ISO INTERNATIONAL STANDARD 23500-1 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies Part 1: General requirements Preparation et management de la qualite des liquides d'hemodialyse etdetherapiesannexes Partie1:Exigencesgenerales Reference number IS023500-1:2019(E) ISO @IS02019 IS023500-1:2019(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 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 orIso's memberbody in the countryof therequester. ISO copyright office CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone:+41227490111 Fax:+4122749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2019- All rights reserved IS023500-1:2019(E) Contents Page Foreword ..V Introduction. .. i 1 Scope.. 1.1 General .1 1.2 Inclusions 1.3 Exclusions. .2 2 Normativereferences ..2 3 Terms and definitions ..2 4 Quality requirements .9 4.1 General 4.2 Dialysis water. 9 4.2.1 General. .9 4.2.2 Chemical contaminants indialysis water. .9 4.2.3 OrganicCarbon,pesticidesandotherchemicals ..11 4.2.4 Microbiological contaminants in dialysis water .11 4.3 Requirements forconcentrate. .12 4.3.1 Chemical and microbiological contaminants in concentrate .12 4.3.2 Water used to prepare concentrate. ..12 4.4 Requirements fordialysis fluid ..12 4.4.1 General. ..12 4.4.2 Microbiologicalrequirementsforstandarddialysisfluid .13 4.4.3 Microbiological requirements forultrapure dialysisfluid. ..13 4.4.4 Microbiologicalrequirementsforonline-prepared substitutionfluid. ..13 4.5 Record retention. ..13 5 Critical aspects of system design .14 5.1 General .14 5.2 Technical aspects. .14 5.3 Microbiological aspects .15 5.4 Environmental impact. .16 6 Validationof systemperformance .16 6.1 General .16 6.2 Validation plan .17 6.3 Installationandoperationalqualification ..17 6.4 Performance qualification. ..18 6.5 Routine surveillance and revalidation. .18 7 Quality management .19 7.1 General .19 7.2 Surveillance offluid quality .19 7.2.1 Surveillance of dialysis water quality .19 7.2.2 Surveillance of concentratequality 20 7.2.3 Surveillance of dialysis fluid quality 20 7.3 Surveillance of water treatment equipment 20 7.3.1 General 20 7.3.2 Surveillanceof sedimentfilters. 20 7.3.3 Surveillanceofcartridgefilters 21 7.3.4 Surveillance of softeners. 21 7.3.5 Surveillance of carbon media. .21 7.3.6 Surveillanceof chemical injection systems 22 7.3.7 Surveillance of reverse osmosis. .22 7.3.8 Surveillance of deionization. .24 7.3.9 Surveillanceofendotoxin-retentivefilters 24 7.4 Surveillance of dialysis water storage and distribution 24 @IS0 2019-All rights reserved iii