ISO/FDIS 23500-1

Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements

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.

Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes — Partie 1: Exigences générales

1.1 Généralités Le présent document constitue la norme de base pour un certain nombre d'autres normes portant sur l'équipement de traitement de l'eau, la dialyse de l'eau, les concentrés et les liquides de dialyse (série de normes ISO 23500) et fournit aux médecins dialyseurs des recommandations relatives à la préparation du liquide de dialyse pour des applications en hémodialyse et thérapies apparentées et du liquide de substitution à utiliser pour des traitements en ligne, tels que l'hémodiafiltration et l'hémofiltration. En tant que tel, le présent document se veut une pratique recommandée. Le présent document ne traite pas des problèmes cliniques qui pourraient être associés à un usage inapproprié de l'eau, de l'eau de dialyse, des concentrés ou du liquide de dialyse. Il convient que les professionnels de santé impliqués dans la fourniture d'un traitement pour insuffisance rénale prennent la décision finale concernant les applications avec lesquelles ces liquides sont utilisés, par exemple hémodialyse, hémodiafiltration et hémodialyse à haut flux, ainsi que le retraitement des dialyseurs; il est également nécessaire qu'ils soient conscients des problèmes que l'utilisation d'une qualité de liquide inappropriée soulève pour chaque thérapie. Il convient de ne pas considérer les concepts inclus dans le présent document comme inflexibles ou immuables. Il convient de relire régulièrement les recommandations présentées dans le présent document afin de comprendre que le rôle de la pureté du liquide de dialyse est important eu égard aux résultats médicaux du patient et aux développements technologiques. 1.2 Inclusions Le présent document traite de la responsabilité de l'utilisateur vis-à-vis du liquide de dialyse une fois que l'équipement utilisé pour sa préparation a été délivré et installé. Pour les besoins du présent document, le liquide de dialyse comprend: a) l'eau de dialyse (voir définition en 3.17) utilisée pour la préparation du liquide de dialyse et du liquide de substitution; b) l'eau de dialyse utilisée pour la préparation des concentrés dans l'installation de l'utilisateur; c) les concentrés; d) le liquide de dialyse final et le liquide de substitution. Le domaine d'application du présent document inclut: a) le management de la qualité de l'équipement employé pour traiter et distribuer l'eau utilisée pour préparer le liquide de dialyse et le liquide de substitution, depuis le point d'entrée de l'eau municipale dans le centre de dialyse jusqu'au point d'entrée du liquide de dialyse final dans le dialyseur ou jusqu'au point d'injection du liquide de substitution; b) l'équipement utilisé pour préparer le concentré à partir d'une poudre ou de tout autre milieu très concentré dans un centre de dialyse; et c) la préparation du liquide de dialyse final ou du liquide de substitution à partir d'eau de dialyse et de concentrés. NOTE Comme l'eau utilisée pour préparer le liquide de dialyse peut également être utilisée pour retraiter les dialyseurs non marqués destinés à un usage unique, cet aspect de l'utilisation d'eau est également couvert par le présent document. 1.3 Exclusions Le présent document ne s'applique pas aux systèmes de régénération des liquides de dialyse à base de sorbants qui régénèrent et font recirculer de petits volumes de liquide de dialyse, aux systèmes d'épuration extra-rénale continue qui utilisent des solutions prêtes à l'emploi, ni aux systèmes et solutions utilisés en dialyse péritonéale.

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: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 20-Feb-2024
• Completion Date: 20-Feb-2024

Relations

• Consolidates: ISO 24613-3:2021 - Language resource management — Lexical markup framework (LMF) — Part 3: Etymological extension
• Effective Date: 06-Jun-2022
• Revises: ISO 23500-1:2019 - Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements
• Effective Date: 06-Jun-2022

Standards Content (Sample)

FINAL DRAFT
International
Standard
ISO/FDIS 23500-1
ISO/TC 150/SC 2
Preparation and quality
Secretariat: ANSI
management of fluids for
Voting begins on:
haemodialysis and related
2024-02-20
therapies —
Voting terminates on:
2024-04-16
Part 1:
General requirements
Préparation et management de la qualité des liquides
d'hémodialyse et de thérapies annexes —
Partie 1: Exigences générales
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 23500-1:2024(en) © ISO 2024

---------------------- Page: 1 ----------------------
FINAL DRAFT
ISO/FDIS 23500-1:2024(en)
International
Standard
ISO/FDIS 23500-1
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 1:
General requirements
Préparation et management de la qualité des liquides
d'hémodialyse et de thérapies annexes —
Partie 1: Exigences générales
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 23500-1:2024(en) © ISO 2024

© ISO 2024 – All rights reserved
ii

---------------------- Page: 2 ----------------------
ISO/FDIS 23500-1:2024(en)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Quality requirements .10
4.1 General .10
4.2 Dialysis water .10
4.2.1 General .10
4.2.2 Chemical contaminants in dialysis water .10
4.2
...

ISO/FDIS 23500-1:2023(E)
ISO/TC 150/SC 2
Secretariat: ANSI
Date: 2024-02-02
Preparation and quality management of fluids for haemodialysis
and related therapies — —
Part 1:
General requirements
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes — Partie 1:
Exigences générales —
Second edition
2023-06-22

---------------------- Page: 1 ----------------------
Partie 1: Exigences générales
FDIS stage

---------------------- Page: 2 ----------------------
ISO/FDIS 23500-1:2024(en)
© ISO 2023 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'sISO’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
Email: E-mail: [e-mail]
Website: www.iso.org
Published in Switzerland.
© ISO 2024 – All rights reserved

iv

---------------------- Page: 3 ----------------------
ISO/FDIS 23500-1:2024(en)
Table of
© ISO 2024 – All rights reserved

v

---------------------- Page: 4 ----------------------
ISO/FDIS 23500-1:2024(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 Quality requirements . Error! Bookmark not defined.
4.1 General . Error! Bookmark not defined.
4.2 Dialysis water . Error! Bookmark not defined.
4.3 Requirements for concentrate . Error! Bookmark not defined.
4.4 Requirements for dialysis fluid . Error! Bookmark not defined.
4.5 Record retention . Error! Bookmark not defined.
5 System design and technical considerations . Error! Bookmark not defined.
5.1 General . Error! Bookmark not defined.
5.2 Technical aspects . Error! Bookmark not defined.
5.3 Microbiological aspects . Error! Bookmark not defined.
5.4 Environmental impact . Error! Bookmark not defined.
6 Validation of system performance . Error! Bookmark not defined.
6.1 General . Error! Bookmark not defined.
6.2 Validation plan . Error! Bookmark not defined.
6.3 Installation and operational qualification . Error! Bookmark not defined.
6.4 Performance qualification . Error! Bookmark not defined.
6.5 Validation . Error! Bookmark not defined.
6.6 Monitoring and surveillance . Error! Bookmark not defined.
7 Quality management . Error! Bookmark not defined.
7.1 General . Error! Bookmark not defined.
7.2 Surveillance of fluid quality . Error! Bookmark not defined.
7.3 Surveillance of water treatment equipment . Er
...