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  • BSI
    BS EN ISO 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Water treatment equipment for haemodialysis applications and related therapies
    Edition: 2019
    $418.55
    / user per year

Description of BS EN ISO 23500-2:2019 2019

1.1 General

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

1.2 Inclusions

This document covers devices used to treat potable water intended for use in the delivery of haemodialysis and related therapies, including 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, including dialysis fluid that can be used for the preparation of substitution fluid;

  3. the reprocessing of dialysers intended for single use where permitted for multiple uses,

  4. the reprocessing of dialysers not specifically marked as intended for single use.

This document includes 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 the devices are water purification devices, online water quality monitors (such as conductivity monitors), and piping systems for the distribution of dialysis water.

1.3 Exclusions

This document excludes 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, haemodiafiltration systems, haemofiltration systems, systems that process dialysers for multiple uses, and peritoneal dialysis systems. Some of these devices, such as dialysis fluid delivery systems and concentrates, are addressed in other documents such as ISO 23500‑4 and ISO 23500‑5,

This document also excludes the on-going surveillance of the purity of water used for dialysis fluid, concentrate preparation, or dialyser reprocessing which is addressed in ISO 23500‑1.



Standard NumberBS EN ISO 23500-2:2019
TitlePreparation and quality management of fluids for haemodialysis and related therapies - Water treatment equipment for haemodialysis applications and related therapies
StatusUnder Review
Publication Date2019-03-28
ReplacesBS EN ISO 26722:2015
Identical National Standard OfISO 23500-2:2019, EN ISO 23500-2
DescriptorsPerformance testing, Filtration, Artificial kidneys, Dialysis, Water treatment, Contamination, Chemical technology equipment, Water, Reverse osmosis, Medical equipment, Solutes, Water purification, Biological filters
ICS11.040.20 Transfusion, infusion and injection equipment, 11.040.40 Implants for surgery, prosthetics and orthotics
CommitteeCH/150/2
ISBN978 0 580 89752 8
PublisherBSI
Pages44

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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