标准摘要
[中文适用范围]： 本文件规定了电动牙刷物理性能的要求和测试方法，以促进这些产品在预期用途下的安全性。电动牙刷有不同的技术类型。适用于本文件的电动牙刷的常见特征包括：——电池；——电机；——机械或磁力驱动系统；——带有束状毛丝的活动刷头。电动牙刷的刷头可以以不同的运动方式（例如旋转摆动、并列运动）、频率和速度进行活动。这些类型的电动牙刷通过适当的测试程序或临床研究来测试其使用安全性。本文件中列出的要求适用于所有类型的电动牙刷。然而，可能存在某些要求对所有类型不适用的情况。例如，刷头板固定要求仅适用于刷头部分可从刷柄上拆下的刷头。此外，对于刷毛端部圆滑处理的要求，本文件不适用于非常细（外径小于0.1毫米）或没有锐边（例如锥形、羽毛形、分叉尖端或球形帽）的刷毛类型，以及无法进行端部圆滑处理的非合成刷毛类型。本文件不适用于其他类型的电动口腔清洁设备（例如电动牙缝刷）或手动牙刷。 [外文原描述]： This document specifies requirements and test methods for the physical properties of powered toothbrushes in order to promote the safety of these products for their intended use. There are different technologies of powered toothbrushes. Common features of those powered toothbrushes to which this document applies are: — a battery; — a motor; — a mechanical or magnetic drive system; — a moving brush head with tufted filaments. Powered toothbrushes can have a moving brush head with different motions (e.g. oscillating-rotating, side-by-side), frequencies and velocities. These types of electric toothbrushes are tested for safety in use by means of appropriate test procedures or clinical studies The requirements listed in this document apply to all types of powered toothbrushes. However, there is a possibility that some requirements are not applicable for all types. For example, brush head plate retention can only be applied if the brush has a head portion that can detach from the brush shaft. In addition, for the filaments end-rounding requirements, this document does not apply to filament types that are very thin (less than 0,1 mm outside diameter) or have no sharp edges (e.g. tapered, feathered, with split tips or spherical cap) or non-synthetic filaments, where applying the end-rounding process is inappropriate or impossible. This document is not applicable to other types of powered oral hygiene devices (such as powered interdental brushes) or manual toothbrushes.
英文名称Dentistry — Physical properties of powered toothbrushes