EN ISO 28399:2011

Dentistry - Products for external tooth bleaching (ISO 28399:2011)

ISO 28399:2011 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). It also specifies requirements for their packaging, labelling and instructions for use.
The following tooth bleaching products are not covered by ISO 28399:2011:
those 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.

Zahnheilkunde - Externe Zahnbleichmittel (ISO 28399:2011)

Diese Internationale Norm legt Anforderungen an und Prüfverfahren für externe Zahnbleichmittel fest. Diese
Produkte sind zur Anwendung in der Mundhöhle vorgesehen, entweder durch eine professionelle Anwendung
(Zahnbleichmittel in der Zahnarztpraxis) oder durch den Verbraucher (professionelle oder nichtprofessionelle
häusliche Anwendung von Zahnbleichmitteln), oder beides. Sie legt auch Anforderungen an ihre Verpackung,
Kennzeichnung und Gebrauchsanweisung fest.
Diese Internationale Norm ist nicht anwendbar für folgende Zahnbleichmittel:
— die in ISO 11609 beschrieben sind;
— diejenigen, die dazu vorgesehen sind, die Farbwahrnehmung der natürlichen Zähne durch mechanische
Verfahren (z. B. Entfernung verfärbter Beläge) oder mithilfe restaurativer Verfahren, wie Veneers und Kronen
zu verändern;
— Hilfs- oder Zusatzmaterialien (z. B. Löffelmaterialien) sowie Instrumente oder Geräte (z. B. Lampen), die
zusammen mit den Bleichmitteln verwendet werden.
Diese Internationale Norm beschreibt nicht die biologische Sicherheit von Zahnbleichmitteln.
ANMERKUNG Die biologische Sicherheit eines Zahnbleichmittels kann unter Anwendung von ISO 10993-1 und
ISO 7405 bewertet werden.

Médecine bucco-dentaire - Produits d'éclaircissement dentaire, à usage externe (ISO 28399:2011)

L'ISO 28399:2011 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 prescrits par des professionnels ou disponibles dans le commerce). Elle spécifie également les exigences relatives à l'emballage et à l'étiquetage, y compris la notice d'utilisation.
L'ISO 28399:2011 ne traite pas des produits d'éclaircissement dentaire suivants:
ceux 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 peuvent être utilisés conjointement avec les produits d'éclaircissement.

Zobozdravstvo - Izdelki za zunanje beljenje zob (ISO 28399:2011)

Ta mednarodni standard določa zahteve in preskusne metode za izdelke za zunanje beljenje zob. Ti izdelki so namenjeni uporabi v ustni odprtini ali s strokovnim nanosom (izdelki za beljenje zob v zobozdravstvu) ali z nanosom stranke (strokovna ali nestrokovna uporaba izdelkov za beljenje zob doma) ali oboje. Prav tako določa zahteve za njihovo pakiranje, opremljanje z nalepkami in navodili za uporabo. Ta mednarodni standard ne velja za naslednje izdelke za beljenje zob: – ki so določeni v ISO 11609; – ki so namenjeni spremembi barve zaznave naravnih zob z mehanskimi metodami (npr. odstranitev madežev) ali z uporabo obnovitvenih pristopov, kot so prevleke in krone, pomožni ali nadomestni materiali (npr. materiali za vložke) ter instrumenti ali naprave (npr. luči), ki se uporabljajo skupaj z izdelki za beljenje. Ta mednarodni standard ne določa vidikov biološke varnosti za izdelke za beljenje zob.

General Information

• Status: Withdrawn
• Publication Date: 14-Jan-2011
• Withdrawal Date: 24-Mar-2020
• ICS: 71.100.70 - Cosmetics. Toiletries
• ICS: 97.170 - Body care equipment
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 25-Mar-2020
• Ref Project: SIST EN ISO 28399:2011 - Dentistry - Products for external tooth bleaching (ISO 28399:2011)

Relations

• Replaced By: EN ISO 28399:2020 - Dentistry - External tooth bleaching products (ISO 28399:2020)
• Effective Date: 01-Apr-2020

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 28399:2011
01-marec-2011
Zobozdravstvo - Izdelki za zunanje beljenje zob (ISO 28399:2011)
Dentistry - Products for external tooth bleaching (ISO 28399:2011)
Zahnheilkunde - Äußere Zahnbleichmittel (ISO 28399:2011)
Art dentaire - Produits d'éclaircissement dentaire (ISO 28399:2011)
Ta slovenski standard je istoveten z: EN ISO 28399:2011
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
SIST EN ISO 28399:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 28399:2011

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SIST EN ISO 28399:2011


EUROPEAN STANDARD
EN ISO 28399

NORME EUROPÉENNE

EUROPÄISCHE NORM
January 2011
ICS 97.170
English Version
Dentistry - Products for external tooth bleaching (ISO
28399:2011)
Médecine bucco-dentaire - Produits d'éclaircissement Zahnheilkunde - Externe Zahnbleichmittel (ISO
dentaire, à usage externe (ISO 28399:2011) 28399:2011)
This European Standard was approved by CEN on 11 September 2010.

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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 28399:2011: E
worldwide for CEN national Members.

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SIST EN ISO 28399:2011
EN ISO 28399:2011 (E)
Contents Page
Foreword .3

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SIST EN ISO 28399:2011
EN ISO 28399:2011 (E)
Foreword
This document (EN ISO 28399:2011) 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 July 2011, and conflicting national standards shall be withdrawn at the
latest by July 2011.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 28399:2011 has been approved by CEN as a EN ISO 28399:2011 without any modification.

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SIST EN ISO 28399:2011

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SIST EN ISO 28399:2011

INTERNATIONAL ISO
STANDARD 28399
First edition
2011-01-15


Dentistry — Products for external tooth
bleaching
Médecine bucco-dentaire — Produits d'éclaircissement dentaire, à
usage externe





Reference number
ISO 28399:2011(E)
©
ISO 2011

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SIST EN ISO 28399:2011
ISO 28399:2011(E)
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