ISO 20127:2025
(Main)Dentistry — Physical properties of powered toothbrushes
Dentistry — Physical properties of powered toothbrushes
This document 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. There are different technologies of powered toothbrushes. Common features of those powered toothbrushes to which this document applies are: — a battery; — a motor; — a mechanical or magnetic drive system; — a moving brush head with tufted filaments. Powered toothbrushes can have a moving brush head with different motions (e.g. oscillating-rotating, side-by-side), frequencies and velocities. These types of electric toothbrushes are tested for safety in use by means of appropriate test procedures or clinical studies The requirements listed in this document apply to all types of powered toothbrushes. However, there is a possibility that some requirements are not applicable for all types. For example, brush head plate retention can only be applied if the brush has a head portion that can detach from the brush shaft. In addition, for the filaments end-rounding requirements, this document does not apply to filament types that 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 the end-rounding process is inappropriate or impossible. This document is not applicable to other types of powered oral hygiene devices (such as powered interdental brushes) or manual toothbrushes.
Médecine bucco-dentaire — Caractéristiques physiques des brosses à dents électriques
General Information
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Standards Content (Sample)
International
Standard
ISO 20127
Third edition
Dentistry — Physical properties of
2025-05
powered toothbrushes
Médecine bucco-dentaire — Caractéristiques physiques des
brosses à dents électriques
Reference number
© ISO 2025
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Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 2
4.1 Physical inspection .2
4.2 Electrical safety .2
4.3 Tuft retention .3
4.4 Mechanical strength .3
4.5 Resistance to chemical degradation .3
4.6 Filament end-rounding .3
5 Sampling and pass-fail criteria . 3
5.1 Sampling except for filament end-rounding .3
5.2 Pass-fail criteria except for filament end-rounding .3
5.3 Sampling and pass-fail criteria for filament end-rounding .3
6 Test methods . 3
6.1 General test conditions .3
6.2 Visual inspection .4
6.3 Tactile inspection .4
6.4 Tuft retention .4
6.4.1 Apparatus .4
6.4.2 Procedure .4
6.5 Brush head plate retention .4
6.5.1 Apparatus .4
6.5.2 Procedure .5
6.6 Resistance to chemical degradation .5
6.6.1 Apparatus and chemicals.5
6.6.2 Procedure .6
6.7 Visual inspection for filament end-rounding .6
6.7.1 General .6
6.7.2 Apparatus .6
6.7.3 Procedure .6
7 Test report . 7
8 Marking and labelling . 8
8.1 Powered toothbrush components .8
8.2 Instructions for use .8
8.3 Marking and labelling .8
9 Packaging. 8
Annex A (informative) Gripping device for tuft retention test . 9
Annex B (informative) Gripping device for brush head plate retention test .11
Bibliography . 19
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care
products, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO and CEN
(Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 20127:2020), which has been technically
revised.
The main changes are as follows:
— requirements and procedure for determining filament end-rounding were added.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
Introduction
Powered toothbrushes are used for the removal of dental plaque and oral debris in order to facilitate oral
hygiene.
v
International Standard ISO 20127:2025(en)
Dentistry — Physical properties of powered toothbrushes
1 Scope
This document 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.
There are different technologies of powered toothbrushes. Common features of those powered toothbrushes
to which this document applies are:
— a battery;
— a motor;
— a mechanical or magnetic drive system;
— a moving brush head with tufted filaments.
Powered toothbrushes can have a moving brush head with different motions (e.g. oscillating-rotating, side-
by-side), frequencies and velocities.
These types of electric toothbrushes are tested for safety in use by means of appropriate test procedures or
clinical studies
The requirements listed in this document apply to all types of powered toothbrushes. However, there is a
possibility that some requirements are not applicable for all types. For example, brush head plate retention
can only be applied if the brush has a head portion that can detach from the brush shaft. In addition, for the
filaments end-rounding requirements, this document does not apply to filament types that 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 the end-rounding process is inappropriate or impossible.
This document is not applicable to other types of powered oral hygiene devices (such as powered interdental
brushes) or manual toothbrushes.
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
...
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