prEN ISO 20126
(Main)Dentistry - Manual toothbrushes - General requirements and test methods (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)
Zobozdravstvo - Ročne zobne ščetke - Splošne zahteve in preskusne metode (ISO/DIS 20126:2021)
General Information
RELATIONS
Standards Content (sample)
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.
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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: 97.170THIS 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,
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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
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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
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ii © ISO 2021 – All rights reserved
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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
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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
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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
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oSIST prEN ISO 20126:2021
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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 referencesThe 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 — VocabularyISO 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 definitionsFor 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 cavityNote 1 to entry: Adapted from ISO 22254.
© ISO 2021 – All rights reserved 1
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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 1Note 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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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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