FprEN ISO 23500-4

Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO/FDIS 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/FDIS 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 gilt 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 erhöhen:
   Geräte zum Mischen von Säure und Bicarbonatpulver zur Herstellung von Konzentrat in der Einrichtung des Anwenders.
Dieses Dokument gilt nicht 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 Mengen 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/FDIS 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/FDIS 23500-4:2024)

General Information

• Status: Not Published
• Publication Date: 17-Jun-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: 5060 - Closure of Vote - Formal Approval
• Start Date: 15-Mar-2024
• Completion Date: 15-Mar-2024
• Ref Project: kSIST FprEN ISO 23500-4:2024 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO/FDIS 23500-4:2024)

Relations

• Revises: 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
oSIST prEN ISO 23500-4:2023
01-januar-2023
Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 4. del:
Koncentrati za hemodializo in podobne terapije (ISO/DIS 23500-4:2022)
Preparation and quality management of fluids for haemodialysis and related therapies -
Part 4: Concentrates for haemodialysis and related therapies (ISO/DIS 23500-4:2022)
Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und
verwandte Therapien - Teil 4: Konzentrate für die Hämodialyse und verwandte Therapien
(ISO/DIS 23500-4:2022)
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies
annexes - Partie 4: Concentrés pour hémodialyse et thérapies apparentées (ISO/DIS
23500-4:2022)
Ta slovenski standard je istoveten z: prEN ISO 23500-4
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 23500-4:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 23500-4:2023

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oSIST prEN ISO 23500-4:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23500-4
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 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
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 23500-4:2022(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

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oSIST prEN ISO 23500-4:2023
ISO/DIS 23500-4:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23500-4
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 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
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
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
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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 23500-4:2022(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
  © ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

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oSIST prEN ISO 23500-4:2023
ISO/DIS 23500-4:2022(E)
Contents Page
Foreword .v
Introduction .
...