SIST EN 60601-2-4:2011

SLOVENSKI STANDARD
01-oktober-2011
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Medical electrical equipment - Part 2-4: Particular requirements for basic safety and
essential performance of cardiac defibrillators
Appareils électromédicaux - Partie 2-4: Exigences particulières pour la sécurité de base
et les performances essentielles pour les défibrillateurs cardiaques
Ta slovenski standard je istoveten z: EN 60601-2-4:2011
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-2-4
NORME EUROPÉENNE
August 2011
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN 60601-2-4:2003

English version
Medical electrical equipment -
Part 2-4: Particular requirements for the basic safety and essential
performance of cardiac defibrillators
(IEC 60601-2-4:2010)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-4: Exigences particulières pour la Teil 2-4: Besondere Festlegungen für die
sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles des défibrillateurs cardiaques Leistungsmerkmale von Defibrillatoren
(CEI 60601-2-4:2010) (IEC 60601-2-4:2010)

This European Standard was approved by CENELEC on 2011-01-12. 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, Bulgaria, Croatia, Cyprus,
the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2011 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-4:2011 E
Foreword
The text of document 62D/857/FDIS, future edition 3 of IEC 60601-2-4, prepared by SC 62D,
Electromedical equipment, of IEC 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 2011-01-12.
This European Standard supersedes EN 60601-2-4:2003.
and to implement the decision of IEC SC 62A that the clause numbering structure of particular standards
written to EN 60601-1:2006 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The
aim of this third edition is to bring this particular standard up to date with reference to the third edition of
the general standard through reformatting and technical changes.
The principle technical changes are as follows:
— 201.8.8.3, test 4: added additional test options;
— Figure 201.105: provided example of stainless steel plates. Added note for 10 Hz generator or
shockable rhythm generator;
— Figure 201.101: Changed orientation of the lower diode at the oscilloscope connection;
— 202.6.1, .2, .4: "Additions" and "Replacements" corrected to be as originally intended;
— 201.101.1: Clarified preconditioning of a non-rechargeable battery;
— 201.3.207: Clarified definition of DUMMY COMPONENT;
— 201.15.4.101: In paragraph b), added reduced flex requirements for sterilizable internal paddles with
specified limit on sterilization cycles;
— 201.15.4.3.103: Added an option for devices having non-changeable pre-programmed energy-setting
sequences;
— 201.102.3.1, 2: Changed from specified defibrillation cycles to use of pre-programmed defibrillation
sequence;
— 202.6.2.2.1: Changed ESD discharge sequence to match EN 60601-1-2:2007.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
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) 2012-02-12
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2014-01-12
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of
tables is also in a smaller type.

- 3 - EN 60601-2-4:2011
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD
OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of
Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
– “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
there is guidance or rationale related to that item in Annex AA.
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive MDD (93/42/EEC). See Annex ZZ.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-4:2010 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
[2] IEC 60601-2-27 NOTE  Harmonized as EN 60601-2-27.
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Annex ZA of EN 60601-1:2006 applies except as follows:

Publication Year Title EN/HD Year

Replace IEC 60601-1-2 by:
IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests
Add:
IEC 61000-4-2 - Electromagnetic compatibility (EMC) - EN 61000-4-2 -
Part 4-2: Testing and measurement
techniques - Electrostatic discharge immunity
test
ISO 15223-1 2007 Medical devices - Symbols to be used with - -
medical device labels, labelling and
information to be supplied -
Part 1: General requirements
- 5 - EN 60601-2-4:2011
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives

This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC

Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.

WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
IEC 60601-2-4 ®
Edition 3.0 2010-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-4: Particular requirements for the basic safety and essential performance
of cardiac defibrillators
Appareils électromédicaux –
Partie 2-4: Exigences particulières pour la sécurité de base et les performances
essentielles des défibrillateurs cardiaques

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

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

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

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

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

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

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
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 itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
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 IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This third edition cancels and replaces the second edition published in 2002. This edition
constitutes a technical revision, revised to structurally align it with IEC 60601-1:2005 and to
implement the decision of IEC SC 62A that the clause numbering structure of particular
standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC
Directives, Part 2:2004. The aim of this third edition is to bring this particular standard up to
date with reference to the third edition of the general standard through reformatting and
technical changes.
The principle technical changes are as follows:
· 201.8.8.3, test 4: added additional test options;

60601-2-4 Ó IEC:2010 – 5 –
· Figure 201.105: provided example of stainless steel plates. Added note for 10 Hz
generator or shockable rhythm generator;
· Figure 201.101: Changed orientation of the lower diode at the oscilloscope connection;
· 202.6.1, .2, .4: "Additions" and "Replacements" corrected to be as originally intended;
· 201.101.1: Clarified preconditioning of a non-rechargeable battery;
· 201.3.207: Clarified definition of DUMMY COMPONENT;
· 201.15.4.101: In paragraph b), added reduced flex requirements for sterilizable internal
paddles with specified limit on sterilization cycles;
· 201.15.4.3.103: Added an option for devices having non-changeable pre-programmed
energy-setting sequences;
· 201.102.3.1, 2: Changed from specified defibrillation cycles to use of pre-programmed
defibrillation sequence;
· 202.6.2.2.1: Changed ESD discharge sequence to match IEC 60601-1-2, third edition.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/857/FDIS 62D/878/RVD
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;

– 6 – 60601-2-4 Ó IEC:2010
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the stability 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.
60601-2-4 Ó IEC:2010 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –

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

201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
CARDIAC DEFIBRILLATORS, hereafter referred to as ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This particular standard does not apply to implantable defibrillators, remote control
DEFIBRILLATORS, external transcutaneous pacemakers, or separate stand-alone cardiac
monitors (which are standardized by IEC 60601-2-27 [2] ). 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 addresses considerations in waveform selection.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for cardiac defibrillators as defined in 201.3.202.
—————————
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.
Numbers in square brackets refer to the bibliography.

– 8 – 60601-2-4 Ó IEC:2010
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2 applies as modified in Clause 202. All other published collateral standards in
the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). 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 or applicable
collateral 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 or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general

60601-2-4 Ó IEC:2010 – 9 –
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the bibliography beginning on page 73.
Clause 2 of the general standard applies, except as follows:
Amendment:
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
Addition:
IEC 61000-4-2, Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement
techniques – Electrostatic discharge immunity test
ISO 15223-1:2007, Medical devices – Symbols to be used with medical device labels,
labelling and information to be supplied – Part 1: General requirements
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005
apply, except as follows:
Addition:
NOTE An index of defined terms is found beginning on page 74.
201.3.201
AUTOMATED EXTERNAL DEFIBRILLATOR
AED
DEFIBRILLATOR that, once activated by the OPERATOR, analyses the ECG obtained from
electrodes placed on the patient’s skin 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. A semi-automatic
DEFIBRILLATOR requires manual shock activation. A fully automatic DEFIBRILLATOR will provide shock without
OPERATOR intervention.
201.3.202
CARDIAC DEFIBRILLATOR
MEDICAL ELECTRICAL EQUIPMENT intended to normalize the rhythm of the heart by an electrical
pulse via electrodes applied either to the PATIENT's skin with external electrodes or to the
exposed heart with internal electrodes
NOTE 1 A CARDIAC DEFIBRILLATOR can be referred to in this standard as a DEFIBRILLATOR or as ME EQUIPMENT.
NOTE 2 Such ME EQUIPMENT may also include other monitoring or therapeutic functions.
201.3.203
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
– 10 – 60601-2-4 Ó IEC:2010
201.3.204
DEFIBRILLATOR ELECTRODE
electrode 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.
201.3.205
DELIVERED ENERGY
energy which is delivered through the DEFIBRILLATOR ELECTRODES and dissipated in the
PATIENT or in a resistance of specified value
201.3.206
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
201.3.207
DUMMY COMPONENT
test replacement for moulded components like transformers, resistors, semiconductors etc.
NOTE The DUMMY COMPONENT has a geometry equal to that of the component it will replace during the test, but
provides dielectric isolation. The volume may lack parts of the original components (for example: semiconductor
die, 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. The DUMMY COMPONENT shall be identical to the component replaced with respect to conductive external
details such as metal legs, pins etc.
201.3.208
DEFIBRILLATOR TESTER
instrument capable of measuring the energy output from a CARDIAC DEFIBRILLATOR while
generating a simulated ECG output to the CARDIAC DEFIBRILLATOR
201.3.209
ENERGY STORAGE DEVICE
component that is charged with the energy necessary to deliver an electrical defibrillation
pulse to the PATIENT
NOTE A capacitor is a typical example of the component.
201.3.210
FREQUENT USE
term used to describe a DEFIBRILLATOR designed to endure more than 2 500 discharges (see
201.103)
201.3.211
INFREQUENT USE
term used to describe a DEFIBRILLATOR designed to endure less than 2 500 discharges (see
201.103)
201.3.212
INTERNAL DISCHARGE CIRCUIT
circuit within the DEFIBRILLATOR which discharges the ENERGY STORAGE DEVICE without
energizing the DEFIBRILLATOR ELECTRODES
201.3.213
MANUAL DEFIBRILLATOR
DEFIBRILLATOR capable of being manually operated by the OPERATOR for selection of energy,
charging and discharging
60601-2-4 Ó IEC:2010 – 11 –
201.3.214
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 ME 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.
201.3.215
RHYTHM RECOGNITION DETECTOR
RRD
a system that analyzes the ECG and identifies whether a cardiac rhythm is shockable
NOTE The algorithm in an AED is designed for sensitivity and specificity for the detection of arrhythmias for which
a defibrillation shock is clinically indicated. May be referred to as RRD.
201.3.216
SELECTED ENERGY
energy which the defibrillator is intended to deliver, as determined by the setting of a manual
control or by an automatic protocol
201.3.217
SEPARATE MONITORING ELECTRODE
electrode applied to the PATIENT for the purpose of monitoring the PATIENT
NOTE These electrodes are not used to apply defibrillation pulses to the PATIENT.
201.3.218
STAND-BY
mode of operation in which the ME EQUIPMENT is operational except that the ENERGY STORAGE
DEVICE is not yet charged
201.3.219
STORED ENERGY
energy which is stored in the DEFIBRILLATOR ENERGY STORAGE DEVICE
201.3.220
SYNCHRONIZER
device allowing the DEFIBRILLATOR discharge to be synchronized with a specific phase of the
cardiac cycle
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.2 RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS
Addition:
201.4.2.101 * Additional RISK MANAGEMENT requirements
MANUFACTURER shall address readiness for use in the RISK MANAGEMENT fILE.
Check compliance by inspection of RISK MANAGEMENT FILE.
201.4.3 ESSENTIAL PERFORMANCE
Addition:
– 12 – 60601-2-4 Ó IEC:2010
201.4.3.101 * Additional ESSENTIAL PERFORMANCE requirements
Each of the three capabilities listed in Table 201.101, when included in a defibrillator, will be
considered ESSENTIAL PERFORMANCE.
Where engineering judgement by the MANUFACTURER specifies performance in excess of
ESSENTIAL PERFORMANCE, that performance may be degraded by external factors such as
EMC, as long as the RISK MANAGEMENT FILE documents that ESSENTIAL PERFORMANCE is met.
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
Requirement
Description (Sub)clause
Deliver defibrillation therapy 201.12.1
Deliver synchronized defibrillation therapy 201.104
Accurately differentiate between shockable and nonshockable rhythms 201.107
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.3 * Ambient temperature, humidity, atmospheric pressure
Addition:
aa) The test required in 201.102.2 and 201.102.3 shall be performed at an ambient
temperature of 0 °C ± 2 °C.
201.5.4 Other conditions
Addition:
aa) Unless otherwise specified in this standard, all tests apply to all kinds of DEFIBRILLATOR
types (manual, AEDs, INFREQUENT USE and FREQUENT USE DEFIBRILLATORS).
201.5.8 Sequence of tests
Addition:
The endurance test required in Clause 201.103 shall be performed after the test for excessive
temperatures (see B.19 of the general standard).
The tests required in Clauses 201.101, 201.102, 201.104, 201.105 and 201.106 shall be
performed after test B.35 of the general standard.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.2 * Protection against electric shock
Amendment:
Delete TYPE B APPLIED PART.
60601-2-4 Ó IEC:2010 – 13 –
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.7 * Electrical input power from the SUPPLY MAINS
Replacement of paragraph beginning "If the rating of ME EQUIPMENT includes .":
The RATED power input of mains operated ME EQUIPMENT shall be the maximum value attained
by averaging the power input over any period of 2 s.
Additional subclauses:
201.7.2.101 * 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.
Check compliance of auditory commands by the following test:
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 61672-1).
201.7.2.102 * INTERNALLY POWERED ME EQUIPMENT
INTERNALLY POWERED ME EQUIPMENT and any separate battery charger shall be marked with
brief instructions for, as appropriate, the re-charging or replacement of the battery.
If a connection to the SUPPLY MAINS or to a separate battery charger is provided, the
ME EQUIPMENT shall be marked to indicate any limitations of operation when the ME EQUIPMENT
is connected to the SUPPLY MAINS or to the battery charger. Such marking shall include a
description of the function as well as any limitations of operation of the ME EQUIPMENT with a
discharged or missing battery.
201.7.2.103 Disposable defibrillator electrodes
The labelling accompanying the electrode package shall include, at a minimum, the following
information:
a) symbols (in accordance with ISO 15223-1:2007) or a statement indicating the date the
electrodes will expire (e.g., "use before ____") and the lot number or the date of
manufacture;
b) 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;
c) appropriate instructions for use, including procedures for skin preparation;
d) instructions describing storage requirements, if applicable.
201.7.4 Marking of controls and instruments
Additional subclause:
– 14 – 60601-2-4 Ó IEC:2010
201.7.4.101 * Selected energy control
The DEFIBRILLATOR shall be provided with a means for choosing the SELECTED ENERGY, unless
the ME EQUIPMENT provides an automatic protocol for choosing the SELECTED ENERGY.
If the DEFIBRILLATOR is provided with means for the selection, continuously or in steps, of the
SELECTED ENERGY then an indication of the SELECTED ENERGY in joules shall be incorporated,
expressed as the nominal DELIVERED ENERGY in joules to a resistive load of 50 W.
Alternatively, the DEFIBRILLATOR may deliver a single preset energy, or a sequence of energies
according to a preset protocol described in the instructions for use. If the DEFIBRILLATOR is
designed to supply a single energy, or a programmed sequence of energies, no indication of
the SELECTED ENERGY is required.
Check compliance by inspection.
201.7.9.2 Instructions for use
201.7.9.2.4 * Electrical power source
Replacement:
For mains-operated ME EQUIPMENT with an additional power source not automatically
maintained in a fully usable condition, the instructions for use shall include a warning
statement referring to the necessity for periodic checking or replacement of such an additional
power source.
If leakage from a battery would result in an unacceptable RISK, the instructions for use shall
include a warning to remove the battery if the ME EQUIPMENT is not likely to be used for some
time.
The instructions for use shall provide information on 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.
If an INTERNAL ELECTRICAL POWER SOURCE is replaceable, the instructions for use shall state its
specification, and include full details of the charging procedure.
* The instructions for use shall contain advice on the periodic replacement of any primary or
rechargeable battery.
If loss of the power source would result in an unacceptable RISK, the instructions for use shall
contain a warning that the ME EQUIPMENT must be connected to an app
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