IEC 80601-2-26:2019
(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.
The contents of the corrigendum of October 2021 have been included in this copy.
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.
Le contenu du corrigendum d'octobre 2021 a été pris en considération dans cet exemplaire.
General Information
Relations
Overview
IEC 80601-2-26:2019 is an international standard developed by the International Electrotechnical Commission (IEC) specifically addressing the basic safety and essential performance of electroencephalographs (EEGs). This standard applies to EEG medical electrical equipment intended for professional healthcare facilities, emergency medical services, and home healthcare environments.
It sets out the mandatory and recommended requirements for the design, testing, and operation of EEG devices to ensure their safety and reliability. The 2019 edition replaces the previous 2012 edition (IEC 60601-2-26) with technical revisions to align with amendments in the general IEC 60601-1 series and other related standards. The 2024 amendment incorporates the latest updates to maintain relevance and effectiveness.
Key Topics
Scope and Applicability
IEC 80601-2-26:2019 focuses on the safety measures and essential performance parameters of EEG equipment. It excludes related equipment such as phono-photic stimulators, EEG data storage and retrieval systems, and devices specifically for electro-convulsive therapy monitoring.Basic Safety Requirements
It outlines protection against electrical, mechanical, radiation, and temperature hazards to ensure patient and operator safety. Special attention is given to electrical hazards including testing for defibrillation effects and ensuring electrical isolation.Essential Performance Criteria
Defining accuracy, reliability, and operational stability of EEG readings to maintain diagnostic integrity. This includes measures for noise reduction, signal accuracy, and the robustness of controls and instruments.Electromagnetic Compatibility (EMC)
Compliance with EMC requirements is necessary to minimize interference from other medical electrical equipment and environmental electromagnetic disturbances, ensuring uninterrupted and accurate EEG operation.Programmable Electrical Medical Systems (PEMS)
Specifications for programmable features within EEG systems, focusing on risk management associated with software and firmware functionalities.Documentation and Marking
Requirements for clear identification, labeling, and documentation to assist users in safe handling, maintenance, and operation of EEG equipment.
Applications
IEC 80601-2-26:2019 is crucial for manufacturers, testing laboratories, healthcare providers, and regulatory bodies:
Manufacturers use this standard to design and produce EEG equipment that meets international safety and performance requirements, facilitating global market access.
Healthcare providers benefit from standardized EEG devices that ensure reliable monitoring and diagnosis, reducing risks associated with electrical and mechanical hazards.
Certification and Testing Bodies apply this standard during compliance testing and certification processes to verify that EEG equipment adheres to health and safety regulations.
Emergency Medical Services and Home Care environments rely on this standard to ensure that EEG devices used outside traditional clinical settings remain safe and effective.
Related Standards
IEC 80601-2-26:2019 builds upon and complements the general standard IEC 60601-1 series, particularly:
IEC 60601-1:2005 (and amendments): General requirements for basic safety and essential performance of medical electrical equipment.
IEC 60601-1-2: Requirements for electromagnetic compatibility of medical electrical equipment.
Other collateral standards addressing risk management, software lifecycle processes, and particular safety aspects related to medical electrical devices.
Adherence to IEC 80601-2-26 ensures compatibility and compliance within the broader framework of medical device regulations and standards, supporting interoperability and safety across medical electrical products.
Keywords: IEC 80601-2-26, electroencephalographs, EEG safety standards, medical electrical equipment, essential performance, IEC 60601, electroencephalography, medical device standards, programmable electrical medical systems, EMC medical equipment, healthcare EEG devices.
Frequently Asked Questions
IEC 80601-2-26:2019 is a standard published by the International Electrotechnical Commission (IEC). Its full title is "Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs". This standard covers: 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. The contents of the corrigendum of October 2021 have been included in this copy.
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. The contents of the corrigendum of October 2021 have been included in this copy.
IEC 80601-2-26:2019 is classified under the following ICS (International Classification for Standards) categories: 11.040.01 - Medical equipment in general. The ICS classification helps identify the subject area and facilitates finding related standards.
IEC 80601-2-26:2019 has the following relationships with other standards: It is inter standard links to IEC 60601-2-26:2012, IEC 80601-2-26:2019/AMD1:2024, IEC 80601-2-26:2019/COR1:2021. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase IEC 80601-2-26:2019 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of IEC standards.
Standards Content (Sample)
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
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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
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
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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
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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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.
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.
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.
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.
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;
– 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.
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.
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 after the first three dashes of item b)):
– with any input selectors or montage selectors set so as to produce the worst-case
conditions; the worst case shall be determined by inspection of the circuit diagram and/or
the ELECTROENCEPHALOGRAPH and its associated ACCESSORIES;
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.8 * Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Amendment (add after the note):
If the SUPPLY MAINS to the ELECTROENCEPHALOGRAPH is interrupted for less than 30 s, no
change of OPERATOR settings shall occur, including the mode of operation, and all stored
PATIENT data shall remain available.
NOTE 101 The ELECTROENCEPHALOGRAPH does not have to remain in operation during the interruption of the
SUPPLY MAINS.
Compliance is checked by observing the ELECTROENCEPHALOGRAPH operating mode,
OPERATOR settings, and stored data and interrupting the SUPPLY MAINS for a period of between
25 s and 30 s by disconnecting the POWER SUPPLY CORD.
If the SUPPLY MAINS is interrupted for more than 30 s, the subsequent operation shall be one of
the following:
– reversion to the MANUFACTURER’S default settings;
– reversion to previous RESPONSIBLE ORGANIZATION’S default settings; or
– reversion to the last settings used.
Means may be provided to the OPERATOR to select one or more than one of the above options.
Compliance shall be checked by functional testing.
If the ELECTROENCEPHALOGRAPH contains an INTERNAL ELECTRICAL POWER SOURCE and the
SUPPLY MAINS is interrupted, the ELECTROENCEPHALOGRAPH shall continue normal operation by
switching automatically to operating from its INTERNAL ELECTRICAL POWER SOURCE, and the
mode of operation, all OPERATOR settings and stored data shall not be changed. Power-saving
measures may be taken provided the ELECTROENCEPHALOGRAPH continues to conform to this
particular standard.
The ELECTROENCEPHALOGRAPH shall visually indicate the operation from its
INTERNAL ELECTRICAL POWER SOURCE.
Compliance is checked by interrupting the SUPPLY MAINS and observing that OPERATOR
settings and stored data are not changed, that normal operation continues, and that a visual
indication is displayed that the ELECTROENCEPHALOGRAPH is operating from its
INTERNAL ELECTRICAL POWER SOURCE. The ‘on-off’ switch shall remain in the ‘on’ position.
Additional subclause:
201.11.8.101 Protection against depletion of the INTERNAL ELECTRICAL POWER SOURCE
ELECTROENCEPHALOGRAPHS powered from an INTERNAL ELECTRICAL POWER SOURCE shall not
cause a HAZARDOUS SITUATION to the PATIENT when the state of discharg
...
IEC 80601-2-26
Edition 1.1 2024-02
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
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IEC 80601-2-26
Edition 1.1 2024-02
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 978-2-8322-8318-9
IEC 80601-2-26
Edition 1.1 2024-02
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
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
– 2 – IEC 80601-2-26:2019+AMD1:2024 CSV
© IEC 2024
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 . 25
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 25
201.15 Construction of ME EQUIPMENT . 25
201.16 ME SYSTEMS . 25
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 25
202 Electromagnetic disturbances – Requirements and tests . 25
206 USABILITY . 30
Annexes . 32
Annex AA (informative) Particular guidance and rationale . 33
Bibliography . 36
Index of defined terms used in this particular standard . 37
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 . 22
Figure 201.105 – Test circuit for noise and common mode rejection (see 201.12.1.104
and 201.12.1.106) . 24
Figure 202.101 – Test layout for radiated and conducted EMISSION test and radiated
IMMUNITY test (see 202.4.3.1) . 26
Figure 202.102 –Test circuit for HF SURGICAL EQUIPMENT protection measurement
according to 202.8.101 . 29
Figure 202.103 – Test setup for HF SURGICAL EQUIPMENT measurement according to
202.8.101 . 30
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 11
Table 201.102 – Input voltage ranges and rates of variation . 20
© IEC 2024
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,
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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
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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
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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
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expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
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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.
This consolidated version of the official IEC Standard and its amendment has been
prepared for user convenience.
IEC 80601-2-26 edition 1.1 contains the first edition (2019-05) [documents
62D/1666/FDIS and 62D/1681/RVD] and its corrigendum 1 (2021-10), and its
amendment 1 (2024-02) [documents 62D/2106/FDIS and 62D/2115/RVD].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendment 1. Additions are in green text, deletions are in strikethrough
red text. A separate Final version with all changes accepted is available in this
publication.
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© IEC 2024
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 edition constitutes a technical revision to align with Amendment 1:2012 of IEC 60601-
1:2005, new versions of collateral standards and amendments thereto.
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 2024
The committee has decided that the contents of this document and its amendment will remain
unchanged until the stability date indicated on the IEC website under webstore.iec.ch in the
data related to the specific document. At this date, the document will be
• reconfirmed,
• withdrawn, or
• revised.
NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC 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.
IMPORTANT – The "colour inside" logo on the cover page of this document indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
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© IEC 2024
INTRODUCTION
This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ELECTROENCEPHALOGRAPHS. It amends and supplements IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
IEC 60601-1-2:2014, IEC 60601-1-2:2014/AMD1:2020 and IEC 60601-1-6:2010,
IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020 through technical
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 2024
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, IEC 60601-1:2005/AMD1:2012 and IEC 60601 1:2005/AMD2:2020,
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
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© IEC 2024
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, IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:20132010,
IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020 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 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 are referred to in this particular standard document 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 3.154, 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 2024
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 60601-1-2:2014/AMD1:2020
IEC 60601-1-6:20132010, Medical electrical equipment – Part 1-6: General requirements for
basic safety and essential performance – Collateral standard: Usability
IEC 60601-1-6:2010/AMD1:2013
IEC 60601-1-6:2010/AMD2:2020
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 60601-1:2005/AMD2:2020
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 60601-1-11:2015/AMD1:2020
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 60601-1-12:2014/AMD1:2020
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 60601-1:2005/AMD2:2020, IEC 60601-1-2:2014,
IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:20132010,
IEC 60601-1-6:2010/AMD1:2013, IEC 60601-1-6:2010/AMD2:2020, IEC 60601-1-11:2015,
IEC 60601-1-11:2015/AMD1:2020, IEC 60601-1-12:2014, IEC 60601-1-12:2014/AMD1:2020,
IEC 60601-2-2:2017 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
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© IEC 2024
• 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 37.
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
LEAD WIRES to the ELECTROENCEPHALOGRAPH
multiwire cable or junction box used to connect
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 2024
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.
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© IEC 2024
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 2024
– 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.
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© IEC 2024
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 2024
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, P3 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:
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© IEC 2024
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 2024
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+AMD1:2024 CSV
© IEC 2024
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 after the first three dashes of item b)):
– with any input selectors or montage selectors set so as to produce the worst-case
conditions; the worst case shall be determined by inspection of the circuit diagram and/or
the ELECTROENCEPHALOGRAPH and its associated ACCESSORIES;
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies.
© IEC 2024
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.8 * Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Amendment (add after the note):
If the SUPPLY MAINS to the ELECTROENCEPHALOGRAPH is interrupted for less than 30 s, no
change of OPERATOR settings shall occur, including the mode of operation, and all stored
PATIENT data shall remain available.
NOTE 101 The ELECTROENCEPHALOGRAPH does not have to remain in operation during the interruption of the
SUPPLY MAINS.
Compliance is checked by observing the ELECTROENCEPHALOGRAPH operating mode,
OPERATOR settings, and s
...
IEC 80601-2-26:2019 is a comprehensive standard that delineates the particular requirements for the basic safety and essential performance of electroencephalographs (EEGs). Its primary scope encompasses medical electrical equipment involved in the operation of EEGs, specifically for use in professional healthcare facilities, emergency medical services environments, and home healthcare settings. This thorough focus ensures that all stakeholders, including manufacturers and healthcare providers, can operate within a framework that prioritizes patient safety and the essential performance of relevant equipment. One of the key strengths of this standard is its clear delineation of applicable clauses and subclauses. It explicitly differentiates between requirements intended for medical equipment only and those applicable to medical systems, which enhances the standard's usability for manufacturers. Furthermore, it governs the responsibilities of manufacturers by requiring them to specify which safety measures are integrated into the equipment versus the system. This clarification facilitates better compliance with safety regulations and underscores the accountability of manufacturers regarding the performance of their products. Moreover, IEC 80601-2-26:2019's alignment with the Amendment 1:2012 of IEC 60601-1:2005 and updates from collateral standards demonstrates its relevance and adaptability to modern technologies and practices in healthcare. The incorporation of the contents of the corrigendum of October 2021 also ensures that the document stays current with the latest technological advancements and safety requirements, making it a vital resource for the industry. While it notably does not cover other specific EEG-related equipment like phono-photic stimulators or systems for monitoring during electroconvulsive therapy, its focused scope on electroencephalographs allows for a deep and robust exploration of requirements that matter most to EEG safety and performance. This targeted approach helps to avoid ambiguity and keeps the document relevant to practitioners and manufacturers alike in an evolving healthcare landscape. In conclusion, IEC 80601-2-26:2019 stands out for its comprehensive approach to regulating electroencephalographs, emphasizing basic safety, essential performance, and clarity in regulatory compliance. Its strengths in scope, usability, and relevance represent a significant advancement in the standardization of medical electrical equipment safety.
IEC 80601-2-26:2019は、電気生理学機器の基本的な安全性と必須性能に関する特定の要件を定めた重要な文書です。この標準は、特に電気脳波計（EEG）の基本的な安全性と必須性能に焦点を当てており、専門医療機関や緊急医療サービスの環境、さらに在宅医療環境での使用に適用されます。 この標準の強みは、明確な適用範囲にあります。IEC 80601-2-26:2019は、ME機器（医療機器）およびMEシステム（医療システム）の両方に対して評価基準を提供しており、これにより製造業者は必要な安全機能や性能基準を十分に理解し、遵守することが可能になります。特に、ME機器とMEシステムの機能や安全要件が文書内で明確に区別されているのは、大きな利点です。 また、この文書は、IEC 60601-1:2005の改訂に合わせて技術的な見直しを行っており、関連する標準の新バージョンや改正にも対応しています。この点は、電気脳波計の進化や技術の更新に対しても柔軟に対応していることを示します。 さらに、掲載されている修正指示（2021年10月のコリンダム）が反映されていることで、最新の情報や要件が反映されていることも評価できます。これにより、現場での実務においても、より実用的で信頼性の高いデータ提供が可能となります。 全体として、IEC 80601-2-26:2019は、電気脳波計の安全性と性能を確保するための不可欠な基盤を提供し、医療の品質を向上させるために非常に重要な役割を果たしています。
IEC 80601-2-26:2019 표준은 전기 생리학 장비 중 하나인 뇌전도 검사기(EEG)와 관련된 기본 안전성과 필수 성능에 대한 요구사항을 다루고 있습니다. 이 표준은 의료 전기 장비(ME EQUIPMENT) 및 의료 시스템(ME SYSTEM)의 적용 범위를 명확히 하며, 이를 사용하기 위한 전문 의료 시설, 응급 의료 서비스 환경 및 가정 건강 관리 환경에서의 안전한 사용을 보장합니다. 이 표준의 강점 중 하나는 뇌전도 검사기와 관련된 안전성 요구사항을 정리하여, 의료 기기의 안전한 작동을 위한 명확한 기준을 마련한다는 점입니다. 또한, IEC 80601-2-26:2019는 특정 요구 사항이 ME EQUIPMENT 또는 ME SYSTEM에만 적용될 경우를 명확하게 언급하여 해석의 혼란을 줄이고, 사용자 및 제조자가 해당 장비의 기능 및 안전 요건을 이해하는 데 큰 도움을 줍니다. 또한, 이 문서는 전기 생리학 장비의 생리적 기능과 관련된 내재적 위험을 다루지는 않지만, 전문 의료 환경에서의 요구 사항을 충족하여 신뢰할 수 있는 진단 도구로서의 중요성을 강조하고 있습니다. 이는 의료 기기 제조업체가 해당 장비의 안전 및 성능을 책임지고 명확한 문서화를 요구하는 점에서 ME EQUIPMENT 제조업체에게도 유용합니다. IEC 80601-2-26:2019 표준은 2012년에 발표된 IEC 60601-2-26 제3판을 대체하며, IEC 60601-1:2005의 개정판과 새로운 부수 표준 및 이에 대한 개정 사항과의 정렬을 위한 기술적 수정 내용을 포함하고 있습니다. 이를 통해 업계의 최신 요구와 기술 변화를 반영하여 필수 성능과 안전성을 보장하고 있습니다. 이러한 점에서 IEC 80601-2-26:2019 표준은 뇌전도 검사기와 관련된 의료 전기 장비의 안전성과 성능이 무엇보다도 중요하다는 사실을 잘 드러내며, 관련 업계와 의료 종사자들에게 매우 중요한 지침서로 자리매김하고 있습니다.
The article discusses the standard IEC 80601-2-26:2019, which pertains to the basic safety and essential performance of electroencephalographs (EEGs). The document applies to EEGs used in professional healthcare facilities, emergency medical services environments, and home healthcare environments. It does not cover requirements for other equipment used in electroencephalography, such as phono-photic stimulators, EEG data storage and retrieval, and monitoring equipment used during electro-convulsive therapy. The article also mentions that the standard applies to both EEG equipment and EEG systems unless specified otherwise. Hazardous aspects related to the intended physiological function of the equipment or systems are not covered in the standard. Lastly, the article notes that IEC 80601-2-26:2019 replaces the previous edition published in 2012 and includes the contents of a corrigendum from October 2021.
記事タイトル：IEC 80601-2-26:2019 - 医療電気機器 - 第2-26部：脳波計の基本的な安全性と必須の性能の特定要件 記事内容：IEC 80601-2-26:2019は、201.3.204で定義された脳波計の基本的な安全性と必須の性能に適用されます。以下、ME機器またはMEシステムとも呼ばれます。この文書は、専門の医療施設、緊急医療サービス環境、または在宅医療環境で使用される脳波計に適用されます。 この文書は、以下の脳波計以外の脳波検査に使用される他の機器の要件をカバーしていません： - 音光刺激装置 - 脳波データの保存と検索 - 電気けいれん療法中のモニタリングに特に使用されるME機器 ある節または副節がME機器にのみ適用される場合、その節または副節のタイトルまたは内容にそれが明記されています。そうでない場合は、節または副節はME機器とMEシステムの両方に適用されます。 節または副節は、デフォルトでME機器に適用されます。ME機器の対応する安全措置や機能がME機器に完全に統合されず、代わりにMEシステムに実装された場合、ME機器の製造業者は同様の機能と安全要件がこの文書を遵守するためにMEシステムによって提供されるかどうかを付属文書で明示します。MEシステムはそれに応じて検証されます。 本文書の対象とする設備またはシステムの意図された生理学的機能に固有の危険要素は、本文書の具体的な要件ではカバーされていません。 IEC 80601-2-26:2019は、2012年に発行されたIEC 60601-2-26の第3版を取り消し、代わりにIEC 60601-1:2005の修正1:2012、関連規格の新バージョンおよびその修正に対応する技術的改訂となっています。 このコピーには、2021年10月の修正書の内容が含まれています。
제목: IEC 80601-2-26:2019 - 의료 전기 장비 - 제2-26 부: 뇌파계의 기본 안전 및 필수 성능에 대한 특정 요구 사항 내용: IEC 80601-2-26:2019은 201.3.204에서 정의된 의료 전기 장비 뇌파계의 기본 안전 및 필수 성능에 적용되며, 이후로 ME 장비 또는 ME 시스템이라고도 불립니다. 이 문서는 전문 보건 시설, 응급 의료 서비스 환경 또는 가정 의료 환경에서 사용되는 뇌파계에 적용됩니다. 본 문서는 뇌파계 사용 시 다음과 같은 기타 장비의 요구 사항을 다루지 않습니다: - 음향 - 광 자극기 - 뇌파 데이터 저장 및 검색 - 전기 쇼크 요법 중 모니터링 목적으로 사용되는 특수하게 의도된 ME 장비 특정 절 또는 부 절이 ME 장비 또는 ME 시스템에만 적용될 경우 해당 절 또는 부 절의 제목 또는 내용에 명시됩니다. 그렇지 않은 경우 해당 절 또는 부 절은 ME 장비와 ME 시스템에 모두 적용됩니다. 절 또는 부 절은 ME 장비에 대해 기본적으로 적용됩니다. ME 장비의 기능이 완전히 통합되지 않고 ME 시스템에 구현된 경우, ME 장비 제조업체는 동반 문서에서 해당 기능 및 안전 요구 사항이 이 문서를 준수하기 위해 ME 시스템에 의해 제공되는지 명시합니다. ME 시스템은 이에 따라 검증됩니다. 본 문서의 적용 범위 내에서 의도된 생리학적 기능에 내재된 위험은 별도의 요구 사항으로 다루지 않습니다. IEC 80601-2-26:2019는 2012년에 발행된 IEC 60601-2-26의 제3판을 대체합니다. 이 버전은 IEC 60601-1:2005의 1번 수정안, 연관 표준의 새 버전 및 해당 수정안과의 기술적 개정에 맞추기 위한 기술적 개정으로 구성됩니다. 2021년 10월 교정표의 내용이 이 복사본에 포함되어 있습니다.
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