prEN IEC 60601-2-57:2022

SLOVENSKI STANDARD
oSIST prEN IEC 60601-2-57:2022
01-september-2022
Medicinska električna oprema - 2-57. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme z nelaserskim svetlobnim virom, namenjene za
terapevtsko, diagnostično, nadzorovalno in kozmetično/estetsko uporabo

Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and

essential performance of non-laser light source equipment intended for therapeutic,

Medizinische elektrische Geräte - Teil 2-57: Besondere Festlegungen für die Sicherheit

Appareils électromédicaux - Partie 2-57: Exigences particulières pour la sécurité de base

et les performances essentielles des appareils à source de lumière non-laser prévus

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

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

Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and

essential performance of non-laser light source equipment intended for therapeutic, diagnostic,

Copyright © 2022 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

2 v17: 27-Feb-2022; the initial document is the WORD file, which was submitted as a

7 observations have been included in comment bubbles, leaving the text body including

10 March 19 2022, were implemented in this v18. Draft to be distributed among WG4 for

14 v19.1: Clause 201.10.102 Output uniformity, was reconsidered, Refer to Comments

19 v21: v20.1 cleaned. Approved by the voting majority of the experts of WG4, V21 is

20 now submitted as a CDV. It is intended that the NC comments to be received will be

21 observed during the WG4 meeting along with the TC76 meeting planned to take place

22 in September 19-23, 2022, in Sydney. To inform the NCs about the past of this draft,

28 FOREWORD ........................................................................................................................... 5

29 INTRODUCTION ..................................................................................................................... 7

30 MEDICAL ELECTRICAL EQUIPMENT .................................................................................... 8

31 201.1 Scope, object and related standards ....................................................................... 8

32 201.1.1 *Scope............................................................................................................. 8

33 201.1.2 Object .............................................................................................................. 8

34 201.1.3 Collateral standards ......................................................................................... 9

35 201.1.4 Particular standards ......................................................................................... 9

36 201.2 Normative references ............................................................................................ 10

37 201.3 Terms and definitions ............................................................................................ 10

38 201.4 General requirements ........................................................................................... 13

39 201.5 General requirements for testing ME EQUIPMENT .................................................... 14

40 201.6 Classification of ME EQUIPMENT .............................................................................. 14

41 201.6.1 General ......................................................................................................... 14

42 201.6.1.101 Classification responsibilities ...................................................... 14

43 201.6.1.102 Classification rules ...................................................................... 14

44 201.7 ME EQUIPMENT identification, marking and documents .................................................. 14

45 201.7.9 ACCOMPANYING DOCUMENTS ............................................................................ 14

46 201.7.9.1 General ........................................................................................................ 14

47 201.7.9.2 Instructions for use ....................................................................................... 14

48 201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts ................. 15

49 201.7.2.101 Labels and marking of LS EQUIPMENT ........................................... 16

50 201.7.101.2 Product label design and labelling information ............................ 17

51 201.7.101.3 EMISSION APERTURE label ............................................................. 17

52 201.7.101.4 Radiation output and standards information ................................ 18

53 201.8 Protection against electrical HAZARDS from ME EQUIPMENT ..................................... 18

55 control devices .............................................................................................. 18

56 201.8.11 MAINS PARTS, components and layout ............................................................ 18

57 201.8.11.101 Cooling liquid ........................................................................................... 18

58 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS ........... 18

59 201.10 Protection against unwanted and excessive radiation HAZARDS ............................. 18

60 201.10.101 Means for detecting GOOD CONTACT ............................................. 18

61 201.10.102 Output uniformity ........................................................................ 20

62 201.10.103 Controls and indicators ............................................................... 20

63 201.10.104 Exposure termination .................................................................. 20

65 RADIATION .............................................................................................................. 20

66 201.11 Protection against excessive temperatures and other HAZARDS ............................. 21

68 outputs .......................................................................................................................... 21

69 201.12.1 Accuracy of controls and instruments ............................................................ 21

70 201.12.1.101 *Indication of LS EQUIPMENT OUTPUT ............................................. 21

71 201.12.4.2 *Indication of parameters relevant to safety ................................................. 21

72 201.12.4.101 EMERGENCY STOP for OPTICAL RADIATION ....................................... 21

73 201.13 HAZARDOUS SITUATIONS and fault conditions .......................................................... 22

74 201.13.1 Specific HAZARDOUS SITUATIONS ...................................................................... 22

75 201.13.1.101 OPTICAL RADIATION HAZARDS ......................................................... 22

76 201.14 Programmable electrical medical systems (pems) ................................................. 22

77 201.15 Construction of ME EQUIPMENT ............................................................................... 22

78 201.16 ME SYSTEMS .......................................................................................................... 22

79 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ........................... 22

80 Annex AA (informative) Particular guidance and rationale ................................................... 23

81 AA.1 General guidance .................................................................................................. 23

82 AA.2 Rationale for particular clauses and subclauses .................................................... 23

83 Annex BB (informative) Protective eyewear for LS EQUIPMENT .............................................. 25

84 Annex CC (informative) Summary of MANUFACTURER’S requirements ................................... 26

85 Annex DD (informative) Symbols on marking ....................................................................... 27

86 Bibliography .......................................................................................................................... 28

87 Index of defined terms used in this particular standard .......................................................... 29

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

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

103 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and

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109 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.

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

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

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

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

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

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

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

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

132 International Standard IEC 60601-2-57 has been prepared by IEC technical committee

136 Full information on the voting for the approval of this standard can be found in the

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

142 – Informative material appearing outside of tables, such as notes, examples and

143 references: in smaller type. Normative text of tables is also in a smaller type.

144 – Terms defined in Clause 3 of the general standard, in this particular standard or as

148 contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2,

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

153 followed by the clause number. References to subclauses within this particular

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

157 The verbal forms used in this standard conform to usage described in Annex H of the

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

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

161 – “should” means that compliance with a requirement or a test is recommended but is

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

166 table title indicates that there is guidance or rationale related to that item in annex AA.

167 A list of all parts of the IEC 60601 series, published under the general title: Medical

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

The National Committees are requested to note that for this publication the stability date is [....]

179 This particular standard amends and supplements IEC 60601-1:2005+AMD1:2012+AMD2:2020

180 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential

182 This edition of the standard constitutes a major review of the previous edition and covers the

183 recent development of LS EQUIPMENT. It now includes the Risk Group 1C (RG-1C). LS EQUIPMENT

184 of RG-1C incorporates technical means which inhibit emission into free space when the

186 It now excludes LS EQUIPMENT of RG-1 and RG-2 as these are assumed to represent no hazard.

188 This edition of the standard clarifies its relation to the concept of Risk Groups (RGs), as

189 introduced in IEC 62471-1. The information about classification and rules for the determination

191 Although this particular standard was applicable to LS EQUIPMENT containing UV sources, more

192 emphasis was given to UV applications of the equipment than in the previous edition.

193 This edition of the standard now excludes LS EQUIPMENT which is intended to be used on animals.

194 The requirements of this particular standard should be taken as the minimum to comply with, in

195 order to achieve a reasonable level of safety and reliability during operation and application of

196 non-laser light source equipment intended for therapeutic, diagnostic, monitoring and

198 An asterisk (*) notes clauses for which there is rationale comment in annex AA. It is considered

199 that knowledge of the reasons for these requirements will facilitate the proper application of this

200 particular standard and be of use in any revision that may be necessitated by changes in clinical

214 This particular Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment

215 incorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to

216 3 000 nm, with the exception of laser radiation, and intended to create photobiological effects

217 in humans for therapeutic, diagnostic, monitoring, or cosmetic/aesthetic applications; hereafter

219 This particular standard applies to LS EQUIPMENT of Risk Group 1C (but only if the embedded

222 This particular standard does not apply to equipment for sun tanning such as sunlamp products,

223 for ophthalmic instruments, for lighting purposes in medical/cosmetic environments, for

224 photography/video, for equipment which produces visual or non-visual effects such as circadian

225 entrainment, or for infant phototherapy and infant radiant warmers. This particular standard

227 This particular standard does not apply to home-use appliances. It does not apply to home light

228 therapy equipment, such as equipment which is intended to be used in the HOME HEALTHCARE

230 Note: Home-use appliances are covered by IEC 60335-2-113:2016. Appliances for skin exposure to OPTICAL

231 RADIATION, such as sunlamp products are covered by IEC 60335-2-27. Home light therapy equipment providing light

232 therapy by means of eye-mediated photobiological effects, which can be visual or non-visual, and skin-mediated

233 photobiological effects, possible applications including pain relief, psoriasis treatment, and treatment of winter

235 Note: Safety requirements in this particular standard are intended to address only HAZARDS to the eye and superficial

236 tissues including skin or mucosa. As OPTICAL RADIATION does not penetrate more than a few mm in tissue, HAZARDS

241 – to establish the risk from OPTICAL RADIATION, specify basic safety and essential performance

243 – to specify requirements for the MANUFACTURER to supply information and establish

The general standard is IEC 60601-1:2005, including Amendment 1:2012 and Amendment 2:2020, Medical electrical equipment

245 – to provide warning to individuals of risks associated with accessible OPTICAL RADIATION from

247 – to reduce the possibility of adverse effects and injuries by minimizing unnecessary

248 accessible OPTICAL RADIATION; to provide means of improved control of the HAZARDS related

250 – to specify requirements for protection against other HAZARDS resulting from the operation

255 This particular standard refers to the applicable collateral standards that are listed in Clause 2

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

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

262 ME EQUIPMENT under consideration, and may add other basic safety and essential performance

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

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

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

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

269 content of Clause 1 of the general standard) or applicable collateral standard with the prefix

270 “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this

271 particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard,

272 203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral

273 standard, etc.). The changes to the text of the general standard are specified by the use of the

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

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

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

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

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

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

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

283 standard are numbered 3.1 through 3.139, additional definitions in this particular standard are

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

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

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

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

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

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

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

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

300 IEC 60947-3, Low voltage switchgear and controlgear – Part 3: Switches, disconnectors, switch-

302 IEC 62471-1:xxxx, Photobiological safety of lamps and lamp systems - Part 1: General

304 ISO 3864-2, Graphical symbols – Safety colours and safety signs – Part 2: Design principles

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

312 A mechanical or optical means of transferring OPTICAL RADIATION from the source to the human

316 operation with a continuous OPTICAL RADIATION output for a duration equal to or greater than