牙科. 牙齿外漂白用产品

[中文适用范围]： 本标准规定了外牙漂白产品的要求和测试方法。 这些产品旨在用于口腔，可以通过专业应用（办公室牙齿漂白产品）或消费者应用（专业或非专业家庭使用牙齿漂白产品），或两者兼而有之。 它还规定了其包装、标签和制造商使用说明的要求。 本文件不适用于牙齿漂白产品： ——ISO 11609 中规定； ——旨在通过机械方法（例如去除污渍）或使用修复方法（例如贴面或牙冠）改变天然牙齿的颜色感知； ——与漂白产品一起使用的辅助或补充材料（例如托盘材料）和仪器或装置（例如灯）。 本文件没有具体说明牙齿漂白产品的生物安全性。 注：专业或非专业用途的漂白剂的最大浓度取决于各个国家/地区的监管机构。 [外文原描述]： 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.