• EN ISO 28399:2011

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

    Available format(s): 

    Superseded date:  08-04-2020

    Language(s): 

    Published date:  15-01-2011

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Classification
    5 Requirements
    6 Test methods
    7 Packaging, marking and information to be supplied
      by the manufacturer
    Annex A (informative) - Test method for the measurement
            of hydrogen peroxide concentration
    Annex B (informative) - Test method for the measurement
            of erosion of enamel and dentine caused by products
            for external tooth bleaching
    Annex C (informative) - Test method for laboratory
            assessment of tooth bleaching efficacy
    Bibliography

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee CEN/TC 55
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 11609:2017 Dentistry — Dentifrices — Requirements, test methods and marking
    ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO 1942:2009 Dentistry Vocabulary
    ISO 22727:2007 Graphical symbols — Creation and design of public information symbols — Requirements
    ADA 41 : 2015 EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    ISO 6344-1:1998 Coated abrasives Grain size analysis Part 1: Grain size distribution test
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