SIST EN ISO 20127:2025
(Main)Dentistry - Physical properties of powered toothbrushes (ISO 20127:2025)
Dentistry - Physical properties of powered toothbrushes (ISO 20127:2025)
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.
Zahnheilkunde - Physikalische Eigenschaften von elektrischen Zahnbürsten (ISO 20127:2025)
Dieses Dokument legt Anforderungen an und Prüfverfahren für die physikalischen Eigenschaften von elektrischen Zahnbürsten fest, um die Gebrauchssicherheit dieser Produkte zu steigern.
Es gibt verschiedene Technologien bei elektrischen Zahnbürsten. Gemeinsame Eigenschaften dieser elektrischen Zahnbürsten, auf die dieses Dokument Bezug nimmt, sind:
eine Batterie;
ein Motor;
ein mechanisches oder magnetisches Antriebssystem;
ein beweglicher Bürstenkopf mit Filamentbüscheln.
Elektrische Zahnbürsten können einen beweglichen Bürstenkopf mit verschiedenen Bewegungen (z. B. oszillierend-rotierend, rüttelnd), Frequenzen und Geschwindigkeiten aufweisen.
Diese Arten von elektrischen Zahnbürsten werden zur Anwendungssicher durch geeignete Prüfverfahren oder klinische Studien geprüft.
Die in diesem Dokument angegebenen Anforderungen sind für alle Arten von elektrischen Zahnbürsten anwendbar. Jedoch treffen einige Anforderungen möglicherweise nicht auf alle Arten zu. Die Retention der Bürstenkopfscheibe kann z. B. nur angewandt werden, wenn die Bürste über ein Kopfteil verfügt, das sich vom Bürstenschaft abziehen lässt. Darüber hinaus, für die Anforderungen an die End-Abrundung der Filamente, gilt dieses Dokument nicht für Filamenttypen, die sehr dünn sind (weniger als 0,1 mm Außendurchmesser) oder die keine scharfen Ecken (z. B. konisch, aufgefächert, mit geteilten Spitzen oder kugelförmiger Kappe) aufweisen oder für nicht-synthetische Filamente, für die das Verfahren zur End-Abrundung nicht geeignet oder nicht möglich ist.
Dieses Dokument ist nicht anwendbar auf andere Arten von elektrisch betriebenen Mundhygienegeräten (z. B. elektrische Interdentalbürsten) oder Handzahnbürsten.
Médecine bucco-dentaire - Caractéristiques physiques des brosses à dents électriques (ISO 20127:2025)
Zobozdravstvo - Fizikalne lastnosti električnih zobnih ščetk (ISO 20127:2025)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2025
Nadomešča:
SIST EN ISO 20127:2020
Zobozdravstvo - Fizikalne lastnosti električnih zobnih ščetk (ISO 20127:2025)
Dentistry - Physical properties of powered toothbrushes (ISO 20127:2025)
Zahnheilkunde - Physikalische Eigenschaften von elektrischen Zahnbürsten (ISO
20127:2025)
Médecine bucco-dentaire - Caractéristiques physiques des brosses à dents électriques
(ISO 20127:2025)
Ta slovenski standard je istoveten z: EN ISO 20127:2025
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
97.170 Oprema za nego telesa Body care equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 20127
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2025
EUROPÄISCHE NORM
ICS 97.170 Supersedes EN ISO 20127:2020
English Version
Dentistry - Physical properties of powered toothbrushes
(ISO 20127:2025)
Médecine bucco-dentaire - Caractéristiques physiques Zahnheilkunde - Physikalische Eigenschaften von
des brosses à dents électriques (ISO 20127:2025) elektrischen Zahnbürsten (ISO 20127:2025)
This European Standard was approved by CEN on 30 April 2025.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20127:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 20127:2025) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which
is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2025, and conflicting national standards
shall be withdrawn at the latest by November 2025.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 20127:2020.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 20127:2025 has been approved by CEN as EN ISO 20127:2025 without any modification.
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 20127:2025(en) © ISO 2025
ISO 20127:2025(en)
© ISO 2025
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
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Published in Switzerland
ii
ISO 20127:2025(en)
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
ISO 20127:2025(en)
Foreword
ISO (the Internati
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