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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

Publication date:   Apr 17, 2024

General information

60.60 Standard published   Apr 17, 2024

ISO

ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems

International Standard

11.040.40   Implants for surgery, prosthetics and orthotics

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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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 23500-5:2019

NOW

PUBLISHED
ISO 23500-5:2024
60.60 Standard published
Apr 17, 2024

REVISED BY

IN_DEVELOPMENT
ISO/PWI 23500-5