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现行 EN ISO 20126:2022
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Dentistry - Manual toothbrushes - General requirements and test methods (ISO 20126:2022) 牙科.手动牙刷.一般要求和试验方法(ISO/FDIS 20126-2021)
发布日期: 2022-03-23
实施日期: 2022-03-23
本文件规定了手动牙刷物理性能的要求和测试方法,以提高这些产品的预期使用安全性。 本文件未规定头部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簇牙刷、一次性、齿间和电动口腔卫生设备。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,对于灯丝末端成圆要求,本文件不适用于非常薄(外径小于0.1 mm)或没有锐边(例如。 g、 锥形、羽状、带分裂尖端或球形帽)或非合成纤维,其中应用端部成圆工艺不合适或不可能。通过适当的测试方法或临床试验来评估这些类型的手动牙刷的使用安全性。
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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归口单位: CEN/TC 55
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