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ISO 23500-5:2024

Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
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ISO 23500-5:2024

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

PUBLISH DATE 2024
ISO 23500-5:2024

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.

SDO ISO: International Organization for Standardization
Document Number ISO 23500
Publication Date April 1, 2024
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 150/SC 2
Publish Date Document Id Type View
April 1, 2024 ISO 23500-5:2024 Revision