NF EN ISO 23500-3

NF EN ISO 23500-3

March 2019
Standard Cancelled

Preparation and quality management of fluids for haemodialysis and related therapies - Part 3 : water for haemodialysis and related therapies

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.

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Main informations

Collections

National standards and national normative documents

Publication date

March 2019

Number of pages

28 p.

Reference

NF EN ISO 23500-3

ICS Codes

11.040.20   Transfusion, infusion and injection equipment
11.040.40   Implants for surgery, prosthetics and orthotics
11.040.60   Therapy equipment

Classification index

S93-305-3

Print number

1

International kinship

ISO 23500-3:2019

European kinship

EN ISO 23500-3:2019
Sumary
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3 : water for haemodialysis and related therapies

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.

Replaced standards (1)
NF EN ISO 13959
February 2016
Standard Cancelled
Water for haemodialysis and related therapies

ISO 13959:2014 specifies minimum requirements for water to be used in haemodialysis and related therapies. ISO 13959:2014 includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.

Standard replaced by (1)
NF EN ISO 23500-3
April 2024
Standard Current
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3 : water for haemodialysis and related therapies

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.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences
  • 5 Essais relatifs aux exigences microbiologiques et chimiques
  • Annex A Justification de l'élaboration et des dispositions du présent document
  • Bibliographie
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