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EVS-EN IEC 60601-2-57:2026

Elektrilised meditsiiniseadmed. Osa 2-57: Erinõuded ravi-, diagnostika-, seire- ja kosmeetilisel/esteetilisel eesmärgil kasutatavate mittelaservalgusallikaga seadmete esmasele ohutusele ja olulistele toimimisnäitajatele

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Kehtiv alates 02.02.2026
Alusdokumendid
IEC 60601-2-57:2023; EN IEC 60601-2-57:2026
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Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
02.02.2026
Põhitekst
02.02.2026
Põhitekst + muudatus
04.05.2011
Põhitekst

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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