2. Getting involved
3. Standards Committees
4. DKE

DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE

Overview

This standard applies to the applies to the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment used for compensation or alleviation of disease, injury or disability. In the case of combined equipment such equipment also comply with any particular standard specifying safety requirements for the additional function. This particular standard does not apply to: - light therapy equipment intended for use in photothermal ablation, coagulation, and hyperthermia; - low-level laser therapy equipment not intended for use with a photosensitizer; or illumination devices intended for observation, monitoring, and diagnosis, but not for use with a photosensitizer. The standard differs from DIN EN IEC 60601-2-75 (VDE 0750-2-75):2020-10 as follows: a) adjustments to terms and references; b) adjustments and updates in Annex AA and Annex BB; c) four additional references. Typical examples include the use of ME devices with one or more sources of optical radiation in the wavelength range from 200 nm to 3 000 nm (excluding laser radiation) that produce photobiological effects on humans or animals for the purposes of therapy, diagnosis, monitoring, or cosmetic/aesthetic or veterinary medical applications.

Document: references other documents

Responsible national committee

DKE/K 804 - Elektrische Geräte und Einrichtungen in medizinischer Anwendung und elektromedizinische Geräte