Medical electrical equipment - Part 2-26: Particular requirements for the 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 : Exigences particulières pour la sécurité de base et les performances essentielles des électroencéphalographes

IEC 80601-2-26:2019 s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des ELECTROENCEPHALOGRAPHES définis en 201.3.204, aussi appelés APPAREILS EM ou SYSTEMES EM dans la présente norme. Le présent document est applicable aux ELECTROENCEPHALOGRAPHES destinés à être utilisés dans les établissements de soins professionnels, l'ENVIRONNEMENT DES SERVICES MEDICAUX D'URGENCE ou l'ENVIRONNEMENT DES SOINS A DOMICILE. Les exigences propres à d'autres appareils également utilisés en électroencéphalographie ne relèvent pas du domaine d'application du présent document, par exemple: – stimulateurs phonophotiques; – appareils de stockage et restitution d'informations d'EEG; – APPAREILS EM destinés particulièrement à la surveillance au cours d'une thérapie électro-convulsive. Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, le titre ou le contenu de cet article ou de ce paragraphe l'indique. Si ce n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux APPAREILS EM et aux SYSTEMES EM, comme suit. L'article ou le paragraphe s'applique aux APPAREILS EM, par défaut. Pour les APPAREILS EM dont la mesure ou la fonction de sécurité correspondante n'est pas complètement intégrée dans l'APPAREIL EM, mais plutôt mise en œuvre dans un SYSTEME EM, le FABRICANT de l'APPAREIL EM spécifie dans les DOCUMENTS D'ACCOMPAGNEMENT les exigences de fonctionnalité et de sécurité qu'assure le SYSTEME EM pour être conforme au présent document. Le SYSTEME EM est vérifié en conséquence. Les DANGERS inhérents à la fonction physiologique prévue des APPAREILS EM ou des SYSTEMES EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document. IEC 80601-2-26:2019 annule et remplace la troisième édition de l'IEC 60601-2-26 parue en 2012. Cette édition constitue une révision technique destinée à s'aligner sur l'Amendement 1:2012 de l'IEC 60601-1:2005 et sur les nouvelles versions des normes collatérales et leurs amendements.

Medicinska električna oprema - 2-26. del: Posebne zahteve za osnovno varnost in bistvene lastnosti elektroencefalografov - Dopolnilo A1 (IEC 80601-2-26:2019/AMD1:2024)

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Status
Published
Publication Date
21-Mar-2024
Current Stage
6060 - Document made available - Publishing
Start Date
22-Mar-2024
Completion Date
22-Mar-2024

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SLOVENSKI STANDARD
01-junij-2024
Medicinska električna oprema - 2-26. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti elektroencefalografov - Dopolnilo A1 (IEC 80601-2-
26:2019/AMD1:2024)
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and
essential performance of electroencephalograph (IEC 80601-2-26:2019/AMD1:2024)
Medizinische elektrische Geräte - Teil 2-26: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Elektroenzephalographen (IEC
80601-2-26:2019/AMD1:2024)
Appareils électromédicaux - Partie 2-26: Exigences particulières pour la sécurité de base
et les performances essentielles des électroencéphalographes (IEC 80601-2-
26:2019/AMD1:2024)
Ta slovenski standard je istoveten z: EN IEC 80601-2-26:2020/A1:2024
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 80601-2-26:2020/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM March 2024
ICS 11.040.01
English Version
Medical electrical equipment - Part 2-26: Particular requirements
for the basic safety and essential performance of
electroencephalographs
(IEC 80601-2-26:2019/AMD1:2024)
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 80601-2-26:2019/AMD1:2024) Elektroenzephalographen
(IEC 80601-2-26:2019/AMD1:2024)
This amendment A1 modifies the European Standard EN IEC 80601-2-26:2020; it was approved by CENELEC on 2024-03-20. 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,
Türkiye 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
© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 80601-2-26:2020/A1:2024 E

European foreword
The text of document 62D/2106/FDIS, future IEC 80601-2-26/AMD1, 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 IEC 80601-2-26:2020/A1:2024.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2024-12-20
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-03-20
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.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 80601-2-26:2019/AMD1:2024 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 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.cencenelec.eu.
The Annex ZA of EN IEC 80601-2-26:2020 applies with the following changes:
Publication Year Title EN/HD Year

Replace the first five entries with the following, without modifying “Addition” or “Replacement”:

IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- -  + corrigendum Mar. 2010
+ A1 2012  + A1 2013
- -  + A12 2014
+ A2 2020  + A2 2021
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
+ A1 2020  + A1 2021
IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: EN 60601-1-6 2010
General requirements for basic safety and
essential performance - Collateral
standard: Usability
+ A1 2013  + A1 2015
+ A2 2020  + A2 2021
IEC 60601-1-11 2015 Medical electrical equipment - Part 1-11: EN 60601-1-11 2015
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
+ A1 2020  + A1 2021
IEC 60601-1-12 2014 Medical Electrical Equipment - Part 1-12: EN 60601-1-12 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Requirements for medical
electrical equipment and medical electrical
systems used in the emergency medical
services environment
+ A1 2020  + A1 2020
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 80601-2-26:2019/AMD1:2024 – 3 –
© 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
...

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