EN 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

• Status: Withdrawn
• Publication Date: 24-Mar-2020
• Withdrawal Date: 06-Apr-2021
• 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: 07-Apr-2021
• Ref Project: SIST EN ISO 28399:2020 - Dentistry - External tooth bleaching products (ISO 28399:2020)

Relations

• Replaces: EN ISO 28399:2011 - Dentistry - Products for external tooth bleaching (ISO 28399:2011)
• Effective Date: 01-Apr-2020
• Replaced By: EN ISO 28399:2021 - Dentistry - External tooth bleaching products (ISO 28399:2021)
• Effective Date: 14-Apr-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 28399:2020
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
SIST EN ISO 28399:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 28399:2020

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SIST EN ISO 28399:2020


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.

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SIST EN ISO 28399:2020
EN ISO 28399:2020 (E)
Contents Page
European foreword . 3

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SIST EN ISO 28399:2020
EN ISO 28399:2020 (E)
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.

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SIST EN ISO 28399:2020

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SIST EN ISO 28399:2020
INTERNATIONAL ISO
STANDARD 28399
Second edition
2020-03
Dentistry — External tooth bleaching
products
Reference number
ISO 28399:2020(E)
©
ISO 2020

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SIST EN ISO 28399:2020
ISO 28399:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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