BS EN ISO 23500-1:2019

This standard BS EN ISO 23500-1:2019 Preparation and quality management of fluids for haemodialysis and related therapies is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics
• 11.040.20 Transfusion, infusion and injection equipment

1.1 General

This document is the base standard for a number of other standards dealing with water treatment equipment, water, dialysis water, concentrates, and dialysis fluid (ISO 23500 series) and provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, this document functions as a recommended practice.

This document does not address clinical issues that might be associated with inappropriate usage of the water, dialysis water, concentrates, or dialysis fluid. Healthcare professionals involved in the provision of treatment for kidney failure should make the final decision regarding the applications with which these fluids are used, for example, haemodialysis, haemodiafiltration, high-flux haemodialysis, and the reprocessing of dialysers, and need to be aware of the issues that the use of inappropriate fluid quality raises in each of the therapies.

The concepts incorporated in this document should not be considered inflexible or static. The recommendations presented here should be reviewed periodically in order to assimilate increased understanding of the role of dialysis fluid purity in patient outcomes and technological developments.

1.2 Inclusions

This document addresses the user's responsibility for dialysis fluid once the equipment used in its preparation has been delivered and installed.

For the purposes of this document, dialysis fluid includes:

1. dialysis water (see 3.17 for definition) used for the preparation of dialysis fluid and substitution fluid,

2. dialysis water used for the preparation of concentrates at the user's facility,

3. concentrates,

4. the final dialysis fluid and substitution fluid.

The scope of this document includes

1. 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 dialyser or the point at which substitution fluid is infused,

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

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

NOTE Because water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document.

1.3 Exclusions

This document 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 pre-packaged solutions, and systems and solutions for peritoneal dialysis.