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SLOVENSKI STANDARD
01-maj-2019
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SIST EN ISO 11663:2016
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Preparation and quality management of fluids for haemodialysis and related therapies -
Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-
5:2019)
Vorbereitung und Qualitätsmanagement von Konzentraten für die Hämodialyse und
verwandte Therapien - Teil 5: Qualität von Flüssigkeiten für die Hämodialyse und
verwandte Therapien (ISO 23500-5:2019)
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies
annexes - Partie 5: Qualité des liquides de dialyse pour hémodialyse et thérapies
apparentées (ISO 23500-5:2019)
Ta slovenski standard je istoveten z: EN ISO 23500-5:2019
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 23500-5
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2019
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 11663:2015
English Version
Preparation and quality management of fluids for
haemodialysis and related therapies - Part 5: Quality of
dialysis fluid for haemodialysis and related therapies (ISO
23500-5:2019)
Préparation et management de la qualité des liquides Vorbereitung und Qualitätsmanagement von
d'hémodialyse et de thérapies annexes - Partie 5: Konzentraten für die Hämodialyse und verwandte
Qualité des liquides de dialyse pour hémodialyse et Therapien - Teil 5: Qualität von Flüssigkeiten für die
thérapies apparentées (ISO 23500-5:2019) Hämodialyse und verwandte Therapien (ISO 23500-
5:2019)
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 23500-5:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 23500-5:2019) 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 11663:2015.
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 23500-5:2019 has been approved by CEN as EN ISO 23500-5:2019 without any
modification.
INTERNATIONAL ISO
STANDARD 23500-5
First edition
2019-02
Preparation and quality management
of fluids for haemodialysis and related
therapies —
Part 5:
Quality of dialysis fluid for
haemodialysis and related therapies
Préparation et management de la qualité des liquides d'hémodialyse
et de thérapies annexes —
Partie 5: Qualité des liquides de dialyse pour hémodialyse et thérapies
apparentées
Reference number
ISO 23500-5:2019(E)
©
ISO 2019
ISO 23500-5:2019(E)
© 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
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Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: [email protected]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
ISO 23500-5:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 Microbiological contaminants in dialysis fluid . 2
4.1.1 General. 2
4.1.2 Microbiological requirements for standard dialysis fluid . 2
4.1.3 Microbiological requirements for ultrapure dialysis fluid . 2
4.1.4 Microbiological requirements for online prepared substitution fluid . 2
4.2 Chemical contaminants in dialysis fluid . 3
5 Tests for conformity with microbiological requirements . 3
5.1 Sampling . 3
5.2 Culture methods . 3
Annex A (informative) Rationale for the development and provisions of this document .5
Annex B (informative) Reference tables . 8
Bibliography .11
ISO 23500-5:2019(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 11663:2014, 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.
iv © ISO 2019 – All rights reserved
ISO 23500-5:2019(E)
Introduction
Haemodialysis patients are directly exposed to large volumes of dialysis fluid, with the dialyser
membrane being the only barrier against transfer of hazardous contaminants from the dialysis fluid
to the patient. It has long been known that there could be hazardous contaminants in the water and
concentrates used to prepare the dialysis fluid. To minimize this hazard, ISO 23500-3 and ISO 23500-4
set forth quality requirements for the water and concentrates used to prepare dialysis fluid. However,
if the dialysis fluid is not prepared carefully, it could contain unacceptable levels of contaminants even
though it is prepared from water and concentrates, conforming to the requirements of ISO 23500-3
and ISO 23500-4. Further, the dialysis fluid might be used as the starting material for the online
preparation of fluids intended for infusion into the patient, for example, in therapies such as online
haemodiafiltration. For these reasons, this document for dialysis fluid quality was developed to
complement the existing International Standards for water and concentrates, ISO 23500-3 and
ISO 23500-4, respectively. Guidelines to aid the user in routinely meeting the requirements of this
document and ISO 23500-3 can be found in ISO 23500-1.
Within these International Standards, measurement techniques current at the time of preparation have
been cited. Other standard methods can be used, provided that such methods have been appropriately
validated and are comparable to the cited methods. The rationale for the development of this document
is given in Annex A.
This document reflects
...