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EN ISO 28399:2011

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

08-04-2020

Published date

15-01-2011

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

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.

Committee
CEN/TC 55
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

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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