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
- Status
- Published
- Publication Date
- 14-Dec-2011
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 21-Oct-2011
- Due Date
- 26-Dec-2011
- Completion Date
- 15-Dec-2011
Relations
- Effective Date
- 01-Jan-2012
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.
SIST EN 1642:2012 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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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