SIST EN IEC 80601-2-26:2020
(Main)Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (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)
IEC 80601-2-26 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.
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)
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
SIST EN IEC 80601-2-26:2020
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
SIST EN IEC 80601-2-26:2020 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
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SIST EN IEC 80601-2-26:2020
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
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SIST EN IEC 80601-2-26:2020
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)
2
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SIST EN IEC 80601-2-26:2020
EN IEC 80601-2-26:2020 (E)
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
3
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SIST EN IEC 80601-2-26:2020
EN IEC 80601-2-26:2020 (E)
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
4
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SIST EN IEC 80601-2-26:2020
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
Warning! Make sure that you obtained this publication from an authorized distributor.
Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.
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SIST EN IEC 80601-2-26:2020
– 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
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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.
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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.
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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.
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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.
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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
1
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
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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.
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SIST EN IEC 80601-2-26:2020
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 o
...
SLOVENSKI STANDARD
oSIST prEN 60601-2-26:2017
01-september-2017
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLHOHNWURHQFHIDORJUDIRY
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
Ta slovenski standard je istoveten z: prEN 60601-2-26:2017
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
oSIST prEN 60601-2-26:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN 60601-2-26:2017
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oSIST prEN 60601-2-26:2017
62D/1488/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-26 ED4
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2017-07-07 2017-09-29
SUPERSEDES DOCUMENTS:
62D/1388/CD,62D/1424A/CC
IEC SC 62D : ELECTROMEDICAL EQUIPMENT
SECRETARIAT: SECRETARY:
United States of America Mr Jeffrey L. Eggleston
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
ISO/TC 121/SC 3
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:
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential
performance of electroencephalograph
NOTE FROM TC/SC OFFICERS:
This Committee Draft for Vote (CDV) was prepared by IEC/SC 62D – ISO/TC 121/SC 3/JWG 22, Electromedical
diagnostic and patient monitoring equipment.
The stability date for this project will be 2022.
Copyright © 2017 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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1 CONTENTS
2 FOREWORD . 3
3 INTRODUCTION . 5
4 201.1 Scope, object and related standards . 6
5 201.2 Normative references . 7
6 201.3 Terms and definitions . 8
7 201.4 General requirements . 9
8 201.5 General requirements for testing of ME EQUIPMENT . 9
9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 10
10 201.7 ME EQUIPMENT identification, marking and documents . 10
11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 11
12 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 16
13 201.10 Protection against unwanted and excessive radiation HAZARDS . 17
14 201.11 Protection against excessive temperatures and other HAZARDS . 17
15 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 18
16 201.13 HAZARDOUS SITUATIONS and fault conditions . 23
17 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23
18 201.15 Construction of ME EQUIPMENT . 23
19 201.16 ME SYSTEMS . 23
20 201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 23
21 202 Electromagnetic disturbances – Requirements and tests . 23
22 206 USABILITY . 29
23 Annexes . 29
24 Annex AA (informative) Particular guidance and rationale . 30
25 Index of defined terms used in this particular standard . 33
26
27 Figure 201.101 – Test of protection against the effects of defibrillation (common mode) . 13
28 Figure 201.102 – Test of protection against the effects of defibrillation (differential mode) . 15
29 Figure 201.103 – Application of the test voltage between LEAD WIRES to test the energy
30 delivered by the defibrillator . 16
31 Figure 201.104 – General test circuit . 20
32 Figure 201.105 – Test circuit for noise and common mode rejection (see 201.12.1.103 and
33 201.12.1.105) . 23
34 Figure 202.101 – Test layout for radiated and conducted EMISSION test and radiated immunity
35 test (see 202.4.3.1) . 25
36 Figure 202.102 –Test circuit for HF SURGICAL EQUIPMENT protection measurement according to
37 subclause 202.8.102 . 27
38 Figure 202.103 – Test setup for HF SURGICAL EQUIPMENT measurement according to subclause
39 202.8.102 . 28
40
41 Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 9
42
43
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44 INTERNATIONAL ELECTROTECHNICAL COMMISSION
45 ____________
46
47 MEDICAL ELECTRICAL EQUIPMENT –
48
49 Part 2-26: Particular requirements for the basic safety
50 and essential performance of electroencephalographs
51
52
53 FOREWORD
54 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all
55 national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-
56 operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to
57 other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available
58 Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical
59 committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work.
60 International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation.
61 IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions
62 determined by agreement between the two organizations.
63 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
64 consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC
65 National Committees.
66 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees
67 in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate,
68 IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user.
69 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently
70 to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication
71 and the corresponding national or regional publication shall be clearly indicated in the latter.
72 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment
73 services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by
74 independent certification bodies.
75 6) All users should ensure that they have the latest edition of this publication.
76 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of
77 its technical committees and IEC National Committees for any personal injury, property damage or other damage of any
78 nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the
79 publication, use of, or reliance upon, this IEC Publication or any other IEC Publications.
80 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
81 indispensable for the correct application of this publication.
82 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights.
83 IEC shall not be held responsible for identifying any or all such patent rights.
84 International standard IEC 60601-2-26 has been prepared by a Joint Working Group of IEC
85 subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in
86 medical practice and ISO subcommittee SC3: Lung ventilators and related equipment, of ISO technical
87 committee 121: Anaesthetic and respiratory equipment.
88 This fourth edition cancels and replaces the third edition of IEC 60601-2-26 published in 2012. This
89 edition constitutes a technical revision to align with Amendment 1:2012 to IEC 60601-1:2005, new
90 versions of collateral standards and amendments thereto.
91 The text of this particular standard is based on the following documents:
FDIS Report on voting
92
93 Full information on the voting for the approval of this particular standard can be found in the report on
94 voting indicated in the above table.
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95
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
96 In this standard, the following print types are used:
97 – Requirements and definitions: roman type.
98 – Test specifications: italic type.
99 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative
100 text of tables is also in a smaller type.
101 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED:
102 SMALL CAPITALS.
103 In referring to the structure of this standard, the term
104 – “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of
105 all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
106 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses
107 of Clause 7).
108 References to clauses within this standard are preceded by the term “Clause” followed by the clause
109 number. References to subclauses within this collateral standard are by number only.
110 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
111 combination of the conditions is true.
112 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
113 Directives, Part 2. For the purposes of this standard, the auxiliary verb:
114 – “shall” means that compliance with a requirement or a test is mandatory for compliance with this
115 standard;
116 – “should” means that compliance with a requirement or a test is recommended but is not mandatory
117 for compliance with this standard;
118 – “may” is used to describe a permissible way to achieve compliance with a requirement or test.
119 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
120 that there is guidance or rationale related to that item in Annex AA.
121 A list of all parts of the IEC 60601 series, published under the general title Medical electrical
122 equipment, can be found on the IEC website.
123 The committee has decided that the contents of this publication will remain unchanged until the
124 stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data related to the
125 specific publication. At this date, the publication will be
126 • reconfirmed,
127 • withdrawn,
128 • replaced by a revised edition, or
129 • amended.
130
131 NOTE The attention of National Committees is drawn to the fact that equipment MANUFACTURERS and testing organizations
132 may need a transitional period following publication of a new, amended or revised IEC or ISO publication in which to make
133 products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the
134 recommendation of the committee that the content of this publication be adopted for mandatory implementation nationally not
135 earlier than 3 years from the date of publication.
136
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137 INTRODUCTION
138 This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of
139 ELECTROENCEPHALOGRAPHS. It amends and supplements IEC 60601-1 (third edition, 2005, Amendment
140 1:2012; Corrigendum 1:2012): Medical electrical equipment – Part 1: General requirements for basic
141 safety and essential performance), hereinafter referred to as the general standard.
142 The aim of this fourth edition is to bring this particular standard up to date with reference to the edition
143 3.1 of the general standard and new versions of collateral standards and amendments thereto through
144 technical changes.
145 The requirements of this particular standard take priority over those of the general standard.
146 A “General guidance and rationale” for the more important requirements of this particular standard is
147 included in Annex AA. It is considered that knowledge of the reasons for these requirements will not
148 only facilitate the proper application of the standard but will, in due course, expedite any revision
149 necessitated by changes in clinical practice or as a result of developments in technology. However,
150 Annex AA does not form part of the requirements of this standard.
151
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152 MEDICAL ELECTRICAL EQUIPMENT –
153
154 Part 2-26: Particular requirements for the basic safety
155 and essential performance of electroencephalographs
156
157
158
159 201.1 Scope, object and related standards
1
160 Clause 1 of the general standard applies, except as follows:
161 201.1.1 * Scope
162 Replacement:
163 This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of
164 ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT or
165 ME SYSTEM. This standard is applicable to ELECTROENCEPHALOGRAPHS intended for use in professional
166 healthcare facilities, the EMERGENCY MEDICAL SERVICE ENVIRONMENT or the
167 HOME HEALTHCARE ENVIRONMENT.
168 This standard does not cover requirements for other equipment used in electroencephalography such
169 as:
170 – phono-photic stimulators;
171 – EEG data storage and retrieval;
172 – ME EQUIPMENT particularly intended for monitoring during electro-convulsive therapy.
173 If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
174 ME SYSTEMS only, the title or content of that clause or subclause will say so. If that is not the case, the
175 clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as follows:
176 The clause or subclause applies to ME EQUIPMENT, as default. If the corresponding safety measure or
177 function is intentionally, by decision of the manufacturer, not completely integrated into the
178 ME EQUIPMENT, but has to be realized in an ME SYSTEM, the manufacturer of the ME EQUIPMENT has to
179 specify in its accompanying documents which functionality and safety requirements have to be
180 provided by the connected ME SYSTEM to fulfil that clause or subclause. The ME SYSTEM, then, has to
181 be verified accordingly.
182 HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the
183 scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and
184 8.4.1 of the general standard.
185 NOTE See also 4.2 of the general standard.
186 201.1.2 Object
187 Replacement:
188 The object of this particular standard is to establish particular BASIC SAFETY and
189 ESSENTIAL PERFORMANCE requirements for ELECTROENCEPHALOGRAPHS as defined in 201.3.204.
1
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance including Amendment 1:2012.
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190 201.1.3 Collateral standards
191 This particular standard refers to those applicable collateral standards that are listed in Clause 2 of
192 the general standard and Clause 201.2 of this particular standard.
193 IEC 60601-1-2:2014 and IEC 60601-1-6:2013 apply as modified in Clause 202 and 206, respectively.
194 IEC 60601-1-3, IEC 60601-1-9 and IEC 60601-1-10 do not apply. All other published collateral
195 standards in the IEC 60601-1 series apply as published.
196 201.1.4 Particular standards
197 Replacement:
198 In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in
199 the general standard and collateral standards as appropriate for the particular ME EQUIPMENT or
200 ME SYSTEM under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE
201 requirements.
202 A requirement of a particular standard takes priority over the general standard and collateral
203 standards.
204 For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral
205 standards are referred to by their document number.
206 The numbering of clauses and subclauses of this particular standard corresponds to that of the
207 general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1
208 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final
209 digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses
210 the content of Clause 4 of the IEC 60601-1-2 collateral standard, etc.). The changes to the text of the
211 general standard and applicable collateral standards are specified by the use of the following words:
212 "Replacement" means that the clause or subclause of the general standard or applicable collateral
213 standard is replaced completely by the text of this particular standard.
214 "Addition" means that the text of this particular standard is additional to the requirements of the
215 general standard or applicable collateral standard.
216 "Amendment" means that the clause or subclause of the general standard or applicable collateral
217 standard is amended as indicated by the text of this particular standard.
218 Subclauses, figures or tables which are additional to those of the general standard are numbered
219 starting from 201.101. However due to the fact that definitions in the general standard are numbered
220 3.1 through 3.139, additional definitions in this standard are numbered beginning from 201.3.201.
221 Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
222 Subclauses, figures or tables which are additional to those of a collateral standard are numbered
223 starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, etc.
224 The term "this standard" is used to make reference to the general standard, any applicable collateral
225 standards and this particular standard taken together.
226 Where there is no corresponding clause or subclause in this particular standard, the clause or
227 subclause of the general standard or applicable collateral standard, although possibly not relevant,
228 applies without modification; where it is intended that any part of the general standard or applicable
229 collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given
230 in this particular standard.
231 201.2 Normative references
232 Clause 2 of the general standard applies, except as follows:
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233 Amendment:
234 IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic safety
235 and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and
236 tests
237 Addition:
238 IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for basic safety
239 and essential performance – Collateral standard: Requirements for medical electrical equipment and
240 medical electrical systems used in the home healthcare environment
241 IEC 60601-1-12:2014, Medical electrical equipment – Part 1-12: General requirements for basic safety
242 and essential performance – Collateral standard: Requirements for medical electrical equipment and
243 medical electrical systems intended for use in the emergency medical services environment
244 201.3 Terms and definitions
245 NOTE An index of defined terms is found beginning on page 33.
246 For the purpose of this document, the terms and definitions given in IEC 60601-1:2012, IEC 60601-1-
247 2:2014, IEC 60601-1-6:2013, IEC 60601-1-11:2015, IEC 60601-1-12:2014 and IEC 60601-2-2:2017
248 apply, except as follows:
249 Additional definitions:
250 201.3.201
251 CHANNEL
252 hardware and/or software selection of a particular electroencephalographic LEAD for purposes of
253 display, recording, or transmission
254 201.3.202
255 ELECTRODE
256 sensor that is applied to the scalp, cerebral cortex, or subdural locations to detect electrical activity of
257 the brain
258 201.3.203
259 ELECTROENCEPHALOGRAM
260 EEG
261 presentation (on screen or paper) of the variation with time of voltages taken from ELECTRODES, whose
262 positions are specified
263 201.3.204
264 ELECTROENCEPHALOGRAPH
265 ME EQUIPMENT or ME SYSTEM to produce an ELECTROENCEPHALOGRAM
266 201.3.206
267 LEAD WIRE
268 cable connected between an ELECTRODE and either a PATIENT CABLE or the ELECTROENCEPHALOGRAPH
269 201.3.207
270 NEUTRAL ELECTRODE
271 reference point for differential amplifiers and/or interference suppression circuits
272 201.3.208
273 PATIENT CABLE
274 multiwire cable or junction box used to connect LEAD WIRES to the ELECTROENCEPHALOGRAPH
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275 201.4 General requirements
276 Clause 4 of the general standard applies, except as follows:
277 201.4.3 ESSENTIAL PERFORMANCE
278 Addition:
279 201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements
280 Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in Table 201.101.
281 Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Accuracy of signal reproduction 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 inoperable ELECTROENCEPHALOGRAPH 201.12.4.101
282
283 Box Note 1:
284 National committees are respectfully requested to provide feedback which of the requirements in
285 clauses 201.12.1.102 to 201.12.1.106 constitute the essential performance of an
286 ELECTROENCEPHALOGRAPH.
287 (A) Just, 201.12.1.102 Accuracy of signal reproduction
288 (B) All currently listed clauses 201.12.1.102 to 201.12.1.106
289 (C) Any other subset of 201.12.1.102 to 201.12.106; please specify
290 Please provide rationale for your answer.
291
292 201.5 General requirements for testing of ME EQUIPMENT
293 Clause 5 of the general standard applies, except as follows:
294 201.5.4 Other conditions
295 Addition:
296 aa) If necessary for the purpose of conducting the test, the INTERNAL ELECTRICAL POWER SOURCE may
297 be replaced by an external battery or d.c. power supply to provide the necessary test voltage.
298 bb) The values used in test circuits, unless otherwise specified, shall have at least an accuracy as
299 given below:
300 – resistors: ± 1 %;
301 – capacitors: ± 10 %;
302 – inductors: ± 10 %;
303 – test voltages: ± 1 %.
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304 201.5.8 *Sequence of tests
305 Amendment:
306 Tests called for in 201.8.5.5.1 of this particular standard and in 8.5.5 of the general standard shall be
307 carried out prior to the LEAKAGE CURRENT and dielectric strength tests described in subclauses 8.7 and
308 8.8 of the general standard and prior to the tests specified in subclauses 201.12.1.102 to
309 201.12.1.106 of this particular standard.
310 201.6 Classification of ME EQUIPMENT and ME SYSTEMS
311 Clause 6 of the general standard applies, except as follows:
312 201.6.6 Mode of operation
313 Replacement:
314 ELECTROENCEPHALOGRAPHS shall be classified for CONTINUOUS OPERATION.
315 201.7 ME EQUIPMENT identification, marking and documents
316 Clause 7 of the general standard applies, except as follows:
317 201.7.2.1 * Minimum requirements for marking on ME EQUIPMENT and on interchangeable
318 parts
319 Addition:
320 If the ELECTROENCEPHALOGRAPH is specified as being protected against the effects of defibrillation:
321 Parts of the ELECTROENCEPHALOGRAPH (for example PATIENT CABLES) specified as being protected
322 against the effects of defibrillation shall be marked with symbol 26 or 27 of Table D.1 in Appendix D of
323 the general standard according to the classification as TYPE BF APPLIED PART or TYPE CF APPLIED PART.
324 201.7.9.2 Instructions for use
325 201.7.9.2.2 Warning and safety notices
326 Addition:
327 If protection against the effects of defibrillation is provided (see 201.8.5.5.1), the instructions for use
328 shall include a warning that defibrillator protection requires the use of MANUFACTURER-specified
329 ACCESSORIES, including PATIENT CABLES and LEAD WIRES.
330 Additional subclause:
331 201.7.9.2.101 Additional instructions for use
332 The instructions for use shall also include:
333 a) The INTENDED USE/INTENDED PURPOSE including environment of use.
334 Likely misuse should be identified by RISK ANALYSIS and disclosed, if necessary (e.g. ‘not suitable
335 for electro-cerebral inactivity (ECI) determination’).
336 b) The procedures necessary for safe operation.
337 c) That conductive parts of ELECTRODES and associated connectors for APPLIED PARTS, including the
338 NEUTRAL ELECTRODE, should not co
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