NF EN ISO 11663

NF EN ISO 11663

December 2015
Standard Cancelled

Quality of dialysis fluid for haemodialysis and related therapies

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

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Main informations

Collections

National standards and national normative documents

Publication date

December 2015

Number of pages

27 p.

Reference

NF EN ISO 11663

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S93-304

Print number

1

International kinship

European kinship

EN ISO 11663:2015
Sumary
Quality of dialysis fluid for haemodialysis and related therapies

ISO 11663:2014 specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.

ISO 11663:2014 includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.

Standard replaced by (1)
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

<p>This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.</p> <p>This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.</p> <p>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.</p> <p>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.</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 de la présente Norme internationale
  • Annexe B (informative) Tableaux de référence extraits de l'ISO
    13959
  • 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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