This International Standard is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for hemodialysis or related therapies.

This International Standard covers devices used to treat water intended for use in the delivery of hemodialysis and related therapies. Included in the scope of this International Standard is water used for:
(1) the preparation of concentrates from powder or other highly concentrated media at a dialysis facility;
(2) the preparation of dialysis fluid that may be used for the preparation of substitution fluid; (3) the reprocessing of dialyzers for multiple uses.

Included within the scope of this International Standard are all devices, piping and fittings between the point at which potable water is delivered to the water treatment system and the point of use of the dialysis water. Examples of devices included within the scope of this International Standard are water purification devices, online water quality monitors (such as conductivity monitors), and piping systems for the distribution of dialysis water.

Excluded from the scope of this International Standard are dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid, sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid, dialysis concentrates, hemodiafiltration systems, hemofiltration systems, systems that process dialyzers for multiple uses, and peritoneal dialysis systems. Some of these devices, such as dialysis fluid delivery systems and concentrates, are addressed in other International Standards. Also excluded from the scope of this International Standard are requirements for the ongoing monitoring of the purity of water used for dialysis fluid, concentrate preparation or dialyzer reprocessing.