EN ISO 13959:2015
(Main)Water for haemodialysis and related therapies (ISO 13959:2014)
Water for haemodialysis and related therapies (ISO 13959:2014)
ISO 13959:2014 specifies minimum requirements for water to be used in haemodialysis and related therapies.
ISO 13959:2014 includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.
Wasser für Hämodialyse und verwandte Therapien (ISO 13959:2014)
Diese Internationale Norm legt Mindestanforderungen an das für die Hämodialyse und verwandte Therapien einzusetzende Wasser fest.
Diese Internationale Norm behandelt Wasser für die Herstellung von Konzentraten und Dialysierflüssigkeit für Hämodialyse, Hämodiafiltration und Hämofiltration sowie für die Wiederaufbereitung von Hämodialysatoren.
Der Betrieb der Wasseraufbereitungsausrüstung und das abschließende Mischen des aufbereiteten Wassers mit Konzentraten zur Herstellung der Dialysierflüssigkeit werden nicht von dieser Internationalen Norm abgedeckt. Diese Arbeitsschritte liegen in der alleinigen Verantwortung der professionellen Dialysefachkräfte. Die vorliegende Internationale Norm gilt nicht für Dialysierflüssigkeits-Wiederaufbereitungssysteme.
Eau pour hémodialyse et thérapies apparentées (ISO 13959:2014)
L'ISO 13959:2014 spécifie les exigences minimales pour l'eau utilisée dans le cadre d'hémodialyses et de thérapies apparentées.
L'ISO 13959:2014 inclut l'eau utilisée pour préparer les concentrés et les fluides de dialyse pour hémodialyse, hémodiafiltration et hémofiltration et pour retraiter les hémodialyseurs.
Voda za hemodializo in podobne terapije (ISO 13959:2014)
Ta mednarodni standard določa minimalne zahteve glede vode, uporabljene pri hemodializi in podobnih terapijah. Ta mednarodni standard zajema vodo za pripravo koncentratov, dializnih tekočin za hemodializo, hemodiafiltracijo in hemofiltracijo ter ponovno obdelavo v hemodializatorjih. Postopek uporabe opreme za pripravo vode in končno mešanje pripravljene vode s koncentrati za proizvodnjo dializne tekočine ne spadata v področje uporabe tega mednarodnega standarda. Za takšne postopke so izključno odgovorni strokovnjaki za dializo. Ta mednarodni standard se ne uporablja za sisteme za regeneracijo dializne tekočine.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2016
Voda za hemodializo in podobne terapije (ISO 13959:2014)
Water for haemodialysis and related therapies (ISO 13959:2014)
Wasser für Hämodialyse und ähnliche Therapien (ISO 13959:2014)
Eau pour hémodialyse et thérapies apparentées (ISO 13959:2014)
Ta slovenski standard je istoveten z: EN ISO 13959:2015
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 13959
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2015
EUROPÄISCHE NORM
ICS 11.040.40
English Version
Water for haemodialysis and related therapies (ISO
13959:2014)
Eau pour hémodialyse et thérapies apparentées (ISO Wasser für Hämodialyse und ähnliche Therapien (ISO
13959:2014) 13959:2014)
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 13959:2015 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 . 4
European foreword
The text of ISO 13959:2014 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 13959:2015 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(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
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 13959:2014 has been approved by CEN as EN ISO 13959:2015 without any modification.
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
3.2 8
3.2 13.1
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 13959
Third edition
2014-04-01
Water for haemodialysis and related
therapies
Eau pour hémodialyse et thérapies apparentées
Reference number
ISO 13959:2014(E)
©
ISO 2014
ISO 13959:2014(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 13959:2014(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 1
3 Dialysis water requirements . 5
3.1 Dialysis water verification and monitoring . 5
3.2 Microbiological requirements. 5
3.3 Chemical contaminants . 5
4 Tests for compliance with microbiological and chemical requirements .6
4.1 Microbiology of dialysis water . 6
4.2 Chemical contaminants test methods . 7
Annex A (informative) Rationale for the development and provisions of this
International Standard .10
Bibliography .14
ISO 13959:2014(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
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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
This third edition cancels and replaces the second edition (ISO 13959:2009), which has been technically
revised.
iv © ISO 2014 – All rights reserved
ISO 13959:2014(E)
Introduction
Assurance of adequate water quality is one of the most important aspects of ensuring a safe and effective
delivery of haemodialysis, haemodiafiltration, or haemofiltration.
This International Standard contains minimum requirements, chemical and microbiological, for the water
to be used for preparation of dialysis fluids, concentrates, and for the reprocessing of haemodialysers
and the necessary steps to ensure compliance with those requirements.
Haemodialysis and haemodiafiltration can expose the patient to more than 500 l of water per week across
the semi-permeable membrane of the haemodialyser or haemodiafilter. Healthy individuals seldom have
a weekly oral intake above 12 l. This over 40-fold increase in exposure requires control and monitoring of
water quality to avoid excesses of known or suspected harmful substances. Since knowledge of potential
injury from trace elements and contaminants of microbiological origin over long periods is still growing
and techniques for treating drinking water are continuously developed, this International Standard
will evolve and be refined accordingly. The physiological effects attributable to the presence of organic
contaminants in dialysis water are important areas for research. At the time this International Standard
was published it was not possible to specify threshold values for organic contaminants permitted in
water used for the preparation of dialysis fluids, concentrates, and reprocessing of haemodialysers. The
issue of organic contaminants will be reassessed on the next revision of this International Standard.
Within this International Standard, measurement techniques current at the time of publication have
been cited. Other st
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