Příprava a management kvality roztoků pro hemodialýzu a související léčebné metody - Část 5: Kvalita dialyzačních roztoků pro hemodialýzu a související léčebné metody (Norma k přímému použití jako ČSN).
NORMA vydána dne 1.10.2024
Designation standards: ČSN EN ISO 23500-5
Classification mark: 856214
Catalog number: 519713
Publication date standards: 1.10.2024
The number of pages: 28
Approximate weight : 84 g (0.19 lbs)
Country: Czech technical standard
Kategorie: Technické normy ČSN
This document specifies the minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies.
This document applies to
- dialysis fluids used for haemodialysis and haemodiafiltration,
- substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid
This document does not apply to
- the water and concentrates used to prepare dialysis fluid or the equipment to produce dialysis fluid
- 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.
The delivery and monitoring of the dialysis fluid composition and its permitted deviation from set points is governed by protective systems defined in IEC 60601-2-16