EN ISO 23500-4:2024

Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2024)

This document specifies the chemical and microbiological requirements for concentrates used for haemodialysis and related therapies and applies to the manufacturer of such concentrates.
This document is applicable to:
—     concentrates in both liquid and powder forms;
—     additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid;
—     equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
This document does not apply to:
—     concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility;
—     pre-packaged and sterile dialysis fluid;
—     sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid;
—     equipment to perform patient treatment; this is addressed IEC 60601-2-16.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.

Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und verwandte Therapien - Teil 4: Konzentrate für die Hämodialyse und verwandte Therapien (ISO 23500-4:2024)

Dieses Dokument legt die chemischen und biologischen Anforderungen an Konzentrate für die Hämodialyse und verwandte Therapien fest und gilt für Hersteller dieser Konzentrate.
Dieses Dokument ist anwendbar für:
-   Konzentrate sowohl in Flüssig  als auch in Pulverform;
-   Zusätze, auch Spikes genannt. Dies sind Chemikalien, die dem Konzentrat hinzugefügt werden können, um eine oder mehrere der im Konzentrat vorkommenden Ionen und somit auch in der fertigen Dialysierflüssigkeit zu ergänzen oder zu erhöhen:
-   Geräte zum Mischen von Säure und Bicarbonatpulver zur Herstellung von Konzentrat in der Einrichtung des Anwenders.
Dieses Dokument ist nicht anwendbar für:
-   Konzentrate aus vorverpackten Salzen sowie Wasser in einer Dialyseeinrichtung zur Verwendung in der Dialyseeinrichtung;
-   vorverpackte Beutel mit steriler Dialysierflüssigkeit;
-   sorbensbasierte Dialysierflüssigkeits Wiederaufbereitungssysteme, die geringe Volumen der Dialysierflüs¬sigkeit wiederaufbereiten und wieder in Umlauf bringen;
-   Geräte für die Behandlung von Patienten. Dies ist Gegenstand der IEC 60601 2 16.
Dieses Dokument behandelt nicht die Dialysierflüssigkeit, die zur klinischen Dialyse bei Patienten verwendet wird. Dialysierflüssigkeit wird in ISO 23500 5 definiert. Die Herstellung von Dialysierflüssigkeit beinhaltet die Dosierung von Konzentraten und Wasser am Krankenbett oder in einem zentralen Dialysierflüssigkeits Zufuhrsystem. Obwohl die Etikettenanforderungen an Dialysierflüssigkeiten auf dem Etikett des Konzentrats vermerkt sind, liegt die Verantwortung für dessen sachgemäße Benutzung beim Anwender.

Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes - Partie 4: Concentrés pour hémodialyse et thérapies apparentées (ISO 23500-4:2024)

Le présent document spécifie les exigences chimiques et microbiologiques pour les concentrés utilisés à des fins d’hémodialyse et thérapies apparentées, et s’applique au fabricant de ces concentrés.
Le présent document est applicable à ce qui suit :
—     les concentrés sous forme de liquide et de poudre ;
—     les additifs, également appelés dopants, qui sont des substances chimiques pouvant être ajoutées au concentré pour enrichir ou augmenter la concentration d’un ou de plusieurs ions existants dans le concentré, et donc dans le liquide de dialyse final ;
—     l’appareil utilisé pour mélanger les poudres d’acide et de bicarbonate dans le concentré au sein de l’installation de l’utilisateur.
Le présent document ne s’applique pas à ce qui suit :
—     les concentrés préparés à partir d’eau de dialyse et de sels préemballés produits au centre de dialyse en vue d’être utilisés dans ce centre ;
—     le liquide de dialyse stérile et préemballé ;
—     les systèmes de régénération de liquide de dialyse sorbants qui régénèrent et recyclent de petites quantités de liquide de dialyse ;
—     l’équipement nécessaire au traitement du patient, qui est couvert par l’IEC 60601-2-16.
Le présent document ne concerne pas les liquides de dialyse utilisés pour la dialyse clinique des patients. Le liquide de dialyse est traité dans l’ISO 23500-5. La production de liquides de dialyse implique le dosage de concentré et d’eau au chevet du patient ou dans un système de distribution de liquide de dialyse centralisé. Bien que les exigences d’étiquetage des liquides de dialyse portent sur l’étiquetage du concentré, il est de la responsabilité de l’utilisateur d’en garantir la bonne utilisation.

Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 4. del: Koncentrati za hemodializo in podobne terapije (ISO 23500-4:2024)

Ta dokument določa minimalne zahteve glede koncentratov za hemodializo in podobne terapije.
Ta dokument je namenjen proizvajalcem takšnih koncentratov. V nekaterih izdajah tega dokumenta je obravnavana dializna tekočina, ki jo pripravi končni uporabnik, da bi s tem pojasnili zahteve za proizvodnjo koncentratov. Ker proizvajalec koncentrata nima nadzora nad končno dializno tekočino, so vsi sklici na dializno tekočino namenjeni pojasnitvi in ne predstavljajo zahteve za proizvajalca.
Ta dokument zajema koncentrate v obliki tekočin in praškov. Zajema tudi aditive, imenovane tudi dodatki, ki so kemična sredstva za dodajanje h koncentratu, s čimer se dopolni ali poveča koncentracija enega ali več obstoječih ionov v koncentratu in s tem tudi v končni dializni tekočini.
Ta dokument podaja tudi zahteve za opremo za mešanje kislin in bikarbonatnih praškov v koncentrat v uporabnikovi opremi.
Koncentrati, pripravljeni v dializni opremi iz vnaprej pakiranih soli in vode, ki se uporabljajo v takšni opremi, ne spadajo na področje uporabe tega dokumenta. Čeprav se v tem dokumentu pojavljajo sklici na dializno tekočino, ta dokument ne obravnava dializne tekočine, kot jo pripravi končni uporabnik. Ta dokument prav tako ne vsebuje zahtev glede pogostosti nadzora za čistost vode, ki se uporablja za pripravo dializne tekočine v dializni opremi. Ta dokument ne obravnava vrečk v sistemih za regeneracijo sterilne dializne tekočine ali sorbentne dializne tekočine, ki regenerirajo in recirkulirajo majhne količine dializne tekočine.
Ta dokument ne zajema dializne tekočine, ki se uporablja pri klinični dializi bolnikov. Dializna tekočina je obravnavana v standardu ISO 23500-5. Priprava dializne tekočine vključuje določanje deleža koncentrata in vode v obposteljnih in centralnih sistemih dovajanja dializne tekočine. Čeprav so zahteve o označevanju za dializno tekočino navedene na etiketi koncentrata, je uporabnik odgovoren, da zagotovi pravilno uporabo.
Ta dokument ne zajema opreme za hemodializo, ki je obravnavana v standardu IEC 60601-2-16:2012.

General Information

• Status: Published
• Publication Date: 23-Apr-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: 24-Apr-2024
• Completion Date: 24-Apr-2024
• Ref Project: SIST EN ISO 23500-4:2024 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2024)

Relations

• Replaces: EN ISO 23500-4:2019 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2019)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2024
Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 4. del:
Koncentrati za hemodializo in podobne terapije (ISO 23500-4:2024)
Preparation and quality management of fluids for haemodialysis and related therapies -
Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2024)
Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und
verwandte Therapien - Teil 4: Konzentrate für die Hämodialyse und verwandte
Therapien (ISO 23500-4:2024)
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies
annexes - Partie 4: Concentrés pour hémodialyse et thérapies apparentées (ISO 23500-
4:2024)
Ta slovenski standard je istoveten z: EN ISO 23500-4:2024
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 23500-4
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2024
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 23500-4:2019
English Version
Preparation and quality management of fluids for
haemodialysis and related therapies - Part 4: Concentrates
for haemodialysis and related therapies (ISO 23500-
4:2024)
Préparation et management de la qualité des liquides Herstellung und Qualitätsmanagement von
d'hémodialyse et de thérapies annexes - Partie 4: Flüssigkeiten für die Hämodialyse und verwandte
Concentrés pour hémodialyse et thérapies apparentées Therapien - Teil 4: Konzentrate für die Hämodialyse
(ISO 23500-4:2024) und verwandte Therapien (ISO 23500-4:2024)
This European Standard was approved by CEN on 18 April 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 23500-4:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 23500-4:2024) 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 October 2024, and conflicting national standards shall
be withdrawn at the latest by October 2024.
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 23500-4:2019.
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 23500-4:2024 has been approved by CEN as EN ISO 23500-4:2024 without any
modification.
International
Standard
ISO 23500-4
Second edition
Preparation and quality
2024-04
management of fluids for
haemodialysis and related
therapies —
Part 4:
Concentrates for haemodialysis and
related therapies
Préparation et management de la qualité des liquides
d'hémodialyse et de thérapies annexes —
Partie 4: Concentrés pour hémodialyse et thérapies apparentées
Reference number
ISO 23500-4:2024(en) © ISO 2024

ISO 23500-4:2024(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
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Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 23500-4:2024(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 2
4.1 Concentrates .2
4.1.1 Physical state .2
4.1.2 Water .3
4.1.3 Bacteriology of concentrates .3
4.1.4 Endotoxin levels .3
4.1.5 Fill quantity . .3
4.1.6 Chemical grade . .3
4.1.7 Particulates .4
4.1.8 Additives — “Spikes” .4
4.1.9 Containers .4
4.1.10 Bulk-delivered concentrate .4
4.1.11 Concentrate generators .4
4.2 Manufacturing equipment .5
4.3 Systems for bulk mixing concentrate at a dialysis facility .5
4.3.1 General .5
4.3.2 Materials compatibility .5
4.3.3 Disinfection protection.5
4.3.4 Safety requirements .6
4.3.5 Bulk storage tanks .6
4.3.6 Ultraviolet irradiators .6
4.3.7 Piping systems.6
4.3.8 Electrical safety requirements .6
5 Tests . 7
5.1 General .7
5.2 Concentrates .7
5.2.1 Physical state .7
5.2.2 Solute concentrations .7
5.2.3 Water .8
5.2.4 Microbial contaminant test methods for bicarbonate concentrates.8
5.2.5 Endotoxin levels .8
5.2.6 Fill quantity . .9
5.2.7 Chemical grade . . .9
5.2.8 Particulates .9
5.2.9 Additives — “Spikes” .
...