Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2019)

This document specifies minimum requirements for concentrates used for haemodialysis and related
therapies.
This document is addressed to the manufacturer of such concentrates. In several instances in this
document, the dialysis fluid is addressed, which is made by the end user, to help clarify the requirements
for manufacturing concentrates. Because the manufacturer of the concentrate does not have control
over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of
the manufacturer.
This document includes concentrates in both liquid and powder forms. It also includes additives, also
called spikes, which are chemicals that can be added to the concentrate to supplement or increase the
concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid.
This document also specifies requirements for equipment used to mix acid and bicarbonate powders
into concentrate at the user's facility.
Concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility
are excluded from the scope of this document. Although references to dialysis fluid appear herein,
this document does not address dialysis fluid as made by the end user. This document also excludes
requirements for the surveillance frequency of water purity used for the making of dialysis fluid by the
dialysis facility. This document does not address bags of sterile dialysis fluid or sorbent dialysis fluid
regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid
is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and
water at the bedside or in a central dialysis fluid delivery system. Although the label requirements
for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure
proper use.
This document does not cover haemodialysis equipment, which is addressed in IEC 60601-2-16:2012.

Leitfaden für die Vorbereitung und das Qualitätsmanagement von Konzentraten für die Hämodialyse und verwandte Therapien - Teil 4: Konzentrate für die Hämodialyse und verwandte Therapien (ISO 23500-4:2019)

Dieses Dokument legt die Mindestanforderungen an Konzentrate für die Hämodialyse und verwandte Therapien fest.
Dieses Dokument richtet sich an den Hersteller dieser Konzentrate. An mehreren Stellen in diesem Dokument wird die vom Endanwender hergestellte Dialysierflüssigkeit benannt, um die Anforderungen an die Konzentratherstellung zu präzisieren. Da der Hersteller des Konzentrates keine Kontrolle über die fertige Dialysierflüssigkeit hat, dient jede Referenz auf die Dialysierflüssigkeit der Präzisierung und ist keine Anforderung des Herstellers.
Dieses Dokument behandelt Konzentrate sowohl in Flüssig  als auch in Pulverform. Ebenfalls abgehandelt werden Zusätze, auch Spikes genannt. Dies sind Chemikalien, die dem Konzentrat hinzuge¬fügt werden dürfen, um eine oder mehrere der im Konzentrat vorkommenden Ionen und somit auch in der fertigen Dialysierflüssigkeit zu erhöhen.
Dieses Dokument stellt auch Anforderungen an die Geräte zum Mischen von Säure und Bicarbonatpulver zur Herstellung von Konzentrat in der Einrichtung des Anwenders.
Konzentrate aus vorverpackten Salzen sowie Wasser in einer Dialyseeinrichtung zur Verwendung in ebendieser sind vom Anwendungsbereich dieses Dokuments ausgeschlossen. Obwohl in ihr Referenzen zu Dialysierflüssigkeiten auftauchen, behandelt dieses Dokumentkeine Dialysierflüssigkeiten, die vom Endan-wender hergestellt werden. Dieses Dokument umfasst auch keine Anforderungen an die Überwachungshäufigkeit der Wasserreinheit für Dialysierflüssigkeiten, die in einer Dialyseeinrichtung hergestellt werden. Dieses Dokument behandelt keine Beutel mit steriler Dialysierflüssigkeit oder sorbensbasierte Dialysierflüssigkeits Wiederaufbereitungssysteme, die geringe Mengen der Dialysierflüs-sigkeit wiederaufbereiten und wieder in Umlauf bringen.
Dieses Dokument behandelt nicht die Dialysierflüssigkeit, die zur klinischen Dialyse bei Patienten verwendet wird. Dialysierflüssigkeit wird in ISO 23500 5 definiert. Die Herstellung von Dialysierflüssigkeit beinhaltet die Dosierung von Konzentraten und Wasser am Krankenbett oder in einem zentralen Dialysierflüssigkeits Zufuhrsystem. Obwohl die Etikettenanforderungen an Dialysierflüssigkeiten auf dem Etikett des Konzentrats vermerkt sind, liegt die Verantwortung für dessen sachgemäße Benutzung beim Anwender.
Dieses Dokument behandelt nicht die Geräte für Hämodialyse, die in IEC 60601 2 16:2012 dargestellt wer¬den.

Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes - Partie 4: Concentrés pour hémodialyse et thérapies apparentées (ISO 23500-4:2019)

Le présent document spécifie les exigences minimales relatives aux concentrés utilisés pour l'hémodialyse et les thérapies apparentées.
Le présent document est destiné aux fabricants de ces concentrés. Le présent document aborde à plusieurs endroits la question du liquide de dialyse produit par l'utilisateur final, afin de clarifier les exigences de production des concentrés. Étant donné que le fabricant du concentré n'a aucun contrôle sur le liquide de dialyse final, toute référence au liquide de dialyse est donnée à titre de clarification et ne constitue pas une exigence du fabricant.
Le présent document inclut les concentrés sous forme liquide et sous forme pulvérulente. Il traite également des additifs, également appelés dopants, qui sont des substances chimiques pouvant être ajoutées au concentré pour enrichir ou augmenter la concentration d'un ou de plusieurs ions existants dans le concentré, et donc dans le liquide de dialyse final.
Le présent document spécifie également des exigences relatives à l'appareil utilisé pour mélanger les poudres d'acide et de bicarbonate dans le concentré au sein de l'installation de l'utilisateur.
Les concentrés préparés à partir de sels préemballés et d'eau dans un centre de dialyse aux fins d'y être utilisés sont exclus du domaine d'application du présent document. Bien qu'il contienne des références au liquide de dialyse, le présent document ne concerne pas le liquide de dialyse produit par l'utilisateur final. Le présent document exclut également du domaine d'application les exigences relatives à la fréquence de surveillance de la pureté de l'eau utilisée pour la production du liquide de dialyse par le centre de dialyse. Le présent document ne traite pas des sacs de liquide de dialyse stériles ou des systèmes de régénération des liquides de dialyse à base de sorbant qui régénèrent et remettent en circulation de petits volumes de liquide de dialyse.
Le présent document ne concerne pas les liquides de dialyse utilisés pour la dialyse clinique des patients. Le liquide de dialyse est abordé dans l'ISO 23500‑5. La production de liquides de dialyse implique le dosage de concentré et d'eau au chevet du patient ou dans un système de distribution de liquide de dialyse centralisé. Bien que les exigences d'étiquetage des liquides de dialyse portent sur l'étiquetage du concentré, il est de la responsabilité de l'utilisateur d'en garantir la bonne utilisation.
De plus, le présent document ne concerne pas l'appareil d'hémodialyse, qui est abordé dans la IEC 60601‑2‑16:2012.

Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 4. del: Koncentrati za hemodializo in podobne terapije (ISO 23500-4:2019)

Ta dokument določa minimalne zahteve glede koncentratov za hemodializo in podobne terapije.
Ta dokument je namenjen proizvajalcem takšnih koncentratov. V nekaterih izdajah tega
dokumenta je obravnavana dializna tekočina, ki jo pripravi končni uporabnik, za namene pojasnitve zahtev za proizvodnjo koncentratov. Ker proizvajalec koncentrata nima nadzora nad končno dializno tekočino, so vsi sklici na dializno tekočino namenjeni pojasnitvi in ne pomenijo zahteve za proizvajalca.
Ta dokument zajema koncentrate v obliki tekočin in praškov. Zajema tudi aditive, imenovane tudi dodatki, ki so kemična sredstva za dodajanje h koncentratu, s čimer se dopolni ali poveča
koncentracija enega ali več obstoječih ionov v koncentratu in s tem tudi v končni dializni tekočini.
Dokument prav tako določa zahteve za opremo, ki se uporablja za mešanje bikarbonatnih praškov
v koncentrat v uporabnikovi opremi.
Koncentrati, pripravljeni v dializni opremi iz vnaprej pakiranih soli in vode, ki se uporabljajo v takšni opremi,
ne spadajo na področje uporabe tega dokumenta. Čeprav se v tem dokumentu pojavljajo sklici na dializno tekočino,
ta dokument ne obravnava dializne tekočine, kot jo pripravi končni uporabnik. Ta dokument prav tako ne zajema
zahtev glede pogostosti nadzora za čistost vode, ki se uporablja za pripravo dializne tekočine v dializni opremi. Ta dokument ne obravnava vrečk v sistemih za regeneracijo sterilne dializne tekočine ali sorbentne dializne tekočine, ki regenerirajo in recirkulirajo majhne količine dializne tekočine.
Ta dokument ne zajema dializne tekočine, ki se uporablja pri klinični dializi bolnikov. Dializna tekočina je obravnavana v standardu ISO 23500-5. Priprava dializne tekočine vključuje določanje deleža koncentrata in vode v obposteljnih in centralnih sistemih dovajanja dializne tekočine. Čeprav so zahteve o označevanju za dializno tekočino navedene na etiketi koncentrata, je uporabnik odgovoren, da zagotovi pravilno uporabo.
Ta dokument ne zajema opreme za hemodializo, ki je obravnavana v standardu IEC 60601-2-16:2012.

General Information

Status
Published
Public Enquiry End Date
19-Jun-2017
Publication Date
08-Apr-2019
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
02-Apr-2019
Due Date
07-Jun-2019
Completion Date
09-Apr-2019

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SLOVENSKI STANDARD
SIST EN ISO 23500-4:2019
01-maj-2019
1DGRPHãþD
SIST EN ISO 13958:2016

3ULSUDYDLQYRGHQMHNDNRYRVWLWHNRþLQ]DKHPRGLDOL]RLQSRGREQHWHUDSLMHGHO

.RQFHQWUDWL]DKHPRGLDOL]RLQSRGREQHWHUDSLMH ,62

Preparation and quality management of fluids for haemodialysis and related therapies -

Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2019)

Leitfaden für die Vorbereitung und das Qualitätsmanagement von Konzentraten für die

Hämodialyse und verwandte Therapien - Teil 4: Konzentrate für die Hämodialyse und

verwandte Therapien (ISO 23500-4:2019)

Préparation et management de la qualité des liquides d'hémodialyse et de thérapies

annexes - Partie 4: Concentrés pour hémodialyse et thérapies apparentées (ISO 23500-

4:2019)
Ta slovenski standard je istoveten z: EN ISO 23500-4:2019
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
SIST EN ISO 23500-4:2019 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 23500-4:2019
---------------------- Page: 2 ----------------------
SIST EN ISO 23500-4:2019
EN ISO 23500-4
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2019
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 13958:2015
English Version
Preparation and quality management of fluids for
haemodialysis and related therapies - Part 4: Concentrates
for haemodialysis and related therapies (ISO 23500-
4:2019)

Préparation et management de la qualité des liquides Leitfaden für die Vorbereitung und das

d'hémodialyse et de thérapies annexes - Partie 4: Qualitätsmanagement von Konzentraten für die

Concentrés pour hémodialyse et thérapies apparentées Hämodialyse und verwandte Therapien - Teil 4:

(ISO 23500-4:2019) Konzentrate für die Hämodialyse und verwandte
Therapien (ISO 23500-4:2019)
This European Standard was approved by CEN on 14 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 23500-4:2019 E

worldwide for CEN national Members.
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SIST EN ISO 23500-4:2019
EN ISO 23500-4:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 23500-4:2019
EN ISO 23500-4:2019 (E)
European foreword

This document (EN ISO 23500-4:2019) 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 13958:2015.

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 23500-4:2019 has been approved by CEN as EN ISO 23500-4:2019 without any

modification.
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SIST EN ISO 23500-4:2019
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SIST EN ISO 23500-4:2019
INTERNATIONAL ISO
STANDARD 23500-4
First edition
2019-02
Preparation and quality management
of fluids for haemodialysis and related
therapies —
Part 4:
Concentrates for haemodialysis and
related therapies
Préparation et management de la qualité des liquides d'hémodialyse
et de thérapies annexes —
Partie 4: Concentrés pour hémodialyse et thérapies apparentées
Reference number
ISO 23500-4:2019(E)
ISO 2019
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SIST EN ISO 23500-4:2019
ISO 23500-4:2019(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
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SIST EN ISO 23500-4:2019
ISO 23500-4:2019(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Requirements .......................................................................................................................................................................................................... 2

4.1 Concentrates ............................................................................................................................................................................................. 2

4.1.1 Physical state ....................................................................................................................................................................... 2

4.1.2 Water .......................................................................................................................................................................................... 3

4.1.3 Bacteriology of concentrates ................................................................................................................................. 3

4.1.4 Endotoxin levels ............................................................................................................................................................... 3

4.1.5 Fill quantity .......................................................................................................................................................................... 3

4.1.6 Chemical grade .................................................................................................................................................................. 3

4.1.7 Particulates ........................................................................................................................................................................... 4

4.1.8 Additives — “Spikes” .................................................................................................................................................... 4

4.1.9 Containers.............................................................................................................................................................................. 4

4.1.10 Bulk-delivered concentrate..................................................................................................................................... 4

4.1.11 Concentrate generators.............................................................................................................................................. 4

4.2 Manufacturing equipment ............................................................................................................................................................ 4

4.3 Systems for bulk mixing concentrate at a dialysis facility ................................................................................. 4

4.3.1 General...................................................................................................................................................................................... 4

4.3.2 Materials compatibility .............................................................................................................................................. 5

4.3.3 Disinfection protection ............................................................................................................................................... 5

4.3.4 Safety requirements ...................................................................................................................................................... 5

4.3.5 Bulk storage tanks .......................................................................................................................................................... 5

4.3.6 Ultraviolet irradiators ................................................................................................................................................. 6

4.3.7 Piping systems ................................................................................................................................................................... 6

4.3.8 Electrical safety requirements ............................................................................................................................. 6

5 Tests ................................................................................................................................................................................................................................... 6

5.1 General ........................................................................................................................................................................................................... 6

5.2 Concentrates ............................................................................................................................................................................................. 6

5.2.1 Physical state ....................................................................................................................................................................... 6

5.2.2 Solute concentrations .................................................................................................................................................. 7

5.2.3 Water .......................................................................................................................................................................................... 7

5.2.4 Microbial contaminant test methods for bicarbonate concentrates ................................... 7

5.2.5 Endotoxin levels ............................................................................................................................................................... 8

5.2.6 Fill quantity .......................................................................................................................................................................... 8

5.2.7 Chemical grade .................................................................................................................................................................. 8

5.2.8 Particulates ........................................................................................................................................................................... 8

5.2.9 Additives — “Spikes” .................................................................................................................................................... 9

5.2.10 Containers.............................................................................................................................................................................. 9

5.2.11 Bulk delivered concentrate ..................................................................................................................................... 9

5.2.12 Concentrate generators.............................................................................................................................................. 9

5.3 Manufacturing equipment ............................................................................................................................................................ 9

5.4 Systems for mixing concentrate at a dialysis facility .............................................................................................. 9

5.4.1 General...................................................................................................................................................................................... 9

5.4.2 Materials compatibility .............................................................................................................................................. 9

5.4.3 Disinfection protection ............................................................................................................................................... 9

5.4.4 Safety requirements ...................................................................................................................................................10

5.4.5 Bulk storage tanks .......................................................................................................................................................10

5.4.6 Ultraviolet irradiators ..............................................................................................................................................10

5.4.7 Piping systems ................................................................................................................................................................10

© ISO 2019 – All rights reserved iii
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SIST EN ISO 23500-4:2019
ISO 23500-4:2019(E)

5.4.8 Electrical safety requirements ..........................................................................................................................10

6 Labelling .....................................................................................................................................................................................................................10

6.1 General ........................................................................................................................................................................................................10

6.2 General labelling requirements for concentrates ..................................................................................................11

6.3 Labelling requirements for liquid concentrate ........................................................................................................12

6.4 Labelling requirements for powder concentrate ...................................................................................................12

6.5 Additives ....................................................................................................................................................................................................13

6.6 Labelling requirements for concentrate generators ...........................................................................................13

6.7 Labelling for concentrate mixer systems ......................................................................................................................14

6.7.1 General...................................................................................................................................................................................14

6.7.2 Product literature for concentrate mixers ..............................................................................................14

Annex A (informative) Rationale for the development and provisions of this document .........................16

Bibliography .............................................................................................................................................................................................................................22

iv © ISO 2019 – All rights reserved
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SIST EN ISO 23500-4:2019
ISO 23500-4:2019(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 13958:2014, 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 of 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
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SIST EN ISO 23500-4:2019
ISO 23500-4:2019(E)
Introduction

The requirements and goals established by this document will help ensure the effective, safe

performance of haemodialysis concentrates and related materials. This document reflects the

conscientious efforts of concerned physicians, clinical engineers, nurses, dialysis technicians and

dialysis patients, in consultation with device manufacturers and regulatory agency representatives, to

develop a standard for performance levels that could be reasonably achieved at the time of publication.

The term “consensus” as applied to the development of voluntary medical device standards does not

imply unanimity of opinion, but rather reflects the compromise necessary in some instances when a

variety of interests shall be merged.

The rationale for the development of this document is given in informative Annex A.

Throughout this document, requirements and recommendations are made to use ISO-quality water.

Therefore, it is recommended to refer to ISO 23500-3 along with this document.

For the purpose of this document, “concentrates” are a mixture of chemicals and water, or chemicals

in the form of dry powder or other highly concentrated media, which are delivered to the end user to

make dialysis fluid used to perform haemodialysis and related therapies.
vi © ISO 2019 – All rights reserved
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SIST EN ISO 23500-4:2019
INTERNATIONAL STANDARD ISO 23500-4:2019(E)
Preparation and quality management of fluids for
haemodialysis and related therapies —
Part 4:
Concentrates for haemodialysis and related therapies
1 Scope

This document specifies minimum requirements for concentrates used for haemodialysis and related

therapies.

This document is addressed to the manufacturer of such concentrates. In several instances in this

document, the dialysis fluid is addressed, which is made by the end user, to help clarify the requirements

for manufacturing concentrates. Because the manufacturer of the concentrate does not have control

over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of

the manufacturer.

This document includes concentrates in both liquid and powder forms. It also includes additives, also

called spikes, which are chemicals that can be added to the concentrate to supplement or increase the

concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid.

This document also specifies requirements for equipment used to mix acid and bicarbonate powders

into concentrate at the user's facility.

Concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility

are excluded from the scope of this document. Although references to dialysis fluid appear herein,

this document does not address dialysis fluid as made by the end user. This document also excludes

requirements for the surveillance frequency of water purity used for the making of dialysis fluid by the

dialysis facility. This document does not address bags of sterile dialysis fluid or sorbent dialysis fluid

regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.

This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid

is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and

water at the bedside or in a central dialysis fluid delivery system. Although the label requirements

for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure

proper use.

This document does not cover haemodialysis equipment, which is addressed in IEC 60601-2-16:2012.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 23500-1, Preparation and quality management of fluids for haemodialysis and related therapies —

Part 1: General requirements

ISO 23500-3, Preparation and quality management of fluids for haemodialysis and related therapies —

Part 3: Water for haemodialysis and related therapies

ISO 23500-5, Preparation and quality management of fluids for haemodialysis and related therapies —

Part 5: Quality of dialysis fluid for haemodialysis and related therapies
© ISO 2019 – All rights reserved 1
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SIST EN ISO 23500-4:2019
ISO 23500-4:2019(E)

IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential

performance

IEC 61010-1, Safety requirements for electrical equipment for measurement, control, and laboratory use —

Part 1: General requirements
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 23500-1 and the following apply.

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3.1
batch system

apparatus in which the dialysis fluid is prepared in bulk before each dialysis session

Note 1 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.

3.2
bicarbonate dialysis fluid
dialysis fluid containing physiological or higher concentrations of bicarbonate
3.3
concentrate mixer

mixer for preparation of dialysis concentrate for dialysis fluid at a dialysis facility

4 Requirements
4.1 Concentrates
4.1.1 Physical state

The concentrate for haemodialysis can be supplied in dry or aqueous form. Packaging can be for direct

use with a single dialysis machine or for use in systems supplying multiple dialysis machines (bulk use).

4.1.1.1 Liquid solute concentrations

All electrolytes identified on the label shall be present within ± 5 % or ± 0,1 mEq/l (expressed as dialysis

fluid concentrations), whichever is greater, of the stated concentration, with the exception of sodium,

which shall be present within ± 2,5 % of the labelled concentration or shall be present according

to approved specifications by the local regulations. If used, glucose shall be present within ± 5 %

or ± 0,05 g/l (when measured as properly diluted dialysis fluid), whichever is greater, of the labelled

concentration, or shall be present according to approved specifications by the local regulations. Where

concentrates include non-traditional constituents, such as antioxidants and iron compounds, these

constituents shall be present at nominal concentrations with ± 5 % tolerances or shall be present

according to approved specifications by the local regulations. If alternate, locally approved tolerances

are used, the tolerances shall be similarly stated and the rationale for their use documented.

Most concentrates are manufactured with standard traditional chemicals such as sodium chloride,

potassium chloride, magnesium chloride, calcium chloride, acetic acid, and glucose. New concentrates

are available which include additional chemicals or in which certain chemicals have been substituted

by others; for example, citric acid has been substituted for acetic acid. Where this occurs, the labelling

shall correctly reflect this and the substitute chemicals shall be present at nominal concentrations

2 © ISO 2019 – All rights reserved
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SIST EN ISO 23500-4:2019
ISO 23500-4:2019(E)
with ± 5 % tolerances, or shall be prese
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