oSIST prEN IEC 60601-2-40:2023
(Main)Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
Medizinische elektrische Geräte - Teil 2-40: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektromyographen und Geräten für evozierte Potentiale
Appareils électromédicaux - Partie 2-40: Exigences particulières pour la sécurité de base et les performances essentielles des électromyographes et des appareils à potentiel évoqué
Medicinska električna oprema - 2-40. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za elektromiografe in opremo za izzvane odzive
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN IEC 60601-2-40:2023
01-maj-2023
Medicinska električna oprema - 2-40. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za elektromiografe in opremo za izzvane odzive
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and
essential performance of electromyographs and evoked response equipment
Medizinische elektrische Geräte - Teil 2-40: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Elektromyographen und
Geräten für evozierte Potentiale
Appareils électromédicaux - Partie 2-40: Exigences particulières pour la sécurité de base
et les performances essentielles des électromyographes et des appareils à potentiel
évoqué
Ta slovenski standard je istoveten z: prEN IEC 60601-2-40:2023
ICS:
11.040.50 Radiografska oprema Radiographic equipment
oSIST prEN IEC 60601-2-40:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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62D/2019/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-40 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2023-03-17 2023-06-09
SUPERSEDES DOCUMENTS:
62D/1901/CD, 62D/1928A/CC
IEC SC 62D : PARTICULAR MEDICAL EQUIPMENT, SOFTWARE, AND SYSTEMS
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 ,
• any relevant “in some countries” clauses to be included should this proposal proceed. Recipients are remin ded
that the enquiry stage is the final stage for submitting "in some countries" clauses. See AC/22/2007.
TITLE:
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential
performance of electromyographs and evoked response equipment
PROPOSED STABILITY DATE: 2029
Copyright © 2023 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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NOTE FROM TC/SC OFFICERS:
IEC 60601-2-40 is revised to align to the Amendment projects of the IEC 60601-1 series and to incorporate
several significant technical changes. Please refer to 62D/1792/DC and 62D/1808/INF for maintenance
decision. National Committees are invited to vote on the Committee Draft for Vote at this stage.
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1 CONTENTS
2 FOREWORD . 4
3 INTRODUCTION . 7
4 201.1 Scope, object and related standards . 8
5 201.2 Normative references . 10
6 201.3 Terms and definitions . 10
7 201.4 General requirements . 12
8 201.5 General requirements for testing of ME EQUIPMENT . 12
9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
10 201.7 ME EQUIPMENT identification, marking and documents . 12
11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
12 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
13 201.10 Protection against unwanted and excessive radiation HAZARDS . 15
14 201.11 Protection against excessive temperatures and other HAZARDS . 15
15 201.12 Accuracy of controls and instruments and protection against hazardous
16 outputs . 16
17 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 18
18 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 19
19 201.15 Construction of ME EQUIPMENT . 19
20 201.16 ME SYSTEMS . 19
21 201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 19
22 202 * ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 19
23 Annexes . 24
24 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
25 and ME SYSTEMS . 24
26 Annex AA (informative) Particular guidance and rationale . 25
27 Bibliography . 31
28 Index of defined terms used in this particular standard . 32
29
30 Figure AA.1 – Suggested test layout for EMISSION and IMMUNITY testing . 28
31 Figure AA.2 – Example of test setup for protection against the effects of HF SURGICAL
32 ME EQUIPMENT . 29
33 Figure AA.3 – Example of test setup for protection against the effects of HF SURGICAL
34 ME EQUIPMENT . 30
35
36 Table 202.101 – Pass/fail criteria for Table 4 of IEC 60601-1-2:2014/AMD1:2020 . 21
37 Table 202.102 – Pass/fail criteria for Table 7 of IEC 60601-1-2:2014/AMD1:2020 . 22
38 Table 202.103 – Pass/fail criteria for Table 8 of IEC 60601-1-2:2014/AMD1:2020 . 23
39 Table 202.104 – Pass/fail criteria for Table 5, 6, 9 of IEC 60601-1-2:2014/AMD1:2020 . 23
40
41 Table 201.C.101 – Marking on the outside of ELECTROMYOGRAPHS and EVOKED
42 RESPONSE EQUIPMENT or its parts . 24
43
44
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45 INTERNATIONAL ELECTROTECHNICAL COMMISSION
46 _____________
47
48 MEDICAL ELECTRICAL EQUIPMENT –
49
50 Part 2-40: Particular requirements for the basic safety and essential
51 performance of electromyographs and evoked response equipment
52
53 FOREWORD
54 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
55 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
56 international co-operation on all questions concerning standardization in the electrical and electronic fields. To
57 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
58 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
59 Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
60 in the subject dealt with may participate in this preparatory work. International, governmental and non -
61 governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
62 with the International Organization for Standardization (ISO) in accordance with conditions determined by
63 agreement between the two organizations.
64 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
65 consensus of opinion on the relevant subjects since each technical committee has representation from all
66 interested IEC National Committees.
67 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
68 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
69 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
70 misinterpretation by any end user.
71 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
72 transparently to the maximum extent possible in their national and regional publications. Any divergence
73 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
74 the latter.
75 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
76 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
77 services carried out by independent certification bodies.
78 6) All users should ensure that they have the latest edition of this publication.
79 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
80 members of its technical committees and IEC National Committees for any personal injury, property damage or
81 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
82 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
83 Publications.
84 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
85 indispensable for the correct application of this publication.
86 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
87 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
88 International Standard IEC 60601-2-40 has been prepared by subcommittee 62D:
89 Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
90 practice.
91 This third edition cancels and replaces the second edition of IEC 60601-2-40 published in
92 2016. This edition constitutes a technical revision.
93 This edition includes the following significant technical changes with respect to the previous
94 edition:
95 a) added requirements for constant voltage stimulators ;
96 b) clarified requirements for VISUAL STIMULATORS.
97 The text of this standard is based on the following documents:
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FDIS Report on voting
62D/XXXX/FDIS 62D/XXXX/RVD
98
99 Full information on the voting for the approval of this standard can be found in the report on
100 voting indicated in the above table.
101 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
102 In this standard, the following print types are used:
103 – Requirements and definitions: roman type.
104 – Test specifications: italic type.
105 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
106 Normative text of tables is also in a smaller type.
107 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
108 NOTED: SMALL CAPITALS.
109 In referring to the structure of this document, the term
110 – “clause” means one of the seventeen numbered divisions within the table of contents,
111 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
112 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
113 subclauses of Clause 7).
114 References to clauses within this document are preceded by the term “Clause” followed by
115 the clause number. References to subclauses within this particular standard are by number
116 only.
117 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
118 combination of the conditions is true.
119 The verbal forms used in this document conform to usage described in Clause 7 of the
120 ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
121 – “shall” means that compliance with a requirement or a test is mandatory for compliance
122 with this document;
123 – “should” means that compliance with a requirement or a test is recommended but is not
124 mandatory for compliance with this document;
125 – “may” is used to describe a permissible way to achieve compliance with a requirement or
126 test.
127 An asterisk (*) as the first character of a title, or at the beginning of a paragraph or table title,
128 indicates that there is guidance or rationale related to that item in Annex AA.
129 A list of all parts of the IEC 60601 series, published under the general title Medical electrical
130 equipment, can be found on the IEC website.
131
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132 The committee has decided that the contents of this publication will remain unchanged until
133 the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data
134 related to the specific publication. At this date, the publication will be
135 • reconfirmed,
136 • withdrawn,
137 • replaced by a revised edition, or
138 • amended.
139
140
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141 INTRODUCTION
142 This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of
143 ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT. It amends and supplements
144 IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety
145 and essential performance (IEC 606011:2005, IEC 606011:2005/AMD1:2012, and IEC
146 60601-1:2005/AMD2:2020), hereinafter referred to as the general standard.
147 The aim of this revision is to bring this particular standard up to date with reference to edition
148 3.2 of the general standard.
149 The requirements of this particular standard take priority over those of the general standard.
150 A “General guidance and rationale” for the more important requirements of this
151 particular standard is included in Annex AA. It is considered that knowledge of the
152 reasons for these requirements will not only facilitate the proper application of the
153 document but will, in due course, expedite any revision necessitated by changes in
154 clinical practice or as a result of developments in technology. However, Annex AA
155 does not form part of the requirements of this document.
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156 MEDICAL ELECTRICAL EQUIPMENT –
157 Part 2-40: Particular requirements for the basic safety and essential
158 performance of electromyographs and evoked response equipment
159
160
161 201.1 Scope, object and related standards
1
162 Clause 1 of the general standard applies, except as follows:
163 201.1.1 Scope
164 Replacement:
165 This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
166 ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT.
167 NOTE 1 Myofeedback equipment, where the capturing of muscle contraction is based on electromyography, is
168 within the scope of this particular standard.
169 NOTE 2 EMG/EP equipment is intended for diagnostic and monitoring applications.
170 NOTE 3 If the ME EQUIPMENT supports both ELECTROMYOGRAPHY and EVOKED RESPONSE STIMULATION,
171 clauses for electrical, auditory, and visual stimulators are applicable. In case the equipment supports
172 ELECTROMYOGRAPHY, but not EVOKED RESPONSE STIMULATION, clauses concerning solely requirements for
173 stimulators are NOT within scope.
174 If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
175 ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
176 case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
177 The following ME EQUIPMENT are excluded:
178 ME EQUIPMENT intended for therapeutic application
179 ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle
180 stimulators (ME EQUIPMENT covered by IEC 60601-2-10.)
181 201.1.2 Object
182 Replacement:
183 The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
184 PERFORMANCE requirements for ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT [as
185 defined in 201.3.201 and 201.3.202.]
186 201.1.3 Collateral standards
187 Addition:
188 This particular standard refers to those applicable collateral standards that are listed in
189 Clause 2 of the general standard and Clause 201.2 of this particular standard.
___________
1
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020, Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance
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190 IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 apply as modified in Clause 202.
191 IEC 60601-1-3, IEC 60601-1-8 and IEC 60601-1-10 do not apply. All other published collateral
192 standards in the IEC 60601-1 series apply as published.
193 201.1.4 Particular standards
194 Replacement:
195 In the IEC 60601 series, particular standards may modify, replace or delete requirements
196 contained in the general standard and collateral standards as appropriate for the particular
197 ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
198 PERFORMANCE requirements.
199 A requirement of a particular standard takes priority over the general standard.
200 For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
201 Collateral standards are referred to by their document number.
202 The numbering of clauses and subclauses of this particular standard corresponds to that of
203 the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
204 of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”,
205 where is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
206 particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
207 standard, 203.4 in this particular standard addresses the content of Clause 4 of the
208 IEC 60601-1-3 collateral standard, etc.) The changes to the text of the general standard are
209 specified by the use of the following words:
210 "Replacement" means that the clause or subclause of the general standard or applicable
211 collateral standard is replaced completely by the text of this particular standard.
212 "Addition" means that the text of this particular standard is additional to the requirements of
213 the general standard or applicable collateral standard.
214 "Amendment" means that the clause or subclause of the general standard or applicable
215 collateral standard is amended as indicated by the text of this particular standard.
216 Subclauses, figures or tables which are additional to those of the general standard are
217 numbered starting from 201.101. However, due to the fact that definitions in the general
218 standard are numbered 3.1 through 3.154, additional definitions in this standard are
219 numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
220 additional items aa), bb), etc.
221 Subclauses, figures or tables which are additional to those of a collateral standard are
222 numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
223 IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
224 The term "this standard" is used to make reference to the general standard, any applicable
225 collateral 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
228 relevant, applies without modification; where it is intended that any part of the general
229 standard or applicable collateral standard, although possibly relevant, is not to be applied, a
230 statement to that effect is given in this particular standard.
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231 201.2 Normative references
232 The following documents, in whole or in part, are normatively referenced in this document and
233 are indispensable for its application. For dated references, only the edition cited applies. For
234 undated references, the latest edition of the referenced document (including any
235 amendments) applies.NOTE Informative references are listed in the bibliography beginning on page 31.
236 Addition:
237 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
238 safety and essential performance
239 Amendment 1:2012
240 Amendment 2:2020
241
242 IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
243 safety and essential performance – Collateral standard: Electromagnetic disturbances –
244 Requirements and tests
245 Amendment 1:2020
246
247 IEC 60318 (all parts), Electroacoustics – Simulators of human head and ear
248 ISO 15004-2, Ophthalmic instruments – Fundamental requirements and test methods – Part 2:
249 Light hazard protection
250 201.3 Terms and definitions
251 For the purposes of this document, the terms and definitions given in IEC 606011:2005,
252 IEC 606011:2005/AMD1:2012 and IEC 606011:2005/AMD2:2020 and the following apply.
253 ISO and IEC maintain terminological databases for use in standardization at the following
254 addresses:
255 • IEC Electropedia: available at http://www.electropedia.org/
256 • ISO Online browsing platform: available at http://www.iso.org/obp
257 NOTE An index of defined terms is found beginning on page 32.
258 Addition:
259 201.3.201
260 ELECTROMYOGRAPH
261 ME EQUIPMENT for the detection or recording of biopotentials accompanying nerve and muscle
262 action, either spontaneously, intentionally or evoked by electrical or other stimulation
263 201.3.202
264 EVOKED RESPONSE EQUIPMENT
265 ME EQUIPMENT for the detection or recording of biopotentials resulting from an evoking
266 stimulus
267 Note 1 to entry: The stimulus may be electrical, tactile, auditory, visual, olfactory, etc.
268 201.3.203
269 ELECTRICAL STIMULATOR
270 part of ME EQUIPMENT for the application of electric currents via ELECTRODES in direct contact
271 with the PATIENT, for the evoking of biopotentials
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272 201.3.204
273 PULSE DURATION
274 duration of the electrical stimulus pulse WAVEFORM at 50 % of the peak amplitude
275 201.3.205
276 WAVEFORM
277 variations in magnitude of an electrical stimulus output (either voltage or current) as a
278 function of time appearing in the APPLIED PART(S) of the ELECTRICAL STIMULATOR or the
279 collected biopotentials by the BIOPOTENTIALS INPUT PART
280 201.3.206
281 AUDITORY STIMULATOR
282 part of ME EQUIPMENT for the application of sound pressure from a transducer (headphone,
283 bone conductor or free-field) to the ear(s) of the PATIENT, for the evoking of biopotentials
284 201.3.207
285 VISUAL STIMULATOR
286 part of ME EQUIPMENT for the application of pulsed electromagnetic radiation in the visible
287 spectrum from a transducer to the eyes of the PATIENT, for the evoking of biopotentials
288 201.3.208
289 BIOPOTENTIAL INPUT PART
290 APPLIED PART(S) of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT for the collection of
291 biopotentials
292 201.3.209
293 ELECTRODE
294 conductive portion that is applied to the PATIENT to detect electrical activity and/or to apply the
295 stimulus from the ELECTRICAL STIMULATOR to the PATIENT
296 201.3.210
297 PATIENT LEAD
298 cable connected between an ELECTRODE and either a PATIENT CABLE or the ME EQUIPMENT
299 201.3.211
300 PATIENT CABLE
301 multiwire cable used to connect PATIENT LEADS to ME EQUIPMENT
302
303
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304 201.4 General requirements
305 Clause 4 of the general standard applies, except as follows:
306 201.4.2 *RISK MANAGEMENT PROCESS for ME EQUIPMENT and ME SYSTEMS
307 Addition:
308 MANUFACTURERS shall include, within their RISK MANAGEMENT FILE, the RISK associated with the
309 potential use of their STIMULATORS and accessories to deliver current exceeding 10 mA r.m.s
2
310 or current densities for any ELECTRODE exceeding 2 mA/cm .
311 201.4.3 ESSENTIAL PERFORMANCE
312 Addition:
313 NOTE Because of the variety of clinical applications for ELECTROMYOGRAPHS and EVOKED RESPONSE, no additional
314 ESSENTIAL PERFORMANCE is specified in this particular standard. However, ESSENTIAL PERFORMANCE shall be
315 determined by the manufacturer in accordance with the requirements of subclause 4.3 of the general standard.
316 201.4.11 Power input
317 Replacement:
318 The power input is measured with a load resistance of the lowest value specified in the
319 technical description (see 201.7.9.3.101 a)), and with any output controls set to result in
320 maximum power input.
321 201.5 General requirements for testing of ME EQUIPMENT
322 Clause 5 of the general standard applies, except as follows.
323 201.5.4 Other conditions
324 Addition:
325 Where values of voltage and current are used in this document, they mean the r.m.s. values
326 of an alternating, direct or composite voltage or current averaged over 1 s unles s stated
327 otherwise.
328 201.6 Classification of ME EQUIPMENT and ME SYSTEMS
329 Clause 6 of the general standard applies, except as follows:
330 201.6.2 * Protection against electric shock
331 Amendment:
332 Delete TYPE B APPLIED PART.
333 201.7 ME EQUIPMENT identification, marking and documents
334 Clause 7 of the general standard applies, except as follows:
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335 201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
336 201.7.2.3 * Consult ACCOMPANYING DOCUMENTS
337 Replacement:
338 Safety sign ISO 7010-M002 shall be used (see Table D.2, safety sign 10 in Annex D of the
339 general standard).
340 201.7.2.7 Electrical input power from the SUPPLY MAINS
341 Replacement:
342 The RATED power input of MAINS operated ME EQUIPMENT shall be the maximum power input
343 averaged over any period of 5 s under the specified operating conditions set out by the
344 manufacturer.
345 201.7.2.8 Output connectors
346 201.7.2.8.2 Other power sources
347 Addition:
348 See also 201.12.4.102.
349 201.7.2.13 * Physiological effects (safety signs and warning statements)
350 Addition:
351 ME EQUIPMENT capable of delivering electrical stimulus outputs into a load resistance of
352 1 000 in excess of 10 mA r.m.s or 10 V
...
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