DIN EN 60601-2-16:2016-02

This International Standard applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment, hereafter referred to as haemodialysis equipment. This International Standard does not take into consideration the dialysis fluid control system of haemodialysis equipment using regeneration of dialysis fluid control system of Haemodialysis equipment. It does however take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. This International Standard specifies the minimum safety requirements for haemodialysis equipment. These devices are intended for use either by medical staff or for use by the patient or other trained personnel under the supervision of medical expertise. This International Standard includes all medical electrical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. The responsible committee is DKE/GUK 812.6 "Apparate für extrakorporale Zirkulations- und Infusionstechnik" ("Apparatus for extracorporeal circulation and infusion technology") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.