EN 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)

This document specifies requirements and recommendations for individual water treatment devices and water treatment systems assembled from one or more of such devices. This document is directed at the individual or company that specifies the complete water treatment system and, the supplier who assembles and installs the system. Since systems can be assembled from a number of individual water treatment devices, the provisions of this document are also directed at the manufacturers of these devices, provided that the manufacturer indicates that the device is intended to be used to supply water for haemodialysis and related therapies.
This document is applicable to all devices, piping and fittings between the point at which water is delivered to the water purification system and the point of use of the purified water. Such components include but are not necessarily limited to water purification devices, online water quality monitors (such as conductivity monitors) and piping systems for the distribution of purified water.
This document does not apply to
—     equipment used in the preparation of concentrates from powder or other highly concentrated media at a dialysis facility either for a single patient or multiple patients,
—     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 or haemofiltration systems,
—     systems that process dialysers for multiple uses, and
—     peritoneal dialysis systems.
Requirements for the ongoing monitoring of water purity in terms of chemical and microbiological quality are given in ISO 23500-3.

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)

Le présent document spécifie des exigences et des recommandations concernant les dispositifs de traitement d’eau individuels et les systèmes de traitement d’eau assemblés à partir d’un ou de plusieurs de ces dispositifs. Le présent document s’adresse à la personne ou à la société qui spécifie l’ensemble du système de traitement d’eau, ainsi qu’au fournisseur qui assemble et installe le système. Comme les systèmes peuvent être assemblés à partir de dispositifs de traitement d’eau individuels, les dispositions du présent document s’adressent également aux fabricants desdits dispositifs, à condition que le fabricant indique que le dispositif est destiné à servir à fournir de l’eau pour l’hémodialyse et les thérapies apparentées.
Le présent document s’applique à tous les dispositifs, tuyauteries et raccords situés entre le point de distribution de l’eau au système de purification d’eau et le point d’utilisation de l’eau purifiée. Ces composants incluent, sans nécessairement s’y limiter, 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 purifiée.
Le présent document ne s’applique pas:
—     aux équipements utilisés pour préparer des concentrés à partir d’une poudre ou d’autres milieux hautement concentrés dans un centre de dialyse, que ce soit pour un seul patient ou plusieurs patients;
—     aux systèmes d’alimentation en liquide de dialyse qui mélangent de l’eau et des concentrés pour produire le liquide de dialyse;
—     aux systèmes de régénération de liquide de dialyse sur sorbant qui régénèrent et recyclent de petites quantités de liquide de dialyse;
—     aux concentrés de dialyse;
—     aux systèmes d’hémodiafiltration ou d’hémofiltration;
—     aux systèmes de traitement des hémodialyseurs réutilisables; et
—     aux systèmes de dialyse péritonéale.
Les exigences relatives à la surveillance continue de la pureté de l’eau en matière de qualité chimique et microbiologique sont énoncées dans l’ISO 23500-3.

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

• Status: Published
• Publication Date: 30-Jul-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: 31-Jul-2024
• Completion Date: 31-Jul-2024
• Ref Project: SIST EN 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)

Relations

• Replaces: EN ISO 23500-2:2019 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2019)
• Effective Date: 18-Jan-2023

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,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
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
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
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
...