NF EN ISO 13959

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.

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Main informations

Collections

National standards and national normative documents

Publication date

February 2016

Number of pages

30 p.

Reference

NF EN ISO 13959

ICS Codes

11.040.20   Transfusion, infusion and injection equipment
11.040.60   Therapy equipment

Classification index

S93-307

Print number

1

International kinship

ISO 13959:2014

European kinship

EN ISO 13959:2015
Sumary
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
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.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Termes et définitions
  • 3 Exigences relatives à l'eau de dialyse
  • 4 Essais de conformité aux exigences microbiologiques et chimiques
  • Annexe A(informative) Justification de l'élaboration et des dispositions de la présente Norme internationale
  • Annexe ZA(informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive européenne 93/42/CEE relative aux dispositifs médicaux
  • Bibliographie
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