scope:

This Technical Information Report (TIR) addresses the preparation of ultrapure dialysis fluid from water and concentrates and its use in performing hemodialysis and related therapies in dialysis facilities (dialysis units).

Inclusions

The Technical Information Report includes the definition of ultrapure dialysis fluid, the rationale for its use, and some means by which it can be prepared and other considerations. Manufacturer and user roles and responsibilities are presented.

Exclusions

This Technical Information Report does not cover peritoneal dialysis fluids or prepackaged dialysis fluids, such as those used in continuous renal replacement therapies (CRRT). This TIR does not apply to home dialysis systems.

NOTE While this TIR is primarily directed at the preparation of ultrapure dialysate in dialysis facilities, aspects of it might also apply to home dialysis with standard dialysis machines.