BS EN ISO 20127:2005 – Dentistry — Powered toothbrushes — General requirements and test methods
1 Scope
This International Standard specifies requirements and test methods for the physical properties of powered toothbrushes in order to promote the safety of these products for their intended use.
Specifically excluded are other types of powered oral hygiene devices (such as powered interdental brushes) and manual toothbrushes.
2 Normative references
The following referenced documents are indispensable for the application 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
IEC 60335-1:2004, Household and similar electrical appliances — Safety — Part 1: General requirements
IEC 60335-2-52, Household and similar electrical appliances — Safety — Part 2-52: Particular requirements for oral hygiene appliances
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
powered toothbrush
hand-held electrically-powered appliance, the brush head of which carries filaments, used primarily for cleaning surfaces within the oral cavity
3.2
brush head
fixed or removable working end of an electrically-powered toothbrush to which the filaments are attached
3.3
filament
single strand within the brush head
3.4
tuft
group of filaments gathered together and attached to the brush head
4 Requirements
4.1 Pass-fail criteria Eight electrically-powered toothbrushes shall be tested. If none of the eight sampled powered toothbrushes fail, the powered toothbrush passes. If one toothbrush does not meet the minimum requirement, another eight powered toothbrushes shall be tested. If no more toothbrushes fail, the powered toothbrush passes. If a total of two or more powered toothbrushes of the sixteen fail, the powered toothbrush fails.
4.2 Physical inspection The powered toothbrush, its components and all accessories shall be intact and free of visible contamination and sharp or rough surfaces when examined according to 5.3.
4.3 Electrical safety All the powered toothbrushes and related accessories shall conform to the requirements described in IEC 60335-1 and IEC 60335-2-52.
4.4 Tuft retention The tuft removal force shall not be less than 15 N when tested according to 5.4.
4.5 Mechanical strength All powered toothbrushes and related accessories shall conform to the requirements described in IEC 60335-1:2004, Clause 21 and IEC 60335-2-52. 4.6 Resistance to chemical challenge After being subjected to a chemical challenge test according to 5.5, the brush head shall conform to the requirements of the spring operated impact test as described in IEC 60335-1:2004, Clause 21, and the brush head shall be operational and free of sharp or rough surfaces when examined.
BS EN ISO 20127:2005 – Dentistry — Powered toothbrushes — General requirements and test methods