EN ISO 23500-2:2024
(Main)Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2024)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2024)
This document specifies requirements and recommendations for individual water treatment devices and water treatment systems assembled from one or more of such devices. This document is directed at the individual or company that specifies the complete water treatment system and, the supplier who assembles and installs the system. Since systems can be assembled from a number of individual water treatment devices, the provisions of this document are also directed at the manufacturers of these devices, provided that the manufacturer indicates that the device is intended to be used to supply water for haemodialysis and related therapies.
This document is applicable to all devices, piping and fittings between the point at which water is delivered to the water purification system and the point of use of the purified water. Such components include but are not necessarily limited to water purification devices, online water quality monitors (such as conductivity monitors) and piping systems for the distribution of purified water.
This document does not apply to
— equipment used in the preparation of concentrates from powder or other highly concentrated media at a dialysis facility either for a single patient or multiple patients,
— dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid,
— sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid,
— dialysis concentrates,
— haemodiafiltration or haemofiltration systems,
— systems that process dialysers for multiple uses, and
— peritoneal dialysis systems.
Requirements for the ongoing monitoring of water purity in terms of chemical and microbiological quality are given in ISO 23500-3.
Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und verwandte Therapien - Teil 2: Ausstattung zur Wasseraufbereitung zur Verwendung in der Hämodialyse und in verwandten Therapien (ISO 23500‑2:2024)
Dieses Dokument legt Empfehlungen und Anforderungen für einzelne Wasseraufbereitungsgeräte und Wasseraufbereitungssysteme fest, die aus einem oder mehreren dieser Geräte zusammengesetzt sind. Das Dokument richtet sich an die Person oder Firma, die das komplette Wasseraufbereitungssystem spezifiziert, und an den Lieferanten, der das System zusammenbaut und installiert. Da Systeme aus einer Reihe von einzelnen Wasseraufbereitungsgeräten zusammengesetzt werden können, richten sich die Bestimmungen dieses Dokuments auch an die Hersteller dieser Geräte, sofern der Hersteller angibt, dass das Gerät für die Bereitstellung von Wasser für die Hämodialyse und verwandte Therapien bestimmt ist.
Dieses Dokument ist anwendbar für alle Geräte, Rohrleitungen und Armaturen zwischen dem Punkt, an dem das Wasser in das Wasseraufbereitungssystem eingespeist wird, und dem Punkt, an dem das gereinigte Wasser verwendet wird. Solche Komponenten sind u. a. Wasseraufbereitungsgeräte, Online-Wasserqualitätsmonitore (z. B. Leitfähigkeitsmonitore) und Rohrleitungssysteme für die Verteilung von gereinigtem Wasser, sind aber nicht unbedingt darauf beschränkt.
Dieses Dokument ist nicht anwendbar für
- Geräte, die in einer Dialyseeinrichtung für die Zubereitung von Konzentraten aus Pulver oder anderen hochkonzentrierten Medien für einen einzelnen oder mehrere Patienten verwendet werden,
- Versorgungssysteme für Dialyseflüssigkeit, die Wasser und Konzentrate zur Herstellung von Dialyseflüssigkeit mischen,
- Systeme zur Regeneration von Dialysierflüssigkeit mit Sorbenzien, welche geringe Mengen der Dialysierflüssigkeit regenerieren und wieder in den Kreislauf zurückführen,
- Dialysekonzentrate,
- Hämodiafiltrations- oder Hämofiltrationssysteme,
- Systeme, die Dialysatoren für die Mehrfachverwendung aufbereiten,
- Peritonealdialysesysteme.
Anforderungen an die laufende Überwachung der Reinheit des Wassers in Bezug auf die chemische und mikrobiologische Qualität sind in ISO 23500 3 enthalten.
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes - Partie 2: Équipement de traitement de l'eau pour des applications en hémodialyse et aux thérapies apparentées (ISO 23500-2:2024)
Le présent document spécifie des exigences et des recommandations concernant les dispositifs de traitement d’eau individuels et les systèmes de traitement d’eau assemblés à partir d’un ou de plusieurs de ces dispositifs. Le présent document s’adresse à la personne ou à la société qui spécifie l’ensemble du système de traitement d’eau, ainsi qu’au fournisseur qui assemble et installe le système. Comme les systèmes peuvent être assemblés à partir de dispositifs de traitement d’eau individuels, les dispositions du présent document s’adressent également aux fabricants desdits dispositifs, à condition que le fabricant indique que le dispositif est destiné à servir à fournir de l’eau pour l’hémodialyse et les thérapies apparentées.
Le présent document s’applique à tous les dispositifs, tuyauteries et raccords situés entre le point de distribution de l’eau au système de purification d’eau et le point d’utilisation de l’eau purifiée. Ces composants incluent, sans nécessairement s’y limiter, les dispositifs de purification d’eau, les dispositifs de surveillance de la qualité de l’eau en ligne (comme les dispositifs de surveillance de la conductivité) et les systèmes de canalisations d’alimentation en eau purifiée.
Le présent document ne s’applique pas:
— aux équipements utilisés pour préparer des concentrés à partir d’une poudre ou d’autres milieux hautement concentrés dans un centre de dialyse, que ce soit pour un seul patient ou plusieurs patients;
— aux systèmes d’alimentation en liquide de dialyse qui mélangent de l’eau et des concentrés pour produire le liquide de dialyse;
— aux systèmes de régénération de liquide de dialyse sur sorbant qui régénèrent et recyclent de petites quantités de liquide de dialyse;
— aux concentrés de dialyse;
— aux systèmes d’hémodiafiltration ou d’hémofiltration;
— aux systèmes de traitement des hémodialyseurs réutilisables; et
— aux systèmes de dialyse péritonéale.
Les exigences relatives à la surveillance continue de la pureté de l’eau en matière de qualité chimique et microbiologique sont énoncées dans l’ISO 23500-3.
Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 2. del: Oprema za pripravo vode za uporabo pri hemodializi in podobnih terapijah (ISO 23500-2:2024)
1.1 Splošno
Ta dokument je namenjen proizvajalcem in/ali dobaviteljem sistemov in/ali naprav za pripravo vode, ki se uporabljajo izključno za zagotavljanje vode za hemodializo ali podobne terapije.
1.2 Vključitve
Ta dokument zajema naprave za pripravo pitne vode, namenjene za uporabo pri izvajanju hemodialize in podobnih terapij, vključno z vodo, ki se uporablja za:
a) pripravo koncentratov iz prahu ali drugih visoko koncentriranih medijev v dializni opremi;
b) pripravo dializne tekočine, vključno z dializno tekočino, ki jo je mogoče uporabiti za pripravo nadomestne tekočine;
c) predelavo dializatorjev za enkratno uporabo v dializatorje za večkratno uporabo, kjer je to dovoljeno;
d) predelavo dializatorjev, ki niso posebej označeni za enkratno uporabo.
Ta dokument vključuje vse naprave, cevovode in priključke med točko dovajanja pitne vode v sistem za pripravo vode in točko uporabe dializne vode. Primeri takšnih naprav so naprave za čiščenje vode, naprave za nadzor kakovosti vode (npr. naprave za nadzor prevodnosti) in cevni sistemi za distribucijo dializne vode.
1.3 Izključitve
Ta dokument ne vključuje sistemov za oskrbo z dializno tekočino, ki usklajujejo delež vode in koncentratov za proizvodnjo dializne tekočine, sistemov za regeneracijo sorbentne dializne tekočine, ki regenerirajo in recirkulirajo majhne količine dializne tekočine, dializnih koncentratov, sistemov za hemodiafiltracijo, sistemov za hemofiltracijo, sistemov za obdelavo dializatorjev za večkratno uporabo ter sistemov za peritonealno dializo. Nekatere od teh naprav, kot so sistemi za dovajanje dializne tekočine in koncentrati, so obravnavane v drugih dokumentih, npr. v standardih ISO 23500-4 in ISO 23500-5.
Ta dokument prav tako ne vključuje stalnega nadzora čistosti vode, ki se uporablja za dializno tekočino, pripravo koncentratov ali predelavo dializatorjev; to je obravnavano v standardu ISO 23500-1.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2024
Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 2. del:
Oprema za pripravo vode za uporabo pri hemodializi in podobnih terapijah (ISO
23500-2:2024)
Preparation and quality management of fluids for haemodialysis and related therapies -
Part 2: Water treatment equipment for haemodialysis applications and related therapies
(ISO 23500-2:2024)
Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und
verwandte Therapien - Teil 2: Ausstattung zur Wasseraufbereitung zur Verwendung in
der Hämodialyse und in verwandten Therapien (ISO 23500-2:2024)
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies
annexes - Partie 2: Équipement de traitement de l'eau pour des applications en
hémodialyse et aux thérapies apparentées (ISO 23500-2:2024)
Ta slovenski standard je istoveten z: EN ISO 23500-2:2024
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 23500-2
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2024
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 23500-2:2019
English Version
Preparation and quality management of fluids for
haemodialysis and related therapies - Part 2: Water
treatment equipment for haemodialysis applications and
related therapies (ISO 23500-2:2024)
Préparation et management de la qualité des liquides Herstellung und Qualitätsmanagement von
d'hémodialyse et de thérapies annexes - Partie 2: Flüssigkeiten für die Hämodialyse und verwandte
Équipement de traitement de l'eau pour des Therapien - Teil 2: Ausstattung zur
applications en hémodialyse et aux thérapies Wasseraufbereitung zur Verwendung in der
apparentées (ISO 23500-2:2024) Hämodialyse und in verwandten Therapien (ISO
23500-2:2024)
This European Standard was approved by CEN on 23 May 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 23500-2:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 23500-2:2024) 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 January 2025, and conflicting national standards shall
be withdrawn at the latest by January 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 ISO 23500-2:2019.
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 23500-2:2024 has been approved by CEN as EN ISO 23500-2:2024 without any
modification.
International
Standard
ISO 23500-2
Second edition
Preparation and quality
2024-07
management of fluids for
haemodialysis and related
therapies —
Part 2:
Water treatment equipment for
haemodialysis applications and
related therapies
Préparation et management de la qualité des liquides
d’hémodialyse et de thérapies annexes —
Partie 2: Équipement de traitement de l’eau pour des applications
en hémodialyse et aux thérapies apparentées
Reference number
ISO 23500-2:2024(en) © ISO 2024
ISO 23500-2:2024(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.
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
ii
ISO 23500-2:2024(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 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 contaminant requirements .2
4.1.3 Organic carbon, pesticides and other chemicals .3
4.1.4 Microbiology of dialysis water .3
4.2 Water treatment equipment requirements .3
4.2.1 General .3
4.2.2 Backflow prevention .5
4.2.3 Tempering valves .5
4.2.4 Sediment filters .5
4.2.5 Cartridge filters .5
4.2.6 Softeners .5
4.2.7 Anion exchange resin tank .5
4.2.8 Carbon media .5
4.2.9 Chemical injection systems .7
4.2.10 Reverse osmosis .7
4.2.11 Deionization .8
4.2.12 Bacteria and endotoxin retentive filters .8
4.2.13 Storage and distribution of dialysis water .8
4.3 Electrical safety of water treatment equipment for haemodialysis applications and
related therapies .10
5 Testing. 10
5.1 C onformity with dialysis water quality requirements.10
5.1.1 General .10
5.1.2 Microbiology of dialysis water .11
5.1.3 Maximum level of chemical contaminants . 12
5.2 C onformity with water treatment equipment requirements . 12
5.2.1 General . 12
5.2.2 Backflow prevention . 13
5.2.3 Tempering valves . 13
5.2.4 Sediment filters . 13
5.2.5 Cartridge filters . 13
5.2.6 Softeners . 13
5.2.7 Anion exchange resin tanks . 13
5.2.8 Carbon media .14
5.2.9 Chemical injection systems .14
5.2.10 Reverse osmosis .14
5.2.11 Deionization .14
5.2.12 Endotoxin retentive filters .14
5.2.13 Storage and distribution of dialysis water .14
6 Labelling .15
6.1 General . 15
6.2 Device or system markings . 15
6.3 Product literature . 15
Annex A (informative) Rationale for the development and provisions of this document .18
Annex B (informative) Reference tables .29
iii
ISO 23500-2:2024(en)
Bibliography .31
iv
ISO 23500-2:2024(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 23500-2:2019), which has been technically
revised. The main changes are as follows:
— alternative water treatment technologies (e.g. reverse osmosis pre-treatment with ultrafiltration) have
been added;
— alternatives to classic microbial analytical methods [endotoxin testing using involving recombinant
Factor C (rFC)] have been added.
A list of all parts of 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.
v
ISO 23500-2:2024(en)
Introduction
This document reflects the conscientious efforts of concerned physicians, clinical engineers, nurses, dialysis
technicians and dialysis patients, in consultation with device manufacturers and regulatory authority
representatives, to develop an International Standard for performance levels that can be reasonably achieved
at the time of its publication. The term “consensus,” as applied to the development of voluntary medical
device documents, does not imply unanimity of opinion, but rather reflects the compromise necessary in
some instances when a variety of interests should be merged.
This document applies to individual water treatment devices and to water treatment systems assembled
from one or more of these devices. This document is applicable, firstly, to the individual or company that
specifies the complete water treatment system and, secondly, to the supplier who assembles and installs the
system. Since systems can be assembled from a number of individual water treatment devices, the provisions
of this document are also applicable to the manufacturers of these devices, provided that the manufacturer
indicates that the device is intended for use in haemodialysis applications. This document is written
principally to address water treatment systems for dialysis facilities treating multiple patients. However,
many of its provisions apply equally to water treatment systems used in applications where a single patient
is treated, such as in a home dialysis or acute hospital dialysis setting. Specifically, requirements for the
chemical and microbiological quality of water are considered to apply in all settings, regardless of whether a
single patient or many patients are being treated.
Increasingly, self-contained, integrated systems designed and validated to produce water and dialysis
fluid are becoming available and used clinically. The provisions included in this document apply to
systems assembled from individual components. Consequently, some of the provisions in ISO 23500-1
and ISO 23500-2 do not apply to integrated systems, however such systems are required to comply with
[47] [48]
ISO 23500-3, ISO 23500-4 and ISO 23500-5 .
This document helps protect haemodialysis patients from adverse effects arising from known chemical and
microbial contaminants found in water supplies. However, dialysis and patient safety is ultimately dependent
on the quality of the dialysis fluid. Since the manufacturer or supplier of water treatment equipment does
not have control over the dialysis fluid, any reference to dialysis fluid in this document is for clarification
only and not a requirement of the manufacturer. The responsibility for assuring that the dialysis fluid is not
contaminated, mismatched or otherwise damaging to the patient rests with the clinical professionals caring
for the patient under the supervision of the medical director. Requirements and recommendations on the
preparation and handling of water and dialysis fluid in a dialysis facility are provided in ISO 23500-3 and
[48]
ISO 23500-5 respectively. The rationale for the development of this document is given in Annex A.
Since the chemical and microbiological content of the water produced need to meet the requirements of
ISO 23500-3, the maximum allowable levels of contaminants are given in Tables B.1 and B.2. The values
shown include the anticipated uncertainty associated with the analytical methodologies, which are listed in
Table B.3.
vi
International Standard ISO 23500-2:2024(en)
Preparation and quality management of fluids for
haemodialysis and related therapies —
Part 2:
Water treatment equipment for haemodialysis applications
and related therapies
1 Scope
This document specifies requirements and recommendations for individual water treatment devices and
water treatment systems assembled from one or more of such devices. This document is directed at the
individual or company that specifies the complete water treatment system and, the supplier who assembles
and installs the system. Since systems can be assembled from a number of individual water treatment
devices, the provisions of this document are also directed at the manufacturers of these devices, provided
that the manufacturer indicates that the device is intended to be used to supply water for haemodialysis and
related therapies.
This document is applicable to all devices, piping and fittings between the point at which water is delivered
to the water purification system and the point of use of the purified water. Such components include but are
not necessarily limited to water purification devices, online water quality monitors (such as conductivity
monitors) and piping systems for the distribution of purified water.
This document does not apply to
— equipment used in the preparation of concentrates from powder or other highly concentrated media at a
dialysis facility either for a single patient or multiple patients,
— dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid,
— sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the
dialysis fluid,
— dialysis concentrates,
— haemodiafiltration or haemofiltration systems,
— systems that process dialysers for multiple uses, and
— peritoneal dialysis systems.
Requirements for the ongoing monitoring of water purity in terms of chemical and microbiological quality
are given in ISO 23500-3.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 23500-1, Preparation and quality management of fluids for haemodialysis and related therapies — Part 1:
General requirements
ISO 23500-2:2024(en)
ISO 23500-3, Preparation and quality management of fluids for haemodialysis and related therapies — Part 3:
Water for haemodialysis and related therapies
IEC 60601-1-11, Medical electrical equipment — Part 1-11: General requirements for basic safety and essential
performance — Collateral standard: Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 23500-1 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
microfilter
filter designed to remove particles down to 0,1 µm in size
Note 1 to entry: Microfilters have an absolute size cut-off and are available in both dead-end and cross-flow
configurations. Some microfilters can reduce the concentration of endotoxins by adsorption.
4 Requirements
4.1 Dialysis water quality requirements
4.1.1 General
The requirements contained in this document apply to the dialysis water as it enters the equipment used
to prepare concentrates from powder or other concentrated media at a dialysis facility, to prepare dialysis
fluid, or to reprocess dialysers. As such, these requirements apply to the water treatment system as a whole
including the distribution network and not only to each of the individual devices that make up the system.
4.1.2 Chemical contaminant requirements
Dialysis water used to prepare dialysis fluid or concentrates from powder at a dialysis facility, or to reprocess
dialysers for multiple uses, shall not contain chemical contaminants at concentrations in excess of those in
ISO 23500-1:2024, Tables 1 and 2 (reproduced as Tables B.1 and B.2). The manufacturer or supplier of a
complete water treatment system shall recommend a system capable of meeting the requirements of Clause 4
based on the analysis of the feed water. The system design should reflect possible seasonal variations in feed
water quality. The manufacturer or supplier of a complete water treatment and distribution system shall
demonstrate that the complete water treatment, storage and distribution system is capable of meeting the
requirements of this document at the time of installation.
For disposable water treatment and distribution systems that have been validated to produce dialysis water
meeting the quality requirements of this document for a specified time, incoming water shall be surveyed to
ensure that the input to the treatment system is in the range for which the system has been validated. The
manufacturer's recommendation for surveying the final dialysis water can be followed when the system is
operated according to the manufacturer's instructions. Alternatively, the quality of the dialysis water can be
closely observed as outlined for non-validated systems.
NOTE 1 If the manufacturer or supplier does not install the water storage and distribution system, then the
responsibility of the manufacturer or supplier is limited to demonstrating that the water treatment system, excluding
the water storage and distribution system, meets the requirements of this document. If individual devices of the water
treatment system are provided by different manufacturers or suppliers, the person or organization specifying the
devices is responsible for demonstrating that the complete system meets the requirements of this document at the
time of installation.
ISO 23500-2:2024(en)
NOTE 2 Following the installation of a water treatment, storage and distribution system, the user is responsible for
continued surveillance of the levels of chemical contaminants in the water and for complying with the requirements of
this document.
4.1.3 Organic carbon, pesticides and other chemicals
The impact of organic compounds, such as pesticides, polycyclic aromatic hydrocarbons and other chemicals
such as pharmaceutical products and endocrine disruptors with respect to haemodialysis patients are
difficult to specify. Consequences of exposure are probably of a long-term nature and it is technically difficult
and costly to measure these substances on a routine basis. Furthermore, there is an absence of evidence of
their widespread presence in water although it is recognized that inadvertent discharges are possible. In
view of this, it is not possible to currently specify limits for their presence in water used in the preparation
of dialysis fluid.
Nanofiltration and reverse osmosis are capable of significant rejection of many such compounds. Granular
activated carbon (GAC) is also highly effective at removing majority of such compounds. However, as
granular activated carbon is widely used in the removal of chlorine/chloramine, their use in the removal
of organic carbons, pesticides and other chemicals depends on the size of the carbon filters and/or beds,
and users shall be aware of appropriate dimensioning since the majority of carbon valences can be already
occupied and unavailable for further removal activity.
4.1.4 Microbiology of dialysis water
Dialysis water used to prepare dialysis fluid or concentrates from powder at a dialysis facility, or to reprocess
dialysers for multiple uses, shall comply with the requirements specified in ISO 23500-3.
The manufacturer or supplier of a complete water treatment and distribution system shall demonstrate that
the complete water treatment, storage and distribution system meets the requirements of this document,
including those related to action levels at the time of installation.
For disposable water treatment systems validated by the manufacturer to produce dialysis water meeting
the quality requirements of this document for a specified time, the incoming feed water shall be surveyed
to ensure that the input to the treatment system is in the range for which the system has been validated.
The manufacturer's recommendations for surveying the dialysis water can be followed when the system is
operated according to the manufacturer's instructions. Alternatively, the quality of the dialysis water can be
observed as outlined for non-validated systems.
NOTE 1 If the manufacturer or supplier does not install the water storage and distribution system, then the
responsibility of the manufacturer or supplier is limited to demonstrating that the water treatment system, excluding
the water storage and distribution system, meets the requirements of this document. If individual devices of the water
treatment system are provided by different manufacturers or suppliers, the person or organization specifying the
devices is responsible for demonstrating that the complete system meets the requirements of this document at the
time of installation.
NOTE 2 Following installation of a water treatment, storage and distribution system, the user is responsible for
continued surveillance of the water bacteriology of the system and for complying with the requirements of this
document, including those requirements related to action levels.
4.2 Water treatment equipment requirements
4.2.1 General
4.2.1.1 Water treatment system
The supplier of the feed water or the supplier of the water treatment system or a laboratory specified by the
user shall perform chemical analyses on the feed water to determine the compatibility of the system with
the feed water and the suitability of the system for providing dialysis water meeting the requirements of
4.1.2. The result of the chemical analyses shall be available to the user in charge of dialysis. In the case of an
individual device, the person incorporating the device into the water treatment system is responsible for
ISO 23500-2:2024(en)
ensuring that incorporation of the device does not compromise the ability of the overall system to deliver
dialysis water capable of meeting the requirements of 4.1.2 and 4.1.4.
The water treatment and distribution system should include appropriate pressure gauges, flow meters,
sample ports and other ancillary equipment necessary to allow surveillance of the performance of individual
system devices and the system as a whole.
Valves can be included in the water treatment system to allow individual devices to be bypassed when
there is device failure or to facilitate replacement of a device. Bypass valves should have a physical lockout
installed and be labelled with a warning notifying the user of the result of its removal.
If it is possible to bypass a device of the water treatment system, then the manufacturer or installer of that
component shall inform the user of the risks associated with bypassing that device and the need for clearly
defining the responsibility for operating the bypass. Where such valves are installed, however, a means
should be included to minimize the likelihood that the device will be inadvertently bypassed during normal
operation of the system.
Bypass valves should not be used to bypass deionization tanks, carbons and other critical components e.g.
reverse osmosis (RO) systems. They should not be used on ultrafilters used in conjunction with deionization
tanks for patient treatment.
Operating controls shall be positioned so as to minimize inadvertent resetting.
Electrical circuits shall be separate from hydraulic circuits and adequately protected from fluid leaks.
4.2.1.2 Materials compatibility
Materials that are in contact with dialysis water (including materials used in piping, storage and distribution
systems) shall not interact chemically or physically with that water so as to adversely affect its purity
or quality. Water-contacting surfaces shall be fabricated from non-reactive materials (e.g. plastics) or
appropriate stainless steel. The use of materials known to cause toxicity in haemodialysis, such as copper,
brass, galvanized metal or aluminium, are specifically prohibited at any point beyond the water treatment
device used to remove contaminating metal ions, most commonly a reverse osmosis system or a deionizer.
The materials of any water treatment devices (including piping, storage, and distribution systems) shall be
compatible with the means used to disinfect those devices. Chemicals infused into the water in the pre-
treatment section, such as chlorine, acid, flocculants and complexing agents, shall be adequately removed
from dialysis water before they reach any point of use. Monitors or specific test procedures to verify removal
of additives shall be provided.
4.2.1.3 Regenerated or reconstituted devices
All devices that are regenerated or reconstituted at a site remote from the dialysis facility, such as
deionizers, shall be disinfected at the time of regeneration or reconstitution so that contaminated water is
not reintroduced into the system after regeneration or reconstitution. Separate processes shall be used to
ensure no intermixing of devices or their component parts between devices returned from medical or other
non-medical (e.g. domestic or industrial) water users.
4.2.1.4 Disinfection protection
When the manufacturer recommends the use of chemical disinfectants, means shall be provided to
restore the equipment and the system in which it is installed to a safe condition with respect to residual
disinfectant presence prior to the dialysis water being used for dialysis applications. When recommending
chemical disinfectants, the manufacturer shall also recommend methods for testing for residual levels of the
disinfectants. When disinfection is accomplished automatically by chemical disinfectants, including ozone,
or by high temperature procedures, the activation of the disinfection system shall result in the activation of
a warning system and measures to prevent patient exposure to an unsafe condition.
If sodium hypochlorite (bleach) is used for cleaning or disinfecting the internal pathways of dialysis
equipment, including but not limited to water treatment loops, concentrate containers, mixers and delivery
ISO 23500-2:2024(en)
systems, the post rinse water residual level of free chlorine shall be as specified by the manufacturer’s
instructions.
4.2.2 Backflow prevention
A backflow prevention device e.g. pipe disconnector, system separator or free fall section to isolate the
water treatment system from the water supply according to local plumbing codes should be fitted to all
water treatment systems.
NOTE The testing frequency of backflow prevention devices is specified by local plumbing codes or regulations.
4.2.3 Tempering valves
Tempering valves, if used, shall be sized to accommodate the anticipated range of flow rates of hot and cold
water. They shall be fitted with a mechanism to prevent backflow of water into the hot and cold water lines
and with a means to measure the outlet water temperature.
4.2.4 Sediment filters
Sediment filters should have an opaque housing or other means to inhibit proliferation of algae. Filters
should be fitted with pressure gauges on the inlet and outlet water lines to measure the pressure drop, ΔP,
across the filter.
NOTE Sediment filters are also known as multimedia or sand filters.
4.2.5 Cartridge filters
Cartridge filters should have an opaque housing or other means to inhibit proliferation of algae. Filters
should be fitted with pressure gauges on the inlet and outlet water lines to measure the pressure drop, ΔP,
across the filter during use.
4.2.6 Softeners
Water softeners should be fitted with a mechanism to prevent water containing the high concentrations
of sodium chloride used during regeneration from entering the product water line during regeneration.
Automatic regeneration can be performed on a volume schedule or on a time schedule. For softeners that are
regenerated automatically on a time schedule, the face of the timers used to control the regeneration cycle
should be visible to the user. Operating controls shall be positioned so as to minimize inadvertent resetting.
4.2.7 Anion exchange resin tank
Anion exchange resin, sometimes referred to as an organic scavenger, can remove organic matter and other
contaminants from the source water and protect carbon media from fouling, which can shorten its effective
life for chlorine/chloramine removal. If an organic scavenger is installed to protect the carbon media, the
scavenger should be installed upstream of the carbon beds. Anion exchange resins can also be used to
remove contaminants that can otherwise foul the reverse osmosis membrane.
4.2.8 Carbon media
Carbon is used to remove small organic compounds, chlorine and chloramine. At least one carbon bed or
filter should be installed even if the water supply is from a well and no chlorine is present. Carbon removes
organic contaminants from ground water, including solvents, pesticides, industrial wastes and substances
leaking from underground storage tanks.
To mitigate possible risks, due to depletion of available valences in activated carbon, regular replacement
of activated carbon shall be undertaken, even when chlorine breakthrough hasn’t occurred. Replacement
frequency is typically based on manufacturer’s instructions or activated carbon performance indicators
(e.g. total organic compounds). Potential risks and dialysis treatment practices should be considered when
choosing the replacement frequency.
ISO 23500-2:2024(en)
When carbon is used for the removal of chloramine, it shall be adapted specifically to the maximum
anticipated water flow rate of the system and the level of chloramine in the feed water.
If small cartridge filters are used, the data sheet of the manufacturer regarding chlorine rejection capacity
has to be observed.
Due to the risk of harm to a patient in the event of total chlorine breakthrough in cases where the water is
known to be continuously chlorinated or chloraminated or subject to organic contamination, the system
shall be designed to prevent patient exposure to unsafe product water in the event of a single point failure.
Protective measures can be incorporated into the system design through several means, including:
— the use of two carbon beds in series with off-line analysis or testing of product water from the first bed in
each series (see off-line testing in ISO 23500-1:2024, 7.3.5); each of the carbon beds shall have an empty-
bed contact time (EBCT) of at least 5 min at the maximum product water flow rate (a total EBCT of at
least 10 min);
— the use of redundant means of chloramines removal with off-line analysis or testing of product water
after the primary device (see off-line testing in ISO 23500-1:2024, 7.3.5); possible alternatives include a
granular activated carbon bed followed by a dense carbon block or two carbon block filters in series;
— the use of carbon systems used to prepare water for portable dialysis systems are exempt from
the requirement for the second carbon and a 10 min EBCT, provided that there is a redundant
means of chloramine removal with off-line sampling after the primary device (see off-line testing in
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