DANSK DSF/FPREN 60601-2-75 PDF

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE – See also 4.2 of the General Standard. This standard applies to PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT used for compensation or alleviation of disease, injury or disability. In the case of combined equipment (e.g. equipment additionally provided with a function or an applied part for the target area) such equipment shall 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. • Illumination equipment intended for use in observation, monitoring, and diagnosis, not intended for use with a PHOTOSENSITIZER.