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.
DIN EN ISO 28399-2011由德国标准化学会 DE-DIN 发布于 2011-05。
DIN EN ISO 28399-2011 在中国标准分类中归属于: C33 口腔科器械、设备与材料,Y43 牙膏、肥皂、洗涤剂,在国际标准分类中归属于: 71.100.70 美容品、化妆品。
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