EN 60601-2-26:2015

SLOVENSKI STANDARD
01-september-2015
1DGRPHãþD
SIST EN 60601-2-26:2004
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLHOHNWURHQFHIDORJUDIRY
Medical electrical equipment - Part 2-26: Particular requirements for basic safety and
essential performance of electroencephalographs
Medizinische elektrische Geräte - Teil 2-26: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Elektroenzephalographen
Appareils électromédicaux - Partie 2-26: Règles particulières pour la sécurité de base et
les performances essentielles des électroencéphalographes
Ta slovenski standard je istoveten z: EN 60601-2-26:2015
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-26

NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.040.55; 11.040.99 Supersedes EN 60601-2-26:2003
English Version
Medical electrical equipment - Part 2-26: Particular requirements
for the basic safety and essential performance of
electroencephalographs
(IEC 60601-2-26:2012)
Appareils électromédicaux - Partie 2-26: Exigences Medizinische elektrische Geräte - Teil 2-26: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des électroencéphalographes wesentlichen Leistungsmerkmale von
(IEC 60601-2-26:2012) Elektroenzephalographen
(IEC 60601-2-26:2012)
This European Standard was approved by CENELEC on 2015-04-14. 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 CEN-CENELEC
Management Centre 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 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-26:2015 E
Foreword
The text of document 62D/990/FDIS, future edition 3 of IEC 60601-2-26, 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 60601-2-26:2015.
The following dates are fixed:
(dop) 2016-01-14
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2018-04-14
• latest date by which the national standards conflicting with
the document have to be withdrawn

This document supersedes EN 60601-2-26:2003.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 60601-2-26:2012 was approved by CENELEC as a
European Standard without any modification.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When 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.

Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
In Annex ZA of EN 60601-1:2006 replace IEC 60601-1-2 by:
IEC 60601-1-2 (mod) 2007 Medical electrical equipment - EN 60601-1-2 2007
Part 1-2: General requirements for basic
- -  + corrigendum Mar. 2010
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and tests
Add to Annex ZA of EN 60601-1:2006 the following new references:
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic
- -  + corrigendum Mar. 2010
safety and essential performance
- -  + A12 2014
IEC 60601-2-27 2011 Medical electrical equipment - EN 60601-2-27 2014
Part 2-27: Particular requirements for the
basic safety and essential performance
of electrocardiographic monitoring
equipment
Annex ZZ
(informative)
Coverage of Essential Requirements of EU 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 given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
IEC 60601-2-26 ®
Edition 3.0 2012-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

Part 2-26: Particular requirements for the basic safety and essential performance

of electroencephalographs
Appareils électromédicaux –
Partie 2-26: Exigences particulières pour la sécurité de base et les performances

essentielles des électroencéphalographes

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX U
ICS 11.040.55; 11.040.99 ISBN 978-2-83220-117-6

– 2 – 60601-2-26 © IEC:2012
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 8
201.3 Terms and definitions . 8
201.4 General requirements . 9
201.5 General requirements for testing of ME EQUIPMENT . 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 10
201.7 ME EQUIPMENT identification, marking and documents. 11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 12
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 17
201.10 Protection against unwanted and excessive radiation HAZARDS . 17
201.11 Protection against excessive temperatures and other HAZARDS . 17
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 18
201.13 HAZARDOUS SITUATIONS and fault conditions . 23
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23
201.15 Construction of ME EQUIPMENT . 23
201.16 ME SYSTEMS . 23
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 23
202 ELECTROMAGNETIC COMPATIBILITY – Requirements and tests . 23
Annexes . 26
Annex AA (informative) Particular guidance and rationale . 27
Index of defined terms used in this particular standard. 29

Figure 201.101 – Test of protection against the effects of defibrillation (common mode) . 14
Figure 201.102 – Test of protection against the effects of defibrillation (differential
mode) . 15
Figure 201.103 – Application of the test voltage between LEAD WIRES to test the energy
delivered by the defibrillator . 16
Figure 201.104 – General test circuit . 20
Figure 201.105 – Test circuit for COMMON MODE REJECTION . 22
Figure 202.101 – Test layout for radiated and conducted EMISSION test and radiated
immunity test . 24
Figure 202.102 – Set-up for radiated immunity test according to 202.6.2.3.2 . 25

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 10

60601-2-26 © IEC:2012 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-26: Particular requirements for the basic safety
and essential performance of electroencephalographs

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 60601-2-26 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 of IEC 60601-2-26 published in
2002. This edition constitutes a technical revision to the new structure of the third edition
(2005) of IEC 60601-1.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/990/FDIS 62D/1012/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.

– 4 – 60601-2-26 © IEC:2012
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 collateral 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.
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.
60601-2-26 © IEC:2012 – 5 –
INTRODUCTION
This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ELECTROENCEPHALOGRAPHS. It amends and supplements IEC 60601-1 (third edition, 2005):
Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance), hereinafter referred to as the general standard.
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 requirements of this particular standard take priority over those of the general standard.
A “General guidance and rationale” for the more important requirements of this particular
standard is included in Annex AA. It is considered that 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.
– 6 – 60601-2-26 © IEC:2012
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-26: Particular requirements for the basic safety
and essential performance of electroencephalographs

201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of
ELECTROENCEPHALOGRAPHS (EEG) as defined in 201.3.63, hereafter referred to as
ME EQUIPMENT. This standard is applicable to ME EQUIPMENT used in a clinical environment
(e.g., hospital, physician’s office, etc.).
This standard does not cover requirements for other equipment used in
electroencephalography such as:
– phono-photic stimulators;
– electroencephalographic telemetry;
– EEG data storage and retrieval;
– ME EQUIPMENT particularly intended for monitoring during electro-convulsive therapy;
– ambulatory electroencephalographic recorders.
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.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for ELECTROENCEPHALOGRAPHS as defined in 201.3.63.
201.1.3 Collateral standards
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.
—————————
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.

60601-2-26 © IEC:2012 – 7 –
IEC 60601-1-2 applies as modified in Clause 202. IEC 60601-1-3 and IEC 60601-1-10 do not
apply. 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
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
—————————
IEC 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for basic safety and
essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop
controllers
– 8 – 60601-2-26 © IEC:2012
201.2 Normative references
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 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-2-27:2011, Medical electrical equipment – Part 2-27: Particular requirements for
the basic safety and essential performance of electrocardiographic monitoring equipment
201.3 Terms and definitions
NOTE An index of defined terms is found beginning on page 29.
For the purpose of this document, the terms and definitions given in IEC 60601-1:2005 apply,
except as follows:
201.3.63
MEDICAL ELECTRICAL EQUIPMENT
Replacement:
ELECTROENCEPHALOGRAPH
ME EQUIPMENT
device to produce an ELECTROENCEPHALOGRAM
Additional definitions:
201.3.201
CHANNEL
hardware and/or software selection of a particular electroencephalographic LEAD for purposes
of display, recording, or transmission
[SOURCE: IEC 60601-2-25:2011, definition 201.3.202, modified – The definition has been
LEAD. ]
changed to refer to an electroencephalographic rather than an electrocardiographic
201.3.202
ELECTROENCEPHALOGRAM
EEG
presentation (on screen or paper) of the variation with time of voltages taken from
ELECTRODES, whose positions are specified
[SOURCE: IEC 60050-891:1998, 891-04-23, modified – The wording of the definition has
been changed slightly.]
201.3.203
ELECTRODE
sensor that is applied to the scalp or is inserted into a region of the brain to detect electrical
activity
60601-2-26 © IEC:2012 – 9 –
[SOURCE: IEC 60601-2-25:2011, definition 201.3.208 modified – The definition has been
changed to refer specifically to an electroencephalographic application.]
201.3.204
GAIN
ratio of the amplitude of the output signal to the amplitude of the input signal
Note 1 to entry GAIN is expressed in mm/µV.
201.3.205
LEAD
voltage between ELECTRODES
[SOURCE: IEC 60601-2-27:2011, definition 201.3.206]
201.3.206
LEAD WIRE
cable connected between an ELECTRODE and either a PATIENT CABLE or the ME EQUIPMENT
[SOURCE: IEC 60601-2-27:2011, definition 201.3.208]
201.3.207
NEUTRAL ELECTRODE
reference point for differential amplifiers and/or interference suppression circuits, not intended
to be used to calculate any LEAD
[SOURCE: IEC 60601-2-25:2011, definition 201.3.213]
201.3.208
PATIENT CABLE
multiwire cable used to connect LEAD WIRES to ME EQUIPMENT
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Addition:
201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements
Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
Table 201.101.
– 10 – 60601-2-26 © IEC:2012
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Accuracy of signal reproduction 201.12.1.101.1
Input dynamic range and differential offset voltage 201.12.1.101.2
Input noise 201.12.1.101.3
Frequency response 201.12.1.101.4
Common mode rejection 201.12.1.101.5

201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.4 Other conditions
Addition:
aa) Unless otherwise stated, tests shall be carried out with the ACCESSORIES and the recording
materials specified by the MANUFACTURER.
For ME EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE, if the test result is
affected by the INTERNAL ELECTRICAL POWER SOURCE voltage, then the test shall be
performed using the least favourable INTERNAL ELECTRICAL POWER SOURCE voltage
specified by the MANUFACTURER. If necessary for the purpose of conducting the test, an
external battery or d.c. power supply may be used to provide the necessary test voltage.
The values used in test circuits, unless otherwise specified, shall have at least an
accuracy as given below:
– resistors: ± 1 %;
– capacitors: ± 10 %;
– inductors: ± 10 %;
– test voltages: ± 1 %.
201.5.8 *Sequence of tests
Amendment:
Tests called for in 201.8.5.5.1 of this particular standard and in 8.5.5 of the general standard
shall be carried out prior to the LEAKAGE CURRENT and dielectric strength tests described in
subclauses 8.7 and 8.8 of the general standard and prior to the tests specified in
subclause 201.12.1.101 of this particular 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
Replacement of the last paragraph:

60601-2-26 © IEC:2012 – 11 –
APPLIED PARTS shall be classified as TYPE BF or TYPE CF APPLIED PARTS (see 7.2.10 and 8.3 b)
of the general standard).
201.6.6 Mode of operation
Replacement:
ME EQUIPMENT shall be classified for CONTINUOUS OPERATION.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
*201.7.2.1 Minimum requirements for marking on ME EQUIPMENT and on
interchangeable parts
Addition:
If the ME EQUIPMENT is specified as being protected against the effects of defibrillation:
Parts of ME EQUIPMENT (for example, PATIENT CABLES or sensors) specified as being protected
against the effects of defibrillation shall be marked with symbol 26 or 27 of Table D.1 in
Appendix D of the general standard according to the classification as TYPE BF APPLIED PART or
TYPE CF APPLIED PART.
201.7.9.2 Instructions for use
Additional subclause:
201.7.9.2.101 Additional instructions for use
The instructions for use shall also include:
a) The INTENDED USE/INTENDED PURPOSE including environment of use.
Likely misuse should be identified by risk analysis and disclosed if necessary (e.g. ‘not for
determination of brain death’).
b) The procedures necessary for safe operation.
POTENTIAL EQUALIZATION CONDUCTOR, if applicable.
c) Instructions for connecting a
d) That conductive parts of ELECTRODES and associated connectors for APPLIED PARTS,
including the NEUTRAL ELECTRODE, should not contact other conductive parts including
earth.
e) Advise for the OPERATOR regarding whether the ME EQUIPMENT incorporates means to
protect the PATIENT against burns when used with high frequency surgical equipment.
Advice shall be given regarding the location of ELECTRODES and LEAD WIRES etc, to reduce
the hazard of burns in the event of a defect in the neutral electrode connection of the high
frequency surgical equipment.
f) *The need for regular testing of the ME EQUIPMENT and its ACCESSORIES.
PATIENT; a description of how the
g) Precautions to take when using a defibrillator on a
discharge of a defibrillator affects the ME EQUIPMENT; a warning that defibrillator protection
requires use of MANUFACTURER specified ACCESSORIES including LEAD WIRES and
PATIENT CABLES. The specification (or type-number) of such accessories shall be disclosed
(see 201.8.5.5.1).
h) The choice and application of specified PATIENT CABLES and LEAD WIRES; the choice and
application of ELECTRODES.
– 12 – 60601-2-26 © IEC:2012
i) The subsequent operation of the ME EQUIPMENT after interruption of SUPPLY MAINS
exceeding 30 s (see 201.11.8).
j) Any HAZARD due to simultaneous use of other PATIENT-connected ME EQUIPMENT, for
example, a cardiac pacemaker or other electrical stimulators.
k) Technical specifications for the ME EQUIPMENT of sufficient detail to allow the OPERATOR to
understand what is being measured and any limitations. Minimally this shall include:
– frequency range and bandwidth;
– a description of all functions;
– a description of waveform displays (if applicable).
l) *Any known susceptibilities to electromagnetic phenomena.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
201.8.1 Fundamental rule of protection against electrical shock
Addition:
201.8.101 Multipurpose channel(s)
If ELECTROENCEPHALOGRAPHS allow CHANNELS to be used for signals other than EEG, then this
facility shall be tested to applicable clauses of relevant standards.
Compliance is checked by inspection.
201.8.3 Classification of APPLIED PARTS
Replacement of items a), b), and c):
The APPLIED PART of the ME EQUIPMENT shall be TYPE BF APPLIED PART or
TYPE CF APPLIED PART.
Compliance is checked by inspection.
201.8.5.2.3 PATIENT LEADS
Addition:
NOTE 101 For EMC (ELECTROMAGNETIC COMPATIBILITY) and physical cable management, LEADS of
ELECTROENCEPHALOGRAPH are usually kept short and tied together. Therefore any LEAD which falls off will stay in
the vicinity of the PATIENT’S head, therefore there are no additional requirements for conductive connections to the
part of the LEAD which connects to the ELECTRODE (PATIENT-side).
201.8.5.5 DEFIBRILLATION-PROOF APPLIED PARTS
201.8.5.5.1 Defibrillation protection
Addition:
If protection against the effects of defibrillation is provided for ME EQUIPMENT the following
tests shall be performed:
For defibrillator testing the ME EQUIPMENT is operated using the PATIENT CABLES as specified
by the MANUFACTURER.
60601-2-26 © IEC:2012 – 13 –
The following requirements and tests apply in addition to the requirements and tests as
specified in 8.5.5.1 of the general standard.
• Common mode test
Addition:
Within 30 s after exposure to the defibrillation voltage, the ME EQUIPMENT shall resume normal
operation in the previous operating mode, without loss of any OPERATOR settings or stored
data, and shall continue to perform its intended function as specified in this particular
standard.
Compliance is checked according to Figure 201.101.
For ME EQUIPMENT of CLASS I, apply the test voltage between all LEAD WIRES (E …E ),
2 x
including the NEUTRAL ELECTRODE E, connected together and the PROTECTIVE
N
EARTH TERMINAL. Energize the ME EQUIPMENT for these tests.
In the case of ME EQUIPMENT of CLASS II and ME EQUIPMENT with an
INTERNAL ELECTRICAL POWER SOURCE, apply the test voltage between all LEAD WIRES, including
the NEUTRAL ELECTRODE, connected together and the FUNCTIONAL EARTH TERMINAL and/or
metal foil in close contact with the ENCLOSURE. Energize the ME EQUIPMENT for these tests.
Test ME EQUIPMENT having an INTERNAL ELECTRICAL POWER SOURCE, which is rechargeable
from the SUPPLY MAINS with and without the SUPPLY MAINS connection if the ME EQUIPMENT is
capable of operating while connected to SUPPLY MAINS.
Set the GAIN of the ME EQUIPMENT such that a 0,5 mV signal produces a maximum display
deflection without clipping the signal. With S2 closed and S3 open, adjust the 10 Hz sine
wave generator to produce a 0,5 mV peak-to-valley output signal. Open switch S2 and close
S3.
Connect S1 to position A and charge the capacitor C. After about 10 s, connect S1 to
position B. Leave in position B for 200 ms ± 50 %. Allow recovery to begin opening S2 to
remove residual voltages from the ME EQUIPMENT.
Immediately close S2 and open S3. Within 30 s, verify that the recorded test signal
is not less than 0,5 mV peak-to-valley referred to the input.
Repeat the above test with the polarity of the high voltage source reversed. Repeat the tests
with positive and negative polarities 5 times.
The ME EQUIPMENT shall resume normal operation in the previous operating mode, without
loss of any OPERATOR settings or stored data within 30 s and shall continue to perform its
intended function as specified in this particular standard.

– 14 – 60601-2-26 © IEC:2012
G
S
R
R 50 Ω
470 kΩ
R
V non-inductive
P 1
E
V
A B
S
S
EUT
5 kV d.c.
E
R
L 500 µH
100 Ω
R (d.c.) ≤ 10 Ω
L
E
non-
inductive
E
x
C 32 µF E
N
P 2
F
IEC  1010/12
Components
G Sine wave generator 10 Hz
V High voltage source 5 kV d.c.
Foil, simulating capacitance for CLASS II ME EQUIPMENT
Ⓕ
S Switch; max. load 60 A, 5 kV
S Switch activating the signal source
S Switch applying the signal source to LEAD WIRES
R d.c. resistance of inductance L
L
R Current limiting resistor
V
P1, P2 Connecting points for EUT (includes PATIENT CABLES)
Test to be conducted with MANUFACTURER’S recommended PATIENT CABLE and LEAD WIRES.
Figure 201.101 – Test of protection against the effects of defibrillation
(common mode)
• Differential mode test
Addition:
Within 30 s after exposure to the defibrillation voltage, the ME EQUIPMENT shall resume normal
operation in the previous operating mode, without loss of any OPERATOR settings or stored
data, and shall continue to perform its intended function as described in this particular
standard.
ME EQUIPMENT having an INTERNAL ELECTRICAL POWER SOURCE which is rechargeable from the
SUPPLY MAINS shall be tested with and without the SUPPLY MAINS connection if the
ME EQUIPMENT is capable of operating while connected to the SUPPLY MAINS.
Compliance is checked by the following test:

60601-2-26 © IEC:2012 – 15 –
The ME EQUIPMENT is connected to the test circuit shown in Figure 201.102. The test voltage is
applied to each LEAD WIRE in turn with all the remaining LEAD WIRES being connected to earth.
Initially, the test is conducted applying the test voltage between the E LEAD WIRE and all
remaining LEAD WIRES (E …E ) connected to the E LEAD WIRE. The ME EQUIPMENT shall be
2 x
N
energized for these tests.
Set the GAIN of the ME EQUIPMENT such that a 0,5 mV signal produces a maximum display
deflection without clipping the signal. With S2 closed, adjust the 10 Hz sine wave generator to
produce a 0,5 mV peak-to-valley output signal. Open switch S2.
Connect S1 to position A and charge the capacitor C. After about 10 s, connect S1 to position
B. Leave in position B for 200 ms ± 50 %. Allow recovery to begin by opening S1 to remove
residual voltages from ME EQUIPMENT.
Immediately close S2 and open S3. Within 30 s, verify that the recorded test signal
is not less than 0,5 mV peak-to-valley referred to the input:
Repeat the test for any other LEAD WIRE with all remaining LEAD WIRES connected to the
E LEAD WIRE. The discharge test is applied at 20 s intervals in those cases where more than
N
one discharge is indicated.
G
S
R
R 50 Ω
470 kΩ
non-inductive
R
V P 1
E
V
A B
S
5 kV d.c.
EUT
R 100 Ω
L 500 µH
non-inductive
E
R (d.c.) ≤ 10 Ω
L
E
E
x
C 32 µF
E
N
P 2
IEC  1011/12
Components
G Sine wave generator 10 Hz
V High voltage source 5 kV d.c.
S Switch; max. load 60 A, 5 kV
S Switch activating the signal source
R d.c. resistance of inductance L
L
R Current limiting resistor
V
P1, P2 Connecting points for EUT (includes PATIENT CABLES)
Test to be conducted with MANUFACTURER’s recommended PATIENT CABLE.
Figure 201.102 – Test of protection against the effects of defibrillation
(differential mode)
– 16 – 60601-2-26 © IEC:2012
201.8.5.5.2 Energy reduction test
Addition:
The test setup for energy reduction test is shown in Figure 201.103:
R 400 Ω
non-inductive
R
V
E
C E
V
1 A B
S
5 kV d.c.
R 100 Ω
EUT
L 25 mH ± 10 %
non-inductive
R (d.c.) ≤ 10 Ω
L E
E
C 32 µF ±10 %
E
x
E
N
D
F
IEC  1012/12
Components
① Energy test equipment
V High voltage source 5 kV d.c.
S Switch; max. load 60 A, 5 kV
R d.c. resistance of inductance L
L
RV Current limiting resistor
E, F Connecting points for energy test equipment
Connecting points for EUT (includes PATIENT CABLE)
C, D
(Energy test equipment can be a defibrillator tester)
Test to be conducted with MANUFACTURER’s recommended PATIENT CABLE.
Figure 201.103 – Application of the test voltage between LEAD WIRES to test the energy
delivered by the defibrillator
201.8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
201.8.7.1 General requirements
Addition:
After the first three dashes of item b), insert a new dash
– with any input selectors or montage selectors set so as to produce the worst case
conditions and so that the test requirements of the general standard are fulfilled. The
worst case shall be determined by inspection of the circuit diagram and/or the
ELECTROENCEPHALOGRAPH and its associated ACCESSORIES;

60601-2-26 © IEC:2012 – 17 –
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
ME SYSTEMS
Clause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.6.3 *Spillage on ME EQUIPMENT and ME SYSTEMS
Replacement:
PORTABLE/TRANSPORTABLE ME EQUIPMENT or parts of the ME EQUIPMENT separable while
remaining functioning shall be so constructed so that, in the event of spillage of liquids
(accidental wetting), no HAZARDOUS SITUATION results from the ingress of liquids.
ME EQUIPMENT shall meet the dielectric strength requirements specified in 8.8.3 of the
The
general standard and shall comply with the requirements of this particular standard.
Compliance is checked by the following test:
Place the PORTABLE/TRANSPORTABLE ME EQUIPMENT or parts of the ME EQUIPMENT in the least
favourable position of NORMAL USE. Subject the ME EQUIPMENT for 30 s to an artificial rainfall of
3 mm/min falling vertically from a height of 0,5 m above the top of the ME EQUIPMENT.
A test apparatus is shown in Figure 3 of IEC 60529.
An intercepting device may be used to determine the duration of the test.
Immediately after 30 s exposure, remove any visible moisture on the ENCLOSURE.
Immediately after the above test, verify (by inspection) that any water that entered the
ME EQUIPMENT cannot adversely affect the BASIC SAFETY of the ME EQUIPMENT. Verify that the
ME EQUIPMENT meets the relevant dielectric strength test (8.8.3 of the general standard) and
HAZARDOUS SITUATION.
does not result in a
After this test, verify that the ME EQUIPMENT complies with the requirements of this particular
standard.
201.11.8 *Interruption of the power supply / SUPPL
...