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CEN

EN ISO 17730:2020

(Main)

Dentistry - Fluoride varnishes (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
Publication Date
06-Oct-2020
Withdrawal Date
29-Apr-2021
ICS
71.100.70 - Cosmetics. Toiletries
97.170 - Body care equipment
Technical Committee
CEN/TC 55 - Dentistry
Drafting Committee
CEN/TC 55 - Dentistry
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
07-Oct-2020
Completion Date
07-Oct-2020
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Ref Project
SIST EN ISO 17730:2020 - Dentistry - Fluoride varnishes (ISO 17730:2020)

Relations

Replaces
EN ISO 17730:2014 - Dentistry - Fluoride varnishes (ISO 17730:2014)
Effective Date
14-Oct-2020
Revised
prEN ISO 17730 - Dentistry - Fluoride varnishes (ISO/DIS 17730:2023)
Effective Date
09-Nov-2022

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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

2

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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.

3

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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,
...

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