ISO 23500-5:2024

Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies

This document specifies the minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies. This document applies to — dialysis fluids used for haemodialysis and haemodiafiltration, — substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid This document does not apply to — the water and concentrates used to prepare dialysis fluid or the equipment to produce dialysis fluid — 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. The delivery and monitoring of the dialysis fluid composition and its permitted deviation from set points is governed by protective systems defined in IEC 60601-2-16.

Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes — Partie 5: Qualité des liquides de dialyse pour hémodialyse et thérapies apparentées

Le présent document spécifie les exigences minimales de qualité chimique et microbiologique pour les liquides de dialyse dans le cadre d’hémodialyses et de thérapies apparentées. Le présent document s’applique à ce qui suit: — les liquides de dialyse utilisés à des fins d’hémodialyse et d’hémodiafiltration; — le liquide de substitution produit en ligne à des fins d’hémodiafiltration et d’hémofiltration sur la base du liquide de dialyse. Le présent document ne s’applique pas à ce qui suit: — l’eau et les concentrés utilisés pour préparer le liquide de dialyse ou l’équipement permettant de produire du liquide de dialyse; — les systèmes de régénération de liquide de dialyse à base de sorbants qui régénèrent et recyclent de petites quantités de liquide de dialyse; — les systèmes d’épuration extrarénale continue qui utilisent des solutions prêtes à l’emploi; et — les systèmes et solutions utilisés en dialyse péritonéale. La fourniture et la surveillance de la composition du liquide de dialyse et ses écarts admis par rapport aux points de consigne sont régis par des systèmes de protection définis dans l’IEC 60601-2-16.

General Information

• Status: Published
• Publication Date: 16-Apr-2024
• 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: 6060 - International Standard published
• Start Date: 17-Apr-2024
• Due Date: 03-Dec-2023
• Completion Date: 17-Apr-2024

Relations

• Revises: ISO 23500-5:2019 - Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
• Effective Date: 06-Jun-2022

Standards Content (Sample)

International
Standard
ISO 23500-5
Second edition
Preparation and quality
2024-04
management of fluids for
haemodialysis and related
therapies —
Part 5:
Quality of dialysis fluid for
haemodialysis and related therapies
Préparation et management de la qualité des liquides
d'hémodialyse et de thérapies annexes —
Partie 5: Qualité des liquides de dialyse pour hémodialyse et
thérapies apparentées
Reference number
ISO 23500-5:2024(en) © ISO 2024

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ISO 23500-5:2024(en)
COPYRIGHT PROTECTED DOCUMENT
© 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

© ISO 2024 – All rights reserved
ii

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ISO 23500-5:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 Microbiological contaminants in dialysis fluid .2
4.1.1 General .2
4.1.2 Microbiological requirements for standard dialysis fluid .2
4.1.3 Microbiological requirements for ultrapure dialysis fluid .2
4.1.4 Microbiological requirements for online prepared substitution fluid .2
4.2 Chemical composition of dialysis fluid .3
4.3 Chemical contaminants in dialysis fluid .3
5 Tests for conformity . 3
5.1 Microbiological requirements.3
5.1.1 Sampling .3
5.1.2 Culture methods .3
5.2 Chemical requirements . .5
Annex A (informative) Rationale for the development and provisions of this docu
...

Norme
internationale
ISO 23500-5
Deuxième édition
Préparation et management de la
2024-04
qualité des liquides d'hémodialyse
et de thérapies annexes —
Partie 5:
Qualité des liquides de dialyse
pour hémodialyse et thérapies
apparentées
Preparation and quality management of fluids for haemodialysis
and related therapies —
Part 5: Quality of dialysis fluid for haemodialysis and related
therapies
Numéro de référence
ISO 23500-5:2024(fr) © ISO 2024

---------------------- Page: 1 ----------------------
ISO 23500-5:2024(fr)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2024
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: [phone]
E-mail: [e-mail]
Web: www.iso.org
Publié en Suisse

© ISO 2024 – Tous droits réservés
ii

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ISO 23500-5:2024(fr)
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 2
4 Exigences . 2
4.1 Contaminants microbiologiques dans le liquide de dialyse .2
4.1.1 Généralités .2
4.1.2 Exigences microbiologiques relatives au liquide de dialyse standard .2
4.1.3 Exigences microbiologiques relatives au liquide de dialyse ultrapur .2
4.1.4 Exigences microbiologiques relatives au liquide de substitution préparé en ligne .3
4.2 Composition chimique du liquide de dialyse .3
4.3 Contaminants chimiques présents dans le liquide de dialyse.3
5 Essais de conformité . 3
5.1 Exigences microbiologiques .3
5.1.1 Échantillonnage.3
5.1.2 Méthodes de culture .4
5.2 Exigences chimiques .5
Annexe A (informative) Justification de l’élaboration et des dispositions du présent document . 6
Annexe B (informative) Tableaux de référence .
...

FINAL DRAFT
International
Standard
ISO/FDIS 23500-5
ISO/TC 150/SC 2
Preparation and quality
Secretariat: ANSI
management of fluids for
Voting begins on:
haemodialysis and related
2024-01-19
therapies —
Voting terminates on:
2024-03-15
Part 5:
Quality of dialysis fluid for
haemodialysis and related therapies
Préparation et management de la qualité des liquides
d'hémodialyse et de thérapies annexes —
Partie 5: Qualité des liquides de dialyse pour 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 23500-5:2024(en) © ISO 2024

---------------------- Page: 1 ----------------------
FINAL DRAFT
ISO/FDIS 23500-5:2024(en)
International
Standard
ISO/FDIS 23500-5
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 5:
Quality of dialysis fluid for
haemodialysis and related therapies
Préparation et management de la qualité des liquides
d'hémodialyse et de thérapies annexes —
Partie 5: Qualité des liquides de dialyse pour 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 23500-5:2023(en) © ISO 2023

© ISO 2024 – All rights reserved
ii

---------------------- Page: 2 ----------------------
ISO/FDIS 23500-5:2023(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 Microbiological contaminants in dialysis fluid .2
4.1.1 General .2
4.1.2 Microbiological requirements for standard dialysis fluid .2
4.1.3 Microbiological requirements for ultrapure dialysis fluid .
...

ISO/FDIS 23500--5:2023(E)
ISO/TC 150/SC 2
Secretariat: ANSI
Preparation and quality management of fluids for haemodialysis and related therapies
— Part 5: Quality of dialysis fluid for haemodialysis and related therapies
La Préparation et le management de la qualité des liquides d'hémodialyse et de thérapies annexes
— Partie 5: Qualité des liquides de dialyse pour hémodialyse et thérapies apparentées
Second edition
Date: 2023-05-1612-12

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ISO/FDIS 23500-5:2023(E)
© ISO 2023
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
© ISO 2023 – All rights reserved iii

---------------------- Page: 2 ----------------------
ISO/FDIS 23500-5:2023(E)
Table of Contents
Foreword . 5
Introduction . 6
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 2
4.1 Microbiological contaminants in dialysis fluid . 2
4.1.1 General . 2
4.1.2 Microbiological requirements for standard dialysis fluid . 2
4.1.3 Microbiological requirements for ultrapure dialysis fluid . 2
4.1.4 Microbiological requirements for online prepared substitution fluid . 3
4.2 Chemical composition of dialysis fluid . 3
4.3 Chemical contaminants in dialysis fluid . 3
5 Tests for conformity . 3
5.1 Microbiological requirements . 3
5.1.1 Sampling . 3
5.1.2 Culture methods . 4
5.2 Chemical requirements . 5
Annex A (informative) Rationale for the development and provisions of this document . 6
Annex B (informative) Reference tables . 9
Bibliography . 13

iv © ISO 2023 – All rights reserved

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ISO/FDIS 23500-5:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing In
...