ISO 23500-2

Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies

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.

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

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.

General Information

• Status: Not Published
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems
• Drafting Committee: ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems
• Current Stage: 6000 - International Standard under publication
• Completion Date: 23-Apr-2024

Relations

• Consolidates: ISO 24613-4:2021 - Language resource management — Lexical markup framework (LMF) — Part 4: TEI serialization
• Effective Date: 06-Jun-2022
• Revises: 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
• Effective Date: 06-Jun-2022

Standards Content (Sample)

FINAL DRAFT
International
Standard
ISO/FDIS 23500-2
ISO/TC 150/SC 2
Preparation and quality
Secretariat: ANSI
management of fluids for
Voting begins on:
haemodialysis and related
2024-02-26
therapies —
Voting terminates on:
2024-04-22
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 thérapies apparentées
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 SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 23500-2:2024(en) © ISO 2024

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FINAL DRAFT
ISO/FDIS 23500-2:2024(en)
International
Standard
ISO/FDIS 23500-2
ISO/TC 150/SC 2
Preparation and quality
Secretariat: ANSI
management of fluids for
Voting begins on:
haemodialysis and related
therapies —
Voting terminates on:
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 thérapies apparentées
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
COPYRIGHT PROTECTED DOCUMENT
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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 Reference number
ISO/FDIS 23500-2:2024(en) © ISO 2024

© ISO 2024 – All rights reserved
ii

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ISO/FDIS 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 .
...

DRAFT INTERNATIONAL STANDARD
ISO/FDIS 23500-2:2023(E)
ISO/TC 150/SC 2
Secretariat: ANSI
Date: 2024-02-08
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 —
Second edition
2023-04-16

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Partie 2: Équipement de traitement de l'eau pour des applications en hémodialyse et thérapies apparentées
FDIS stage
© ISO 2022 – All rights reserved.
ii

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ISO/FDIS 23500-2:2024(en)
© ISO 20232024
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: + 41 22 749 01 11
EmailE-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
© ISO 2024 – All rights reserved

iii

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ISO/FDIS 23500-2:2024(en)
Table of
© ISO 2024 – All rights reserved

iv

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ISO/FDIS 23500-2:2024(en)
Contents
Foreword . Error! Bookmark not defined.
Introduction . Error! Bookmark not defined.
1 Scope . Error! Bookmark not defined.
2 Normative references . Error! Bookmark not defined.
3 Terms and definitions . Error! Bookmark not defined.
4 Requirements . Error! Bookmark not defined.
4.1 Dialysis water quality requirements . Error! Bookmark not defined.
4.2 Water treatment equipment requirements . Error! Bookmark not defined.
4.3 Electrical safety of water treatment equipment for haemodialysis applications and related
therapies . Error! Bookmark not defined.
5 Testing . Error! Bookmark not defined.
5.1 Conformity with dialysis water quality requirements . Error! Bookmark not defined.
5.2 Conformity with water treatment equipment requirements . Error! Bookmark not defined.
6 Labelling . Error! Bookmark not defined.
6.1 General . Error! Bookmark not defined.
6.2 Device or system markings . Error! Bookmark not defined.
6.3 Product literature . Error! Bookmark not defined.
(informative) Rationale for the development and provisions of this documentError! Bookmark not
defined.
(informative) . Error! Bookmark not defined.
Bibliography . Error! Bookmark not defined.

© ISO 2024 – All rights reserved

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ISO/FDIS 23500-2:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical
...