prEN ISO 17730

SLOVENSKI STANDARD
01-marec-2024
Zobozdravstvo - Fluoridni premazi (ISO/DIS 17730:2023)
Dentistry - Fluoride varnishes (ISO/DIS 17730:2023)
Zahnheilkunde - Fluoridlacke (ISO/DIS 17730:2023)
Médecine bucco-dentaire - Vernis fluorés (ISO/DIS 17730:2023)
Ta slovenski standard je istoveten z: prEN ISO 17730
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.

DRAFT INTERNATIONAL STANDARD
ISO/DIS 17730
ISO/TC 106/SC 7 Secretariat: JISC
Voting begins on: Voting terminates on:
2023-12-28 2024-03-21
Dentistry — Fluoride varnishes
Médecine bucco-dentaire — Vernis fluorés
ICS: 97.170
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
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NATIONAL REGULATIONS.
ISO/DIS 17730:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

ISO/DIS 17730:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 17730
ISO/TC 106/SC 7 Secretariat: JISC
Voting begins on: Voting terminates on:

Dentistry — Fluoride varnishes
Médecine bucco-dentaire — Vernis fluorés
ICS: 97.170
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 17730:2023(E)
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ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

ISO/DIS 17730:2023(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 . 6
Annex A (informative) Test for fluoride release potential . 7
Bibliography .11
iii
ISO/DIS 17730:2023(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).
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.
This third edition cancels and replaces the second edition (ISO 17730:2020), which has been technically
revised.
The main changes are as follows:
— Edits for removal of abbreviations/jargon to improve clarity of the document.
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/DIS 17730:2023(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 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.
v
DRAFT INTERNATIONAL STANDARD ISO/DIS 17730:2023(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.
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 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 https:// 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/DIS 17730:2023(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
...