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ILNAS-EN ISO 23500-3:2024 Edition 04/2024
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2024)
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Abstract

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.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 205 : Non-active medical devices

Implementation

start of the vote on the project    17/11/2022   date of ratification (dor)    18/04/2024
end of the vote on the project    10/02/2023   date of anouncement (doa)    31/07/2024
start of the vote on the final project    18/01/2024   date of publication (dop)    31/10/2024
end of the vote on the final project    15/03/2024   date of withdrawal (dow)    31/10/2024


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

Relations to older standards
ILNAS-EN ISO 23500-3:2019

Relations to international standards
ISO 23500-3 
ISO 23500-3:2024 

International Classification for Standards (ICS codes) :

11.040.40 : Implants for surgery, prosthetics and orthotics

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