scope:

This International Standard specifies requirements and their test methods for products for external tooth bleaching, intended for use in the oral cavity either by dental professionals (in-office tooth bleaching products) and/or at home by individuals (professional or nonprofessional home-use tooth bleaching products). It also specifies requirements for their packaging and labelling, including instructions for use. The following tooth bleaching products are not covered by this Standard: 1) those covered by ISO-11609; 2) those intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers and crowns; and, 3) auxiliary or supplementary materials (e.g., tray materials) and instruments or devices (e.g., lights) that may be used in conjunction with the bleaching products.