SIST EN 1641:2010
(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
- 17-Dec-2009
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 20-Nov-2009
- Due Date
- 25-Jan-2010
- Completion Date
- 18-Dec-2009
Relations
- Effective Date
- 01-Jan-2010
Overview
SIST EN 1641:2010 is a European Standard established by CEN that specifies general requirements for materials used in dentistry and orthodontics, particularly for restorative purposes. This standard applies to medical devices designed to restore the form and function of teeth and orthodontic applications. It excludes dental implants, which are covered by EN 1642. The standard addresses various aspects including material composition, biocompatibility, performance, sterilization, packaging, labeling, and manufacturer-provided information.
This standard plays a crucial role in ensuring the safety, quality, and effectiveness of dental restorative and orthodontic materials used across the European Union. It helps manufacturers meet regulatory requirements under EU Directive 93/42/EEC, fostering high standards in dental medical devices.
Key Topics
Scope and Applicability
EN 1641 covers a broad range of dental materials, including filling, lining, impression materials, denture base resins, orthodontic wires, and elastomeric auxiliaries. It excludes dental implants but includes materials used transiently in the mouth.Material Composition and Properties
The standard mandates compliance with compositional requirements referenced from related ISO and EN standards, ensuring materials meet safety, chemical, and physical property criteria suited for dental applications.Biocompatibility Requirements
All materials must undergo thorough biocompatibility testing according to EN ISO 7405 and EN ISO 10993-1. Special attention is required for substances with carcinogenic, mutagenic, or reproductive toxicity concerns.Risk Management
Manufacturers must conduct and document risk assessments in line with EN ISO 14971, identifying and mitigating potential hazards associated with dental materials.Contamination Control
Materials should be produced to minimize microbial contamination, and packaging must maintain cleanliness during transport and storage, especially for non-sterile supplies.Clinical Evaluation
A clinical evaluation is mandatory for all restorative and orthodontic materials, with clinical investigations adhering to EN ISO 14155 to ensure safety and performance in actual use.Marking and Labelling
Detailed requirements for product labeling and instructions for use are included, supporting safe application by dental professionals. Labels must contain key information such as manufacturer details, material description, batch number, and expiry date, following EN 980 and EN 1041 standards.
Applications
Restorative Dentistry
The standard is vital for materials used in tooth restoration, including composites, cements, ceramics, and casting alloys. It ensures these materials restore dental form and function effectively and safely.Orthodontics
EN 1641 sets requirements for materials utilized in orthodontic treatments, including wires, elastomeric auxiliaries, and related components, ensuring their suitability and safety for correcting dental alignment.Dental Laboratories and Manufacturers
Provides guidance for designing, manufacturing, and labeling dental materials compliant with EU regulations and harmonized standards, supporting reliable product development.Regulatory Compliance
Enables manufacturers to demonstrate conformity with essential EU medical device directives, facilitating market access throughout Europe.
Related Standards
EN 1641 references and complements multiple specific standards, including:
- EN 1642 – Medical devices – Dental implants
- EN ISO 7405 – Biocompatibility evaluation for dental devices
- EN ISO 14971 – Risk management for medical devices
- EN ISO 14155 – Clinical investigations of medical devices for human subjects
- EN 980 – Symbols for medical device labeling
- EN 1041 – Manufacturer information for medical devices
- Various EN ISO standards related to specific dental materials such as zinc oxide cements (EN ISO 3107), polymer-based materials (EN ISO 4049), dental ceramics (EN ISO 6872), and orthodontic wires (EN ISO 15841).
SIST EN 1641:2010 is fundamental for maintaining high quality and safety standards in dental material manufacturing and clinical use across Europe. Compliance with this standard supports optimized patient outcomes, regulatory acceptance, and trust in dental restorative and orthodontic medical devices.
Frequently Asked Questions
SIST EN 1641:2010 is a standard published by the Slovenian Institute for Standardization (SIST). 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.
SIST EN 1641:2010 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.
SIST EN 1641:2010 has the following relationships with other standards: It is inter standard links to SIST EN 1641:2005. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 1641:2010 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 1641:2010 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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