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EVS-EN IEC 60601-2-57:2026

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

General information

Valid from 02.02.2026
Base Documents
IEC 60601-2-57:2023; EN IEC 60601-2-57:2026
Directives or regulations
None

Standard history

Status
Date
Type
Name
02.02.2026
Main
02.02.2026
Main + amendment
04.05.2011
Main

IEC 60601-2-57 applies to the basic safety and essential performance of equipment that incorporates one or more sources of optical radiation in the wavelength range from 200 nm to 3 000 nm. Laser radiation is excluded from the scope of this document.

The equipment is intended to create photobiological effects in humans for therapeutic, diagnostic, monitoring, and cosmetic or aesthetic applications. Such equipment is referred to as light source equipment (LS equipment).

The requirements of IEC 60601-2-57 represent the minimum necessary to achieve a reasonable level of safety and reliability. They apply to the operation and use of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, and cosmetic or aesthetic purposes.

IEC 60601-2-57:2023 text has been approved in Europe as EN IEC 60601-2-57:2026 without any changes.

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