EN IEC 80601-2-26:2020
(Main)Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
IEC 80601-2-26:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. This document is applicable to ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities, the EMERGENCY MEDICAL SERVICES ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT. This document does not cover requirements for other equipment used in electroencephalography such as: – phono-photic stimulators; – EEG data storage and retrieval; – ME EQUIPMENT particularly intended for monitoring during electro-convulsive therapy. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title or 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 follows. The clause or subclause applies to ME EQUIPMENT, as default. For ME EQUIPMENT with the corresponding safety measure or function not completely integrated into the ME EQUIPMENT but instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER specifies in the ACCOMPANYING DOCUMENTS which functionality and safety requirements are provided by the ME SYSTEM to comply with this document. The ME SYSTEM is verified accordingly. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document. IEC 80601-2-26:2019 cancels and replaces the third edition of IEC 60601-2-26 published in 2012. This edition constitutes a technical revision to align with Amendment 1:2012 of IEC 60601-1:2005, new versions of collateral standards and amendments thereto.
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 (IEC 80601-2-26:2019)
Standard IEC 80601-2-26 se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ELEKTROENCEFALOGRAFOV, kot je določeno v točki 201.3.204, v nadaljevanju ELEKTROMEDICINSKA OPREMA oziroma ELEKTROMEDICINSKI SISTEM. Ta dokument se uporablja za ELEKTROENCEFALOGRAFE, namenjene uporabi v strokovnih zdravstvenih ustanovah, v OKOLJU NUJNIH ZDRAVSTVENIH STORITEV ali v OKOLJU DOMAČE ZDRAVSTVENE OSKRBE. Ta dokument ne zajema zahtev za drugo opremo, ki se uporablja pri elektroencelografiji, npr.: – fono-fotične stimulatorje; – shranjevanje in dostop do podatkov EEG; – ELEKTROMEDICINSKO OPREMO, namenjeno izključno za nadzor med elektrokonvulzivno terapijo. Če je točka ali podtočka namenjena samo uporabi za ELEKTROMEDICINSKO OPREMO ali ELEKTROMEDICINSKE SISTEME, bo to zapisano v naslovu oziroma vsebini dane točke ali podtočke. Če ni zapisano, se točka ali podtočka uporablja za ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME, kot je navedeno v nadaljevanju. Točka ali podtočka se privzeto uporablja za ELEKTROMEDICINSKO OPREMO. Za ELEKTROMEDICINSKO OPREMO z ustreznim varnostnim ukrepom ali funkcijo, ki ni v celoti integrirana v ELEKTROMEDICINSKO OPREMO, temveč je implementirana v ELEKTROMEDICINSKI SISTEM, PROIZVAJALEC ELEKTROMEDICINSKE OPREME v SPREMNI DOKUMENTACIJI navede, s katerimi funkcijami in varnostnimi zahtevami ELEKTROMEDICINSKI SISTEM zagotavlja skladnost s tem dokumentom. ELEKTROMEDICINSKI SISTEM se ustrezno preveri. Posebne zahteve tega dokumenta ne vključujejo temeljnih TVEGANJ pri predvideni fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje uporabe tega dokumenta.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2020
Nadomešča:
SIST EN 60601-2-26:2015
Medicinska električna oprema - 2-26. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti elektroencefalografov (IEC 80601-2-26:2019)
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and
essential performance of electroencephalographs (IEC 80601-2-26:2019)
Medizinische elektrische Geräte - Teil 2-26: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Elektroenzephalographen (IEC
80601-2-26:2019)
Appareils électromédicaux - Partie 2-26: Exigences particulières pour la sécurité de base
et les performances essentielles des électroencéphalographes (IEC 80601-2-26:2019)
Ta slovenski standard je istoveten z: EN IEC 80601-2-26:2020
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
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2020
ICS 11.040.55; 11.040.99 Supersedes EN 60601-2-26:2015 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-26: Particular requirements
for the basic safety and essential performance of
electroencephalographs
(IEC 80601-2-26:2019)
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) Elektroenzephalographen
(IEC 80601-2-26:2019)
This European Standard was approved by CENELEC on 2020-01-01. 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, 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,
Turkey 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
© 2020 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 E
European foreword
The text of document 62D/1666/FDIS, future edition 1 of IEC 80601-2-26, 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 IEC 80601-2-26:2020.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-10-03
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-04-03
document have to be withdrawn
This document supersedes EN 60601-2-26:2015 and all of its amendments and corrigenda (if any).
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.
This document has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association.
Endorsement notice
The text of the International Standard IEC 80601-2-26:2019 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60601-1-3 NOTE Harmonized as EN 60601-1-3
IEC 60601-1-9 NOTE Harmonized as EN 60601-1-9
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10
IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015 (not modified)
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.cenelec.eu.
Clause 2 of l’EN 60601-1:2006 is applicable, except as follows.
Publication Year Title EN/HD Year
Replace
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 2013 +A1 2015
IEC 60601-1-6 2013 Medical electrical equipment - Part 1-6: - -
General requirements for basic safety and
essential performance - Collateral
standard: Usability
Addition
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
+A12 2014
+EN 60601-2010
1:2006/corrigendum
Mar. 2010
+AC 2014
+A11 2011
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
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
Publication Year Title EN/HD Year
IEC 60601-2-2 2017 Medical electrical equipment - Part 2-2: EN IEC 60601-2-2 2018
Particular requirements for the basic safety
and essential performance of high
frequency surgical equipment and high
frequency surgical accessories
IEC 80601-2-26
Edition 1.0 2019-05
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
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-6765-3
– 2 – IEC 80601-2-26:2019 © IEC 2019
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 10
201.5 General requirements for testing ME EQUIPMENT . 11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 13
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
201.10 Protection against unwanted and excessive radiation HAZARDS . 19
201.11 Protection against excessive temperatures and other HAZARDS . 19
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 20
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 24
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 24
201.15 Construction of ME EQUIPMENT . 24
201.16 ME SYSTEMS . 24
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 24
202 Electromagnetic disturbances – Requirements and tests . 24
206 USABILITY . 28
Annexes . 29
Annex AA (informative) Particular guidance and rationale . 30
Bibliography . 33
Index of defined terms used in this particular standard . 34
Figure 201.101 – Test of protection against the effects of defibrillation (common mode) . 15
Figure 201.102 – Test of protection against the effects of defibrillation (differential
mode) . 17
Figure 201.103 – Application of the test voltage between LEAD WIRES to test the energy
delivered by the defibrillator . 18
Figure 201.104 – General test circuit . 21
Figure 201.105 – Test circuit for noise and common mode rejection (see 201.12.1.104
and 201.12.1.106) . 23
Figure 202.101 – Test layout for radiated and conducted EMISSION test and radiated
IMMUNITY test (see 202.4.3.1) . 25
Figure 202.102 –Test circuit for HF SURGICAL EQUIPMENT protection measurement
according to 202.8.101 . 27
Figure 202.103 – Test setup for HF SURGICAL EQUIPMENT measurement according to
202.8.101 . 28
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 11
Table 201.102 – Input voltage ranges and rates of variation . 20
IEC 80601-2-26:2019 © IEC 2019 – 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
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) 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 80601-2-26 has been prepared by a Joint Working Group of IEC
subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical
equipment in medical practice, and ISO subcommittee SC3: Lung ventilators and related
equipment, of ISO technical committee 121: Anaesthetic and respiratory equipment.
This publication is published as a double logo standard.
This document cancels and replaces the third edition of IEC 60601-2-26 published in 2012.
This edition constitutes a technical revision to align with Amendment 1:2012 of IEC 60601-
1:2005, new versions of collateral standards and amendments thereto.
– 4 – IEC 80601-2-26:2019 © IEC 2019
The text of this standard is based on the following documents of IEC:
FDIS Report on voting
62D/1666/FDIS 62D/1681/RVD
Full information on the voting for the approval of this document can be found in the report on
voting indicated in the above table. In ISO, the standard has been approved by xxx
P members out of yyy having cast a vote.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, 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 document, 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 document are preceded by the term "Clause" followed by
the clause number. References to subclauses within this particular standard are by number
only.
In this document, 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 document conform to usage described in Clause 7 of the
ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance
with this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "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 80601 International Standard, published under the general title
Medical electrical equipment, can be found on the IEC website.
IEC 80601-2-26:2019 © IEC 2019 – 5 –
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
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 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 committees that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.
– 6 – IEC 80601-2-26:2019 © IEC 2019
INTRODUCTION
This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ELECTROENCEPHALOGRAPHS. It amends and supplements IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012, Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance, hereinafter referred to as the general standard.
The aim of this document is to bring this particular standard up to date with reference to the
edition 3.1 of the general standard and new versions of collateral standards and amendments
thereto through 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 document.
IEC 80601-2-26:2019 © IEC 2019 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-26: Particular requirements for the basic safety
and essential performance of electroencephalographs
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This part of the 80601 International Standard applies to the BASIC SAFETY and
ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also
referred to as ME EQUIPMENT or ME SYSTEM. This document is applicable to
ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities, the
EMERGENCY MEDICAL SERVICES ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT.
This document does not cover requirements for other equipment used in
electroencephalography such as:
– phono-photic stimulators;
– EEG data storage and retrieval;
– ME EQUIPMENT particularly intended for monitoring during electroconvulsive therapy.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title or 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 follows.
The clause or subclause applies to ME EQUIPMENT, as default. For ME EQUIPMENT with the
corresponding safety measure or function not completely integrated into the ME EQUIPMENT but
instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER specifies in the
ACCOMPANYING DOCUMENTS which functionality and safety requirements are provided by the
ME SYSTEM to comply with this document. The ME SYSTEM is verified accordingly.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within
the scope of this document are not covered by specific requirements in this document.
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 201.3.204.
___________
1 The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance
– 8 – IEC 80601-2-26:2019 © IEC 2019
201.1.3 Collateral standards
Addition:
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.
IEC 60601-1-2:2014 and IEC 60601-1-6:2013 apply as modified in Clause 202 and 206,
respectively. IEC 60601-1-3, IEC 60601-1-9 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 or ME SYSTEM under consideration, and may add other BASIC SAFETY and
ESSENTIAL PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard and collateral
standards.
For brevity, IEC 60601-1 and IEC 60601-1:2005/AMD1:2012 are 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 document 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, etc.). The changes to the text of the general standard and applicable collateral
standards 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 3.147, additional definitions in this document 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, etc.
The term "this document" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
IEC 80601-2-26:2019 © IEC 2019 – 9 –
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.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
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 60601-1-6:2013, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1-11:2015, 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 60601-1-12:2014, 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 60601-2-2:2017, Medical electrical equipment – Part 2-2: Particular requirements for the
basic safety and essential performance of high frequency surgical equipment and high
frequency surgical accessories
201.3 Terms and definitions
For the purpose of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013,
IEC 60601-1-11:2015, IEC 60601-1-12:2014 and IEC 60601-2-2:2017 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An index of defined terms is found beginning on page 34.
– 10 – IEC 80601-2-26:2019 © IEC 2019
Addition:
201.3.201
CHANNEL
hardware and/or software selection of a particular electroencephalographic voltage between
ELECTRODES for purposes of display, recording, or transmission
201.3.202
ELECTRODE
sensor that is applied to the scalp, cerebral cortex, or subdural locations to detect electrical
activity of the brain
201.3.203
ELECTROENCEPHALOGRAM
EEG
presentation (on screen or paper) of the variation with time of voltages taken from
ELECTRODES, whose positions are specified
201.3.204
ELECTROENCEPHALOGRAPH
ME EQUIPMENT or ME SYSTEM to produce an ELECTROENCEPHALOGRAM
201.3.205
LEAD WIRE
cable connected between an ELECTRODE and either a PATIENT CABLE or the
ELECTROENCEPHALOGRAPH
201.3.206
NEUTRAL ELECTRODE
reference point for differential amplifiers and/or interference suppression circuits
201.3.207
PATIENT CABLE
multiwire cable or junction box used to connect LEAD WIRES to the ELECTROENCEPHALOGRAPH
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Additional subclause:
201.4.3.101 * Additional ESSENTIAL PERFORMANCE requirements
Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
Table 201.101.
IEC 80601-2-26:2019 © IEC 2019 – 11 –
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Accuracy of amplitude and rate of variation 201.12.1.102
Input dynamic range and differential offset voltage 201.12.1.103
Input noise 201.12.1.104
Frequency response 201.12.1.105
Common mode rejection 201.12.1.106
or
Indication of invalid data 201.12.4.101
For ELECTROENCEPHALOGRAPHS having more than 10 identical EEG CHANNELS, testing 10 of
these CHANNELS is sufficient to verify ESSENTIAL PERFORMANCE.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.4 Other conditions
Addition:
aa) If necessary for the purpose of conducting the test, the
INTERNAL ELECTRICAL POWER SOURCE may be replaced by an external battery or DC
power supply to provide the necessary test voltage.
bb) 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
Replacement:
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 8.7
and 8.8 of the general standard and prior to the tests specified in 201.12.1.102 to
201.12.1.106 of this particular standard.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.6 Mode of operation
Replacement:
ELECTROENCEPHALOGRAPHS shall be classified for CONTINUOUS OPERATION.
– 12 – IEC 80601-2-26:2019 © IEC 2019
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 ELECTROENCEPHALOGRAPH is specified as being protected against the effects of
defibrillation:
Parts of the ELECTROENCEPHALOGRAPH (for example PATIENT CABLES) specified as being
protected against the effects of defibrillation shall be marked with symbol 26 or 27 of
Table D.1 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
201.7.9.2.2 Warning and safety notices
Addition:
If protection against the effects of defibrillation is provided (see 201.8.5.5.1), the instructions
for use shall include a warning that defibrillator protection requires the use of MANUFACTURER-
specified ACCESSORIES, including PATIENT CABLES and LEAD WIRES.
Additional subclause:
201.7.9.2.101 Additional instructions for use
The instructions for use shall also include the following.
a) The INTENDED USE including environment of use.
Likely misuse should be identified by RISK ANALYSIS and disclosed, if necessary (e.g. "not
suitable for electro-cerebral inactivity (ECI) determination").
b) The procedures necessary for safe operation.
c) Conductive parts of ELECTRODES and associated connectors for APPLIED PARTS, including
the NEUTRAL ELECTRODE, should not contact other conductive parts including earth.
d) Information whether the ELECTROENCEPHALOGRAPH incorporates means to protect the
PATIENT against burns when used with HF SURGICAL EQUIPMENT and advice regarding the
location of ELECTRODES and LEAD WIRES etc., to reduce the HAZARD of burns in the event of
a defect in the NEUTRAL ELECTRODE connection of the HF SURGICAL EQUIPMENT.
e) * The need for regular testing of the ELECTROENCEPHALOGRAPH and its ACCESSORIES.
f) Precautions to take when using a defibrillator on a PATIENT, if APPLIED PARTS not protected
against the effects of defibrillation are being used; a description of how the discharge of a
defibrillator affects the ELECTROENCEPHALOGRAPH.
g) The subsequent operation of the ELECTROENCEPHALOGRAPH after interruption of
SUPPLY MAINS exceeding 30 s (see 201.11.8).
h) Any HAZARD due to simultaneous use of other PATIENT-connected ME EQUIPMENT, for
example, a cardiac pacemaker or other electrical stimulators.
i) Technical specifications for the ELECTROENCEPHALOGRAPH of sufficient detail to allow the
OPERATOR to understand what is being measured and any limitations. Minimally this shall
include:
– accuracy of signal reproduction;
IEC 80601-2-26:2019 © IEC 2019 – 13 –
– input dynamic range and maximum offset voltage;
– noise;
– frequency range and bandwidth;
– common mode rejection
– a description of all functions;
– a description of waveform displays (if applicable).
j) * Any known susceptibilities to electromagnetic phenomena.
k) If applicable, limitations of multipurpose CHANNELS (e.g. that these CHANNELS are not
suitable for monitoring and of ECG or EMG) and to which clauses of applicable standards
(e.g. IEC 80601-2-xx) they were tested, if any.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
201.8.1 Fundamental rule of protection against electrical shock
Additional subclause:
201.8.1.101 * Multipurpose CHANNEL(S)
ELECTROENCEPHALOGRAPH allows CHANNELS to be used for signals other than EEG, then
If the
this facility shall be tested to applicable clauses of relevant standards as specified by the
MANUFACTURER in the ACCOMPANYING DOCUMENTS.
Compliance is checked by inspection.
201.8.5.2.3 * PATIENT leads or PATIENT cables
Addition:
Any detachable ELECTRODE connector of a LEAD WIRE shall, when separated from the
ELECTRODE, have an air clearance between connector pins and a flat surface of at least
0,5 mm.
201.8.5.5 DEFIBRILLATION-PROOF APPLIED PARTS
201.8.5.5.1 * Defibrillation protection
Addition:
ELECTROENCEPHALOGRAPH
If protection against the effects of defibrillation is provided, the
shall resume normal operation in the previous operating mode, without loss of any OPERATOR
settings or stored data, and shall continue to perform its intended function as specified in this
particular standard within 30 s after exposure to the defibrillation voltage.
For defibrillator testing, the ELECTROENCEPHALOGRAPH shall be operated using the
PATIENT CABLES and LEAD WIRES specified by the MANUFACTURER.
• Common mode test
Addition:
Compliance is checked according to Figure 201.101.
– 14 – IEC 80601-2-26:2019 © IEC 2019
For ELECTROENCEPHALOGRAPHS of CLASS I, apply the test voltage between all LEAD WIRES
(E …E ), including the NEUTRAL ELECTRODE E , connected together and the PROTECTIVE
1 x N
EARTH TERMINAL. Energize the ELECTROENCEPHALOGRAPH for these tests.
For ELECTROENCEPHALOGRAPHS of CLASS II and ELECTROENCEPHALOGRAPHS with an
INTERNAL ELECTRICAL POWER SOURCE, apply the test voltage between all LEAD WIRES (E …E ),
1 x
NEUTRAL ELECTRODE E , connected together and the FUNCTIONAL EARTH TERMINAL
including the
N
or metal foil in close contact with the ENCLOSURE. Energize the ELECTROENCEPHALOGRAPH for
these tests.
Test ELECTROENCEPHALOGRAPHS having an INTERNAL ELECTRICAL POWER SOURCE, which is
rechargeable from the SUPPLY MAINS, with and without the SUPPLY MAINS connection, if the
ELECTROENCEPHALOGRAPH is capable of operating while connected to SUPPLY MAINS.
Set the scale of the ELECTROENCEPHALOGRAPH such that a 0,5 mV peak-to-valley signal can be
displayed without clipping. With S closed and S open, adjust the amplitude of the 10 Hz sine
2 3
wave generator to produce a 0,25 mV peak-to-valley output signal. Open switch S and close
S .
Connect S to position A and charge the capacitor C. After about 10 s, connect S to
1 1
position B for 200 ms ± 50 %. Open S to remove residual voltages from the
ELECTROENCEPHALOGRAPH.
Immediately close S and open S . Verify that after 30 s the recorded test signal is within
2 3
0,2 mV to 0,3 mV peak-to-valley and the ELECTROENCEPHALOGRAPH resumed normal operation
in the previous operating mode, without loss of any OPERATOR settings or stored data.
Repeat the above test with the polarity of the high voltage source reversed. Repeat the tests
with positive and negative polarities 5 times.
IEC 80601-2-26:2019 © IEC 2019 – 15 –
G
S
R3
470 kΩ
R R
V 2
P1
E
V
A B
S
S
EUT
5 kV DC
R4
R
100 Ω
L 500 µH
E
R (d.c.) ≤ 10 Ω
L
E
E
X
C 32 µF
E
N
P2
F
IEC
Components
G sine wave generator 10 Hz
V high voltage source 5 kV DC
Ⓕ foil, simulating capacitance for CLASS II or INTERNALLY POWERED ELECTROENCEPHALOGRAPHS
S switch; max. load 60 A, 5 kV
S switch activating the signal source
S switch connecting LEAD WIRE E to remaining LEAD WIRES
3 1
R 100 Ω ± 10 %, 5 kV dielectric strength, 400 J pulse energy dissipation capability, low inductance
R
50 Ω ± 10 %, 5 kV dielectric strength, 400 J pulse energy dissipation capability, low inductance
R DC resistance of inductance L
L
R current limiting resistor
V
P1, P2 connecting points for EUT (includes PATIENT CABLE and LEAD WIRES)
Figure 201.101 – Test of protection against the effects
of defibrillation (common mode)
• Differential mode test
Addition:
– 16 – IEC 80601-2-26:2019 © IEC 2019
Compliance is checked by the following test:
The ELECTROENCEPHALOGRAPH is connected to the test circuit shown in Figure 201.102. The
test voltage is applied to each LEAD WIRE in turn with all the remaining LEAD WIRES being
connected to earth. Initially, the test is conducted applying the test voltage between the E
LEAD WIRE and all remaining LEAD WIRES (E …E and E ) connected to earth. The
2 x N
ELECTROENCEPHALOGRAPH shall be energized for these tests.
Set the scale of the ELECTROENCEPHALOGRAPH such that a 0,5 mV peak-to-valley signal can be
displayed without clipping. With S closed, adjust the amplitude of the 10 Hz sine wave
generator to produce a 0,25 mV peak-to-valley output signal. Open switch S .
Connect S to position A and charge the capacitor C. After about 10 s, connect S to position
1 1
B for 200 ms ± 50 %. Open S to remove residual voltages from the ELECTROENCEPHALOGRAPH.
Immediately close S . Verify that after 30 s the recorded test signal is within 0,2 mV to 0,3 mV
peak-to-valley and the ELECTROENCEPHALOGRAPH has resumed normal operation in the
previous operating mode, without loss of any OPERATOR settings or stored data.
Repeat the test for any other LEAD WIRE with all remaining LEAD WIRES connected to earth.
IEC 80601-2-26:2019 © IEC 2019 – 17 –
G
S
R
470 kΩ
R
R 2
V P1
E
V
A B
S
5 kV DC
EUT
R
L 500 µH
E
R (d.c.) ≤ 10 Ω
L
E
E
x
C 32 µF
E
N
P2
IEC
Components
sine wave generator 10 Hz
G
V high voltage source 5 kV DC
S switch; max. load 60 A, 5 kV
S switch activating the signal source
R 100 Ω ± 10 %, 5 kV dielectric strength, 400 J pulse energy dissipation capability, low inductance
R 50 Ω ± 10 %, 5 kV dielectric strength, 400 J pulse energy dissipation capability, low inductance
R DC resistance of inductance L
L
R current limiting resistor
V
P1, P2 connecting points for EUT (includes PATIENT CABLE and LEAD WIRES)
Figure 201.102 – Test of protection against the effects
of defibrillation (differential mode)
201.8.5.5.2 Energy reduction test
Addition:
The test setup for the energy reduction test is shown in Figure 201.103.
– 18 – IEC 80601-2-26:2019 © IEC 2019
R
R 2
V
E C E
V
1 A B
S
5 kV DC
EUT
L 25 mH R
R (d.c.) ≤ 10 Ω
L E
E
E
x
C 32 µF
E
N
D
F
IEC
Components
① energy test equipment
V high voltage source 5 kV DC
S switch; max. load 60 A, 5 kV
R 100 Ω ± 10 %, 5 kV dielectric strength, 400 J pulse energy dissipation capability, low inductance
R 400 Ω ± 10 %, 5 kV dielectric strength, 400 J pulse energy dissipation capability, low inductance
R DC resistance of inductance L
L
R current limiting resistor
V
E, F connecting points for energy test equipment
connecting points for EUT (includes PATIENT CABLE and LEAD WIRES; energy test equipment can be a
C, D
defibrillator tester)
Figure 201.103 – Application of the test voltage between LEAD WIRES
to test the energy delivered by the defibrillator
EAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
201.8.7 L
201.8.7.1 General requirements
Amendment (add aft
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...