ISO 20126:2022 PDF
Dentistry — Manual toothbrushes — General requirements and test methods
Dentistry — Manual toothbrushes — General requirements and test methods
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 11
- Дата публикации:
- 8 марта 2022 г.
- Издание:
- ISO IS 20126 edition 3 version 1
- ICS:
- 97.170
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.
Abstract
Overview
ISO 20126:2022 - "Dentistry - Manual toothbrushes - General requirements and test methods" is an ISO standard that defines core physical safety requirements and standardized test methods for hand‑powered manual toothbrushes. The third edition (2022) focuses on measurable physical properties - such as tuft retention, handle strength, fatigue resistance and filament tip geometry - to promote product safety in normal use. The scope excludes toothbrushes with fully elastomeric cleaning elements, single‑tuft, single‑use, interdental and powered devices, and certain very thin or non‑synthetic filaments for which end‑rounding is impractical.
Key topics and technical requirements
ISO 20126:2022 specifies test procedures and pass/fail criteria. Key technical topics include:
- Physical inspection: visual and tactile checks for contamination, sharp or rough surfaces (see clause 5.3).
- Tuft retention: minimum tuft removal force of 15 N when tested per clause 5.4.
- Handle impact strength: handles should not fracture under specified impact; if fracture occurs the minimum absorbed energy at fracture is 0.8 J (clause 4.4, 5.5).
- Fatigue resistance: toothbrushes must complete 75 000 cycles without breaking (clause 4.5, 5.6).
- Fatigue after chemical challenge: repeat fatigue test after exposure to defined chemicals to confirm durability (clauses 4.6, 5.7).
- Filament end‑rounding: visual inspection requires at least 50% of filaments (from sampled tufts) to be free of sharp tip geometries, with exceptions for very thin (
Технические детали
- Технический комитет
- ISO/TC 106/SC 7 - Oral care products
- SKU
- ISO 20126:2022
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