AAMI 23500

Description / Abstract: General

This International Standard provides dialysis practitioners with guidance on the preparation of dialysis fluid for hemodialysis and related therapies and substitution fluid for use in online therapies, such as hemodiafiltration and hemofiltration. As such, this International Standard functions as a recommended practice.

Inclusions

This International Standard addresses the user's responsibility for the dialysis fluid once the equipment used in its preparation has been delivered and installed. For the purposes of this International Standard, the dialysis fluid includes dialysis water (see 3.18 for definition) used for the preparation of dialysis fluid and substitution fluid, dialysis water used for the preparation of concentrates at the user's facility, as well as concentrates and the final dialysis fluid and substitution fluid.

The scope of this International Standard includes

a) the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyzer or the point at which substitution fluid is infused,

b) equipment used to prepare concentrate from powder or other highly concentrated media at a dialysis facility, and

c) preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates.

NOTE Because water used to prepare dialysis fluid is commonly prepared and distributed using the same equipment as the water used to reprocess dialyzers, water used to reprocess dialyzers is also covered by this International Standard.

Exclusions This International Standard does not apply to 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.