SIST EN ISO 13958:2016
(Main)Concentrates for haemodialysis and related therapies (ISO 13958:2014)
Concentrates for haemodialysis and related therapies (ISO 13958:2014)
This International Standard specifies minimum requirements for concentrates used for haemodialysis and related therapies. For the purpose of this International Standard, “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.
This International Standard is addressed to the manufacturer of such concentrates. In several instances in this International Standard, it became necessary to address the dialysis fluid, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer.
This International Standard 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. This International Standard also gives requirements for equipment used to mix acid and bicarbonate
powders into concentrate at the user’s facility.
Concentrates prepared from prepackaged salts and water at a dialysis facility for use in that facility are excluded from the scope of this International Standard. Although references to dialysis fluid appear herein, this International Standard does not address dialysis fluid as made by the end user. Also excluded from the scope of this International Standard are requirements for the monitoring frequency of water purity used for the making of dialysis fluid by the dialysis facility. Recommendations from the technical committee responsible for this International Standard for monitoring water quality are contained in ISO 23500. This International Standard does not address bags of sterile dialysis fluid or sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.
Konzentrate für Hämodialyse und ähnliche 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
SIST EN ISO 13958:2016
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
SIST EN ISO 13958:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 13958:2016
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SIST EN ISO 13958:2016
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.
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SIST EN ISO 13958:2016
EN ISO 13958:2015 (E)
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
2
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SIST EN ISO 13958:2016
EN ISO 13958:2015 (E)
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.
3
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SIST EN ISO 13958:2016
EN ISO 13958:2015 (E)
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
1
ISO 11663 ISO 11663:2014
EN ISO 11663:2015
2
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.
4
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SIST EN ISO 13958:2016
EN ISO 13958:2015 (E)
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)
5
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SIST EN ISO 13958:2016
EN ISO 13958:2015 (E)
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.
6
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SIST EN ISO 13958:2016
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
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SIST EN ISO 13958:2016
ISO 13958:2014(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
Case postale 56 • CH-1211 Geneva 20
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
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SIST EN ISO 13958:2016
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 development and provisions of this
International Standard .20
Bibliography .25
© ISO 2014 – All rights reserved iii
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SIST EN ISO 13958:2016
ISO 13958:2014(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 13958:2009), which has been technically
revised.
iv © ISO 2014 – All rights reserved
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SIST EN ISO 13958:2016
ISO 13958:2014(E)
Introduction
The requirements and goals established by this International Standard will help ensure the effective,
safe performance of haemodialysis concentrates and related materials. This International Standard
reflects the conscientious efforts of concerned physicians, clinical engineers, nurses, dialysis technicians
and dialysis patients, in consultation with device manufacturers and government representatives, to
develop a standard for performance levels that could be reasonably achieved at the time of publication.
The term “consensus” as applied to the development of voluntary medical device standards does not
imply unanimity of opinion, but rather reflects the compromise necessary in some instances when a
variety of interests must be merged.
Throughout this International Standard, recommendations are made to use ISO-quality water. Therefore,
it is recommended to review ISO 13959 along with this International Standard.
This International Standard does not cover the dialysis fluid that is used to clinically dialyse patients.
Dialysis fluid is covered in ISO 11663. The making of dialysis fluid involves the proportioning of
concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label
requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user’s responsibility
to ensure proper use.
In addition, this International Standard does not cover haemodialysis equipment, which is addressed in
IEC 60601-2-16:2012.
The verbal forms used in this International Standard conform to usage described in Annex H of the
ISO/IEC Directives, Part 2. For the purposes of this International Standard, the auxiliary verb
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
International Standard,
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this International Standard, and
— “may” is used to describe a permissible way to achieve compliance with a requirement or test.
© ISO 2014 – All rights reserved v
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SIST EN ISO 13958:2016
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SIST EN ISO 13958:2016
INTERNATIONAL STANDARD ISO 13958:2014(E)
Concentrates for haemodialysis and related therapies
1 Scope
This International Standard specifies minimum requirements for concentrates used for haemodialysis
and related therapies. For the purpose of this International Standard, “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.
This International Standard is addressed to the manufacturer of such concentrates. In several instances
in this International Standard, it became necessary to address the dialysis fluid, which is made by the
end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer
of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for
clarification and is not a requirement of the manufacturer.
This International Standard 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.
This International Standard also gives requirements for equipment used to mix acid and bicarbonate
powders into concentrate at the user’s facility.
Concentrates prepared from prepackaged salts and water at a dialysis facility for use in that facility
are excluded from the scope of this International Standard. Although references to dialysis fluid appear
herein, this International Standard does not address dialysis fluid as made by the end user. Also excluded
from the scope of this International Standard are requirements for the monitoring frequency of water
purity used for the making of dialysis fluid by the dialysis facility. Recommendations from the technical
committee responsible for this International Standard for monitoring water quality are contained in
ISO 23500. This International Standard does not address bags of sterile dialysis fluid or sorbent dialysis
fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 11663, Quality of dialysis fluid for haemodialysis and related therapies
ISO 13959, Water for haemodialysis and related therapies
ISO 14971, Medical devices — Application of risk management to medical devices
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
IEC 61010-1, Safety requirements for electrical equipment for measurement, control, and laboratory use —
Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
© ISO 2014 – All rights reserved 1
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SIST EN ISO 13958:2016
ISO 13958:2014(E)
3.1
acetate concentrate
concentrated solution of salts containing acetate, which, when diluted with dialysis water, yields
bicarbonate-free dialysis fluid for use in dialysis
Note 1 to entry: Acetate concentrate may contain glucose.
Note 2 to entry: Sodium acetate is used to provide a buffer in place of sodium bicarbonate.
Note 3 to entry: Acetate concentrate is used as a single concentrate.
3.2
acid concentrate
A-concentrate
acidified concentrated mixture of salts that, when diluted with dialysis water and bicarbonate
concentrate, yields dialysis fluid for use in dialysis
Note 1 to entry: The term “acid” refers to the small amount of acid (for example, acetic acid or citric acid) that is
included in the concentrate.
Note 2 to entry: Acid concentrate may contain glucose.
Note 3 to entry: Acid concentrate may be in the form of a liquid, a dry powder, other highly concentrated media,
or some combination of these forms.
3.3
action level
concentration of a contaminant at which steps should be taken to interrupt the trend toward higher,
unacceptable levels
3.4
additive
spike
small amount of a single chemical that, when added to the concentrate, will increase the concentration
of a single existing chemical by a value labelled on the additive packaging
3.5
batch system
apparatus in which the dialysis fluid is prepared in bulk before each dialysis session
3.6
bicarbonate concentrate
B-concentrate
concentrated preparation of sodium bicarbonate that, when diluted with dialysis water and acid
concentrate, makes dialysis fluid used for dialysis
Note 1 to entry: Sodium bicarbonate is also known as sodium hydrogen carbonate.
Note 2 to entry: Some bicarbonate concentrates also contain sodium chloride.
Note 3 to entry: Bicarbonate concentrate may be in the form of a liquid or a dry powder.
Note 4 to entry: Dry sodium bicarbonate, without added sodium chloride, is also used in concentrate generators
to produce a concentrated solution of sodium bicarbonate used by the dialysis machine to make dialysis fluid.
3.7
bicarbonate dialysis fluid
dialysis fluid containing physiological or higher concentrations of bicarbonate
Note 1 to entry: Bicarbonate dialysis fluid is generally produced from two concentrates: one containing bicarbonate
and the other containing acid and other electrolytes. See acid concentrate (3.2) and bicarbonate concentrate (3.6).
2 © ISO 2014 – All rights reserved
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SIST EN ISO 13958:2016
ISO 13958:2014(E)
3.8
biofilm
microbially derived sessile community characterized by cells that are irreversibly attached to a
substratum or interface or to each other, are imbedded in a matrix of extracellular polymeric substances
that they have produced, and exhibit an altered phenotype with respect to growth rate and gene
transcription
Note 1 to entry: The matrix, a slimy material secreted by the cells, protects the bacteria from antibiotics and
chemical disinfectants.
Note 2 to entry: A certain amount of biofilm formation is considered unavoidable in dialysis water systems. When
the level of biofilm is such that the action levels for microorganisms and endotoxins in the dialysis water cannot
be routinely achieved, the operation of the system is compromised from a medical and technical point of view.
This level of biofilm formation is often referred to as biofouling.
3.9
bulk delivery
delivery of large containers of concentrate to a dialysis facility
Note 1 to entry: Bulk delivery includes containers such as drums, which can be pumped into a storage tank
maintained at the user’s facility. Alternatively, the drums can be left at the facility and used to fill transfer
containers to transfer the concentrate to the dialysis machines. Bulk delivery can also include large containers
for direct connection to a central concentrate supply system.
Note 2 to entry: Bulk delivery also includes dry powder concentrates intended to be used with an appropriate
concentrate mixer.
3.10
central concentrate system
system that prepares and/or stores concentrate at a central point for subsequent distribution to its
points of use
3.11
central dialysis fluid delivery system
system that produces dialysis fluid from dialysis water and concentrate or powder at a central point and
distributes the dialysis fluid from the central point to individual dialysis machines
3.12
concentrate generator
system where the concentrate is delivered to the user as a powder in a container, suitable for attachment
to the dialysis machine with which it is intended to be used, and then the powder is converted into a
concentrated solution by the dialysis machine
Note 1 to entry: The solution produced by the concentrate generator is used by the dialysis machine to make the
final dialysis fluid delivered to the dialyser.
3.13
concentrate mixer
mixer for preparation of dialysis concentrate or dialysis fluid at a dialysis facility
3.14
device
individual water purification unit, such as a softener, carbon bed, reverse osmosis unit, or deionizer
Note 1 to entry: This term is synonymous with the term “component” as used by the US Food and Drug
[15]
Administration (see Reference ).
© ISO 2014 – All rights reserved 3
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SIST EN ISO 13958:2016
ISO 13958:2014(E)
3.15
dialysis fluid
dialysate
dialysis solution
aqueous fluid containing electrolytes and, usually, buffer and glucose, which is intended to exchange
solutes with blood during haemodialysis
Note 1 to entry: The term “dialysis fluid” is used throughout this International Standard to mean the fluid made
from dialysis water and concentrates that is delivered to the dialyser by the dialysis fluid delivery system. Such
phrases as “dialysate” or “dialysis solution” are used in place of dialysis fluid in some countries; however, that
usage is discouraged to avoid confusion.
Note 2 to entry: The dialysis fluid entering the dialyser is referred to as “fresh dialysis fluid”, while the fluid
leaving the dialyser is referred to as “spent dialysis fluid.”
Note 3 to entry: Dialysis fluid does not include prepackaged parenteral fluids used in some renal replacement
therapies, such as haemodiafiltration and haemofiltration.
3.16
dialysis fluid delivery system
device that: prepares dialysis fluid online from dialysis water and concentrates or that stores and
distributes premixed dialysis fluid; circulates the dialysis fluid through the dialyser; monitors the
dialysis fluid for temperature, conduc
...
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