ČSN EN ISO 23500-2 (856214)

Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies

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STANDARD published on 1.1.2025


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The information about the standard:

Designation standards: ČSN EN ISO 23500-2
Classification mark: 856214
Catalog number: 520339
Publication date standards: 1.1.2025
SKU: NS-1209538
The number of pages: 48
Approximate weight : 144 g (0.32 lbs)
Country: Czech technical standard
Category: Technical standards ČSN

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Annotation of standard text ČSN EN ISO 23500-2 (856214):

This document specifies requirements and recommendations for individual water treatment devices and water treatment systems assembled from one or more of such devices. This document is directed at the individual or company that specifies the complete water treatment system and, the supplier who assembles and installs the system. Since systems can be assembled from a number of individual water treatment devices, the provisions of this document are also directed at the manufacturers of these devices, provided that the manufacturer indicates that the device is intended to be used to supply water for haemodialysis and related therapies.

This document is applicable to all devices, piping and fittings between the point at which water is delivered to the water purification system and the point of use of the purified water. Such components include but are not necessarily limited to water purification devices, online water quality monitors (such as conductivity monitors) and piping systems for the distribution of purified water.

This document does not apply to

- equipment used in the preparation of concentrates from powder or other highly concentrated media at a dialysis facility either for a single patient or multiple patients,

- 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 or haemofiltration systems,

- systems that process dialysers for multiple uses, and

- peritoneal dialysis systems.

Requirements for the ongoing monitoring of water purity in terms of chemical and microbiological quality are given in ISO 23500-3

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