Draft Details
Designation:CSA Z23500-5:26
Source:CSA
Contact:[email protected]
Contact name:Ankita Shah
Review start date:Aug 6, 2025
Review end date:Oct 5, 2025
Categories:Health Care and Medical Devices
Contact email:angelique.coyle(at)csagroup.org
Associated materials (click link to download). You will need to be logged in to download any files:
- ISO 23500-5_2024.pdf (PDF document, 344 KB)
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Draft Scope/Description:
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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