DIN Standards Committee Health Technologies
DIN 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); German version EN ISO 23500-5:2024
Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und verwandte Therapien - Teil 5: Qualität von Flüssigkeiten für die Hämodialyse und verwandte Therapien (ISO 23500-5:2024); Deutsche Fassung EN ISO 23500-5:2024
Overview
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. These aspects 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 pre-packaged solutions, and - systems and solutions for peritoneal dialysis are excluded from the scope of this document. The responsible national standardization committee is Working Committee NA 176-04-06 AA "Extrakorporaler Kreislauf, Apparate und Einmalartikel" ("Extracorporeal circuits, equipment and disposables") at DIN Standards Committee Health Technologies (NAGesuTech).
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-04-06 AA - Extracorporeal circuits, equipment and disposables
Responsible european committee
CEN/TC 205 - Non-active medical devices
Responsible international committee
ISO/TC 150/SC 2/WG 5 - Renal replacement, detoxification and apheresis
