IEC 60601-2-57:2011

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

IEC 60601-2-57:2011 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 non-visual photo-biological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment. IEC 60601-2-57:2011 does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy. Light source equipment may consist of a single or multiple sources of optical radiation, with or without power supply, or may be incorporated into a complex system that includes optical, electricalor mechanical systems or sources of other radiation.

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

La CEI 60601-2-57:2011 s'applique à la sécurité de base et aux performances essentielles des appareils intégrant une ou plusieurs sources de rayonnement optique dans la gamme des longueurs d'onde de 200 nm à 3 000 nm, à l'exception du rayonnement laser, et prévus pour créer des effets photobiologiques non visibles sur les humains ou sur les animaux, pour applications thérapeutiques, de diagnostic, de surveillance, cosmétiques/esthétiques ou vétérinaires, dénommés ci-après appareils à source de lumière. La CEI 60601-2-57:2011 n'est pas applicable aux appareils de bronzage, aux appareils ophtalmiques ou de photothérapie pour nourrissons. Les appareils à source de lumière peuvent consister en une unique ou en de multiples sources de rayonnement optique, avec ou sans alimentation électrique, ou bien peuvent être intégrés à un système complexe incluant des systèmes optiques, électriques ou mécaniques, ou des sources d'autres rayonnements.

General Information

• Status: Published
• Publication Date: 30-Jan-2011
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.50 - Radiographic equipment
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: TC 76 - Optical radiation safety and laser equipment
• Drafting Committee: WG 4 - TC 76/WG 4
• Current Stage: DELPUB - Deleted Publication
• Start Date: 23-Dec-2021
• Completion Date: 27-Jul-2023

Relations

• Revised: IEC 60601-2-57:2023 - 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
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-57 ®
Edition 1.0 2011-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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

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
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IEC 60601-2-57 ®
Edition 1.0 2011-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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

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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX V
ICS 11.040.50; 11.040.60 ISBN 978-2-88912-344-5
– 2 – 60601-2-57  IEC:2011
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards. 8
201.2 Normative references . 10
201.3 Terms and definitions . 10
201.4 General requirements . 13
201.5 General requirements for testing ME EQUIPMENT . 13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 19
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
201.10 Protection against unwanted and excessive radiation HAZARDS . 20
201.11 Protection against excessive temperatures and other HAZARDS . 21
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 21
201.13 HAZARDOUS SITUATIONS and fault conditions . 22
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23
201.15 Construction of ME EQUIPMENT . 23
201.16 ME SYSTEMS. 23
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23
Annexes . 23
Annex AA (informative) Particular guidance and rationale . 24
Annex BB (informative) Exposure limit values . 26
Annex CC (informative) Protective eyewear for LS EQUIPMENT . 30
Annex DD (informative) Summary of MANUFACTURER’S requirements . 31
Annex EE (informative) Symbols on marking . 32
Bibliography . 33
Index of defined terms used in this particular standard. 34

Figure 201.101 – Example of explanatory label for a device with multiple HAZARD

spectral regions . 18
Figure 201.102 – Warning label – HAZARD symbol . 19

Table 201.101 – EMISSION LIMITS for risk groups of LS EQUIPMENT . 14
Table 201.102 – Risk group time base criteria for classification of LS EQUIPMENT . 15
Table 201.103 – Applicable ANGLE OF ACCEPTANCE for the assessment of accessible
emission from LS EQUIPMENT . 15
Table 201.104 – Requirements for labelling of LS EQUIPMENT according to risk group
classification . 17
Table BB.1 – EXPOSURE LIMIT values for non-coherent OPTICAL RADIATION . 26
Table BB.2 – S(λ) [dimensionless], 200 nm to 400 nm . 28
Table BB.3 – B (λ), R (λ) [dimensionless], 300 nm to 1 400 nm . 29

60601-2-57  IEC:2011 – 3 –
Table DD.1 – Summary of MANUFACTURER’S requirements . 31
Table EE.1 – Symbols, references and descriptions . 32

– 4 – 60601-2-57  IEC:2011
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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

FOREWORD
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International Standard IEC 60601-2-57 has been prepared by IEC technical committee TC 76:
Optical radiation safety and laser equipment
The text of this standard is based on the following documents:
FDIS Report on voting
76/438/FDIS 76/441/RVD
Full information on the voting for the approval of this s
...