DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN IEC 60601-2-83
; VDE 0750-2-83:2026-03
Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment (IEC 60601-2-83:2019 + AMD1:2022); German version EN IEC 60601-2-83:2020 + A11:2021 + A1:2025
Medizinische elektrische Geräte - Teil 2-83: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Heim-Lichttherapiegeräten (IEC 60601-2-83:2019 + AMD1:2022); Deutsche Fassung EN IEC 60601-2-83:2020 + A11:2021 + A1:2025
Overview
This part of IEC 60601 applies to the basic safety and essential performance home light therapy equipment intended for use in the home healthcare environment. Home light therapy equipment is typically used by a lay operator. The scope of this document includes all light sources except lasers. The standard differs from DIN EN IEC 60601-2-83 (VDE 0750-2-83):2021-05 and DIN EN IEC 60601-2-83/A11 (VDE 0750-2-83/A11):2022-08 as follows: a) cross-reference to the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and IEC 60601-1:2005/AMD2:2020 updated; b) references to the standards IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020, as well as IEC 60601-1-11:2015 and IEC 60601-1-11:2015/ AMD1:2020 have been updated; c) the clause with regard to normative references has been revised; d) the clause "Assessment of skin pigmentation" has been revised and expanded; e) the clause "Ingress of water or solid materials into medical electrical devices" has been revised; f) adjustments have been made to Annexes ZZA and ZZB. The scope of this document includes all light sources (home light therapy equipment) except lasers.