SIST EN 1642:2012
(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.
Médecine bucco-dentaire - Dispositifs médicaux pour la médecine 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
Relations
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.
Frequently Asked Questions
SIST EN 1642:2012 is a standard published by the Slovenian Institute for Standardization (SIST). 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.
SIST EN 1642:2012 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.
SIST EN 1642:2012 has the following relationships with other standards: It is inter standard links to SIST EN 1642:2010. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 1642:2012 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.
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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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The SIST EN 1642:2012 standard provides a comprehensive framework for dental implants and their accessories, addressing a critical area in the field of dentistry. This European Standard is instrumental in specifying general requirements that ensure the safety, efficacy, and quality of dental implants. The scope of the standard explicitly focuses on surgically implantable devices, while delineating the boundaries by stating that restorative materials, as defined in EN 1641, are excluded from its purview. One of the significant strengths of the SIST EN 1642:2012 standard lies in its detailed requirements pertaining to various aspects of dental implants. It encompasses intended performance metrics, which are crucial in assessing the functionality of dental implants in clinical settings. Additionally, the specification of design attributes ensures that manufacturers adhere to best practices, promoting innovation while maintaining patient safety. The standard provides clear guidelines concerning components, emphasizing that each element of an implant system undergoes rigorous scrutiny to meet established safety standards. Furthermore, it addresses critical factors such as sterilization and packaging, which are indispensable for controlling infection risks in dental procedures. The inclusion of requirements for marking and labelling ensures that information is readily available to both practitioners and patients, thereby fostering informed decision-making. Additionally, the SIST EN 1642:2012 standard emphasizes the importance of information supplied by the manufacturer, which is vital in ensuring proper usage and care of dental implants. This aspect strengthens the communication between dental professionals and patients, promoting transparency and trust in dental treatments. Overall, the SIST EN 1642:2012 standard stands as a vital reference in dentistry, aligning with regulatory expectations and enhancing the reliability of dental implants and their associated accessories. Its emphasis on performance, safety, and comprehensive manufacturer guidelines makes it a cornerstone document in the healthcare landscape where dental implants are concerned.
Die SIST EN 1642:2012 ist ein bedeutendes europäisches Dokument, das spezifische Anforderungen für Zahnimplantate und Zubehör festlegt. Der Fokus dieser Norm liegt auf den allgemeinen Anforderungen, die für die Sicherheit und Wirksamkeit der zahnmedizinischen Geräte von entscheidender Bedeutung sind. Ein herausragendes Merkmal dieser Norm ist die klare Abgrenzung zu chirurgisch implantierbaren zahnmedizinischen Materialien, die als restaurative Materialien definiert sind und in der EN 1641 behandelt werden. Die Norm ist umfassend und deckt verschiedene Aspekte ab, die für die Herstellung und den Einsatz von Zahnimplantaten relevant sind. Dazu gehören die angestrebte Leistung, die Designmerkmale, die einzelnen Komponenten, die Sterilisation, die Verpackung sowie die Kennzeichnung und die bereitgestellten Informationen des Herstellers. Diese umfassende Herangehensweise sorgt dafür, dass Zahnarztpraxen und Labore über alle notwendigen Informationen verfügen, um die Qualität und Sicherheit der Implantate zu gewährleisten. Ein anderer wesentlicher Vorteil der SIST EN 1642:2012 ist ihre Relevanz in der zahnärztlichen Praxis. Mit dem wachsenden Einsatz von Zahnimplantaten im Bereich der Zahnmedizin unterstützt diese Norm die Schaffung eines einheitlichen Standards, der die Qualität und Zuverlässigkeit der Produkte fördert. Durch die klare Definition der Anforderungen trägt die Norm dazu bei, das Vertrauen der Patienten in zahnmedizinische Behandlungen zu stärken und die Risiken zu minimieren. Insgesamt bietet die SIST EN 1642:2012 eine solide Grundlage für die Entwicklung, Herstellung und Anwendung von Zahnimplantaten, was sie zu einem essenziellen Dokument für Fachleute im Bereich der Zahnmedizin macht. Die Norm stellt sicher, dass alle Produkte, die auf dem Markt angeboten werden, den hohen Standards von Sicherheit und Leistung entsprechen.
La norme SIST EN 1642:2012 est une référence cruciale dans le domaine de la dentisterie, spécifiquement en ce qui concerne les dispositifs médicaux pour les implants dentaires. Son champ d'application est clairement défini et se concentre sur les exigences générales relatives aux implants dentaires et leurs accessoires. L'un des points forts de cette norme est son attention portée aux exigences de performance attendue pour les implants dentaires. Elle établit des critères rigoureux qui doivent être respectés pour garantir la sécurité et l'efficacité des dispositifs recherchés par les professionnels de la santé dentaire. Cela témoigne d'une volonté d'assurer un haut niveau de qualité dans le secteur dentaire. Un autre aspect important de la norme est l'inclusion de spécifications sur les attributs de conception et les composants des implants dentaires. Cela permet aux fabricants de suivre des directives précises tout en concevant des produits innovants, répondant aux besoins variés des patients. De plus, le traitement des exigences de stérilisation, d'emballage, de marquage et d'étiquetage est essentiel pour garantir que les produits sont non seulement sûrs à utiliser, mais également conformes aux normes réglementaires en vigueur. La norme SIST EN 1642:2012 est particulièrement pertinente pour les fabricants et les professionnels de la santé dentaire, car elle facilite la communication des informations nécessaires à la bonne compréhension des produits. En fournissant des directives claires sur les informations à fournir par le fabricant, elle assure que les utilisateurs sont dûment informés des spécifications et de l'utilisation appropriée des implants dentaires. En résumé, la norme SIST EN 1642:2012 s’affirme comme un document fondamental, consolidant la sécurité, la performance et la réglementation dans le domaine des implants dentaires, ce qui en fait un outil indispensable pour les acteurs du secteur dentaire.
SIST EN 1642:2012는 치과 의료기기를 위한 유럽 표준으로, 치과 임플란트 및 부속품에 대한 일반 요구사항을 규정하고 있습니다. 이 표준은 치과 임플란트의 성능, 설계 속성, 구성 요소, 멸균, 포장, 마킹, 라벨링 및 제조업체가 제공하는 정보에 대한 요구사항을 포함하고 있습니다. 이러한 내용을 통해 SIST EN 1642:2012는 안전하고 효과적인 치과 임플란트를 보장하기 위한 기초를 제공합니다. 이 표준의 강점은 치과 임플란트에 대한 명확한 지침을 제공함으로써 의료기기 개발자 및 제조업체가 품질 높은 제품을 설계하고 생산할 수 있도록 지원한다는 것입니다. 또한, SIST EN 1642:2012는 임플란트의 안전성과 효율성을 높이기 위한 성능 요구사항을 명시하고 있어, 사용자에게 신뢰성을 제공합니다. 특히, 임플란트와 그 부속품의 모든 단계에 대해 체계적인 접근을 시도하며, 멸균 및 포장에 관한 명확한 기준을 설정함으로써 제품의 안전성을 더욱 강화하고 있습니다. 이는 치과 분야에서의 환자 안전을 최우선으로 하는 데 중요한 역할을 합니다. SIST EN 1642:2012는 치과 분야의 최신 기준을 반영하고 있으며, 치과 임플란트 제품을 규정하는 데 매우 중요한 표준으로 자리 잡고 있습니다. 따라서 치과 의료기기 분야에서의 전문성과 신뢰성을 담보하기 위해 이 표준을 준수하는 것은 필수적입니다.
SIST EN 1642:2012は歯科医療における医療機器、特に歯科インプラントに関する欧州標準であり、その範囲は非常に広範です。この標準は、歯科インプラントとそのアクセサリーに対する一般的な要件を明確に規定しています。特に、修復材料として定義される外科的に植込み可能な歯科材料は除外されており、これがEN 1641にて詳述されています。 この標準の強みは、インプラントの意図された性能や設計属性、構成部品、滅菌、包装、マーキング、ラベリング、および製造者から提供される情報など、多くの重要な要件を包含している点です。これにより、歯科インプラントに関連する製品が高い品質を維持し、患者や医療提供者に安心感を与えることができます。 さらに、SIST EN 1642:2012は、歯科インプラントの設計と製造における国際的なコンプライアンスを促進し、各国での市場アクセスを容易にする役割も果たします。この標準の適用は、革新的な医療技術の発展を支えるだけでなく、患者の安全性を高めるためにも重要です。 このように、SIST EN 1642:2012は歯科インプラントにおける医療機器の品質保証と信頼性向上に寄与する重要な基準であり、歯科医療の現場での適用が期待されます。
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