EN ISO 20127:2020
(Main)Dentistry - Physical properties of powered toothbrushes (ISO 20127:2020)
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
- Withdrawn
- Publication Date
- 15-Sep-2020
- Withdrawal Date
- 20-May-2025
- Technical Committee
- CEN/TC 55 - Dentistry
- Drafting Committee
- CEN/TC 55 - Dentistry
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 16-Sep-2020
- Completion Date
- 16-Sep-2020
Relations
- Effective Date
- 23-Sep-2020
- Replaced By
EN ISO 20127:2025 - Dentistry - Physical properties of powered toothbrushes (ISO 20127:2025) - Effective Date
- 04-Oct-2023
Frequently Asked Questions
EN ISO 20127:2020 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Physical properties of powered toothbrushes (ISO 20127:2020)". This standard covers: 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.
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.
EN ISO 20127:2020 is classified under the following ICS (International Classification for Standards) categories: 97.170 - Body care equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 20127:2020 has the following relationships with other standards: It is inter standard links to EN ISO 20127:2005, EN ISO 20127:2025. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN ISO 20127:2020 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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
ISO 20127:2020(E)
© 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
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 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
ISO 20127:2020(E)
Introduction
Powered toothbrushes are used for the removal of dental plaque and oral debris in order to facilitate
oral hygiene.
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 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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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
ISO 20127:2020(E)
© 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
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 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
ISO 20127:2020(E)
Introduction
Powered toothbrushes are used for the removal of dental plaque and oral debris in order to facilitate
oral hygiene.
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
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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
...
La norme EN ISO 20127:2020, intitulée "Dentisterie - Propriétés physiques des brosses à dents électriques", offre un cadre essentiel pour les exigences et les méthodes d'essai liées aux propriétés physiques des brosses à dents alimentées. Son objectif principal est de promouvoir la sécurité de ces produits pour leur utilisation prévue, un aspect fondamental dans le domaine de l'hygiène dentaire. Le champ d'application de cette norme est clairement défini, s'appliquant à divers types de brosses à dents électriques équipées d'une batterie, d'un moteur et d'un système d'entraînement mécanique ou magnétique. L'inclusion de caractéristiques telles que des têtes de brosse mobiles avec des filaments tuftés souligne la diversité des technologies utilisées. Il convient de noter que les mouvements des têtes de brosse, qu'ils soient oscillants-rotatifs ou latéraux, ainsi que les variations de fréquence et de vitesse, sont clairement pris en compte, renforçant ainsi la pertinence de cette norme pour l'ensemble du secteur. Les exigences énoncées dans le document sont complètes et adaptées aux différentes catégories de brosses à dents électriques, ce qui constitue un point fort indéniable. Toutefois, il est important de mentionner que certaines exigences peuvent ne pas être applicables à tous les types de brosses, comme la rétention de la plaque de tête de brosse, qui ne concerne que les modèles susceptibles de dissocier la tête du corps de la brosse. Cette nuance témoigne d'une compréhension approfondie des technologies en jeu et renforce la crédibilité de la norme. De plus, la distinction faite dans ce document entre les brosses à dents électriques et d'autres dispositifs d'hygiène buccale alimentés, tels que les brosses interdentaires électriques, ainsi que les brosses manuelles, souligne la spécialisation de cette norme et sa pertinence spécifique pour les utilisateurs finaux. En somme, la norme EN ISO 20127:2020 représente une avancée significative dans la standardisation des brosses à dents électriques, abordant de manière exhaustive les aspects critiques de sécurité et de performance.
SIST EN ISO 20127:2020は、電動歯ブラシの物理的特性に関する重要な標準であり、これらの製品が意図された使用法に対して安全性を促進するための要求事項と試験方法を明確に定義しています。この標準は、バッテリー、モーター、機械的または磁気駆動システム、そして毛束のついた動くブラシヘッドといった、電動歯ブラシに共通する特徴を持つ製品に適用されます。 この文書の強みは、電動歯ブラシの多様な技術と動きに対応した要求事項を網羅している点にあります。特に、オシレーティング、回転、サイドバイサイドといった異なる動きや周波数、速度に関しても考慮されており、さまざまな製品に対して一貫した基準を提供しています。これにより、メーカーは品質を確保し、安全性を保証するための明確な指針を持つことができます。 また、この標準はすべての種類の電動歯ブラシに適用される要求事項を列挙していますが、特定のケースにおいては一部の要件が適用できない可能性もある点を明示しているため、実務における柔軟性を持たせています。たとえば、ブラシヘッドがシャフトから外れる可能性がある場合に限り、ブラシヘッドプレートの保持に関する要件が適用されることが挙げられます。 ただし、この文書は電動間歯ブラシや手動歯ブラシなど、他のタイプの電動口腔衛生機器には適用されないことも明確に示されており、この点も使用範囲の特異性と関連性を強調しています。 全体として、SIST EN ISO 20127:2020は、電動歯ブラシの物理的特性に関する規格を確立することで、安全性を促進し、業界全体における質の高い製品の供給を支える重要な文書です。
EN ISO 20127:2020 표준 문서는 전동 칫솔의 물리적 특성에 대한 요구 사항 및 시험 방법을 명시하여, 사용자에게 해당 제품의 안전성을 보장하는 데 중점을 두고 있습니다. 이 표준은 배터리, 모터, 기계적 또는 자기 구동 시스템, 그리고 이동하는 칫솔 머리를 갖춘 전동 칫솔에 적용됩니다. 이 문서의 강점 중 하나는 전동 칫솔의 다양한 기술을 포괄적으로 다룬다는 점입니다. 칫솔 머리가 진동-회전, 좌우 등 다양한 움직임을 가질 수 있으며, 그에 따른 주파수와 속도도 다를 수 있습니다. 이처럼 다양한 형태의 전동 칫솔에 적용 가능한 요구 사항들은 사용자가 제품을 선택할 때 유용한 정보를 제공합니다. 또한, 이 표준은 전동 칫솔의 모든 유형에 적용되지만 일부 요구 사항은 특정 유형에만 적합할 수 있다는 점을 명확히 하고 있습니다. 예를 들어, 칫솔 헤드 판 고정 요구사항은 칫솔이 분리 가능한 헤드 부분을 가지고 있는 경우에만 적용될 수 있습니다. 이는 소비자 안전을 위해 중요하며, 전동 칫솔 설계자들에게 실질적인 참고자료가 됩니다. EN ISO 20127:2020 표준은 전동 구강 위생 장치(예: 전동 치간 칫솔)나 수동 칫솔에는 적용되지 않는다는 것 또한 명시하여, 대상 제품의 한계를 분명히 하고 있습니다. 이를 통해 사용자는 자신에게 적합한 구강 위생 도구를 선택하는 데 도움을 받을 수 있습니다. 결론적으로, EN ISO 20127:2020 표준은 전동 칫솔의 안전성과 효율성을 향상시키기 위한 지침을 제공함으로써, 소비자 보호와 제품 품질 향상에 기여하는 중요한 문서입니다.
The EN ISO 20127:2020 standard presents a comprehensive framework for assessing the physical properties of powered toothbrushes, establishing critical guidelines aimed at enhancing safety and effectiveness in dental hygiene practices. This standard's scope is particularly well-defined, explicitly delineating its applicability to powered toothbrushes featuring various technologies, including those with battery-powered motors, mechanical or magnetic drive systems, and multifunctional brush heads with tufted filaments. One of the standard's key strengths lies in its inclusivity of numerous powered toothbrush designs, encompassing those utilizing different modes of motion such as oscillating-rotating or side-by-side actions. By addressing the diverse functionalities of these devices, the EN ISO 20127:2020 ensures that safety measures are relevant and applicable across the spectrum of powered toothbrushes, while also allowing for variations in performance and engineering. Moreover, the document articulates specific requirements and standardized test methods, promoting consistency and reliability in product manufacturing. These requirements serve as a benchmark for manufacturers, enabling them to assess compliance and guarantee that their products meet the necessary safety parameters. The careful consideration of factors like brush head retention underscores a focused approach to safety, ensuring that potential risks associated with the detachment of brush components are systematically examined. Additionally, the standard clearly excludes powered oral hygiene devices not classified as powered toothbrushes, which sharpens its relevance and applicability. This delineation prevents ambiguity and ensures that manufacturers can concentrate on specific safety and effectiveness criteria tailored to their products, thus enhancing the standard's practical implementation and usability. In conclusion, EN ISO 20127:2020 stands out as a vital resource for manufacturers in the dental products industry, facilitating the development of safe and effective powered toothbrushes while promoting consumer confidence in dental care products. The standard's detailed specifications and rigorous testing requirements contribute significantly to the overarching goal of improving oral hygiene practices through enhanced product safety and efficacy.
Die Norm EN ISO 20127:2020 befasst sich mit den physikalischen Eigenschaften von elektrischen Zahnbürsten und legt Anforderungen sowie Prüfmethoden fest, um die Sicherheit dieser Produkte für den vorgesehenen Gebrauch zu fördern. Der Fokus der Norm liegt auf den wichtigsten Merkmalen von elektrischen Zahnbürsten, darunter die Verwendung von Batterien, Motoren und Antriebssystemen – sei es mechanisch oder magnetisch. Ein herausragendes Merkmal dieser Norm ist die umfassende Betrachtung verschiedener Technologien von elektrischen Zahnbürsten. Während der Standard für alle Typen von elektrischen Zahnbürsten gilt, berücksichtigt er dennoch deren unterschiedlichen Bewegungsarten wie oszillierend-rotierend oder seitlich sowie die variierenden Frequenzen und Geschwindigkeiten der Bürstenköpfe. Diese Differenzierung stellt sicher, dass die Norm sowohl für einfache Modelle als auch für komplexere Geräte anwendbar ist. Die Stärke der EN ISO 20127:2020 liegt in ihrer detaillierten Spezifikation von Anforderungen, die entscheidend sind, um sowohl die Benutzerfreundlichkeit als auch die Sicherheit der elektrischen Zahnbürsten zu garantieren. Die Norm hebt insbesondere die Anforderungen an die Halterung des Bürstenkopfes hervor, was für Modelle mit abnehmbaren Bürstenköpfen von Bedeutung ist. Hierdurch wird einem potenziellen Sicherheitsrisiko Rechnung getragen, was den Standard für Hersteller und Verbraucher von zentraler Relevanz macht. Darüber hinaus ist anzumerken, dass die Norm nicht auf andere Arten von elektrischen Zahnreinigungsgeräten, wie elektrische Interdentalbürsten oder manuelle Zahnbürsten, anwendbar ist. Dies schafft Klarheit über den Anwendungsbereich und hilft, Missverständnisse zu vermeiden. Insgesamt ist die EN ISO 20127:2020 ein wesentlicher Standard zur Gewährleistung der Sicherheit und Effektivität von elektrischen Zahnbürsten, der sowohl Herstellern als auch Nutzern als wertvolle Leitlinie dient.
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