Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies

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.