AAMI 11663

Description / Abstract: This International Standard specifies minimum quality requirements for dialysis fluids used in hemodialysis and related therapies. This International Standard includes dialysis fluids used for hemodialysis and hemodiafiltration, including substitution fluid for hemodiafiltration and hemofiltration. 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.