SIST EN ISO 17730:2020

Dentistry - Fluoride varnishes (ISO 17730:2020)

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

Zahnheilkunde - Fluoridlacke (ISO 17730:2020)

Dieses Dokument legt Anforderungen und Prüfverfahren für den gesamten wasserlöslichen Fluoridgehalt und für ein minimales Fluoridfreisetzungspotential in fluoridhaltigen Dentallacken fest, die zur direkten Anwendung auf den Außenflächen der Zähne und der Füllungen in der Mundhöhle vorgesehen sind. Es legt auch Anforderungen an die Verpackung und Etikettierung einschließlich der Gebrauchsanweisung fest. Dieses Dokument ist anzuwenden für Fluoridlacke, die durch Mitarbeiter in der zahnmedizinischen Gesundheitsvorsorge aufgetragen werden.

Médecine bucco-dentaire - Vernis fluorés (ISO 17730:2020)

Le présent document spécifie les exigences et les méthodes d'essai relatives à la teneur totale en fluorures digestibles et un potentiel minimal de libération des fluorures solubles 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. Il spécifie également les exigences relatives à l'emballage et à l'étiquetage, y compris les instructions d'utilisation. Le présent document s'applique aux vernis fluorés destinés à être appliqués par des professionnels de la santé bucco-dentaire.

Zobozdravstvo - Fluoridni premazi (ISO 17730:2020)

General Information

• Status: Published
• Public Enquiry End Date: 04-Sep-2019
• Publication Date: 11-Nov-2020
• ICS: 11.060.01 - Dentistry in general
• ICS: 71.100.70 - Cosmetics. Toiletries
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 19-Oct-2020
• Due Date: 24-Dec-2020
• Completion Date: 12-Nov-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN ISO 17730:2020 - Dentistry - Fluoride varnishes (ISO 17730:2020)

Relations

• Replaces: SIST EN ISO 17730:2015 - Dentistry - Fluoride Varnishes (ISO 17730:2014)
• Effective Date: 01-Dec-2020

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 17730:2020
01-december-2020
Nadomešča:
SIST EN ISO 17730:2015
Zobozdravstvo - Fluoridni premazi (ISO 17730:2020)
Dentistry - Fluoride varnishes (ISO 17730:2020)
Zahnheilkunde - Fluoridlacke (ISO 17730:2020)
Médecine bucco-dentaire - Vernis fluorés (ISO 17730:2020)
Ta slovenski standard je istoveten z: EN ISO 17730:2020
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
SIST EN ISO 17730:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 17730:2020
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SIST EN ISO 17730:2020
EN ISO 17730
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2020
EUROPÄISCHE NORM
ICS 97.170 Supersedes EN ISO 17730:2014
English Version
Dentistry - Fluoride varnishes (ISO 17730:2020)

Médecine bucco-dentaire - Vernis fluorés (ISO Zahnheilkunde - Fluoridlacke (ISO 17730:2020)

17730:2020)
This European Standard was approved by CEN on 20 September 2020.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, 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

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17730:2020 E

worldwide for CEN national Members.
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SIST EN ISO 17730:2020
EN ISO 17730:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 17730:2020
EN ISO 17730:2020 (E)
European foreword

This document (EN ISO 17730:2020) 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 April 2021, and conflicting national standards shall be

withdrawn at the latest by April 2021.

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.

This document supersedes EN ISO 17730:2014.

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, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 17730:2020 has been approved by CEN as EN ISO 17730:2020 without any modification.

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SIST EN ISO 17730:2020
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SIST EN ISO 17730:2020
INTERNATIONAL ISO
STANDARD 17730
Second edition
2020-09
Dentistry — Fluoride varnishes
Médecine bucco-dentaire — Vernis fluorés
Reference number
ISO 17730:2020(E)
ISO 2020
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SIST EN ISO 17730:2020
ISO 17730:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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SIST EN ISO 17730:2020
ISO 17730:2020(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

4.2 Fluoride release potential ............................................................................................................................................................. 2

5 Sampling ........................................................................................................................................................................................................................ 2

6 Measurement and test methods ........................................................................................................................................................... 2

6.1 Test conditions ........................................................................................................................................................................................ 2

6.2 Test for total fluoride content .................................................................................................................................................... 2

6.2.1 Chemicals and solutions ............................................................................................................................................ 2

6.2.2 Apparatus ............................................................................................................................................................................... 3

6.2.3 Procedure ............................................................................................................................................................................... 3

6.3 Tests for conformance with “Instructions for use” and “Packaging and labelling” ...................... 5

7 Test report ................................................................................................................................................................................................................... 5

8 Instructions for use ........................................................................................................................................................................................... 5

9 Packaging and marking/labelling ...................................................................................................................................................... 5

9.1 Packaging ..................................................................................................................................................................................................... 5

9.2 Marking/labelling ................................................................................................................................................................................. 5

Annex A (informative) Test for fluoride release potential ............................................................................................................. 7

Bibliography .............................................................................................................................................................................................................................11

© ISO 2020 – All rights reserved iii
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SIST EN ISO 17730:2020
ISO 17730:2020(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, in collaboration with the European Committee for Standardization (CEN) Technical

Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between

ISO and CEN (Vienna Agreement).

This second edition cancels and replaces the first edition (ISO 17730:2014), which has been technically

revised.
The main changes compared to the previous edition are as follows:

— Additional subclause to indicate three samples are tested for total fluoride. Two aliquots are

analysed for each sample.

— A requirement of minimum soluble fluoride release potential and a relevant test method have

been added.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved
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SIST EN ISO 17730:2020
ISO 17730:2020(E)
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 test methods for demonstrating freedom from unacceptable

biological hazards are not included in this document, but it is recommended that, for the assessment

of possible biological or toxicological hazards, reference should be made to ISO 10993-1 and ISO 7405.

© ISO 2020 – All rights reserved v
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SIST EN ISO 17730:2020
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SIST EN ISO 17730:2020
INTERNATIONAL STANDARD ISO 17730:2020(E)
Dentistry — Fluoride varnishes
1 Scope

This document specifies requirements and test methods for total digestible fluoride content and a

minimum soluble fluoride release potential in dental varnishes containing fluoride, intended for use

in the oral cavity directly on the outer surfaces of teeth and fillings. It also specifies packaging and

labelling requirements, including the instructions for use. This document covers fluoride varnishes to

be applied by dental health care workers.
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 648:2008, Laboratory glassware — Single-volume pipettes
ISO 835:2007, Laboratory glassware — Graduated pipettes
ISO 1942, Dentistry — Vocabulary

ISO 3696:1987, Water for analytical laboratory use — Specification and test methods

ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules

ISO 8601-2, Date and time — Representations for information interchange — Part 2: Extensions

ISO 19448, Dentistry — Analysis of fluoride concentration in aqueous solutions by use of fluoride ion-

selective electrode
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
fluoride varnish

dental product, in paintable liquid/paste form containing fluoride compound for topical application to

the outer surfaces of teeth and fillings, intended primarily to prevent tooth caries or reduce dentine

hypersensitivity
3.2
total fluoride content
mass percent of fluoride in the fluoride varnish (3.1)
3.3
fluoride release potential

detectable soluble fluoride released from the fluoride varnish (3.1) into an aqueous medium

© ISO 2020 – All rights reserved 1
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SIST EN ISO 17730:2020
ISO 17730:2020(E)
3.4
outermost packaging

packaging used to combine material and additional items, including instructions for use and any

proportioning or mixing devices that are supplied with the material
4 Requirements
4.1 Total fluoride content

The total fluoride content shall not deviate by more than 20 % from the stated amount on the package

when tested in accordance with 6.2 or other validated methods for total fluoride content.

4.2 Fluoride release potential

The fluoride release potential shall be equal to or higher than 14,2 ng F/mm as determined by the test

method in Annex A. Other validated measurement methods on fluoride release potential with simil

...