ISO 20126:2022 pdf – Dentistry — Manual toothbrushes — General requirements and test methods

ISO 20126:2022 pdf – 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/
4 Requirements 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 set passes. 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 toothbrush fails. 4.1.2? Pass-fail? criteria? for? filament? end-rounding All filaments from three tufts from three randomly selected toothbrushes shall be used for this test. If the brush head contains two or more types of filaments, test all the filaments from three tufts of each type. If none of the three toothbrushes fail, the sample set passes. If one sample does not meet the minimum requirement, test another three toothbrushes. If no more samples fail, the toothbrush passes. If two or more samples out of the six fail, the toothbrush fails. 4.2 Physical inspection The toothbrush shall be intact and free of visible contamination and sharp or rough surfaces when examined according to 5.3. 4.3 Tuft retention The tuft removal force shall be not less than 15 N when tested according to 5.4. 4.4 Handle impact strength When tested in accordance with 5.5, the handle should not fracture. If the handle does fracture, however, the minimum absorbed energy at fracture shall be 0,8 J.
4.5 Fatigue resistance The toothbrush shall complete 75 000 cycles without breaking when tested according to 5.6. 4.6 Fatigue resistance after chemical challenge The toothbrush shall comply with 4.5 after being subjected to a chemical challenge according to 5.7. 4.7 Filament end-rounding The percentage of filaments without sharp geometries at the tips shall be at least 50 % to provide a level of safety in-use for the oral soft tissues when tested according to 5.8. This requirement 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 to non-synthetic filaments, where applying an end-rounding process is inappropriate or impossible. These types of manual toothbrushes should be evaluated for safety in-use appropriately. 5 Test method 5.1 Sampling Obtain the toothbrushes for testing as manufactured and not modified in any way except as specified in this document. 5.2 General test conditions Conduct the tests using dry toothbrushes at (23 ± 5) °C and relative humidity of (50 ± 10) %. 5.3 Physical inspection Inspect the toothbrush and related accessories using normal acuity without magnification. Use tactile inspection to detect sharp or rough surfaces. 5.4 Tuft retention test 5.4.1 Apparatus 5.4.1.1 Gripping unit to secure the brush head, having a structure such that compressive force is not induced on the tufts. See Figure 2. 5.4.1.2 Clamp, for securely holding all of the filaments in one tuft, for example, a tuft-gripping clamp or a Collet chuck used to grip a tuft, and consisting of an outer shell that slips over the filaments and a probe which screws into the shell, pinching the filaments between it and the shell.