Dentistry - Manual toothbrushes - General requirements and test methods (ISO 20126:2022)

This document specifies requirements and test methods for the physical properties of manual toothbrushes in order to promote the safety of these products for their intended use.
This document does not specify any requirements and test methods for the physical properties of toothbrushes for which all the cleaning elements in the head are elastomer.
This document does not apply to manual single tuft toothbrushes, single use, interdental and powered oral hygiene devices. These types of oral hygiene products are evaluated for their safety in-use by appropriate test methods or clinical trials.
In addition, for the filaments end-rounding requirements, this document does not apply to particular filament types which are very thin (less than 0,1 mm outside diameter) or have no sharp edges (e.g. tapered, feathered, with split tips, or spherical cap) or non-synthetic filaments, where applying end-rounding process is inappropriate or impossible. These types of manual toothbrushes are evaluated for their safety in-use by appropriate test methods or clinical trials appropriately.

Zahnheilkunde - Handzahnbürsten - Allgemeine Anforderungen und Prüfverfahren (ISO 20126:2022)

Dieses Dokument legt Anforderungen an und Prüfverfahren für die physikalischen Eigenschaften von Handzahnbürsten fest, um die Gebrauchssicherheit dieser Produkte zu steigern.
Dieses Dokument legt keine Anforderungen und Prüfverfahren für die physikalischen Eigenschaften von Zahnbürsten fest, bei denen alle Reinigungselemente im Bürstenkopf Elastomere sind.
Dieses Dokument gilt nicht für Handzahnbürsten mit einem Büschel, Einwegzahnbürsten, Interdental-und elektrische Mundhygieneprodukte. Diese Arten von Mundhygieneprodukten werden durch geeignete Prüfverfahren oder klinische Studien auf ihre Sicherheit bei der Anwendung untersucht.
Darüber hinaus gilt dieses Dokument nicht für bestimmte Filamenttypen die sehr dünn sind (weniger als 0,1 mm Außendurchmesser) oder die keine scharfen Ecken (z. B. konisch, aufgefächert, mit geteilten Spitzen oder kugelförmiger Kappe) aufweisen oder für nicht-synthetische Filamente, für die die Endabrundung nicht geeignet oder nicht möglich sind. Diese Arten von Handzahnbürsten werden durch geeignete Prüfverfahren oder klinische Studien auf ihre Sicherheit bei der Anwendung untersucht werden.

Médecine bucco-dentaire - Brosses à dents manuelles - Exigences générales et méthodes d'essai (ISO 20126:2022)

Le présent document spécifie les exigences et les méthodes d'essai relatives aux caractéristiques physiques des brosses à dents manuelles afin de promouvoir la sécurité de ces produits dans les conditions d’utilisation prévues.
Le présent document ne spécifie pas les exigences et les méthodes d’essai relatives aux caractéristiques physiques des brosses à dents dont tous les éléments nettoyants de la tête sont en élastomère.
Le présent document ne s’applique pas aux brosses à dents manuelles monotouffe et aux dispositifs électriques interdentaires d’hygiène bucco-dentaire à usage unique. La sécurité d’emploi de ces types de produits d’hygiène bucco-dentaire est évaluée en appliquant des méthodes d’essai et des essais cliniques appropriés.
De plus, en ce qui concerne les exigences d’arrondissage des extrémités de filaments, le présent document ne s’applique pas aux types particuliers de filaments qui sont très fins (moins de 0,1 mm de diamètre extérieur) ou qui n’ont pas d’arêtes vives (par exemple effilés, amincis, à pointes divisées ou à calotte) ou aux filaments non synthétiques dans lesquels l’application du processus d’arrondissage des extrémités est inappropriée ou impossible. La sécurité d’emploi de ces types de brosses à dents manuelles est évaluée en appliquant des méthodes d’essai et des essais cliniques appropriés.

Zobozdravstvo - Ročne zobne ščetke - Splošne zahteve in preskusne metode (ISO 20126:2022)

General Information

Status
Published
Public Enquiry End Date
19-May-2021
Publication Date
11-May-2022
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
25-Apr-2022
Due Date
30-Jun-2022
Completion Date
12-May-2022

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SLOVENSKI STANDARD
SIST EN ISO 20126:2022
01-junij-2022
Nadomešča:
SIST EN ISO 20126:2012
SIST EN ISO 20126:2012/A1:2018
Zobozdravstvo - Ročne zobne ščetke - Splošne zahteve in preskusne metode (ISO
20126:2022)
Dentistry - Manual toothbrushes - General requirements and test methods (ISO
20126:2022)

Zahnheilkunde - Handzahnbürsten - Allgemeine Anforderungen und Prüfverfahren (ISO

20126:2022)
Médecine bucco-dentaire - Brosses à dents manuelles - Exigences générales et
méthodes d'essai (ISO 20126:2022)
Ta slovenski standard je istoveten z: EN ISO 20126:2022
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
97.170 Oprema za nego telesa Body care equipment
SIST EN ISO 20126:2022 en,fr,de

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

---------------------- Page: 1 ----------------------
SIST EN ISO 20126:2022
---------------------- Page: 2 ----------------------
SIST EN ISO 20126:2022
EN ISO 20126
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2022
EUROPÄISCHE NORM
ICS 97.170 Supersedes EN ISO 20126:2012, EN ISO
20126:2012/A1:2018
English Version
Dentistry - Manual toothbrushes - General requirements
and test methods (ISO 20126:2022)

Médecine bucco-dentaire - Brosses à dents manuelles - Zahnheilkunde - Handzahnbürsten - Allgemeine

Exigences générales et méthodes d'essai (ISO Anforderungen und Prüfverfahren (ISO 20126:2022)

20126:2022)
This European Standard was approved by CEN on 12 February 2022.

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

© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20126:2022 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 20126:2022
EN ISO 20126:2022 (E)
Contents Page

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

---------------------- Page: 4 ----------------------
SIST EN ISO 20126:2022
EN ISO 20126:2022 (E)
European foreword

This document (EN ISO 20126:2022) 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 September 2022, and conflicting national standards

shall be withdrawn at the latest by September 2022.

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 20126:2012.

Any feedback and questions on this document should be directed to the users’ national standards

body/national committee. A complete listing of these bodies can be found on the CEN website.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 20126:2022 has been approved by CEN as EN ISO 20126:2022 without any modification.

---------------------- Page: 5 ----------------------
SIST EN ISO 20126:2022
---------------------- Page: 6 ----------------------
SIST EN ISO 20126:2022
INTERNATIONAL ISO
STANDARD 20126
Third edition
2022-03
Dentistry — Manual toothbrushes
— General requirements and test
methods
Médecine bucco-dentaire — Brosses à dents manuelles — Exigences
générales et méthodes d'essai
Reference number
ISO 20126:2022(E)
© ISO 2022
---------------------- Page: 7 ----------------------
SIST EN ISO 20126:2022
ISO 20126:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022

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
© ISO 2022 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 20126:2022
ISO 20126:2022(E)
Contents Page

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

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

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

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

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

4 Requirements .......................................................................................................................................................................................................... 3

4.1 Pass-fail criteria .................................................................................................................................................................................... 3

4.1.1 Pass-fail criteria except for filament end-rounding ............................................................................ 3

4.1.2 Pass-fail criteria for filament end-rounding .............................................................................................. 3

4.2 Physical inspection ............................................................................................................................................................................. 3

4.3 Tuft retention ........................................................................................................................................................................................... 3

4.4 Handle impact strength .................................................................................................................................................................. 3

4.5 Fatigue resistance ................................................................................................................................................................................ 4

4.6 Fatigue resistance after chemical challenge ................................................................................................................ 4

4.7 Filament end-rounding .................................................................................................................................................................... 4

5 Test method ............................................................................................................................................................................................................... 4

5.1 Sampling ....................................................................................................................................................................................................... 4

5.2 General test conditions ................................................................................................................................................................... 4

5.3 Physical inspection ............................................................................................................................................................................. 4

5.4 Tuft retention test ................................................................................................................................................................................ 4

5.4.1 Apparatus ................................................................................................................................................................................. 4

5.4.2 Procedure ................................................................................................................................................................................. 4

5.5 Handle impact test .............................................................................................................................................................................. 5

5.5.1 Apparatus ................................................................................................................................................................................. 5

5.5.2 Procedure ................................................................................................................................................................................. 6

5.6 Fatigue resistance test ........................................................................................................................................... .......................... 7

5.6.1 Apparatus ................................................................................................................................................................................. 7

5.6.2 Procedure ................................................................................................................................................................................. 8

5.7 Fatigue resistance test after chemical challenge ..................................................................................................... 8

5.7.1 Apparatus and chemicals............................................................................................................................................ 8

5.7.2 Procedure ................................................................................................................................................................................. 8

5.8 Visual inspection for filament end-rounding .............................................................................................................. 9

5.8.1 General ........................................................................................................................................................................................ 9

5.8.2 Apparatus ................................................................................................................................................................................. 9

5.8.3 Procedure ................................................................................................................................................................................. 9

6 Test report ...............................................................................................................................................................................................................10

7 Marking and labelling .................................................................................................................................................................................10

8 Packaging..................................................................................................................................................................................................................10

Bibliography .............................................................................................................................................................................................................................11

iii
© ISO 2022 – All rights reserved
---------------------- Page: 9 ----------------------
SIST EN ISO 20126:2022
ISO 20126:2022(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 third edition cancels and replaces the second edition (ISO 20126:2012), which has been technically

revised. It also incorporates the Amendment ISO 20126:2012/Amd.1:2018.
The main changes compared to the previous edition are as follows:

— a requirement (4.7) and a test method (5.8) for filament end-rounding have been added;

— the scope has been contracted to exclude specific types of manual toothbrushes from the application

of this document.

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.
© ISO 2022 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 20126:2022
ISO 20126:2022(E)
Introduction

This document is intended to determine the physical properties of manual toothbrushes which are used

for the removal of dental plaque and oral debris in order to facilitate oral hygiene.

Specific qualitative and quantitative requirements for freedom from biological hazards are not included

in this document. It is recommended that, in assessing possible biological hazards, reference be made to

ISO 7405 and ISO 10993-1.
© ISO 2022 – All rights reserved
---------------------- Page: 11 ----------------------
SIST EN ISO 20126:2022
---------------------- Page: 12 ----------------------
SIST EN ISO 20126:2022
INTERNATIONAL STANDARD ISO 20126:2022(E)
Dentistry — Manual toothbrushes — General requirements
and test methods
1 Scope

This document specifies requirements and test methods for the physical properties of manual

toothbrushes in order to promote the safety of these products for their intended use.

This document does not specify any requirements and test methods for the physical properties of

toothbrushes for which all the cleaning elements in the head are elastomer.

This document does not apply to manual single tuft toothbrushes, single use, interdental and powered

oral hygiene devices. These types of oral hygiene products are evaluated for their safety in-use by

appropriate tes
...

SLOVENSKI STANDARD
oSIST prEN ISO 20126:2021
01-maj-2021
Zobozdravstvo - Ročne zobne ščetke - Splošne zahteve in preskusne metode
(ISO/DIS 20126:2021)
Dentistry - Manual toothbrushes - General requirements and test methods (ISO/DIS
20126:2021)
Zahnheilkunde - Handzahnbürsten - Allgemeine Anforderungen und Prüfverfahren
(ISO/DIS 20126:2021)
Médecine bucco-dentaire - Brosses à dents manuelles - Exigences générales et
méthodes d'essai (ISO/DIS 20126:2021)
Ta slovenski standard je istoveten z: prEN ISO 20126
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
97.170 Oprema za nego telesa Body care equipment
oSIST prEN ISO 20126:2021 en,fr,de

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

---------------------- Page: 1 ----------------------
oSIST prEN ISO 20126:2021
---------------------- Page: 2 ----------------------
oSIST prEN ISO 20126:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 20126
ISO/TC 106/SC 7 Secretariat: JISC
Voting begins on: Voting terminates on:
2021-03-08 2021-05-31
Dentistry — Manual toothbrushes — General requirements
and test methods

Médecine bucco-dentaire — Brosses à dents manuelles — 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 20126:2021(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 2021
---------------------- Page: 3 ----------------------
oSIST prEN ISO 20126:2021
ISO/DIS 20126:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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 2021 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 20126:2021
ISO/DIS 20126:2021(E)
Contents Page

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

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

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

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

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

4 Requirements .......................................................................................................................................................................................................... 3

4.1 Pass-fail criteria...................................................................................................................................................................................... 3

4.2 Physical inspection .............................................................................................................................................................................. 3

4.3 Tuft retention ........................................................................................................................................................................................... 4

4.4 Handle impact strength ................................................................................................................................................................... 4

4.5 Fatigue resistance ................................................................................................................................................................................. 4

4.6 Fatigue resistance after chemical challenge .................................................................................................................. 4

4.7 Filament end-rounding .................................................................................................................................................................... 4

5 Test method ............................................................................................................................................................................................................... 4

5.1 Sampling ....................................................................................................................................................................................................... 4

5.2 General test conditions .................................................................................................................................................................... 4

5.3 Physical inspection .............................................................................................................................................................................. 4

5.4 Tuft retention test ................................................................................................................................................................................ 4

5.5 Handle impact test ............................................................................................................................................................................... 5

5.6 Fatigue resistance test ...................................................................................................................................................................... 7

5.7 Fatigue resistance test after chemical challenge ....................................................................................................... 8

5.8 Visual inspection for filament end-rounding ................................................................................................................ 9

6 Test report ................................................................................................................................................................................................................10

7 Marking and labelling ..................................................................................................................................................................................10

8 Packaging ..................................................................................................................................................................................................................10

Bibliography .............................................................................................................................................................................................................................11

© ISO 2021 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 20126:2021
ISO/DIS 20126:2021(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 http:// 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 http:// 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 on 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 WTO principles in

the Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral

care products.

This third edition cancels and replaces the second edition (ISO 20126:2012), which has been technically

revised. It also incorporates the Amendment (ISO 20126:2012/Amd.1:2018).
The main changes compared to the previous edition are as follows:

— a requirement (4.7) and a test method (5.8) for filament end-rounding have been added;

— To exclude specific types of manual toothbrushes from the application of this document, the scope

has been contracted.

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 2021 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 20126:2021
ISO/DIS 20126:2021(E)
Introduction

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

hygiene. This document is intended to determine the physical properties of manual toothbrushes. This

document does not specify the physical properties of toothbrushes with injection moulded filaments.

It will be developed as another part of this document after a methodology can be evaluated by the

working group.

Specific qualitative and quantitative requirements for freedom from biological hazards are not included

in this document. It is recommended that, in assessing possible biological hazards, reference be made to

ISO 7405 and ISO 10993-1.
© ISO 2021 – All rights reserved v
---------------------- Page: 7 ----------------------
oSIST prEN ISO 20126:2021
---------------------- Page: 8 ----------------------
oSIST prEN ISO 20126:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 20126:2021(E)
Dentistry — Manual toothbrushes — General requirements
and test methods
1 Scope

This document specifies requirements and test methods for the physical properties of manual

toothbrushes in order to promote the safety of these products for their intended use.

This document does not specify any requirements and test methods for the physical properties of

toothbrushes for which all the cleaning elements in the head are elastomer.

This document does not apply to manual single tuft toothbrushes, single use, interdental, powered oral

hygiene devices, and non-flat trim profile tufts (e.g. dual textured, bi-level, multi-level, rippled, or angled

in opposing directions). These types of oral hygiene products should be evaluated for their safety in-use

by appropriate test methods or clinical trials.

In addition, this document does not apply to particular designs of filament ends (e.g. tapered, feathered,

with split tips, or spherical cap) or filament types (e.g. non-synthetic filaments, very thin, spiral or

twisted) for the filaments end-rounding requirements. These types of manual toothbrushes should be

evaluated for their safety in-use by appropriate test methods or clinical trials appropriately.

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

ISO 22254, Dentistry — Manual toothbrushes — Resistance of tufted portion to deflection

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO1942 and ISO 22254, 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/
3.1
manual toothbrush

hand-powered device, the working end of which carries filaments primarily for cleaning surfaces

within the oral cavity
Note 1 to entry: Adapted from ISO 22254.
© ISO 2021 – All rights reserved 1
---------------------- Page: 9 ----------------------
oSIST prEN ISO 20126:2021
ISO/DIS 20126:2021(E)
3.2
brush head
working end of a manual toothbrush to which the filaments are attached
Note 1 to entry: Adapted from ISO 22254.
3.3
filament
single strand within the brush head
[SOURCE: ISO 22254:2005, definition 3,3]
3.4
tuft
group of filaments gathered together and attached to the brush head
[SOURCE: ISO 22254:2005, definition 3.4]
3.5
tuft removal force
force required to remove one tuft from the brush head
3.6
tuft hole plane

plane between the bases of the tufts (where they meet the tufted hole surface) at the top of the brush

head and the base of the tufts at the bottom of the brush head. See Figure 1
Note 1 to entry: Adapted from ISO 22254.
Key
1 tuft hole surface
2 top of brush head
3 bottom of brush head
4 tuft hole plane
Figure 1 — Tuft hole plane
2 © ISO 2021 – All rights reserved
---------------------- Page: 10 ----------------------
oSIST prEN ISO 20126:2021
ISO/DIS 20126:2021(E)
3.7
period of oscillation of the pendulum

period, expressed in seconds, of a single complete oscillation (to and from) of the pendulum, oscillating

...

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