標準號：DIN EN ISO 28399-2011
中文標準名稱：牙科學.外部牙齒漂白用產品(ISO 28399-2011).德文版本EN ISO 28399-2011
英文標準名稱：Dentistry - Products for external tooth bleaching (ISO 28399:2011); German version EN ISO 28399:2011
標準類型：C33;Y43
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C33;Y43
國際標準分類號：71.100.70
適用范圍：This International Standard 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. This International Standard 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 International Standard 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 and ISO 7405.