SIST EN ISO 23500-1:2019
(Main)Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2019)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2019)
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.
Leitfaden für die Vorbereitung und das Qualitätsmanagement von Konzentraten für die Hämodialyse und verwandte Therapien - Teil 1: Allgemeine Anforderungen (ISO 23500-1:2019)
Dieses Dokument ist die grundlegende Norm für eine Zahl anderer Normen, die Wasserbehandlungsausstattung, Wasser, Dialysierwasser, Konzentrate und Dialysierflüssgkeit behandeln (ISO 23500 Reihe) und gibt im Dialysebereich tätigen praktischen Ärzten eine Anleitung zur Herstellung von Dialysierflüssigkeit für Hämodialyse und verwandte Therapien sowie Substitutionsflüssigkeiten für den Einsatz bei Online-Therapien, wie der Hämodiafiltration und der Hämofiltration, zur Verfügung. Damit fungiert dieses Dokument als empfohlene Praxis.
Dieses Dokument behandelt keine klinischen Aspekte, die mit der unsachgemäßen Verwendung von Wasser, Dialysewasser, Konzentraten oder Dialysierflüssigkeit im Zusammenhang stehen können. Die endgültige Entscheidung hinsichtlich der Anwendung dieser Flüssigkeiten, z. B. für Hämodialyse, Hämodiafiltration, Hochfluss Hämodialyse, sowie zur Regeneration der Dialysatoren sollte durch die medizinischen Fachkräfte getroffen werden, die die Behandlung in Fällen des Nierenversagens bereitstellen und die sich auch der Probleme im Zusammenhang mit einer unsachgemäßen Qualität der Flüssigkeiten bei jeder dieser Therapien bewusst sein müssen.
Die in diesem Dokument enthaltenen Konzepte sollten nicht als unflexibel oder statisch verstanden werden. Die gegebenen Empfehlungen sollten regelmäßig überprüft werden, um das Verständnis für die Bedeutung der Reinheit der Dialysierflüssigkeit in die Patientenbehandlung und die technologische Entwicklung einzubeziehen.
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes - Partie 1: Exigences générales (ISO 23500-1:2019)
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 péri
Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 1. del: Splošne zahteve (ISO 23500-1:2019)
Ta dokument je osnovni standard za številne druge standarde, ki obravnavajo opremo za pripravo vode, vodo, dializno vodo, koncentrate in dializno tekočino (skupina standardov ISO 23500) ter zagotavlja zdravnikom, ki predpišejo zdravljenje z dializo, smernice za pripravo tekočine za hemodializo in podobne terapije ter nadomestne tekočine za uporabo pri terapijah »on-line«, kot so hemodiafiltracija in hemofiltracija. Ta dokument se tako uporablja kot priporočena praksa.
Ta dokument ne obravnava kliničnih vprašanj, ki so morda povezana z neustrezno uporabo vode, dializne vode, koncentratov ali dializne tekočine. Zdravstveni delavci, ki so vključeni v zdravljenje pri odpovedi ledvic, morajo sprejeti dokončno odločitev v zvezi z uporabo teh tekočin, na primer za hemodializo, hemodiafiltracijo, visokopretočno hemodializo in ponovno obdelavo dializatorjev, ter morajo biti seznanjeni s težavami, ki se lahko pojavijo zaradi uporabe neustrezne tekočine pri posamezni terapiji.
Pojmov, ki so vključeni v ta dokument, se ne sme upoštevati kot neprilagodljive ali statične. Tukaj predstavljena priporočila naj se pregledujejo redno, da se zagotovi boljše
razumevanje vloge čistosti dializne tekočine pri rezultatih zdravljenja in tehnoloških napredkih.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 23500-1:2019
01-maj-2019
1DGRPHãþD
SIST EN ISO 23500:2015
3ULSUDYDLQYRGHQMHNDNRYRVWLWHNRþLQ]DKHPRGLDOL]RLQSRGREQHWHUDSLMHGHO
6SORãQH]DKWHYH ,62
Preparation and quality management of fluids for haemodialysis and related therapies -
Part 1: General requirements (ISO 23500-1:2019)
Leitfaden für die Vorbereitung und das Qualitätsmanagement von Konzentraten für die
Hämodialyse und verwandte Therapien - Teil 1: Allgemeine Anforderungen (ISO 23500-
1:2019)
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies
annexes - Partie 1: Exigences générales (ISO 23500-1:2019)
Ta slovenski standard je istoveten z: EN ISO 23500-1:2019
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
SIST EN ISO 23500-1:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 23500-1:2019
---------------------- Page: 2 ----------------------
SIST EN ISO 23500-1:2019
EN ISO 23500-1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2019
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 23500:2015
English Version
Preparation and quality management of fluids for
haemodialysis and related therapies - Part 1: General
requirements (ISO 23500-1:2019)
Préparation et management de la qualité des liquides Leitfaden für die Vorbereitung und das
d'hémodialyse et de thérapies annexes - Partie 1: Qualitätsmanagement von Konzentraten für die
Exigences générales (ISO 23500-1:2019) Hämodialyse und verwandte Therapien - Teil 1:
Allgemeine Anforderungen (ISO 23500-1:2019)
This European Standard was approved by CEN on 18 January 2019.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23500-1:2019 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 23500-1:2019
EN ISO 23500-1:2019 (E)
Contents Page
European foreword . 3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 23500-1:2019
EN ISO 23500-1:2019 (E)
European foreword
This document (EN ISO 23500-1:2019) has been prepared by Technical Committee ISO/TC 150
"Implants for surgery" in collaboration with Technical Committee CEN/TC 205 “Non-active medical
devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2019, and conflicting national standards
shall be withdrawn at the latest by September 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 23500:2015.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 23500-1:2019 has been approved by CEN as EN ISO 23500-1:2019 without any
modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 23500-1:2019
---------------------- Page: 6 ----------------------
SIST EN ISO 23500-1:2019
INTERNATIONAL ISO
STANDARD 23500-1
First edition
2019-02
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
Reference number
ISO 23500-1:2019(E)
©
ISO 2019
---------------------- Page: 7 ----------------------
SIST EN ISO 23500-1:2019
ISO 23500-1:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 23500-1:2019
ISO 23500-1:2019(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
1.1 General . 1
1.2 Inclusions . 1
1.3 Exclusions . 2
2 Normative references . 2
3 Terms and definitions . 2
4 Quality requirements . 9
4.1 General . 9
4.2 Dialysis water . 9
4.2.1 General. 9
4.2.2 Chemical contaminants in dialysis water . 9
4.2.3 Organic Carbon, pesticides and other chemicals .11
4.2.4 Microbiological contaminants in dialysis water .11
4.3 Requirements for concentrate .12
4.3.1 Chemical and microbiological contaminants in concentrate .12
4.3.2 Water used to prepare concentrate .12
4.4 Requirements for dialysis fluid .12
4.4.1 General.12
4.4.2 Microbiological requirements for standard dialysis fluid .13
4.4.3 Microbiological requirements for ultrapure dialysis fluid .13
4.4.4 Microbiological requirements for online-prepared substitution fluid.13
4.5 Record retention .13
5 Critical aspects of system design .14
5.1 General .14
5.2 Technical aspects .14
5.3 Microbiological aspects .15
5.4 Environmental impact .16
6 Validation of system performance .16
6.1 General .16
6.2 Validation plan .17
6.3 Installation and operational qualification .17
6.4 Performance qualification .18
6.5 Routine surveillance and revalidation .18
7 Quality management .19
7.1 General .19
7.2 Surveillance of fluid quality .19
7.2.1 Surveillance of dialysis water quality .19
7.2.2 Surveillance of concentrate quality .20
7.2.3 Surveillance of dialysis fluid quality .20
7.3 Surveillance of water treatment equipment .20
7.3.1 General.20
7.3.2 Surveillance of sediment filters.20
7.3.3 Surveillance of cartridge filters .21
7.3.4 Surveillance of softeners .21
7.3.5 Surveillance of carbon media .21
7.3.6 Surveillance of chemical injection systems.22
7.3.7 Surveillance of reverse osmosis.22
7.3.8 Surveillance of deionization .24
7.3.9 Surveillance of endotoxin-retentive filters .24
7.4 Surveillance of dialysis water storage and distribution .24
© ISO 2019 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 23500-1:2019
ISO 23500-1:2019(E)
7.4.1 Surveillance of water storage tanks .24
7.4.2 Surveillance of the water distribution systems .24
7.4.3 Surveillance of bacterial control devices .25
7.5 Surveillance of concentrate preparation .25
7.5.1 Surveillance of mixing systems .25
7.5.2 Surveillance of additives .26
7.6 Surveillance of concentrate distribution .26
7.7 Surveillance of dialysis fluid proportioning .26
8 Strategies for microbiological control .26
8.1 General .26
8.2 Disinfection .27
8.2.1 General.27
8.2.2 Microbiological aspects of fluid system design .27
8.2.3 Disinfection frequency .28
8.3 Microbiological surveillance methods .29
8.3.1 General.29
8.3.2 Sample collection .29
8.3.3 Heterotrophic plate count .30
8.3.4 Bacterial endotoxin test .32
8.3.5 Determination of yeast and mould .32
9 Location of and access to the water treatment system .32
10 Personnel .32
Annex A (informative) Rationale for the development and provisions of this document .33
Annex B (informative) Equipment .38
Annex C (informative) Surveillance guidelines for water treatment equipment,
distribution systems, and dialysis fluid .56
Annex D (informative) Strategies for microbiological control .61
Annex E (informative) Validation .68
Annex F (informative) Special considerations for home haemodialysis .71
Annex G (informative) Special considerations for acute haemodialysis .77
Bibliography .82
iv © ISO 2019 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 23500-1:2019
ISO 23500-1:2019(E)
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 Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 2, Cardiovascular implants and extracorporeal systems.
This first edition cancels and replaces ISO 23500:2014, which has been technically revised. The main
changes compared to the previous edition are as follows:
— The document forms part of a revised and renumbered series dealing with the preparation and
quality management of fluids for haemodialysis and related therapies. The series comprise
ISO 23500-1 (previously ISO 23500), ISO 23500-2, (previously ISO 26722), ISO 23500-3, (previously
ISO 13959), ISO 23500-4, (previously ISO 13958), and ISO 23500-5, (previously ISO 11663).
A list of all parts in the ISO 23500 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
© ISO 2019 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 23500-1:2019
ISO 23500-1:2019(E)
Introduction
This document is the base standard for a number of other standards dealing with water treatment and
the production of dialysis fluid (ISO 23500 series).
The objective of the ISO 23500 series is to provide users with guidance for handling water and
concentrates and for the production and quality oversight of dialysis fluid used for haemodialysis.
The need for such guidance is based on the critical role of dialysis fluid quality in providing safe and
effective haemodialysis, and the recognition that day-to-day dialysis fluid quality is under the control
of the healthcare professionals who deliver dialysis therapy.
Annex A provides further information on the rationale for the development and provisions of this
document.
The equipment used in the various stages of dialysis fluid preparation is generally obtained from
specialized vendors. Dialysis practitioners are generally responsible for maintaining that equipment
following its installation. Therefore, this document provides guidance on quality oversight and
maintenance of the equipment to ensure that dialysis fluid quality is acceptable at all times. At various
places throughout this International Standard, the user is advised to follow the manufacturer's
instructions regarding the operation and maintenance of equipment. In those instances in which the
equipment is not obtained from a specialized vendor, it is the responsibility of the user to validate the
performance of the equipment in the haemodialysis setting and to ensure that appropriate operating
and maintenance manuals are available.
Annex B to this document provides further information on the system components that are used for
water treatment, concentrate, and dialysis fluid preparation at a dialysis facility. These descriptions are
intended to provide the user with a basis for understanding why certain equipment might be required
and how it should be configured; they are not intended as detailed design standards. Requirements for
water treatment equipment are provided in ISO 23500-2.
Increasingly, self-contained, integrated systems designed and validated to produce water and dialysis
fluid are becoming available and used clinically. This document applies to systems assembled from
individual components. Consequently, some of the requirements in ISO 23500-1 and ISO 23500-2 might
not apply to integrated systems, however such systems are required to comply with the requirements
of ISO 23500-3, ISO 23500-4, and ISO 23500-5. In order to ensure conformity when using such systems,
adherence to the manufacturer's instructions regarding the operation, testing, and maintenance of
such systems is required to ensure that the system is being operated under the validated conditions.
This document reflects the conscientious efforts of healthcare professionals, patients, and medical
device manufacturers to develop recommendations for handling water and concentrates and for the
production and surveillance of dialysis fluid for haemodialysis and protecting haemodialysis patients
from adverse effects arising from known chemical and microbial contaminants that might be found
in improperly prepared dialysis fluid. Annexes F and G provide further information in respect of
special considerations for home and acute haemodialysis The standard together with its constituent
parts is directed towards the healthcare professionals involved in the management or routine care of
haemodialysis patients and responsible for the quality of dialysis fluid. However, the physician in charge
of dialysis has the ultimate responsibility for ensuring that the dialysis fluid is correctly formulated
and meets the requirements of all applicable quality standards.
The provisions contained in this document might not be applicable in all circumstances and they are
not intended for regulatory application.
vi © ISO 2019 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 23500-1:2019
INTERNATIONAL STANDARD ISO 23500-1:2019(E)
Preparation and quality management of fluids for
haemodialysis and related therapies —
Part 1:
General requirements
1 Scope
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
...
SLOVENSKI STANDARD
oSIST prEN ISO 23500-1:2017
01-junij-2017
6PHUQLFH]DSULSUDYRLQYRGHQMHNDNRYRVWLWHNRþLQ]DKHPRGLDOL]RLQSRGREQH
WHUDSLMHGHO 6SORãQH]DKWHYH ,62',6
Guidance for the preparation and quality management of fluids for haemodialysis and
related therapies - Part 1: General requirements (ISO/DIS 23500-1:2017)
Leitfaden für die Vorbereitung und das Qualitätsmanagement von Konzentraten für die
Hämodialyse und verwandte Therapien - Teil 1: Allgemeine Anforderungen (ISO/DIS
23500-1:2017)
Directives concernant la préparation et le management de la qualité des fluides
d'hémodialyse et de thérapies annexes - Partie 1: Exigences générales (ISO/DIS 23500-
1:2017)
Ta slovenski standard je istoveten z: prEN ISO 23500-1
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
oSIST prEN ISO 23500-1:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 23500-1:2017
---------------------- Page: 2 ----------------------
oSIST prEN ISO 23500-1:2017
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23500-1
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2017-04-07 2017-06-29
Guidance for the preparation and quality management of
fluids for haemodialysis and related therapies —
Part 1:
General requirements
Directives concernant la préparation et le management de la qualité des fluides d’hémodialyse et de
thérapies annexes —
Partie 1: Exigences générales
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
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 23500-1:2017(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 2017
---------------------- Page: 3 ----------------------
oSIST prEN ISO 23500-1:2017
ISO/DIS 23500-1:2017(E) ISO/DIS 23500-1
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 Commission (IEC) on all
matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO's adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
This third edition cancels and replaces the second edition (ISO 23500:2014), which has been technically
revised and forms part of a revised and renumbered series dealing with water treatment (ISO 23500-2,
previously ISO 26722), water quality (ISO 23500-3, previously ISO 13959), concentrates used for the
preparation of dialysis fluid (ISO 23500-4, previously ISO 13958), and dialysis fluid quality (ISO 23500-
5, previously ISO 11663).
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
© ISO 2017 – All rights reserved iii
---------------------- Page: 4 ----------------------
oSIST prEN ISO 23500-1:2017
---------------------- Page: 5 ----------------------
oSIST prEN ISO 23500-1:2017
ISO/DIS 23500-1
Contents Page
Foreword .iii
Introduction . iv
1 Scope . 2
2 Normative references . 2
3 Terms and definitions . 3
4 Summary of quality requirements of ISO 23500-4, ISO 23500-3 and ISO 23500-5 . 10
5 Critical aspects of system design . 15
6 Validation of system performance . 18
7 Quality management . 21
8 Strategies for microbiological control . 28
9 Location of and access to water treatment system . 33
10 Personnel . 34
Annex A (informative) Rationale for the development and provisions of this
International Standard . 36
Annex B (informative) Equipment . 41
Annex C (informative) Monitoring guidelines for water treatment equipment,
distribution systems, and dialysis fluid . 60
Annex D (informative) Strategies for microbiological control . 65
Annex E (informative) Validation . 73
Annex F (informative) Special considerations for home haemodialysis . 76
Annex G (informative) Special considerations for acute haemodialysis . 83
Bibliography . 88
ii © ISO 2017 – All rights reserved.
---------------------- Page: 6 ----------------------
oSIST prEN ISO 23500-1:2017
ISO/DIS 23500-1
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 Commission (IEC) on all
matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO's adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
This third edition cancels and replaces the second edition (ISO 23500:2014), which has been technically
revised and forms part of a revised and renumbered series dealing with water treatment (ISO 23500-2,
previously ISO 26722), water quality (ISO 23500-3, previously ISO 13959), concentrates used for the
preparation of dialysis fluid (ISO 23500-4, previously ISO 13958), and dialysis fluid quality (ISO 23500-
5, previously ISO 11663).
© ISO 2017 – All rights reserved iii
---------------------- Page: 7 ----------------------
oSIST prEN ISO 23500-1:2017
ISO/DIS 23500-1
Introduction
This International Standard was developed by ISO/TC 150/SC 2. It is the base standard for a number of
other standards dealing with water treatment equipment (ISO 23500-2 replacing ISO 26722:2014),
water quality (ISO 23500-3 replacing ISO 13959:2014), concentrates (ISO 23500-4 replacing ISO
13958:2014) and the quality of dialysis fluid (ISO 23500-5 replacing ISO 11663:2014)
The objective of these standards is to provide users with guidance for handling water and concentrates
and for the production and monitoring of dialysis fluid used for haemodialysis. The need for such
guidance is based on the critical role of dialysis fluid quality in providing safe and effective
haemodialysis, and the recognition that day-to-day dialysis fluid quality is under the control of the
healthcare professionals who deliver dialysis therapy.
This International Standard 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 equipment used in the various stages of dialysis fluid preparation is generally obtained from
specialized vendors. Dialysis practitioners are generally responsible for maintaining that equipment
following its installation. Therefore, this International Standard provides guidance on monitoring and
maintenance of the equipment to ensure that dialysis fluid quality is acceptable at all times. At various
places throughout this International Standard, the user is advised to follow the manufacturer's
instructions regarding the operation and maintenance of equipment. In those instances in which the
equipment is not obtained from a specialized vendor, it is the responsibility of the user to validate the
performance of the equipment in the haemodialysis setting and to ensure that appropriate operating
and maintenance manuals are available. Annex B provides a general description of the system
components that are used for water treatment, concentrate, and dialysis fluid preparation at a dialysis
facility. These descriptions are intended to provide the user with a basis for understanding why certain
equipment might be required and how it should be configured; they are not intended as detailed design
standards. Requirements for water treatment equipment are provided in ISO 23500-2 (previously ISO
26722)
Increasingly, self-contained, integrated systems designed and validated to produce water and dialysis
fluid are becoming available and used clinically. The provisions included in this International Standard
apply to systems assembled from individual components. Consequently, some of the provisions in ISO
23500-1 and ISO 23500-2 might not apply to integrated systems, however such systems are required to
comply with the requirements of ISO 23500-3, ISO 23500-4, and ISO 23500-5. In order to ensure
compliance when using such systems, the user shall follow the manufacturer's instructions regarding
the operation, testing, and maintenance of such systems in order to ensure that the system is being
operated under the validated conditions.
The verbal forms used in this International Standard conform to usage described in Annex H of the
ISO/IEC Directives, Part 2:2004. For the purposes of this International Standard, the auxiliary verb:
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
International Standard;
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this International Standard;
iv © ISO 2017 – All rights reserved.
---------------------- Page: 8 ----------------------
oSIST prEN ISO 23500-1:2017
ISO/DIS 23500-1
— “may” is used to describe a permissible way to achieve compliance with a requirement or test.
This International Standard reflects the conscientious efforts of healthcare professionals, patients, and
medical device manufacturers to develop recommendations for handling water and concentrates and
for the production and monitoring of dialysis fluid for haemodialysis. This International Standard is
directed towards the healthcare professionals involved in the management or routine care of
haemodialysis patients and responsible for the quality of dialysis fluid. The recommendations contained
in this International Standard might not be applicable in all circumstances and they are not intended for
regulatory application.
The guidance provided by this International Standard is aimed at protecting haemodialysis patients
from adverse effects arising from known chemical and microbial contaminants that might be found in
improperly prepared dialysis fluid. However, the physician in charge of dialysis has the ultimate
responsibility for ensuring that the dialysis fluid is correctly formulated and meets the requirements of
all applicable quality standards.
The concepts incorporated in this International Standard 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.
© ISO 2017 – All rights reserved v
---------------------- Page: 9 ----------------------
oSIST prEN ISO 23500-1:2017
ISO/DIS 23500-1
Guidance for the preparation and quality management of fluids
for haemodialysis and related therapies — Part 1: General
requirements
1 Scope
1.1 General
This International Standard 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 International Standard functions as a
recommended practice.
1.2 Inclusions
This International Standard 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 International Standard, dialysis fluid includes:
a) dialysis water (see 3.18 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 International Standard 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 International Standard.
1.3 Exclusions
This International Standard 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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
© ISO 2017 – All rights reserved 2
---------------------- Page: 10 ----------------------
oSIST prEN ISO 23500-1:2017
ISO/DIS 23500-1
ISO 23500-5, Guidance for the preparation and quality management of fluids for haemodialysis and
related therapies – Part 5: Quality of dialysis fluid for haemodialysis and related therapies
ISO 23500-4, Guidance for the preparation and quality management of fluids for haemodialysis and
related therapies – Part 4: Concentrates for haemodialysis and related therapies
ISO 23500-3, Guidance for the preparation and quality management of fluids for haemodialysis and
related therapies – Part 3: Water for haemodialysis and related therapies
ISO 23500-2, Guidance for the preparation and quality management of fluids for haemodialysis and
related therapies – Part 2: Water treatment equipment for haemodialysis applications and related
therapies
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
acetate concentrate
concentrated solution of salts containing acetate, which, when diluted with dialysis water, yields
bicarbonate-free dialysis fluid for use in dialysis
Note 1 to entry: Acetate concentrate may contain glucose.
Note 2 to entry: Sodium acetate is used to provide buffer in place of sodium bicarbonate.
Note 3 to entry: Acetate concentrate is used as a single concentrate.
3.2
acid concentrate
A-concentrate
acidified concentrated mixture of salts that, when diluted with dialysis water and bicarbonate
concentrate, yields dialysis fluid for use in dialysis
Note 1 to entry: The term “acid” refers to the small amount of acid (for example, acetic acid or citric acid) that is
included in the concentrate.
Note 2 to entry: Acid concentrate may contain glucose.
Note 3 to entry: Acid concentrate may be in the form of a liquid, a dry powder, other highly concentrated media, or
some combination of these forms.
3.3
action level
concentration of a contaminant at which steps should be taken to interrupt the trend toward higher,
unacceptable levels
3.4
additive
spike
small amount of a single chemical that, when added to the concentrate, will increase the concentration
of a single existing chemical by a value labelled on the additive packaging
3.5
bicarbonate concentrate
B-concentrate
© ISO 2017 – All rights reserved 3
---------------------- Page: 11 ----------------------
oSIST prEN ISO 23500-1:2017
ISO/DIS 23500-1
concentrated preparation of sodium bicarbonate that, when diluted with dialysis water and acid
concentrate, makes dialysis fluid used for dialysis
Note 1 to entry: Sodium bicarbonate is also known as sodium hydrogen carbonate.
Note 2 to entry: Some bicarbonate concentrates also contain sodium chloride.
Note 3 to entry: Bicarbonate concentrate may be in the form of a liquid or a dry powder.
Note 4 to entry: Dry sodium bicarbonate, without added sodium chloride, is also used in concentrate generators to
produce a concentrated solution of sodium bicarbonate used by the dialysis machine to make dialysis fluid.
3.6
biofilm
microbially-derived sessile community characterized by cells that are irreversibly attached to a
substratum or interface or to each other, are imbedded in a matrix of extracellular polymeric
substances that they have produced, and exhibit an altered phenotype with respect to growth rate and
gene transcription
Note 1 to entry: The matrix, a slimy material secreted by the cells, protects the bacteria from antibiotics and
chemical disinfectants.
Note 2 to entry: A certain amount of biofilm formation is considered unavoidable in dialysis water systems. When
the level of biofilm is such that the action levels for microorganisms and endotoxins in the dialysis water are
routinely reached or exceeded, the operation of the system is compromised from a medical and technical point of
view. This level of biofilm formation is often referred to as biofouling.
3.7
bulk delivery
delivery of large containers of concentrate to a dialysis facility
Note 1 to entry: Bulk delivery includes containers such as drums, which can be pumped into a storage tank
maintained at the user's facility. Alternatively, the drums can be left at the facility and used to fill transfer
containers to transfer the concentrate to the dialysis machines. Bulk delivery can also include large containers for
direct connection to a central concentrate supply system.
Note 2 to entry: Bulk delivery also includes dry powder concentrates intended to be used with an appropriate
concentrate mixer.
3.8
central concentrate system
system that prepares and/or stores concentrate at a central point for subsequent distribution to its
points of use
3.9
central dialysis fluid delivery system
system that produces dialysis fluid from dialysis water and concentrate or powder at a central point
and distributes the dialysis fluid from the central point to individual dialysis machines
3.10
chlorine, combined
chlorine that is chemically combined, such as in chloramine compounds
Note 1 to entry: There is no direct test for measuring combined chlorine, but it can be measured indirectly by
measuring both total and free chlorine and calculating the difference.
3.11
chlorine, free
© ISO 2017 – All rights reserved 4
---------------------- Page: 12 ----------------------
oSIST prEN ISO 23500-1:2017
ISO/DIS 23500-1
chlorine present in water as dissolved molecular chlorine (Cl), hypochlorous acid (HOCl), and
−
hypochlorite ion (OCl )
Note 1 to entry: The three forms of free chlorine exist in equilibrium.
3.12
chlorine, total
sum of free and combined chlorine
Note 1 to entry: Chlorine can exist in water as dissolved molecular chlorine, hypochlorous acid, and/or
hypochlorite ion (free chlorine) or in chemically combined forms (combined chlorine). Where chloramine is used
to disinfect water supplies, chloramine is usually the principal component of combined chlorine.
3.13
colony-forming unit
CFU
measure of bacterial or fungal cell numbers that theoretically arise from a single cell when grown on
solid media
Note 1 to entry: Colonies can also form from groups of organisms when they occur in aggregates.
3.14
concentrate generator
system where the concentrate is delivered to the user as a powder in a container, suitable for
attachment to the dialysis machine with which it is intended to be used, and then the powder is
converted into a concentrated solution by the dialysis machine
Note 1 to entry: The solution produced by the concentrate generator is used by the dialysis machine to make the
final dialysis fluid delivered to the dialyser.
3.15
dialysis fluid
dialysate
dialysis solution
aqueous fluid containing electrolytes and, usually, buffer and glucose, which is intended to exchange
solutes with blood during haemodialysis and haemodiafiltration
Note 1 to entry: The term “dialysis fluid” is used throughout this International Standard to mean the fluid made
from dialysis water and concentrates that is delivered to the dialyser by the dialysis fluid delivery system. Such
phrases as “dialysate” or “dialysis solution” are used in place of dialysis fluid in some countries; however, that
usage is discouraged to avoid confusion.
Note 2 to entry: The dialysis fluid entering the dialyser is referred to as “fresh dialysis fluid”, while the fluid
leaving the dialyser is referred to as “spent dialysis fluid”.
Note 3 to entry: Dialysis fluid does not include prepackaged parenteral fluids used in some renal replacement
therapies, such as haemodiafiltration and haemofiltration.
3.16
dialysis fluid delivery system
device that prepares dialysis fluid online from dialysis water and concentrates or that stores and
distributes premixed dialysis fluid; circulates the dialysis fluid through the dialyser; monitors the
dialysis fluid for temperature, conductivity (or equivalent), pressure, flow, and blood leaks; and,
prevents dialysis during disinfection or cleaning modes
Note 1 to entry: The term includes reservoirs, conduits, proportioning devices for the dialysis fluid, and monitors
and associated alarms and controls assembled as a system for the purposes listed above.
© ISO 2017 – All rights reserved 5
---------------------- Page: 13 ----------------------
oSIST prEN ISO 23500-1:2017
ISO/DIS 23500-1
Note 2 to entry: The dialysis fluid delivery system may be an integral part of the single-patient dialysis machine or
a centralized preparation system which feeds multiple bedside monitoring systems.
Note 3 to entry: Dialysis fluid delivery systems are also known as proportioning systems and dialysis fluid supply
systems.
3.17
dialysis water
water that has been treated to meet the requirements of ISO 23500-3 and which is suitable for use in
haemodialysis applications, including the preparation of dialysis fluid, reprocessing of dialysers,
preparation of concentrates and preparation of substitution fluid for online convective therapies
3.18
disinfection
destruction of pathogenic and other kinds of microorganisms by thermal or chemical means
Note 1 to entry: Disinfection is a less lethal process than sterilization because it destroys most recognized
pathogenic microorganisms but does not necessarily destroy all microbial forms.
Note 2 to entry; Appropriate disinfection strategies need to include: disinfection type, disinfectant concentration,
exposure time and temperature
3.19
empty-bed contact time
EBCT
time taken by a fluid to pass through an empty volume equal to the volume of a particle bed
Note 1 to entry: EBCT (min) is calculated from the following formula:
EBCT = V/Q
where
V 3
is the volume of the particle bed, in cubic metres (m );
Q 3
is the flow rate of water through the bed, in cubic metres per minute (m /min).
Note 2 to entry: EBCT is used as
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.