IEC 80601-2-26:2019/AMD1:2024

IEC 80601-2-26
Edition 1.0 2024-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
AMENDMENT 1
AMENDEMENT 1
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 80601-2-26:2019-05/AMD1:2024-02(en-fr)

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IEC 80601-2-26
Edition 1.0 2024-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
A MENDMENT 1
AM ENDEMENT 1
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
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-8177-2

– 2 – IEC 80601-2-26:2019/AMD1:2024
© IEC 2024
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

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

AMENDMENT 1
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) IEC and ISO draw attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC and ISO take no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, IEC and ISO had not received notice of
(a) patent(s), which may be required to implement this document. However, implementers are cautioned that this
may not represent the latest information, which may be obtained from the patent database available at
https://patents.iec.ch and/or www.iso.org/patents. IEC and ISO shall not be held responsible for identifying any
or all such patent rights.
Amendment 1 to IEC 80601-2-26:2019 has been prepared by subcommittee 62D: Particular
medical equipment, software, and systems, of IEC technical committee 62: Medical equipment,
software, and systems, and ISO subcommittee SC3: Respiratory devices and related equipment
used for patient care, of ISO technical committee 121: Anaesthetic and respiratory equipment.

© IEC 2024
The text of this Amendment is based on the following documents:
Draft Report on voting
62D/2106/FDIS 62D/2115/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this Amendment is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/standardsdev/publications/.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn,or
• revised.
NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC or
ISO publication in which to make products in accordance with the new requirements and to equip themselves for
conducting new or revised tests. It is the recommendation of the committee that the content of this publication be
adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.

__________
INTRODUCTION
Replace, in the existing first paragraph, “IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012”
with “IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020”.
Replace the existing second paragraph with the following:
The aim of this document is to bring this particular standard up to date with reference to
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
IEC 60601-1-2:2014, IEC 60601-1-2:2014/AMD1:2020 and IEC 60601-1-6:2010,
IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020 through technical
changes.
201.1 Scope, object and related standards
Replace the existing text in footnote 1 with the following:
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020, Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance.

– 4 – IEC 80601-2-26:2019/AMD1:2024
© IEC 2024
201.1.3 Collateral standards
Replace, in the existing second paragraph, the first sentence with the following:
IEC 60601-1-2:2014, IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010,
IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020 apply as modified in
Clauses 202 and 206 respectively.
201.1.4 Particular standards
Replace, in the third paragraph, the first sentence with the following:
For brevity, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 are referred to in this particular document as the general
standard.
Replace, in the eighth paragraph, "3.147" with "3.154".
201.2 Normative references
Replace the first five entries with the following, without modifying “Addition” or “Replacement”:
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
IEC 60601-1-2:2014/AMD1:2020
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
IEC 60601-1-6:2010/AMD1:2013
IEC 60601-1-6:2010/AMD2:2020
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for basic
safety and essential performance – Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-11:2015/AMD1:2020
IEC 60601-1-12:2014, Medical electrical equipment – Part 1-12: General requirements for basic
safety and essential performance – Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems intended for use in the emergency medical services
environment
IEC 60601-1-12:2014/AMD1:2020
© IEC 2024
201.3 Terms and definitions
Replace the existing first sentence with the following:
For the purpose of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020, IEC 60601-1-2:2014,
IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013,
IEC 60601-1-6:2010/AMD2:2020, IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020,
IEC 60601-1-12:2014, IEC 60601-1-12:2014/AMD1:2020, IEC 60601-2-2:2017 and the
following apply.
201.12.1.104 Input noise
Replace the existing second paragraph of this subclause with the following:
Compliance is checked using the test circuit of Figure 201.105. Set any adjustable filters of the
ELECTROENCEPHALOGRAPH, if provided, such that the frequency response specified in
201.12.1.105 is obtained. Turn on the mains frequency notch filter of the
ELECTROENCEPHALOGRAPH, if provided.
201.12.1.105 Frequency response
Replace the existing second paragraph of this subclause with the following:
Compliance is checked by inspection of the filter frequency response characteristic
documentation of the ELECTROENCEPHALOGRAPH and using the test circuit of Figure 201.104.
ELECTROENCEPHALOGRAPH, if
The mains frequency notch filter and any other filter of the
provided, shall be switched off for this test.
201.12.1.106 * Common mode rejection
Replace the existing second paragraph of this subclause with the following:
Compliance is checked using the test circuit of Figure 201.105 with any mains frequency notch
filter of the ELECTROENCEPHALOGRAPH, if provided, turned off.
Figure 201.105 – Test circuit for noise and common mode rejection (see 201.12.1.104
and 201.12.1.106)
PATIENT cable” with “PATIENT CABLE”.
Replace, in the NOTE to figure, “
202 Electromagnetic disturbances – Requirements and tests
Replace the existing first sentence with the following:
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 apply, except as follows:
202.4.3.1 Configurations
Replace, in the existing third paragraph, “IEC 60601-1-2:2014” with “IEC 60601-1-2:2014 and
IEC 60601-1-2:2014/AMD1:2020”.

– 6 – IEC 80601-2-26:2019/AMD1:2024
© IEC 2024
Figure 202.101 – Test layout for radiated and conducted EMISSION test and radiated
IMMUNITY test
Replace, in the existing note, “IEC 60601-1-2:2014” with “IEC 60601-1-2:2014 and
IEC 60601-1-2:2014/AMD1:2020”.
202.8.1 * General
Replace the existing text in brackets in the first paragraph with the following:
(i.e. electrostatic discharge, electrical fast transients/bursts, surges, electrical transient
conduction along supply lines and proximity magnetic fields)
Add, before the existing last two paragraphs, the following new paragraph:
Requirements for voltage interruptions, see 201.11.8.
Replace, in the existing last-but-one paragraph, “IEC 60601-1-2:2014, Table 4 through 9” with
“IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, Table 4 to 9 and Table 11”.
...