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EVS-EN ISO 28399:2021

Dentistry - External tooth bleaching products (ISO 28399:2021)

General information
Valid from 15.04.2021
Base Documents
EN ISO 28399:2021; ISO 28399:2021
Directives or regulations
None
Standard history
Status
Date
Type
Name
15.04.2021
Main
02.04.2020
Main
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.
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Standard monitoring