UNE-EN IEC 60601-2-39:2019

Replacement:This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE ofPERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, hereafter referred to asPD EQUIPMENT. It applies to PD EQUIPMENT intended for use either by medical staff or under thesupervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless ofwhether the PD EQUIPMENT is used in a hospital or domestic environment.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 SYSTEMS withinthe scope of this standard are not covered by specific requirements in this standard except in7.2.13 and 8.4.1 of the general standard.NOTE See also 4.2 of the general standard.This standard can also be applied to PD EQUIPMENT used for compensation or alleviation ofdisease, injury or disability.These particular requirements do not apply to the DIALYSING SOLUTION, or the DIALYSINGSOLUTION CIRCUIT