IEC 60601-2-26:2012

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



IEC 60601-2-26:2012

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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



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

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– 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

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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
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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.

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– 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.

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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.

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MEDICAL ELECTRICAL EQUIPMENT –



Part 2-26: Particular requirements for the basic safety

and essential performance of electroencephalographs








201.1 Scope, object and related standards


1
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.
—————————
1
 The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.

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60601-2-26 © IEC:2012 – 7 –


2
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.
—————————
2
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

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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

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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.

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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:

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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.
...