This International Standard specifies minimum requirements for dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration. 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.

Excluded from the scope of this International Standard are 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.