SIST EN ISO 17730:2025

SLOVENSKI STANDARD
01-november-2025
Nadomešča:
SIST EN ISO 17730:2020
Zobozdravstvo - Fluoridni premazi (ISO 17730:2025)
Dentistry - Fluoride varnishes (ISO 17730:2025)
Zahnheilkunde - Fluoridlacke (ISO 17730:2025)
Médecine bucco-dentaire - Vernis fluorés (ISO 17730:2025)
Ta slovenski standard je istoveten z: EN ISO 17730:2025
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 17730
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2025
EUROPÄISCHE NORM
ICS 71.100.70 Supersedes EN ISO 17730:2020
English Version
Dentistry - Fluoride varnishes (ISO 17730:2025)
Médecine bucco-dentaire - Vernis fluorés (ISO Zahnheilkunde - Fluoridlacke (ISO 17730:2025)
17730:2025)
This European Standard was approved by CEN on 18 August 2025.

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, Türkiye 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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17730:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 17730:2025) 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 March 2026, and conflicting national standards shall
be withdrawn at the latest by March 2026.
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 17730:2020.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 17730:2025 has been approved by CEN as EN ISO 17730:2025 without any modification.

International
Standard
ISO 17730
Third edition
Dentistry — Fluoride varnishes
2025-09
Médecine bucco-dentaire — Vernis fluorés
Reference number
ISO 17730:2025(en) © ISO 2025
ISO 17730:2025(en)
© ISO 2025
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 17730:2025(en)
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
7 Test report . 5
8 Instructions for use . . 5
9 Packaging and marking/labelling . 5
9.1 Packaging .5
9.2 Marking/labelling .6
Annex A (informative) Test for fluoride release potential . 7
Bibliography .11

iii
ISO 17730:2025(en)
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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of 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 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 third edition cancels and replaces the second edition (ISO 17730:2020), which has been technically
revised.
The main changes are as follows:
— Abbreviated terms and jargon have been removed and edited for clarity.
2 2
— A.2.3: The minimum size range of the plastic rod was changed from 30 mm to 60 mm to be more
2 2
precise at 28,3 mm to 60 mm .
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 17730:2025(en)
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 for several hours.
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological
hazards are not included in this document, but, for the assessment of possible biological or toxicological
hazards, reference should be made to ISO 10993-1 and ISO 7405.

v
International Standard ISO 17730:2025(en)
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. This also specifies packaging and labelling requirements,
including the instructions for use. This document covers fluoride varnishes to be applied by dental health
care workers.
This document does not apply to fast acting topical fluoride products such as fluoride oral rinses.
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 met
...