SIST EN 60601-2-4:2003
(Main)Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators (IEC 60601-2-4:2002)
Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators (IEC 60601-2-4:2002)
Specifies requirements for the safety of cardiac defibrillators.
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)
Medicinska električna oprema - 2-4. del: Posebne varnostne zahteve za srčne defibrilatorje (IEC 60601-2-4:2002)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 60601-2-4:2003
01-april-2003
1DGRPHãþD
SIST HD 395.2.4 S1:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQHYDUQRVWQH]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
SIST EN 60601-2-4:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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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
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EN 60601-2-4:2003 - 2 -
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.
__________
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- 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.
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EN 60601-2-4:2003 - 4 -
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.
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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
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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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Pour prix, voir catalogue en vigueur
For price, see current catalogue
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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
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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
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60601-2-4 IEC:2005 – 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
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
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). 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. 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 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 IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. 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.
This bilingual version (2005-09) replaces the English version.
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60601-2-4 IEC:2005 – 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.
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60601-2-4 IEC:2005 – 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.
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60601-2-4 IEC:2005 – 13 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-4: 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).
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60601-2-4 IEC:2005 – 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:
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60601-2-4 IEC:2005 – 17 –
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.
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
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60601-2-4 IEC:2005 – 19 –
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
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
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60601-2-4 IEC:2005 – 21 –
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
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:
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