UNE-EN IEC 60601-2-75:2019

Clause 1 of the general standard1 applies, except as follows:201.1.1 ScopeReplacement:This International Standard applies to the BASIC SAFETY and ESSENTIALPERFORMANCE of PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSISEQUIPMENT.If a clause or subclause is specifically intended to be applicable toME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clauseor subclause will say so. If that is not the case, the clause or subclause appliesboth to ME EQUIPMENT and to ME SYSTEMS, as relevant.HAZARDS inherent in the intended physiological function of ME EQUIPMENT orME SYSTEMS within the scope of this standard are not covered by specificrequirements in this standard except in 7.2.13 and 8.4.1 of the generalstandard.NOTE See also 4.2 of the General Standard.This standard applies to PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSISEQUIPMENT used for compensation or alleviation of disease, injury or disability.In the case of combined equipment (e.g. equipment additionally provided witha function or an applied part for the target area) such equipment shall alsocomply with any Particular Standard specifying safety requirements for theadditional 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 aPHOTOSENSITIZER." Illumination equipment intended for use in observation, monitoring, anddiagnosis, not intended for use with a PHOTOSENSITIZER.