SIST EN 60601-2-4:2011
Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators
Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators
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. 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). 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.
Medizinische elektrische Geräte - Teil 2-4: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Defibrillatoren
Appareils électromédicaux - Partie 2-4: Exigences particulières pour la sécurité de base et les performances essentielles pour les défibrillateurs cardiaques
La CEI 60601-2-4:2010 établit des exigences particulières de sécurité de base et de performances essentielles pour les défibrillateurs cardiaques. Cette troisième édition annule et remplace la deuxième édition publiée en 2002. La présente édition constitue une révision technique dont la structure est alignée sur la CEI 60601-1:2005, et est destinée à mettre en oeuvre la décision du SC 62A de la CEI selon laquelle la structure de numérotation des articles des normes particulières rédigées selon la CEI 60601-1:2005 respecterait la forme spécifiée dans les directives ISO/CEI, partie 2:2004. Cette troisième édition est destinée à mettre à jour la présente norme particulière par rapport à la troisième édition de la norme générale par une nouvelle mise en forme et des modifications techniques.
Medicinska električna oprema - 2-4. del: Posebne zahteve za osnovno varnost in bistvene lastnosti srčnih defibrilatorjev
Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI SRČNIH DEFIBLIRATORJEV, v nadaljevanju ME OPREME. Če bo točka ali podtočka izrecno namenjena samo uporabi za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te točke ali podtočke to tudi navedla. Sicer točka in podtočka veljata za ustrezno ME OPREMO in ME SISTEME. NEVARNOSTI, ki so del fiziološkega delovanja ME OPREME ali ME SISTEMOV v okviru uporabe tega standarda, niso zajete s posebnimi zahtevami tega standarda, razen v točkah 7.2.13 in 8.4.1 splošnega standarda. Ta določeni standard ne velja za vsajene defibrilatorje, DEFIBLIRATORJE z daljinskim upravljanjem, zunanje transkutane srčne spodbujevalnike ali ločene samostojne srčne monitorje (ki so standardizirani z IEC 60601-2-27). Srčni monitorji, ki uporabljajo ločene elektrode ECG za spremljanje, niso v okviru uporabe tega standarda, razen če se uporabljajo izključno za zaznavo prepoznave ritma AED ali zaznave utripa za sinhronizirano kardioverzijo. Tehnologija defibrilatorskih valovnih oblik se hitro razvija. Objavljene študije navajajo, da se učinkovitost valovnih oblik razlikuje. Izbira določene valovne oblike, vključno z obliko vala, dobavljeno energijo, učinkovitostjo in varnostjo, je bila izrecno izključena iz uporabe tega standarda. Vendar so bili zaradi kritične pomembnosti terapevtske valovne oblike utemeljitvi, ki obravnava razloge za valovno obliko in njeno izbiro, dodani komentarji.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 60601-2-4:2011
01-oktober-2011
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLVUþQLKGHILEULODWRUMHY
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
SIST EN 60601-2-4:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 60601-2-4:2011
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SIST EN 60601-2-4:2011
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
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SIST EN 60601-2-4:2011
EN 60601-2-4:2011 - 2 -
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.
EN 60601-2-4:2011 constitutes a technical revision, revised to structurally align it with EN 60601-1:2006
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.
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– 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.
__________
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SIST EN 60601-2-4:2011
EN 60601-2-4:2011 - 4 -
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
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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.
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SIST EN 60601-2-4:2011
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SIST EN 60601-2-4:2011
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
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN 60601-2-4:2011
– 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
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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
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SIST EN 60601-2-4:2011
– 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;
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SIST EN 60601-2-4:2011
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;
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SIST EN 60601-2-4:2011
– 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.
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SIST EN 60601-2-4:2011
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
1
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
2
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.
—————————
1
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.
2
Numbers in square brackets refer to the bibliography.
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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 tha
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