SIST EN ISO 23500-2:2024
(Main)Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2024)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2024)
1.1 General
This document is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies.
1.2 Inclusions
This document covers devices used to treat potable water intended for use in the delivery of haemodialysis and related therapies, including water used for:
a) the preparation of concentrates from powder or other highly concentrated media at a dialysis facility;
b) the preparation of dialysis fluid, including dialysis fluid that can be used for the preparation of substitution fluid;
c) the reprocessing of dialysers intended for single use where permitted for multiple uses,
d) the reprocessing of dialysers not specifically marked as intended for single use.
This document includes all devices, piping and fittings between the point at which potable water is delivered to the water treatment system, and the point of use of the dialysis water. Examples of the devices are water purification devices, online water quality monitors (such as conductivity monitors), and piping systems for the distribution of dialysis water.
1.3 Exclusions
This document excludes dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid, sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid, dialysis concentrates, haemodiafiltration systems, haemofiltration systems, systems that process dialysers for multiple uses, and peritoneal dialysis systems. Some of these devices, such as dialysis fluid delivery systems and concentrates, are addressed in other documents such as ISO 23500-4 and ISO 23500‑5,
This document also excludes the on-going surveillance of the purity of water used for dialysis fluid, concentrate preparation, or dialyser reprocessing which is addressed in ISO 23500‑1.
Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und verwandte Therapien - Teil 2: Ausstattung zur Wasseraufbereitung zur Verwendung in der Hämodialyse und in verwandten Therapien (ISO 23500-2:2024)
Dieses Dokument enthält Leitlinien für einzelne Wasseraufbereitungsgeräte und Wasseraufbereitungssysteme, die aus einem oder mehreren dieser Geräte zusammengesetzt sind. Es richtet sich an die Person oder Firma, die das komplette Wasseraufbereitungssystem spezifiziert, und an den Lieferanten, der das System zusammenbaut und installiert. Da Systeme aus einer Reihe von einzelnen Wasseraufbereitungsgeräten zusammengesetzt werden können, richten sich die Bestimmungen dieses Dokuments auch an die Hersteller dieser Geräte, sofern der Hersteller angibt, dass das Gerät für die Bereitstellung von Wasser für die Hämodialyse und verwandte Therapien bestimmt ist.
Dieses Dokument ist anwendbar auf alle Geräte, Rohrleitungen und Armaturen zwischen dem Punkt, an dem das Wasser in das Wasseraufbereitungssystem eingespeist wird, und dem Punkt, an dem das gereinigte Wasser verwendet wird. Solche Komponenten sind u. a. Wasseraufbereitungsgeräte, Online-Wasserqualitätsmonitore (z. B. Leitfähigkeitsmonitore) und Rohrleitungssysteme für die Verteilung von gereinigtem Wasser, sind aber nicht unbedingt darauf beschränkt.
Dieses Dokument gilt nicht für
Geräte, die in einer Dialyseeinrichtung für die Zubereitung von Konzentraten aus Pulver oder anderen hochkonzentrierten Medien für einen einzelnen oder mehrere Patienten verwendet werden,
Versorgungssysteme für Dialyseflüssigkeit, die Wasser und Konzentrate zur Herstellung von Dialyseflüssigkeit mischen,
Systeme zur Regeneration von Dialysierflüssigkeit mit Sorbenzien, welche geringe Mengen der Dialysierflüssigkeit regenerieren und wieder in den Kreislauf zurückführen,
Dialysekonzentrate,
Hämodiafiltrations- oder Hämofiltrationssysteme,
Systeme, die Dialysatoren für die Mehrfachverwendung aufbereiten,
Peritonealdialysesysteme.
Anforderungen an die laufende Überwachung der Reinheit des Wassers in Bezug auf die chemische und mikrobiologische Qualität sind in ISO 23500 3 enthalten.
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes - Partie 2: Équipement de traitement de l'eau pour des applications en hémodialyse et aux thérapies apparentées (ISO 23500-2:2024)
1.1 Généralités
Le présent document s'adresse au fabricant et/ou au fournisseur de systèmes de traitement d'eau et/ou de dispositifs utilisés expressément pour fournir de l'eau pour hémodialyse ou thérapies apparentées.
1.2 Inclusions
Le présent document couvre les dispositifs utilisés pour traiter l'eau potable destinée à des applications en hémodialyse et thérapies apparentées, y compris l'eau utilisée pour:
a) la préparation de concentrés à partir de poudres ou de milieux hautement concentrés dans un centre de dialyse;
b) la préparation de liquides de dialyse, y compris les liquides de dialyse pouvant être utilisés pour la préparation de liquides de substitution;
c) le retraitement de dialyseurs à usage unique dont la réutilisation est autorisée;
d) le retraitement de dialyseurs qui ne sont pas spécifiquement marqués comme étant à usage unique.
Le présent document inclut tous les dispositifs, tuyauteries et raccords situés entre le point de distribution de l'eau potable au système de traitement d'eau et le point d'utilisation de l'eau de dialyse. Parmi les exemples de dispositifs inclus figurent les dispositifs de purification d'eau, les dispositifs de surveillance de la qualité de l'eau en ligne (comme les dispositifs de surveillance de la conductivité) et les systèmes de canalisations d'alimentation en eau de dialyse.
1.3 Exclusions
Le présent document exclut les systèmes d'alimentation en liquide de dialyse qui mélangent l'eau et les concentrés pour produire le liquide de dialyse, les systèmes de régénération de liquide de dialyse sorbants qui régénèrent et recyclent de petites quantités de liquide de dialyse, les concentrés de dialyse, les systèmes d'hémodiafiltration, les systèmes d'hémofiltration, les systèmes de traitement des hémodialyseurs réutilisables et les systèmes de dialyse péritonéale. Certains de ces dispositifs, tels que les systèmes de distribution de liquide de dialyse et les concentrés, sont traités dans d'autres documents, comme l'ISO 23500‑4 ou l'ISO 23500‑5.
Le présent document exclut également la surveillance continue de la pureté de l'eau utilisée pour la préparation de liquide de dialyse, de concentrés ou pour le retraitement des dialyseurs, qui sont abordés dans l'ISO 23500‑1.
Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 2. del: Oprema za pripravo vode za uporabo pri hemodializi in podobnih terapijah (ISO 23500-2:2024)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 23500-2:2023
01-januar-2023
Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 2. del:
Oprema za pripravo vode za uporabo pri hemodializi in podobnih terapijah
(ISO/DIS 23500-2:2022)
Preparation and quality management of fluids for haemodialysis and related therapies -
Part 2: Water treatment equipment for haemodialysis applications and related therapies
(ISO/DIS 23500-2:2022)
Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und
verwandte Therapien - Teil 2: Ausstattung zur Wasseraufbereitung zur Verwendung in
der Hämodialyse und in verwandten Therapien (ISO/DIS 23500-2:2022)
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies
annexes Partie 2: Équipement de traitement de l'eau pour des applications en
hémodialyse et aux thérapies apparentées (ISO/DIS 23500-2:2022)
Ta slovenski standard je istoveten z: prEN ISO 23500-2
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 23500-2:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 23500-2:2023
oSIST prEN ISO 23500-2:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23500-2
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-11-18 2023-02-10
Preparation and quality management of fluids for
haemodialysis and related therapies —
Part 2:
Water treatment equipment for haemodialysis
applications and related therapies
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes —
Partie 2: Équipement de traitement de l'eau pour des applications en hémodialyse et aux thérapies
apparentées
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/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
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STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
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NATIONAL REGULATIONS.
ISO/DIS 23500-2:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
oSIST prEN ISO 23500-2:2023
ISO/DIS 23500-2:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23500-2
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 2:
Water treatment equipment for haemodialysis
applications and related therapies
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes —
Partie 2: Équipement de traitement de l'eau pour des applications en hémodialyse et aux thérapies
apparentées
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
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
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TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
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CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
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WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 23500-2:2022(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 23500-2:2023
ISO/DIS 23500-2:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
1.1 General . 1
1.2 Inclusions. 1
1.3 Exclusions . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 2
4.1 Dialysis water quality requirements . 2
4.1.1 General . 2
4.1.2 Chemical contaminant requirements . 2
4.1.3 Organic Carbon, pesticides and other chemicals . 3
4.1.4 Microbiology of dialysis water . 3
4.2 Water treatment equipment requirements . 4
4.2.1 General . 4
4.2.2 Backflow prevention device . 5
4.2.3 Tempering valves . 5
4.2.4 Sediment filters . 5
4.2.5 Cartridge filters . 5
4.2.6 Softeners . 6
4.2.7 Anion exchange resin tank . 6
4.2.8 Carbon media . 6
4.2.9 Chemical injection systems . 8
4.2.10 Reverse osmosis . 8
4.2.11 Deionization . 8
4.2.12 Bacteria and endotoxin retentive filters . 9
4.2.13 Storage and distribution of dialysis water . 9
4.3 Electrical safety of water treatment equipment for haemodialysis applications
and related therapies . 11
5 Testing.11
5.1 Conformity with dialysis water quality requirements. 11
5.1.1 General . 11
5.1.2 Microbiology of dialysis water . 11
5.1.3 Maximum level of chemical contaminants .13
5.2 Conformity with water treatment equipment requirements .13
5.2.1 General .13
5.2.2 Backflow prevention devices . 14
5.2.3 Tempering valves . 14
5.2.4 Sediment filters . 14
5.2.5 Cartridge filters . 14
5.2.6 Softeners . 14
5.2.7 Anion exchange resin tanks . 14
5.2.8 Carbon media .15
5.2.9 Chemical injection systems . 15
5.2.10 Reverse osmosis .15
5.2.11 Deionization . 15
5.2.12 Endotoxin retentive filters . 15
5.2.13 Storage and distribution of dialysis water . 16
6 Labelling .16
6.1 General . 16
6.2 Device markings . . 16
iii
oSIST prEN ISO 23500-2:2023
ISO/DIS 23500-2:2022(E)
6.3 Product literature . 17
Annex A (informative) Rationale for the devel
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