EN ISO 13958:2015
(Main)Concentrates for haemodialysis and related therapies (ISO 13958:2014)
Concentrates for haemodialysis and related therapies (ISO 13958:2014)
ISO 13958:2014 specifies minimum requirements for concentrates used for haemodialysis and related therapies. For the purpose of ISO 13958:2014, "concentrates" are a mixture of chemicals and water, or chemicals in the form of dry powder or other highly concentrated media, that are delivered to the end user to make dialysis fluid used to perform haemodialysis and related therapies. ISO 13958:2014 is addressed to the manufacturer of such concentrates.
ISO 13958:2014 includes concentrates in both liquid and powder forms. Also included are additives, also called spikes, which are chemicals that may be added to the concentrate to increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. ISO 13958:2014 also gives requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
Konzentrate für Hämodialyse und verwandte Therapien (ISO 13958:2014)
Diese Internationale Norm legt Mindestanforderungen an die in der Hämodialyse und verwandten Therapien eingesetzten Konzentrate fest. Für die Anwendung dieser Internationalen Norm, handelt es sich bei „Konzentraten“ um Gemische aus Chemikalien und Wasser oder Chemikalien in Form trockener Pulver oder anderer hochkonzentrierter Medien, die zum Endanwender befördert werden, um Dialysierflüssigkeit für die Durchführung der Hämodialyse und verwandter Therapien herzustellen. Diese Internationale Norm richtet sich an die Hersteller derartiger Konzentrate. An mehreren Stellen wurde es in dieser Internationalen Norm erforderlich, auf die durch den Endanwender hergestellte Dialysierflüssigkeit einzugehen, um die Anforderungen an die Herstellung der Konzentrate näher erläutern zu können. Da der Hersteller der Konzentrate keine Kontrolle über die fertige Dialysierflüssigkeit hat, dient jede Bezugnahme auf die Dialysierflüssigkeit lediglich der Erläuterung und stellt keine Anforderung an den Hersteller dar.
Die vorliegende Internationale Norm behandelt Konzentrate in sowohl flüssiger als auch Pulverform. Ebenso behandelt werden Zusätze, auch als Aufstockung bezeichnet, bei denen es sich um Chemikalien handelt, die zum Konzentrat hinzugefügt werden dürfen, um die Konzentration an einem oder mehreren der vorliegenden Ionen im Konzentrat und damit in der fertigen Dialysierflüssigkeit zu erhöhen. Diese Internationale Norm enthält auch Anforderungen an die Ausrüstung zum Mischen von Säure und Bicarbonatpulver zum Konzentrat beim Endanwender.
Konzentrate, die in der Dialyseeinrichtung aus vorverpackten Salzen und Wasser für die Anwendung in der Einrichtung hergestellt werden, sind vom Anwendungsbereich dieser Internationalen Norm ausgenommen. Obwohl diese Internationale Norm Bezug auf Dialysierflüssigkeiten nimmt, behandelt sie keine vom Endanwender hergestellten Dialysierflüssigkeiten. Ebenfalls vom Anwendungsbereich dieser Internationalen Norm ausgenommen sind Anforderungen an die Häufigkeit der Überwachung der Reinheit des Wassers, das durch die Dialyseeinrichtung zur Herstellung der Dialysierflüssigkeit verwendet wird. ISO 23500 enthält Empfehlungen des für diese Internationale Norm verantwortlichen technischen Komitees hinsichtlich der Überwachung der Wasserqualität. Die vorliegende Internationale Norm behandelt keine Beutel, die sterile Dialysierflüssigkeit enthalten, oder sorbensbasierte Dialysierflüssigkeits-Wiederaufbereitungssysteme, in denen kleine Volumina der Dialysierflüssigkeit wiederaufbereitet und wieder in Umlauf gebracht werden.
Concentrés pour hémodialyse et thérapies apparentées (ISO 13958:2014)
L'ISO 13958:2014 spécifie les exigences minimales relatives aux concentrés utilisés pour l'hémodialyse et les thérapies apparentées. Pour les besoins de l'ISO 13958:2014, les «concentrés» désignent un mélange de composés chimiques et d'eau, ou de composés chimiques sous forme de poudre sèche ou d'autres milieux hautement concentrés, qui sont distribués à l'utilisateur final pour produire le fluide de dialyse utilisé pour effectuer l'hémodialyse et les thérapies apparentées. La présente Norme internationale est destinée aux fabricants de ce type de concentrés. L'ISO 13958:2014, il s'est révélé nécessaire dans plusieurs cas d'aborder la question du fluide de dialyse qui est produit par l'utilisateur final, afin de clarifier les exigences de production des concentrés. Étant donné que le fabricant du concentré n'a aucun contrôle sur le fluide de dialyse final, toute référence au fluide de dialyse est donnée à titre de clarification et ne constitue pas une exigence du fabricant.
L'ISO 13958:2014 inclut les concentrés sous forme liquide et sous forme pulvérulente. Sont également concernés les additifs, également appelés dopants, qui sont des composés chimiques pouvant être ajoutés au concentré pour augmenter la concentration d'un ou de plusieurs ions existants dans le concentré et donc dans le fluide de dialyse final. L'ISO 13958:2014 donne également les exigences relatives à l'équipement utilisé pour mélanger les poudres d'acide et de bicarbonate dans le concentré dans l'installation de l'utilisateur.
Koncentrati za hemodializo in podobne terapije (ISO 13958:2014)
Ta mednarodni standard določa minimalne zahteve glede koncentratov za hemodializo in podobne terapije. V tem mednarodnem standardu izraz »koncentrati« označuje mešanico kemičnih sredstev in vode ali kemičnih sredstev v obliki suhega praška ali druge medije z visoko koncentracijo, ki so dobavljene končnemu uporabniku za pripravo dializne tekočine, s katero se izvaja hemodializo in podobne terapije. Ta mednarodni standard je namenjen proizvajalcem takšnih koncentratov. V nekaterih izdajah tega mednarodnega standarda se je pokazala potreba po obravnavi dializne tekočine, ki jo pripravi končni uporabnik, da bi s tem pojasnili zahteve za proizvodnjo koncentratov. Ker proizvajalec koncentrata nima nadzora nad končno dializno tekočino, so vsi sklici na dializno tekočino namenjeni pojasnitvi in ne predstavljajo zahteve za proizvajalca. Ta mednarodni standard zajema koncentrate v obliki tekočin in praškov. Zajema tudi aditive, imenovane tudi dodatki, ki so kemična sredstva za dodajanje h koncentratu, s čimer se poveča koncentracija enega ali več obstoječih ionov v koncentratu in s tem tudi v končni dializni tekočini. Ta mednarodni standard podaja zahteve za opremo za mešanje kislin in bikarbonatnih praškov v koncentrat v uporabnikovi opremi. Koncentrati, pripravljeni v dializni opremi iz vnaprej pakiranih soli in vode, ki se uporabljajo v takšni opremi, ne spadajo v področje uporabe tega mednarodnega standarda. Čeprav se v tem mednarodnem standardu pojavljajo sklici na dializno tekočino, ta standard ne obravnava dializne tekočine, kot jo pripravi končni uporabnik. V področje uporabe tega mednarodnega standarda prav tako ne spadajo zahteve glede pogostosti nadzora za čistost vode, ki se uporablja za pripravo dializne tekočine v dializni opremi. Priporočila tehničnega odbora, pristojnega za ta mednarodni standard za nadzor kakovosti vode, so navedena v standardu ISO 23500. Ta mednarodni standard ne obravnava vrečk v sistemih za regeneracijo sterilne dializne tekočine ali sorbentne dializne tekočine, ki regenerirajo in recirkulirajo majhne količine dializne tekočine.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2016
1DGRPHãþD
SIST EN 13867:2003+A1:2009
Koncentrati za hemodializo in podobne terapije (ISO 13958:2014)
Concentrates for haemodialysis and related therapies (ISO 13958:2014)
Konzentrate für Hämodialyse und ähnliche Therapien (ISO 13958:2014)
Concentrés pour hémodialyse et thérapies apparentées (ISO 13958:2014)
Ta slovenski standard je istoveten z: EN ISO 13958:2015
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 13958
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2015
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN 13867:2002+A1:2009
English Version
Concentrates for haemodialysis and related therapies (ISO
13958:2014)
Concentrés pour hémodialyse et thérapies apparentées Konzentrate für Hämodialyse und ähnliche Therapien
(ISO 13958:2014) (ISO 13958:2014)
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 13958:2015 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 13958:2014 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 13958:2015 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 supersedes EN 13867:2002+A1:2009.
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.
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 11663 ISO 11663:2014
EN ISO 11663:2015
ISO 13959 ISO 13959:2014
EN ISO 13959:2015
ISO 14971 EN ISO 14971:2012 ISO 14971:2007
IEC 60601-1 EN 60601- IEC 60601-
1:2006+Cor.:2010+A1:2013 1:2005+Cor.:2006+Cor.:2007+A1:2012
IEC 61010-1 EN 61010-1:2010 IEC 61010-1:2010+Cor.:2011
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 13958:2014 has been approved by CEN as EN ISO 13958:2015 without any modification.
1)
To be published
2)
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
6.3 7.2
6.4 7.3
5.3 7.5
4.1.4.2 8
4.1.10 8.3
4 8.6
4 9.1
4.2, 4.3 9.2
6 13.1
6.2, 6.3, 6.4 13.2
6.2, 6.3, 6.4 13.3. (a)
6.2, 6.3, 6.4 13.3. (b)
Essential Requirements (ERs) of
Clause(s)/sub-clause(s) of this EN Qualifying remarks/Notes
Directive 93/42/EEC
6.2, 6.3, 6.4 13.3. (d)
6.2, 6.3, 6.4 13.3. (e)
6.2, 6.3, 6.4 13.3. (g)
6.2, 6.3, 6.4 13.3. (i)
6.2, 6.3, 6.4 13.3. (j)
6.2, 6.3, 6.4 13.3. (k)
6.2, 6.3, 6.4 13.3. (l)
6.2, 6.3, 6.4 13.4
6.2, 6.3, 6.4 13.6. (q)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 13958
Third edition
2014-04-01
Concentrates for haemodialysis and
related therapies
Concentrés pour hémodialyse et thérapies apparentées
Reference number
ISO 13958:2014(E)
©
ISO 2014
ISO 13958:2014(E)
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2014 – All rights reserved
ISO 13958:2014(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 7
4.1 Concentrates . 7
4.2 Manufacturing equipment . 9
4.3 Systems for mixing concentrate at a dialysis facility . 9
5 Tests .11
5.1 General .11
5.2 Concentrates .11
5.3 Manufacturing equipment .13
5.4 Systems for mixing concentrate at a dialysis facility .13
6 Labelling .14
6.1 General .14
6.2 General labelling requirements for concentrates .15
6.3 Labelling requirements for liquid concentrate .16
6.4 Labelling requirements for powder concentrate .16
6.5 Additives .17
6.6 Labelling requirements for concentrate generators .17
6.7 Labelling for concentrate mixer systems .18
Annex A (informative) Rationale for the d
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