EN 1641:2009
(Main)Dentistry - Medical devices for dentistry - Materials
Dentistry - Medical devices for dentistry - Materials
This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices. For the purposes of this standard these materials are defined as restorative materials. Dental implants are specifically excluded and described in EN 1642. This standard also specifies general requirements for materials used in the practice of orthodontics. This standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.
Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.
Zahnheilkunde - Medizinprodukte für die Zahnheilkunde - Werkstoffe
Diese Europäische Norm legt allgemeine Anforderungen an die Werkstoffe fest, die in der Zahn-, Mund- und Kieferheilkunde für die Wiederherstellung der Form und Funktion der Zähne verwendet werden und die Medi-zinprodukte sind. Für die Anwendung dieser Norm werden diese Werkstoffe als restaurative und kieferorthopädische Werkstoffe bezeichnet. Dentalimplantate sind ausdrücklich ausgeschlossen und werden in EN 1642 beschrieben. Diese Norm enthält auch allgemeine Anforderungen an Werkstoffe, die in der Kieferorthopädie verwendet werden. Diese Norm legt Anforderungen an die geplante Leistung, die Konstruktionsmerkmale, die Bestandteile, die Sterilisation, die Verpackung, die Kennzeichnung, die Etikettierung und an die vom Hersteller bereitzu¬stellenden Informationen fest.
Für Prüfungen, die die Konformität mit dieser Norm nachweisen, gelten die entsprechenden Normen der Ebene 3, falls anwendbar.
Art dentaire - Dispositifs médicaux pour l'art dentaire - Produits
La présente Norme européenne établit les exigences générales relatives aux produits utilisés dans la pratique de l’art dentaire pour la restauration morphologique et fonctionnelle de la denture et qui sont des dispositifs médicaux. Pour les besoins de la présente norme, ces produits sont définis comme des produits de restauration et d’orthodontie. Les implants dentaires sont exclus du domaine d’application de cette norme et décrits dans l’EN 1642. La présente norme spécifie également les exigences générales relatives aux produits utilisés dans les pratiques orthodontiques. La présente norme comporte également 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.
Les essais prouvant la conformité à la présente norme sont décrits, le cas échéant, dans les normes de niveau 3.
Zobozdravstvo - Medicinski pripomočki za zobozdravstvo - Materiali
Ta evropski standard določa splošne zahteve za materiale, ki se uporabljajo v zobozdravstveni praksi za obnavljanje oblike in funkcije zob in so medicinski pripomočki. Za namene tega standarda se ti materiali opredelijo kot restavrativni in ortodontski materiali. Dentalni vsadki so izrecno izključeni in so opisani v standardu EN 1642. Ta standard določa tudi splošne zahteve za materiale, ki se uporabljajo v ortodontski praksi. Ta standard vključuje zahteve za predvideno delovanje, lastnosti modela, sestavne dele, sterilizacijo, pakiranje, označevanje, uporabo nalepk in informacije, ki jih priskrbi proizvajalec. Preskusi za dokazovanje skladnosti s tem standardom so navedeni v standardih 3. ravni, če je to primerno.
General Information
- Status
- Published
- Publication Date
- 27-Oct-2009
- Withdrawal Date
- 29-Apr-2010
- Technical Committee
- CEN/TC 55 - Dentistry
- Drafting Committee
- CEN/TC 55/WG 7 - Steering Committee
- Current Stage
- 9093 - Decision to confirm - Review Enquiry
- Start Date
- 22-May-2024
- Completion Date
- 11-Feb-2026
- Directive
- Not Harmonized93/42/EEC - Medical devicesOJ Ref: C, C 183 OJ Date: 07-Jul-2010
Relations
- Effective Date
- 08-Jun-2022
- Effective Date
- 29-Apr-2026
- Effective Date
- 28-Jan-2026
- Refers
EN ISO 10271:2020 - Dentistry - Corrosion test methods for metallic materials (ISO 10271:2020) - Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Refers
EN ISO 21606:2022 - Dentistry - Elastomeric auxiliaries for use in orthodontics (ISO 21606:2022) - Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
Overview
EN 1641:2009 - Dentistry – Medical devices for dentistry – Materials is a European Standard developed by CEN specifying fundamental requirements for materials intended for use as restorative and orthodontic medical devices in dental practice. Covering aspects such as performance, safety, design, marking, labelling, sterilization, packaging, and information for use, EN 1641:2009 is a core standard ensuring the quality and regulatory compliance of materials utilized to restore or maintain the form and function of dentition. Importantly, dental implants are outside the scope of this standard and are covered by EN 1642.
Key Topics
General Requirements
EN 1641:2009 applies to dental materials defined as restorative (restoring the form and function of teeth) and orthodontic (used in orthodontic treatments). The standard ensures these materials meet the necessary criteria for their intended use.Chemical and Physical Properties
- Materials must comply with relevant composition standards.
- The standard emphasizes the importance of biocompatibility and mandates assessment for potential health risks, including toxicity and allergenicity.
Risk Management
Conformity with EN ISO 14971 is required, which involves risk analysis and documentation to minimize hazards associated with dental materials.Control of Contamination
- Design and manufacturing must prioritize minimal contamination.
- Packaging for non-sterile materials should maintain cleanliness throughout transport and storage.
Performance and Clinical Evaluation
Clinical evaluation is mandatory to demonstrate the safety and effectiveness of restorative and orthodontic materials. Procedures must align with relevant clinical investigation standards.Marking, Labelling, and Manufacturer Information
- Detailed labelling requirements ensure traceability, correct usage, and handling by dental professionals.
- Information may be provided in electronic format when appropriate, making it accessible and up-to-date.
Applications
EN 1641:2009 provides essential guidance and requirements for:
Dental Manufacturers and Suppliers
Assists industry professionals in ensuring their products meet European regulatory standards and are suitable for market release.Regulatory Compliance and Market Access
Enables products to presume conformity to the EU Medical Devices Directive (93/42/EEC), facilitating CE marking and access to European markets.Dental Clinics and Laboratories
Assures dental professionals and laboratories that the materials used for restorative or orthodontic purposes are safe, compliant, and supported by documented performance and clinical evidence.Quality Assurance and Procurement
Provides benchmarks for evaluating, selecting, and auditing dental materials for clinical use, helping reduce risks and improve patient outcomes.
Related Standards
For comprehensive quality and regulatory coverage in dental materials and medical devices, EN 1641:2009 should be utilized alongside:
EN 1642 - Dentistry - Medical devices for dentistry - Dental implants
(for standards related to dental implants)EN ISO 14971 - Medical devices - Application of risk management
(risk management procedures for medical devices)EN 980 - Symbols for use in the labelling of medical devices
EN 1041 - Information supplied by manufacturers of medical devices
EN ISO 10993-1 and EN ISO 7405 - Biocompatibility evaluation of medical devices in dentistry
Standards specifying materials for particular dental applications, e.g. EN ISO 4049 (polymer-based restorative materials), EN ISO 9917-1 (water-based cements), EN ISO 22674 (metallic materials for restorations).
Adopting EN 1641:2009 supports dental product quality, safety, and compliance, reinforcing confidence in dental materials throughout Europe.
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Frequently Asked Questions
EN 1641:2009 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Medical devices for dentistry - Materials". This standard covers: This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices. For the purposes of this standard these materials are defined as restorative materials. Dental implants are specifically excluded and described in EN 1642. This standard also specifies general requirements for materials used in the practice of orthodontics. This standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer. Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.
This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices. For the purposes of this standard these materials are defined as restorative materials. Dental implants are specifically excluded and described in EN 1642. This standard also specifies general requirements for materials used in the practice of orthodontics. This standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer. Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.
EN 1641:2009 is classified under the following ICS (International Classification for Standards) categories: 11.060.10 - Dental materials. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 1641:2009 has the following relationships with other standards: It is inter standard links to EN 1641:2004, EN ISO 14155:2026, EN ISO 9333:2022, EN ISO 10271:2020, EN ISO 6874:2015, EN ISO 22674:2022, EN ISO 7405:2025, EN ISO 15841:2014, EN ISO 4823:2025, EN ISO 6873:2013, EN 1090-5:2017, EN ISO 9917-1:2025, EN ISO 21606:2022, EN ISO 6876:2025, EN 21942-1:1991. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1641:2009 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.
EN 1641:2009 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.LZahnheilkunde - Medizinprodukte für die Zahnheilkunde - WerkstoffeArt dentaire - Dispositifs médicaux pour l'art dentaire - ProduitsDentistry - Medical devices for dentistry - Materials11.060.10Dental materialsICS:Ta slovenski standard je istoveten z:EN 1641:2009SIST EN 1641:2010en,fr,de01-januar-2010SIST EN 1641:2010SLOVENSKI
STANDARDSIST EN 1641:20051DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1641
October 2009 ICS 11.060.10 Supersedes EN 1641:2004English Version
Dentistry - Medical devices for dentistry - Materials
Art dentaire - Dispositifs médicaux pour l'art dentaire - Produits
Zahnheilkunde - Medizinprodukte für die Zahnheilkunde - Werkstoffe This European Standard was approved by CEN on 19 September 2009.
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 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 Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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 © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1641:2009: ESIST EN 1641:2010
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 10Bibliography . 11
1) Addition of new relevant product standards, issued after 2004: EN ISO 3107, EN ISO 9333,
EN ISO 9917-1, EN ISO 10139-1, EN ISO 14971, EN ISO 15841, EN ISO 15854, EN ISO 21606,
EN ISO 22112, EN ISO 22674, EN ISO 24234. 2) Deletion of the following withdrawn standards: EN 21560, EN 23107, EN 26874, EN 29333, EN 29917,
EN 30139-1, EN ISO 1559, EN ISO 1561, EN ISO 1562, EN ISO 1567, EN ISO 3336, EN ISO 4824,
EN ISO 6871-1, EN ISO 8891, EN ISO 12163. c) 4.5 Clinical evaluation: Clarification of requirement for a clinical evaluation; d) 4.6.4 Instructions for use: Clarification of requirement that information may be provided in an electronic format; e) Annex ZA: Actualisation of correspondence between this European Standard and Directive 93/42/EEC, as amended by Directive 2007/47/EC. 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, 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 the United Kingdom.
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