ISO 20126:2022 pdf download – Dentistry — Manual toothbrushes — General requirements and test methods.
1 Scope 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. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1942, Dentistry — Vocabulary ISO 3696:1987, Water for analytical laboratory use — Specification and test methods ISO 22254, Dentistry — Manual toothbrushes — Resistance of tufted portion to deflection 3? Terms? and? definitions For the purposes of this document, the terms and definitions given in ISO 1942 and ISO 22254 and the following apply. ISO and IEC maintain terminology databases for use in standardization at the following addresses: — ISO Online browsing platform: available at https:// www .iso .org/ obp — IEC Electropedia: available at https:// www .electropedia .org/ 3.1 manual toothbrush hand-powered device, the working end of which carries filaments (3.3) primarily for cleaning surfaces within the oral cavity 3.2 brush head working end of a manual toothbrush (3.1) to which the filaments (3.3) are attached [SOURCE: ISO 22254:2005, 3.2, modified — the word “manual” has been added.]
3.8 centre of percussion point on a pendulum at which a perpendicular impact in the plane of swing does not cause reaction forces at the axis of rotation of the pendulum [SOURCE: ISO 13802:2015, 3.4] 3.9 pendulum length L p distance between the axis of rotation of the pendulum and the centre of percussion (3.8), equal to an equivalent theoretical pendulum mass concentrated at the point which gives the same period of oscillation, T p (3.7), as the actual pendulum Note 1 to entry: The pendulum length is expressed in metres. 3.10 impact length distance between the axis of rotation of the pendulum and the pendulum striking edge 3.11 end-rounding procedure of manufacturing toothbrushes to eliminate the sharp edge of the free end of filaments (3.3)
ISO 20126:2022 pdf download – Dentistry — Manual toothbrushes — General requirements and test methods
