SIST EN ISO 28399:2011
(Main)Dentistry - Products for external tooth bleaching (ISO 28399:2011)
Dentistry - Products for external tooth bleaching (ISO 28399:2011)
This International Standard 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 instructions for use. This International Standard is not applicable to tooth bleaching products: - specified in ISO 11609; - 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. This International Standard does not specify biological safety aspects of tooth bleaching products.
Zahnheilkunde - Äußere 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.
Art dentaire - Produits d'éclaircissement dentaire (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
Relations
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 28399:2011
EN ISO 28399:2011 (E)
Contents Page
Foreword .3
2
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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.
3
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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
---------------------- Page: 7 ----------------------
SIST EN ISO 28399:2011
ISO 28399:2011(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2011 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 28399:2011
ISO 28399:2011(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Classification .2
4.1 General .2
4.2 Products for professional application.2
4.3 Products for consumer application.2
5 Requirements.2
5.1 Concentration of active ingredients for bleaching .2
5.2 Surface microhardness.2
5.3 Surface erosion .2
6 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.3
7.3 Marking and instructions for use.3
Annex A (informative) Test method for the measurement of hydrogen peroxide concentration.5
Annex B (informative) Test method for the measurement of erosion of enamel and dentine caused
by products for external tooth bleaching .6
Annex C (informative) Test method for laboratory assessment of tooth bleaching efficacy .10
Bibliography.13
© ISO 2011 – All rights reserved iii
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SIST EN ISO 28399:2011
ISO 28399:2011(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 28399 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care
products.
iv © ISO 2011 – All rights reserved
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SIST EN ISO 28399:2011
ISO 28399:2011(E)
Introduction
Products for external tooth bleaching 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
International Standard includes requirements and test methods for products intended for external bleaching of
natural teeth by chemical means.
© ISO 2011 – All rights reserved v
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SIST EN ISO 28399:2011
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SIST EN ISO 28399:2011
INTERNATIONAL STANDARD ISO 28399:2011(E)
Dentistry — Products for external tooth bleaching
1 Scope
This International Standard 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 instructions for use.
This International Standard is not applicable to tooth bleaching products:
⎯ specified in ISO 11609;
⎯ 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.
This International Standard does not specify biological safety aspects of tooth bleaching products.
NOTE A tooth bleaching product can be evaluated for its biological safety using ISO 10993-1 and ISO 7405.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 1942:2009 Dentistry — Vocabulary
ISO 6344-1, Coated abrasives — Grain size analysis — Part 1: Grain size distribution test
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 terms and definitions given in ISO 1942 and the following apply.
3.1
bleaching
〈natural teeth〉 removal of intrinsic or acquired discolorations of natural teeth through the use of chemicals,
sometimes in combination with the application of auxiliary means
NOTE Adapted from ISO 1942:2009, 2.28.
© ISO 2011 – All rights reserved 1
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SIST EN ISO 28399:2011
ISO 28399:2011(E)
3.2
professional home use
〈of a product〉 use prescribed by a professional and for use at home under the repeated supervision of the
dentist
4 Classification
4.1 General
Products for external tooth bleaching can be classified for either:
a) professional application; or
b) consumer application.
NOTE Products for external tooth bleaching can be used alone or in conjunction with auxiliary means of application.
4.2 Products for professional application
These products are tooth bleaching products that are intended by the manufacturer to be applied only by
dental professionals (in-office tooth bleaching products).
4.3 Products for consumer application
These products are tooth bleaching products that are intended by the manufacturer to be applied by the
consumer (for professional home use or for non-professional home use).
NOTE Such external bleaching products can be prescribed by a dental professional or directly available to
consumers.
5 Requirements
5.1 Concentration of active ingredients for bleaching
The concentration of active ingredients for bleaching (equivalent to hydrogen peroxide) delivered by the
unexpired product according to manufacturer's instructions for use shall be within the range of +10 % and
−30 % of the original concentration stated by the manufacturer for the unopened product, when tested in
accordance with Annex A or other equivalent method.
5.2 Surface microhardness
The reduction in the Knoop hardness (KHN) or Vickers hardness (VHN) after the treatment shall be not more
than 10 %, when tested in accordance with 6.3.
5.3 Surface erosion
Surface erosion of the teeth tested in accordance with B.6.1 shall be no more than three times the level which
is caused by the positive control (B.6.2.1), when tested in accordance with Annex B or other equivalent
methods.
2 © ISO 2011 – All rights reserved
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SIST EN ISO 28399:2011
ISO 28399:2011(E)
6 Test methods
6.1 Preparation of tooth specimens
Prepare enamel and dentine specimens taken from a consistent location on extracted human or bovine teeth
that have been stored in a 0,2 % solution (mass concentration) of sodium azide or other solutions of
equivalent efficacy for disinfection purpose. Grind the specimen surface using a sequence starting at P400
and sequentially to a minimum of P1200 silicon carbide paper in accordance with ISO 6344-1 under a
constant flow of water and then polish the surface using a slurry or paste of 0,3 µm mean particle size
aluminium oxide. Ensure a minimum of 1 mm thickness of enamel or dentine tissue for the test specimen.
Prevent dehydration of test specimens during the specimen preparation procedure.
6.2 Preparation and application of tooth bleaching product
The dispensing, processing and application of the tooth bleaching product used in tests shall follow
manufacturer's instructions for use. The method of bleach application shall simulate the clinical procedure
relative to quantity, frequency and duration of the application. Specimens shall be stored in a 37 °C artificial
[6]
saliva solution similar to the one described in the ANSI/ADA Specification No. 41 between bleaching
intervals and for 24 h after the last bleach application prior to testing.
6.3 Surface microhardness
Evaluate enamel surface hardness before and after bleaching treatment.
Determine the surface microhardness with the KHN or VHN by applying a load of 0,49 N (equivalent to a 50 g
load) for 15 s. Evaluate a minimum of 10 specimens for each group, with three indentations for each specimen.
Prevent dehydration of test specimens during the specimen preparation procedure.
7 Packaging, marking and information to be supplied by the manufacturer
7.1 General
Additional information may be included at the discretion of the manufacturer or as required by regulation.
7.2 Packaging
The components of the material shall be supplied in properly sealed containers which adequately protect the
contents and do not adversely affect the quality of the product.
7.3 Marking and instructions for use
For each package, the following applies.
a) Information shall be clearly marked on the outermost package or containers appropriate to the product, as
indicated in Table 1.
b) Instructions shall accompany each package of the product and shall include the information appropriate
to the product, as indicated in Table 1.
© ISO 2011 – All rights reserved 3
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SIST EN ISO 28399:2011
ISO 28399:2011(E)
Table 1 — Requirements for marking and instructions for use
Manufacturer's
Outermost
No. I
...
SLOVENSKI STANDARD
oSIST prEN ISO 28399:2009
01-julij-2009
Zobobzdravstvo - Izdelki za zunanje beljenje zob (ISO/DIS 28399:2009)
Dentistry - Products for external tooth bleaching (ISO/DIS 28399:2009)
Zahnheilkunde - Äußere Zahnbleichmittel (ISO/DIS 28399:2009)
Art dentaire - Produits d'éclaircissement dentaire (ISO/DIS 28399:2009)
Ta slovenski standard je istoveten z: prEN ISO 28399
ICS:
97.170 Oprema za nego telesa Body care equipment
oSIST prEN ISO 28399:2009 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 28399:2009
---------------------- Page: 2 ----------------------
oSIST prEN ISO 28399:2009
EUROPEAN STANDARD
DRAFT
prEN ISO 28399
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2009
ICS 97.170
English Version
Dentistry - Products for external tooth bleaching (ISO/DIS
28399:2009)
Art dentaire - Produits d'éclaircissement dentaire (ISO/DIS
28399:2009)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 55.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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 Management Centre has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 28399:2009: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
oSIST prEN ISO 28399:2009
prEN ISO 28399:2009 (E)
Contents Page
Foreword .3
2
---------------------- Page: 4 ----------------------
oSIST prEN ISO 28399:2009
prEN ISO 28399:2009 (E)
Foreword
This document (prEN ISO 28399:2009) 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 document is currently submitted to the parallel Enquiry.
Endorsement notice
The text of ISO/DIS 28399:2009 has been approved by CEN as a prEN ISO 28399:2009 without any
modification.
3
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oSIST prEN ISO 28399:2009
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oSIST prEN ISO 28399:2009
DRAFT INTERNATIONAL STANDARD ISO/DIS 28399
ISO/TC 106/SC 7 Secretariat: JISC
Voting begins on: Voting terminates on:
2009-03-26 2009-08-26
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Dentistry — Products for external tooth bleaching
Art dentaire — Produits d'éclaircissement dentaire
ICS 97.170
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
©
International Organization for Standardization, 2009
---------------------- Page: 7 ----------------------
oSIST prEN ISO 28399:2009
ISO/DIS 28399
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall
not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the
unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user's country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying,
recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO's
member body in the country of the requester.
ISO copyright office
Case postale 56 CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
©
ii ISO 2009 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 28399:2009
ISO/DIS 28399
Contents Page
Foreword. iv
Introduction. v
1 Scope .1
2 Normative references.1
3 Terms and definitions .1
3.1 Bleaching (of natural teeth).1
4 Classification.2
4.1 Professionally applied.2
4.2 Consumer applied .2
5 Requirements .2
5.1 Peroxide concentration .2
5.2 Surface microhardness .2
5.3 Surface erosion.2
6 Test methods.2
6.1 Preparation of tooth specimens.2
6.2 Preparation and application of Test samples.2
6.3 Surface microhardness .2
7 Packaging, marking and information to be supplied by the manufacturer .3
7.1 Packaging .3
7.2 Marking and instructions for use .3
Annex A (Normative).5
Test method for the measurement of hydrogen peroxide concentration.5
Annex B (Informative) .6
Test method for the measurement of erosion of enamel and dentine by products for external tooth bleaching .6
Annex C (Informative) .8
A method for laboratory assessment of tooth bleaching efficacy .8
Bibliography.10
© ISO 2002 – All rights reserved iii
DRAFT 2009
---------------------- Page: 9 ----------------------
oSIST prEN ISO 28399:2009
ISO/DIS 28399
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 28339 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care
products
iv © ISO 2002 – All rights reserved
DRAFT 2009
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oSIST prEN ISO 28399:2009
ISO/DIS 28399
Introduction
Products for external tooth bleaching are used in dentistry primarily for changing the colour of natural teeth towards lighter or whiter
direction. They are applied in the oral cavity directly on the outer surfaces of teeth. This Standard includes requirements and test
methods for products intended for external bleaching natural teeth by chemical means. A tooth bleaching product should be
evaluated to determine its biological safety according to ISO 10993-1 and ISO 7405.
The efficacy of a bleaching product should be established by clinically relevant tooth colour change towards lighter or whiter direction
using acceptable methods such as shade guides and/or electronic instruments; the methods should be described adequately and
available for validation. In the case that clinical data on the efficacy of a tooth bleaching product is not available, users of this
standard intending to assess the efficacy in vitro are advised to consider using a laboratory method as that given in Annex C
(Informative).
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oSIST prEN ISO 28399:2009
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oSIST prEN ISO 28399:2009
WORKING DRAFT
ISO/DIS 28399
Dentistry — Products for external tooth bleaching
1 Scope
This International Standard specifies requirements and their test methods for products for external tooth bleaching, intended for use in
the oral cavity either by dental professionals (in-office tooth bleaching products) and/or at home by individuals (professional or non-
professional home-use tooth bleaching products). It also specifies requirements for their packaging and labelling, including
instructions for use.
The following tooth bleaching products are not covered by this Standard:
1) those covered by ISO-11609;
2) those intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative
approaches, such as veneers and crowns; and,
3) auxiliary or supplementary materials (e.g., tray materials) and instruments or devices (e.g., lights) that may be used in conjunction
with the bleaching products.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition
cited applies. For undated references, the latest edition of the referenced document, including any amendments applies.
ISO 7405, Dentistry — Preclinical evaluation of biocompatibility of medical devices used in dentistry - test methods for dental
materials.
ISO 1942, Dentistry — Vocabulary
ISO 3696, Water for analytical use — Specification and test methods
ISO 8601, Data elements and interchange formats — Information exchange - Representation of dates and times
ISO 11609, Dentistry — Dentifrices – Requirements, test methods and marking
ISO 22727, Graphical symbols — Creation and design of public information symbols – Requirements
ISO/IEC Directives, part 2 – Rules for the structure and drafting of International Standards.
3 Terms and definitions
For the purposes of this Standard, the terms and definitions as given in ISO 1942 and the following apply.
3.1 Bleaching (of natural teeth)
Removal of intrinsic or acquired discolorations from natural teeth through the use of chemicals, sometimes in combination with the
application of auxiliary means.
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oSIST prEN ISO 28399:2009
ISO/DIS 28399
4 Classification
NOTE Products for external tooth bleaching may be used alone or in conjunction with auxiliary means.
4.1 Professionally applied
Tooth bleaching products that are intended by the manufacturer to be applied only by dental professionals.
4.2 Consumer applied
Tooth bleaching products that are intended by the manufacturer to be applied by individuals.
NOTE Such bleaching products may be prescribed by dental professional or directly available to consumers.
5 Requirements
5.1 Peroxide concentration
The peroxide concentration equivalent to hydrogen peroxide shall be within the range of +10% and -30% of the original
concentration stated by the manufacturer for the unopened product, using the test in accordance with Annex A or other
equivalent method.
5.2 Surface microhardness
The reduction in the Knoop hardness (KHN) or Vickers hardness (VHN) after the treatment shall be not more than 10%,
using the test in accordance with 6.3.
5.3 Surface erosion
Surface erosion shall be no more than 20 micrometres of depth using a test equivalent to that described in Annex B.
6 Test methods
6.1 Preparation of tooth specimens
Prepare enamel and dentine specimens from a consistent location on extracted human or bovine teeth. Gr
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