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Standard
ISO 23500-4
Second edition
Preparation and quality
2024-04
management of fluids for
haemodialysis and related
therapies —
Part 4:
Concentrates for haemodialysis and
related therapies
Préparation et management de la qualité des liquides
d'hémodialyse et de thérapies annexes —
Partie 4: Concentrés pour hémodialyse et thérapies apparentées
Reference number
ISO 23500-4:2024(en) © ISO 2024
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ISO 23500-4:2024(en)
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Published in Switzerland
© ISO 2024 – All rights reserved
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ISO 23500-4:2024(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 2
4.1 Concentrates .2
4.1.1 Physical state .2
4.1.2 Water .3
4.1.3 Bacteriology of concentrates .3
4.1.4 Endotoxin levels .3
4.1.5 Fill quantity . .3
4.1.6 Chemical grade . .3
4.1.7 Particulates .4
4.1.8 Additives — “Spikes” .4
4.1.9 Containers .4
4.1.10 Bulk-delivered concentrate .4
4.1.11 Concentrate generators .
...