scope:

1.1 General This International Standard specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies. 1.2 Inclusions This International Standard includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration. 1.3 Exclusions This International Standard does not address the requirements for the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other ISO standards. Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use prepackaged solutions, and systems and solutions for peritoneal dialysis are excluded from this standard.