ISO/DIS 20126

Dentistry -- Manual toothbrushes -- General requirements and test methods

Médecine bucco-dentaire -- Brosses à dents manuelles -- Exigences générales et méthodes d'essai

Standards Content (sample)

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
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ISO/DIS 20126:2021(E)
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ISO/DIS 20126:2021(E)
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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
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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
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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
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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
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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
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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

at angles of oscillation of less than 5 ° to each side of the vertical
[SOURCE: ISO 13802:1999, definition 3.3]
3.8
centre of percussion

point on pendulum at which a perpendicular impact in the plane of swing does not cause reaction forces

at the axis of rotation of the pendulum
[SOURCE: ISO 13802:1999, definition 3.4]
3.9
pendulum length

distance, expressed in metres, between the axis of rotation of the pendulum and the centre of percussion

(3.8), equal to an equivalent theoretical pendul
...