Dentistry - Fluoride Varnishes (ISO 17730:2014)

This Standard specifies requirements and their test methods for total fluoride content in dental varnishes containing fluoride, intended for use in the oral cavity directly on the outer surfaces of teeth and fillings. It also specifies the requirements for their packaging and labelling, including the instructions for use. This standard covers fluoride varnishes to be applied by dental health care workers.

Zahnheilkunde - Fluoridlacke (ISO 17730:2014)

Diese Internationale Norm legt Anforderungen an und Prüfverfahren für den Gesamtfluoridgehalt in fluoridhaltigen Dentallacken fest, die zur direkten Anwendung auf den Zahnaußenflächen und Füllungen in der Mundhöhle vorgesehen sind. Sie enthält auch Anforderungen an die Verpackung, Etikettierung und Gebrauchsanweisung. Diese Norm gilt für Fluoridlacke, die durch Beschäftigte in der zahnmedizinischen Versorgung aufgetragen werden.

Vernis fluorés (ISO 17730:2014)

L'ISO 17730:2014 spécifie des exigences, et les méthodes d'essai correspondantes, relatives à la teneur totale en fluorures digestibles des vernis dentaires qui en contiennent et qui sont destinés à être utilisés dans la cavité buccale, directement sur la surface extérieure des dents ou obturations. L'ISO 17730:2014 spécifie également les exigences relatives à l'emballage et à l'étiquetage, y compris les instructions d'utilisation. Elle s'applique aux vernis fluorés destinés à être appliqués par des professionnels de la santé bucco-dentaire.

Zobozdravstvo - Fluoridni premazi (ISO 17730:2014)

Ta standard določa zahteve in njihove preskusne metode za skupno vsebnost fluorida v dentalnih premazih, ki vsebujejo fluorid in so namenjeni za uporabo v ustni votlini neposredno na zunanjih površinah zob in plomb. Prav tako določa zahteve za njihov pakiranje in označevanje, vključno z navodili za uporabo. Ta standard zajema fluoridne premaze, ki jih uporabljajo zobozdravstveni delavci.

General Information

Status
Withdrawn
Public Enquiry End Date
30-Jul-2013
Publication Date
02-Feb-2015
Withdrawal Date
11-Nov-2020
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
12-Nov-2020
Due Date
05-Dec-2020
Completion Date
12-Nov-2020

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SLOVENSKI STANDARD
SIST EN ISO 17730:2015
01-marec-2015
Zobozdravstvo - Fluoridni premazi (ISO 17730:2014)
Dentistry - Fluoride Varnishes (ISO 17730:2014)
Zahnheilkunde - Fluoridlacke (ISO 17730:2014)
Vernis fluorés (ISO 17730:2014)
Ta slovenski standard je istoveten z: EN ISO 17730:2014
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
SIST EN ISO 17730:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 17730:2015

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SIST EN ISO 17730:2015

EUROPEAN STANDARD
EN ISO 17730

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2014
ICS 97.170
English Version
Dentistry - Fluoride varnishes (ISO 17730:2014)
Médecine bucco-dentaire - Vernis fluorés (ISO 17730:2014) Zahnheilkunde - Fluoridlacke (ISO 17730:2014)
This European Standard was approved by CEN on 23 August 2014.

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
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17730:2014 E
worldwide for CEN national Members.

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SIST EN ISO 17730:2015
EN ISO 17730:2014 (E)
Contents Page
Foreword .3
2

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SIST EN ISO 17730:2015
EN ISO 17730:2014 (E)
Foreword
This document (EN ISO 17730:2014) 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 May 2015, and conflicting national standards shall be withdrawn at the
latest by May 2015.
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.
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 17730:2014 has been approved by CEN as EN ISO 17730:2014 without any modification.
3

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SIST EN ISO 17730:2015

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SIST EN ISO 17730:2015
INTERNATIONAL ISO
STANDARD 17730
First edition
2014-11-01
Dentistry — Fluoride varnishes
Médecine bucco-dentaire — Vernis fluorés
Reference number
ISO 17730:2014(E)
©
ISO 2014

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SIST EN ISO 17730:2015
ISO 17730:2014(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 17730:2015
ISO 17730:2014(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and Definitions . 1
4 Requirements . 2
4.1 Total fluoride content . 2
5 Sampling . 2
6 Test method . 2
6.1 Test for total fluoride content . 2
6.2 Test conditions . 3
7 Test report . 4
8 Instructions for use . 4
9 Packaging, labelling, and marking . 5
9.1 Packaging . 5
9.2 Labelling . 5
Bibliography . 6
© ISO 2014 – All rights reserved iii

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SIST EN ISO 17730:2015
ISO 17730:2014(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 106, Dentistry, Subcommittee SC7, Oral care
products.
iv © ISO 2014 – All rights reserved

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SIST EN ISO 17730:2015
ISO 17730:2014(E)

Introduction
Fluoride varnishes are used in dentistry primarily for caries prevention and reduction of dentine
hypersensitivity. Fluoride varnishes are applied in th
...

SLOVENSKI STANDARD
oSIST prEN ISO 17730:2013
01-julij-2013
Zobozdravstvo - Fluoridni premazi (ISO/DIS 17730:2013)
Dentistry - Fluoride Varnishes (ISO/DIS 17730:2013)
Zahnheilkunde - Fluoridlacke (ISO/DIS 17730:2013)
Vernis fluorés (ISO/DIS 17730:2013)
Ta slovenski standard je istoveten z: prEN ISO 17730
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
oSIST prEN ISO 17730:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 17730:2013

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oSIST prEN ISO 17730:2013


EUROPEAN STANDARD
DRAFT
prEN ISO 17730
NORME EUROPÉENNE

EUROPÄISCHE NORM

April 2013
ICS 97.170
English Version
Dentistry - Fluoride Varnishes (ISO/DIS 17730:2013)
Vernis fluorés (ISO/DIS 17730:2013) Zahnheilkunde - Fluoridlacke (ISO/DIS 17730:2013)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 55.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 17730:2013: E
worldwide for CEN national Members.

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oSIST prEN ISO 17730:2013
prEN ISO 17730:2013 (E)
Contents
Page
Foreword .3


2

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oSIST prEN ISO 17730:2013
prEN ISO 17730:2013 (E)
Foreword
This document (prEN ISO 17730:2013) 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 document is currently submitted to the parallel Enquiry.
Endorsement notice
The text of ISO/DIS 17730:2013 has been approved by CEN as prEN ISO 17730:2013 without any
modification.
3

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oSIST prEN ISO 17730:2013

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oSIST prEN ISO 17730:2013

DRAFT INTERNATIONAL STANDARD ISO/DIS 17730
ISO/TC 106/SC 7 Secretariat: JISC
Voting begins on Voting terminates on

2013-04-04 2013-09-04
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION  •  МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ  •  ORGANISATION INTERNATIONALE DE NORMALISATION


Dentistry — Fluoride Varnishes
Vernis fluorés —

ICS 97.170





ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.

To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.



THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
©  International Organization for Standardization, 2013

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oSIST prEN ISO 17730:2013
ISO/DIS 17730

COPYRIGHT PROTECTED DOCUMENT


©  ISO 2013
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 2013 – All rights reserved

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oSIST prEN ISO 17730:2013
ISO/DIS 17730
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Requirements ………………………………………………………………………………………….1
5 Sampling ……………………………………………………………………………………………………….2
6 Test method ………………………………………………………………………………………………….2
7 Test report ………………………………………………………………………………………………………4
8 Instructions for use ……………………………………………………………………………………………5
9 Packaging, labelling and marking ……………………………………………………………………….5
Bibliography …………………………………………………………………………………………………………….6
© ISO 2006 – All rights reserved iii

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oSIST prEN ISO 17730:2013
ISO/DIS17730

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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO DIS 17730 was prepared by Technical Committee ISO/TC 106, Dentistry, SC7 Oral Care Products.
iv © ISO 2006 – All rights reserved

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oSIST prEN ISO 17730:2013
ISO/DIS 17730

Introduction
Fluoride varnishes are used in dentistry primarily for caries prevention and reduction of dentine hypersensitivity.
Fluoride varnishes are applied in the oral cavity directly on the outer surfaces of teeth and fillings and are
intended to remain at least for several hours.
Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this
International Standard, but it is recommended that when assessing possible biological or toxicological hazards
reference should be made to ISO 10 993-1 and ISO 7405.

© ISO 2006 – All rights reserved v

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