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ISO 23500-2:2024

Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies
25 korr 2024

General information

60.60     25 korr 2024

ISO

ISO/TC 150/SC 2

International Standard

11.040.40  

anglisht   frëngjisht  

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 23500-2:2019

NOW

PUBLISHED
ISO 23500-2:2024
60.60 Standard published
25 korr 2024

REVISED BY

IN_DEVELOPMENT
ISO/AWI 23500-2

National adoptions

Përgatitja dhe menaxhimi i cilësisë së lëngjeve për hemodializën dhe terapive që lidhen me të - Pjesa 2: Pajisje për trajtimin e ujit për proceset e hemodializës dhe terapive që lidhen me të (ISO 23500-2:2024)

40.20 DIS ballot initiated: 12 weeks

DPS/KT 205 më tepër