EN 60601-2-4:2011

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

IEC 60601-2-4:2010 establishes particular basic safety and essential performance requirements for cardiac defibrillators. 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.

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 des 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

• Status: Published
• Publication Date: 18-Aug-2011
• Withdrawal Date: 11-Jan-2014
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 19-Aug-2011
• Completion Date: 19-Aug-2011
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-4:2011 - Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators

Relations

• Replaces: EN 60601-2-4:2003 - Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators
• Effective Date: 28-Jan-2023
• Amended By: EN 60601-2-4:2011/A1:2019 - Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
• Effective Date: 26-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2011
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]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
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 .
...