SIST EN ISO 20127:2020

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.

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SIST EN ISO 20127:2020

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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.

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SIST EN ISO 20127:2020
EN ISO 20127:2020 (E)
Contents Page
European foreword . 3

2

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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.

3

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SIST EN ISO 20127:2020

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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

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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

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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

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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

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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

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SIST EN ISO 20127:2020

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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
...

SLOVENSKI STANDARD
oSIST prEN ISO 20127:2019
01-julij-2019
Zobozdravstvo - Fizikalne lastnosti električnih zobnih ščetk (ISO/DIS 20127:2019)
Dentistry - Physical properties of powered toothbrushes (ISO/DIS 20127:2019)
Zahnheilkunde - Physikalische Eigenschaften von elektrischen Zahnbürsten (ISO/DIS
20127:2019)
Médecine bucco-dentaire - Caractéristiques physiques des brosses à dents électriques
(ISO/DIS 20127:2019)
Ta slovenski standard je istoveten z: prEN ISO 20127
ICS:
97.170 Oprema za nego telesa Body care equipment
oSIST prEN ISO 20127:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 20127:2019

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oSIST prEN ISO 20127:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 20127
ISO/TC 106/SC 7 Secretariat: JISC
Voting begins on: Voting terminates on:
2019-03-29 2019-06-21
Dentistry — Physical properties of powered toothbrushes
Art dentaire — Brosses à dents électriques — Exigences générales et méthodes d'essai
ICS: 97.170
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 20127:2019(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2019

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oSIST prEN ISO 20127:2019
ISO/DIS 20127:2019(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 20127:2019
ISO/DIS 20127:2019(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 Toothbrush 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 toothbrush head plate retention test .9
© ISO 2019 – All rights reserved iii

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oSIST prEN ISO 20127:2019
ISO/DIS 20127:2019(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 [or Project Committee] ISO/TC 106, Subcommittee
SC 7, Oral care products.
This second edition cancels and replaces the first edition (ISO 20127:2005), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— a requirement and a test method for toothbrush head plate retention have been added;
— clarification in Scope to fulfil 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 2019 – All rights reserved

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oSIST prEN ISO 20127:2019
ISO/DIS 20127:2019(E)

Introduction
Powered toothbrushes are used for the removal of dental plaque and oral debris in order to facilitate
oral hygiene.
© ISO 2019 – All rights reserved v

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oSIST prEN ISO 20127:2019

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oSIST prEN ISO 20127:2019
DRAFT INTERNATIONAL STANDARD ISO/DIS 20127:2019(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 power toothbrushes. Common features of those powered
toothbrushes for which this document applies:
— a battery;
— a motor;
— a mechanical or magnetic drive system;
— a moving brush head with tufts.
Power toothbrushes may have different motions of the moving brush head (e.g. oscillating-rotating,
side-by-side) and may have different frequencies and velocities for the moving brush head.
The requirements listed in this document shall be fulfilled for all types of power toothbrushes if
applicable. However, some requirements may not be applicable for all types, e.g. brush head retention
can only be applied if the brush has a head portion that might get detached from the brush tube.
Excluded are other types of powered oral hygiene devices (such as powered interdental brushes) and
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 3696:1987, 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 2019 – All rights reserved 1

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oSIST prEN ISO 20127:2019
ISO/DIS 20127:2019(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]
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
toothbrush 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
tuft removal force
force required to remove one tuft from the brush head
[SOURCE: ISO 20126:2012, 3.5]
4 Requirements
4.1 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 6.2 and 6.3.
4.2 Electrical safety
The powered toothbrushes and related accessories shall conform to the requirements described in
IEC 60335-1 and IEC 60335-2-52.
4.3 Tuft retention
The tuft removal force shall not be less than 15 N when tested according to 6.4.
4.4 Mechanical strength
The powered toothbrushes and related accessories shall conform to the requirements described in
IEC 60335-1 and IEC 60335-2-52.
The retention force of the toothbrush head plate shall not be lower than 50 N for each individual sample
when tested according to 6.5.
2 © ISO 2019 – All rights reserved

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oSIST prEN ISO 20127:2019
ISO/DIS 20127:2019(E)

4.5 Resistance to chemical degradation
Subject the brush head to a chemical degradation test according to 6.6. After this test, the brush head
shall conform to the requirements of the spring-operated impact test as described in IEC 60335-1 and
the brush head shall be operational and free of sharp or rough surfaces when examined.
5 Sampling and pass-fail criteria
5.1 Sampling
Eight powered toothbrushes of each type shall be tested.
The powered toothbrushes sampled for testing shall be as manufactured and not modified in any way
except as specified for this document.
5.2 Pass-fail criteria
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 b
...