kSIST fprEN IEC 60601-2-57:2023

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,
diagnostic, monitoring and cosmetic/aesthetic use
Medizinische elektrische Geräte - Teil 2-57: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Geräten mit Nicht-Laser-
Lichtquellen für die Anwendung in der Therapie, Diagnose, Überwachung und für
kosmetische/ästhetische Zwecke
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
pour des utilisations thérapeutiques, de diagnostic, de surveillance et de
cosmétique/esthétique
Ta slovenski standard je istoveten z: prEN IEC 60601-2-57:2022
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
11.040.60 Terapevtska oprema Therapy equipment
oSIST prEN IEC 60601-2-57:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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76/706/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-57 ED2
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-06-24 2022-09-16
SUPERSEDES DOCUMENTS:
76/696/CD, 76/703/CC

IEC TC 76 : OPTICAL RADIATION SAFETY AND LASER EQUIPMENT
SECRETARIAT: SECRETARY:
United States of America Mr William Ertle
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:

SC 62A
Other TC/SCs are requested to indicate their interest, if
any, in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.

TITLE:
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,
monitoring and cosmetic/aesthetic use

PROPOSED STABILITY DATE: 2026

NOTE FROM TC/SC OFFICERS:



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
permission in writing from IEC.

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1 History
2 v17: 27-Feb-2022; the initial document is the WORD file, which was submitted as a
3 CD, 76/696/CD, closing date 2022-02-18. Comments have been received from the
4 NCs and from SC62D. A total of 60 comments (AU1, GB 4, IR 8, JP 15, SC62D 32)
5 were collated and numbered, file name
6 220419_CC_76_696_CD_NC including SC62D comments_observed.docx. The
7 observations have been included in comment bubbles, leaving the text body including
8 the line numbering almost unaltered.
9 v18: Edits were done, technical changes remain marked. LC’s comments, received
th
10 March 19 2022, were implemented in this v18. Draft to be distributed among WG4 for
11 further input, due April 30, 2022.
12 v19: Markings were cleaned; comment bubbles were removed. Comments from WG4
13 experts have been observed and included as marked.
14 v19.1: Clause 201.10.102 Output uniformity, was reconsidered, Refer to Comments
15 GB3, GB4. WG4 comments were considered.
16 v20: v19.1 cleaned.
17 v20.1: Comments from YL 220425, as observed by the convenor, implemented,
18 marked.
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,
23 its history is retained in the CDV.
24
25

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26 CONTENTS
27
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
54 201.8.10.4 Cord-connected HAND-HELD parts and cord-connected foot-operated
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
64 201.10.105 *Protection against HAZARDOUS or visually disturbing STRAY OPTICAL
65 RADIATION . 20
66 201.11 Protection against excessive temperatures and other HAZARDS . 21
67 201.12 Accuracy of controls and instruments and protection against HAZARDOUS
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

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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
88
89

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90
91 INTERNATIONAL ELECTROTECHNICAL COMMISSION
92 __________
93
94 MEDICAL ELECTRICAL EQUIPMENT
95
96 Part 2-57: Particular requirements for the basic safety and essential
97 performance of non-laser light source equipment intended for therapeutic,
98 diagnostic, monitoring and cosmetic/aesthetic use
99
100 FOREWORD
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
104 in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
105 Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
106 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
107 may participate in this preparatory work. International, governmental and non-governmental organizations liaising
108 with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
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
112 interested IEC National Committees.
113 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
114 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
115 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
116 misinterpretation by any end user.
117 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
118 transparently to the maximum extent possible in their national and regional publications. Any divergence between
119 any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
120 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
121 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
122 services carried out by independent certification bodies.
123 6) All users should ensure that they have the latest edition of this publication.
124 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
125 members of its technical committees and IEC National Committees for any personal injury, property damage or
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
129 indispensable for the correct application of this publication.
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
133 TC 76: Optical radiation safety and laser equipment
134 The text of this standard is based on the following documents:
FDIS Report on voting

135
136 Full information on the voting for the approval of this standard can be found in the
137 report on voting indicated in the above table.
138 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
139 In this standard, the following print types are used:
140 – Requirements and definitions: roman type.
141 – Test specifications: italic type.

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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
145 noted: small capitals.
146 In referring to the structure of this standard, the term
147 – “clause” means one of the seventeen numbered divisions within the table of
148 contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2,
149 etc.);
150 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are
151 all subclauses of Clause 7).
152 References to clauses within this standard are preceded by the term “Clause”
153 followed by the clause number. References to subclauses within this particular
154 standard are by number only.
155 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true
156 if any combination of the conditions 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
160 compliance with this standard;
161 – “should” means that compliance with a requirement or a test is recommended but is
162 not mandatory for compliance with this standard;
163 – “may” is used to describe a permissible way to achieve compliance with a
164 requirement or test.
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
168 electrical equipment can be found on the IEC website.
169 The committee has decided that the contents of this publication will remain
170 unchanged until the stability date1 indicated on the IEC web site under
171 "http://webstore.iec.ch" in the data related to the specific publication. At this date, the
172 publication will be
173 • reconfirmed,
174 • withdrawn,
175 • replaced by a revised edition, or
176 • amended.
177
––––––––––
1
The National Committees are requested to note that for this publication the stability date is [.]

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178 INTRODUCTION
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
181 performance.
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
185 APPLICATOR is not in GOOD CONTACT with the target tissue.
186 It now excludes LS EQUIPMENT of RG-1 and RG-2 as these are assumed to represent no hazard.
187 RG-1C is only included if the incorporated light source is of RG-3.
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
190 of Risk Groups is now linked to IEC 62471-1.
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
197 cosmetic/aesthetic use.
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
201 practice or as a result of developments in technology.
202

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203 MEDICAL ELECTRICAL EQUIPMENT
204
205 Part 2-57: Particular requirements for the basic safety and essential
206 performance of non-laser light source equipment intended for therapeutic,
207 diagnostic, monitoring and cosmetic/aesthetic use
208
209
210 201.1 Scope, object and related standards
2)
211 Clause 1 of the general standard applies, except as follows:
212 201.1.1 *Scope
213 Replacement:
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
218 referred to as light source equipment (LS EQUIPMENT).
219 This particular standard applies to LS EQUIPMENT of Risk Group 1C (but only if the embedded
220 source of OPTICAL RADIATION is of RG-3), and of Risk Group 3.
221 Note: Classification rules for Risk Groups, see 201.6.1.102
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
226 does not apply to sterilisation equipment.
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
229 ENVIRONMENT and is typically used by a LAY OPERATOR.
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
234 depression (SAD), is covered by IEC 60601-2-83:2019. See Bibliography.
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
237 to underlying tissues are not considered.
238 201.1.2 Object
239 Replacement:
240 The objects of this particular standard are:
241 – to establish the risk from OPTICAL RADIATION, specify basic safety and essential performance
242 requirements for LS EQUIPMENT;
243 – to specify requirements for the MANUFACTURER to supply information and establish
244 procedures so that proper precautions can be adopted;
––––––––––
2)
The general standard is IEC 60601-1:2005, including Amendment 1:2012 and Amendment 2:2020, Medical electrical equipment
– Part 1: General requirements for basic safety and essential performance.

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245 – to provide warning to individuals of risks associated with accessible OPTICAL RADIATION from
246 LS EQUIPMENT through signs, labels and instructions;
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
249 to OPTICAL RADIATION through engineering controls;
250 – to specify requirements for protection against other HAZARDS resulting from the operation
251 and use of LS EQUIPMENT.
252
253 201.1.3 Collateral standards
254 Addition:
255 This particular standard refers to the applicable collateral standards that are listed in Clause 2
256 of the general standard.
257 All collateral standards apply, except IEC 60601-1-11 which does not apply.
258 201.1.4 Particular standards
259 Replacement:
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
263 requirements.
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.
266 Collateral standards are referred to by their document number.
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
274 following words:
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
278 general standard or applicable collateral standard.
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
285 additional items aa), bb), etc.
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
288 60601-1-2, 203 for IEC 60601-1-3, etc.

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289 The term "this standard" is used to make reference to the general standard, any applicable
290 collateral standards and this particular standard taken together.
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
295 to that effect is given in this particular standard.
296 201.2 Normative references
297 NOTE Informative references are listed in the Bibliography.
298 Clause 2 of the general standard applies, except as follows:
299 Addition:
300 IEC 60947-3, Low voltage switchgear and controlgear – Part 3: Switches, disconnectors, switch-
301 disconnectors and fuse-combination units
302 IEC 62471-1:xxxx, Photobiological safety of lamps and lamp systems - Part 1: General
303 requirements and Risk Group determination [currently under development]
304 ISO 3864-2, Graphical symbols – Safety colours and safety signs – Part 2: Design principles
305 for product safety labels
306 201.3 Terms and definitions
307 For the purposes of this document, the terms and definitions given in IEC 60601-1 and the
308 following apply.
309 Addition:
310 201.3.201
311 APPLICATOR
312 A mechanical or optical means of transferring OPTICAL RADIATION from the source to the human
313 tissue
314 201.3.202
315 CONTINUOUS OPERATION
316 operation with a continuous OPTICAL RADIATION output for a duration equal to or greater than
317 0,25 s for wavelengths i
...