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ILNAS-EN ISO 23500-5:2019 Edition 03/2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)
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Abstract

This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies. This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration. This document excludes the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards. Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis are excluded from this document.

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)    30/06/2019
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 23500-5

Relations to older standards
ILNAS-EN ISO 11663:2015

Relations to international standards
ISO 23500-5 
ISO 23500-5:2019 

International Classification for Standards (ICS codes) :

11.040.40 : Implants for surgery, prosthetics and orthotics

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