SIST EN ISO 16409:2017

Dentistry - Oral care products - Manual interdental brushes (ISO 16409:2016)

ISO 16409:2016 specifies requirements and test methods for performance criteria for manual interdental brushes with a round cross-section of the brush head and consisting of a wired stem with inserted filaments. It also specifies the accompanying information such as manufacturer's instructions for use and labelling of the packaging.
Excluded are interdental brushes with a plastic core.
ISO 16409:2016 is not applicable to powered interdental brushes, manual toothbrushes, dental floss, tapes, and strings and to interdental cleaners that do not include filaments.

Zahnheilkunde - Mundhygieneprodukte - Manuelle Interdentalbürsten (ISO 16409:2016)

Diese Internationale Norm legt Anforderungen an und Prüfverfahren für die Leistungskriterien für manuelle Interdentalbürsten fest, die aus einem Bürstenkopf mit rundem Querschnitt und einem Drahtkern mit eingefügten Filamenten bestehen. Sie legt auch die Begleitangaben wie Gebrauchsanweisung und die Kennzeichnung der Verpackung fest.
Ausgeschlossen sind Interdentalbürsten mit einem Kunststoffkern.
Diese Internationale Norm gilt nicht für elektrisch betriebene Interdentalbürsten, Handzahnbürsten, Zahn¬seiden, Bänder und Reinigungsfäden sowie Interdentalreiniger, die keine Filamente enthalten.

Médecine bucco-dentaire - Produits de soins bucco-dentaires - Brosses interdentaires manuelles (ISO 16409:2016)

ISO 16409:2016 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 et qui sont composées d'une base filaire avec insertion de filaments. Elle spécifie également les informations d'accompagnement, telles que les instructions du fabricant en matière d'utilisation et d'étiquetage de l'emballage.
Les brossettes interdentaires avec partie centrale en plastique sont exclues.
ISO 16409:2016 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 16409:2016)

Ta mednarodni standard določa zahteve in preskusne metode za merila zmogljivosti za ročne interdentalne ščetke z okroglim prerezom glave ščetke, ki jo sestavlja žični držaj z vstavljenimi filamenti. Podaja tudi informacije, ki spremljajo proizvod, kot na primer navodila za uporabo proizvajalca ter navodila za označevanje embalaže.
Interdentalne ščetke s plastičnim jedrom niso zajete.
Ta mednarodni standard se ne uporablja za električne interdentalne ščetke, ročne zobne ščetke, zobne nitke in trakove ter za interdentalne ščetke brez filamentov.

General Information

• Status: Published
• Public Enquiry End Date: 29-Jul-2014
• Publication Date: 10-Jan-2017
• ICS: 71.100.70 - Cosmetics. Toiletries
• ICS: 97.170 - Body care equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 16-Dec-2016
• Due Date: 20-Feb-2017
• Completion Date: 11-Jan-2017
• Ref Project: EN ISO 16409:2016 - Dentistry - Oral care products - Manual interdental brushes (ISO 16409:2016)

Relations

• Replaces: SIST EN ISO 16409:2006 - Dentistry - Oral hygiene products - Manual interdental brushes (ISO 16409:2006)
• Effective Date: 01-Feb-2017
• Replaces: SIST EN ISO 16409:2006/A1:2010 - Dentistry - Oral hygiene products - Manual interdental brushes - Amendment 1 (ISO 16409:2006/Amd 1:2010)
• Effective Date: 01-Feb-2017

Overview

EN ISO 16409:2016 - Dentistry - Oral care products - Manual interdental brushes (ISO 16409:2016) is a CEN-adopted international standard that defines performance requirements and test methods for hand‑powered interdental brushes with a round brush‑head cross‑section and a wired stem with inserted filaments. The standard covers product classification, test procedures, required accompanying information (instructions for use and labelling) and packaging requirements. It excludes interdental brushes with a plastic core and is not applicable to powered interdental brushes, manual toothbrushes, dental floss/tape/string or filament‑free interdental cleaners.

Key topics and technical requirements

• Scope & exclusions: Applies to manual interdental brushes with wired stems and filaments; excludes plastic‑core and powered devices.
• Classification: Three product types - replacement heads for handles (Type 1), permanently affixed brush heads (Type 2), and stems that function as handles (Type 3).
• Brush size: Brush size is indexed by the passage hole diameter (minimum hole a brush head can pass through). Table 1 in the standard defines brush‑size ranges.
• Performance tests (Clause 7): Standardised test methods include visual inspection, passage hole diameter measurement, filament retention, stem retention force, and stem durability. The document specifies sampling and pass/fail criteria for these tests.
• Sampling: The revised edition specifies the number of test samples to be used in evaluation.
• Accompanying information: Manufacturer’s instructions for use, required labelling on the package, and packaging requirements to ensure product safety and correct user guidance.

Applications and who uses it

• Manufacturers of interdental brushes use EN ISO 16409:2016 to design, validate and quality‑control products so they meet recognised performance and safety criteria.
• Test laboratories and quality assurance teams apply the standard test methods to verify filament retention, stem durability, and size conformity.
• Regulatory and procurement bodies use the standard as a benchmark for product acceptance and market conformity in CEN member countries.
• Dental professionals and hygiene product specifiers rely on the standard to select suitable interdental brushes for clinical recommendations and patient guidance.

Related standards

• ISO 1942 (Dentistry - Vocabulary) is normatively referenced for terminology.
• Adopted by CEN as EN ISO 16409:2016 for harmonised use across European national standards bodies.

Keywords: EN ISO 16409:2016, manual interdental brushes, interdental brush, oral care products, dentistry standard, test methods, brush size, filament retention, stem durability, labelling.

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2017
1DGRPHãþD
SIST EN ISO 16409:2006
SIST EN ISO 16409:2006/A1:2010
=RER]GUDYVWYR,]GHONL]DXVWQRKLJLHQR5RþQHLQWHUGHQWDOQHãþHWNH,62

Dentistry - Oral care products - Manual interdental brushes (ISO 16409:2016)
Zahnheilkunde - Mundhygieneprodukte - Manuelle Interdentalbürsten (ISO 16409:2016)
Médecine bucco-dentaire - Produits de soins bucco-dentaires - Brosses interdentaires
manuelles (ISO 16409:2016)
Ta slovenski standard je istoveten z: EN ISO 16409:2016
ICS:
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
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 16409
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2016
EUROPÄISCHE NORM
ICS 97.170 Supersedes EN ISO 16409:2006
English Version
Dentistry - Oral care products - Manual interdental
brushes (ISO 16409:2016)
Médecine bucco-dentaire - Produits de soins bucco- Zahnheilkunde - Mundhygieneprodukte - Manuelle
dentaires - Brosses interdentaires manuelles (ISO Interdentalbürsten (ISO 16409:2016)
16409:2016)
This European Standard was approved by CEN on 14 August 2016.

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, Former Yugoslav Republic of Macedonia, 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

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16409:2016 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 16409:2016) 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 May 2017, and conflicting national standards shall be
withdrawn at the latest by May 2017.
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 16409:2006.
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, Former Yugoslav Republic of Macedonia,
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 16409:2016 has been approved by CEN as EN ISO 16409:2016 without any modification.

INTERNATIONAL ISO
STANDARD 16409
Second edition
2016-10-15
Dentistry — Oral care products —
Manual interdental brushes
Médecine bucco-dentaire — Produits de soins bucco-dentaires —
Brosses interdentaires manuelles
Reference number
ISO 16409:2016(E)
©
ISO 2016
ISO 16409:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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.
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ii © ISO 2016 – All rights reserved

ISO 16409:2016(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 . 3
7.4.1 Apparatus . 3
7.4.2 Procedure . 4
7.4.3 Evaluation . 5
7.5 Filament retention . 6
7.5.1 Apparatus . 6
7.5.2 Procedure . 6
7.5.3 Evaluation . 6
7.6 Stem retention . 6
7.6.1 Apparatus . 6
7.6.2 Procedure . 7
7.6.3 Evaluation . 8
7.7 Stem durability. 8
7.7.1 Apparatus . 8
7.7.2 Procedure .10
7.7.3 Evaluation .11
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 .12
ISO 16409:2016(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 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 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 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: Foreword - Supplementary information.
The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care
products.
This second edition cancels an
...