EN 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 Wasser, 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 gilt 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 Dokuments gilt nicht 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,
—   Systeme und Lösungen für die Peritonealdialyse.
Dieses Dokument befasst sich nicht mit klinischen Problemen, 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)

General Information

• Status: Published
• Publication Date: 03-Sep-2024
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 04-Sep-2024
• Completion Date: 04-Sep-2024
• Ref Project: SIST EN ISO 23500-1:2024 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2024)

Relations

• Replaces: EN ISO 23500-1:2019 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2019)
• Effective Date: 19-Jan-2023

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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Phone: [phone]
Email: [e-mail]
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 .
...