DIN Standards Committee Health Technologies
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
Abstract
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.
Begin
2025-03-05
WI
00205420
Planned document number
prEN ISO 23500-5 rev
Responsible national committee
NA 176-04-06 AA - Extracorporeal circuits, equipment and disposables
Responsible european committee
CEN/TC 205 - Non-active medical devices
