EN IEC 60601-2-57:2026

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.

oSIST prEN IEC 60601-2-57:2022

oSIST prEN IEC 60601-2-57:2022
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:
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.
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26 CONTENTS
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
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91 INTERNATIONAL ELECTROTECHNICAL COMMISSION
92 __________
94 MEDICAL ELECTRICAL EQUIPMENT
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
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
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.
––––––––––
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.
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203 MEDICAL ELECTRICAL EQUIPMENT
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
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.
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 in the range 400 to 700 nm and 10 s for all other wavelengths
318 [SOURCE: IEC 60601-1, 3.18, modified]
319 201.3.203
320 EMERGENCY STOP
321 device intended to stop the LS EQUIPMENT OUTPUT immediately in case of emergency
322 201.3.204
323 EMISSION APERTURE
324 opening or window through which the OPTICAL RADIATION is emitted
325 201.3.205
326 EXPOSURE DURATION
327 duration of a PULSE, or series, or train of PULSES or of continuous emission of OPTICAL RADIATION
328 incident upon the human body during operation, maintenance or servicing of LS EQUIPMENT
329 Note to entry: For a single PULSE, this is the duration between the half-peak power point of the leading edge and the
330 corresponding point on the trailing edge. For a train of PULSES (or subsections of a train of PULSES), this is the

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331 duration between the first half-peak power point of the leading PULSE and the last half-peak power point of the last
332 PULSE.
333 SI Unit: second (s)
335 201.3.206
336 GOOD CONTACT
337 state that is established when the APPLICATOR of the LS EQUIPMENT which is classified RG-1C
338 is positioned at the target tissue so that the tissue surface acts to effectively prevent
339 HAZARDOUS eye exposure to STRAY OPTICAL RADIATION
340 [SOURCE: IEC 60335-2-113:2016, 3.104, modified]
341 201.3.207
342 INFRARED
343 IR
344 Optical radiation in the range between 780 nm and 1 mm
345 Note to entry: For INFRARED radiation, the range between 780 nm and 1 mm is commonly subdivided into: IR-A (780
346 nm to 1400 nm), IR-B (1400 nm to 3000 nm), and IR-C (3000 nm to 1 mm). In this standard INFRARED radiation at
347 wavelengths longer than 3000 nm is not considered
349 [SOURCE: IEC 62471-1, modified]
350 201.3.208
351 LS EQUIPMENT
352 ME EQUIPMENT which incorporates one or more sources of OPTICAL RADIATION in the wavelength
353 range 200 nm to 3 000 nm, with the exception of laser radiation, and which is intended to create
354 photobiological effects for therapeutic, diagnostic, monitoring or cosmetic/aesthetic applications
355 201.3.209
356 LS EQUIPMENT OUTPUT
357 either radiant power, radiant energy, irradiance or radiant exposure emitted by and as relevant
358 to the LS EQUIPMENT
359 201.3.210
360 OCULAR EXPOSURE LIMIT
361 maximum level of exposure to the eye that is not expected to result in adverse biological effects
362 [SOURCE: IEC 62471-1, 3.10]
363 Note 1 to entry: For the determination of the OCULAR EXPOSURE LIMITS refer to IEC 62471-1, Annex C
364 Note 2 to entry: OCULAR EXPOSURE LIMITS may be found in https://www.icnirp.org,
365 https://www.icnirp.org/cms/upload/publications/ICNIRPVisible_Infrared2013.pdf, see Bibliography [3]
366 https://www.icnirp.org/cms/upload/publications/ICNIRPUV2004.pdf, see Bibliography [10]
368 201.3.211
369 OCULAR HAZARD DISTANCE
370 OHD
371 shortest distance from an EMISSION APERTURE at which the projected radiant exposure or
372 irradiance for a given EXPOSURE DURATION equals the applicable OCULAR EXPOSURE LIMIT
373 [SOURCE: IEC 62471-1, 3.13, “hazard distance”, modified to restrict the hazard distance to eye
374 exposure]
375 SI Unit: m
376 Note to entry: For the determination of the OCULAR HAZARD DISTANCE refer to IEC 62471-1, Annex I

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377 201.3.212
378 OPERATOR
379 person handling the LS EQUIPMENT
380 [SOURCE: IEC 60601-1, 3.73, modified]
381 Note to entry: in general, the OPERATOR controls the delivery of optical radiation. The OPERATOR may appoint other
382 person(s) who assist with the selection and/or setting of the parameters. The more general term “user” is interpreted
383 in its generic meaning. The meaning of “user” may include the definition of “OPERATOR”
384 201.3.213
385 OPTICAL RADIATION
386 electromagnetic radiation with wavelengths between 100 nm and 1 mm
387 201.3.214
388 PATIENT
389 person undergoing the treatment or diagnostic procedure
390 [SOURCE: 3.76 of 60601-1, 3.76, modified. Animals are excluded, persons receiving treatments
391 in non-medical settings such as beauty care environments are included in the meaning of the
392 term]
393 201.3.215
394 PULSE
395 PULSED
396 emission with the duration shorter than 0,25 s in the range 400 nm to 700 nm and shorter than
397 10 s at all other wavelengths
398 201.3.216
399 PULSE DURATION
400 time increment measured between the half peak (50 %) power points at the leading and trailing
401 edges of a PULSE
402 SI Unit: second (s)
403 201.3.217
404 PULSE INTERVAL
405 time between the end of one PULSE and the onset of the following PULSE, measured at the 50 %
406 trailing and leading edges respectively
407 SI Unit: second (s)
408 201.3.218
409 PULSE TRAIN
410 series of PULSES where the total on time of the PULSES in any series of PULSES in any single
411 exposure sequence does not exceed 0,25 s for wavelengths in the range 400 nm to 700 nm and
412 does not exceed 10 s for all other wavelengths
413 201.3.219
414 READY
415 ready condition: the LS EQUIPMENT is capable of emitting OPTICAL RADIATION when the control
416 switch is activated
417 201.3.220
418 READY INDICATOR
419 visible or audible signal that indicates when LS EQUIPMENT is in the READY condition
420 Note to entry: the purpose of the READY INDICATOR is to make all persons present in the vicinity aware of the need to
421 take precautions against HAZARDOUS OPTICAL RADIATION

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422 201.3.221
423 RG-1C
424 any LS EQUIPMENT which is designed explicitly for contact application to the skin or non-ocular
425 tissue and that
426 – during operation ocular HAZARD is prevented by engineering means, i.e. the accessible
427 emission is stopped or reduced to below the limits of RG-2 when the APPLICATOR is
428 removed from contact with the skin or non-ocular tissue, and
429 – during operation and when in contact with skin or non-ocular tissue, irradiance or radiant
430 exposure levels may exceed the limits of RG-2,
431 can be classified as RG-1C
433 Note 1 to entry: As tests for the determination of the classification of the LS EQUIPMENT are limited to tests during
434 operation, it may be the case that radiation above the limits of RG-2 can become accessible during maintenance or
435 service when the engineering means such as interlocks are overridden or the APPLICATOR is opened or disassembled.
436 Note 2 to entry: At the publication date of this document the next edition of IEC 62471-1 may still be under
437 development. IEC 62471-1 may introduce the anticipated new RG-1C (“C” stands for “contact”), which is intended to
438 be attributed to light sources intended to be applied to the skin, and which have sensors or interlocks incorporated
439 to allow emission only when GOOD CONTACT is provided. In case that the new edition of IEC 62471-1 becomes
440 published and the term RG-1C deviates technically from its definition in this document, an amendment may be issued
441 so that conflicts of interpretation are avoided. Meanwhile the text of this document has priority.
442 201.3.222
443 SET VALUE
444 intended LS EQUIPMENT OUTPUT incident on the TREATMENT AREA, as set by the OPERATOR
445 201.3.223
446 STAND-BY
447 stand-by condition: the power supply (SUPPLY MAINS or battery) is connected, and the SUPPLY
448 MAINS switch activated; the LS EQUIPMENT is not capable of emitting the OPTICAL RADIATION even
449 if the control switch is activated
450 201.3.224
451 STRAY OPTICAL RADIATION
452 OPTICAL RADIATION that is unintentionally emitted from the EMISSION APERTURE or from the target
453 tissue, including scattered, reflected and leakage radiation
454 201.3.225
455 TREATMENT AREA
456 The extent of the field over which the OPTICAL RADIATION is intended to produce a therapeutic
457 response.
458 LS EQUIPMENT where OPTICAL RADIATION exposure is carried out in contact with the surface to be
Note to entry: For
459 treated, this is equivalent to the device aperture
460 201.3.226
461 ULTRAVIOLET
462 UV
463 OPTICAL RADIATION having wavelengths between 100 nm and 400 nm
464 Note to entry: For ultraviolet (UV) radiation, the range between 100 nm and 400 nm is commonly subdivided into:
465 UV-A, from 315 nm to 400 nm; UV-B, from 280 nm to 315 nm; and UV-C, from 100 nm to 280 nm. These designations
466 for the UV should not be taken as precise limits, particularly for photobiological effects. In some fields of photobiology
467 the wavelength bands are taken from 200 nm to 290 nm, from 290 nm to 320 nm, and from 320 nm to 400 nm.
468 Sometimes these are (incorrectly) called by the names UV-A, UV-B and UV-C, respectively
469 201.3.227
470 VISIBLE
471 VIS
472 OPTICAL RADIATION having wavelengths between 380 nm and 780 nm
473 201.4 General requirements
474 Clause 4 of the general standard applies.

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475 201.5 General requirements for testing ME EQUIPMENT
476 Clause 5 of the general standard applies.
477 201.6 Classification of ME EQUIPMENT
478 Clause 6 of the general standard applies, except as follows:
479 201.6.1 General
480 Addition:
481 201.6.1.101 Classification responsibilities
482 The LS EQUIPMENT shall be classified by the manufacturer according to the classification rules
483 as defined in IEC 62471-1
484 201.6.1.102 Classification rules
485 LS EQUIPMENT is different from lamps used in general lighting, as the radiation is used for
486 treatment or diagnosis purposes on humans rather than general exposure purposes such as
487 general lighting, illumination or disinfection. To be able to attribute a Risk Group to LS EQUIPMENT,
488 its handpieces, APPLICATORS or its incorporated freely emitting sources shall be considered as
489 “lamps” as covered by IEC 62471-1.
490 201.7 ME EQUIPMENT identification, marking and documents
491 Clause 7 of the general standard applies, except as follows:
492 201.7.9 ACCOMPANYING DOCUMENTS
493 201.7.9.1 General
494 Addition:
495 MANUFACTURERS of LS EQUIPMENT shall provide instructions for proper operation, including clear
496 warnings concerning precautions to avoid possible exposure to HAZARDOUS OPTICAL RADIATION.
497 201.7.9.2 Instructions for use
498 201.7.9.2.13 Maintenance
499 Addition:
500 MANUFACTURERS of LS EQUIPMENT shall provide instructions for maintenance including warnings
501 concerning precautions to avoid possible exposure to HAZARDous OPTICAL RADIATION.
502 201.7.9.2.17 ME EQUIPMENT emitting radiation
503 Addition:
504 201.7.9.2.17.101 Specific information for LS EQUIPMENT
505 201.7.9.2.17.101.1 Information on output
506 The MANUFACTURER of LS EQUIPMENT shall provide the following information:
507 – Spectral irradiance or spectral radiant exposure measured at the TREATMENT AREA for all
508 intended configurations of LS EQUIPMENT;

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509 – maximum LS EQUIPMENT OUTPUT for all intended configurations of LS EQUIPMENT, measured
510 at the TREATMENT AREA. If the LS EQUIPMENT is designed for providing treatment in different
511 TREATMENT AREAS, these parameters shall be specified for each of the TREATMENT AREAS;
512 – maximum variation of the LS EQUIPMENT OUTPUT from the mean value across the TREATMENT
513 AREA for all intended configurations of the LS EQUIPMENT;
514 – OCULAR HAZARD DISTANCE when the LS EQUIPMENT is classified Risk Group 3.
515 For PULSED LS EQUIPMENT, for all intended operational SET VALUES of the equipment, the
516 MANUFACTURER shall provide an additional statement of:
517 – PULSE DURATION of individual PULSES;
518 – duration of a PULSE TRAIN;
519 – PULSE INTERVAL;
520 – PULSE repetition rate;
521 – number of PULSES in a PULSE TRAIN.
522 201.7.9.2.17.101.2 Safety information
523 MANUFACTURERS of LS EQUIPMENT shall provide the following information in the user instructions,
524 if applicable:
525 – Instructions for installation, maintenance, pre-use checks and safe use, including clear
526 warnings concerning precautions to avoid possible exposure to HAZARDOUS radiation or risk
527 of fire;
528 – Description of the procedures of the intended use, indications, pre-treatment evaluations,
529 counter-indications. When the LS EQUIPMENT emits UV-A, UV-B or UV-C, warning about the
530 risks of PATIENTS suffering from future potential carcinogenic occurrences.
531 – recommendations for training;
532 – legible reproductions (colour optional) of all required labels and HAZARD warnings affixed to
533 the LS EQUIPMENT;
534 – a clear indication of all locations of EMISSION APERTURES;
535 – a list of controls, adjustments and procedures for operation and maintenance, including the
536 warning "Caution – Use of controls or adjustments or performance of procedures other than
537 those specified herein may result in HAZARDOUS radiation exposure";
538 – a note, saying that LS EQUIPMENT should be protected against unauthorised use, for example
539 by removal of the key from the key switch;
540 – when technical means are insufficient to provide a safe environment e.g. when the
541 APPLICATOR can freely be moved while the emission can be triggered, recommendations for
542 eye and skin protection for the personnel and for the PATIENT. This includes a technical
543 specification of the recommended safety eyewear and a technical specification of the
544 recommended skin protection or cloth;
545 – when the LS EQUIPMENT is RG-1C, instructions for recommended use so that GOOD CONTACt
546 is maintained. This is to include clear warnings concerning possible exposure to HAZARDOUS
547 radiation if the contact sensors are inappropriately manipulated by the OPERATOR or
548 malfunctioning due to a technical SINGLE FAULT CONDITION or any other foreseeable reason;
549 – advice about the measures to minimize visual disturbances to personnel, such as increasing
550 the level of ambient light, applying spot lighting of the target area and use of protective
551 eyewear.
553 201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
554 Additional subclauses
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555 201.7.2.101 Labels and marking of LS EQUIPMENT
556 201.7.2.101.1 Specification of labels and marking
...