This International Standard specifies minimum requirements for the quality of dialysis fluids used in hemodialysis and related therapies. This International Standard covers dialysis fluids used for hemodialysis and hemodiafiltration, including replacement fluid for hemodiafiltration and hemofiltration. This International Standard does not cover the requirements for the water and concentrates and the equipment for producing the dialysis fluid. These aspects are covered by other international standards. Sorbent-based dialysis fluid reprocessing systems in which small volumes of dialysis fluid are reprocessed and recirculated; Continuous renal replacement therapy systems using prepackaged solutions and peritoneal dialysis systems and solutions are excluded from the scope of this International Standard.
EN ISO 11663:2015 Referenced Document
ISO 13958:2014 Concentrates for haemodialysis and related therapies
ISO 13959:2014 Water for haemodialysis and related therapies
ISO 23500:2014 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
EN ISO 11663:2015 history
2015EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies