Dentistry - Physical properties of powered toothbrushes (ISO 20127:2020)

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.
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 might get detached from the brush shaft.
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 20127:2020)

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.
Die in diesem Dokument angegebenen Anforderungen sind für alle Arten von elektrischen Zahnbürsten anwendbar. Jedoch treffen einige Anforderungen möglicherweise nicht auf alle Arten zu, z. B. kann die Retention der Bürstenkopfscheibe nur angewandt werden, wenn die Bürste über ein Kopfteil verfügt, das sich vom Bürstenschaft abziehen lässt.
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 20127:2020)

Le présent document spécifie les exigences et les méthodes d'essai relatives aux caractéristiques physiques des brosses à dents électriques, dans l'intention de favoriser la sécurité de ces produits lors de l'utilisation pour laquelle ils sont conçus.
Il existe différentes technologies de brosses à dents électriques. Les caractéristiques communes de ces brosses à dents électriques auxquelles s'applique le présent document sont:
—          une batterie;
—          un moteur;
—          un système d'entraînement mécanique ou magnétique;
—          une tête de brosse mobile garnie de touffes de filaments.
Dans les brosses à dents électriques, la tête de brosse mobile peut effectuer différents mouvements (par exemple, oscillo-rotatifs, transversaux) et peut avoir différentes fréquences et vitesses.
Les exigences mentionnées dans le présent document doivent s'appliquer à tous les types de brosses à dents électriques. Toutefois, certaines exigences peuvent ne pas être applicables à tous les types, par exemple l'exigence d'ancrage de la tête de brosse ne peut s'appliquer que si la brosse possède une tête détachable du corps de la brosse.
Le présent document n'est pas applicable aux autres types d'appareils électriques d'hygiène buccale (notamment les brosses interdentaires électriques) ou les brosses à dents manuelles.

Zobozdravstvo - Fizikalne lastnosti električnih zobnih ščetk (ISO 20127:2020)

General Information

Status
Published
Publication Date
30-Dec-2020
Withdrawal Date
30-Mar-2021
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
16-Sep-2020
Completion Date
16-Sep-2020

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SLOVENSKI STANDARD
SIST EN ISO 20127:2020
01-november-2020
Nadomešča:
SIST EN ISO 20127:2005
Zobozdravstvo - Fizikalne lastnosti električnih zobnih ščetk (ISO 20127:2020)
Dentistry - Physical properties of powered toothbrushes (ISO 20127:2020)
Zahnheilkunde - Physikalische Eigenschaften von elektrischen Zahnbürsten (ISO
20127:2020)

Médecine bucco-dentaire - Caractéristiques physiques des brosses à dents électriques

(ISO 20127:2020)
Ta slovenski standard je istoveten z: EN ISO 20127:2020
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
97.170 Oprema za nego telesa Body care equipment
SIST EN ISO 20127:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 20127:2020
---------------------- Page: 2 ----------------------
SIST EN ISO 20127:2020
EN ISO 20127
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2020
EUROPÄISCHE NORM
ICS 97.170 Supersedes EN ISO 20127:2005
English Version
Dentistry - Physical properties of powered toothbrushes
(ISO 20127:2020)

Médecine bucco-dentaire - Caractéristiques physiques Zahnheilkunde - Physikalische Eigenschaften von

des brosses à dents électriques (ISO 20127:2020) elektrischen Zahnbürsten (ISO 20127:2020)

This European Standard was approved by CEN on 4 August 2020.

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, Turkey 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

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20127:2020 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 20127:2020
EN ISO 20127:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 20127:2020
EN ISO 20127:2020 (E)
European foreword

This document (EN ISO 20127:2020) 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 March 2021, and conflicting national standards shall

be withdrawn at the latest by March 2021.

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 20127:2005.

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, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 20127:2020 has been approved by CEN as EN ISO 20127:2020 without any modification.

---------------------- Page: 5 ----------------------
SIST EN ISO 20127:2020
---------------------- Page: 6 ----------------------
SIST EN ISO 20127:2020
INTERNATIONAL ISO
STANDARD 20127
Second edition
2020-08
Dentistry — Physical properties of
powered toothbrushes
Médecine bucco-dentaire — Caractéristiques physiques des brosses à
dents électriques
Reference number
ISO 20127:2020(E)
ISO 2020
---------------------- Page: 7 ----------------------
SIST EN ISO 20127:2020
ISO 20127:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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 the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 20127:2020
ISO 20127:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Requirements .......................................................................................................................................................................................................... 2

4.1 Physical inspection .............................................................................................................................................................................. 2

4.2 Electrical safety ...................................................................................................................................................................................... 2

4.3 Tuft retention ........................................................................................................................................................................................... 2

4.4 Mechanical strength ........................................................................................................................................................................... 2

4.5 Resistance to chemical degradation ..................................................................................................................................... 3

5 Sampling and pass-fail criteria .............................................................................................................................................................. 3

5.1 Sampling ....................................................................................................................................................................................................... 3

5.2 Pass-fail criteria...................................................................................................................................................................................... 3

6 Test methods ............................................................................................................................................................................................................. 3

6.1 General test conditions .................................................................................................................................................................... 3

6.2 Visual inspection ................................................................................................................................................................................... 3

6.3 Tactile inspection .................................................................................................................................................................................. 3

6.4 Tuft retention ........................................................................................................................................................................................... 3

6.4.1 Apparatus ............................................................................................................................................................................... 3

6.4.2 Procedure ............................................................................................................................................................................... 4

6.5 Brush head plate retention ........................................................................................................................................................... 4

6.5.1 Apparatus ............................................................................................................................................................................... 4

6.5.2 Procedure ............................................................................................................................................................................... 4

6.6 Resistance to chemical degradation ..................................................................................................................................... 5

6.6.1 Apparatus and chemicals ......................................................................................................................................... 5

6.6.2 Procedure ............................................................................................................................................................................... 5

7 Test report ................................................................................................................................................................................................................... 6

8 Marking and labelling ..................................................................................................................................................................................... 6

8.1 Powered toothbrush components .......................................................................................................................................... 6

8.2 Instructions for use ............................................................................................................................................................................. 6

8.3 Marking and labelling ....................................................................................................................................................................... 6

9 Packaging ..................................................................................................................................................................................................................... 6

Annex A (informative) Gripping device for tuft retention test .................................................................................................. 7

Annex B (informative) Gripping device for brush head plate retention test ..............................................................9

Bibliography .............................................................................................................................................................................................................................17

© ISO 2020 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 20127:2020
ISO 20127:2020(E)
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).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

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 second edition cancels and replaces the first edition (ISO 20127:2005), which has been technically

revised.
The main changes to the previous edition are as follows:

— a requirement and a test method for brush head plate retention have been added;

— clarification in scope to include all types of powered toothbrushes.

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 © ISO 2020 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 20127:2020
ISO 20127:2020(E)
Introduction

Powered toothbrushes are used for the removal of dental plaque and oral debris in order to facilitate

oral hygiene.
© ISO 2020 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 20127:2020
---------------------- Page: 12 ----------------------
SIST EN ISO 20127:2020
INTERNATIONAL STANDARD ISO 20127:2020(E)
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.

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 might get detached from the brush shaft.

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, the latest edition of the referenced document (including any amendments) applies.

ISO 1942, Dentistry — Vocabulary
ISO 3696, Water for analytical laboratory use — Specification and test methods
IEC 60068-2-75, Environmental testing — Part 2-75: Tests — Test Eh: Hammer tests

IEC 60335-1, 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.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
© ISO 2020 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST EN ISO 20127:2020
ISO 20127:2020(E)
3.1
brush head

working end of an electrically powered toothbrush to which the filaments are attached

[SOURCE: ISO 22254:2005, 3.2, modified – adapted to an electrically powered toothbrush]

3.2
filament
single strand within the brush head
[SOURCE: ISO 22254:2005, 3.3]
3.3
powered toothbrush

hand-held electrically powered appliance, the brush head of which carries filaments, used primarily for

cleaning surfaces within the oral cavity
3.4
brush head removal force
force required to remove the toothbrush tuft plate from the toothbrush shaft
3.5
tuft
group of filaments gathered together and attached to the brush head
[SOURCE: ISO 22254:2005, 3.4]
3.6
tuf
...

SLOVENSKI STANDARD
SIST EN ISO 20127:2020
01-november-2020
Nadomešča:
SIST EN ISO 20127:2005
Zobozdravstvo - Fizikalne lastnosti električnih zobnih ščetk (ISO 20127:2020)
Dentistry - Physical properties of powered toothbrushes (ISO 20127:2020)
Zahnheilkunde - Physikalische Eigenschaften von elektrischen Zahnbürsten (ISO
20127:2020)

Médecine bucco-dentaire - Caractéristiques physiques des brosses à dents électriques

(ISO 20127:2020)
Ta slovenski standard je istoveten z: EN ISO 20127:2020
ICS:
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
97.170 Oprema za nego telesa Body care equipment
SIST EN ISO 20127:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 20127:2020
---------------------- Page: 2 ----------------------
SIST EN ISO 20127:2020
EN ISO 20127
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2020
EUROPÄISCHE NORM
ICS 97.170 Supersedes EN ISO 20127:2005
English Version
Dentistry - Physical properties of powered toothbrushes
(ISO 20127:2020)

Médecine bucco-dentaire - Caractéristiques physiques Zahnheilkunde - Physikalische Eigenschaften von

des brosses à dents électriques (ISO 20127:2020) elektrischen Zahnbürsten (ISO 20127:2020)

This European Standard was approved by CEN on 4 August 2020.

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, Turkey 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

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20127:2020 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 20127:2020
EN ISO 20127:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 20127:2020
EN ISO 20127:2020 (E)
European foreword

This document (EN ISO 20127:2020) 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 March 2021, and conflicting national standards shall

be withdrawn at the latest by March 2021.

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 20127:2005.

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, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 20127:2020 has been approved by CEN as EN ISO 20127:2020 without any modification.

---------------------- Page: 5 ----------------------
SIST EN ISO 20127:2020
---------------------- Page: 6 ----------------------
SIST EN ISO 20127:2020
INTERNATIONAL ISO
STANDARD 20127
Second edition
2020-08
Dentistry — Physical properties of
powered toothbrushes
Médecine bucco-dentaire — Caractéristiques physiques des brosses à
dents électriques
Reference number
ISO 20127:2020(E)
ISO 2020
---------------------- Page: 7 ----------------------
SIST EN ISO 20127:2020
ISO 20127:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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 the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 20127:2020
ISO 20127:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Requirements .......................................................................................................................................................................................................... 2

4.1 Physical inspection .............................................................................................................................................................................. 2

4.2 Electrical safety ...................................................................................................................................................................................... 2

4.3 Tuft retention ........................................................................................................................................................................................... 2

4.4 Mechanical strength ........................................................................................................................................................................... 2

4.5 Resistance to chemical degradation ..................................................................................................................................... 3

5 Sampling and pass-fail criteria .............................................................................................................................................................. 3

5.1 Sampling ....................................................................................................................................................................................................... 3

5.2 Pass-fail criteria...................................................................................................................................................................................... 3

6 Test methods ............................................................................................................................................................................................................. 3

6.1 General test conditions .................................................................................................................................................................... 3

6.2 Visual inspection ................................................................................................................................................................................... 3

6.3 Tactile inspection .................................................................................................................................................................................. 3

6.4 Tuft retention ........................................................................................................................................................................................... 3

6.4.1 Apparatus ............................................................................................................................................................................... 3

6.4.2 Procedure ............................................................................................................................................................................... 4

6.5 Brush head plate retention ........................................................................................................................................................... 4

6.5.1 Apparatus ............................................................................................................................................................................... 4

6.5.2 Procedure ............................................................................................................................................................................... 4

6.6 Resistance to chemical degradation ..................................................................................................................................... 5

6.6.1 Apparatus and chemicals ......................................................................................................................................... 5

6.6.2 Procedure ............................................................................................................................................................................... 5

7 Test report ................................................................................................................................................................................................................... 6

8 Marking and labelling ..................................................................................................................................................................................... 6

8.1 Powered toothbrush components .......................................................................................................................................... 6

8.2 Instructions for use ............................................................................................................................................................................. 6

8.3 Marking and labelling ....................................................................................................................................................................... 6

9 Packaging ..................................................................................................................................................................................................................... 6

Annex A (informative) Gripping device for tuft retention test .................................................................................................. 7

Annex B (informative) Gripping device for brush head plate retention test ..............................................................9

Bibliography .............................................................................................................................................................................................................................17

© ISO 2020 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 20127:2020
ISO 20127:2020(E)
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).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

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 second edition cancels and replaces the first edition (ISO 20127:2005), which has been technically

revised.
The main changes to the previous edition are as follows:

— a requirement and a test method for brush head plate retention have been added;

— clarification in scope to include all types of powered toothbrushes.

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 © ISO 2020 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 20127:2020
ISO 20127:2020(E)
Introduction

Powered toothbrushes are used for the removal of dental plaque and oral debris in order to facilitate

oral hygiene.
© ISO 2020 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 20127:2020
---------------------- Page: 12 ----------------------
SIST EN ISO 20127:2020
INTERNATIONAL STANDARD ISO 20127:2020(E)
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.

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 might get detached from the brush shaft.

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, the latest edition of the referenced document (including any amendments) applies.

ISO 1942, Dentistry — Vocabulary
ISO 3696, Water for analytical laboratory use — Specification and test methods
IEC 60068-2-75, Environmental testing — Part 2-75: Tests — Test Eh: Hammer tests

IEC 60335-1, 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.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
© ISO 2020 – All rights reserved 1
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SIST EN ISO 20127:2020
ISO 20127:2020(E)
3.1
brush head

working end of an electrically powered toothbrush to which the filaments are attached

[SOURCE: ISO 22254:2005, 3.2, modified – adapted to an electrically powered toothbrush]

3.2
filament
single strand within the brush head
[SOURCE: ISO 22254:2005, 3.3]
3.3
powered toothbrush

hand-held electrically powered appliance, the brush head of which carries filaments, used primarily for

cleaning surfaces within the oral cavity
3.4
brush head removal force
force required to remove the toothbrush tuft plate from the toothbrush shaft
3.5
tuft
group of filaments gathered together and attached to the brush head
[SOURCE: ISO 22254:2005, 3.4]
3.6
...

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