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
- Status
- Withdrawn
- Publication Date
- 30-Sep-2006
- Withdrawal Date
- 13-Apr-2025
- Technical Committee
- CEN/TC 55 - Dentistry
- Drafting Committee
- CEN/TC 55 - Dentistry
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 30-Nov-2016
- Completion Date
- 14-Apr-2025
Relations
- Replaced By
EN ISO 16409:2016 - Dentistry - Oral care products - Manual interdental brushes (ISO 16409:2016) - Effective Date
- 07-Dec-2016
- Effective Date
- 08-Jun-2022
Frequently Asked Questions
EN ISO 16409:2006 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Oral hygiene products - Manual interdental brushes (ISO 16409:2006)". This standard covers: 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.
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.
EN ISO 16409:2006 is classified under the following ICS (International Classification for Standards) categories: 97.170 - Body care equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 16409:2006 has the following relationships with other standards: It is inter standard links to EN ISO 16409:2016, EN ISO 16409:2006/A1:2010. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN ISO 16409:2006 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
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)
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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
...
La norme EN ISO 16409:2006 est un document fondamental pour le domaine de l'hygiène bucco-dentaire, car elle établit des critères de performance précis pour les brosses interdentaires manuelles à section transversale ronde. Son cadre couvre non seulement les exigences techniques de conception et de performance de ces produits, mais également les méthodes d'essai pour vérifier leur efficacité. Parmi les points forts de cette norme, on trouve des spécifications claires concernant les instructions d'utilisation fournies par le fabricant, ainsi que les exigences d'étiquetage de l'emballage. Cela garantit que les consommateurs sont bien informés de la manière d'utiliser ces brosses interdentaires manuelles de manière optimale, contribuant ainsi à une meilleure santé bucco-dentaire. Il est à noter que la norme ne s'applique pas aux brosses interdentaires motorisées, aux brosses à dents manuelles, ni aux produits tels que le fil dentaire, les bandes ou les cordes. Cette restriction est pertinente car elle permet de concentrer l'effort normatif sur un type de produit spécifique, assurant ainsi une harmonisation et une standardisation adaptées au marché des brosses interdentaires manuelles. La pertinence de la norme EN ISO 16409:2006 réside dans son rôle essentiel pour les fabricants et les consommateurs, fournissant un cadre fiable pour la qualité et l'efficacité des brosses interdentaires. En intégrant des critères de performance rigoureux, cette norme favorise d'excellentes pratiques d'hygiène bucco-dentaire, ce qui est un aspect crucial pour la prévention des maladies dentaires.
SIST EN ISO 16409:2006は、手動のインターデンタルブラシに関する標準化文書であり、特にその性能基準と試験方法を規定しています。この標準は、ブラシヘッドの断面が円形である手動インターデンタルブラシに特化しており、明確な要件を提供することで、製品の品質確保に寄与しています。 この標準の強みは、性能基準が詳細に記載されていることです。これにより、製造者は製品を設計する際の指針を得ることができ、消費者に対しても信頼性の高い製品が提供されることが保証されます。また、製品に関する情報、例えば使用方法の説明や包装に関するラベリングのガイドラインが定められているため、ユーザーが正しく理解し、適切に使用できるよう配慮されています。 さらに、ISO 16409:2006は、手動インターデンタルブラシに特化しているため、他の製品、例えば電動インターデンタルブラシや手動歯ブラシ、デンタルフロス、テープ、ストリング、フィラメントを含まないインターデンタルクリーナーには適用されません。この明確な範囲設定は、歯科関連製品の使用者にとって、適切な選択を行う際の重要な指針となっています。 このように、SIST EN ISO 16409:2006は、手動インターデンタルブラシの設計、製造、及び使用において大変重要な役割を果たしており、その実用性と関連性において、高い評価を受けています。
SIST EN ISO 16409:2006 표준은 수동 치간 브러시의 성능 기준을 규정하는 중요한 문서로, 치과 분야에서의 구강 위생 제품의 품질 보장을 위한 핵심 지침을 제공합니다. 본 표준은 원형 단면을 가진 수동 치간 브러시의 요구사항과 시험 방법을 명시하고 있습니다. 이 표준의 가장 큰 강점은 치간 브러시의 사용 성능을 평가하는 데 필요한 구체적이고 명확한 기준을 제공한다는 점입니다. 시험 방법의 규정은 제조업체들이 일관된 품질의 치간 브러시를 생산할 수 있도록 도와주며, 이는 소비자에게 신뢰할 수 있는 제품을 제공합니다. 또한, SIST EN ISO 16409:2006은 제조업체의 사용 지침과 포장 라벨링에 대한 정보도 함께 규정하고 있어, 최종 사용자에게 올바른 제품 사용법을 안내합니다. 이는 사용자의 안전과 제품 사용성을 증대시키는 데 기여합니다. 한편, ISO 16409:2006은 전동 치간 브러시, 수동 칫솔, 치실, 테이프 및 끈과 같은 다른 구강 위생 제품에는 적용되지 않으며, 이는 본 표준이 특정 제품 범위에만 국한되어 있음을 명확히 하고 있습니다. 이러한 특화된 범위 설정은 관련 제품의 시장의 혼란을 줄이고, 품질 관리에 있어 더욱 명확한 기준을 제공합니다. 결론적으로, SIST EN ISO 16409:2006는 수동 치간 브러시의 성능 기준을 체계적으로 정의함으로써 치과 구강 위생 제품의 품질 향상에 기여하고 있습니다. 이 표준은 제조업체와 소비자 모두에게 유용한 지침서로 작용하며, 구강 건강 증진에 중요성을 더하고 있습니다.
The EN ISO 16409:2006 standard establishes a comprehensive framework for the evaluation and performance of manual interdental brushes with a round cross-section. By specifying precise requirements and test methods, this standard ensures a high level of quality and effectiveness in oral hygiene products intended for cleaning between teeth, which is essential for maintaining optimal dental health. One of the key strengths of ISO 16409:2006 lies in its detailed approach to performance criteria. The standard outlines essential parameters that manufacturers must meet, providing a clear benchmark for the quality and effectiveness of manual interdental brushes. This level of standardization is crucial in enabling consumers and dental professionals to make informed choices, thus enhancing the overall efficacy of oral hygiene routines. Additionally, the standard places importance on the accompanying information, including the manufacturer's instructions for use and appropriate labelling on the packaging. This requirement is vital as it enhances user safety by ensuring that consumers are well-informed on how to properly utilize the products. By addressing both performance and user instructions, ISO 16409:2006 fosters a comprehensive understanding of manual interdental brushes, ensuring that end-users can achieve the best results from their oral hygiene efforts. Moreover, the standard's clear delineation of scope is significant; it explicitly states that ISO 16409:2006 is not applicable to powered interdental brushes, manual toothbrushes, dental floss, tapes, and strings, nor to interdental cleaners that lack filaments. This focused scope allows manufacturers and consumers alike to clearly understand the specific applications of the standard, thereby preventing potential misinterpretations and guiding innovation within the appropriate categories of oral hygiene products. In summary, EN ISO 16409:2006 is a pivotal standard that plays a critical role in the dental care sector by setting high-quality performance criteria for manual interdental brushes. Its strengths lie in its detailed requirements, informative guidance for consumers, and clear focus on relevant product types, making it a significant foundation for the development and marketing of effective oral hygiene products.
Die Norm EN ISO 16409:2006 legt umfassende Anforderungen und Testmethoden für die Leistungsmerkmale von manuellen Interdentalbürsten mit einem runden Querschnitt des Bürstenkopfes fest. Sie stellt sicher, dass diese Produkte den notwendigen Qualitätsstandards entsprechen und die Wirksamkeit bei der Mundhygiene garantieren. Ein herausragendes Merkmal dieser Norm ist die präzise Definition der Anforderungen, die eine konsistente Qualität der Interdentalbürsten ermöglichen. Die Norm sieht außerdem detaillierte Richtlinien zur Bereitstellung von Begleitinformationen vor, einschließlich der Anweisungen für die Verwendung durch den Hersteller sowie der Kennzeichnung der Verpackung. Diese Aspekte sind entscheidend, um den Verbrauchern klare und nützliche Informationen zu bieten, die die sichere und effektive Nutzung der Produkte unterstützen. Die Relevanz der EN ISO 16409:2006 ergibt sich aus dem wachsenden Bewusstsein für Mundhygiene und der zunehmenden Verbreitung von Interdentalbürsten als unverzichtbare Hilfsmittel zur Verbesserung der Zahnhygiene. Diese Norm trägt dazu bei, die Qualität und Sicherheit dieser Produkte zu gewährleisten und Verbraucher vor minderwertigen Angeboten zu schützen. Es ist wichtig zu betonen, dass die Norm nicht für elektrische Interdentalbürsten, manuelle Zahnbürsten, Zahnseide, -bänder und -schnüre oder Interdentalreiniger ohne Borsten gilt. Diese Differenzierung unterstreicht die spezialisierte Anwendung der EN ISO 16409:2006, die auf die Anforderungen an manuelle Interdentalbürsten fokussiert ist und damit den spezifischen Bedürfnissen der Nutzer Rechnung trägt. Insgesamt bietet die EN ISO 16409:2006 einen soliden Rahmen für die Qualitätssicherung und Verbesserung der Mundhygiene durch die Verwendung von Interdentalbürsten und ist somit eine bedeutende Ressource für Hersteller, Fachleute im Zahngesundheitswesen und Verbraucher.
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