EVS-EN ISO 11663:2015

This International Standard specifies minimum quality requirements for dialysis fluids used in
haemodialysis and related therapies.
This International Standard includes 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
International 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 International Standard.