EN 60601-2-26:2015

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

IEC 60601-2-26:2012 standard applies to basic safety and essential performance of electroencephalographs used in a clinical environment (e.g., hospital, physician's office, etc.). This standard does not cover requirements for other equipment used in electroencephalography. This third edition cancels and replaces the second edition of IEC 60601-2-26 published in 2003. 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 IEC 60601-1:2005 Edition 3, through reformatting and technical changes.

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

La CEI 60601-2-26:2012 s'applique à la sécurité de base et aux performances essentielles des électroencéphalographes utilisés dans un environnement hospitalier (par exemple, hôpital, cabinet médical, etc.). Les exigences propres à d'autres appareils également utilisés en électroencéphalographie ne sont pas du domaine de cette norme. Cette troisième édition annule et remplace la deuxième édition de la CEI 60601-2-26 publiée en 2003. L'objectif de cette troisième édition est de mettre à jour la présente norme particulière par rapport à la troisième édition de la norme générale CEI 60601-1:2005 Edition 3, par l'intermédiaire d'une nouvelle mise en forme et de modifications techniques.

Medicinska električna oprema - 2-26. del: Posebne zahteve za osnovno varnost in bistvene lastnosti elektroencefalografov

Ta standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ELEKTROENCEFALOGRAFOV (EEG), kot je določeno v 201.3.63, v nadaljevanju: ELEKTROMEDICINSKA OPREMA. Ta standard se uporablja za ELEKTROMEDICISNKO OPREMO, ki se uporablja v kliničnem okolju (npr. bolnišnice, zdravniška ordinacija, itd.).
Ta standard ne zajema zahtev za drugo opremo, ki se uporablja pri elektroencelografiji, kot na primer:
– fono-fotični stimulatorji;
– elektroencefalografska telemetrija;
– shranjevanje in dostop do podatkov EEG;
– ELEKTROMEDICISNKA OPREMA, namenjena izključno za nadzor med elektrokonvulzivno terapijo;
– ambulantni elektrocegfalograski snemalniki.
Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME. Posebne zahteve tega standarda ne vključujejo temeljnih TVEGANJ pri nameravani fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje uporabe tega standarda, razen v točkah 7.2.13 in 8.4.1 splošnega standarda.

General Information

• Status: Withdrawn
• Publication Date: 21-May-2015
• Withdrawal Date: 13-Apr-2018
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 03-Apr-2023
• Completion Date: 03-Apr-2023
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-26:2015 - Medical electrical equipment - Part 2-26: Particular requirements for basic safety and essential performance of electroencephalographs

Relations

• Replaces: EN 60601-2-26:2003 - Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs
• Effective Date: 28-Jan-2023
• Replaced By: EN IEC 80601-2-26:2020 - Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
• Effective Date: 16-Aug-2016

Standards Content (Sample)

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
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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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