EN ISO 16409:2006
(Main)Dentistry - Oral hygiene products - Manual interdental brushes (ISO 16409:2006)
Dentistry - Oral hygiene products - Manual interdental brushes (ISO 16409:2006)
ISO 16409:2006 specifies requirements and test methods for performance criteria for manual interdental brushes with a round cross-section of the brush head.
It also specifies the accompanying information, such as the manufacturer's instructions for use and labelling of the packaging.
ISO 16409:2006 is not applicable to powered interdental brushes, manual toothbrushes, dental floss, tapes, and strings, nor is it applicable to interdental cleaners that do not include filaments.
Zahnheilkunde - Mundhygieneprodukte - Manuelle Interdentalbürsten (ISO 16409:2006)
Diese Internationale Norm legt Anforderungen an und Prüfverfahren für die Leistungskriterien von manuellen Interdentalbürsten mit einem Bürstenkopf mit rundem Querschnitt fest. Sie legt auch die Begleitinformationen wie Gebrauchsanweisung des Herstellers sowie die Kennzeichnung der Verpackung fest.
Diese Internationale Norm gilt nicht für elektrisch betriebene Interdentalbürsten, Handzahnbürsten, Zahn-seiden, -bänder und -reinigungsfäden sowie Interdentalreiniger ohne Filamente.
Art dentaire - Produits d'hygiène bucco-dentaire - Brosses interdentaires manuelles (ISO 16409:2006)
L'ISO 16409:2006 spécifie les exigences et les méthodes d'essai permettant de déterminer les critères de performance des brossettes interdentaires manuelles dont la tête présente une section ronde.
L'ISO 16409:2006 spécifie également les informations d'accompagnement, telles que les instructions du fabricant en matière d'utilisation et d'étiquetage de l'emballage.
L'ISO 16409:2006 ne s'applique ni aux brossettes interdentaires électriques, ni aux brosses à dents manuelles, fils de soie dentaires, rubans et cordons ni aux nettoyants interdentaires ne comportant pas de filaments.
Zobozdravstvo - Izdelki za ustno higieno - Ročne interdentalne ščetke (ISO 16409:2006)
Ta mednarodni standard določa zahteve in preskusne metode za merila delovanja za ročne interdentalne ščetke z zaobljenim presekom ščetkine glave. Določa tudi spremne informacije, kot so proizvajalčeva navodila za uporabo in uporaba nalepk na embalaži. Ta mednarodni standard ne velja za gnane interdentalne ščetke, ročne zobne ščetke, zobne nitke, trakove in vrvice, niti ne velja za interdentalne čistilce, ki ne vključujejo filamentov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2006
=RER]GUDYVWYR,]GHONL]DXVWQRKLJLHQR5RþQHLQWHUGHQWDOQHãþHWNH ,62
Dentistry - Oral hygiene products - Manual interdental brushes (ISO 16409:2006)
Zahnheilkunde - Mundhygieneprodukte - Manuelle Interdentalbürsten (ISO 16409:2006)
Art dentaire - Produits d'hygiene bucco-dentaire - Brosses interdentaires manuelles (ISO
16409:2006)
Ta slovenski standard je istoveten z: EN ISO 16409:2006
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 16409
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2006
ICS 97.170
English Version
Dentistry - Oral hygiene products - Manual interdental brushes
(ISO 16409:2006)
Art dentaire - Produits d'hygiène bucco-dentaire - Brosses Zahnheilkunde - Mundhygieneprodukte - Manuelle
interdentaires manuelles (ISO 16409:2006) Interdentalbürsten (ISO 16409:2006)
This European Standard was approved by CEN on 18 September 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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 and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16409:2006: E
worldwide for CEN national Members.
Foreword
This document (EN ISO 16409:2006) 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 April 2007, and conflicting national
standards shall be withdrawn at the latest by April 2007.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
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 and United Kingdom.
Endorsement notice
The text of ISO 16409:2006 has been approved by CEN as EN ISO 16409:2006 without any
modifications.
INTERNATIONAL ISO
STANDARD 16409
First edition
2006-10-01
Dentistry — Oral hygiene products —
Manual interdental brushes
Art dentaire — Produits d'hygiène bucco-dentaire — Brosses
interdentaires manuelles
Reference number
ISO 16409:2006(E)
©
ISO 2006
ISO 16409:2006(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2006
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 2006 – All rights reserved
ISO 16409:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Classification.2
5 Requirements.2
5.1 Defects or contamination.2
5.2 Brush size.2
5.3 Filament retention.3
5.4 Stem retention.3
5.5 Stem durability.3
6 Sampling.3
7 Test methods.3
7.1 General.3
7.2 Pass/fail criteria .3
7.3 Visual inspection .3
7.4 Passage hole diameter.4
7.5 Filament retention.5
7.6 Stem retention.6
7.7 Stem durability.7
8 Test report .11
9 Accompanying information .11
9.1 Manufacturer's instructions for use .11
9.2 Labelling on the package.11
10 Packaging .11
ISO 16409:2006(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 16409 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care
products.
iv © ISO 2006 – All rights reserved
ISO 16409:2006(E)
Introduction
Manual interdental brushes are used for oral hygiene purposes intended to provide health benefits. Their main
application purpose is mechanical plaque removal, primarily from the interdental region.
INTERNATIONAL STANDARD ISO 16409:2006(E)
Dentistry — Oral hygiene products — Manual interdental
brushes
1 Scope
This International Standard specifies requirements and test methods for performance criteria for manual
interdental brushes with a round cross-section of the brush head.
It also specifies the accompanying information, such as the manufacturer's instructions for use and labelling of
the packaging.
This International Standard is not applicable to powered interdental brushes, manual toothbrushes, dental
floss, tapes, and strings, nor is it applicable to interdental cleaners that do not include filaments.
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
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
manual interdental brush
hand-powered device composed of filaments emanating radially from a stem, intended for cleaning of
interdental surfaces
3.2
interdental brush head
portion of manual interdental brush, which passes in and out of spaces between the teeth to clean the
exposed surfaces
NOTE The brush head can be fixed or removable, but is fixed during use.
3.3
interdental brush handle
portion of manual interdental brush which holds the stem of the manual interdental brush
3.4
stem
central support structure of the manual interdental brush head, usually composed of twisted wire, which
secures the filaments
ISO 16409:2006(E)
NOTE The stem is secured in the handle or in a connector, or fulfils the function of a handle itself.
3.5
filament
single strand attached to the stem
3.6
stem retention force
force required to remove the stem from the interdental brush handle holding it
3.7
passage hole diameter
minimum diameter of a hole through which a manual interdental brush head can pass without stem
deformation
3.8
brush size
index of brush sizes determined by the passage hole diameter
4 Classification
Manual interdental brushes shall be classified as follows:
⎯ Type 1: replacement heads may be mounted into a handle;
⎯ Type 2: the brush head is permanently affixed into the handle;
⎯ Type 3: the stem fulfils the function of a handle.
5 Requirements
5.1 Defects or contamination
Manual interdental brushes, including all supplied parts, shall be free of apparent defects or contamination.
Testing shall be done in accordance with 7.3.
5.2 Brush size
The brush size of manual interdental brushes shall be in accordance with Table 1.
Table 1 — Brush size of interdental brushes
Dimensions in millimetres
Brush size Passage hole diameter
u 0,8
2 0,9 to 1,0
3 1,1 to 1,2
4 1,3 to 1,5
5 1,6 to 1,8
W 1,9
2 © ISO 2006 – All rights reserved
ISO 16409:2006(E)
Determine the brush size of a manual interdental brush by using the passage hole diameter in accordance
with 7.4
5.3 Filament retention
The filaments of manual interdental brushes shall not be removed when tested in accordance with 7.5.
5.4 Stem retention
The stem of manual interdental brushes of Type 1 and Type 2 shall withst
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.