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Standard ÖNORM EN ISO 23500-5 1.10.2024 preview

ÖNORM EN ISO 23500-5

Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2024)

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STANDARD published on 1.10.2024


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The information about the standard:

Designation standards: ÖNORM EN ISO 23500-5
Publication date standards: 1.10.2024
SKU: NS-1199374
The number of pages: 21
Approximate weight : 63 g (0.14 lbs)
Country: Austrian technische Norm
Category: Technical standards ÖNORM

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Annotation of standard text ÖNORM EN ISO 23500-5 :

Dieses Dokument legt die Mindestanforderungen an die chemische und mikrobiologische Qualität von Dialysierflüssigkeiten fest, die bei der Hämodialyse und verwandten Therapien zum Einsatz kommen. Dieses Dokument ist anwendbar für: - Dialysierflüssigkeiten, die für die Hämodialyse und die Hämodiafiltration eingesetzt werden; - online-hergestellte Substitutionsflüssigkeit für die Hämodiafiltration und die Hämofiltration, basierend auf Dialysierflüssigkeit. Dieses Dokument ist nicht anwendbar für: - das Wasser und die Konzentrate oder die Ausrüstung zur Herstellung der Dialysierflüssigkeit; - Sorbent-basierte Dialysierflüssigkeits-Wiederaufbereitungssysteme, in denen kleine Volumina der Dialysierflüssigkeit wiederaufbereitet und wieder in Umlauf gebracht werden; - Systeme für die kontinuierliche Nierenersatztherapie, bei denen vorverpackte Lösungen zum Einsatz kommen; und - Systeme und Lösungen für die Peritonealdialyse. Die Anlieferung und Überwachung der Zusammensetzung der Dialysierflüssigkeiten und ihrer erlaubten Abweichungen von den Sollwerten wird durch die in IEC 60601-2-16 definierten Schutzsysteme festgelegt.

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