NF EN ISO 23500-5

NF EN ISO 23500-5

March 2019
Standard Current

Preparation and quality management of fluids for haemodialysis and related therapies - Part 5 : quality of dialysis fluid for haemodialysis and related therapies

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.

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Main informations

Collections

National standards and national normative documents

Publication date

March 2019

Number of pages

24 p.

Reference

NF EN ISO 23500-5

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

S93-305-5

Print number

1

International kinship

ISO 23500-5:2019

European kinship

EN ISO 23500-5:2019
Sumary
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5 : quality of dialysis fluid for haemodialysis and related therapies

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.

Replaced standards (1)
NF EN ISO 11663
December 2015
Standard Cancelled
Quality of dialysis fluid for haemodialysis and related therapies

<p>ISO 11663:2014 specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.</p> <p>ISO 11663:2014 includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.</p>

Table of contents
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  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences
  • 5 Essais de conformité aux exigences microbiologiques
  • Annexe A (informative) Justification de l'élaboration et des dispositions du présent document
  • Annexe B (informative) Tableaux de référence
  • Bibliographie
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