ILNAS-EN ISO 23500-2:2019
Preparation and quality management
of fluids for haemodialysis and related
therapies - Part 2: Water treatment
equipment for haemodialysis
Préparation et management de la qualité
des liquides d'hémodialyse et de
thérapies annexes - Partie 2: Équipement
de traitement de l'eau pour des
Herstellung und Qualitätsmanagement
von Flüssigkeiten für die Hämodialyse
und verwandte Therapien - Teil 2:
Ausstattung zur Wasseraufbereitung zur
03/2019
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National Foreword
This European Standard EN ISO 23500-2:2019 was adopted as Luxembourgish
Standard ILNAS-EN ISO 23500-2:2019.
Every interested party, which is member of an organization based in Luxembourg, can
participate for FREE in the development of Luxembourgish (ILNAS), European (CEN,
CENELEC) and International (ISO, IEC) standards:
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Participate in the design of standards
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Nothing from this publication may be reproduced or utilized in
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ILNAS-EN ISO 23500-2:2019
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EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
EN ISO 23500-2
March 2019
ICS 11.040.40 Supersedes EN ISO 26722:2015
English Version
Preparation and quality management of fluids for
haemodialysis and related therapies - Part 2: Water
treatment equipment for haemodialysis applications and
related therapies (ISO 23500-2:2019)
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes - Partie 2:
Équipement de traitement de l'eau pour des applications en hémodialyse et aux thérapies
apparentées (ISO 23500-2:2019)
Leitfaden für die Vorbereitung und das Qualitätsmanagement von Konzentraten für die Hämodialyse und verwandte Therapien - Teil 2: Ausstattung zur Wasseraufbereitung zur Verwendung in der Hämodialyse und in verwandten Therapien (ISO
23500-2:2019) This European Standard was approved by CEN on 8 February 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 C O M I T É E UR O P É E N DE N O R M A L I SA T I O N E UR O P Ä I SC H E S KO M I T E E F ÜR N O R M UN G
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
worldwide for CEN national Members. Ref. No. EN ISO 23500-2:2019 E
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EN ISO 23500-2:2019 (E)
2
Contents
Page
European foreword ... 3
ILNAS-EN ISO 23500-2:2019
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EN ISO 23500-2:2019 (E)
3
European foreword
This document (EN ISO 23500-2:2019) 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 26722:2015.
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 23500-2:2019 has been approved by CEN as EN ISO 23500-2:2019 without any
modification.
ILNAS-EN ISO 23500-2:2019
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©
ISO 2019
Preparation and quality management
of fluids for haemodialysis and related
therapies —
Part 2:
Water treatment equipment for
haemodialysis applications and
related therapies
Préparation et management de la qualité des liquides d'hémodialyse
et de thérapies annexes —
Partie 2: Équipement de traitement de l'eau pour des applications en
hémodialyse et aux thérapies apparentées
INTERNATIONAL
STANDARD
23500-2
ISO
First edition
2019-02
Reference number
ISO 23500-2:2019(E)
ILNAS-EN ISO 23500-2:2019
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ISO 23500-2:2019(E)
ii
© ISO 2019 – All rights reservedCOPYRIGHT 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.
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ILNAS-EN ISO 23500-2:2019
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ISO 23500-2:2019(E)
Foreword
...v
Introduction
...vi
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
Requirements
...2
4.1
Dialysis water quality requirements
...2
4.1.1 General
...2
4.1.2 Chemical contaminant requirements
...2
4.1.3 Organic Carbon, pesticides and other chemicals
...3
4.1.4 Microbiology of dialysis water
...3
4.2
Water treatment equipment requirements
...4
4.2.1 General
...4
4.2.2 Backflow prevention device
...5
4.2.3 Tempering valves
...5
4.2.4 Sediment filters
...5
4.2.5 Cartridge filters
...5
4.2.6 Softeners
...5
4.2.7 Anion exchange resin tank
...5
4.2.8 Carbon media
...5
4.2.9 Chemical injection systems
...7
4.2.10 Reverse osmosis
...7
4.2.11 Deionization
...8
4.2.12 Bacteria and endotoxin retentive filters
...8
4.2.13 Storage and distribution of dialysis water
...8
5
Testing
...10
5.1
Conformity with dialysis water quality requirements
...10
5.1.1 General
...10
5.1.2 Microbiology of dialysis water
...10
5.1.3 Maximum level of chemical contaminants
...11
5.2
Conformity with water treatment equipment requirements
...12
5.2.1 General
...12
5.2.2 Backflow prevention devices
...13
5.2.3 Tempering valves
...13
5.2.4 Sediment filters
...13
5.2.5 Cartridge filters
...13
5.2.6 Softeners
...13
5.2.7 Anion exchange resin tanks
...13
5.2.8 Carbon media
...13
5.2.9 Chemical injection systems
...14
5.2.10 Reverse osmosis
...14
5.2.11 Deionization
...14
5.2.12 Endotoxin retentive filters
...14
5.2.13 Storage and distribution of dialysis water
...14
6 Labelling
...15
6.1
General
...15
6.2
Device markings
...15
6.3
Product literature
...15
Annex A (informative) Rationale for the development and provisions of this document
...18
© ISO 2019 – All rights reserved