EN 1642:2011
(Main)Dentistry - Medical devices for dentistry - Dental implants
Dentistry - Medical devices for dentistry - Dental implants
This European Standard specifies general requirements for dental implants and accessories. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641.
This European Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.
Zahnheilkunde - Medizinprodukte für die Zahnheilkunde - Dentalimplantate
Diese Europäische Norm legt allgemeine Anforderungen an Dentalimplantate fest. Chirurgische implantier¬bare zahnärztliche Werkstoffe, definiert als restaurative Werkstoffe, sind insbesondere ausgeschlossen und werden in EN 1641 beschrieben.
Diese Norm legt Anforderungen an die geplante Leistung, die Konstruktionsmerkmale, die Bestandteile, die Sterilisation, die Verpackung, die Kennzeichnung, die Etikettierung und die Informationen durch den Hersteller fest.
Médicine bucco-dentaire - Dispositifs médicaux pour la médicine bucco-dentaire - Implants dentaires
La présente Norme européenne établit les exigences générales relatives aux implants dentaires et accessoires. Les produits dentaires chirurgicalement implantables, qui relèvent de la définition des produits de restauration, sont spécifiquement exclus. Ils sont décrits dans l’EN 1641.
La présente Norme européenne établit les exigences relatives à la performance attendue, aux caractéristiques de conception, aux composants, à la stérilisation, à l’emballage, au marquage, à l’étiquetage ainsi qu’aux informations fournies par le fabricant.
Zobozdravstvo - Medicinski pripomočki za zobozdravstvo - Dentalni vsadki (implantati)
Ta evropski standard določa splošne zahteve za dentalne vsadke in pribor. Zobozdravstveni materiali za kirurško vsaditev, opredeljeni kot restavrativni materiali, so izrecno izključeni in so opisani v standardu EN 1641. Ta evropski standard vključuje zahteve za predvideno delovanje, lastnosti modela, sestavne dele, sterilizacijo, pakiranje, označevanje, uporabo nalepk in informacije, ki jih priskrbi proizvajalec.
General Information
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Overview
EN 1642:2011 - Dentistry - Medical devices for dentistry - Dental implants (CEN) is the European level‑2 standard that defines general requirements for dental implants and their accessories. It specifies expectations for intended performance, design attributes, components, sterilization, packaging, marking, labelling and the information a manufacturer must supply. Surgically implantable restorative materials are excluded and covered separately in EN 1641.
Key topics and technical requirements
- Scope and conformity: Applies to dental implants and accessories; manufacturers must demonstrate conformity with applicable subclauses.
- Risk management: Risk analysis and documented risk management are required in accordance with EN ISO 14971.
- Technical file: Contents must follow EN ISO 10451 and, where applicable, EN ISO 22794 / EN ISO 22803.
- Materials and biocompatibility: Materials chosen for intended purpose; biological testing guided by EN ISO 7405 and EN ISO 10993‑1 with attention to carcinogenic, mutagenic or reproduction‑toxic substances.
- Mechanical stability: Fatigue and mechanical stability testing per EN ISO 14801 for endosseous implants; orthodontic anchors require appropriate mechanical tests.
- Contamination control & sterilization:
- Sterile products must comply with EN 556‑1; sterilization processes validated and controlled (EN ISO 11135‑1 for EO, EN ISO 11137‑1 for radiation).
- Packaging validation per EN ISO 11607‑1 / ‑2 to maintain sterility; non‑sterile packaging must preserve cleanliness and indicate recommended sterilization method if required.
- Animal‑origin materials: Sourced and processed per applicable guidance (e.g., EN ISO 22442 references).
- Clinical investigation & evaluation: Clinical investigations per EN ISO 14155‑1/‑2 unless reliance on justified existing clinical data; a clinical evaluation report is required.
- Marking, labelling & instructions for use:
- Minimum label elements: manufacturer name/address, device description (name/size/material), sterile status and method, LOT/SN, use‑by (ISO 8601), single‑use indication, storage/handling, warnings.
- Use of symbols per EN 980; IFU may be provided electronically where appropriate.
Applications and users
EN 1642:2011 is primarily used by:
- Dental implant manufacturers for product design, technical documentation and regulatory compliance.
- Regulatory affairs and quality teams preparing CE marking dossiers under EU Directive 93/42/EEC.
- Notified bodies and conformity assessors evaluating compliance.
- Test laboratories performing biocompatibility, sterilization validation and mechanical fatigue testing.
- Clinicians and procurement specialists who require compliant product information, labelling and IFU.
Related standards (normative references)
Notable referenced standards include EN ISO 14971 (risk management), EN ISO 7405 / EN ISO 10993‑1 (biocompatibility), EN ISO 14801 (fatigue testing), EN ISO 11135‑1 / EN ISO 11137‑1 (sterilization), EN ISO 11607‑1/‑2 (sterile packaging), EN ISO 14155 (clinical investigation) and EN 1041 / EN 980 (labelling/symbols). EN 1641 covers surgically implantable restorative materials.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.LPSODQWDWLZahnheilkunde - Medizinprodukte für die Zahnheilkunde - DentalimplantateMédecine bucco-dentaire - Dispositifs médicaux pour la médecine bucco-dentaire - Implants dentairesDentistry - Medical devices for dentistry - Dental implants11.060.15Zobni implantatiDental implantsICS:Ta slovenski standard je istoveten z:EN 1642:2011SIST EN 1642:2012en,fr,de01-januar-2012SIST EN 1642:2012SLOVENSKI
STANDARDSIST EN 1642:20101DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1642
October 2011 ICS 11.060.15 Supersedes EN 1642:2009English Version
Dentistry - Medical devices for dentistry - Dental implants
Médicine bucco-dentaire - Dispositifs médicaux pour la médicine bucco-dentaire - Implants dentaires
Zahnheilkunde - Medizinprodukte für die Zahnheilkunde - Dentalimplantate This European Standard was approved by CEN on 20 September 2011.
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 and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1642:2011: ESIST EN 1642:2012
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 10Bibliography . 11 SIST EN 1642:2012
EN ISO 11137-1, EN ISO 11607-1, EN ISO 11607-2, EN ISO 14801, EN ISO 14971, EN ISO 22794,
EN ISO 22803; 2) deletion of the following withdrawn standards: EN 550, EN 552, EN ISO 14727; b) 4.5 Clinical evaluation: clarification of requirement for a clinical evaluation; c) 4.6.4 Instructions for use: clarification of requirement that information may be provided in an electronic format; d) Annex ZA: actualisation of the annex. 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 and United Kingdom.
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Frequently Asked Questions
EN 1642:2011 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Medical devices for dentistry - Dental implants". This standard covers: This European Standard specifies general requirements for dental implants and accessories. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641. This European Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.
This European Standard specifies general requirements for dental implants and accessories. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641. This European Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.
EN 1642:2011 is classified under the following ICS (International Classification for Standards) categories: 11.060.15 - Dental implants. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 1642:2011 has the following relationships with other standards: It is inter standard links to EN 1642:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1642:2011 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN 1642:2011 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.
SIST EN 1642:2012 문서는 치과용 임플란트 및 관련 장치에 대한 유럽 표준으로, 치과 분야에서의 의료 기기 표준화의 중요한 기준을 제공합니다. 이 문서의 범위는 치과 임플란트와 그 액세서리의 일반 요구 사항을 명확히 규정하고 있으며, 임플란트 성능을 보장하는 데 필요한 필수 요소들을 포괄적으로 다룹니다. 강점으로는, SIST EN 1642:2012가 치과 임플란트의 설계 특성, 구성 요소, 멸균, 포장, 마킹, 라벨링 및 제조자가 제공하는 정보에 대한 요구 사항을 상세히 기술하고 있다는 점입니다. 이러한 명확한 요구 사항은 제조업체가 고품질의 안전한 임플란트를 생산하도록 유도하며, 환자의 안전을 최우선으로 고려합니다. 또한, 이 표준은 기존의 EN 1641에서 명시된 수복 재료와는 다른 영역에서 작용하여, 임플란트에 관한 세부적이고 전문적인 가이드라인을 제공합니다. 이는 임플란트의 기대 성능을 충족시키기 위한 설계 개발 과정에서 필수적인 자료로 작용할 수 있습니다. 최신 연구와 기술 발전을 반영하여, SIST EN 1642:2012는 치과 수술에 필요한 다양한 장치와 관련 사항을 포괄적으로 정리하고 있어, 실무에 직접 적용 가능한 유용한 문서로 자리 잡고 있습니다. 이러한 내용들은 치과 의료 기기의 품질 향상과 함께 산업 전반의 신뢰성 증대에 기여하고 있습니다.
Die Norm EN 1642:2011 legt die allgemeinen Anforderungen für Zahnimplantate und deren Zubehör fest und bietet somit einen umfassenden Rahmen für die Entwicklung und Bewertung von zahnmedizinischen Medizinprodukten. Ein wesentlicher Bestandteil dieser Norm ist die klare Abgrenzung zu chirurgisch implantierbaren dentalen Materialien, die als restaurative Materialien definiert sind und in der Norm EN 1641 behandelt werden. Ein herausragendes Merkmal der EN 1642:2011 ist die detaillierte Anforderung an die beabsichtigte Leistung der dentalen Implantate. Diese Anforderungen sorgen dafür, dass die Produkte nicht nur sicher, sondern auch effektiv in der Anwendung sind. Zudem werden spezifische Designattribute und Komponenten berücksichtigt, die für die Langlebigkeit und Funktionalität der Implantate von entscheidender Bedeutung sind. Des Weiteren erhebt die Norm klare Vorgaben zur Sterilisation, Verpackung, Kennzeichnung und Kennzeichnung, was die Rückverfolgbarkeit und Sicherheit für den Endverbraucher erhöht. Durch die Anforderung an die vom Hersteller bereitgestellten Informationen wird sichergestellt, dass Zahnärzte und Patienten umfassend über die Eigenschaften und den sicheren Gebrauch der Implantate informiert sind. Die Relevanz der EN 1642:2011 ist im Kontext des sich ständig weiterentwickelnden zahnmedizinischen Marktes und der steigenden Anforderungen an die Qualität von Medizinprodukten nicht zu unterschätzen. Diese Norm schafft Vertrauen und Sicherheit in die Verfahren und Produkte der Zahnmedizin, unterstützt die Innovationsfähigkeit und gewährleistet die Übereinstimmung mit den europäischen Richtlinien. Die klare Struktur und die umfangreichen Anforderungen dieser Norm machen sie zu einem unverzichtbaren Dokument für Hersteller von Zahnimplantaten und damit auch für die dentalen Fachkräfte, die diese Produkte verwenden.
La norme EN 1642:2011 est un texte fondamental dans le domaine de la dentisterie, car elle précise les exigences générales relatives aux implants dentaires et à leurs accessoires. Son champ d'application est surtout pertinent pour les professionnels de la santé dentaire et les fabricants, car il établit des critères clairs pour la performance élaborée, les attributs de conception, ainsi que pour la stérilisation, l'emballage, le marquage et l'étiquetage des dispositifs médicaux dentaires. Les points forts de cette norme incluent son approche exhaustive qui garantit non seulement la sécurité des patients, mais également la qualité des produits fournis sur le marché. En créant un cadre pour les exigences de performance et de conception des implants dentaires, la norme EN 1642:2011 permet d'assurer que seul du matériel de haute qualité est utilisé lors des interventions chirurgicales. Cela a des répercussions positives sur l’efficacité des traitements et la satisfaction des patients. La norme est particulièrement pertinente à l'heure actuelle, compte tenu de l'importance croissante des implants dentaires dans les pratiques cliniques modernes. En fournissant une directive sur les informations à remettre par le fabricant, elle renforce la transparence et la confiance au sein de l'industrie dentaire. En outre, la distinction faite entre les implants dentaires et les matériaux de restauration, qui sont abordés dans la norme EN 1641, témoigne de la précision et de l'attention portée à différents types de dispositifs médicaux. En résumé, la norme EN 1642:2011 se positionne comme un outil essentiel pour garantir la qualité et la sécurité des implants dentaires, ce qui en fait un document indispensable pour tous les acteurs du secteur dentaire.
The EN 1642:2011 standard provides a comprehensive framework for the requirements of dental implants and their accessories, making it a crucial reference point within the dentistry sector. Its scope explicitly delineates the general requirements applicable to dental implants, clearly noting that surgically implantable restorative materials are categorized separately under EN 1641. This distinction is significant, as it allows for a focused approach to the regulation and standardization of dental implants, reducing ambiguity in compliance and quality assurance. One of the notable strengths of this standard is its thorough approach to intended performance, ensuring that dental implants not only meet the necessary safety and efficacy criteria but also contribute positively to patient outcomes. The inclusion of detailed design attributes promotes innovation while safeguarding the performance standards expected in dental care. Moreover, the standard addresses essential components associated with dental implants, including requirements for sterilization, packaging, marking, and labeling. This comprehensive consideration ensures that products are not only safe for use but are also presented in a manner that facilitates proper use and understanding by both dental professionals and patients. Furthermore, the obligations regarding information supplied by the manufacturer enhance transparency and trust in the dental implant market, allowing practitioners to make informed decisions based on reliable data. The focus on clear labeling and comprehensive information is pivotal in supporting safe clinical practices and patient safety. In conclusion, EN 1642:2011 is highly relevant and impactful within the field of dentistry, providing well-defined requirements that enhance product quality, safety, and efficacy of dental implants, ultimately benefiting both practitioners and patients alike. Its detailed nature and focus on key elements of dental implants establish it as a standard of excellence in the industry.
EN 1642:2011は、歯科用インプラント及びその付属品に関するヨーロッパの標準であり、業界の品質向上を目的とした包括的なガイドラインを提供しています。この標準は、歯科領域における医療機器としての歯科インプラントの一般要件を規定しており、特に性能、設計特性、構成要素、滅菌、包装、マーキング、ラベリング及び製造者によって提供される情報に関する要件が含まれています。 EN 1642:2011の強みは、その詳細で包括的な要件にあり、歯科インプラントの安全性と効果を保証するための基盤を提供しています。特に、設計属性や性能の意図に関する規定は、インプラントの使用における成功率を高める重要な要素となります。また、滅菌や包装に関するガイドラインは、患者の安全性を確保するための必須条件です。 さらに、この標準は歯科医療における品質管理の重要性を強調しており、関連する法規制への適合も迫る内容となっています。EN 1642:2011は、歯科インプラントの設計および製造プロセスに不可欠な基準を提供することで、業界全体の信頼性を向上させる役割を果たしています。したがって、歯科医療分野においてEN 1642:2011は極めて関連性の高い標準と言えるでしょう。
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