FprEN IEC 60601-2-57:2023
(Main)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, cosmetic and aesthetic use
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, cosmetic and aesthetic use
IEC 60601-2-57:2023 applies to basic safety and essential performance of equipment incorporating one or more sources of optical radiation in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create photobiological effects in humans for therapeutic, diagnostic, monitoring, and cosmetic or aesthetic applications; hereafter referred to as light source equipment (ls equipment).
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 destinés à des usages thérapeutiques, de diagnostic, de surveillance, cosmétiques et esthétiques
IEC 60601-2-57:2023 s'applique à la sécurité de base et aux performances essentielles des équipements incorporant une ou plusieurs sources de rayonnement optique dans la gamme de longueurs d'onde comprises entre 200 nm et 3 000 nm, à l'exception du rayonnement laser, et destinés à créer des effets photobiologiques chez l'homme pour des applications thérapeutiques, diagnostiques, de surveillance et cosmétiques ou esthétiques; Ci-après dénommés équipements d'origine lumineuse (équipements LS).
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
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Standards Content (Sample)
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.
oSIST prEN IEC 60601-2-57:2022
IEC CDV 60601-2-57 ED2 IEC:2022 -2- 76/706/CDV
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.
oSIST prEN IEC 60601-2-57:2022
IEC CDV 60601-2-57 ED2 IEC:2022 -3- 76/706/CDV
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
oSIST prEN IEC 60601-2-57:2022
IEC CDV 60601-2-57 ED2 IEC:2022 -4- 76/706/CDV
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
oSIST prEN IEC 60601-2-57:2022
IEC CDV 60601-2-57 ED2 IEC:2022 -5- 76/706/CDV
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
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