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)

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)

1.1 Splošno
Ta dokument je namenjen proizvajalcem in/ali dobaviteljem sistemov in/ali naprav za pripravo vode, ki se uporabljajo izključno za zagotavljanje vode za hemodializo ali podobne terapije.
1.2 Vključitve
Ta dokument zajema naprave za pripravo pitne vode, namenjene za uporabo pri izvajanju hemodialize in podobnih terapij, vključno z vodo, ki se uporablja za:
a) pripravo koncentratov iz prahu ali drugih visoko koncentriranih medijev v dializni opremi;
b) pripravo dializne tekočine, vključno z dializno tekočino, ki jo je mogoče uporabiti za pripravo nadomestne tekočine;
c) predelavo dializatorjev za enkratno uporabo v dializatorje za večkratno uporabo, kjer je to dovoljeno;
d) predelavo dializatorjev, ki niso posebej označeni za enkratno uporabo.
Ta dokument vključuje vse naprave, cevovode in priključke med točko dovajanja pitne vode v sistem za pripravo vode in točko uporabe dializne vode. Primeri takšnih naprav so naprave za čiščenje vode, naprave za nadzor kakovosti vode (npr. naprave za nadzor prevodnosti) in cevni sistemi za distribucijo dializne vode.
1.3 Izključitve
Ta dokument ne vključuje sistemov za oskrbo z dializno tekočino, ki usklajujejo delež vode in koncentratov za proizvodnjo dializne tekočine, sistemov za regeneracijo sorbentne dializne tekočine, ki regenerirajo in recirkulirajo majhne količine dializne tekočine, dializnih koncentratov, sistemov za hemodiafiltracijo, sistemov za hemofiltracijo, sistemov za obdelavo dializatorjev za večkratno uporabo ter sistemov za peritonealno dializo. Nekatere od teh naprav, kot so sistemi za dovajanje dializne tekočine in koncentrati, so obravnavane v drugih dokumentih, npr. v standardih ISO 23500-4 in ISO 23500-5.
Ta dokument prav tako ne vključuje stalnega nadzora čistosti vode, ki se uporablja za dializno tekočino, pripravo koncentratov ali predelavo dializatorjev; to je obravnavano v standardu ISO 23500-1.

General Information

• Status: Published
• Public Enquiry End Date: 30-Jan-2023
• Publication Date: 18-Aug-2024
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 08-Aug-2024
• Due Date: 13-Oct-2024
• Completion Date: 19-Aug-2024
• Ref Project: 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

• Revised: SIST 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: 22-Dec-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2024
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)
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)
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)
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)
Ta slovenski standard je istoveten z: EN ISO 23500-2:2024
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 23500-2
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2024
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 23500-2:2019
English Version
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)
Préparation et management de la qualité des liquides Herstellung und Qualitätsmanagement von
d'hémodialyse et de thérapies annexes - Partie 2: Flüssigkeiten für die Hämodialyse und verwandte
Équipement de traitement de l'eau pour des Therapien - Teil 2: Ausstattung zur
applications en hémodialyse et aux thérapies Wasseraufbereitung zur Verwendung in der
apparentées (ISO 23500-2:2024) Hämodialyse und in verwandten Therapien (ISO
23500-2:2024)
This European Standard was approved by CEN on 23 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 23500-2:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 23500-2:2024) 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 January 2025, and conflicting national standards shall
be withdrawn at the latest by January 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 23500-2:2019.
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 23500-2:2024 has been approved by CEN as EN ISO 23500-2:2024 without any
modification.
International
Standard
ISO 23500-2
Second edition
Preparation and quality
2024-07
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
Reference number
ISO 23500-2:2024(en) © ISO 2024

ISO 23500-2:2024(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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 23500-2:2024(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 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 .3
4.2.1 General .3
4.2.2 Backflow prevention .5
4.2.3 Tempering valves .5
4.2.4 Sediment filters .5
4.2.5 Cartridge filters .5
4.2.6 Softeners .5
4.2.7 Anion exchange resin tank .5
4.2.8 Carbon media .5
4.2.9 Chemical injection systems .7
4.2.10 Reverse osmosis .7
4.2.11 Deionization .8
4.2.12 Bacteria and endotoxin retentive filters .8
4.2.13 Storage and distribution of dialysis water .8
4.3 Electrical safety of water treatment equipment for haemodialysis applications and
related therapies .10
5 Testing. 10
5.1 C onformity with dialysis water quality requirements.10
5.1.1 General .10
5.1.2 Microbiology of dialysis water .11
5.1.3 Maximum level of chemical contaminants . 12
5.2 C onformity with water treatment equipment requirements . 12
5.2.1 General . 12
5.2.2 Backflow prevention . 13
5.2.3 Tempering valves . 13
5.2.4 Sediment filters . 13
5.2.5 Cartridge filters . 13
5.2.6 Softeners . 13
5.2.7 Anion exchange resin tanks .
...