SIST EN IEC 80601-2-26:2020/A1:2024
(Amendment)Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalograph (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)
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)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN IEC 80601-2-26:2020/A1:2024
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
SIST EN IEC 80601-2-26:2020/A1:2024 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 80601-2-26:2020/A1:2024
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SIST EN IEC 80601-2-26:2020/A1:2024
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
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SIST EN IEC 80601-2-26:2020/A1:2024
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.
2
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SIST EN IEC 80601-2-26:2020/A1:2024
EN IEC 80601-2-26:2020/A1:2024 (E)
Annex ZA
(normative)
Norma
...
SLOVENSKI STANDARD
SIST EN IEC 80601-2-26:2020/oprA1:2021
01-november-2021
Dopolnilo A1 - Medicinska električna oprema - 2-26. del: Posebne zahteve za
osnovno varnost in bistvene lastnosti elektroencefalografov
Amendment 1 - Medical electrical equipment - Part 2-26: Particular requirements for the
basic safety and essential performance of electroencephalograph
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
Ta slovenski standard je istoveten z: EN IEC 80601-2-26:2020/prA1:2021
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
SIST EN IEC 80601-2- en
26:2020/oprA1:2021
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 80601-2-26:2020/oprA1:2021
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SIST EN IEC 80601-2-26:2020/oprA1:2021
62D/1897/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-26/AMD1 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2021-09-10 2021-12-03
SUPERSEDES DOCUMENTS:
62D/1833/RR
IEC SC 62D : ELECTROMEDICAL EQUIPMENT
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
Other TC/SCs are requested to indicate their interest, if
any, in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.
TITLE:
Amendment 1 - Medical electrical equipment - Part 2-26: Particular requirements for the basic
safety and essential performance of electroencephalograph
PROPOSED STABILITY DATE: 2027
NOTE FROM TC/SC OFFICERS:
IEC 80601-2-26 amendment is to align to the Amendment projects of the IEC 60601-1 series. Please
see IEC 62D/1808/INF and 62D/1828/AC for more information.
Copyright © 2021 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to
download this electronic file, to make a copy and to print out the content for the sole purpose of preparing
National Committee positions. You may not copy or "mirror" the file or printed version of the document, or any
part of it, for any other purpose without permission in writing from IEC.
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SIST EN IEC 80601-2-26:2020/oprA1:2021
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SIST EN IEC 80601-2-26:2020/oprA1:2021
62D/1897/CDV – 2 – IEC CDV 80601-2-26:2019/AMD1:2021 © IEC 2021
1 CONTENTS
2 FOREWORD . 3
3 INTRODUCTION . 6
4 201.1 Scope, object and related standards . 7
5 201.2 Normative references . 9
6 201.3 Terms and definitions . 9
7 201.4 General requirements . 10
8 201.5 General requirements for testing ME EQUIPMENT . 11
9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11
10 201.7 ME EQUIPMENT identification, marking and documents . 12
11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 13
12 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
13 201.10 Protection against unwanted and excessive radiation HAZARDS . 19
14 201.11 Protection against excessive temperatures and other HAZARDS . 19
15 201.12 Accuracy of controls and instruments and protection agai
...
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