Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT. Its scope excludes, in particular: - equipment for RADIOTHERAPY; - equipment for COMPUTED TOMOGRAPHY; - ACCESSORIES intended to be introduced into the PATIENT; - mammographic X-RAY EQUIPMENT; - dental X-RAY EQUIPMENT. NOTE 1 Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, for which the use of INTERVENTIONAL X-RAY EQUIPMENT complying with this standard is recommended, are given in Annex AA. NOTE 2 Specific requirements for magnetic navigation devices, and for the use of INTERVENTIONAL X-RAY EQUIPMENT in an operating room environment were not considered in this particular standard; therefore no specific requirements have been developed for these devices or uses. In any case, such devices or uses remain under the general clause requirements. NOTE 3 INTERVENTIONAL X-RAY EQUIPMENT, when used for cone-beam CT mode, is covered by this standard and not by IEC 60601-2-44 [2]2. No additional requirements for operation in cone-beam CT mode were identified for this standard (see also Note 4 in 203.6.4.5). INTERVENTIONAL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this standard. If a clause or subclause is specifically intended to be applicable to INTERVENTIONAL X-RAY EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to INTERVENTIONAL X-RAY EQUIPMENT and to ME SYSTEMS, as relevant. NOTE 4 See also 4.2 of the general standard. The subclauses of this standard supersede IEC 60601-2-54 subclauses. IEC 60601-2-54 applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do not apply.

Medizinische elektrische Geräte – Teil 2-43: Besondere Festlegungen für die Sicherheit und wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für interventionelle Verfahren

Appareils électromédicaux - Partie 2-43: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X lors d'interventions

Medicinska električna oprema - 2-43. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenske opreme za interventne postopke

General Information

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Not Published
Current Stage
4020 - Enquiry circulated
Due Date
03-Dec-2021
Completion Date
03-Dec-2021

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SLOVENSKI STANDARD
oSIST prEN IEC 60601-2-43:2022
01-februar-2022
Medicinska električna oprema - 2-43. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti rentgenske opreme za interventne postopke

Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and

essential performance of X-ray equipment for interventional procedures

Appareils électromédicaux - Partie 2-43: Exigences particulières pour la sécurité de base

et les performances essentielles des appareils à rayonnement X lors d'interventions

Ta slovenski standard je istoveten z: prEN IEC 60601-2-43:2021
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
oSIST prEN IEC 60601-2-43:2022 en

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

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oSIST prEN IEC 60601-2-43:2022
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oSIST prEN IEC 60601-2-43:2022
62B/1264/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-43 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2021-12-03 2022-02-25
SUPERSEDES DOCUMENTS:
62B/1263/RR
IEC SC 62B : DIAGNOSTIC IMAGING EQUIPMENT
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
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

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:

Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and

essential performance of X-ray equipment for interventional procedures
PROPOSED STABILITY DATE: 2025
NOTE FROM TC/SC OFFICERS:

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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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 .................................................................................................. 10

7 201.4 General requirements .................................................................................................. 11

8 201.5 General requirements for testing of ME EQUIPMENT ....................................................... 12

9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS .......................................................... 13

10 201.7 ME EQUIPMENT identification, marking and documents .................................................. 13

11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT ............................................ 17

12 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .................. 17

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 outputs ....... 21

16 201.13 HAZARDOUS SITUATIONS and fault conditions ............................................................... 24

17 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).................................................. 24

18 201.15 Construction of ME EQUIPMENT ................................................................................... 24

19 201.16 ME SYSTEMS ............................................................................................................... 25

20 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ................................ 25

21 202 Electromagnetic disturbances – Requirements and tests ................................................ 25

22 203 RADIATION PROTECTION in diagnostic X-RAY EQUIPMENT .................................................... 25

23 Annexes................................................................................................................................ 37

24 Annex AA (informative) Particular guidance and rationale .................................................... 38

25 Annex BB (normative) Distribution maps of STRAY RADIATION ................................................ 50

26 Bibliography .......................................................................................................................... 53

27 Index of defined terms used in this particular standard .......................................................... 56

29 Figure BB.1 – Example of isokerma map at 100 cm height in lateral configuration ................ 51

30 Figure BB.2 – Example of isokerma map at 100 cm height in vertical configuration ............... 52

32 Table 201.101 – Additional list of potential ESSENTIAL PERFORMANCE to be considered

33 by MANUFACTURER in the RISK MANAGEMENT analysis .............................................................. 11

34 Table 201.102 – Other subclauses requiring statements in ACCOMPANYING DOCUMENTS ......... 17

35 Table 2 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS ............................. 26

36 Table AA.1 – Examples of prolonged RADIOSCOPICALLY GUIDED INTERVENTIONAL

37 PROCEDURES for which deterministic effects of IRRADIATION are possible ................................ 38

38 Table AA.2 – Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES for

39 which deterministic effects are unlikely ................................................................................. 39

40 Table AA.3 – Examples of isodose boundaries and colour codes for SKIN DOSE MAP and

41 AIR KERMA map ...................................................................................................................... 47

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44 INTERNATIONAL ELECTROTECHNICAL COMMISSION
46 ____________
48 MEDICAL ELECTRICAL EQUIPMENT –
50 Part 2-43: Particular requirements for the basic safety and essential
51 performance of X-ray equipment for interventional procedures
54 FOREWORD

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

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

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

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

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

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

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

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

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

64 agreement between the two organizations.

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

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

67 interested IEC National Committees.

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

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

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

71 misinterpretation by any end user.

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

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

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

75 the latter.

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

77 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for a ny

78 services carried out by independent certification bodies.

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

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

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

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

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

84 Publications.

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

86 indispensable for the correct application of this publication.

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

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

89 International standard IEC 60601-2-43 has been prepared by IEC subcommittee 62B:

90 Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical

91 practice.
92 This third edition constitutes a technical revision.

93 This particular standard has been revised to introduce changes to reference the second

94 amendment:2020 to IEC 60601-1:2005. The present edition remains a system standard for X-

95 RAY EQUIPMENT designed for the use during interventional procedures using X-ray imaging,

96 whether of prolonged or normal duration.

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

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

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

102 Normative text of tables is also in a smaller type.

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

104 NOTED: SMALL CAPITALS.
105 In referring to the structure of this standard, the term

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

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

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

109 subclauses of Clause 7).

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

111 clause number. References to subclauses within this particular standard are by number only.

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

113 combination of the conditions is true.

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

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

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

117 with this standard;

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

119 mandatory for compliance with this standard;

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

121 test.

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

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

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

125 equipment, can be found on the IEC website.
126
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127 The committee has decided that the contents of the base publication and its amendments will

128 remain unchanged until the stability date indicated on the IEC web site under

129 "http://webstore.iec.ch" in the data related to the specific publication. At this date, the

130 publication will be
131 • reconfirmed,
132 • withdrawn,
133 • replaced by a revised edition, or
134 • amended.
135

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates

that it contains colours which are considered to be useful for the correct

understanding of its contents. Users should therefore print this document using a

colour printer.
136
137
138
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139 INTRODUCTION

140 The purpose of this new edition is to introduce changes to reference the second

141 amendment:2020 to IEC 60601-1:2005 and some minor technical clarifications.

142 X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES may subject

143 PATIENTS and OPERATORS to higher levels of RADIATION than those which normally prevail

144 during diagnostic X-ray imaging procedures. One consequence for the PATIENT may be the

145 occurrence of deterministic injury when RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES

146 involve the delivery of substantial amounts of RADIATION to localized areas. Another

147 consequence can be an increased RISK of stochastic effects, such as cancer. These health

148 concerns apply also to the OPERATOR. In addition, for this particular type of equipment, there

149 is a need for availability of critical functions with minimal periods of loss.

150 RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES of the type envisaged are well

151 established in clinical fields such as:
152 – invasive cardiology;
153 – interventional RADIOLOGY;
154 – interventional neuroradiology.

155 These RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES also include many newly

156 developing and emerging applications in a wide range of medical and surgical specialities.

157 NOTE Attention is drawn to the existence of legislation in some countries concerning RADIOLOGICAL PROTECTION,

158 which may not align with the provisions of this standard.
159
160
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161 MEDICAL ELECTRICAL EQUIPMENT –
162
163 Part 2-43: Particular requirements for the basic safety and essential
164 performance of X-ray equipment for interventional procedures
165
166
167
168 201.1 Scope, object and related standards
169 Clause 1 of the general standard applies, except as follows:
170 201.1.1 * Scope
171 Replacement:

172 This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both

173 FIXED and MOBILE X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for

174 RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as
175 INTERVENTIONAL X-RAY EQUIPMENT. Its scope excludes, in particular:
176 – equipment for RADIOTHERAPY;
177 – equipment for COMPUTED TOMOGRAPHY;
178 – ACCESSORIES intended to be introduced into the PATIENT;
179 – mammographic X-RAY EQUIPMENT;
180 – dental X-RAY EQUIPMENT.

181 NOTE 1 Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, for which the use of INTERVENTIONAL

182 X-RAY EQUIPMENT complying with this standard is recommended, are given in Annex AA.

183 NOTE 2 Specific requirements for magnetic navigation devices, and for the use of INTERVENTIONAL X-RAY

184 EQUIPMENT in an operating room environment were not considered in this particular standard; therefore no specific

185 requirements have been developed for these devices or uses. In any case, such devi ces or uses remain under the

186 general clause requirements.

187 NOTE 3 INTERVENTIONAL X-RAY EQUIPMENT, when used for cone-beam CT mode, is covered by this standard and

188 not by IEC 60601-2-44 [2] . No additional requirements for operation in cone-beam CT mode were identified for

189 this standard (see also Note 4 in 203.6.4.5).

190 INTERVENTIONAL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for

191 RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT

192 SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this

193 standard.

194 If a clause or subclause is specifically intended to be applicable to INTERVENTIONAL X-RAY

195 EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will

196 say so. If that is not the case, the clause or subclause applies both to INTERVENTIONAL X-RAY

197 EQUIPMENT and to ME SYSTEMS, as relevant.
198 NOTE 4 See also 4.2 of the general standard.

199 The subclauses of this standard supersede IEC 60601-2-54 subclauses. IEC 60601-2-54

200 applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do

201 not apply.
—————————

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.

Figures in square brackets refer to the Bibliography.
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202 201.1.2 Object
203 Replacement:
204 The object of this particular standard is:

205 – to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for the

206 design and manufacture of X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL

207 PROCEDURES, as defined in 201.3.205.

208 – to specify information which is to be provided with such INTERVENTIONAL X-RAY EQUIPMENT

209 for the assistance of the RESPONSIBLE ORGANIZATION and OPERATOR in managing the

210 RADIATION RISK and equipment failure RISK arising from these RADIOSCOPICALLY GUIDED

211 INTERVENTIONAL PROCEDURES which could affect PATIENTS or staff.
212 201.1.3 Collateral standards
213 Addition:

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

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

216 IEC 60601-1-2 and IEC 60601-1-3 apply as modified in Clause 202 and Clause 203

3 ) 4 ) 5 ) 6 )

217 respectively. IEC 60601-1-8 , IEC 60601-1-9 , IEC 60601-1-10 , IEC 60601-1-11 and

218 IEC 60601-1-12 do not apply. All other published collateral standards in the IEC 60601-1

219 series apply as published.
220 201.1.4 Particular standards
221 Replacement:

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

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

224 ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL

225 PERFORMANCE requirements.

226 A requirement of a particular standard takes priority over the general standard.

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

228 Collateral standards are referred to by their document number.

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

230 the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content

231 of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”

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

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

—————————

3) IEC 60601-1-8, Medical electrical equipment – Part 1-8: General requirements for basic safety and essential

performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical

electrical equipment and medical electrical systems

4) IEC 60601-1-9, Medical electrical equipment – Part 1-9: General requirements for basic safety and essential

performance – Collateral Standard: Requirements for environmentally conscious design

5) IEC 60601-1-10, Medical electrical equipment – Part 1-10: General requirements for basic safety and essential

performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers

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

performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical

systems used in the home healthcare environment

7) IEC 60601-1-12, Medical electrical equipment – Part 1-12: General requirements for basic safety and essential

performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical

systems intended for use in the emergency medical services environment
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234 standard, 203.4 in this particular standard addresses the content of Clause 4 of the

235 IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are

236 specified by the use of the following words:

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

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

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

240 the general standard or applicable collateral standard.

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

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

243 Subclauses, figures or tables which are additional to those of the general standa rd are

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

245 standard are numbered 3.1 through 3.139, additional definitions in this standard are numbered

246 beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items

247 aa), bb), etc.

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

249 numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for

250 IEC 60601-1-2, 203 for IEC 60601-1-3, etc.

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

252 collateral standards and this particular standard taken together.

253 Where there is no corresponding clause or subclause in this particular standard, the cla use or

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

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

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

257 statement to that effect is given in this particular standard.
258 201.2 Normative references
259 Clause 2 of the general standard applies, except as follows:

260 NOTE Informative references are listed in the Bibliography beginning on page 54.

261 Amendment:
262 IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)
263 IEC 60529:1989/AMD1:1999
264 IEC 60529:1989/AMD2:2013

265 IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic

266 safety and essential performance – Collateral standard: Radiation protection in diagnostic X-

267 ray equipment
268 IEC 60601-1-3:2008/AMD1:2013
269 IEC 60601-1-3:2008/AMD2:2021
270 IEC 60601-1-8 does not apply.
271 Addition:
272 IEC 60580:2019, Medical electrical equipment – Dose area product meters
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273 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic

274 safety and essential performance
275 IEC 60601-1:2005/AMD1:2012
276 IEC 60601-1:2005/AMD2:2020

277 IEC 60601-2-54:20xx, Medical electrical equipment – Part 2-54: Particular requirements for

278 the basic safety and essential performance of X-ray equipment for radiography and

279 radioscopy
280 IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms

281 IEC 61910-1:2014, Medical electrical equipment – Radiation dose documentation – Part 1:

282 Radiation dose structured reports for radiography and radioscopy

283 IEC 62220-1-1:2015, Medical electrical equipment – Characteristics of digital X-ray imaging

284 devices – Part 1-1: Determination of the detective quantum efficiency – Detectors used in

285 radiographic imaging
286 201.3 Terms and definitions

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

288 IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, IEC 60601-1-3:2008,

289 IEC 60601-1-3/AMD1:2013 and IEC 60601-1-3/AMD2:2021, IEC 60601-2-54:20xx,

290 IEC TR 60788:2004, IEC 61910-1:2014, IEC 62220-1-1:2015 and the following apply.

291 NOTE 1 An index of defined terms is found beginning on page 56.
292 Addition:
293 201.3.201
294 DOSE MAP
295 representation of the spatial distribution of a RADIATION dose quantity
296 201.3.202
297 EMERGENCY RADIOSCOPY

298 RADIOSCOPY with availability of a limited set of functions (emergency functions), for use during

299 recovery from a recoverable failure of the INTERVENTIONAL X-RAY EQUIPMENT
300 201.3.203
301 * IMAGE DISPLAY DELAY

302 during RADIOSCOPY or RADIOGRAPHY, time delay between an event captured during an X-ray

303 LOADING used to create an image and the DISPLAY of this event on the image
304 201.3.204
305 INTERVENTIONAL X-RAY EQUIPMENT
306 X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES
307 201.3.205
308 RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURE
309 RGI PROCEDURE

310 invasive procedure (involving the introduction of a device, such as a needle or a catheter into

311 the PATIENT) using RADIOSCOPY as the principal means of guidance, and intended to effect

312 treatment or diagnosis of the medical condition of the PATIENT
313 201.3.206
314 SKIN DOSE
315 estimated ABSORBED DOSE to the skin at a specific point
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316 201.3.207
317 SKIN DOSE MAP
318 DOSE MAP of the SKIN DOSE
319 201.4 General requirements
320 Clause 4 of the general standard applies, except as follows:
321 201.4.3 * ESSENTIAL PERFORMANCE
322 Subclause 201.4.3 of IEC 60601-2-54:20xx, except as follows:
323 Addition:

324 NOTE Subclause 203.6.4.3.104.2 (Accuracy of LOADING FACTORS in automatic control mode) of IEC 60601-2-54

325 specifies a limitation in applying subclause 203.6.4.3.104.3 (Accuracy of X-RAY TUBE VOLTAGE) and 203.6.4.3.104.4

326 (Accuracy of X-RAY TUBE CURRENT). This limitation is also valid for the ESSENTIAL PERFORMANCE list.

327 Additional potential ESSENTIAL PERFORMANCE requirements are found in the subclauses listed

328 in Table 201.101.

329 Table 201.101 – Additional list of potential ESSENTIAL PERFORMANCE to be considered by

330 MANUFACTURER in the RISK MANAGEMENT analysis
Requirement Subclause
Recovery management 201.4.101
RADIATION dose documentation 201.4.102
331
332 201.4.10.2 SUPPLY MAINS FOR ME EQUIPMENT and ME SYSTEMS
333 Subclause 201.4.10.2 of IEC 60601-2-54:20xx applies.
334 Additional subclauses:
335 201.4.101 * Recovery management

336 The time to recover all of the functions necessary for performing EMERGENCY RADIOSCOPY,

337 after a failure recoverable automatically or by the OPERATOR shall be as short as reasonably

338 practicable. The RISK MANAGEMENT shall take into account the availability of emergency power

339 supply i
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