NF EN ISO 11663
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.
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.
<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>
- Avant-propos
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1 Domaine d'application
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2 Références normatives
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3 Termes et définitions
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4 Exigences
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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'ISO13959
- 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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