EN 1641:1996
(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 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 Medizinprodukte sind. Für die Anwendung dieser Norm werden diese Werkstoffe als restaurative Werkstoffe bezeichnet. Dentalimplantate sind ausdrücklich ausgeschlossen und werden in prEN 1642 beschrieben. Diese Norm umfaßt Anforderungen an die geplante Leistung, die Konstruktionsmerkmale, die Bestandteile, die Sterilisation, die Verpackung, die Kennzeichnung, die Etikettierung,...
Art dentaire - Dispositifs 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 restaurer la forme et la fonction des dents et qui sont des dispositifs médicaux. Pour les besoins de la présente norme, ces produits sont définis comme étant des produits pour restauration. Les implants dentaires sont spécifiquement exclus et décrits dans le prEN 1642. Cette norme établit également les exigences relatives aux performances attendues, aux caractéristiques relatives à la conception, aux composants, à la stérilisation, à l'emballage, au marquage, à l'étiquetage,...
Zobozdravstvo - Medicinski pripomočki za zobozdravstvo - Materiali
General Information
- Status
- Withdrawn
- Publication Date
- 20-Aug-1996
- Withdrawal Date
- 01-Jun-2004
- Technical Committee
- CEN/TC 55 - Dentistry
- Drafting Committee
- CEN/TC 55/WG 7 - Steering Committee
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 02-Jun-2004
- Completion Date
- 02-Jun-2004
- Directive
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN 1641:1996 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 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 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 1641:1996 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 1641:1996 has the following relationships with other standards: It is inter standard links to EN 1641:2004. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1641:1996 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 1641:1996 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 pour l'art dentaire - ProduitsDentistry - Medical devices for dentistry - Materials11.060.10Dental materialsICS:Ta slovenski standard je is
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