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EN IEC 60601-2-57:2026 Standard

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  Keywords:

#iec #equipment #radiation #nm #applies

This standard can be totally or partially supervised by:
  •   EN IEC 60601-2-57:2026/A11:2026
  •   Directive

    Medical devices Regulation ((EU) 2017/745)

      Last Official Journal reference

    Monday 9th of November 2026

      Description:

    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

      Purpose

    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.

      Publication

    Monday 9th of November 2026

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