DIN EN ISO 28399:2025-08
Dentistry - External tooth bleaching products (ISO/DIS 28399:2025); German and English version prEN ISO 28399:2025 / Note: Date of issue 2025-07-18*Intended as replacement for DIN EN ISO 28399 (2021-07).
| Fecha edición: |
2025-08-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | 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. |
| Keywords: | Bleaches|Bleaching|Brightening|Care of the mouth|Chemical composition|Chemical properties|Classification|Colour changes|Definitions|Dental|Dentistry|Hydrogen peroxide|Instructions for use|Labelling|Marking|Packages|Pastes|Peroxides|Physical properties|Specification (approval)|Testing|Tooth bleaching products|Toothpastes |
| ICS: | 97.170 - Equipo para el cuidado del cuerpo, 71.100.70 - Cosméticos. Artículos de tocador |
| CTN: |
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