Approved Work Item
ISO/AWI 23500-5
Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
Reference number
ISO/AWI 23500-5
Edition 3
© ISO 2025
Approved Work Item
Under development
A working group has prepared a draft.
Will replace ISO 23500-5:2024

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.

General information

  • Status
     : Under development
    Stage
    : New project registered in TC/SC work programme [20.00]
  • Edition
     : 3
  • Technical Committee :
    ISO/TC 150/SC 2
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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