ISO 20126 pdf download Dentistry — Manual toothbrushes — General requirements and test methods
This document specifies requirements and test methods for the physical properties of manualtoothbrushes 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 oftoothbrushes 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 poweredoral hygiene devices.These types of oral hygiene products are evaluated for their safety in-use byappropriate test methods or clinical trials.
In addition, for the filaments end-rounding requirements, this document does not apply to particularfilament 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 fortheir safety in-use by appropriate test methods or clinical trials appropriately.
The following documents are referred to in the text in such a way that some or all of their contentconstitutes requirements of this document. For dated references, only the edition cited applies. Forundated 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 methodsISO 22254, Dentistry —Manual toothbrushes — Resistance of tufted portion to deflection
3Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and ISo 22254 and thefollowing 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/
hand-powered device, the working end of which carries filaments (3.3) primarily for cleaning surfaceswithin the oral cavity
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.J
centre of percussion
point on a pendulum at which a perpendicular impact in the plane of swing does not cause reactionforces at the axis of rotation of the pendulum
distance between the axis of rotation of the pendulum and the centre of percussion(3.8), equal to anequivalent theoretical pendulum mass concentrated at the point which gives the same period ofoscillation, Tp (3.7), as the actual pendulum
Note 1 to entry: The pendulum length is expressed in metres.3.10
distance between the axis of rotation of the pendulum and the pendulum striking edge3.11
procedure of manufacturing toothbrushes to eliminate the sharp edge of the free end of filaments (3.3)
4.1 Pass-fail criteria
4.1.1 Pass-fail criteria except for filament end-rounding
Eight manual toothbrushes shall be tested.If none of the eight manual toothbrushes fail, the sample setpasses.If one sample does not meet the minimum requirement, test another eight manual toothbrushes.if no more samples fail, the toothbrush passes. If two or more samples out of the 16 fail, the toothbrushfails.
4.1.2Pass-fail criteria for filament end-rounding
All filaments from three tufts from three randomly selected toothbrushes shall be used for this test.lf the brush head contains two or more types of filaments, test all the filaments from three tufts ofeach type.Ilf none of the three toothbrushes fail, the sample set passes. If one sample does not meet theminimum requirement, test another three toothbrushes.if no more samples fail, the toothbrush passes.lf two or more samples out of the six fail, the toothbrush fails.
The toothbrush shall be intact and free of visible contamination and sharp or rough surfaces whenexamined according to 5.3.