EN 1642:1996
(Main)Dentistry - Medical devices for dentistry - Dental implants
Dentistry - Medical devices for dentistry - Dental implants
This European Standard specifies general requirements for dental implants. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641. This 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
Die Europäische Norm legt allgemeine Anforderungen an Dentalimplantate fest. Chirurgische implantierbare zahnärztliche Werkstoffe, definiert als restaurative Werkstoffe, sind insbesondere ausgeschlossen und werden in prEN 1641 beschrieben. Diese Norm beihaltet Anforderungen an die geplante Leistung, die Konstruktionsmerkmale, die Bestandteile, die Sterilisation, die Verpackung, die Kennzeichnung, die Etikettierung und die Informationen durch den Hersteller.
Art dentaire - Dispositifs médicaux pour l'art dentaire - Implants dentaires
La présente norme européenne établit les exigences générales relatives aux implants dentaires. Les produits dentaires chirurgicalement implantables, qui relèvent de la définition des produits pour restauration, sont spécifiquement exclus et décrits dans le prEN 1641. La présente norme établit les exigences relatives à la performance attendue, aux caractéristiques relatives à la 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)
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- Withdrawn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 1642:1996 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Medical devices for dentistry - Dental implants". This standard covers: This European Standard specifies general requirements for dental implants. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641. This 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. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641. This standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.
EN 1642:1996 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.
EN 1642:1996 has the following relationships with other standards: It is inter standard links to EN 1642:2004. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1642:1996 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 1642:1996 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.YVDGNLLPSODQWDWLZahnheilkunde - Medizinprodukte für die Zahnheilkunde - DentalimplantateArt dentaire - Dispositifs médicaux pour l'art dentaire - Implants dentairesDentistry - Medical devices for dentistry - Dental implants11.060.15Zobni implantatiDenta
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