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Standards Development
This document specifies requirements and test methods for the physical properties of mechanical oral care products intended for the use by children to promote the safety of these products for their intended use.
This document is positioned as child-specific supplementary requirements to existing standards such as ISO 20126, ISO 20127, ISO 16409. In addition to the applicable requirements in the existing standards, the requirements of this document shall take precedence.
Mechanical oral care products are used for the removal of dental plaque and oral debris to facilitate oral hygiene. This document is intended to determine the physical properties of such products intended for the use by children to promote the safety of these products for their intended use.
The needs of mechanical oral care products for vulnerable populations, such as children, differ in various aspects from standard products but these needs are similar across different groups of vulnerable people.
Currently there are dedicated standards for different product groups, e.g. ISO 20126, Manual toothbrushes, ISO 20127, Power toothbrushes & ISO 16409, Interdental brushes. However, all these standards do not consider special needs of various groups of vulnerable users. Such groups are, for example, children up to 14 years of age, elderly people as well as people who get their teeth brushed by nurses.
The requirements included in this new standard will build on requirements included in the existing standards (with adjusted limit values, if needed) and include new, specific requirements addressing such features and use scenarios which are unique for products for children.
Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this document. It is recommended that, in assessing possible biological hazards, reference be made to ISO 7405 and ISO 10993-1.
(See also SC 7 Resolution 22/2025 – ISO/TC 106/SC 7 approved the ISO/TC 106/SC 7/WG 11 recommendation to start a NWIP on “Dentistry – Requirements for mechanical oral care products for children”)
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