IEC/DIS 60601-2-26

Medical electrical equipment

Appareils électromédicaux

Standards Content (sample)

DRAFT INTERNATIONAL STANDARD
IEC/DIS 60601-2-26
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2017-07-07 2017-09-29
Medical electrical equipment —
Part 2-26:
Particular requirements for the basic safety and essential
performance of electroencephalographs
Appareils électromédicaux —
Partie 2-26: Titre manque
ICS: 11.140
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
This document is circulated as received from the committee secretariat.
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
This draft is submitted to a parallel vote in ISO and in IEC.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
IEC/DIS 60601-2-26:2017(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. IEC 2017
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1 CONTENTS

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

3 INTRODUCTION .................................................................................................................... 5

4 201.1 Scope, object and related standards ............................................................................. 6

5 201.2 Normative references ................................................................................................... 7

6 201.3 Terms and definitions ................................................................................................... 8

7 201.4 General requirements ................................................................................................... 9

8 201.5 General requirements for testing of ME EQUIPMENT ........................................................ 9

9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS ......................................................... 10

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

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

12 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS ................. 16

13 201.10 Protection against unwanted and excessive radiation HAZARDS ................................. 17

14 201.11 Protection against excessive temperatures and other HAZARDS ................................. 17

15 201.12 Accuracy of controls and instruments and protection against hazardous outputs ...... 18

16 201.13 HAZARDOUS SITUATIONS and fault conditions .............................................................. 23

17 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ................................................. 23

18 201.15 Construction of ME EQUIPMENT ................................................................................... 23

19 201.16 ME SYSTEMS .............................................................................................................. 23

20 201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS .......................... 23

21 202 Electromagnetic disturbances – Requirements and tests ............................................... 23

22 206 USABILITY ...................................................................................................................... 29

23 Annexes .............................................................................................................................. 29

24 Annex AA (informative) Particular guidance and rationale ................................................... 30

25 Index of defined terms used in this particular standard ......................................................... 33

27 Figure 201.101 – Test of protection against the effects of defibrillation (common mode) ...... 13

28 Figure 201.102 – Test of protection against the effects of defibrillation (differential mode) ... 15

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

30 delivered by the defibrillator ................................................................................................. 16

31 Figure 201.104 – General test circuit .................................................................................... 20

32 Figure 201.105 – Test circuit for noise and common mode rejection (see 201.12.1.103 and

33 201.12.1.105) ....................................................................................................................... 23

34 Figure 202.101 – Test layout for radiated and conducted EMISSION test and radiated immunity

35 test (see 202.4.3.1) .............................................................................................................. 25

36 Figure 202.102 –Test circuit for HF SURGICAL EQUIPMENT protection measurement according to

37 subclause 202.8.102 ............................................................................................................ 27

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

39 202.8.102 ............................................................................................................................. 28

41 Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements ....................................... 9

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

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

55 national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-

56 operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to

57 other activities, IEC publishes International Standards, Technical Specificati ons, Technical Reports, Publicly Available

58 Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical

59 committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work.

60 International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation.

61 IEC collaborates closely with the International Organization for Standardization (ISO) in accordance wi th conditions

62 determined by agreement between the two organizations.

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

64 consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC

65 National Committees.

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

67 in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate,

68 IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user.

69 4) In order to promote international uniformity, IEC National Committees undertake to ap ply IEC Publications transparently

70 to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication

71 and the corresponding national or regional publication shall be clearly indicated in the latter.

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

73 services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by

74 independent certification bodies.

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

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

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

78 nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the

79 publication, use of, or reliance upon, this IEC Publication or any other IEC Publications.

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

81 indispensable for the correct application of this publication.

82 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights.

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

84 International standard IEC 60601-2-26 has been prepared by a Joint Working Group of IEC

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

86 medical practice and ISO subcommittee SC3: Lung ventilators and related equipment, of ISO technical

87 committee 121: Anaesthetic and respiratory equipment.

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

89 edition constitutes a technical revision to align with Amendment 1:2012 to IEC 60601-1:2005, new

90 versions of collateral standards and amendments thereto.
91 The text of this particular standard is based on the following documents:
FDIS Report on voting

93 Full information on the voting for the approval of this particular standard can be found in the report on

94 voting indicated in the above table.
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95 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

96 In this standard, the following print types are used:
97 – Requirements and definitions: roman type.
98 – Test specifications: italic type.

99 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative

100 text of tables is also in a smaller type.

101 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED:

102 SMALL CAPITALS.
103 In referring to the structure of this standard, the term

104 – “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of

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

106 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses

107 of Clause 7).

108 References to clauses within this standard are preceded by the term “Clause” followed by the clause

109 number. References to subclauses within this collateral standard are by number only.

110 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any

111 combination of the conditions is true.

112 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC

113 Directives, Part 2. For the purposes of this standard, the auxiliary verb:

114 – “shall” means that compliance with a requirement or a test is mandatory for compliance with this

115 standard;

116 – “should” means that compliance with a requirement or a test is recommended but is not mandatory

117 for compliance with this standard;

118 – “may” is used to describe a permissible way to achieve compliance with a requirement or test.

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

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

121 A list of all parts of the IEC 60601 series, published under the general title Medical electrical

122 equipment, can be found on the IEC website.

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

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

125 specific publication. At this date, the publication will be
126 • reconfirmed,
127 • withdrawn,
128 • replaced by a revised edition, or
129 • amended.
130

131 NOTE The attention of National Committees is drawn to the fact that equipment MANUFACTURERS and testing organizations

132 may need a transitional period following publication of a new, amended or revised IEC or ISO publication in which to make

133 products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the

134 recommendation of the committee that the content of this publication be adopted for mandatory implementation nationally not

135 earlier than 3 years from the date of publication.
136
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137 INTRODUCTION

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

139 ELECTROENCEPHALOGRAPHS. It amends and supplements IEC 60601-1 (third edition, 2005, Amendment

140 1:2012; Corrigendum 1:2012): Medical electrical equipment – Part 1: General requirements for basic

141 safety and essential performance), hereinafter referred to as the general standard.

142 The aim of this fourth edition is to bring this particular standard up to date with reference to the edition

143 3.1 of the general standard and new versions of collateral standards and amendments thereto through

144 technical changes.

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

146 A “General guidance and rationale” for the more important requirements of this particular standard is

147 included in Annex AA. It is considered that knowledge of the reasons for these requirements will not

148 only facilitate the proper application of the standard but will, in due course, expedite any revision

149 necessitated by changes in clinical practice or as a result of developments in technology. However,

150 Annex AA does not form part of the requirements of this standard.
151
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152 MEDICAL ELECTRICAL EQUIPMENT –
153
154 Part 2-26: Particular requirements for the basic safety
155 and essential performance of electroencephalographs
156
157
158
159 201.1 Scope, object and related standards
160 Clause 1 of the general standard applies, except as follows:
161 201.1.1 * Scope
162 Replacement:

163 This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of

164 ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT or

165 ME SYSTEM. This standard is applicable to ELECTROENCEPHALOGRAPHS intended for use in professional

166 healthcare facilities, the EMERGENCY MEDICAL SERVICE ENVIRONMENT or the
167 HOME HEALTHCARE ENVIRONMENT.

168 This standard does not cover requirements for other equipment used in electroencephalography such

169 as:
170 – phono-photic stimulators;
171 – EEG data storage and retrieval;

172 – ME EQUIPMENT particularly intended for monitoring during electro-convulsive therapy.

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

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

175 clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as follows:

176 The clause or subclause applies to ME EQUIPMENT, as default. If the corresponding safety measure or

177 function is intentionally, by decision of the manufacturer, not completely integrated into the

178 ME EQUIPMENT, but has to be realized in an ME SYSTEM, the manufacturer of the ME EQUIPMENT has to

179 specify in its accompanying documents which functionality and safety requirements have to be

180 provided by the connected ME SYSTEM to fulfil that clause or subclause. The ME SYSTEM, then, has to

181 be verified accordingly.

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

183 scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and

184 8.4.1 of the general standard.
185 NOTE See also 4.2 of the general standard.
186 201.1.2 Object
187 Replacement:

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

189 ESSENTIAL PERFORMANCE requirements for ELECTROENCEPHALOGRAPHS as defined in 201.3.204.

The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety

and essential performance including Amendment 1:2012.
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190 201.1.3 Collateral standards

191 This particular standard refers to those applicable collateral standards that are listed in Clause 2 of

192 the general standard and Clause 201.2 of this particular standard.

193 IEC 60601-1-2:2014 and IEC 60601-1-6:2013 apply as modified in Clause 202 and 206, respectively.

194 IEC 60601-1-3, IEC 60601-1-9 and IEC 60601-1-10 do not apply. All other published collateral

195 standards in the IEC 60601-1 series apply as published.
196 201.1.4 Particular standards
197 Replacement:

198 In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in

199 the general standard and collateral standards as appropriate for the particular ME EQUIPMENT or

200 ME SYSTEM under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE

201 requirements.

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

203 standards.

204 For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral

205 standards are referred to by their document number.

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

207 general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1

208 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final

209 digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses

210 the content of Clause 4 of the IEC 60601-1-2 collateral standard, etc.). The changes to the text of the

211 general standard and applicable collateral standards are specified by the use of the following words:

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

213 standard is replaced completely by the text of this particular standard.

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

215 general standard or applicable collateral standard.

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

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

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

219 starting from 201.101. However due to the fact that definitions in the general standard are numbered

220 3.1 through 3.139, additional definitions in this standard are numbered beginning from 201.3.201.

221 Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

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

223 starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, etc.

224 The term "this standard" is used to make reference to the general standard, any applicable collateral

225 standards and this particular standard taken together.

226 Where there is no corresponding clause or subclause in this particular standard, the clause or

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

228 applies without modification; where it is intended that any part of the general standard or applicable

229 collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given

230 in this particular standard.
231 201.2 Normative references
232 Clause 2 of the general standard applies, except as follows:
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233 Amendment:

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

235 and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and

236 tests
237 Addition:

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

239 and essential performance – Collateral standard: Requirements for medical electrical equipment and

240 medical electrical systems used in the home healthcare environment

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

242 and essential performance – Collateral standard: Requirements for medical electrical equipment and

243 medical electrical systems intended for use in the emergency medical services environment

244 201.3 Terms and definitions
245 NOTE An index of defined terms is found beginning on page 33.

246 For the purpose of this document, the terms and definitions given in IEC 60601-1:2012, IEC 60601-1-

247 2:2014, IEC 60601-1-6:2013, IEC 60601-1-11:2015, IEC 60601-1-12:2014 and IEC 60601-2-2:2017

248 apply, except as follows:
249 Additional definitions:
250 201.3.201
251 CHANNEL

252 hardware and/or software selection of a particular electroencephalograp hic LEAD for purposes of

253 display, recording, or transmission
254 201.3.202
255 ELECTRODE

256 sensor that is applied to the scalp, cerebral cortex, or subdural locations to detect electrical activity of

257 the brain
258 201.3.203
259 ELECTROENCEPHALOGRAM
260 EEG

261 presentation (on screen or paper) of the variation with time of voltages taken from ELECTRODES, whose

262 positions are specified
263 201.3.204
264 ELECTROENCEPHALOGRAPH
265 ME EQUIPMENT or ME SYSTEM to produce an ELECTROENCEPHALOGRAM
266 201.3.206
267 LEAD WIRE

268 cable connected between an ELECTRODE and either a PATIENT CABLE or the ELECTROENCEPHALOGRAPH

269 201.3.207
270 NEUTRAL ELECTRODE

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

272 201.3.208
273 PATIENT CABLE

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

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275 201.4 General requirements
276 Clause 4 of the general standard applies, except as follows:
277 201.4.3 ESSENTIAL PERFORMANCE
278 Addition:
279 201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements

280 Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in Table 201.101.

281 Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Accuracy of signal reproduction 201.12.1.102
Input dynamic range and differential offset voltage 201.12.1.103
Input noise 201.12.1.104
Frequency response 201.12.1.105
Common mode rejection 201.12.1.106
Indication of inoperable ELECTROENCEPHALOGRAPH 201.12.4.101
282
283 Box Note 1:

284 National committees are respectfully requested to provide feedback which of the requirements in

285 clauses 201.12.1.102 to 201.12.1.106 constitute the essential performance of an

286 ELECTROENCEPHALOGRAPH.
287 (A) Just, 201.12.1.102 Accuracy of signal reproduction
288 (B) All currently listed clauses 201.12.1.102 to 201.12.1.106
289 (C) Any other subset of 201.12.1.102 to 201.12.106; please specify
290 Please provide rationale for your answer.
291
292 201.5 General requirements for testing of ME EQUIPMENT
293 Clause 5 of the general standard applies, except as follows:
294 201.5.4 Other conditions
295 Addition:

296 aa) If necessary for the purpose of conducting the test, the INTERNAL ELECTRICAL POWER SOURCE may

297 be replaced by an external battery or d.c. power supply to provide the necessary test voltage.

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

299 given below:
300 – resistors:  1 %;
301 – capacitors:  10 %;
302 – inductors:  10 %;
303 – test voltages:  1 %.
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304 201.5.8 *Sequence of tests
305 Amendment:

306 Tests called for in 201.8.5.5.1 of this particular standard and in 8.5.5 of the general standard shall be

307 carried out prior to the LEAKAGE CURRENT and dielectric strength tests described in subclauses 8.7 and

308 8.8 of the general standard and prior to the tests specified in subclauses 201.12.1.102 to

309 201.12.1.106 of this particular standard.
310 201.6 Classification of ME EQUIPMENT and ME SYSTEMS
311 Clause 6 of the general standard applies, except as follows:
312 201.6.6 Mode of operation
313 Replacement:
314 ELECTROENCEPHALOGRAPHS shall be classified for CONTINUOUS OPERATION.
315 201.7 ME EQUIPMENT identification, marking and documents
316 Clause 7 of the general standard applies, except as follows:

317 201.7.2.1 * Minimum requirements for marking on ME EQUIPMENT and on interchangeable

318 parts
319 Addition:

320 If the ELECTROENCEPHALOGRAPH is specified as being protected against the effects of defibrillation:

321 Parts of the ELECTROENCEPHALOGRAPH (for example PATIENT CABLES) specified as being protected

322 against the effects of defibrillation shall be marked with symbol 26 or 27 of Table D.1 in Appendix D of

323 the general standard according to the classification as TYPE BF APPLIED PART or TYPE CF APPLIED PART.

324 201.7.9.2 Instructions for use
325 201.7.9.2.2 Warning and safety notices
326 Addition:

327 If protection against the effects of defibrillation is provided (see 201.8.5.5.1), the instructions for use

328 shall include a warning that defibrillator protection requires the use of MANUFACTURER-specified

329 ACCESSORIES, including PATIENT CABLES and LEAD WIRES.
330 Additional subclause:
331 201.7.9.2.101 Additional instructions for use
332 The instructions for use shall also include:
333 a) The INTENDED USE/INTENDED PURPOSE including environment of use.

334 Likely misuse should be identified by RISK ANALYSIS and disclosed, if necessary (e.g. ‘not suitable

335 for electro-cerebral inactivity (ECI) determination’).
336 b) The procedures necessary for safe operation.

337 c) That conductive parts of ELECTRODES and associated connectors for APPLIED PARTS, including the

338 NEUTRAL ELECTRODE, should not contact other conductive parts including earth.

339 d) Information whether the ELECTROENCEPHALOGRAPH incorporates means to protect the PATIENT

340 against burns when used with HF SURGICAL EQUIPMENT and advice regarding the location of

341 ELECTRODES and LEAD WIRES etc, to reduce the HAZARD of burns in the event of a defect in the

342 neutral electrode connection of the HF SURGICAL EQUIPMENT.
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343 e) * The need for regular testing of the ELECTROENCEPHALOGRAPH and its ACCESSORIES.

344 f) Precautions to take when using a defibrillator on a PATIENT, if APPLIED PARTS not being protected

345 against the effects of defibrillation are being used; a description of how the discharge of a

346 defibrillator affects the ELECTROENCEPHALOGRAPH.

347 g) The subsequent operation of the ELECTROENCEPHALOGRAPH after interruption of SUPPLY MAINS

348 exceeding 30 s (see 201.11.8).

349 h) Any HAZARD due to simultaneous use of other PATIENT-connected ME EQUIPMENT, for example, a

350 cardiac pacemaker or other electrical stimulators.

351 i) Technical specifications for the ELECTROENCEPHALOGRAPH of sufficient detail to allow the OPERATOR

352 to understand what is being measured and any limitations. Minimally this shall include:

353 – accuracy of signal reproduction
354 – input dynamic range and maximum offset voltage
355 – noise
356 – frequency range and bandwidth;
357 – common mode rejection
358 – a description of all functions;
359 – a description of waveform displays (if applicable).
360 j) * Any known susceptibilities to electromagnetic phenomena.

361 k) If applicable, limitations of multipurpose channels (e.g. that these channels are not suitable for

362 monitoring and of ECG or EMG) and to which clauses of applicable standards (e.g. IEC 80601-2-

363 xx) they were tested, if any.
364 201.8 Protection against electrical HAZARDS from ME EQUIPMENT
365 Clause 8 of the general standard applies, except as follows:
366 201.8.1 Fundamental rule of protection against electrical shock
367 A
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