EN 1642:2009

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.

Art dentaire - Dispositifs médicaux pour l'art 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• Status: Withdrawn
• Publication Date: 27-Oct-2009
• Withdrawal Date: 18-Oct-2011
• ICS: 11.060.15 - Dental implants
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55/WG 7 - Steering Committee
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 19-Oct-2011
• Completion Date: 19-Oct-2011
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 1642:2010 - Dentistry - Medical devices for dentistry - Dental implants

Relations

• Replaces: EN 1642:2004 - Dentistry - Medical devices for dentistry - Dental implants
• Effective Date: 31-Oct-2009
• Replaced By: EN 1642:2011 - Dentistry - Medical devices for dentistry - Dental implants
• Effective Date: 08-Oct-2011

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.LPSODQWDWLZahnheilkunde - Medizinprodukte für die Zahnheilkunde - DentalimplantateArt dentaire - Dispositifs médicaux pour l'art dentaire -Implants dentairesDentistry - Medical devices for dentistry - Dental implants11.060.15Zobni implantatiDental implantsICS:Ta slovenski standard je istoveten z:EN 1642:2009SIST EN 1642:2010en,de01-januar-2010SIST EN 1642:2010SLOVENSKI
STANDARDSIST EN 1642:20051DGRPHãþD



SIST EN 1642:2010



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1642
October 2009 ICS 11.060.15 Supersedes EN 1642:2004English Version
Dentistry - Medical devices for dentistry - Dental implants
Art dentaire - Dispositifs médicaux pour l'art dentaire -Implants dentaires
Zahnheilkunde - Medizinprodukte für die Zahnheilkunde - Dentalimplantate 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 1642:2009: ESIST EN 1642:2010



EN 1642:2009 (E) 2 Contents page Foreword . 3Introduction . 41Scope . 52Normative references . 53Terms and definitions . 64Requirements . 64.1General . 64.2Design and properties . 64.2.1Materials . 64.2.2Contents of technical file . 64.2.3Biocompatibility . 64.2.4Biophysical properties and modelling . 64.3Control of contamination . 74.3.1General . 74.3.2Dental implants supplied sterile . 74.3.3Dental implants supplied non-sterile . 74.3.4Dental implants which incorporate materials of animal origin .
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