CAN/CSA-ISO 11663-11

This is the first edition of CAN/CSA-ISO 11663, Quality of dialysis fluid for haemodialysis and related therapies, which is an adoption, without modification, of the identically titled ISO (International Organization for Standardization) Standard 11663 (first edition, 2009-04-15). Together with CAN/CSA-ISO 26722 and CAN/CSA-ISO 13959, it replaces CSA Z364.2.2-03, Water Treatment Equipment and Water Quality Requirements for Hemodialysis.

Scope

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.