EN ISO 23500-5:2019

Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)

Publication date:   Jun 17, 2019

General information

60.60 Standard published   Mar 20, 2019

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics

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Scope

This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.
This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.
This document excludes the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards.
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 are excluded from this document.

Life cycle

PREVIOUSLY

Replaces
EN ISO 11663:2015

NOW

PUBLISHED
EN ISO 23500-5:2019
60.60 Standard published
Mar 20, 2019

REVISED BY

IN_DEVELOPMENT
prEN ISO 23500-5 rev