DIN EN ISO 23500-5:2024-09

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).