Amendment 1 - Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalograph

Medizinische elektrische Geräte - Teil 2-26: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektroenzephalographen

Appareils électromédicaux - Partie 2-26: Exigences particulières pour la sécurité de base et les performances essentielles des électroencéphalographes

IEC 80601-2-26:2019 s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des ELECTROENCEPHALOGRAPHES définis en 201.3.204, aussi appelés APPAREILS EM ou SYSTEMES EM dans la présente norme. Le présent document est applicable aux ELECTROENCEPHALOGRAPHES destinés à être utilisés dans les établissements de soins professionnels, l'ENVIRONNEMENT DES SERVICES MEDICAUX D'URGENCE ou l'ENVIRONNEMENT DES SOINS A DOMICILE.
Les exigences propres à d'autres appareils également utilisés en électroencéphalographie ne relèvent pas du domaine d'application du présent document, par exemple:
– stimulateurs phonophotiques;
– appareils de stockage et restitution d'informations d'EEG;
– APPAREILS EM destinés particulièrement à la surveillance au cours d'une thérapie électro-convulsive.
Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, le titre ou le contenu de cet article ou de ce paragraphe l'indique. Si ce n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux APPAREILS EM et aux SYSTEMES EM, comme suit.
L'article ou le paragraphe s'applique aux APPAREILS EM, par défaut. Pour les APPAREILS EM dont la mesure ou la fonction de sécurité correspondante n'est pas complètement intégrée dans l'APPAREIL EM, mais plutôt mise en œuvre dans un SYSTEME EM, le FABRICANT de l'APPAREIL EM spécifie dans les DOCUMENTS D'ACCOMPAGNEMENT les exigences de fonctionnalité et de sécurité qu'assure le SYSTEME EM pour être conforme au présent document. Le SYSTEME EM est vérifié en conséquence.
Les DANGERS inhérents à la fonction physiologique prévue des APPAREILS EM ou des SYSTEMES EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document.
IEC 80601-2-26:2019 annule et remplace la troisième édition de l'IEC 60601-2-26 parue en 2012. Cette édition constitue une révision technique destinée à s'aligner sur l'Amendement 1:2012 de l'IEC 60601-1:2005 et sur les nouvelles versions des normes collatérales et leurs amendements.

Dopolnilo A1 - Medicinska električna oprema - 2-26. del: Posebne zahteve za osnovno varnost in bistvene lastnosti elektroencefalografov

General Information

Status
Not Published
Public Enquiry End Date
30-Nov-2021
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
17-Sep-2021
Due Date
04-Feb-2022

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SLOVENSKI STANDARD
SIST EN IEC 80601-2-26:2020/oprA1:2021
01-november-2021
Dopolnilo A1 - Medicinska električna oprema - 2-26. del: Posebne zahteve za
osnovno varnost in bistvene lastnosti elektroencefalografov

Amendment 1 - Medical electrical equipment - Part 2-26: Particular requirements for the

basic safety and essential performance of electroencephalograph

Medizinische elektrische Geräte - Teil 2-26: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von Elektroenzephalographen

Appareils électromédicaux - Partie 2-26: Exigences particulières pour la sécurité de base

et les performances essentielles des électroencéphalographes
Ta slovenski standard je istoveten z: EN IEC 80601-2-26:2020/prA1:2021
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
SIST EN IEC 80601-2- en
26:2020/oprA1:2021

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 80601-2-26:2020/oprA1:2021
62D/1897/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-26/AMD1 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2021-09-10 2021-12-03
SUPERSEDES DOCUMENTS:
62D/1833/RR
IEC SC 62D : ELECTROMEDICAL EQUIPMENT
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
Other TC/SCs are requested to indicate their interest, if
any, in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY

SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING

Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.

Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of

which they are aware and to provide supporting documentation.
TITLE:

Amendment 1 - Medical electrical equipment - Part 2-26: Particular requirements for the basic

safety and essential performance of electroencephalograph
PROPOSED STABILITY DATE: 2027
NOTE FROM TC/SC OFFICERS:

IEC 80601-2-26 amendment is to align to the Amendment projects of the IEC 60601-1 series. Please

see IEC 62D/1808/INF and 62D/1828/AC for more information.

Copyright © 2021 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to

download this electronic file, to make a copy and to print out the content for the sole purpose of preparing

National Committee positions. You may not copy or "mirror" the file or printed version of the document, or any

part of it, for any other purpose without permission in writing from IEC.
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62D/1897/CDV – 2 – IEC CDV 80601-2-26:2019/AMD1:2021 © IEC 2021
1 CONTENTS

2 FOREWORD ........................................................................................................................... 3

3 INTRODUCTION ..................................................................................................................... 6

4 201.1 Scope, object and related standards ....................................................................... 7

5 201.2 Normative references .............................................................................................. 9

6 201.3 Terms and definitions .............................................................................................. 9

7 201.4 General requirements ........................................................................................... 10

8 201.5 General requirements for testing ME EQUIPMENT .................................................... 11

9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS .................................................... 11

10 201.7 ME EQUIPMENT identification, marking and documents ........................................... 12

11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT ..................................... 13

12 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS ........... 18

13 201.10 Protection against unwanted and excessive radiation HAZARDS ............................. 19

14 201.11 Protection against excessive temperatures and other HAZARDS ............................. 19

15 201.12 Accuracy of controls and instruments and protection against hazardous

16 outputs .......................................................................................................................... 20

17 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT ............................... 24

18 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ............................................. 24

19 201.15 Construction of ME EQUIPMENT ............................................................................... 24

20 201.16 ME SYSTEMS .......................................................................................................... 24

21 201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS ...................... 24

22 202 Electromagnetic disturbances – Requirements and tests ............................................... 24

23 206 USABILITY ....................................................................................................................... 29

24 Annexes ............................................................................................................................... 31

25 Annex AA (informative) Particular guidance and rationale .................................................... 32

26 Bibliography .......................................................................................................................... 35

27 Index of defined terms used in this particular standard .......................................................... 36

29 Figure 201.101 – Test of protection against the effects of defibrillation (common mode)Error! Bookmark not

30 Figure 201.102 – Test of protection against the effects of defibrillation (differential

31 mode) ................................................................................................................................... 17

32 Figure 201.103 – Application of the test voltage between LEAD WIRES to test the energy

33 delivered by the defibrillator .................................................................................................. 18

34 Figure 201.104 – General test circuit .................................................................................... 21

35 Figure 201.105 – Test circuit for noise and common mode rejection (see 201.12.1.104

36 and 201.12.1.106) ................................................................................................................. 23

37 Figure 202.101 – Test layout for radiated and conducted EMISSION test and radiated

38 IMMUNITY test (see 202.4.3.1) ................................................................................................ 25

39 Figure 202.102 –Test circuit for HF SURGICAL EQUIPMENT protection measurement

40 according to 202.8.101 ......................................................................................................... 28

41 Figure 202.103 – Test setup for HF SURGICAL EQUIPMENT measurement according to

42 202.8.101 ............................................................................................................................. 29

44 Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements ...................................... 11

45 Table 201.102 – Input voltage ranges and rates of variation ................................................. 20

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47 INTERNATIONAL ELECTROTECHNICAL COMMISSION
48 ____________
50 MEDICAL ELECTRICAL EQUIPMENT –
52 Part 2-26: Particular requirements for the basic safety
53 and essential performance of electroencephalographs
55 FOREWORD

56 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

57 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

58 international co-operation on all questions concerning standardization in the electrical and electronic fields. To

59 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

60 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC

61 Publication(s)"). Their preparation is entrusted to technical committees; any IEC National Committee interested

62 in the subject dealt with may participate in this preparatory work. International, governmental and non-

63 governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

64 with the International Organization for Standardization (ISO) in accordance with conditions determined by

65 agreement between the two organizations.

66 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

67 consensus of opinion on the relevant subjects since each technical committee has representation from all

68 interested IEC National Committees.

69 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

70 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

71 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

72 misinterpretation by any end user.

73 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

74 transparently to the maximum extent possible in their national and regional publications. Any divergence

75 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

76 the latter.

77 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

78 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

79 services carried out by independent certification bodies.

80 6) All users should ensure that they have the latest edition of this publication.

81 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

82 members of its technical committees and IEC National Committees for any personal injury, property damage or

83 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

84 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

85 Publications.

86 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

87 indispensable for the correct application of this publication.

88 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

89 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

90 International standard IEC 80601-2-26 has been prepared by a Joint Working Group of IEC

91 subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical

92 equipment in medical practice, and ISO subcommittee SC3: Lung ventilators and related

93 equipment, of ISO technical committee 121: Anaesthetic and respiratory equipment.

94 This publication is published as a double logo standard.

95 This document cancels and replaces the third edition of IEC 60601-2-26 published in 2012.

96 This edition constitutes a technical revision to align with Amendment 1:2012 of IEC 60601-

97 1:2005, new versions of collateral standards and amendments thereto.
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98 The text of this standard is based on the following documents of IEC:
FDIS Report on voting
62D/xxxx/FDIS 62D/xxxx/RVD

100 Full information on the voting for the approval of this document can be found in the report on

101 voting indicated in the above table. In ISO, the standard has been approved by xxx

102 P members out of yyy having cast a vote.

103 This document has been drafted in accordance with the ISO/IEC Directives, Part 2.

104 In this document, the following print types are used:
105 – requirements and definitions: roman type;
106 – test specifications: italic type;

107 – informative material appearing outside of tables, such as notes, examples and references: in smaller type.

108 Normative text of tables is also in a smaller type;

109 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS

110 NOTED: SMALL CAPITALS.
111 In referring to the structure of this document, the term

112 – "clause" means one of the seventeen numbered divisions within the table of contents,

113 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);

114 – "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all

115 subclauses of Clause 7).

116 References to clauses within this document are preceded by the term "Clause" followed by

117 the clause number. References to subclauses within this particular standard are by number

118 only.

119 In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any

120 combination of the conditions is true.

121 The verbal forms used in this document conform to usage described in Clause 7 of the

122 ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:

123 – "shall" means that compliance with a requirement or a test is mandatory for compliance

124 with this document;

125 – "should" means that compliance with a requirement or a test is recommended but is not

126 mandatory for compliance with this document;

127 – "may" is used to describe a permissible way to achieve compliance with a requirement or

128 test.

129 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title

130 indicates that there is guidance or rationale related to that item in Annex AA.

131 A list of all parts of the 80601 International Standard, published under the general title

132 Medical electrical equipment, can be found on the IEC website.
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133 The committee has decided that the contents of this document will remain unchanged until the

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

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

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

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

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

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

144 implementation nationally not earlier than 3 years from the date of publication.

145
146
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147 INTRODUCTION

148 This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of

149 ELECTROENCEPHALOGRAPHS. It amends and supplements IEC 60601-1:2005 and

150 IEC 60601-1:2005/AMD1:2012, Medical electrical equipment – Part 1: General requirements

151 for basic safety and essential performance, hereinafter referred to as the general standard.

152 The aim of this document is to bring this particular standard up to date with reference to the

153 edition 3.1 of the general standard and new versions of collateral standards and amendments

154 thereto through technical changes.

155 The requirements of this particular standard take priority over those of the general standard.

156 A general guidance and rationale for the more important requirements of this particular

157 standard is included in Annex AA. It is considered that knowledge of the reasons for these

158 requirements will not only facilitate the proper application of the standard but will, in due

159 course, expedite any revision necessitated by changes in clinical practice or as a result of

160 developments in technology. However, Annex AA does not form part of the requirements of

161 this document.
162
163
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164 MEDICAL ELECTRICAL EQUIPMENT –
165
166 Part 2-26: Particular requirements for the basic safety
167 and essential performance of electroencephalographs
168
169
170
171 201.1 Scope, object and related standards
172 Clause 1 of the general standard applies, except as follows:
173 201.1.1 * Scope
174 Replacement:

175 This part of the 80601 International Standard applies to the BASIC SAFETY and

176 ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also

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

178 ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities, the

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

184 – ME EQUIPMENT particularly intended for monitoring during electroconvulsive therapy.

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

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

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

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

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

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

191 ACCOMPANYING DOCUMENTS which functionality and safety requirements are provided by the

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

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

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

195 NOTE See also 4.2 of the general standard.
196 201.1.2 Object
197 Replacement:

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

199 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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200 201.1.3 Collateral standards
201 Addition:

202 This particular standard refers to those applicable collateral standards that are listed in

203 Clause 2 of the general standard and Clause 201.2 of this particular standard.

204 IEC 60601-1-2:2014, IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010,

205 IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020 apply as modified in

206 Clause 202 and 206, respectively. IEC 60601-1-3, IEC 60601-1-9 and IEC 60601-1-10 do not

207 apply. All other published collateral standards in the IEC 60601-1 series apply as published.

208 201.1.4 Particular standards
209 Replacement:

210 In the IEC 60601 series, particular standards may modify, replace or delete requirements

211 contained in the general standard and collateral standards as appropriate for the particular

212 ME EQUIPMENT or ME SYSTEM under consideration, and may add other BASIC SAFETY and

213 ESSENTIAL PERFORMANCE requirements.

214 A requirement of a particular standard takes priority over the general standard and collateral

215 standards.

216 For brevity, IEC 60601-1, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are

217 referred to in this particular standard as the general standard. Collateral standards are

218 referred to by their document number.

219 The numbering of clauses and subclauses of this particular standard corresponds to that of

220 the general standard with the prefix "201" (e.g. 201.1 in this document addresses the content

221 of Clause 1 of the general standard) or applicable collateral standard with the prefix "20x"

222 where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this

223 particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral

224 standard, etc.). The changes to the text of the general standard and applicable collateral

225 standards are specified by the use of the following words:

226 "Replacement" means that the clause or subclause of the general standard or applicable

227 collateral standard is replaced completely by the text of this particular standard.

228 "Addition" means that the text of this particular standard is additional to the requirements of

229 the general standard or applicable collateral standard.

230 "Amendment" means that the clause or subclause of the general standard or applicable

231 collateral standard is amended as indicated by the text of this particular standard.

232 Subclauses, figures or tables which are additional to those of the general standard are

233 numbered starting from 201.101. However due to the fact that definitions in the general

234 standard are numbered 3.1 through 3.147, additional definitions in this document are

235 numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and

236 additional items aa), bb), etc.

237 Subclauses, figures or tables which are additional to those of a collateral standard are

238 numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for

239 IEC 60601-1-2, etc.

240 The term "this document" is used to make reference to the general standard, any applicable

241 collateral standards and this particular standard taken together.
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242 Where there is no corresponding clause or subclause in this particular standard, the clause or

243 subclause of the general standard or applicable collateral standard, although possibly not

244 relevant, applies without modification; where it is intended that any part of the general

245 standard or applicable collateral standard, although possibly relevant, is not to be applied, a

246 statement to that effect is given in this particular standard.
247 201.2 Normative references
248 NOTE Informative references are listed in the Bibliography.
249 Clause 2 of the general standard applies, except as follows:
250 Replacement:

251 IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic

252 safety and essential performance – Collateral standard: Electromagnetic disturbances –

253 Requirements and tests
254 IEC 60601-1-2:2014/AMD1:2020

255 IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic

256 safety and essential performance – Collateral standard: Usability
257 IEC 60601-1-6:2010/AMD1:2013
258 IEC 60601-1-6:2010/AMD2:2020
259 Addition:

260 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic

261 safety and essential performance
262 IEC 60601-1:2005/AMD1:2012
263 IEC 60601-1:2005/AMD2:2020

264 IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for

265 basic safety and essential performance – Collateral standard: Requirements for medical

266 electrical equipment and medical electrical systems used in the home healthcare environment

267 IEC 60601-1-11:2015/AMD1:2020

268 IEC 60601-1-12:2014, Medical electrical equipment – Part 1-12: General requirements for

269 basic safety and essential performance – Collateral standard: Requirements for medical

270 electrical equipment and medical electrical systems intended for use in the emergency

271 medical services environment
272 IEC 60601-1-12:2014/AMD1:2020

273 IEC 60601-2-2:2017, Medical electrical equipment – Part 2-2: Particular requirements for the

274 basic safety and essential performance of high frequency surgical equipment and high

275 frequency surgical accessories
276 201.3 Terms and definitions

277 For the purpose of this document, the terms and definitions given in IEC 60601-1:2005,

278 IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020, IEC 60601-1-2:2014,

279 IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013,

280 IEC 60601-1-6:2010/AMD2:2020, IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020,

281 IEC 60601-1-12:2014, IEC 60601-1-12:2014/AMD1:2020, IEC 60601-2-2:2017 and the

282 following apply.

283 ISO and IEC maintain terminological databases for use in standardization at the following

284 addresses:
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285 • IEC Electropedia: available at http://www.electropedia.org/
286 • ISO Online browsing platform: available at http://www.iso.org/obp
287 NOTE An index of defined terms is found beginning on page 36.
288 Addition:
289 201.3.201
290
CHANNEL

291 hardware and/or software selection of a particular electroencephalographic voltage between

292 ELECTRODES for purposes of display, recording, or transmission
293 201.3.202
294 ELECTRODE

295 sensor that is applied to the scalp, cerebral cortex, or subdural locations to detect electrical

296 activity of the brain
297 201.3.203
298 ELECTROENCEPHALOGRAM
299 EEG

300 presentation (on screen or paper) of the variation with time of voltages taken from

301 ELECTRODES, whose positions are specified
302 201.3.204
303 ELECTROENCEPHALOGRAPH
304 ME EQUIPMENT or ME SYSTEM to produce an ELECTROENCEPHALOGRAM
305 201.3.205
306 LEAD WIRE
307 cable connected between an ELECTRODE and either a PATIENT CABLE or the
308
ELECTROENCEPHALOGRAPH
309 201.3.206
310 NEUTRAL ELECTRODE

311 reference point for differential amplifiers and/or interference suppression circuits

312 201.3.207
313 PATIENT CABLE

314 multiwire cable or junction box used to connect LEAD WIRES to the ELECTROENCEPHALOGRAPH

315 201.4 General requirements
316 Clause 4 of the general standard applies, except as follows:
317 201.4.3 ESSENTIAL PERFORMANCE
318 Additional subclause:
319 201.4.3.101 * Additional ESSENTIAL PERFORMANCE requirements

320 Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in

321 Table 201.101.
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SIST EN IEC 80601-2-26:2020/oprA1:2021
IEC CDV 80601-2-26:2019/AMD1:2021 © IEC 2021– 11 – 62D/1897/CDV
322 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
Indication of invalid data 201.12.4.101
323

324 For ELECTROENCEPHALOGRAPHS having more than 10 identical EEG CHANNELS, testing 10 of

325 these CHANNELS is sufficient to verify ESSENTIAL PERFORMANCE.
326 201.5 General requirements for testing ME EQUIPMENT
327 Clause 5 of the general standard applies, except as follows:
328 201.5.4 Other conditions
329 Addition:
330 aa) If necessary for the purpose of conducting the test, the

331 INTERNAL ELECTRICAL POWER SOURCE may be replaced by an external battery or DC

332 power supply to provide the necessary test voltage.

333 bb) The values used in test circuits, unless otherwise specified, shall have at least an

334 accuracy as given below:
335 – resistors: ±1 %;
336 – capacitors: ±10 %;
337 – inductors: ±10 %;
338 – test voltages: ±1 %.
339 201.5.8 * Sequence of tests
340 Replacement:
341 Tests called for in 201.8.5.5.1 of this particular standard and
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