YY/T 0825-2011 in English

本标准规定了对牙齿外漂白产品的要求和试验方法。这些产品通过牙科医生或牙科专业人士(诊室用牙齿漂白产品)或通过牙科医生或牙科专业人士指导消费者(专业家庭用牙齿漂白产品)在口腔内使用。本标准也规定了对产品包装、标签和使用说明书的要求。
本标准对下列牙齿漂白产品不适用:
———ISO11609中所规定的内容;
———通过机械方法(例如去除色斑)或采用修复的方法,例如贴面或冠等,改变天然牙齿的颜色;
———与漂白产品一起使用的辅助或附加的材料(如托盘材料)和器具或装置(如灯)。
本标准没有对牙齿漂白产品的生物安全性方面作出规定。

Scope

This standard specifies the requirements and test methods for external tooth bleaching products. These products are intended for use in the mouth by a dentist or dental professional (in-office teeth bleaching products) or by a dentist or dental professional under the direction of the consumer (professional home teeth bleaching products). This standard also specifies requirements for product packaging, labels and instructions for use. This standard does not apply to the following tooth bleaching products:
　——content specified in ISO 11609;
　——changing the color of natural teeth through mechanical methods (such as removal of stains) or restorative methods, such as veneers or crowns;
　——Auxiliary or additional materials (such as tray materials) and appliances or devices (such as lamps) used with bleaching products. This standard does not address the biosafety of tooth bleaching products.