge ready at maximum
energy.
8) for AEDs, information on the maximum time from the initiation of rhythm analysis to

readiness for discharge,
a) with RATED MAINS VOLTAGE and, for an INTERNALLY POWERED DEFIBRILLATOR, with a
new fully charged battery;
b) as a), but for a MAINS VOLTAGE of 90 % of the RATED value and for AN INTERNALLY
POWERED DEFIBRILLATOR after 15 maximum energy discharges for a FREQUENT USE
DEFIBRILLATOR or 6 discharges for an INFREQUENT USE DEFIBRILLATOR.
c) as b) but measured from initially switching power on to charge ready at maximum
energy;
9) for AEDs, information on whether or not the RHYTHM RECOGNITION DETECTOR will continue
analyzing the ECG after the RRD has detected a shockable rhythm and the DEFIBRILLATOR
is charged and ready to shock and in this case bring the AED into a state where
defibrillation is prohibited;
10) a warning that use of a DEFIBRILLATOR in the presence of flammable agents or in an
oxygen enriched atmosphere presents an explosion and fire hazard.
11) For EQUIPMENT intended for INFREQUENT USE, the intent shall be clearly stated and the
limitations of the EQUIPMENT shall be clearly defined. Recommended or required status
tests or preventive maintenance shall also be stated.
12) For EQUIPMENT that delivers energy according to a preset protocol, information regarding
the automatic selection of DELIVERED ENERGY and the conditions for resetting of the
protocol shall be described in the instructions for use. The instruction for use shall also
contain information of how to change the protocol if applicable.
6.8.3 Technical description
Additional item:
*aa) The technical description shall additionally provide:
1) essential performance data for defibrillation:
a) graphical plots in terms of time and current or voltage of the waveforms of the

delivered pulses when the DEFIBRILLATOR is connected in turn to resistive loads of
25 Ω, 50 Ω, 75 Ω, 100 Ω, 125 Ω 150 Ω and 175 Ω and set to its maximum output,
or according to an automatic protocol for the SELECTED ENERGY if applicable;
b) energy accuracy specifications for the DELIVERED ENERGY in a 50 Ω resistor;
c) if the DEFIBRILLATOR has a mechanism to inhibit its output when the PATIENT
impedance is outside certain limits, disclosure of those limits;
2) essential performance data of any SYNCHRONIZER, including:
a) the meaning of any displayed synchronization or marker pulse,
b) the maximum time delay between the synchronization pulse and delivery of the
energy, once the output has been activated, including details of how the time
delay was measured, and
c) a statement concerning any conditions which will de-select the synchronized
mode;
60601-2-4 © IEC:2002(E) – 15 –

3) essential performance data of the RHYTHM RECOGNITION DETECTOR, including:

a) ECG Database Test Report
The ECG database for validation of rhythm recognition performance shall include,

at a minimum, ventricular fibrillation (VF) rhythms of varying amplitudes,

ventricular tachycardia (VT) rhythms of varying rates and QRS width, various
sinus rhythms including supraventricular tachycardias, atrial fibrillation and atrial

flutter, sinus rhythm with PVC (premature ventricular contraction), asystole and

pacemaker rhythms. All rhythms shall have been collected using electrode

systems and ECG signal processing characteristics similar to the device being

tested, and shall be of appropriate length to allow decisions to be made by the

detector system.
A test report describing the recording methods, rhythm source, rhythm selection
criteria, and annotation methods and criteria shall be available. The results of
detector performance shall be reported in terms of specificity, true predictive
value, sensitivity, and false positive rates, as follows:
Table 101 – Rhythm recognition detector categories
VF and VT All other ECG rhythms
Shock A B
No shock C D
A true positive (A) is a correct classification of a shockable rhythm. A true
negative (D) is a correct classification of all rhythms for which a shock is not
indicated. A false positive (B) is an organized or perfusing rhythm or asystole
that has been incorrectly classified as a shockable rhythm. A false negative (C)
is a VF or VT associated with cardiac arrest that has been incorrectly classified
as non-shockable.
The sensitivity of the device for shockable rhythms is A/(A+C). The true
predictive value is expressed as A/(A+B). The specificity of the device for non-
shockable rhythms is D/(B+D). The false positive rate is expressed as B/(B+D).
The report shall clearly summarize the sensitivity for detecting VF, and the
sensitivity for detecting VT for those devices designed to treat VT. For those
devices designed to treat certain types of ventricular tachycardia (VT) a
description of the requirements for indication of VT as a shockable rhythm shall
be included. The positive predictive accuracy, the false positive rate and overall
specificity of the device shall also be reported. Reporting the specificity of the
device for each non-shockable rhythm group (i.e. normal sinus rhythm,
supraventricular rhythms such as atrial fibrillation and atrial flutter, ventricular
ectopy, idioventricular rhythms and asystole) is recommended but not required.

The sensitivity of the device to recognize VF at maximum peak to peak
amplitude of 200 μV or greater shall exceed 90 % in the absence of artifacts
(e.g., induced by cardiopulmonary resuscitation). For those devices which
detect VT, the sensitivity shall exceed 75 %. The specificity of the detector in
correctly differentiating non-shockable rhythms shall exceed 95 % in the
absence of artifacts.
b) If the detector initiates analysis of the rhythm either automatically or following
manual initiation by the OPERATOR, this shall be described.
c) If the DEFIBRILLATOR incorporates a system that detects and analyzes
physiological information other than the ECG, in order to increase the sensitivity
or specificity of the AED, the technical description shall explain the method of
operation of this system and the criteria for recommending shock delivery.

– 16 – 60601-2-4  IEC:2002(E)

6.8.101 Accompanying documents related to electromagnetic compatibility

In accordance with IEC 60601-1-2, the manufacturer shall include information regarding

electromagnetic compatibility of the EQUIPMENT. Specifically, Tables 201, 202 and 203a shall be

provided and applicable statements in accordance with 6.8.201.2 shall be included in the

instructions for use.
SECTION TWO – ENVIRONMENTAL CONDITIONS

The clauses and subclauses of this section of the General Standard apply except as follows:
10 Environmental conditions
This clause of the General Standard applies except as follows:
*10.2 Operation
10.2.1 Environment
Amendment:
a) Ambient temperature between 0 °C and +40 °C.
b) Relative humidity between 30 % and 95 %, without condensation.
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
The clauses and subclauses of this section of the General Standard apply except as follows:
14 Requirements related to classification
This clause of the General Standard applies except as follows:
14.6 Types b, bf and cf applied parts
Addition
*aa) Any APPLIED PART consisting of SEPARATE MONITORING ELECTRODES for monitoring the
ECG shall be TYPE CF.
*17 Separation
This clause of the General Standard applies except as follows:
*h) first dash
Additional bullet:
• APPLIED PARTS of other PATIENT CIRCUITS;
Amendment:
Delete sixth dash (“the EQUIPMENT shall not be energized;”).

60601-2-4 © IEC:2002(E) – 17 –

Replace second to last paragraph (“Each test is repeated with V reversed.”) by the following:
T
Each test is performed both with the EQUIPMENT energized and not energised in turn and is

repeated with V reversed in each case.
T
Additional items:
aa) Arrangements to isolate the DEFIBRILLATOR ELECTRODES from other parts shall be so

designed that, during the discharge of the ENERGY STORAGE DEVICE, hazardous

electrical energies are excluded from the following:

1) the ENCLOSURE;
2) all PATIENT CONNECTIONS belonging to other PATIENT CIRCUITS;
3) any SIGNAL INPUT PART and/or any SIGNAL OUTPUT PART;
4) a metal foil on which the EQUIPMENT is placed and which has an area at least equal to
that of the base of the EQUIPMENT (CLASS II EQUIPMENT or EQUIPMENT with an INTERNAL
ELECTRICAL POWER SOURCE).
Compliance shall be checked by the following test:
The above requirement is met when, after a discharge of the DEFIBRILLATOR connected
as shown in Figure 101, the peak voltage between the points Y1 and Y2 does not
exceed 1 V. Transients might be imposed on the measurement during the energy
discharge. These shall be excluded from the measurement. This voltage corresponds to
a charge of 100 μC from the part under test.
In the case where an active signal output part would effect the measured voltage
between Y1 and Y2 the specific signal output port is excluded from the measurement.
However the ground reference of such a signal output port shall be measured.
In the case where the connection of the measurement circuit of fig. 101 to an
input/output port would create a failure of the device to function properly, the specific
input/output port is excluded from measurement. However the ground reference of such
an input/output signal shall be measured.
DEFIBRILLATORS requiring an impedance within a certain range to be present at the
output of the DISCHARGE CIRCUIT are to be tested connected to a 50 Ω resistive load. In
the case of DEFIBRILLATORS requiring the detection of a shockable ECG in order to
deliver a shock, an ECG simulator incorporating a 50 Ω resistive load is to be used.
Measurements shall be done at the maximum energy level of the device.
CLASS I EQUIPMENT shall be tested while connected to the protective earth.
CLASS I EQUIPMENT which is capable of operation without a SUPPLY MAINS, e.g. having an
internal battery, shall also be tested without the protective earth connection.
Any connection to a FUNCTIONAL EARTH TERMINAL shall be removed.

The test shall be repeated with the earth connection transferred to the other
DEFIBRILLATOR ELECTRODE.
*bb) Any APPLIED PARTS not being DEFIBRILLATOR ELECTRODES shall be DEFIBRILLATION-PROOF
APPLIED PARTS unless the manufacturer has taken steps to prevent their use at the
same time as performing defibrillation with the same DEFIBRILLATOR.
*cc) Unintentional charging of the ENERGY STORAGE DEVICE shall not occur when testing the
requirements for DEFIBRILLATION-PROOF APPLIED PARTS according to this clause.

– 18 – 60601-2-4  IEC:2002(E)

19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS

This clause of the General Standard applies except as follows:

*19.1 General requirements
Item b), third dash
Addition:
For the measurement of PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT the
EQUIPMENT shall be operated in turn:

a) in STAND-BY;
b) while the ENERGY STORAGE DEVICE is being charged to maximum energy;
c) while the ENERGY STORAGE DEVICE is maintained at maximum energy until internal
energy discharge is automatically performed, or for 1 min;
d) for 1 min, starting 1 s after the commencement of the output pulse into a 50 Ω load (the
period of discharge being excluded).
Item e)
Addition:
For the DEFIBRILLATOR ELECTRODES the requirements of the General Standard are replaced
by the following:
The PATIENT LEAKAGE CURRENT shall be measured with the DEFIBRILLATOR ELECTRODES
connected to a 50 Ω load, The measurement shall be made from either DEFIBRILLATOR
ELECTRODE to earth, the following parts being connected together and to earth:
a) conductive ACCESSIBLE PARTS;
b) metal foil on which the EQUIPMENT is positioned and which has an area at least equal to
that of the base of the EQUIPMENT;
c) any SIGNAL INPUT PARTS and SIGNAL OUTPUT PARTS which may be connected to earth in
NORMAL USE.
19.2 Single fault conditions
Item b) second dash
Addition:
For the DEFIBRILLATOR ELECTRODES, this requirement of the General Standard is replaced
by the following:
− a voltage equal to 110 % of the highest RATED MAINS VOLTAGE applied between earth
and, in turn, the external DEFIBRILLATOR ELECTRODES connected together and any
internal DEFIBRILLATOR ELECTRODES connected together, metal foil being wrapped
around, and in intimate contact with, the electrode handles and connected to earth and
to the parts of 19.1 e) of this Particular Standard.
* 19.3 Allowable values
Additional item:
*aa) For TYPE CF DEFIBRILLATOR APPLIED PARTS, the allowable value of the PATIENT LEAKAGE
CURRENT for the SINGLE FAULT CONDITION of MAINS VOLTAGE on the DEFIBRILLATOR
ELECTRODES is 0,1 mA.
60601-2-4 © IEC:2002(E) – 19 –

* 20 Dielectric strength
This clause of the General Standard applies except as follows:

20.2 Requirements for EQUIPMENT with an APPLIED PART

and
20.3 Values of test voltages
Amendment:
For the DEFIBRILLATOR high-voltage circuit (for example DEFIBRILLATOR ELECTRODES, CHARGING
CIRCUIT and switching devices) the following requirements and tests shall apply in addition to
those of the General Standard for insulation category B-a and shall replace those of the
General Standard for insulation categories B-b, B-c, B-d and B-e.
The insulation of the above circuit shall withstand a d.c. test voltage of 1,5 times the highest
peak voltage U occurring between the parts concerned during discharging in any mode of
normal operation. The insulation resistance of the above insulation shall not be less than
500 MΩ.
Compliance shall be checked by the following combined dielectric strength and insulation
resistance test:
The external d.c. test voltage is applied:
Test 1: With the switching devices of the DISCHARGE CIRCUIT activated between each pair of
DEFIBRILLATOR ELECTRODES connected together and all of the following parts connected
together:
a) conductive ACCESSIBLE PARTS,
b) the PROTECTIVE EARTH TERMINAL in the case of CLASS I EQUIPMENT or metal foil on
which the EQUIPMENT rests in the case of CLASS II EQUIPMENT or EQUIPMENT with an
INTERNAL ELECTRICAL POWER SOURCE,
c) metal foil in intimate contact with non-conductive parts liable to be handled in
NORMAL USE, and
d) any isolated DISCHARGE CONTROL CIRCUIT and any is
...

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 Standard.89
Annex AA (informative) General guidance and rationale.91
Annex BB (informative) AUTOMATED EXTERNAL DEFIBRILLATORS: background and
rationale. 113

– 6 – 60601-2-4 © CEI:2002
COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE

____________
APPAREILS ÉLECTROMÉDICAUX –
Partie 2-4: Règles particulières de sécurité

pour les défibrillateurs cardiaques

AVANT-PROPOS
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responsable de ne pas avoir identifié de tels droits de propriété et de ne pas avoir signalé leur existence.
La Norme Internationale CEI 60601-2-4 a été établie par le sous-comité 62D: Appareils
électromédicaux, du comité d’études 62 de la CEI: Equipements électriques dans la pratique
médicale.
Cette deuxième édition de la CEI 60601-2-4 annule et remplace la première édition publiée en
1983 dont elle constitue une révision technique.
Cette version bilingue, publiée en 2005-09, correspond à la version anglaise.

60601-2-4 © IEC:2002 – 7 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-4: Particular requirements for the safety of

cardiac defibrillators
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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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.
This bilingual version, published in 2005-09, corresponds to the English version.

– 8 – 60601-2-4 © CEI:2002
Le texte anglais de cette norme est issu des documents 62D/455/FDIS et 62D/460/RVD.

Le rapport de vote 62D/460/RVD donne toute information sur le vote ayant abouti à

l’approbation de la présente norme.

La version française de cette norme n’a pas été soumise au vote.

Le contenu du corrigendum 1 d’avril 2004 a été pris en considération dans cet exemplaire.

Dans la présente Norme Particulière, les caractères d'imprimerie suivants sont utilisés:

– exigences dont la conformité peut être vérifiée par un essai et définitions: caractères
romains;
– notes, explications, conseils, introductions, énoncés de portée générale, exceptions et références: petits
caractères;
– modalités d'essai, en-têtes des paragraphes et des points: caractères italiques;
– TERMES DEFINIS A L’ARTICLE 2 DE LA NORME GENERALE OU DANS LA PRESENTE NORME
PARTICULIERE: PETITES MAJUSCULES.
Le comité a décidé que le contenu de cette publication ne sera pas modifié avant la date de
maintenance indiquée sur le site web de la CEI sous «http://webstore.iec.ch» dans les données
relatives à la publication recherchée. A cette date, la publication sera
• reconduite;
• supprimée;
• remplacée par une édition révisée, ou
• amendée.
60601-2-4 © IEC:2002 – 9 –
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.

The French version of this standard has not been voted upon.

The contents of the corrigendum 1 of April 2004 have been included in this copy.
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;
ERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL
– T
CAPITALS.
The committee has decided that the contents of this publication will remain unchanged until the
maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
– 10 – 60601-2-4 © CEI:2002
INTRODUCTION
La présente Norme Particulière concerne la sécurité des DEFIBRILLATEURS CARDIAQUES. Elle

modifie et complète la CEI 60601-1 (deuxième édition, 1988): Appareils électromédicaux –

Partie 1: Règles générales de sécurité, y compris son Amendement 1 (1991) et son

Amendement 2 (1995), appelée Norme Générale dans la présente Norme.

Une première édition de la présente norme particulière, fondée sur la première édition (1977)

de la CEI 60601-1 a été publiée en 1983. Cette deuxième édition est destinée à mettre à jour

cette norme particulière par des modifications mineures apportées à son contenu technique en

se référant aux publications et documents mentionnés ci-dessus.

Les exigences sont suivies par les modalités d'essai correspondantes.
L'Annexe AA donne, le cas échéant, une justification pour les exigences les plus importantes.
On considère que la connaissance des raisons qui ont conduit à énoncer ces exigences, non
seulement facilitera l’application correcte de la présente norme particulière, mais accélérera en
son temps toute révision rendue nécessaire par les changements dans la pratique clinique ou
par l'évolution technologique. Cependant, cette Annexe AA ne fait pas partie des exigences de
la présente norme.
Les articles et les paragraphes pour lesquels l'Annexe AA donne une justification sont repérés
par un astérisque * placé avant leur numéro dans le texte.

60601-2-4 © IEC:2002 – 11 –
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.

– 12 – 60601-2-4 © CEI:2002
APPAREILS ÉLECTROMÉDICAUX –
Partie 2: Règles particulières de sécurité

pour les défibrillateurs cardiaques

SECTION UN – GÉNERALITÉS
Les articles et paragraphes correspondants de la Norme Générale s’appliquent avec les

exceptions suivantes:
1 Domaine d’application et objet
L'article correspondant de la Norme Générale s’applique avec les exceptions suivantes:
*1.1 Domaine d’application
Addition:
La présente Norme Particulière spécifie les exigences de sécurité relatives aux DEFIBRIL-
LATEURS CARDIAQUES tels qu'ils sont définis en 2.1.101 et qui sont désignés dans la suite du
texte sous le terme APPAREILS.
Cette Norme Particulière ne s'applique pas aux défibrillateurs implantables, aux DEFIBRIL-
LATEURS avec commande à distance, aux stimulateurs cardiaques transcutanés externes ni aux
MONITEURS CARDIAQUES autonomes indépendants (qui sont normalisés dans la CEI 60601-2-27)
Les moniteurs cardiaques qui utilisent des électrodes de surveillance ECG ne font partie du
domaine d'application de la présente norme que s'ils sont utilisés comme moyen unique pour la
détection et la reconnaissance du rythme pour les DEA ou pour la détection des battements
pour la cardioversion synchronisée.
La technologie des formes d'ondes de défibrillation évolue rapidement. Les études qui ont été
publiées indiquent que l'efficacité des formes d'ondes varie. Le choix d'une forme d'onde
particulière avec la forme, l'énergie délivrée, l'efficacité potentielle et la sécurité a été volontai-
rement exclu du domaine d'application de la présente norme.
Cependant, compte tenu de l'importance critique de la forme d'onde thérapeutique, des
commentaires ont été ajoutés aux justifications concernant le choix de la forme d'onde.

1.2 Objet
Remplacement:
L’objet de la présente Norme Particulière est d’établir des exigences particulières pour la
sécurité des DEFIBRILLATEURS CARDIAQUES tels qu'ils sont définis en 2.1.101.
1.3 Normes particulières
Addition:
La présente Norme Particulière fait référence à la CEI 60601-1 (1988): Appareils électro-
médicaux – Partie 1: Règles générales de sécurité comme modifié par son Amendement 1
(1991) et son Amendement 2 (1995).

60601-2-4 © IEC:2002 – 13 –
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 DEFIBRILLATORS as defined in 2.1.101.
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 amendment 2
(1995).
– 14 – 60601-2-4 © CEI:2002
Par souci de concision dans cette norme particulière, la partie 1 est désignée soit par le terme

«Norme générale» soit par l'expression «la ou les exigence(s) générale(s)».

La numérotation des sections, articles et paragraphes de la présente Norme Particulière

correspond à celle de la Norme Générale. Les modifications apportées au texte de la Norme

Générale sont indiquées par les expressions suivantes:

«Remplacement» signifie que l’article ou le paragraphe de la Norme Générale est remplacé

complètement par le texte de la présente Norme Particulière.

«Addition» signifie que le texte de la présente Norme Particulière vient s'ajouter aux exigences

de la Norme Générale.
«Modification» signifie que l’article ou le paragraphe de la Norme Générale est modifié comme
indiqué dans la présente Norme Particulière.
Les paragraphes ou figures venant en complément de ceux de la Norme Générale sont
numérotés à partir de 101, les annexes complémentaires notées AA, BB, etc. et les points
complémentaires aa), bb), etc.
L’expression «la présente norme ou cette Norme» est utilisée pour se référer à la Norme
Générale et à cette Norme Particulière considérées ensemble.
Lorsqu’il n’existe aucune section, aucun article ou paragraphe correspondant dans la présente
norme particulière, la section, l’article ou le paragraphe de la norme générale s’applique sans
modification, bien qu'ils puissent éventuellement ne pas être adaptés.
Lorsqu’il est prévu qu’une partie de la norme générale, bien qu’éventuellement pertinente, ne
doit pas être appliquée, une indication dans ce sens doit être donnée dans la présente norme.
Les exigences de la présente norme particulière priment sur celles de la norme générale.
1.5 Normes collatérales
Addition:
Les normes collatérales suivantes s'appliquent:
CEI 60601-1-1:2000, Appareils électromédicaux – Partie 1-1: Règles générales de sécurité –
Norme collatérale: Règles de sécurité pour systèmes électromédicaux

CEI 60601-1-2:2001, Appareils électromédicaux – Partie 1-2: Règles générales de sécurité –
Norme collatérale: Compatibilité électromagnétique – Prescriptions et essais
CEI 60601-1-4:1996, Appareils électromédicaux – Partie 1: Exigences générales de sécurité –
4. Norme Collatérale: Systèmes électromédicaux programmables
2 Terminologie et définitions
L'article correspondant de la Norme Générale s’applique avec les exceptions suivantes:

60601-2-4 © IEC:2002 – 15 –
For brevity, Part 1 is referred to in this Particular Standard either as the “General Standard” or

as the “General Requirement(s)”.

The numbering of sections, clauses and subclauses of this Particular Standard corresponds

with that of the General Standard. The changes to the text of the General Standard are

specified by the use of 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 that the clause or subclause of the General Standard is amended as
indicated by the text of this Particular Standard.
Subclauses or figures which are additional to those of the General Standard are numbered
starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb),
etc.
The term “this Standard” is used to make reference to the General Standard and this Particular
Standard taken together.
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause of the General Standard, although possibly not relevant, applies
without modification.
Where it is intended that any part of the General Standard, although possibly relevant, is not to
be applied, a statement to that effect is given in this Particular Standard.
The requirements of this Particular Standard take priority over those of the General Standard.
1.5 Collateral Standards
Addition:
The following Collateral Standards apply:
IEC 60601-1-1:2000, Medical electrical equipment – Part 1-1: General requirements for safety
– Collateral standard: Safety requirements for medical electrical systems

IEC 60601-1-2:2001, Medical electrical equipment – Part 1-2: General requirements for safety
– Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-1-4:1996, Medical electrical equipment – Part 1: General requirements for safety –
4. Collateral Standard: Programmable electrical medical systems
2 Terminology and definitions
This clause of the General Standard applies except as follows:

– 16 – 60601-2-4 © CEI:2002
Définitions complémentaires:
2.1.101
DEFIBRILLATEUR CARDIAQUE
APPAREIL ELECTROMEDICAL destiné à défibriller le cœur par une impulsion électrique délivrée

par l'intermédiaire d'électrodes appliquées soit sur la peau du PATIENT (électrodes externes)
soit sur le cœur nu (électrodes internes). Il peut être désigné par le terme DEFIBRILLATEUR ou
APPAREIL
NOTE Un tel APPAREIL peut également assurer d'autres fonctions de surveillance ou d'ordre thérapeutique.

2.1.102
MONITEUR
partie d'un DEFIBRILLATEUR qui fournit un affichage visible de l'activité électrique du cœur du
PATIENT
NOTE Ce terme est utilisé dans la présente norme particulière afin de distinguer un MONITEUR de ce type de ceux
qui forment à eux seuls un APPAREIL indépendant même dans les cas où le moniteur indépendant autonome est
capable de fournir des signaux de synchronisation au DEFIBRILLATEUR, avec une utilisation comme moyen pour la
détection et la reconnaissance du rythme pour les DEA ou pour la fourniture de signaux de commande au
DEFIBRILLATEUR.
2.1.103
CIRCUIT DE CHARGE
circuit à l'intérieur du DEFIBRILLATEUR destiné à charger le DISPOSITIF D'EMMAGASINAGE
D'ENERGIE. Ce circuit comprend toutes les parties reliées électriquement au DISPOSITIF
D'EMMAGASINAGE D'ENERGIE au cours de la période de charge
2.1.104
ELECTRODES DE DEFIBRILLATION
électrodes destinées à délivrer une impulsion électrique au PATIENT en vue d'une défibrillation
cardiaque
NOTE Les ELECTRODES DE DEFIBRILLATION assurent également d'autres fonctions de surveillance (par exemple
acquisition ECG) ou thérapeutiques (par exemple entraînement transcutané) et elles peuvent être à usage unique
ou réutilisables.
2.1.105
CIRCUIT DE DECHARGE
circuit à l'intérieur du DEFIBRILLATEUR qui relie le DISPOSITIF D'EMMAGASINAGE D'ENERGIE aux
ELECTRODES DE DEFIBRILLATION. Ce circuit comprend toutes les connections de commutation
situées entre ce dispositif et les ELECTRODES DE DEFIBRILLATION
2.1.106
CIRCUIT DE COMMANDE DE DECHARGE
circuit comprenant les commandes manuelles de décharge et toutes les parties qui sont reliées

électriquement avec elles
2.1.107
CIRCUIT DE DECHARGE INTERNE
circuit à l'intérieur du DEFIBRILLATEUR qui décharge le DISPOSITIF D'EMMAGASINAGE D'ENERGIE
sans mettre les ELECTRODES DE DEFIBRILLATION sous tension
2.1.108
SYNCHRONISEUR
dispositif permettant de synchroniser la décharge du DEFIBRILLATEUR avec une phase
spécifique du cycle cardiaque
60601-2-4 © IEC:2002 – 17 –
Additional definitions:
2.1.101
CARDIAC DEFIBRILLATOR
MEDICAL ELECTRICAL EQUIPMENT intended to defibrillate the heart by an electrical pulse via

PATIENT's skin (external electrodes) or to the exposed heart
electrodes applied either to the

(internal electrodes). May be referred to as DEFIBRILLATOR or EQUIPMENT

NOTE Such EQUIPMENT may also include other monitoring or therapeutic functions.

2.1.102
MONITOR
part of a DEFIBRILLATOR providing a visual display of the electrical activity of the PATIENT’s heart
NOTE The term is used within this Particular Standard to distinguish such a MONITOR from one which forms a
separate EQUIPMENT in its own right even in cases where the separate stand-alone monitor is able to provide
synchronization signals to the DEFIBRILLATOR, used as basis for AED rhythm recognition detection or providing
control signals to the DEFIBRILLATOR.
2.1.103
CHARGING CIRCUIT
DEFIBRILLATOR intended for charging the ENERGY STORAGE DEVICE. This circuit
circuit within the
includes all parts conductively connected to the ENERGY STORAGE DEVICE during the charging
period
2.1.104
DEFIBRILLATOR ELECTRODES
electrodes intended to deliver an electrical pulse to the PATIENT for the purpose of cardiac
defibrillation
NOTE DEFIBRILLATOR ELECTRODES may also provide other monitoring (e.g. ECG acquisition) or therapeutic (e.g.
transcutaneous pacing) functions and may be disposable or reusable.
2.1.105
DISCHARGE CIRCUIT
circuit within the DEFIBRILLATOR which connects the ENERGY STORAGE DEVICE to the
DEFIBRILLATOR ELECTRODES. This circuit includes all switching connections between that device
and the DEFIBRILLATOR ELECTRODES
2.1.106
DISCHARGE CONTROL CIRCUIT
circuit including the manually operated discharge controls and all parts conductively connected
to them
2.1.107
INTERNAL DISCHARGE CIRCUIT
circuit within the DEFIBRILLATOR which discharges the ENERGY STORAGE DEVICE without
energizing the DEFIBRILLATOR ELECTRODES
2.1.108
SYNCHRONIZER
device allowing the DEFIBRILLATOR discharge to be synchronized with a specific phase of the
cardiac cycle
– 18 – 60601-2-4 © CEI:2002
2.1.109
DEFIBRILLATEUR EXTERNE AUTOMATIQUE (DEA)

DEFIBRILLATEUR qui, à son activation par l'OPERATEUR, analyse l'ECG obtenu par les électrodes

placées sur la poitrine, identifie les rythmes cardiaques qui nécessitent un choc électrique et

met le DEFIBRILLATEUR en marche automatiquement lorsqu'un rythme nécessitant un choc

électrique est détecté, cet appareil est désigné dans la suite du texte par l'abréviation DEA

NOTE Les DEA peuvent présenter des niveaux variables d'automatisme et être désignés sous des termes

différents. Voir l'Annexe BB.
2.1.110
DISPOSITIF D'EMMAGASINAGE D'ENERGIE
composant (par exemple un condensateur) qui est chargé avec l'énergie nécessaire pour
délivrer une impulsion de défibrillation électrique au PATIENT
2.1.111
ELECTRODES DE SURVEILLANCE INDEPENDANTES
électrodes appliquées sur le PATIENT afin d'assurer sa surveillance. Ces électrodes ne sont pas
utilisées pour appliquer des impulsions de défibrillation au PATIENT
2.1.112
DETECTEUR DE RECONNAISSANCE DU RYTHME (DRR)
système qui analyse l'ECG et identifie si un rythme cardiaque nécessite un choc électrique.
L'algorithme d'un DEA est conçu en terme de sensibilité et de détection des spécificités des
arythmies pour lesquelles un choc de défibrillation est cliniquement indiqué. Il peut être
désigné par l'abréviation DRR
2.12.101
ENERGIE DELIVREE
énergie qui passe par les ELECTRODES DE DEFIBRILLATION et qui est dissipée dans le PATIENT ou
dans une résistance d'une valeur spécifiée
2.12.102
EN ATTENTE
APPAREIL est sous tension mais où le DISPOSITIF D'EMMAGASINAGE D'ENERGIE
état dans lequel l'
n'est pas encore chargé
2.12.103
ENERGIE EMMAGASINEE
énergie qui est accumulée dans le DISPOSITIF D'EMMAGASINAGE D'ENERGIE DU DEFIBRILLATEUR
2.12.104
COMPOSANT FICTIF
élément destiné à remplacer au cours des essais les comp
...