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
Overview
EN ISO 23500-1:2024 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2024) defines the general requirements and user responsibilities for preparing dialysis fluids and substitution fluids used in online therapies (e.g., haemodiafiltration, haemofiltration). The standard covers quality management of water treatment and concentrate preparation systems from the point municipal water enters the facility up to the point the final dialysis or substitution fluid reaches the dialyser or is infused. It replaces EN ISO 23500-1:2019 and provides guidance on microbiological control, validation, monitoring and equipment surveillance. Exclusions include sorbent-based recirculating systems, CRRT systems using pre-packaged solutions, and peritoneal dialysis solutions.
Key topics and technical requirements
- Scope of applicability: From facility inlet water to final dialysis/substitution fluid; includes preparation of acid and bicarbonate concentrates from powdered/highly concentrated media.
- Quality requirements: Framework for chemical and microbiological quality of dialysis water, concentrates and final dialysis fluids, including requirements for ultrapure and online-prepared substitution fluids.
- System design & technical considerations: Guidance on technical and microbiological aspects of water treatment, distribution and dialysis fluid proportioning systems.
- Validation: Requirements for installation, operational and performance qualification, initial and periodic validation, and documentation of system performance.
- Surveillance & monitoring: Ongoing testing and record retention for dialysis water, concentrates, filter media, reverse osmosis, deionization, storage/distribution systems, and endotoxin/bacterial control devices.
- Microbiological control strategies: Recommendations on disinfection frequency, sampling methods (including heterotrophic plate counts), and approaches to minimize biofilm and contamination risk.
- User responsibility: Emphasis that dialysis practitioners and facility operators are responsible for fluid quality once equipment is installed and handed over.
Applications
- Ensures safe and consistent preparation of dialysis water, standard and ultrapure dialysis fluid, and online substitution fluids used in haemodialysis, haemodiafiltration and haemofiltration.
- Used to design, validate and operate water treatment and concentrate mixing systems in dialysis clinics, hospitals and satellite units.
- Supports procurement and commissioning decisions for water treatment vendors, clinical engineers, infection control teams and quality managers.
Who should use this standard
- Dialysis practitioners and nephrology clinicians
- Clinical/biomedical engineers and facility managers
- Water treatment manufacturers and service providers
- Quality assurance, infection prevention and regulatory compliance staff
Related standards
- Other parts of the ISO 23500 series and national/regional water quality and medical device guidance documents. (Consult ISO/CEN resources for applicable complementary standards.)
Frequently Asked Questions
SIST EN ISO 23500-1:2024 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2024)". This standard covers: 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.
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.
SIST EN ISO 23500-1:2024 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 23500-1:2024 has the following relationships with other standards: It is inter standard links to SIST EN ISO 23500-1:2019. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase SIST EN ISO 23500-1:2024 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
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
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
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
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
...
SIST EN ISO 23500-1:2024 표준은 혈액투석과 관련된 치료를 위한 액체 준비 및 품질 관리에 대한 일반 요구 사항을 규정하고 있습니다. 이 표준의 적용 범위는 혈액투석의 시행에 있어 필수적인 여러 측면을 포괄하고 있습니다. 특히, 혈액투석과 관련된 모든 치료에 필요한 기본적인 액체의 준비, 즉 농축액 및 대체 액체의 품질 관리를 명확히 하고 있어 의료 종사자들에게 중요한 지침이 됩니다. 이 문서는 혈액투석 치료에 사용되는 액체의 품질 관리와 장비 관리에 대한 책임을 문서화하고 있습니다. 이는 시가에서 병원 시설로 들어오는 물의 품질이 최종적으로 투석기기에 도달할 때까지의 모든 과정을 포함하며, 종합적인 품질 보증 체계를 제공합니다. 이러한 품질 관리는 사용되는 장비와 물의 출처에 대한 명확한 기준을 설정함으로써, 환자의 안전을 최우선적으로 보장합니다. 또한, 이 문서는 혈액투석에서 사용하는 물이 재사용될 수 있는 방법에 대해서도 다루고 있어 유연성을 제공하며, 이를 통해 효율적인 자원 관리를 도울 수 있습니다. 재처리 장비에 관한 지침도 포함되어 있어, 단일 사용으로 표기되지 않은 혈액투석기와 관련된 상황에서도 적절하게 대응할 수 있도록 설정되어 있습니다. SIST EN ISO 23500-1:2024 표준은 혈액투석과 관련된 액체의 품질 관리를 위한 중심적인 역할을 수행하며, 지속적인 품질 개선을 위한 장치와 시스템 관리의 중요성을 강조합니다. 비록 이 문서가 일부 전통적인 헌혈 치료 방법에는 직접적으로 적용되지 않지만, 전반적인 품질 관리와 관련된 지침을 통해 임상 적용에 일정한 가치를 제공하고 있습니다. 따라서 이 표준은 현대의 혈액투석 치료 환경에서 필수적인 지침으로 자리 잡고 있습니다.
SIST EN ISO 23500-1:2024は、血液透析および関連治療のための液体の準備および品質管理に関する基準の重要な文書です。この標準は、血液透析やその関連治療のための液体の準備に必要な一般的要件を明確に定義しており、特にオンライン治療における代替液の使用についても指針を提供しています。 この標準の強みは、血液透析に関与するすべての実務者に対して明確な指示を提供する点にあります。具体的には、透析施設における水の供給から透析液の最終的な供給に至るまでの品質管理プロセスを網羅しています。このように統一された規定に従うことで、透析液の準備における一貫性と信頼性が向上し、患者に対する安全性が確保されます。 さらに、SIST EN ISO 23500-1:2024は、透析液の準備に使用される酸および重炭酸濃縮物を高濃度メディアから作成するための設備の品質管理にも対応しています。このことは、透析治療における品質の確保において極めて重要です。また、透析液を再加工するための水の使用方法についても言及されており、単回使用を目的としない透析器の再処理に関する重要な考慮事項が含まれています。 この文書の適用範囲は広く、透析業界でのガイドラインを提供することで、専門家の責任を明確にし、より良い療法の実施を促進します。一方で、透析液の再生システムやパッケージソリューションを使用する連続腎代替療法、腹膜透析用システムについては適用されない点も明確にされており、それぞれの治療法に特化した基準のもとでの操作が求められています。 このように、SIST EN ISO 23500-1:2024は、血液透析および関連した治療において、治療の質と安全性を保証するための品質管理の枠組みを提供する非常に重要な基準と言えます。
Die Norm SIST EN ISO 23500-1:2024 bietet eine umfassende Anleitung zur Vorbereitung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und verwandte Therapien. Der Anwendungsbereich dieser Norm ist speziell auf die Qualitätsanforderungen ausgerichtet, die für die Herstellung von Dialysat und Ersatzflüssigkeiten erforderlich sind. Dies schließt die Anforderungen an die Qualität des Wassers ein, das bei der Herstellung dieser Flüssigkeiten verwendet wird, und zwar vom Zeitpunkt, an dem das städtische Wasser in die Dialyseeinrichtung eintritt, bis zum Zeitpunkt, an dem die endgültige Dialysatflüssigkeit in den Dialysator gelangt oder die Ersatzflüssigkeit infundiert wird. Ein besonders starker Punkt dieser Norm ist die klare Definition der Verantwortung des Benutzers für die Flüsse, die in der Hämodialyse verwendet werden, was deutlich macht, dass auch die Qualität der verwendeten Ausrüstung von entscheidender Bedeutung ist. Mit dem Fokus auf das Qualitätsmanagement der Geräte, die mit der Aufbereitung und Verteilung von Dialysatwasser zu tun haben, wird sichergestellt, dass alle stakeholders in der Dialysepflege über die notwendigen Standards informiert sind, um die Patientensicherheit zu gewährleisten. Die Norm richtet sich nicht an Sorbens-basierten Systeme zur Regeneration von Dialyseflüssigkeiten, kontinuierliche Nierenersatztherapiesysteme mit vorverpackten Lösungen oder Systeme und Lösungen für die peritoneale Dialyse. Dies zeigt, dass der Geltungsbereich spezifisch und fokussiert ist, um die relevantesten Aspekte der Hämodialyse zu adressieren, ohne in komplexe klinische Fragen abzuschweifen. Insgesamt ist die SIST EN ISO 23500-1:2024 eine essentielle Norm für alle Dialysepraktiker, die sich mit der Qualität und Sicherstellung der Flüssigkeiten befassen, die in die Behandlung von Patienten mit Nierenversagen fließen. Die Standardisierung dieser Anforderungen trägt nicht nur zur Verbesserung der Patientensicherheit bei, sondern auch zur Schaffung von einheitlichen Vorgehensweisen im internationalen Gesundheitswesen, wodurch die Relevanz dieser Norm unterstrichen wird.
The SIST EN ISO 23500-1:2024 standard provides a comprehensive framework for the preparation and quality management of fluids used in haemodialysis and related therapies. The scope of this document is meticulously defined, emphasizing the general requirements necessary for the preparation of dialysis fluids and substitution fluids used in advanced online therapies such as haemodiafiltration and haemofiltration. One of the key strengths of this standard is its clear delineation of user responsibilities regarding the quality of fluids once the requisite equipment has been delivered and installed. By addressing both the treatment and distribution of water utilized for dialysis fluid preparation, it sets precise parameters that practitioners must follow to ensure that the quality of the fluid meets essential safety and efficacy standards. The document also encompasses the quality management of equipment involved in the preparation of acid and bicarbonate concentrate, which is critical in enhancing the efficacy of dialysis therapy. This inclusion highlights the standard’s holistic approach to fluid preparation, addressing variables from the point municipal water enters the facility to the final dialysis fluid entering the dialyser, effectively ensuring that each component meets required quality benchmarks. Moreover, while the document offers significant guidelines, it smartly delineates its limitations by excluding systems like sorbent-based dialysis fluid regeneration systems and continuous renal replacement therapy equipment using pre-packaged solutions. This not only clarifies the focused applicability of the standard but also allows practitioners to concentrate on the scenarios it covers without confusion. The relevance of SIST EN ISO 23500-1:2024 is particularly significant in the current context of increasingly advanced dialysis techniques. As the standards of care in renal therapies continue to evolve, having a document that provides a foundational understanding of fluid preparation is essential for maintaining high-quality treatment protocols. Overall, the SIST EN ISO 23500-1:2024 standard effectively serves as a critical resource for dialysis practitioners, bolstering their capacity to provide reliable and effective therapies through stringent guidelines on fluid preparation and quality management. Its thorough articulation of responsibilities and processes contributes to enhancing patient care in the field of haemodialysis.
Le document de norme SIST EN ISO 23500-1:2024 constitue une référence essentielle dans le domaine de la préparation et de la gestion de la qualité des fluides pour hémodialyse et thérapies connexes. En précisant les exigences générales pour la préparation de ces fluides, il assure une base solide pour les praticiens de l'hémodialyse, en particulier en ce qui concerne l'utilisation de fluides de substitution dans les thérapies en ligne telles que l'hémodiafiltration et l'hémofiltration. Parmi les forces de cette norme, on note une clarté dans les responsabilités des utilisateurs concernant la qualité des fluides utilisés. Le document guide les professionnels sur la gestion de la qualité de l'équipement servant à traiter et à distribuer l'eau pour la préparation des fluides d'hémodialyse, englobant ainsi l'ensemble du processus, depuis l'entrée de l'eau municipale jusqu'à l'incorporation des fluides dans le dialyseur. Cette approche systématique garantit que chaque étape du processus respecte des critères de qualité, ce qui est primordial pour la sécurité et l'efficacité des traitements. Un autre point fort est l'inclusion des exigences concernant la préparation des concentrés acides et bicarbonates à partir de supports en poudre, ainsi que la préparation finale des fluides d'hémodialyse et de substitution. Cela permet de standardiser les pratiques entre les diverses installations de dialyse, renforçant ainsi la qualité des thérapies administrées aux patients. Il convient également de mentionner que cette norme aborde l'utilisation de l'eau dans le contexte de la reprocessing des dialyseurs non destinés à un usage unique, une considération cruciale dans le domaine des soins de santé où la durabilité et la sécurité s'avèrent indispensables. Cependant, il est important de préciser que le SIST EN ISO 23500-1:2024 ne couvre pas certains systèmes spécifiques, tels que les systèmes de régénération de fluides d'hémodialyse basés sur des absorbants ou ceux destinés à la dialyse péritonéale, ce qui pourrait limiter son application dans des situations cliniques spécifiques. En résumé, la norme SIST EN ISO 23500-1:2024 présente un cadre indispensable pour la préparation et la gestion de la qualité des fluides utilisés en hémodialyse, renforçant ainsi la pertinence des pratiques cliniques dans ce domaine et garantissant un niveau de soin élevé pour les patients.
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