scope:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, hereafter referred to as ME EQUIPMENT. It applies to ME EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including ME EQUIPMENT operated by the PATIENT, regardless of whether the ME 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 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 can also be applied to PERITONEAL DIALYSIS ME EQUIPMENT used for compensation or alleviation of disease, injury or disability. These particular requirements do not apply to the DIALYSING SOLUTION, the DIALYSING SOLUTION CIRCUIT, or to ME EQUIPMENT solely intended for use as CONTINUOUS AMBULATORY PERITONEAL DIALYSIS ME EQUIPMENT.