NA 176

DIN Standards Committee Health Technologies

Project

Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2024); German version EN ISO 23500-1:2024

Abstract

This document specifies the general requirements for the preparation of fluids for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration, for dialysis practitioners. This document gives guidance on the user's responsibility for fluids used in haemodialysis and related therapies once the equipment used in its preparation has been delivered and installed. As dialysis water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document.

Begin

2025-11-28

Planned document number

DIN EN ISO 23500-1 Berichtigung 1

Project number

17600159

Responsible national committee

NA 176-04-06 AA - Extracorporeal circuits, equipment and disposables  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 150/SC 2/WG 5 - Renal replacement, detoxification and apheresis  

previous edition(s)

Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2024); German version EN ISO 23500-1:2024
2025-03

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Contact

Dipl.-Ing. (FH)

Petra Bischoff

Alexander-Wellendorff-Str. 2
75172 Pforzheim

Tel.: +49 7231 9188-31
Fax: +49 7231 9188-33

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