IEC 60601-2-26:2002

Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs

Specifies the particular safety requirements for electroencephalographs, i.e. devices to produce an electroencephalogram. This Particular Standard amends and supplements IEC 60601-1 (1988): Medical electrical equipment - Part 1: General requirements for safety as amended by its Amendment 1 (1991) and Amendment 2 (1995).

Appareils électromédicaux - Partie 2-26: Règles particulières de sécurité pour les électroencéphalographes

Spécifie les exigences particulières relatives à la sécurité des électroencéphalographes, c'est à dire des appareils permettant d'obtenir un electroencéphalogramme. La présente Norme Particulière modifie et complète la CEI 60601-1 (1988): Appareils électromédicaux - Partie 1: Règles générales de sécurité modifiée par son Amendement 1 (1991) et son Amendement 2 (1995).

General Information

• Status: Published
• Publication Date: 20-Nov-2002
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 29-May-2012

Relations

• Revised: IEC 60601-2-26:2012 - Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
60601-2-26
Second edition
2002-11
Medical electrical equipment –
Part 2-26:
Particular requirements for the safety
of electroencephalographs
Appareils électromédicaux –
Partie 2-26:
Règles particulières de sécurité pour les
électroencéphalographes
Reference number
Publication numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1.
Consolidated editions
The IEC is now publishing consolidated versions of its publications. For example,
edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the
base publication incorporating amendment 1 and the base publication incorporating
amendments 1 and 2.
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INTERNATIONAL IEC
STANDARD
60601-2-26
Second edition
2002-11
Medical electrical equipment –
Part 2-26:
Particular requirements for the safety
of electroencephalographs
Appareils électromédicaux –
Partie 2-26:
Règles particulières de sécurité pour les
électroencéphalographes
 IEC 2002  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: [phone] Telefax: [phone] E-mail: [e-mail]  Web: www.iec.ch
PRICE CODE
Commission Electrotechnique Internationale
R
International Electrotechnical Commission
Международная Электротехническая Комиссия
For price, see current catalogue

– 2 – 60601-2-26  IEC:2002(E)
CONTENTS
FOREWORD . 4
INTRODUCTION .6
SECTION ONE – GENERAL
*1 Scope and object . 7
2 Terminology and definitions . 8
*4 General requirements for tests. 9
5 Classification . 9
*6 Identification, marking and documents . 9
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13 General .10
14 Requirements related to classification.11
*17 Separation .11
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS .12
*20 Dielectric strength.12
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
*36 ELECTROMAGNETIC COMPATIBILITY.13
SECTION SIX– PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
OTHER SAFETY HAZARDS
*42 Excessive temperatures.14
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION AGAINST
HAZARDOUS OUTPUT
50 Accuracy of OPERATING data.14

60601-2-26 © IEC:2002(E) – 3 –
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly .14
Appendix L References - Publications mentioned in this standard .17
Annex AA (informative) General guidance and rationale .18
Index of defined terms.20
*Figure 101 – Application of the test voltage to test the delivered defibrillator energy
(see 17h)) .15
Figure 102 – Set-up for test of radiated and conducted emissions (see 36.201.1.7) .16

– 4 – 60601-2-26  IEC:2002(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
__________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-26: Particular requirements for the safety of
electroencephalographs
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. Their preparation is
entrusted to technical committees; any IEC National Committee interested in the subject dealt with may
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Organization for Standardization (ISO) in accordance with conditions determined by agreement between the
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2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an
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3) The documents produced have the form of recommendations for international use and are published in the form
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4) In order to promote international unification, IEC National Committees undertake to apply IEC International
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divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-26 has been prepared by sub-committee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition published in 1994 and constitutes a
technical revision.
The text of this standard is based on the following documents:
FDIS Report on Voting
62D/463/FDIS 62D/466/RVD
Full information on the voting for the approval of this standard can be found in the report of
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives Part 2.
In this Particular Standard the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type;
– notes, explanations, advice, introductions, general statements, exceptions and references: smaller roman type;
– test specifications: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD:
SMALL CAPITALS.
60601-2-26 © IEC:2002(E) – 5 –
The committee has decided that the contents of this publication will remain unchanged until
2006. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
– 6 – 60601-2-26  IEC:2002(E)
INTRODUCTION
This Particular Standard concerns the safety of electroencephalographs. It amends and
supplements IEC 60601-1 (second edition 1988): Medical electrical equipment – Part 1:
General requirements for safety, including its Amendment 1 (1991) and Amendment 2 (1995),
hereinafter referred to as the General Standard.
A "General guidance and rationale" for the requirements of this Particular Standard is
included in Annex AA. It is considered that a knowledge of the reasons for these requirements
will not only facilitate the proper application of the standard but will, in due course, expedite
any revision necessitated by changes in clinical practice or as a result of developments in
technology. However, Annex AA does not form part of the requirements of this standard.
An asterisk (*) by a clause or subclause number indicates that explanatory notes are given in
Annex AA of this Particular Standard.

60601-2-26 © IEC:2002(E) – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-26: Particular requirements
for the safety of electroencephalographs
SECTION ONE – GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
*1.1 Scope
Addition:
This Particular Standard specifies the particular safety requirements for ELECTRO-
ENCEPHALOGRAPHS as defined in 2.2.103 and also referred to as EQUIPMENT.
The special requirements for other equipment also used in electroencephalography are not
covered by this standard, for example:
− cerebral function monitors;
− phono-photic stimulators;
− electroencephalographic telemetry;
− EEG data storage and retrieval;
− EQUIPMENT particularly intended for monitoring during electro-convulsive therapy;
− ambulatory electroencephalographic recorders.
1.2 Object
Replacement:
The object of this Particular Standard is to specify particular requirements for the safety of
ELECTROENCEPHALOGRAPHS.
1.3 Particular Standards
Addition:
This Particular Standard amends and supplements IEC 60601-1 (1988): Medical electrical
equipment – Part 1: General requirements for safety as amended by its Amendment 1 (1991)
and Amendment 2 (1995).
For brevity, IEC 60601-1 is referred to in this Particular Standard either as the “General
Standard” or as the “General Requirement(s)”, and IEC 60601-1-2 and IEC 60601-1-4 as the
“Collateral Standards”.
The numbering of sections, clauses and subclauses of this Particular Standard corresponds
with that of the General Standard. The changes to the text of the General Standard are
specified by the use of the following words:
“Replacement” means that the clause or subclause of the General Standard is replaced
completely by the text of this Particular Standard.

– 8 – 60601-2-26  IEC:2002(E)
“Addition” means that the text of this Particular Standard is additional to the requirements of
the General Standard.
“Amendment” means that the clause or subclause of the General Standard is amended as
indicated by the text of this Particular Standard.
Subclauses or figures which are additional to those of the General Standard are numbered
starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb),
etc.
The term “this Standard” is used to make reference to the General Standard and this
Particular Standard taken together.
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause of the General Standard, although possibly not relevant, applies
without modification; where it is intended that any part of the General Standard, although
possibly relevant, is not to be applied, a statement to that effect is given in this Particular
Standard.
The requirements of this Particular Standard take priority over those of the General Standard
and Collateral Standards mentioned above.
1.7 Collateral Standards
IEC 60601-1-2:2001, Medical electrical equipment – Part 1-2: General requirements for safety
– Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-1-4:1996, Medical electrical equipment – Part 1: General requirements for safety –
4. Collateral Standard: Programmable electrical medical systems
2 Terminology and definitions
2.2 EQUIPMENT types (classification)
Addition:
2.2.101
CHANNEL
complete system for the amplification and conditioning of potential differences between a pair
or combination of ELECTRODES
2.2.102
ELECTROENCEPHALOGRAM (EEG)
dis
...

IEC 60601-2-26
Edition 2.0 2002-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-26: Particular requirements for the safety of electroencephalographs

Appareils électromédicaux –
Partie 2-26: Règles particulières de sécurité pour les électroencéphalographes

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IEC 60601-2-26
Edition 2.0 2002-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-26: Particular requirements for the safety of electroencephalographs

Appareils électromédicaux –
Partie 2-26: Règles particulières de sécurité pour les électroencéphalographes

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
S
CODE PRIX
ICS 11.040.55; 11.040.99 ISBN 2-8318-7319-3
– 2 – 60601-2-26 © CEI:2002
SOMMAIRE
AVANT-PROPOS.6
INTRODUCTION.10

SECTION UN – GENERALITES
1 Domaine d’application et objet .12
2 Terminologie et définitions .14
4 Prescriptions générales relatives aux essais.16
5 Classification .16
6 Identification, marquage et documentation .16

SECTION DEUX – CONDITIONS D'ENVIRONNEMENT

SECTION TROIS – PROTECTION CONTRE LES RISQUES DE CHOCS
ELECTRIQUES
13 Généralités .20
14 Prescriptions relatives à la classification .20
17 Séparation .20
19 Courants de fuite permanents et courant auxiliaire patient .22
20 Tension de tenue .22

SECTION QUATRE – PROTECTION CONTRE LES RISQUES MECANIQUES

SECTION CINQ – PROTECTION CONTRE LES RISQUES DUS AUX
RAYONNEMENTS NON DESIRES OU EXCESSIFS
36 Compatibilité électromagnétique .24

SECTION SIX – PROTECTION CONTRE LES RISQUES D'IGNITION
DE MELANGES ANESTHESIQUES INFLAMMABLES

SECTION SEPT – PROTECTION CONTRE LES TEMPERATURES EXCESSIVES
ET LES AUTRES RISQUES
42 Températures excessives .26

SECTION HUIT – PRECISION DES CARACTERISTIQUES DE FONCTIONNEMENT
ET PROTECTION CONTRE LES CARACTERISTIQUES DE SORTIE
PRESENTANT DES RISQUES
50 Précision des caractéristiques de fonctionnement .28

SECTION NEUF – FONCTIONNEMENT ANORMAL ET CONDITIONS DE DEFAUT;
ESSAIS D'ENVIRONNEMENT
60601-2-26 © IEC:2002 – 3 –
CONTENTS
FOREWORD.7
INTRODUCTION.11

SECTION ONE – GENERAL
*1 Scope and object.13
2 Terminology and definitions.15
*4 General requirements for tests .17
5 Classification.17
*6 Identification, marking and documents.17

SECTION TWO – ENVIRONMENTAL CONDITIONS

SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13 General.21
14 Requirements related to classification .21
*17 Separation.21
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS .23
*20 Dielectric strength.23

SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS

SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
*36 ELECTROMAGNETIC COMPATIBILITY.25

SECTION SIX– PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
OTHER SAFETY HAZARDS
*42 Excessive temperatures.27

SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION AGAINST
HAZARDOUS OUTPUT
50 Accuracy of OPERATING data .29

SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
– 4 – 60601-2-26 © CEI:2002
SECTION DIX – REGLES DE CONSTRUCTION
56 Composants et ensembles .28

ANNEXE L (normative) Références – Publications mentionnées dans la présente
norme .34
Annexe AA (informative) Guide général et justifications .36

Index des termes définis .42

*Figure 101 – Application de la tension d’essai pour l’essai de l’énergie délivrée par le
défibrillateur (voir 17h)). 30
Figure 102 – Montage d’essai des émissions rayonnées et conduites (voir 36.201.1 7) .32

60601-2-26 © IEC:2002 – 5 –
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly .29

Appendix L References - Publications mentioned in this standard .35
Annex AA (informative) General guidance and rationale.37

Index of defined terms .43

*Figure 101 – Application of the test voltage to test the delivered defibrillator energy
(see 17h)) .31
Figure 102 – Set-up for test of radiated and conducted emissions (see 36.201.1 b) 1)).33

– 6 – 60601-2-26 © CEI:2002
COMMISSION ELECTROTECHNIQUE INTERNATIONALE
__________
APPAREILS ÉLECTROMÉDICAUX –
Partie 2-26: Règles particulières de sécurité
pour les électroencéphalographes

AVANT-PROPOS
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m
...