EN ISO 23500:2015

SLOVENSKI STANDARD
01-december-2015
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WHUDSLMH,62
Guidance for the preparation and quality management of fluids for haemodialysis and
related therapies (ISO 23500:2014)
Leitfaden für die Vorbereitung und das Qualitätsmanagement von Konzentraten für die
Hämodialyse und verwandte Therapien (ISO 23500:2014)
Directives concernant la préparation et le management de la qualité des fluides
d'hémodialyse et de thérapies annexes (ISO 23500:2014)
Ta slovenski standard je istoveten z: EN ISO 23500:2015
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 23500
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2015
EUROPÄISCHE NORM
ICS 11.040.40
English Version
Guidance for the preparation and quality management of
fluids for haemodialysis and related therapies (ISO
23500:2014)
Directives concernant la préparation et le management Leitfaden für die Vorbereitung und das
de la qualité des fluides d'hémodialyse et de thérapies Qualitätsmanagement von Konzentraten für die
annexes (ISO 23500:2014) Hämodialyse und verwandte Therapien (ISO
23500:2014)
This European Standard was approved by CEN on 27 September 2015.

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, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23500:2015 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 23500:2014 has been prepared by Technical Committee ISO/TC 150 “Implants for
surgery” of the International Organization for Standardization (ISO) and has been taken over as EN ISO
23500:2015 by 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 April 2016, and conflicting national standards shall be
withdrawn at the latest by April 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 23500:2014 has been approved by CEN as EN ISO 23500:2015 without any modification.
INTERNATIONAL ISO
STANDARD 23500
Second edition
2014-04-01
Guidance for the preparation and
quality management of fluids for
haemodialysis and related therapies
Directives concernant la préparation et le management de la qualité
des fluides d’hémodialyse et de thérapies annexes
Reference number
ISO 23500:2014(E)
©
ISO 2014
ISO 23500:2014(E)
© ISO 2014
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
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Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

ISO 23500:2014(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
1.1 General . 1
1.2 Inclusions . 1
1.3 Exclusions . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Summary of quality requirements of ISO 13958, ISO 13959 and ISO 11663 .9
4.1 Dialysis water . 9
4.2 Requirements for concentrate .11
4.3 Requirements for dialysis fluid .11
4.4 Record retention .12
5 Critical aspects of system design .12
5.1 Technical aspects .13
5.2 Microbiological aspects .13
6 Validation of system performance .14
6.1 Validation plan .14
6.2 Installation and operational qualification .15
6.3 Performance qualification .16
6.4 Routine monitoring and revalidation .16
7 Quality management .17
7.1 General .17
7.2 Monitoring of fluid quality .17
7.3 Monitoring of water treatment equipment .18
7.4 Monitoring of dialysis water storage and distribution .21
7.5 Monitoring of concentrate preparation .23
7.6 Monitoring of concentrate distribution .23
7.7 Monitoring of dialysis fluid proportioning .23
8 Strategies for microbiological control .24
8.1 General .24
8.2 Disinfection .24
8.3 Microbiological monitoring methods .26
9 Environment .28
10 Personnel .29
Annex A (informative) Rationale for the development and provisions of this
International Standard .30
Annex B (informative) Equipment .34
Annex C (informative) Monitoring guidelines for water treatment equipment,
distribution systems, and dialysis fluid .52
Annex D (informative) Strategies for microbiological control .57
Annex E (informative) Validation .62
Annex F (informative) Special considerations for home haemodialysis .65
Annex G (informative) Special considerations for acute haemodialysis .71
Bibliography .76
ISO 23500:2014(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
throu
...