DANSK DSF/FPREN 60601-2-16 PDF

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of 63 HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as 64 HAEMODIALYSIS EQUIPMENT. 65 This International Standard does not take into consideration specific safety details of the 66 DIALYSIS FLUID control system of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS 67 FLUID or CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID. It does, however, take into 68 consideration the specific safety requirements of such HAEMODIALYSIS EQUIPMENT concerning 69 electrical safety and PATIENT safety. 70 This International Standard specifies the minimum safety requirements for HAEMODIALYSIS 71 EQUIPMENT. These HAEMODIALYSIS EQUIPMENT are intended for use either by medical staff or 72 for use by the PATIENT or other trained personnel under medical supervision. 73 This International Standard includes all ME EQUIPMENT that is intended to deliver a 74 HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT, 75 independent of the treatment duration and location. 76 If applicable, this international standard applies to the relevant parts of ME EQUIPMENT 77 intended for other extracorporeal blood purification treatments. 78 The particular requirements in this International Standard do not apply to: 79 – EXTRACORPOREAL CIRCUITS (see ISO 8637-2); 80 – DIALYSERS (see ISO 8637-1); 81 – DIALYSIS FLUID CONCENTRATES (see ISO 23500-4); 82 – DIALYSIS WATER supply systems (see ISO 23500-2); 83 – CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID CONCENTRATES (see ISO 23500-4, 4.3); 84 – Equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39).