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SLOVENSKI STANDARD
01-maj-2019
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SIST EN ISO 13958:2016
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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
ISO 23500-4:2019(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.
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Email: [email protected]
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Published in Switzerland
ii © ISO 2019 – All rights reserved
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 Manu
...