ISO 20126:2022 牙科学 手动牙刷 一般要求和试验方法

标准编号：ISO 20126:2022

中文名称：牙科学 手动牙刷 一般要求和试验方法

英文名称：Dentistry — Manual toothbrushes — General requirements and test methods

发布日期：2022-03

标准范围

本文件规定了手动牙刷物理性能的要求和测试方法，以促进这些产品在其预期用途中的安全性。本文件未规定牙刷头上所有清洁元件均为弹性体的牙刷物理性能的任何要求和测试方法。本文件不适用于手动单丛牙刷、一次性、牙间和电动口腔卫生设备。通过适当的测试方法或临床试验，对这些类型的口腔卫生产品的使用安全性进行评估。此外，对于灯丝端部成圆要求，本文件不适用于非常薄（外径小于0.1mm）或没有锐边（例如锥形、羽状、带有分裂尖端或球形帽）或非合成灯丝的特定灯丝类型，在这些类型中，应用端部成圆工艺是不合适或不可能的。对这些类型的手动牙刷在使用中的安全性进行了评估-通过适当的测试方法或临床试验使用。

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.

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