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)

General Information

Status
Published
Public Enquiry End Date
28-Sep-2017
Publication Date
27-Apr-2020
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
22-Apr-2020
Due Date
27-Jun-2020
Completion Date
28-Apr-2020

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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.

---------------------- Page: 1 ----------------------
SIST EN IEC 80601-2-26:2020
---------------------- Page: 2 ----------------------
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)
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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
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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
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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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SIST EN IEC 80601-2-26:2020
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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SIST EN IEC 80601-2-26:2020
– 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.
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SIST EN IEC 80601-2-26:2020
IEC 80601-2-26:2019 © IEC 2019 – 5 –

The committee has decided that the contents of this document will remain unchanged until the

stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to

the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing

organizations may need a transitional period following publication of a new, amended or revised IEC publication in

which to make products in accordance with the new requirements and to equip themselves for conducting new or

revised tests. It is the recommendation of the committees that the content of this publication be adopted for

implementation nationally not earlier than 3 years from the date of publication.
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SIST EN IEC 80601-2-26:2020
– 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.
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SIST EN IEC 80601-2-26:2020
IEC 80601-2-26:2019 © IEC 2019 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-26: Particular requirements for the basic safety
and essential performance of electroencephalographs
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This part of the 80601 International Standard applies to the BASIC SAFETY and

ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also

referred to as ME EQUIPMENT or ME SYSTEM. This document is applicable to

ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities, the

EMERGENCY MEDICAL SERVICES ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT.
This document does not cover requirements for other equipment used in
electroencephalography such as:
– phono-photic stimulators;
– EEG data storage and retrieval;

– ME EQUIPMENT particularly intended for monitoring during electroconvulsive therapy.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to

ME SYSTEMS only, the title or content of that clause or subclause will say so. If that is not the

case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as follows.

The clause or subclause applies to ME EQUIPMENT, as default. For ME EQUIPMENT with the

corresponding safety measure or function not completely integrated into the ME EQUIPMENT but

instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER specifies in the

ACCOMPANYING DOCUMENTS which functionality and safety requirements are provided by the

ME SYSTEM to comply with this document. The ME SYSTEM is verified accordingly.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within

the scope of this document are not covered by specific requirements in this document.

NOTE See also 4.2 of the general standard.
201.1.2 Object
Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and

ESSENTIAL PERFORMANCE requirements for ELECTROENCEPHALOGRAPHS as defined in 201.3.204.

___________

1 The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –

Part 1: General requirements for basic safety and essential performance
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SIST EN IEC 80601-2-26:2020
– 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.
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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
...

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