scope:

This particular standard specifies the minimum safety requirements for peritoneal dialysis equipment as defined in 2.1.102, hereinafter referred to as equipment. It applies to equipment intended for use either by medical staff or under the supervision of medical expertise, including equipment operated by the patient, regardless of whether the equipment is used in a hospital or domestic environement. These particular requirements do not apply to the dialysing solution, the dialysing solution circuit, or to equipment solely intended for use as continuous ambulatory peritoneal dialysis.