EN ISO 20126:2012
(Main)Dentistry - Manual toothbrushes - General requirements and test methods (ISO 20126:2012)
Dentistry - Manual toothbrushes - General requirements and test methods (ISO 20126:2012)
This International Standard 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 International Standard does not apply to manual interdental brushes and powered oral hygiene devices, as these instruments are covered by separate International Standards.
Zahnheilkunde - Handzahnbürsten - Allgemeine Anforderungen und Prüfverfahren (ISO 20126:2012)
Diese Internationale Norm legt Anforderungen an und Prüfverfahren für die physikalischen Eigenschaften von Handzahnbürsten fest, um die Gebrauchssicherheit dieser Produkte zu steigern.
Diese Internationale Norm ist nicht anwendbar auf manuell betätigte Interdentalbürsten und elektrisch betriebene Geräte für die Mundhygiene, da diese Produkte in anderen Internationalen Normen beschrieben werden.
Médecine bucco-dentaire - Brosses à dents manuelles - Exigences générales et méthodes d'essai (ISO 20126:2012)
La présente Norme internationale spécifie les exigences et les méthodes d'essai relatives aux propriétés physiques des brosses à dents manuelles afin de promouvoir la sécurité de ces produits dans les conditions d'utilisation prévues.
Elle ne s'applique pas aux brossettes interdentaires manuelles et aux dispositifs électriques d'hygiène bucco-dentaire qui font l'objet de Normes internationales distinctes.
Zobozdravstvo - Ročne zobne ščetke - Splošne zahteve in preskusne metode (ISO 20126:2012)
Ta mednarodni standard določa zahteve in preskusne metode za fizične lastnosti ročnih zobnih ščetk, da se spodbuja varnost teh izdelkov pri njihovi predvideni uporabi.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2012
1DGRPHãþD
SIST EN ISO 20126:2005
=RER]GUDYVWYR5RþQH]REQHãþHWNH6SORãQH]DKWHYHLQSUHVNXVQHPHWRGH ,62
Dentistry - Manual toothbrushes - General requirements and test methods (ISO
20126:2012)
Zahnheilkunde - Handzahnbürsten - Allgemeine Anforderungen und Prüfverfahren
einschließlich Griffschlagprüfung (ISO 20126:2012)
Médecine bucco-dentaire - Brosses à dents manuelles - Exigences générales et
méthodes d'essai (ISO 20126:2012)
Ta slovenski standard je istoveten z: EN ISO 20126:2012
ICS:
97.170 Oprema za nego telesa Body care equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 20126
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2012
ICS 97.170 Supersedes EN ISO 20126:2005
English Version
Dentistry - Manual toothbrushes - General requirements and test
methods (ISO 20126:2012)
Médecine bucco-dentaire - Brosses à dents manuelles - Zahnheilkunde - Handzahnbürsten - Allgemeine
Exigences générales et méthodes d'essai (ISO Anforderungen und Prüfverfahren (ISO 20126:2012)
20126:2012)
This European Standard was approved by CEN on 28 January 2012.
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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20126:2012: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 20126:2012) 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 2012, and conflicting national standards shall be
withdrawn at the latest by September 2012.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 20126:2005.
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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 20126:2012 has been approved by CEN as a EN ISO 20126:2012 without any modification.
INTERNATIONAL ISO
STANDARD 20126
Second edition
2012-01-15
Dentistry — Manual toothbrushes —
General requirements and test methods
Médecine bucco-dentaire — Brosses à dents manuelles — Exigences
générales et méthodes d’essai
Reference number
ISO 20126:2012(E)
©
ISO 2012
ISO 20126:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
ISO 20126:2012(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 . 3
4.4 Fatigue resistance . 3
4.5 Chemical challenge . 3
4.6 Handle impact strength . 3
5 Test method . 3
5.1 Sampling . 3
5.2 General test conditions . 3
5.3 Physical inspection . 3
5.4 Tuft-retention test . 4
5.5 Fatigue resistance test . 5
5.6 Resistance to chemical challenge . 6
5.7 Handle impact test . 6
6 Test report . 9
7 Marking and labelling .10
8 Packaging .10
Bibliography . 11
ISO 20126:2012(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 20126 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care products.
This second edition cancels and replaces the first edition (ISO 20126:2005), which has been technically revised.
The significant difference between this second edition and the first edition is:
— a requirement (4.6) and a test (5.7) for handle impact resistance have been added.
iv © ISO 2012 – All rights reserved
ISO 20126:2012(E)
Introduction
Manual toothbrushes are used for the removal of dental plaque and oral debris in order to facilitate oral hygiene.
This International Standard is intended to determine the physical properties of manual toothbrushes, including
impact resistance.
Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this
International Standard. It is recommended that, in assessing possible biological hazards, reference be made
to ISO 7405 and ISO 10993-1.
INTERNATIONAL STANDARD ISO 20126:2012(E)
Dentistry — Manual toothbrushes — General requirements
and test methods
1 Scope
This International Standard 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 International Standard does not apply to manual interdental brushes and powered oral hygiene devices,
as these instruments are covered by separate International Standards.
2 Normative references
The following referenced documents are indispensable for the application 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
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 ISO 1942 and ISO 22254 and the
following apply.
3.1
manual toothbrush
hand-powered device, the working end of which carries filaments primarily for cleaning surfaces within the oral cavity
NOTE Adapted from ISO 22254:2005, definition 3.1.
3.2
brush head
working end of a manual toothbrush to which the filaments are attached
NOTE Adapted from ISO 22254:2005, definition 3.2.
3.3
filament
single strand within the brush head
[ISO 22254:2005, definition 3.3]
3.4
tuft
group of filaments gathered together and attached to the brush head
[ISO 22254:2005, definition 3.4]
3.5
tuft-removal force
force required to remove one tuft from the brush head
ISO 20126:2012(E)
3.6
tuft-hole plane
plane between the bases of the tufts (where they meet the tuft-hole surface) at the top of the brush head and
at the base of the tufts at the bottom of the brush head
See Figure 1.
NOTE Adapted from ISO 22254:2005, definition 3.6.
Key
1 tuft-hole surface
2 top of brush head
3 bottom of brush head
4 tuft-hole plane
Figure 1 — Tuft-hole plane
3.7
period of oscillation of the pendulum
T
p
period, expressed in seconds, of a single complete oscillation (to and fro) of the pendulum, oscillating at angles
of oscillation of less than 5° to each side of the vertical
[ISO 13802:1999, definition 3.3]
3.8
centre of percussion
point on pendulum at which
...
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