FprEN ISO 23500-1
(Main)Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO/FDIS 23500-1:2024)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO/FDIS 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/FDIS 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/FDIS 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/FDIS 23500-1:2024)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 23500-1:2023
01-januar-2023
Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 1. del:
Splošne zahteve (ISO/DIS 23500-1:2022)
Preparation and quality management of fluids for haemodialysis and related therapies -
Part 1: General requirements (ISO/DIS 23500-1:2022)
Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und
verwandte Therapien - Teil 1: Allgemeine Anforderungen (ISO/DIS 23500-1:2022)
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies
annexes - Partie 1: Exigences générales (ISO/DIS 23500-1:2022)
Ta slovenski standard je istoveten z: prEN ISO 23500-1
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 23500-1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 23500-1:2023
oSIST prEN ISO 23500-1:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23500-1
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-11-17 2023-02-09
Preparation and quality 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
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
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THEREFORE SUBJECT TO CHANGE AND MAY
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NATIONAL REGULATIONS.
ISO/DIS 23500-1:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
oSIST prEN ISO 23500-1:2023
ISO/DIS 23500-1:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23500-1
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
Preparation and quality 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
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2022
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 23500-1:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
oSIST prEN ISO 23500-1:2023
ISO/DIS 23500-1:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
1.1 General . 1
1.2 Inclusions. 1
1.3 Exclusions . 2
2 Normative references . 2
3 Terms and definitions . 2
4 Quality requirements .10
4.1 General . 10
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 .13
4.3 Requirements for concentrate .13
4.3.1 Chemical and microbiological contaminants in concentrate .13
4.3.2 Water used to prepare concentrate . 13
4.4 Requirements for dialysis fluid . 14
4.4.1 General . 14
4.4.2 Microbiological requirements for standard dialysis fluid . 14
4.4.3 Microbiological requirements for ultrapure dialysis fluid . 14
4.4.4 Microbiological requirements for online-prepared substitution fluid .15
4.5 Record retention .15
5 System design and technical considerations .15
5.1 General . 15
5.2 Technical aspects . 16
5.3 Microbiological aspects . 17
5.4 Environmental impact . 17
6 Validation of system performance .18
6.1 General . 18
6.2 Validation plan . 19
6.3 Installation and operational qualification . 19
6.4 Performance qualification. 20
6.5 Validation . 21
6.5.1 Initial Validation. . 21
6.5.2 Retrospective [Annual] Validation . 21
6.5.3 Revalidation . 21
6.6 Surveillance . 21
7 Quality management .22
7.1 General .22
7.2 Surveillance of fluid quality .22
7.2.1 Surveillance of dialysis water quality . 22
7.2.2 Surveillance of concentrate quality . 23
7.2.3 Surveillance of dialysis fluid quality . 23
7.3 Surveillance of water treatment equipment . 23
7.3.1 General .23
7.3.2 Surveillance of sediment filters . 23
7.3.3 Surveillance of cartridge filters . 23
7.3.4 Surveillance of softeners . 24
7.3.5 Surveillance of carbon media . 24
7.3.6 Surveillance of chemical injection systems . 25
iii
oSIST prEN ISO 23500-1:2023
ISO/DIS 23500-1:2022(E)
7.3.7 Surveillance of reverse osmosis . 25
7.3.8 Surveillance of deionization . 26
7.3.9 Surveillance of endotoxin-retentive filters . 27
7.3.10 Surveillance of water storage tanks . 27
7.3.11 Surveillance of the water distribution systems. 27
7.3.12 Surveillance of bacterial control devices . .
...
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