Dentistry — Manual toothbrushes — General requirements and test methods
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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