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prSSH EN ISO 23500-3:2024

Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2024)

General information

40.20     Feb 10, 2025

40.60    May 6, 2025

DPS

DPS/KT 205

European Norm

11.040.40  

Scope

This document specifies the minimum chemical and microbiological quality requirements, for water used for preparation of dialysis fluids, concentrates, and for the reprocessing of haemodialysers, together with the necessary steps to ensure conformity with the requirements. The document also provides guidance for the ongoing monitoring of the purity of such water in terms of chemical and microbiological quality.
This document is applicable to
—     water used in the preparation of dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration and the reprocessing of haemodialysers, and
—     water used in the preparation of concentrates.
This document does not apply to dialysis fluid regenerating systems.
The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are the sole responsibility of dialysis professionals.

Life cycle

PREVIOUSLY

PUBLISHED
SSH EN ISO 13959:2015

NOW

IN_DEVELOPMENT
prSSH EN ISO 23500-3:2024
40.20 DIS ballot initiated: 12 weeks
Feb 10, 2025

Related project

Adopted from EN ISO 23500-3:2024 IDENTICAL

Adopted from ISO 23500-3:2024 IDENTICAL

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