ISO 23500-3:2024
(Main)Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
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.
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes — Partie 3: Eau pour hémodialyse et thérapies apparentées
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.
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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
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ISO 23500-3:2024(en)
COPYRIGHT PROTECTED DOCUMENT
© 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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2024 – All rights reserved
ii
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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
© ISO 2024 – All rights reserved
iii
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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 Stan
...
Norme
internationale
ISO 23500-3
Deuxième édition
Préparation et management de la
2024-04
qualité des liquides d'hémodialyse
et de thérapies annexes —
Partie 3:
Eau pour hémodialyse et thérapies
apparentées
Preparation and quality management of fluids for haemodialysis
and related therapies —
Part 3: Water for haemodialysis and related therapies
Numéro de référence
ISO 23500-3:2024(fr) © ISO 2024
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ISO 23500-3:2024(fr)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2024
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
© ISO 2024 – Tous droits réservés
ii
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ISO 23500-3:2024(fr)
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Exigences . 2
4.1 Exigences de qualité relatives à l’eau de dialyse .2
4.2 Exigences relatives aux contaminants chimiques .2
4.2.1 Généralités .2
4.2.2 Carbone organique, pesticides et autres substances chimiques .4
4.3 Exigences microbiologiques relatives à l’eau de dialyse .4
5 Essais relatifs aux exigences microbiologiques et chimiques . 4
5.1 Microbiologie de l’eau de dialyse .4
5.2 Méthodes d’essai des contaminants microbiens .4
5.3 Méthodes d’essai des contaminants chimiques .6
Annexe A (informative) Justification de l’élaboration et des dispositions du présent document . 8
Bibliographie . 17
© ISO 2024 – Tous droits réservés
iii
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ISO 23500-3:2024(fr)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes nationaux
de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est en général
confiée aux comités techniques de l’ISO. Chaque comité membre intéressé
...
FINAL DRAFT
International
Standard
ISO/FDIS 23500-3
ISO/TC 150/SC 2
Preparation and quality
Secretariat: ANSI
management of fluids for
Voting begins on:
haemodialysis and related
2024-01-19
therapies —
Voting terminates on:
2024-03-15
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
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 23500-3:2024(en) © ISO 2024
---------------------- Page: 1 ----------------------
FINAL DRAFT
ISO/FDIS 23500-3:2024(en)
International
Standard
ISO/FDIS 23500-3
ISO/TC 150/SC 2
Preparation and quality
Secretariat: ANSI
management of fluids for
Voting begins on:
haemodialysis and related
therapies —
Voting terminates on:
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
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
COPYRIGHT PROTECTED DOCUMENT
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 23500-3:2023(en) © ISO 2023
© ISO 2024 – All rights reserved
ii
---------------------- Page: 2 ----------------------
ISO/FDIS 23500-3:2023(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 .
...
ISO/DIS FDIS 23500--3:2023(E)
ISO/TC 150/SC 2
Secretariat: ANSI
Preparation and quality 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
Second edition
Date: 2023-01-2312-12
---------------------- Page: 1 ----------------------
ISO/FDIS 23500-3:2023(E)
© ISO 2023
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.
ISO Copyright Office
CP 401 • CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland.
ii © ISO 2023 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 23500-3:2023(E)
Table of Contents
Foreword . 4
Introduction . 6
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 . 3
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
© ISO 2023 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/FDIS 23500-3:2023(E)
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 documentsdocument sho
...
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