EN ISO 20126:2022
(Main)Dentistry - Manual toothbrushes - General requirements and test methods (ISO 20126:2022)
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 und Prüfverfahren für die physikalischen Eigenschaften von Handzahnbürsten fest, um für die vorgesehene Anwendung die Gebrauchssicherheit dieser Produkte zu verbessern.
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, zur Einmalanwendung, Interdental-und elektrische Mundhygieneprodukte. Diese Arten von Mundhygieneprodukten werden durch geeignete Prüfverfahren oder klinische Studien auf ihre Sicherheit bei der Anwendung untersucht.
Darüber hinaus, für die Anforderungen an die End-Abrundung der Filamente, 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 das Verfahren zur End-Abrundung nicht geeignet oder nicht möglich ist. Diese Arten von Handzahnbürsten werden durch geeignete Prüfverfahren oder klinische Studien auf ihre Sicherheit bei der Anwendung untersucht.
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)
Ta dokument določa zahteve in preskusne metode za fizične lastnosti ročnih zobnih ščetk, da se spodbuja varnost teh izdelkov pri njihovi predvideni uporabi. Ta dokument ne določa nobenih zahtev in preskusnih metod za fizikalne lastnosti zobnih ščetk, pri katerih so vsi čistilni elementi v glavi elastomerni.
Ta dokument se ne uporablja za ročne zobne ščetke z enim šopom ščetin, ščetke za enkratno uporabo, medzobne ščetke in električne ustne higienske pripomočke. Varnost teh izdelkov za ustno higieno je ocenjena z ustreznimi preskusnimi metodami ali kliničnimi preskušanji.
Poleg tega se ta dokument v zvezi z zahtevami glede zaokroževanja koncev vlaken, ne uporablja za posebne vrste vlaken, ki so zelo tanka (manj kot 0,1 mm zunanjega premera) ali nimajo ostrih robov (npr. zožena, trakasta, z razcepljenimi konicami, sferično kapico) ali nesintetična vlakna, pri katerih je uporaba postopka zaokroževanja neprimerna ali nemogoča. Te vrste ročnih zobnih ščetk so ocenjene z ustreznimi preskusnimi metodami ali kliničnimi preskušanji.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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 20126:2022(E)
© 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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
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Published in Switzerland
ii
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 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
...
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