EN IS0 23500-1 EUROPEAN STANDARD NORME EUROPEENNE EUROPAISCHE NORM September 2024 ICS 11.040.40 Supersedes EN IS0 23500-1:2019 English Version Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (IS0 23500-1:2024) Preparation et management de la qualite des liquides Herstellung und Qualitatsmanagement von Fliussigkeiten fur die Hamodialyse und verwandte d'hémodialyse et dethérapies annexes -Partie 1: Exigences genérales (IS0 23500-1:2024) Therapien - Teil 1: Allgemeine Anforderungen (ISO 23500-1:2024) This European Standard was approved by CEN on 17 May 2024. CENmembersareboundto complywiththeCEN/CENELECInternal Regulations which stipulatetheconditionsforgivingthis European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkiye and United Kingdom. cer EUROPEAN COMMITTEEFOR STANDARDIZATION COMITEEUROPEENDENORMALISATION EUROPAISCHESKOMITEEFURNORMUNG CEN-CENELECManagementCentre:RuedelaScience23,B-1040Brussels All rights of exploitation in any form and by any means reserved 2024CEN Ref. No. EN IS0 23500-1:2024 E worldwide for CEN national Members. EN IS0 23500-1:2024 (E) Contents Page 2 EN IS0 23500-1:2024 (E) European foreword This document (EN IS0 23500-1:2024) has been prepared by Technical Committee IS0/TC 150 devices" the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2025, and conflicting national standards shall be withdrawn at the latest by March 2025. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN IS0 23500-1:2019. Any feedback and questions on this document should be directed to the users' national standards body/nationalcommittee.AcompletelistingofthesebodiescanbefoundontheCENwebsite According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkiye and the United Kingdom. Endorsement notice The text of IS0 23500-1:2024 has been approved by CEN as ENIS0 23500-1:2024 without any modification. 3