EN ISO 23500-3:2024
(Main)Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (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)
This document specifies the minimum chemical and microbiological quality requirements, for water used for preparation of dialysis fluids, concentrates, and for the reprocessing of haemodialysers, together with the necessary steps to ensure conformity with the requirements. The document also provides guidance for the ongoing monitoring of the purity of such water in terms of chemical and microbiological quality.
This document is applicable to
— water used in the preparation of dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration and the reprocessing of haemodialysers, and
— water used in the preparation of concentrates.
This document does not apply to dialysis fluid regenerating systems.
The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are the sole responsibility of dialysis professionals.
Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und verwandte Therapien - Teil 3: Wasser für die Hämodialyse und verwandte Therapien (ISO 23500-3:2024)
Dieses Dokument legt die Mindestanforderungen an die chemische und mikrobiologische Qualität von Wasser fest, das für die Zubereitung von Dialysierflüssigkeiten und -konzentraten sowie für die Wiederaufbereitung von Hämodialysatoren verwendet wird, sowie die notwendigen Schritte, um die Einhaltung der Anforderungen zu gewährleisten. Das Dokument gibt auch einen Leitfaden für die laufende Überwachung der Reinheit dieses Wassers in Bezug auf die chemische und mikrobiologische Qualität.
Dieses Dokument ist anwendbar für
- Wasser für die Zubereitung von Dialysierflüssigkeiten für die Hämodialyse, Hämodiafiltration und Hämofiltration sowie für die Wiederaufbereitung von Hämodialysatoren, und
- Wasser, das zur Herstellung von Konzentraten verwendet wird.
Dieses Dokument ist nicht anwendbar für Systeme zur Regeneration von Dialysierflüssigkeit.
Der Betrieb von Wasseraufbereitungsanlagen und die abschließende Vermischung von behandeltem Wasser mit Konzentraten zur Herstellung von Dialysierflüssigkeit liegen in der alleinigen Verantwortung der Dialysefachkräfte.
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes - Partie 3: Eau pour hémodialyse et thérapies apparentées (ISO 23500-3:2024)
Le présent document spécifie les exigences minimales de qualité chimique et microbiologique applicables à l’eau utilisée pour la préparation des liquides de dialyse et des concentrés, ainsi que le traitement des hémodialyseurs. Il décrit également les étapes nécessaires pour garantir la conformité aux exigences. Le document fournit en outre des recommandations pour la surveillance continue de la pureté de cette eau à l’égard de la qualité chimique et microbiologique.
Le présent document est applicable à ce qui suit:
— l’eau utilisée pour la préparation des liquides de dialyse pour hémodialyse, hémodiafiltration et hémofiltration, ainsi que pour le retraitement des hémodialyseurs; et
— l’eau utilisée pour la préparation des concentrés.
Le présent document ne concerne pas les systèmes de régénération des liquides de dialyse.
Le fonctionnement de l’équipement de traitement de l’eau et le mélange final de l’eau traitée avec les concentrés pour produire le liquide de dialyse relèvent de l’entière responsabilité des néphrologues.
Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 3. del: Voda za hemodializo in podobne terapije (ISO 23500-3:2024)
Ta dokument določa minimalne zahteve glede vode, uporabljene pri hemodializi in podobnih terapijah.
Ta dokument zajema vodo za pripravo koncentratov, dializnih tekočin za hemodializo, hemodiafiltracijo in hemofiltracijo ter ponovno obdelavo v hemodializatorjih.
Ta dokument ne zajema postopka uporabe opreme za pripravo vode in končno mešanje pripravljene vode s koncentrati za proizvodnjo dializne tekočine. Za takšne postopke so izključno odgovorni strokovnjaki za dializo. Ta dokument se ne uporablja za sisteme za regeneracijo dializne tekočine.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2024
Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 3. del:
Voda za hemodializo in podobne terapije (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)
Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und
verwandte Therapien - Teil 3: Wasser für die Hämodialyse und verwandte Therapien
(ISO 23500-3:2024)
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies
annexes - Partie 3: Eau pour hémodialyse et thérapies apparentées (ISO 23500-3:2024)
Ta slovenski standard je istoveten z: EN ISO 23500-3:2024
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 23500-3
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2024
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 23500-3:2019
English Version
Preparation and quality management of fluids for
haemodialysis and related therapies - Part 3: Water for
haemodialysis and related therapies (ISO 23500-3:2024)
Préparation et management de la qualité des liquides Herstellung und Qualitätsmanagement von
d'hémodialyse et de thérapies annexes - Partie 3: Eau Flüssigkeiten für die Hämodialyse und verwandte
pour hémodialyse et thérapies apparentées (ISO Therapien - Teil 3: Wasser für die Hämodialyse und
23500-3:2024) verwandte Therapien (ISO 23500-3:2024)
This European Standard was approved by CEN on 18 April 2024.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
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
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
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, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23500-3:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 23500-3:2024) has been prepared by Technical Committee ISO/TC 150
"Implants for surgery" in collaboration with Technical Committee CEN/TC 205 “Non-active medical
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 October 2024, and conflicting national standards shall
be withdrawn at the latest by October 2024.
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 ISO 23500-3:2019.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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,
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 23500-3:2024 has been approved by CEN as EN ISO 23500-3:2024 without any
modification.
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
ISO 23500-3:2024(en)
© 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.
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
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
iii
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 Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 2, Cardiovascular implants and extracorporeal systems, in collaboration with the European Committee for
Standardization (CEN) Technical Committee CEN/TC 205, Non-active medical devices, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 23500-3:2019), which has been technically
revised.
The main changes are as follows:
— the use of WHO Drinking Water Guideline as the drinking water quality reference has replaced the
previously used EPA Water quality requirements;
— thallium has been removed from the list of contaminants of other trace elements in dialysis water as no
published study reports that this contaminant is of particular concern in the setting of haemodialysis;
— alternatives to classic microbial analytical methods (endotoxin testing using recombinant Factor C [rFC])
have been incorporated.
A list of all parts in the ISO 23500 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO 23500-3:2024(en)
Introduction
Assurance of adequate water quality is one of the most important aspects of ensuring a safe and effective
delivery of haemodialysis, haemodiafiltration or haemofiltration.
This document contains the minimum chemical and microbiological requirements for the water to be used
for preparation of dialysis fluids and concentrates, and for the reprocessing of haemodialysers and the
necessary steps to ensure conformity with those requirements.
Haemodialysis and related therapies such as haemodiafiltration can expose the patient to more than
500 l of water per week across the semi-permeable membrane of the haemodialyser or haemodiafilter.
Healthy individuals seldom have a weekly oral intake above 12 l. This over 40-fold increase in exposure
requires control and regular surveillance of water quality to avoid excesses of known or suspected harmful
substances. Since knowledge of potential injury from trace elements and contaminants of microbiological
origin over long periods is still growing and techniques for treating drinking wate
...
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