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

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).

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).

General Information

• Status: Published
• Publication Date: 26-Jul-2023
• 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: PPUB - Publication issued
• Start Date: 25-Aug-2023
• Completion Date: 27-Jul-2023

Relations

• Revises: 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
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-57 ®
Edition 2.0 2023-07
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, cosmetic and 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 destinés à des usages
thérapeutiques, de diagnostic, de surveillance, cosmétiques et esthétiques
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IEC 60601-2-57 ®
Edition 2.0 2023-07
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, cosmetic and 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 destinés

à des usages thérapeutiques, de diagnostic, de surveillance, cosmétiques et

esthétiques
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50, 11.040.60 ISBN 978-2-8322-7296-1

– 2 – IEC 60601-2-57:2023 © IEC 2023
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 12
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 . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
201.10 Protection against unwanted and excessive radiation HAZARDS . 18
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 for ME EQUIPMENT . 22
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 22
201.15 Construction of ME EQUIPMENT . 22
201.16 ME SYSTEMS . 22
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 22
Annexes . 23
Annex AA (informative) Particular guidance and rationale . 24
Annex BB (informative) Summary of MANUFACTURER’S requirements . 26
Annex CC (informative) Symbols on marking . 27
Bibliography . 28
Index of defined terms used in this document . 29

Figure 201.101 – Example of explanatory label for a device with multiple hazard
spectral regions . 14
Figure 201.102 – Example of explanatory label . 14
Figure 201.103 – Reproduction of the OPTICAL RADIATION warning symbol
(ISO 7010:W027:2011-05) . 15

Table 201.104 – Requirements for marking of LS EQUIPMENT according to risk group
classification . 14
Table BB.1 – Summary of MANUFACTURER’s requirements . 26
Table CC.1 – Symbols, references and descriptions . 27

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, cosmetic and aesthetic use

FOREWORD
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IEC 60601-2-57 has been prepared by IEC technical committee 76: Optical radiation safety and
laser equipment. It is an International Standard.
This second edition cancels and replaces the first edition published in 2011. This edition
...