ISO INTERNATIONAL STANDARD 23500-2 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies Preparation et management de la qualite des liquides d'hemodialyse etdetherapiesannexes- Partie 2: Equipement de traitement de I'eau pour des applications en hemodialyseet aux therapies apparentées Reference number IS023500-2:2019(E) Tso @ ISO 2019 IS023500-2:2019(E) COPYRIGHTPROTECTEDDOCUMENT ISO2019 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 anyform or by any means, electronic or mechanical, including photocopying,or posting beloworIso'smemberbodyinthecountryoftherequester ISO copyright office CP 401: Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone:+41227490111 Fax:+41227490947 Email:
[email protected] Website: www.iso.org Published in Switzerland ii IS0 2019-All rights reserved IS023500-2:2019(E) Contents Page Foreword .. Introduction 1 Scope... ..1 1.1 General 1 1.2 Inclusions 1.3 Exclusions. 1 2 Normative references .1 3 Terms and definitions .2 4 Requirements .2 4.1 Dialysis water quality requirements .2 4.1.1 General. .2 4.1.2 Chemical contaminantrequirements 2 4.1.3 OrganicCarbon,pesticidesandotherchemicals 3 4.1.4 Microbiologyofdialysiswater 3 4.2 Watertreatmentequipmentrequirements 4 4.2.1 General. .4 4.2.2 Backflowpreventiondevice 5 4.2.3 Temperingvalves 55 4.2.4 Sedimentfilters 4.2.5 Cartridge filters 5 4.2.6 Softeners.. 5 4.2.7 Anion exchange resin tank 5 4.2.8 Carbonmedia. 5 4.2.9 Chemical injection systems 7 4.2.10 Reverseosmosis 7 4.2.11 Deionization .8 4.2.12 Bacteriaand endotoxinretentivefilters 8 4.2.13 Storageand distribution of dialysis water .8 5 Testing. ..10 5.1 Conformitywithdialysiswaterqualityrequirements .10 5.1.1 General ..10 5.1.2 Microbiology of dialysis water. .10 5.1.3 Maximumlevelofchemicalcontaminants ..11 5.2 Conformitywithwatertreatmentequipmentrequirements .12 5.2.1 General. 5.2.2 Backflowpreventiondevices .13 5.2.3 Tempering valves ..13 5.2.4 Sedimentfilters 13 5.2.5 Cartridge filters .13 5.2.6 Softeners ..13 5.2.7 Anionexchangeresintanks .13 5.2.8 Carbonmedia. .13 5.2.9 Chemical injectionsystems. .14 5.2.10 Reverse osmosis .14 5.2.11 Deionization .14 5.2.12 Endotoxinretentivefilters ..14. 5.2.13 Storageand distributionofdialysiswater .14 6 Labelling ..15 6.1 General 6.2 Devicemarkings ..15 6.3 Productliterature ..15 AnnexA(informative)Rationaleforthedevelopmentandprovisions ofthisdocument .18 @IS0 2019-All rights reserved ili
ISO 23500-2 2019 Preparation and quality management of fluids for haemodialysis and related therapies — Part 2 Water treatment equipment for haemodialysis applications and related therapies
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