SIST EN ISO 23500-1:2024
(Main)Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2024)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2024)
This document specifies the general requirements for the preparation of fluids for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration, for dialysis practitioners. This document gives guidance on the user's responsibility for fluids used in haemodialysis and related therapies once the equipment used in its preparation has been delivered and installed. As dialysis water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document.
This document is applicable to
— the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused.
— the quality management of the equipment used to prepare acid and bicarbonate concentrate from powdered or other highly concentrated media at a dialysis facility, and
— the preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates.
This document does not apply to
— sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid,
— systems for continuous renal replacement therapy that use pre-packaged solutions, and
— systems and solutions for peritoneal dialysis.
This document does not address clinical issues associated with inappropriate usage of such fluids.
Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und verwandte Therapien - Teil 1: Allgemeine Anforderungen (ISO 23500-1:2024)
Dieses Dokument legt die allgemeinen Anforderungen an die Zubereitung von Flüssigkeiten für die Hämodialyse und verwandte Therapien sowie von Substitutionsflüssigkeiten zur Verwendung bei Online-Therapien, wie z. B. Hämodiafiltration und Hämofiltration, für Dialysefachkräfte fest. Dieses Dokument enthält Leitlinien zur Verantwortung des Anwenders für Flüssigkeiten, die in der Hämodialyse und verwandten Therapien verwendet werden, nachdem die für die Zubereitung verwendeten Geräte geliefert und installiert wurden. Da Dialysewasser, das für die Zubereitung von Dialyseflüssigkeit verwendet wird, auch für die Wiederaufbereitung von Dialysatoren verwendet werden kann, die nicht für den einmaligen Gebrauch bestimmt sind, wird dieser Aspekt der Wassernutzung ebenfalls in diesem Dokument behandelt.
Dieses Dokument ist anwendbar für
das Qualitätsmanagement von Geräten zur Aufbereitung und Verteilung von Wasser, das für die Zubereitung von Dialysierflüssigkeit und Substitutionsflüssigkeit verwendet wird, von der Stelle, an der kommunales Wasser in die Dialyseeinrichtung gelangt, bis zu der Stelle, an dem die endgültige Dialysierflüssigkeit in den Dialysator gelangt oder an dem die Substitutionsflüssigkeit infundiert wird,
- die Ausstattung zur Herstellung von Konzentraten aus Pulver oder anderen hochkonzentrierten Medien in der Dialyseeinrichtung und
- die Herstellung der fertigen Dialysier- oder Substitutionsflüssigkeit aus Dialysewasser und Konzentraten.
Dieses Dokument ist nicht anwendbar für
- Sorbens basierte Dialysierflüssigkeits-Regenerationssysteme, in denen kleine Mengen der Dialysierflüssigkeit regeneriert und wieder in Umlauf gebracht werden,
- Systeme für die kontinuierliche Nierenersatztherapie, die vorverpackte Lösungen verwenden, und
- Systeme und Lösungen für die Peritonealdialyse.
Dieses Dokument ist nicht anwendbar für klinische Probleme, die mit der unsachgemäßen Verwendung solcher Flüssigkeiten verbunden sind.
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes - Partie 1: Exigences générales (ISO 23500-1:2024)
Le présent document spécifie les exigences générales relatives à la préparation des liquides d’hémodialyse et de thérapies apparentées et du liquide de substitution à utiliser pour des traitements en ligne, tels que l’hémodiafiltration et l’hémofiltration, destinées aux médecins dialyseurs. Le présent document donne des recommandations relatives à la responsabilité de l’utilisateur concernant le liquide utilisé pour des applications en hémodialyse et thérapies apparentées une fois que l’équipement utilisé pour sa préparation a été délivré et installé. Comme l’eau utilisée pour préparer le liquide de dialyse peut également être utilisée pour retraiter les dialyseurs non marqués destinés à un usage unique, cet aspect de l’utilisation d’eau est également couvert par le présent document.
Le présent document s’applique:
au management de la qualité de l’équipement employé pour traiter et distribuer l’eau utilisée pour préparer le liquide de dialyse et le liquide de substitution, depuis le point d’entrée de l’eau municipale dans le centre de dialyse jusqu’au point d’entrée du liquide de dialyse final dans le dialyseur ou jusqu’au point d’injection du liquide de substitution;
au management de la qualité de l’équipement utilisé pour préparer les concentrés acide et bicarbonate à partir d’un milieu en poudre ou de tout autre milieu très concentré dans un centre de dialyse; et
à la préparation du liquide de dialyse final ou du liquide de substitution à partir d’eau de dialyse et de concentrés.
Le présent document ne s’applique pas:
aux systèmes de régénération des liquides de dialyse à base de sorbants qui régénèrent et font recirculer de petits volumes de liquide de dialyse;
aux systèmes d’épuration extrarénale continue qui utilisent des solutions prêtes à l’emploi;
aux systèmes et solutions utilisés en dialyse péritonéale.
Le présent document ne traite pas des problèmes cliniques associés à un usage inapproprié de ces fluides.
Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 1. del: Splošne zahteve (ISO 23500-1:2024)
1.1 Splošno
Ta dokument je osnovni standard za številne druge standarde, ki obravnavajo opremo za pripravo vode, vodo, dializno vodo, koncentrate in dializno tekočino (skupina standardov ISO 23500) ter zagotavlja zdravnikom, ki predpišejo zdravljenje z dializo, smernice za pripravo tekočine za hemodializo in podobne terapije ter nadomestne tekočine za hemodiafiltracijo in hemofiltracijo za uporabo pri terapijah »on-line«, kot so hemodiafiltracija in hemofiltracija. Ta dokument se tako uporablja kot priporočena praksa.
Ta dokument ne obravnava kliničnih vprašanj, ki so morda povezana z neustrezno uporabo vode, dializne vode, koncentratov ali dializne tekočine. Zdravstveni delavci, ki so vključeni v zdravljenje pri odpovedi ledvic, morajo sprejeti dokončno odločitev v zvezi z uporabo teh tekočin, na primer za hemodializo, hemodiafiltracijo, visokopretočno hemodializo in ponovno obdelavo dializatorjev, ter morajo biti seznanjeni s težavami, ki se lahko pojavijo zaradi uporabe neustrezne tekočine pri vsaki od teh terapij.
Pojmov, ki so vključeni v ta dokument, naj se ne upošteva kot neprilagodljive ali statične. Tukaj predstavljena priporočila je treba zaradi boljšega razumevanja vloge čistosti dializne tekočine pri rezultatih zdravljenja in tehnoloških napredkih občasno znova prebrati.
1.2 Vključitve
Ta dokument obravnava odgovornost uporabnika za dializno tekočino, ko je oprema, ki se uporablja za njeno pripravo, dostavljena in nameščena.
Za namene tega dokumenta »dializna tekočina« vključuje:
a) dializno vodo (za definicijo glej točko 3.17) za pripravo dializne in nadomestne tekočine;
b) dializno vodo za pripravo koncentratov v uporabnikovi opremi;
c) koncentrate;
d) končno dializno in nadomestno tekočino.
Na področje uporabe tega dokumenta spadajo:
a) vodenje kakovosti opreme za obdelavo in distribucijo vode, ki se uporablja za pripravo dializne in nadomestne tekočine, od točke vstopa komunalne vode v dializno opremo do točke vstopa končne dializne tekočine v dializator ali točke infundiranja nadomestne tekočine;
b) oprema, ki se uporablja za pripravo koncentrata iz prahu ali drugih visoko koncentriranih medijev v dializni opremi; ter
c) priprava končne dializne ali nadomestne tekočine iz dializne vode in koncentratov.
OPOMBA: Vodo za pripravo dializne tekočine je mogoče uporabiti tudi za predelavo dializatorjev, ki niso označeni za enkratno uporabo, zato je ta vidik uporabe vode prav tako zajet v tem dokumentu.
1.3 Izključitve
Ta dokument se ne uporablja za sisteme za regeneracijo dializne tekočine na osnovi sorbenta za regeneracijo in recirkulacijo majhnih količin dializne tekočine, sisteme za neprekinjeno nadomestno ledvično zdravljenje, pri katerih se uporabljajo predpakirane raztopine, ter sisteme in raztopine za peritonealno dializo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2024
Nadomešča:
SIST EN ISO 23500-1:2019
Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 1. del:
Splošne zahteve (ISO 23500-1:2024)
Preparation and quality management of fluids for haemodialysis and related therapies -
Part 1: General requirements (ISO 23500-1:2024)
Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und
verwandte Therapien - Teil 1: Allgemeine Anforderungen (ISO 23500-1:2024)
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies
annexes - Partie 1: Exigences générales (ISO 23500-1:2024)
Ta slovenski standard je istoveten z: EN ISO 23500-1:2024
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 23500-1
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2024
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 23500-1:2019
English Version
Preparation and quality management of fluids for
haemodialysis and related therapies - Part 1: General
requirements (ISO 23500-1:2024)
Préparation et management de la qualité des liquides Herstellung und Qualitätsmanagement von
d'hémodialyse et de thérapies annexes - Partie 1: Flüssigkeiten für die Hämodialyse und verwandte
Exigences générales (ISO 23500-1:2024) Therapien - Teil 1: Allgemeine Anforderungen (ISO
23500-1:2024)
This European Standard was approved by CEN on 17 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 23500-1:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 23500-1:2024) 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 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 ISO 23500-1:2019.
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 23500-1:2024 has been approved by CEN as EN ISO 23500-1:2024 without any
modification.
International
Standard
ISO 23500-1
Second edition
Preparation and quality
2024-08
management of fluids for
haemodialysis and related
therapies —
Part 1:
General requirements
Préparation et management de la qualité des liquides
d'hémodialyse et de thérapies annexes —
Partie 1: Exigences générales
Reference number
ISO 23500-1:2024(en) © ISO 2024
ISO 23500-1:2024(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
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Published in Switzerland
ii
ISO 23500-1:2024(en)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Quality requirements . 9
4.1 General .9
4.2 Dialysis water .10
4.2.1 General .10
4.2.2 Chemical contaminants in dialysis water .10
4.2.3 Organic carbon, pesticides and other chemicals . 12
4.2.4 Microbiological contaminants in dialysis water . 12
4.3 Requirements for concentrate . 12
4.3.1 Chemical and microbiological contaminants in concentrate . 12
4.3.2 Water used to prepare concentrate . 13
4.4 Requirements for dialysis fluid . 13
4.4.1 General . 13
4.4.2 Microbiological requirements for standard dialysis fluid . 13
4.4.3 Microbiological requirements for ultrapure dialysis fluid . 13
4.4.4 Microbiological requirements for online-prepared substitution fluid .14
4.5 Record retention .14
5 System design and technical considerations . 14
5.1 General .14
5.2 Technical aspects . 15
5.3 Microbiological aspects .16
5.4 Environmental impact .16
6 Validation of system performance .16
6.1 General .16
6.2 Validation plan .18
6.3 Installation and operational qualification .18
6.4 Performance qualification.18
6.5 Validation .19
6.5.1 General .19
6.5.2 Initial validation .19
6.5.3 Retrospective (annual) validation .19
6.5.4 Revalidation .19
6.6 Monitoring and surveillance . 20
7 Quality management .20
7.1 General . 20
7.2 Surveillance of fluid quality .21
7.2.1 Surveillance of dialysis water quality .21
7.2.2 Surveillance of concentrate quality .21
7.2.3 Surveillance of dialysis fluid quality .21
7.3 Surveillance of water treatment equipment .21
7.3.1 General .21
7.3.2 Surveillance of sediment filters .21
7.3.3 Surveillance of cartridge filters . 22
7.3.4 Surveillance of softeners . 22
7.3.5 Surveillance of carbon media . 23
7.3.6 Surveillance of chemical injection systems . 23
7.3.7 Surveillance of reverse osmosis .24
7.3.8 Surveillance of deionization . 25
iii
ISO 23500-1:2024(en)
7.3.9 Surveillance of bacteria and endotoxin-retentive filters . 25
7.3.10 Surveillance of dialysis water storage and distribution . 25
7.3.11 Surveillance of bacterial control devices . . 26
7.4 Surveillance of concentrate preparation .27
7.4.1 Surveillance of mixing systems .27
7.4.2 Surveillance of additives .27
7.5 Surveillance of concentrate distribution .27
7.6 Surveillance of dialysis fluid proportioning.27
8 Strategies for microbiological control .28
8.1 General . 28
8.2 Disinfection . 28
8.2.1 General . 28
8.2.2 Microbiological aspects of fluid system design . 28
8.2.3 Disinfection frequency . 29
8.3 Microbiological surveillance methods . 30
8.3.1 General . 30
8.3.2 Sample collection .31
8.3.3 Heterotrophic plate count .32
8.3.4 Bacterial endotoxin test . 34
8.3.5 Determination of yeast and mould . 34
9 Location of and access to the water treatment system .35
10 Personnel .35
Annex A (informative) Rationale for the development and provisions of this document .36
Annex B (informative) Equipment .42
Annex C (informative) Surveillance guidelines for water treatment equipment,
distribution systems and dialysis fluid . 61
Annex D (informative) Strategies for microbiological control .65
Annex E (informative) Validation .75
Annex F (informative) Special considerations for home haemodialysis .83
Annex G (informative) Special considerations for acute haemodialysis .90
Annex H (informative) Further considerations for different water quality monitoring
approaches .95
Annex I (informative) Additional considerations for risk assessment .97
Bibliography .100
iv
ISO 23500-1:2024(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 23500-1:2019), which has been technically
revised.
The main changes are as follows:
— WHO Drinking Water Guideline has been used as the main drinking water quality reference instead of
the US EPA or other European standards;
— thallium has been removed from the list of contaminants, as no studies have reported data to indicate
that this contaminant is of particular concern in the haemodialysis setting;
— alternative water treatment technologies (e.g. reverse osmosis pre-treatment with ultrafiltration) have
been included in the subclauses dealing with water treatment technology (refer to B.2.7 and B.2.8);
— a new annex (Annex H) has been added to provide clarification of the different water quality monitoring
approaches (online versus offline monitoring);
— the microbiological analytic methods have been updated to include endotoxin testing using recombinant
Factor C (rFC), flow cytometry, autofluorescence and rapid tests (e.g. ATP);
— a new annex (Annex I) has been added to provide guidance on risk assessment;
— the validation of water treatment systems has been revised to include validation steps (e.g. installation
qualification, operational qualification, performance qualification and revalidation);
— further guidance has been added on technical needs after the typical technical interventions in Clause E.4.
A list of all parts in the ISO 23500 series can be found on the ISO website.
v
ISO 23500-1:2024(en)
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.
vi
ISO 23500-1:2024(en)
Introduction
This document is the base standard for standards dealing with water treatment and the production of
dialysis fluid in the ISO 23500 series.
The objective of the ISO 23500 series is to provide users with guidance for handling water and concentrates
and for the production and quality oversight of dialysis fluid used for haemodialysis. The need for such
guidance is based on the critical role of dialysis fluid quality in providing safe and effective haemodialysis,
and the recognition that day-to-day dialysis fluid quality is under the control of the healthcare professionals
who deliver dialysis therapy.
Annex A provides further information on the rationale for the development and provisions of this document.
The equipment used in the various stages of dialysis fluid preparation is generally obtained from specialized
vendors. Dialysis practitioners are generally responsible for maintaining that equipment following its
installation. Therefore, this document provides guidance on quality oversight and maintenance of the
equipment to ensure that dialysis fluid quality is acceptable at all times. At various places in this document,
the user is advised to follow the manufacturer's instructions regarding the operation and maintenance
of equipment. In instances in which the equipment is not obtained from a specialized vendor, it is the
responsibility of the user to validate the performance of the equipment in the haemodialysis setting and to
ensure that appropriate operating and maintenance manuals are available.
Annex B provides further information on the system components that are used for water treatment,
concentrate and dialysis fluid preparation at a dialysis facility. These descriptions are intended to provide
the user with a basis for understanding why certain equipment can be required and how it should be
configured; the descriptions are not intended to be detailed design standards. Requirements for water
treatment equipment are provided in ISO 23500-2.
Increasingly, self-contained, integrated systems designed and validated to produce water and dialysis fluid
are becoming available and used clinically. This document applies to systems assembled from individual
components. Consequently, some of the requirements in ISO 23500-1 and ISO 23500-2 do not apply to
integrated systems, however such systems are required to comply with the requirements of ISO 23500-3,
ISO 23500-4 and ISO 23500-5. In order to ensure conformity when using such systems, adherence to the
manufacturer's instructions regarding the operation, testing and maintenance of such systems is required
to ensure that the system is being operated under the validated conditions.
This document reflects the conscientious efforts of healthcare professionals, patients and medical device
manufacturers to develop recommendations for handling water and concentrates and for the production
and surveillance of dialysis fluid for haemodialysis and protecting haemodialysis patients from adverse
effects arising from known chemical and microbial contaminants that can be found in improperly prepared
dialysis fluid.
Annexes F and G provide further information regarding the special considerations for home and acute
haemodialysis. This document together with its constituent parts is directed towards the healthcare
professionals involved in the management or routine care of haemodialysis patients and responsible for
the quality of dialysis fluid. However, the physician in charge of dialysis has the ultimate responsibility for
ensuring that the dialysis fluid is correctly formulated and meets the requirements of all applicable quality
standards.
vii
International Standard ISO 23500-1:2024(en)
Preparation and quality management of fluids for
haemodialysis and related therapies —
Part 1:
General requirements
1 Scope
This document specifies the general requirements for the preparation of fluids for haemodialysis and related
therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration,
for dialysis practitioners. This document gives guidance on the user's responsibility for fluids used in
haemodialysis and related therapies once the equipment used in its preparation has been delivered and
installed. As dialysis water used to prepare dialysis fluid can also be used to reprocess dialysers not marked
intended for single use, this aspect of water use is also covered by this document.
This document is applicable to
— the quality management of equipment used to treat and distribute water used for the preparation of
dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility
to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is
infused.
— the quality management of the equipment used to prepare acid and bicarbonate concentrate from
powdered or other highly concentrated media at a dialysis facility, and
— the preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates.
This document does not apply to
— sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of
dialysis fluid,
— systems for continuous renal replacement therapy that use pre-packaged solutions, and
— systems and solutions for peritoneal dialysis.
This document does not address clinical issues associated with inappropriate usage of such fluids.
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 23500-2, Preparation and quality management of fluids for haemodialysis and related therapies — Part 2:
Water treatment equipment for haemodialysis applications and related therapies
ISO 23500-3, Preparation and quality management of fluids for haemodialysis and related therapies — Part 3:
Water for haemodialysis and related therapies
ISO 23500-4, Preparation and quality management of fluids for haemodialysis and related therapies — Part 4:
Concentrates for haemodialysis and related therapies
ISO 23500-1:2024(en)
ISO 23500-5, Preparation and quality management of fluids for haemodialysis and related therapies — Part 5:
Quality of dialysis fluid for haemodialysis and related therapies
3 Terms and definitions
For the purposes of this document, the following terms and definitions 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
acetate concentrate
concentrated solution of salts containing acetate, which when diluted with dialysis water (3.17), yields
bicarbonate-free dialysis fluid (3.15) for use in dialysis
Note 1 to entry: Acetate concentrate can contain glucose.
Note 2 to entry: Sodium acetate is used to provide buffer in place of sodium bicarbonate.
Note 3 to entry: Acetate concentrate is used as a single concentrate.
3.2
acid concentrate
A-concentrate
low pH mixture of salts that, when diluted with dialysis water (3.17) and bicarbonate concentrate (3.6), yields
dialysis fluid (3.15) for use in dialysis
Note 1 to entry: The term “acid” refers to the small amount of acid (acetic acid or citric acid) that is included in the
concentrate.
Note 2 to entry: Acid concentrate can contain glucose.
Note 3 to entry: Acid concentrate can be in the form of a liquid, a dry powder, other highly concentrated media or some
combination of these forms.
3.3
action level
value from monitoring that necessitates immediate intervention
[SOURCE: ISO 13408-1:2023, 3.1, modified — the word particulate has been excluded.]
3.4
additive
spike
small amount of a single chemical that, when added to the concentrate, increases the concentration of a
single existing chemical by a value labelled on its packaging
3.5
bacteria and endotoxin-retentive filter
BERF
endotoxin retentive filter
ERTF
membrane filter used to remove endotoxins (3.20) and microorganisms from dialysis water (3.17) or dialysis
fluid (3.15)
Note 1 to entry: The performance of an endotoxin-retentive filter is usually expressed as the logarithmic reduction
value (LRV), defined as log of the inlet concentration, divided by the outlet concentration.
Note 2 to entry: Endotoxin-retentive filters can be configured in a cross-flow or dead-end mode. Some endotoxin-
retentive filters also remove endotoxins by adsorption.
ISO 23500-1:2024(en)
3.6
bicarbonate concentrate
B-concentrate
concentrated preparation of sodium bicarbonate that, when diluted with dialysis water (3.17) and acid
concentrate (3.2), makes dialysis fluid (3.15) used for dialysis
Note 1 to entry: Some bicarbonate concentrates also contain sodium chloride.
Note 2 to entry: Bicarbonate concentrate can be in the form of a liquid or a dry powder.
Note 3 to entry: Dry sodium bicarbonate, without added sodium chloride, is also used in concentrate generators to
produce a concentrated solution of sodium bicarbonate used by the dialysis machine to make dialysis fluid.
3.7
biofilm
microbially-derived sessile community characterized by cells that are irreversibly attached to a substratum
or interface or to each other, are embedded in a matrix of extracellular polymeric substances that they have
produced, and exhibit an altered phenotype with respect to growth rate and gene transcription
Note 1 to entry: The matrix, a slimy material secreted by the cells, protects the bacteria from antibiotics and chemical
disinfectants.
Note 2 to entry: A certain amount of biofilm formation is considered unavoidable in dialysis water (3.17) systems.
When the level of biofilm is such that the action levels (3.3) for microorganisms and endotoxins (3.20) in the dialysis
water are routinely reached or exceeded, the operation of the system is compromised from a medical and technical
point of view. This level of biofilm formation is often referred to as biofouling.
3.8
bulk delivery
delivery of large containers of concentrate to a dialysis facility
Note 1 to entry: Bulk delivery canbe containers such as drums, which can be pumped into a storage tank (3.41)
maintained at the user's (3.44) facility. Alternatively, the drums can be left at the facility and used to fill transfer
containers to transfer the concentrate to the dialysis machines. Bulk delivery can also include large containers for
direct connection to a central concentrate supply system.
Note 2 to entry: Bulk delivery also includes dry powder concentrates intended to be used with an appropriate
concentrate mixer.
3.9
central concentrate system
system that prepares and/or stores concentrate at a central point for subsequent distribution to its points of use
3.10
central dialysis fluid delivery system
system that produces dialysis fluid (3.15) from dialysis water (3.17), and concentrate or powder at a central
point, and that distributes the dialysis fluid from the central point to individual dialysis machines
3.11
combined chlorine
chlorine that is chemically combined with other compound(s), such as ammonia, and that results in the
production of chloramine
Note 1 to entry: There is no direct test for measuring combined chlorine, but it can be established indirectly by
measuring both total and free chlorine (3.12) and calculating the difference.
3.12
free chlorine
chlorine present in water as dissolved molecular chlorine (Cl ), hypochlorous acid (HOCl) and hypochlorite
−
ion (OCl )
Note 1 to entry: The three forms of free chlorine exist in equilibrium.
ISO 23500-1:2024(en)
3.13
total chlorine
sum of free chlorine (3.12) and combined chlorine (3.11)
Note 1 to entry: Chlorine can exist in water as dissolved molecular chlorine, hypochlorous acid, and/or hypochlorite
ion (free chlorine) or in chemically combined forms (combined chlorine). Where chloramine is used to disinfect water
supplies, chloramine is usually the principal component of combined chlorine.
3.14
colony-forming unit
CFU
aggregation of microorganisms arising from a single cell or multiple cells
[SOURCE: ISO 11139:2018, 3.53, modified — "visible" has been deleted at the beginning of the definition.]
3.15
dialysis fluid
DEPRECATED: dialysate
DEPRECATED: dialysis solution
aqueous fluid made from dialysis water (3.17) containing electrolytes and, usually, buffer and glucose, that
is delivered to the dialyser by the dialysis fluid delivery system (3.16), which is intended to exchange solutes
with blood during haemodialysis (3.24) and haemodiafiltration (3.23)
Note 1 to entry: ISO 23500-5 defines three levels of dialysis fluid in terms of microbiology: standard dialysis fluid,
ultrapure dialysis fluid and online-prepared substitution fluid (3.42) used for haemodiafiltration.
Note 2 to entry: The dialysis fluid entering the dialyser is referred to as “fresh dialysis fluid”, while the fluid leaving
the dialyser is referred to as “spent dialysis fluid”.
Note 3 to entry: Dialysis fluid does not include pre-packaged parenteral fluids used in some renal replacement
therapies, such as haemodiafiltration and haemofiltration (3.25).
3.16
dialysis fluid delivery system
device that
— prepares dialysis fluid (3.15) online from dialysis water (3.17) and concentrates, or stores and distributes
premixed dialysis fluid,
— circulates the dialysis fluid through the dialyser,
— monitors the dialysis fluid for temperature, conductivity (or equivalent), pressure, flow and blood leaks, and
— prevents dialysis during disinfection (3.18) or cleaning modes
Note 1 to entry: The term includes reservoirs, conduits, proportioning devices for the dialysis fluid and monitors and
associated alarms and controls assembled as dialysis fluid delivery systems.
Note 2 to entry: The dialysis fluid delivery system can be an integral part of the dialysis machine or a centralized
preparation system which feeds multiple individual dialysis consoles.
Note 3 to entry: Dialysis fluid delivery systems are also known as proportioning systems (3.34) and dialysis fluid
supply systems.
3.17
dialysis water
water that has been treated to meet the requirements of ISO 23500-3 and which is suitable for use in
haemodialysis (3.24) applications, including the preparation of dialysis fluid (3.15), reprocessing of dialysers,
preparation of concentrates and preparation of substitution fluid (3.42) for online convective therapies
Note 1 to entry: Some integrated, validated systems, and other new systems by alternative design can provide
ultrapure dialysis water with <0,1 CFU/ml and <0,03 EU/ml. By mixing with sterile (3.40) and non-pyrogenic (3.31)
concentrates and by utilising sterile and non-pyrogenic dialysis fluid pathway, ultrapure dialysis fluid can be produced
in such integrated and validated systems.
ISO 23500-1:2024(en)
3.18
disinfection
process to reduce the number of viable microorganisms to a level specified as appropriate for a defined purpose
3.19
empty-bed contact time
EBCT
measure of the time during which water to be treated is in contact with the treatment medium in a contact
vessel, assuming that all liquid passes through the vessel at the same velocity
Note 1 to entry: EBCT is used as an indirect measure of how much contact occurs between particles, such as activated
carbon, and water as the water flows through a bed of particles.
Note 2 to entry: EBCT, expressed in minutes, is calculated from:
t = v/q
EBCT
where
v is the volume of the particle bed, in cubic metres, (m );
q is the flow rate of water through the bed, in cubic metres per minute (m /min).
3.20
endotoxin
lipopolysaccharide component of the cell wall of Gram-negative bacteria that is heat stable and that elicits a
variety of inflammatory responses in humans
Note 1 to entry: See also pyrogen (3.35).
[SOURCE: ISO 11139:2018, 3.101, modified — "animals and" has been deleted from the definition and Note 1
to entry has been added.]
3.21
endotoxin unit
EU
unit assayed by the Limulus amoebocyte lysate (LAL) test when testing for endotoxins (3.20)
Note 1 to entry: As the activity of endotoxins depends on the bacteria from which they are derived, their activity is
evaluated by reference to a standard endotoxin.
Note 2 to entry: In some countries, endotoxin concentrations are expressed in international units (IU). Since the
harmonization of endotoxin assays, EU and IU are equivalent.
3.22
germicide
agent that kills microorganisms
3.23
haemodiafiltration
process whereby concentrations of water-soluble substances in a patient's blood and an excess of fluid of a
patien
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