ISO 23500-3:2024

Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies

ISO 23500-3:2024

Name:ISO 23500-3:2024   Standard name:Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
Standard number:ISO 23500-3:2024   language:English language
Release Date:16-Apr-2024   technical committee:ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems
Drafting committee:ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems   ICS number:11.040.40 - Implants for surgery, prosthetics and orthotics
International
Standard
ISO 23500-3
Second edition
Preparation and quality
2024-04
management of fluids for
haemodialysis and related
therapies —
Part 3:
Water for haemodialysis and related
therapies
Préparation et management de la qualité des liquides
d'hémodialyse et de thérapies annexes —
Partie 3: Eau pour hémodialyse et thérapies apparentées
Reference number
ISO 23500-3:2024(en) © ISO 2024

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ISO 23500-3:2024(en)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Email: [email protected]
Website: www.iso.org
Published in Switzerland

© ISO 2024 – All rights reserved
ii

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ISO 23500-3:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 Dialysis water quality requirements .2
4.2 Chemical contaminant requirements.2
4.2.1 General .2
4.2.2 Organic carbon, pesticides and other chemicals .4
4.3 Dialysis water microbiological requirements .4
5 Tests for microbiological and chemical requirements . 4
5.1 Dialysis water microbiology .4
5.2 Microbial contaminant test methods .4
5.3 Chemical contaminants test methods .6
Annex A (informative) Rationale for the development and provisions of this document . 8
Bibliography .16

© ISO 2024 – All rights reserved
iii

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ISO 23500-3:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Stan
...

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