Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
Gives particular safety and performance requirements for home light therapy equipment.
The text of this standard is sold by IEC and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| European Union | Harmonized | EN IEC 60601-2-83:2020 with amendments A11:2021 and A1:2025 | - | Recognition number MDR entry 14a. Effective January 5, 2022. Transition until December 15, 2027. The earlier reference without the 2025 amendment is deleted from this date.. Devices that conform to the standard are presumed to conform with the requirements of the Regulation that the standard covers. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: GB 9706.1-2020, IEC 60601-1, JIS T 0601-1, IEC 60601-1-8, IEC 60601-1-11, ISO 14708-1, AS/NZS 3820, AS/NZS 3112, AS/NZS 4417.1, IEC 62133-2. See .
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.