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BS EN ISO 28399:2021

BS EN ISO 28399:2021

$142.49

Dentistry. External tooth bleaching products

Published By Publication Date Number of Pages
BSI 2021 32
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This document specifies the 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.

This document specifies the 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.

PDF Catalog

PDF Pages PDF Title
2 undefined
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 Classification
4.1 General
4.2 Products for professional application
4.3 Products for consumer application
11 5 Requirements
5.1 Concentration of active ingredients for bleaching
5.2 Surface microhardness
5.3 Surface erosion
6 Measurements and test methods
6.1 Preparation of tooth specimens
6.2 Preparation and application of tooth bleaching product
6.3 Surface microhardness
7 Packaging, marking and information to be supplied by the manufacturer
7.1 General
12 7.2 Packaging
7.3 Marking and instructions for use
13 Annex A (informative) Test method for the measurement of hydrogen peroxide concentration
14 Annex B (informative) Light microscopy method for measuring erosion of enamel and dentine caused by external tooth bleaching products
27 Annex C (informative) Test method for laboratory assessment of tooth bleaching efficacy
30 Bibliography

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BS EN ISO 28399:2021
$142.49