EN ISO 23500:2015

Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014) EN ISO 23500:2015

Publication date:   Dec 15, 2015

General information

99.60 Withdrawal effective   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

ISO 23500:2014 provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, ISO 23500:2014 functions as a recommended practice.
ISO 23500:2014 addresses the user's responsibility for the dialysis fluid once the equipment used in its preparation has been delivered and installed. For the purposes of ISO 23500:2014, the dialysis fluid includes dialysis water used for the preparation of dialysis fluid and substitution fluid, dialysis water used for the preparation of concentrates at the user's facility, as well as concentrates and the final dialysis fluid and substitution fluid.

Life cycle

NOW

WITHDRAWN
EN ISO 23500:2015
99.60 Withdrawal effective
Mar 20, 2019

REVISED BY

WITHDRAWN
EN ISO 23500-1:2019

Relations

Adopted from ISO 23500:2014 IDENTICAL