Over deze norm
||Medische elektrische toestellen
IEC 60601-2-50 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANTPHOTOTHERAPY EQUIPMENT, as defined in 201.3.203, also referred to as ME EQUIPMENT.If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or toME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not thecase, 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 SYSTEMSwithin the scope of this document are not covered by specific requirements in this document,except in 7.2.13 and 8.4.1 of the general standard. This particular standard specifies safety requirements for INFANT PHOTOTHERAPY EQUIPMENT,but alternate methods of compliance with a specific clause by demonstrating equivalent safetywill not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISKMANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of anacceptable level when weighed against the benefit of treatment from the device.