ISO 23500-5:2024

International Standard   Current Edition · Approved on 17 April 2024

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 Files

English 12 Pages
Current Edition
28.76 OMR

ISO 23500-5:2024 Scope

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.

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