SIST EN IEC 80601-2-26:2020/oprA1:2021
(Amendment)Amendment 1 - Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalograph
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
Relations
Standards Content (Sample)
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.
---------------------- Page: 1 ----------------------
SIST EN IEC 80601-2-26:2020/oprA1:2021
---------------------- Page: 2 ----------------------
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.
---------------------- Page: 3 ----------------------
SIST EN IEC 80601-2-26:2020/oprA1:2021
---------------------- Page: 4 ----------------------
SIST EN IEC 80601-2-26:2020/oprA1:2021
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
28
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
43
44 Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 11
45 Table 201.102 – Input voltage ranges and rates of variation . 20
46
---------------------- Page: 5 ----------------------
SIST EN IEC 80601-2-26:2020/oprA1:2021
IEC CDV 80601-2-26:2019/AMD1:2021 © IEC 2021– 3 – 62D/1897/CDV
47 INTERNATIONAL ELECTROTECHNICAL COMMISSION
48 ____________
49
50 MEDICAL ELECTRICAL EQUIPMENT –
51
52 Part 2-26: Particular requirements for the basic safety
53 and essential performance of electroencephalographs
54
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.
---------------------- Page: 6 ----------------------
SIST EN IEC 80601-2-26:2020/oprA1:2021
62D/1897/CDV – 4 – IEC CDV 80601-2-26:2019/AMD1:2021 © IEC 2021
98 The text of this standard is based on the following documents of IEC:
FDIS Report on voting
62D/xxxx/FDIS 62D/xxxx/RVD
99
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.
---------------------- Page: 7 ----------------------
SIST EN IEC 80601-2-26:2020/oprA1:2021
IEC CDV 80601-2-26:2019/AMD1:2021 © IEC 2021– 5 – 62D/1897/CDV
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
---------------------- Page: 8 ----------------------
SIST EN IEC 80601-2-26:2020/oprA1:2021
62D/1897/CDV – 6 – IEC CDV 80601-2-26:2019/AMD1:2021 © IEC 2021
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
---------------------- Page: 9 ----------------------
SIST EN IEC 80601-2-26:2020/oprA1:2021
IEC CDV 80601-2-26:2019/AMD1:2021 © IEC 2021– 7 – 62D/1897/CDV
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
1
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
---------------------- Page: 10 ----------------------
SIST EN IEC 80601-2-26:2020/oprA1:2021
62D/1897/CDV – 8 – IEC CDV 80601-2-26:2019/AMD1:2021 © IEC 2021
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.
---------------------- Page: 11 ----------------------
SIST EN IEC 80601-2-26:2020/oprA1:2021
IEC CDV 80601-2-26:2019/AMD1:2021 © IEC 2021– 9 – 62D/1897/CDV
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:
---------------------- Page: 12 ----------------------
SIST EN IEC 80601-2-26:2020/oprA1:2021
62D/1897/CDV – 10 – IEC CDV 80601-2-26:2019/AMD1:2021 © IEC 2021
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.
---------------------- Page: 13 ----------------------
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
or
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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.