Dentistry - Analysis of Fluoride Concentration in Aqueous Solutions by use of Fluoride-Ion Selective Electrode (ISO 19448:2018)

Methods for the quantication of fluoride concentrations in dental products including dentifrice, oral rinse,
fluoride releasing varnishes, and other fluoride containing products. The methods are based on fluoride ionselective
electrode technology for the analysis of fluoride in aqueous samples derived from dental products.

Zahnheilkunde - Analyse der Fluoridkonzentration in wässrigen Lösungen mit einer fluoridionenselektiven Elektrode (ISO 19448:2018)

Dieses Dokument beschreibt Prüfverfahren zur Quantifizierung von Fluoridkonzentrationen in Dentalprodukten, einschließlich Zahnpasten, Mundspüllösungen und Mundwässern sowie in Lacken, die Fluorid freisetzen und in anderen Produkten, die Fluorid enthalten. Die Verfahren basieren auf der Anwendung einer fluoridionenselektiven Elektrode zur Analyse des Gesamtfluoridgehalts in wässrigen Proben, die von Dentalprodukten genommen wurden.

Médecine bucco-dentaire - Analyse de la concentration en fluorure dans les solutions aqueuses à l'aide d'une électrode sélective d'ions fluorures (ISO 19448:2018)

ISO 19448:2018 spécifie des méthodes d'essai applicables à la quantification des concentrations en fluorure dans les produits dentaires tels que les dentifrices, les gels, les bains de bouche, les vernis fluorurés et d'autres produits contenant du fluorure. Les méthodes reposent sur la technologie de l'électrode sélective des ions fluorures pour l'analyse du fluorure dans des échantillons aqueux prélevés sur des produits dentaires.

Zobozdravstvo - Analiza koncentracije fluorida v vodnih raztopinah z uporabo fluorid-ionske selektivne elektrode (ISO 19448:2018)

Metode za kvantifikacijo koncentracij fluorida v izdelkih za nego zob, vključno z zobnimi pastami, sredstvi za izpiranje ust, premazi, ki sproščajo fluorid, in drugimi izdelki, ki vsebujejo fluorid. Metode temeljijo na tehnologiji fluoridnih ionsko-selektivnih elektrod za analizo fluorida v vodnih vzorcih, odvzetih iz izdelkov za nego zob.

General Information

Status
Published
Publication Date
18-Mar-2018
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
14-Feb-2018
Due Date
21-Apr-2018
Completion Date
19-Mar-2018

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SLOVENSKI STANDARD
SIST EN ISO 19448:2018
01-april-2018
Zobozdravstvo - Analiza koncentracije fluorida v vodnih raztopinah z uporabo
fluorid-ionske selektivne elektrode (ISO 19448:2018)
Dentistry - Analysis of Fluoride Concentration in Aqueous Solutions by use of Fluoride-
Ion Selective Electrode (ISO 19448:2018)
Zahnheilkunde - Analyse der Fluoridkonzentration in wässrigen Lösungen mit einer
fluoridionenselektiven Elektrode (ISO 19448:2018)
Médecine bucco-dentaire - Analyse de la concentration en fluorure dans les solutions
aqueuses à l'aide d'une électrode sélective d'ions fluorures (ISO 19448:2018)
Ta slovenski standard je istoveten z: EN ISO 19448:2018
ICS:
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
SIST EN ISO 19448:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 19448:2018

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SIST EN ISO 19448:2018


EN ISO 19448
EUROPEAN STANDARD

NORME EUROPÉENNE

January 2018
EUROPÄISCHE NORM
ICS 71.100.70
English Version

Dentistry - Analysis of Fluoride Concentration in Aqueous
Solutions by use of Fluoride-Ion Selective Electrode (ISO
19448:2018)
Médecine bucco-dentaire - Analyse de la concentration Zahnheilkunde - Analyse der Fluoridkonzentration in
en fluorure dans les solutions aqueuses à l'aide d'une wässrigen Lösungen mit einer fluoridionenselektiven
électrode sélective d'ions fluorures (ISO 19448:2018) Elektrode (ISO 19448:2018)
This European Standard was approved by CEN on 23 December 2017.

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
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19448:2018 E
worldwide for CEN national Members.

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SIST EN ISO 19448:2018
EN ISO 19448:2018 (E)
Contents Page
European Foreword . 3

2

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SIST EN ISO 19448:2018
EN ISO 19448:2018 (E)
European Foreword
This document (EN ISO 19448:2018) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with Technical Committee CEN/TC 55 “Dentistry” 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 July 2018, and conflicting national standards shall be
withdrawn at the latest by July 2018.
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.
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 19448:2018 has been approved by CEN as EN ISO 19448:2018 without any modification.

3

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SIST EN ISO 19448:2018

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SIST EN ISO 19448:2018
INTERNATIONAL ISO
STANDARD 19448
First edition
2018-01
Dentistry — Analysis of fluoride
concentration in aqueous solutions by
use of fluoride ion-selective electrode
Médecine bucco-dentaire — Analyse de la concentration en fluorure
dans les solutions aqueuses en utilisant une électrode sélective des
ions fluorures
Reference number
ISO 19448:2018(E)
©
ISO 2018

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SIST EN ISO 19448:2018
ISO 19448:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

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SIST EN ISO 19448:2018
ISO 19448:2018(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
4 Principle . 1
5  Reagents and materials . 2
6  Apparatus . 2
7 Preparation . 3
7.1 TISAB solution . 3
7.2 TISAB blank solution . 3
7.3 Fluoride standard solutions . 3
7.4 Calibration curve . 4
8  Procedure. 5
8.1 Direct analysis technique . 5
8.2 Standard addition technique . 6
8.3 Dilution analysis technique . 7
8.4 Multiple sample addition technique . 7
8.5 Internal standards technique . 7
9  Technical notes about the analytical techniques . 7
10  Calculations. 8
10.1 Direct analysis technique . 8
10.2 Standard additions technique . 8
10.3 Dilution analysis technique . 9
10.4 Multiple sample addition technique . 9
10.5 Internal standards technique . 9
11 Test report . 9
12  Trouble shooting . 9
Bibliography .11
© ISO 2018 – All rights reserved iii

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SIST EN ISO 19448:2018
ISO 19448:2018(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 voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral
care products.
iv © ISO 2018 – All rights reserved

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SIST EN ISO 19448:2018
ISO 19448:2018(E)

Introduction
Fluoride is used in dentistry primarily for caries prevention. Fluoride is the active ingredient for
caries prevention in many dental products such as dentifrices, gels, oral rinses, and fluoride releasing
varnishes. The fluoride concentration in these products is an integral part of other standards where
the product is intended to be analysed for fluoride content. This document provides methods based
on the use of fluoride ion-selective electrode technology for the analysis of the total fluoride content
in aqueous samples. The methods describe uses for fluoride ion-selective electrode technology and
anticipate that the sample-specific preparations such as digestion, distillation, etc. have been described
in the standards specific to product types.
© ISO 2018 – All rights reserved v

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SIST EN ISO 19448:2018

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SIST EN ISO 19448:2018
INTERNATIONAL STANDARD ISO 19448:2018(E)
Dentistry — Analysis of fluoride concentration in aqueous
solutions by use of fluoride ion-selective electrode
1 Scope
This document specifies test methods for the quantification of fluoride concentrations in dental
products including dentifrices, gels, oral rinses, fluoride releasing varnishes, and other fluoride
containing products. The methods are based on fluoride ion-selective electrode technology for the
analysis of fluoride in aqueous samples derived from dental products.
2  Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 78-2, Chemistry — Layouts for standards — Part 2: Methods of chemical analysis
ISO 835, Laboratory glassware — Graduated pipettes
ISO 1942, Dentistry — Vocabulary
ISO 3696, Water for analytical laboratory use — Specification and test methods
3  Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 78-2 and ISO 1942 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
4 Principle
This test method covers the determination of fluoride concentration in aqueous solutions derived from
dental products. The following test methods are presupposed to use fluoride ion-selective electrodes
(F-ISE) .
The sensing element of the fluoride ion-selective electrode consists of a single crystal of europium (II)-
doped lanthanum fluoride, LaF . When the sensing element is in contact with a solution containing
3
fluoride ions, an electrode potential develops across the sensing element. This potential, which depends
-
on the activity of free fluoride ion in solution {F }, is measured against a constant reference electrode
potential with a digital pH/mV meter or ISE (concentration) potentiometer. A potential (E) is developed
-
which is proportional to the logarithm of the activity of the fluoride ion {F } in solution following the
Nernst Equation.
-
E = E + S * log {F} (1)
0
© ISO 2018 – All rights reserved 1

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SIST EN ISO 19448:2018
ISO 19448:2018(E)

where
E is the measured electrode potential;
E is the reference potential (a constant);
0
-
{F } is the fluoride ion activity level in solution;
S is the electrode slope (58,2 mV per decade change of {F-} at 20 °C).
-
The level of fluoride ion, {F }, is the activity or “effecti
...

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