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Normas DIN – AENOR
DIN EN ISO 23500-5:2019-11

DIN EN ISO 23500-5:2019-11

Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019); German version EN ISO 23500-5:2019

Préparation et management de la qualité des liqudes d'hémodialyse et de thérapies annexes - Partie 5: Qualité des liquides de dialyse pour hémodialyse et thérapies apparentées (ISO 23500-5:2019); Version allemande EN ISO 23500-5:2019

Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und verwandte Therapien - Teil 5: Qualität von Flüssigkeiten für die Hämodialyse und verwandte Therapien (ISO 23500-5:2019); Deutsche Fassung EN ISO 23500-5:2019

Fecha:
2019-11 /Active
Equivalencias internacionales:

EN ISO 23500-5 (2019-03)

ISO 23500-5 (2019-02)

Relación con otras normas DIN:
Resumen:
This International Standard specifies minimum quality requirements for dialysis fluids used inhaemodialysis and related therapies. This International Standard includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration. This International Standard does not address the requirements for 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 prepackaged solutions, and systems and solutions for peritoneal dialysis are excluded from this International Standard.
Keywords:
Blood, Concentrates, Contamination, Dialysis, Haemodiafiltration, Haemodialysis, Liquids, Marking, Medical devices, Medical sciences, Medical technology, Purity, Quality, Quality assurance, Quality requirements, Specification (approval), Therapeutics
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