EN ISO 28399:2020
(Main)Dentistry - External tooth bleaching products (ISO 28399:2020)
Dentistry - External tooth bleaching products (ISO 28399:2020)
This document specifies requirements and test methods for external tooth bleaching products. These products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of tooth bleaching products), or both. It also specifies requirements for their packaging, labelling and manufacturer's instructions for use.
This document is not applicable to tooth bleaching products:
— specified in ISO 11609;
— intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers or crowns;
— auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights) that are used in conjunction with the bleaching products.
This document does not specify biological safety aspects of tooth bleaching products.
NOTE Maximum concentration of a bleaching agent for professional or non-professional use is subject to each country's regulatory body.
Zahnheilkunde - Äußere Zahnbleichmittel (ISO 28399:2020)
Dieses Dokument legt Anforderungen an und Prüfverfahren für äußere Zahnbleichmittel fest. Diese Produkte sind zur Anwendung in der Mundhöhle vorgesehen, entweder durch professionelle Anwendung (Zahnbleichmittel in der Zahnarztpraxis) oder durch den Verbraucher (professionelle oder nichtprofessionelle häusliche Anwendung von Zahnbleichmitteln), oder beides. Es legt auch Anforderungen an ihre Verpackung, Kennzeichnung und Gebrauchsanweisung fest.
Dieses Dokument ist nicht anwendbar für Zahnbleichmittel:
- die in ISO 11609 beschrieben sind;
- die dazu vorgesehen sind, die Farbwahrnehmung der natürlichen Zähne durch mechanische Verfahren (z. B. Entfernung verfärbter Beläge) oder mit restaurativen Verfahren wie Verblendschalen (Veneers) und Kronen zu verändern;
- Hilfs- oder Zusatzmaterialien (z. B. Löffelmaterialien) und Instrumente oder Geräte (z. B. Leuchten), die zusammen mit den Bleichmitteln verwendet werden.
Dieses Dokument legt keine biologischen Sicherheitsaspekte von Zahnbleichmitteln fest.
ANMERKUNG Die höchste Konzentration eines Bleichmittels zur professionellen oder nichtprofessionellen Anwendung unterliegt den Vorschriften der Aufsichtsbehörden eines Landes.
Médecine bucco-dentaire - Produits d'éclaircissement dentaire, à usage externe (ISO 28399:2020)
Le présent document spécifie les exigences et les méthodes d'essai relatives aux produits d'éclaircissement dentaire par voie externe destinés à être utilisés dans la cavité buccale, soit pour un usage professionnel (produits d'éclaircissement dentaire prévus pour une utilisation au cabinet dentaire) soit pour une application directe par le consommateur à domicile (produits d'éclaircissement dentaire spécifiés par des professionnels ou disponibles dans le commerce). Il spécifie également les exigences relatives à l'emballage, à l'étiquetage et à la notice d'utilisation du fabricant.
Le présent document ne s'applique pas aux produits d'éclaircissement dentaire suivants:
— les produits spécifiés dans l'ISO 11609;
— destinés à modifier la perception de la teinte des dents naturelles, soit par des moyens mécaniques (par exemple l'élimination des taches), soit à l'aide de techniques de restauration telles que les facettes prothétiques ou les couronnes;
— les produits auxiliaires ou complémentaires (par exemple les porte-empreintes) et les instruments ou dispositifs (par exemple les sources de lumière) qui sont utilisés conjointement avec les produits d'éclaircissement.
Le présent document ne spécifie pas les aspects relatifs à la sécurité biologique des produits d'éclaircissement dentaire.
NOTE La concentration maximale d'agent d'éclaircissement dentaire à usage professionnel ou non professionnel est fixée par l'organisme de réglementation de chaque pays.
Zobozdravstvo - Proizvodi za zunanje beljenje zob (ISO 28399:2020)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2020
Nadomešča:
SIST EN ISO 28399:2011
Zobozdravstvo - Proizvodi za zunanje beljenje zob (ISO 28399:2020)
Dentistry - External tooth bleaching products (ISO 28399:2020)
Zahnheilkunde - Äußere Zahnbleichmittel (ISO 28399:2020)
Médecine bucco-dentaire - Produits d'éclaircissement dentaire, à usage externe (ISO
28399:2020)
Ta slovenski standard je istoveten z: EN ISO 28399:2020
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 28399
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2020
EUROPÄISCHE NORM
ICS 71.100.70; 97.170 Supersedes EN ISO 28399:2011
English Version
Dentistry - External tooth bleaching products (ISO
28399:2020)
Médecine bucco-dentaire - Produits d'éclaircissement Zahnheilkunde - Äußere Zahnbleichmittel (ISO
dentaire, à usage externe (ISO 28399:2020) 28399:2020)
This European Standard was approved by CEN on 2 March 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 28399:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 28399:2020) 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 September 2020, and conflicting national standards
shall be withdrawn at the latest by September 2020.
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 28399:2011.
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 28399:2020 has been approved by CEN as EN ISO 28399:2020 without any modification.
INTERNATIONAL ISO
STANDARD 28399
Second edition
2020-03
Dentistry — External tooth bleaching
products
Reference number
ISO 28399:2020(E)
©
ISO 2020
ISO 28399:2020(E)
© 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.
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Published in Switzerland
ii © ISO 2020 – All rights reserved
ISO 28399:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification . 2
4.1 General . 2
4.2 Products for professional application . 2
4.3 Products for consumer application . 2
5 Requirements . 3
5.1 Concentration of active ingredients for bleaching . 3
5.2 Surface microhardness . 3
5.3 Surface erosion . 3
6 Measurements and test methods . 3
6.1 Preparation of tooth specimens . 3
6.2 Preparation and application of tooth bleaching product . 3
6.3 Surface microhardness . 3
7 Packaging, marking and information to be supplied by the manufacturer .3
7.1 General . 3
7.2 Packaging . 4
7.3 Marking and instructions for use . 4
Annex A (informative) Test method for the measurement of hydrogen peroxide concentration .5
Annex B (informative) Light microscopy method for measuring erosion of enamel and
dentine caused by external tooth bleaching products . 6
Annex C (informative) Test method for laboratory assessment of tooth bleaching efficacy .19
Bibliography .22
ISO 28399:2020(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 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 second edition cancels and replaces the first edition (ISO 28399:2011), which has been technically
revised. The main changes compared to the previous edition are as follows:
— a light microscopy method is recommended as an example for the measurement of erosion of enamel
and dentine caused by external tooth bleaching products;
— a visual assessment with shade guide has been revised.
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
ISO 28399:2020(E)
Introduction
External tooth bleaching products are used in dentistry for changing the colour of natural teeth
towards a lighter or whiter shade. They are applied in the oral cavity directly on the outer surfaces
of teeth. This document includes requirements and test methods for products intended for external
bleaching of natural teeth by chemical means.
Specific qualitative and quantitative requirements for freedom from biological hazard are not included
in this document. It is recommended, that reference should be made to ISO 10993-1 and ISO 7405 when
assessing possible biological or toxicological hazards.
INTERNATIONAL STANDARD ISO 28399:2020(E)
Dentistry — External tooth bleaching products
1 Scope
This document specifies requirements and test methods for external tooth bleaching products.
These products are intended for use in the oral cavity, either by professional application (in-office
tooth bleaching products) or consumer application (professional or non-professional home use of
tooth bleaching products), or both. It also specifies requirements for their packaging, labelling and
manufacturer’s instructions for use.
This document is not applicable to tooth bleaching pro
...
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