DANSK DSF/FPREN ISO 28399 PDF

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 instructions for use. Maximum concentration of a bleaching agent for professional or non-professional use is subject to each country’s regulatory body. This document 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 document 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[2] and ISO 7405[3].