EN ISO 17730:2014
(Main)Dentistry - Fluoride varnishes (ISO 17730:2014)
Dentistry - Fluoride varnishes (ISO 17730:2014)
ISO 17730:2014 specifies requirements and their test methods for total digestible 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 International 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 gesamten wasserlöslichen
Fluoridgehalt in fluoridhaltigen Dentallacken fest, die zur direkten Anwendung auf den Zahnaußenflächen und
Füllungen in der Mundhöhle vorgesehen sind. Sie beschreibt auch Anforderungen an die Verpackung,
Etikettierung und Gebrauchsanweisung. Diese Internationale Norm gilt für Fluoridlacke, die durch Beschäftigte
in der zahnmedizinischen Versorgung aufgetragen werden.
Médecine bucco-dentaire - 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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .3
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.
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
ISO 17730:2014(E)
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
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ii © ISO 2014 – All rights reserved
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 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
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 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 hazard are not included in this International Standard, 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.
INTERNATIONAL STANDARD ISO 17730:2014(E)
Dentistry — Fluoride varnishes
1 Scope
This International Standard specifies requirements and their test methods for total digestible 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 International Standard covers fluoride varnishes to be applied
by dental health care workers.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates
and times
3 Terms and Definitions
For the purposes of this document, the definitions given in ISO 1942 and the following apply.
3.1
consumer packaging
retail packaging
sales packaging
package, with labelling and contents as a sales unit to the user or consumer at the point of retail
Note 1 to entry: A consumer packaging can consist of a secondary packaging wrapping or container covering
one or more primary packaging elements or, it can consist of a single primary packaging element containing the
product.
Note 2 to entry: Adapted from ISO 21067:2007, definition 2.2.5.
3.2
fluoride varnish
dental product, in paintable liquid 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
3.3
total fluoride
mass percent of fluoride in the fluoride varnish
ISO 17730:2014(E)
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 6.1 or other validated methods for total fluoride content.
5 Sampling
Use packages prepared for retail sale from the same batch containing enough material to carry out the
specified tests, plus an allowance for repeat tests, if necessary.
6 Test method
6.1 Test for total fluoride content
6.1.1 Chemicals and solutions
6.1.1.1 Total ionic strength adjusting buffer (TISAB) solution, described in ASTM D1179-10:2010
18.1 or alternative.
NOTE TISAB II: Sodium chloride 5,8 % (w/v), acetic acid 5,7 % (w/v), CDTA 0,4 % (w/v) adjust to pH 5 to ®
pH 5,5 with sodium hydroxide (5 mol/L). Examples are TISAB II (Orion Res
...
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