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ILNAS-EN ISO 23500-3:2019 Edition 03/2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019)
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Abstract

This document specifies minimum requirements for water to be used in haemodialysis and related therapies. This document includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers. This document excludes the operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid. Those operations are the sole responsibility of dialysis professionals. This document does not apply to dialysis fluid regenerating systems.

Status

Standard - Active

Origin

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

Implementation

start of the vote on the project    13/04/2017   date of ratification (dor)    14/01/2019
end of the vote on the project    30/06/2017   date of anouncement (doa)    20/06/2019
start of the vote on the final project    18/10/2018   date of publication (dop)    30/09/2019
end of the vote on the final project    14/12/2018   date of withdrawal (dow)    30/09/2019


Publication Official Journal
of the Grand-Duchy of Luxembourg
24/04/2019
Reference Mémorial A N° 267

Relations

Evolutions
FprEN ISO 23500-3

Relations to older standards
ILNAS-EN ISO 13959:2015

Relations to international standards
ISO 23500-3 
ISO 23500-3:2019 

International Classification for Standards (ICS codes) :

11.040.40 : Implants for surgery, prosthetics and orthotics

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