EN ISO 26722:2015

SLOVENSKI STANDARD
01-februar-2016
Oprema za pripravo vode za uporabo pri hemodializi in podobnih terapijah (ISO
26722:2014)
Water treatment equipment for haemodialysis applications and related therapies (ISO
26722:2014)
Ausstattung zur Wasseraufbereitung zur Verwendung in der Hämodialyse und in
verwandten Therapien (ISO 26722:2014)
Équipement de traitement de l'eau pour des applications en hémodialyse et aux
thérapies apparentées (ISO 26722:2014)
Ta slovenski standard je istoveten z: EN ISO 26722:2015
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 26722
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2015
EUROPÄISCHE NORM
ICS 11.040.40
English Version
Water treatment equipment for haemodialysis
applications and related therapies (ISO 26722:2014)
Équipement de traitement de l'eau pour des Ausstattung zur Wasseraufbereitung zur Verwendung
applications en hémodialyse et aux thérapies in der Hämodialyse und in verwandten Therapien (ISO
apparentées (ISO 26722:2014) 26722:2014)
This European Standard was approved by CEN on 23 November 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 26722:2015 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices . 5
European foreword
The text of ISO 26722:2014 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 26722:2015 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 June 2016, and conflicting national standards shall be
withdrawn at the latest by June 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.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table 1 — Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO or IEC
standard
)
ISO 13959:2014 ISO 13959:2014
EN ISO 13959:2015
ISO 14971:2007 EN ISO 14971:2012 ISO 14971:2007
IEC 60601-1-8 EN 60601-1- IEC 60601-1-8:2006+A1:2012
8:2007+Cor.:2010+A1:2013
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 26722:2014 has been approved by CEN as EN ISO 26722:2015 without any modification.

1)
To be published.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means of conforming to Essential
Requirements of the New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of
this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption
of conformity with the corresponding Essential Requirements of that Directive and associated EFTA
regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on
medical devices
Essential Requirements (ERs) of
Clause(s)/sub-clause(s) of this EN Qualifying remarks/Notes
Directive 93/42/EEC
4.2.1.1 7.3
4.2.1.1 7.5
4.2.1.4 8
1.2, 4.1.1 9.1
4.1.1 13.3. (a)
4.2.1.4 13.3. (i)
1.2, 1.3 13.6. (c)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 26722
Second edition
2014-04-01
Water treatment equipment for
haemodialysis applications and
related therapies
Équipement de traitement de l’eau pour des applications en
hémodialyse et aux thérapies apparentées
Reference number
ISO 26722:2014(E)
©
ISO 2014
ISO 26722:2014(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
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Published in Switzerland
ii © ISO 2014 – All rights reserved

ISO 26722:2014(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 Requirements . 7
4.1 Dialysis water quality requirements . 7
4.2 Water treatment equipment requirements . 8
5 Tests .13
5.1 Compliance with dialysis water quality requirements .13
5.2 Compliance with water treatment equipment requirements .15
6 Labelling .17
6.1 General .17
6.2 Device markings .17
6.3 Product literature .18
Annex A (informative) Rationale for the development and provisions of this
International Standard .20
Annex B (informative) Reference tables from ISO 13959 .30
Bibliography .33
ISO 26722:2014(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International St
...