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CEN

EN ISO 23500-3:2024

(Main)

Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2024)

Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2024)

This document specifies the minimum chemical and microbiological quality requirements, for water used for preparation of dialysis fluids, concentrates, and for the reprocessing of haemodialysers, together with the necessary steps to ensure conformity with the requirements. The document also provides guidance for the ongoing monitoring of the purity of such water in terms of chemical and microbiological quality.
This document is applicable to
—     water used in the preparation of dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration and the reprocessing of haemodialysers, and
—     water used in the preparation of concentrates.
This document does not apply to dialysis fluid regenerating systems.
The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are the sole responsibility of dialysis professionals.

Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und verwandte Therapien - Teil 3: Wasser für die Hämodialyse und verwandte Therapien (ISO 23500-3:2024)

Dieses Dokument legt die Mindestanforderungen an die chemische und mikrobiologische Qualität von Wasser fest, das für die Zubereitung von Dialysierflüssigkeiten und -konzentraten sowie für die Wiederaufbereitung von Hämodialysatoren verwendet wird, sowie die notwendigen Schritte, um die Einhaltung der Anforderungen zu gewährleisten. Das Dokument gibt auch einen Leitfaden für die laufende Überwachung der Reinheit dieses Wassers in Bezug auf die chemische und mikrobiologische Qualität.
Dieses Dokument gilt für
   Wasser für die Zubereitung von Dialyseflüssigkeiten für die Hämodialyse, Hämodiafiltration und Hämofiltration sowie für die Wiederaufbereitung von Hämodialysatoren, und
   Wasser, das zur Herstellung von Konzentraten verwendet wird.
Dieses Dokument gilt nicht für Systeme zur Regeneration von Dialyseflüssigkeit.
Der Betrieb von Wasseraufbereitungsanlagen und die abschließende Vermischung von behandeltem Wasser mit Konzentraten zur Herstellung von Dialyseflüssigkeit liegen in der alleinigen Verantwortung der Dialysefachkräfte.

Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes - Partie 3: Eau pour hémodialyse et thérapies apparentées (ISO 23500-3:2024)

Le présent document spécifie les exigences minimales de qualité chimique et microbiologique applicables à l’eau utilisée pour la préparation des liquides de dialyse et des concentrés, ainsi que le traitement des hémodialyseurs. Il décrit également les étapes nécessaires pour garantir la conformité aux exigences. Le document fournit en outre des recommandations pour la surveillance continue de la pureté de cette eau à l’égard de la qualité chimique et microbiologique.
Le présent document est applicable à ce qui suit:
—     l’eau utilisée pour la préparation des liquides de dialyse pour hémodialyse, hémodiafiltration et hémofiltration, ainsi que pour le retraitement des hémodialyseurs; et
—     l’eau utilisée pour la préparation des concentrés.
Le présent document ne concerne pas les systèmes de régénération des liquides de dialyse.
Le fonctionnement de l’équipement de traitement de l’eau et le mélange final de l’eau traitée avec les concentrés pour produire le liquide de dialyse relèvent de l’entière responsabilité des néphrologues.

Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 3. del: Voda za hemodializo in podobne terapije (ISO/FDIS 23500-3:2024)

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
kSIST FprEN ISO 23500-3:2024 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO/FDIS 23500-3:2024)

Relations

Replaces
EN ISO 23500-3:2019 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019)
Effective Date
22-Dec-2021

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SLOVENSKI STANDARD
oSIST prEN ISO 23500-3:2023
01-januar-2023
Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 3. del:
Voda za hemodializo in podobne terapije (ISO/DIS 23500-3:2022)
Preparation and quality management of fluids for haemodialysis and related therapies -
Part 3: Water for haemodialysis and related therapies (ISO/DIS 23500-3:2022)
Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und
verwandte Therapien - Teil 3: Wasser für die Hämodialyse und verwandte Therapien
(ISO/DIS 23500-3:2022)
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies
annexes Partie 3: Eau pour hémodialyse et thérapies apparentées (ISO/DIS 23500-
3:2022)
Ta slovenski standard je istoveten z: prEN ISO 23500-3
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 23500-3:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 23500-3:2023

---------------------- Page: 2 ----------------------
oSIST prEN ISO 23500-3:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23500-3
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 3:
Water for haemodialysis and related therapies
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes —
Partie 3: Eau 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 23500-3:2022(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

---------------------- Page: 3 ----------------------
oSIST prEN ISO 23500-3:2023
ISO/DIS 23500-3:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23500-3
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 3:
Water for haemodialysis and related therapies
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes —
Partie 3: Eau 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
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: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 23500-3:2022(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

---------------------- Page: 4 ----------------------
oSIST prEN ISO 23500-3:2023
ISO/DIS 23500-3:2022(E)
Contents Page
Foreword .iv
Introduction .
...

Questions, Comments and Discussion

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1.1  General  This document is the base standard for a number of other standards dealing with water treatment equipment, water, dialysis water, concentrates, and dialysis fluid (ISO 23500 series) and provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, this document functions as a recommended practice.
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b)     dialysis water used for the preparation of concentrates at the user's facility,
c)    concentrates,
d)    the final dialysis fluid and substitution fluid.
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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.
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kSIST FprEN 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,
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kSIST FprEN ISO 23500-1:2024

1.1 General
This document is the base standard for a number of other standards dealing with water treatment equipment, water, dialysis water, concentrates, and dialysis fluid (ISO 23500 series) and provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, this document functions as a recommended practice.
This document does not address clinical issues that might be associated with inappropriate usage of the water, dialysis water, concentrates, or dialysis fluid. Healthcare professionals involved in the provision of treatment for kidney failure should make the final decision regarding the applications with which these fluids are used, for example, haemodialysis, haemodiafiltration, high-flux haemodialysis, and the reprocessing of dialysers, and need to be aware of the issues that the use of inappropriate fluid quality raises in each of the therapies.
The concepts incorporated in this document should not be considered inflexible or static. The recommendations presented here should be reviewed periodically in order to assimilate increased understanding of the role of dialysis fluid purity in patient outcomes and technological developments.
1.2 Inclusions
This document addresses the user's responsibility for dialysis fluid once the equipment used in its preparation has been delivered and installed.
For the purposes of this document, dialysis fluid includes:
a) dialysis water (see 3.17 for definition) used for the preparation of dialysis fluid and substitution fluid,
b) dialysis water used for the preparation of concentrates at the user's facility,
c) concentrates,
d) the final dialysis fluid and substitution fluid.
The scope of this document includes
a) the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused,
b) equipment used to prepare concentrate from powder or other highly concentrated media at a dialysis facility, and
c) preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates.
NOTE Because water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document.
1.3 Exclusions
This document does not apply to sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis.

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