Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators (IEC 60601-2-4:2010/A1:2018)

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 (IEC 60601-2-4:2010/A1:2018)

Appareils électromédicaux - Partie 2-4: Exigences particulières pour la sécurité de base et les performances essentielles des défibrillateurs cardiaques (IEC 60601-2-4:2010/A1:2018)

Medicinska električna oprema - 2-4. del: Posebne zahteve za osnovno varnost in bistvene lastnosti srčnih defibrilatorjev - Dopolnilo A1 (IEC 60601-2-4:2010/A1:2018)

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
04-Nov-2019
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
23-Oct-2019
Due Date
28-Dec-2019
Completion Date
05-Nov-2019

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SLOVENSKI STANDARD
SIST EN 60601-2-4:2011/A1:2019
01-december-2019
Medicinska električna oprema - 2-4. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti srčnih defibrilatorjev - Dopolnilo A1 (IEC 60601-2-
4:2010/A1:2018)

Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and

essential performance of cardiac defibrillators (IEC 60601-2-4:2010/A1:2018)

Medizinische elektrische Geräte - Teil 2-4: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von Defibrillatoren (IEC 60601-2-

4:2010/A1:2018)

Appareils électromédicaux - Partie 2-4: Exigences particulières pour la sécurité de base

et les performances essentielles des défibrillateurs cardiaques (IEC 60601-2-
4:2010/A1:2018)
Ta slovenski standard je istoveten z: EN 60601-2-4:2011/A1:2019
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN 60601-2-4:2011/A1:2019 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 60601-2-4:2011/A1:2019
---------------------- Page: 2 ----------------------
SIST EN 60601-2-4:2011/A1:2019
EUROPEAN STANDARD EN 60601-2-4:2011/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2019
ICS 11.040.10
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/A1:2018)

Appareils électromédicaux - Partie 2-4: Exigences Medizinische elektrische Geräte - Teil 2-4: Besondere

particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der

essentielles des défibrillateurs cardiaques wesentlichen Leistungsmerkmale von Defibrillatoren

(IEC 60601-2-4:2010/A1:2018) (IEC 60601-2-4:2010/A1:2018)

This amendment A1 modifies the European Standard EN 60601-2-4:2011; it was approved by CENELEC on 2018-04-04. CENELEC

members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 CEN-CENELEC

Management Centre or to any CENELEC member.

This amendment 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 CEN-CENELEC Management Centre 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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN 60601-2-4:2011/A1:2019 E
---------------------- Page: 3 ----------------------
SIST EN 60601-2-4:2011/A1:2019
EN 60601-2-4:2011/A1:2019 (E)
European foreword

The text of document 62D/1549/FDIS, future IEC 60601-2-4/A1, prepared by SC 62D "Electromedical

equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to the IEC-

CENELEC parallel vote and approved by CENELEC as EN 60601-2-4:2011/A1:2019.
The following dates are fixed:

• latest date by which the document has to be implemented at national (dop) 2020-04-11

level by publication of an identical national standard or by endorsement

• latest date by which the national standards conflicting with the (dow) 2022-10-11

document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice

The text of the International Standard IEC 60601-2-4:2010/A1:2018 was approved by CENELEC as a

European Standard without any modification.
---------------------- Page: 4 ----------------------
SIST EN 60601-2-4:2011/A1:2019
EN 60601-2-4:2011/A1:2019 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements 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 1 Where an International Publication has been modified by common modifications, indicated by (mod), the relevant

EN/HD applies.

NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:

www.cenelec.eu.
The Annex ZA of EN 60601-1:2006 is applicable, except as follows:
Publication Year Title EN/HD Year
Addition
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
+A12 2014
+EN 60601-2010
1:2006/corrigendum
Mar. 2010
+AC 2014
+A11 2011
IEC 61000-4-2 - Electromagnetic compatibility (EMC) - PartE N 61000-4-2 -
4-2: Testing and measurement techniques
- Electrostatic discharge immunity test
ISO 15223-1 2016 EN ISO 15223-1 2016
+prA1
Amendment
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
---------------------- Page: 5 ----------------------
SIST EN 60601-2-4:2011/A1:2019
---------------------- Page: 6 ----------------------
SIST EN 60601-2-4:2011/A1:2019
IEC 60601-2-4
Edition 3.0 2018-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
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
INTERNATIONALE
ICS 11.040.10 ISBN 978-2-8322-5376-2

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 7 ----------------------
SIST EN 60601-2-4:2011/A1:2019
– 2 – IEC 60601-2-4:2010/AMD1:2018
 IEC 2018
FOREWORD

This amendment has been prepared by subcommittee 62D: Electromedical equipment, of IEC

technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62D/1549/FDIS 62D/1555/RVD

Full information on the voting for the approval of this amendment can be found in the report

on voting indicated in the above table.

The committee has decided that the contents of this amendment and the base publication will

remain unchanged until the stability date indicated on the IEC website 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.
_____________
201.1.1 * Scope
Replace the fourth existing paragraph by the following new paragraph:

This particular standard does not apply to implantable DEFIBRILLATORs, remote control

DEFIBRILLATORS, or separate stand-alone cardiac monitors (which are standardized by

IEC 60601-2-27:2011 [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. DEFIBRILLATOR

electrodes as described in 201.108 can also be used for ECG monitoring; however, due to the

larger electrode area, the requirements of IEC 60601-2-27 are not applicable for
DEFIBRILLATOR ELECTRODES.
201.2 Normative references

Replace, in the "Amendment" section, the existing reference IEC 60601-1-2, including its title,

by the following new reference:

IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic

safety and essential performance – Collateral Standard: Electromagnetic disturbances –

Requirements and tests
_______________
Numbers in square brackets refer to the bibliography.
---------------------- Page: 8 ----------------------
SIST EN 60601-2-4:2011/A1:2019
IEC 60601-2-4:2010/AMD1:2018 – 3 –
 IEC 2018
Replace, in the "Addition" section, the existing reference "ISO 15223-1:2007" by
"ISO 15223-1:2016"
Add, in the "Addition" section, the following new reference:

IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic

safety and essential performance
IEC 60601-1:2005/AMD1:2012
201.3 Terms and definitions
Replace the first existing paragraph by the following new paragraph:

For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and

IEC 60601-1:2005/AMD1:2012 apply, except as follows:
201.3.202
Replace the existing Note 2 by the following new note:

NOTE 2 Such ME EQUIPMENT may also include other monitoring or therapeutic functions (e.g. transcutaneous

pacing).
201.3.203
Add, after the definition, the following new note:

NOTE The CHARGING CIRCUITS for defibrillation and pacing functions may be separate or combined.

201.3.204

Replace the existing definition and note by the following new definition and note:

electrode intended to deliver an electrical pulse for the purpose of cardiac defibrillation and

which may also be used to provide transcutaneous pacing and other monitoring functions

NOTE DEFIBRILLATOR ELECTRODES may be internal or external and disposable or reusable.

201.3.206
Add, after the definition, the following new note:

NOTE The DISCHARGE CIRCUITS for defibrillation and pacing functions may be separate or combined.

201.3.209
Replace the existing note by the following new note:

NOTE The energy storage devices for defibrillation and pacing functions may be separate or combined.

Add, after 201.3.220, the following new term and definition:
201.3.221
PACER
EXTERNAL TRANSCUTANEOUS PACEMAKER

optional circuit within the DEFIBRILLATOR intended to stimulate the heart by a series of

electrical pulses via electrodes applied to the PATIENT's skin
201.7.2.103 Disposable defibrillator electrodes

Replace, in item a) of the existing paragraph, the reference "ISO 15223-1:2007" by

"ISO 15223-1:2016".
---------------------- Page: 9 ----------------------
SIST EN 60601-2-4:2011/A1:2019
– 4 – IEC 60601-2-4:2010/AMD1:2018
 IEC 2018
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Add, after 201.8.3, the following new subclause:
201.8.5.3 * MAXIMUM MAINS VOLTAGE
Addition:

Where the MAXIMUM MAINS VOLTAGE has been assigned the value of 250 V, and the derivation

of test voltage from the value of the MAXIMUM MAINS VOLTAGE includes a 110 % multiplier, that

multiplier shall not apply.
201.8.7.1 General requirements
Replace the existing instruction by the following new instruction:
Replacement of b) dash 4 with:
201.8.8.3 * Dielectric strength

Replace, in the "Addition" section, the first existing paragraph by the following new paragraph:

For the DEFIBRILLATOR and PACER high-voltage circuits, between high-voltage parts of opposite

polarity and high-voltage to low-voltage circuits, the following tests shall replace those of the

general standard.

Delete, in the second paragraph in the "Addition" section, the words "during discharging".

Replace, in the fifth paragraph of Test 1, the term "DEFIBRILLATOR" by "DEFIBRILLATOR or

PACER".

Replace, in the seventh paragraph of Test 1, the term "DEFIBRILLATORS" by "DEFIBRILLATORS or

PACERS".
Add, after the last paragraph of the Subclause, the following new paragraph:

For the dielectric tests of the general standard, the WORKING VOLTAGE is determined without

regard to the presence of defibrillation or pacing voltages.
201.8.9.1.5 * ME EQUIPMENT RATED for high altitudes
Replace the existing paragraph by the following new paragraph:

General standard subclause 8.9.1.5 does not apply to DEFIBRILLATORS rated for use at

altitudes up to 5  000 m.
201.8.9.1.101 * DEFIBRILLATOR ELECTRODES, high-voltage circuits and cables

Delete, in the note, the words "but is under consideration for future application".

Replace the existing item b), excluding the compliance statement, by the following new

paragraphs:

b) * Except for components where the adequacy of ratings can be demonstrated (e.g. by

component manufacturers' ratings or by the dielectric strength tests of 201.8.8.3 of this

standard) the CREEPAGE DISTANCES and AIR CLEARANCES of insulation between the

DEFIBRILLATOR or PACER high-voltage circuits and other parts, and between different parts

of the high-voltage circuits, shall be at least 3 mm/kV.
---------------------- Page: 10 ----------------------
SIST EN 60601-2-4:2011/A1:2019
IEC 60601-2-4:2010/AMD1:2018 – 5 –
 IEC 2018

This requirement shall also apply to the isolating means between the high-voltage circuit

of the DEFIBRILLATOR or PACER and other PATIENT circuits.
201.12.3 ALARM SYSTEMS
Delete the entire subclause, including 201.12.3.101.
201.12.4 Protection against hazardous output
Add, after 201.12.4.103, the following new subclause:
201.12.4.104 * Audible warnings prior to energy delivery

The DEFIBRILLATOR shall include an audible warning signal that indicates the DEFIBRILLATOR is

preparing to or is about to deliver energy to the PATIENT. The preparing-to or about-to-deliver-

energy-to-the-patient warning shall not be capable of being inhibited by the OPERATOR or

RESPONSIBLE ORGANIZATION. The warning shall occur:

a) for manual DEFIBRILLATORS and AEDs with OPERATOR activated discharge control, when the

discharge control is active;

b) for AEDs with automatic discharge control, at least 5 s prior to energy delivery.

The effectiveness of the audible warnings to mitigate the risk of unintentional energy delivery

OPERATOR or bystander shall be included in the RISK MANAGEMENT FILE.
to the
201.15.4.3.101 * Non-rechargeable battery replacement
Replace the existing title by the following new title:
201.15.4.3.101 * Battery replacement
201.101.1 Requirements for FREQUENT USE, MANUAL DEFIBRILLATORS
Replace, in the third paragraph, "201.7.2.101" by "201.7.2.102".
201.101.4 * Requirements for INFREQUENT USE, AUTOMATED EXTERNAL DEFIBRILLATORS
Replace the existing paragraph before the last by the following new paragraph:

In case of a DEFIBRILLATOR with non-rechargeable batteries, the test is to start with a battery

depleted by the delivery of the number of charge/discharge cycles after which it is specified

as still useable by the MANUFACTURER, or when the ME EQUIPMENT indicates that the battery

needs replacement, whichever comes first.
201.102.3.1 FREQUENT USE AED
Add, after the first paragraph, the following new paragraphs:

If the AED is incapable of meeting one of the above criteria due to the implementation of a

fixed protocol which does not meet the above criteria, select and use the available protocol

that most closely matches one of the provided criteria.

For a FREQUENT USE AED with a pre-programmed energy setting sequence, not changeable by

the OPERATOR or RESPONSIBLE ORGANIZATION, the AED shall be able to deliver 20 defibrillation

discharges at the pre-programmed setting. In case of pre-programmed energy setting

sequence being changeable by the OPERATOR or RESPONSIBLE ORGANIZATION, the AED shall be

able to deliver 20 defibrillation discharges at the maximum energy setting sequence

selectable.
---------------------- Page: 11 ----------------------
SIST EN 60601-2-4:2011/A1:2019
– 6 – IEC 60601-2-4:2010/AMD1:2018
 IEC 2018
201.102.3.2 INFREQUENT USE AED
Add, after the first pa
...

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