牙科学.手动牙刷.一般要求和试验方法

[中文适用范围]： 本文件规定了手动牙刷物理性能的要求和测试方法，以提高这些产品预期用途的安全性。 本文件没有对刷头中所有清洁元件均为弹性体的牙刷的物理性能规定任何要求和测试方法。 本文件不适用于手动单毛牙刷、一次性牙刷、齿间牙刷和电动口腔卫生装置。 通过适当的测试方法或临床试验评估这些类型的口腔卫生产品的使用安全性。 此外，对于细丝端部圆化要求，本文件不适用于非常细（外径小于 0.1 毫米）或没有锋利边缘（例如锥形、羽状、带有分叉尖端或）的特定细丝类型。 球形帽）或非合成长丝，其中应用端部倒圆工艺是不合适或不可能的。 通过适当的测试方法或适当的临床试验来评估这些类型的手动牙刷的使用安全性。 [外文原描述]： This document specifies requirements and test methods for the physical properties of manual toothbrushes in order to promote the safety of these products for their intended use. This document does not specify any requirements and test methods for the physical properties of toothbrushes for which all the cleaning elements in the head are elastomer. This document does not apply to manual single tuft toothbrushes, single use, interdental and powered oral hygiene devices. These types of oral hygiene products are evaluated for their safety in-use by appropriate test methods or clinical trials. In addition, for the filaments end-rounding requirements, this document does not apply to particular filament types which 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 end-rounding process is inappropriate or impossible. These types of manual toothbrushes are evaluated for their safety in-use by appropriate test methods or clinical trials appropriately.