标准编号：ISO 28399:2020
中文名称：牙科 牙齿外漂白用产品
英文名称：Dentistry — External tooth bleaching products
发布日期：2020-03
标准范围
This document 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
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.
立即下载标准文件