EN 1642:2009
(Main)Dentistry - Medical devices for dentistry - Dental implants
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
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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
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
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 10Bibliography . 11 SIST EN 1642:2010
1) Addition of new relevant product standards, issued after 2004: EN 1641, EN ISO 11135-1,
EN ISO 11137-1, EN ISO 11607-1, EN ISO 11607-2, EN ISO 14801, EN ISO 14971, EN ISO 22794,
EN ISO 22803; 2) Deletion of the following withdrawn standards: EN 550, EN 552, EN ISO 14727; b) 4.5 Clinical evaluation: Clarification of requirement for a clinical evaluation; c) 4.6.4 Instructions for use: Clarification of requirement that information may be provided in an electronic format; d) 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.
(ISO 14155-1:2003) EN ISO 14155-2, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003) EN ISO 14801, Dentistry — Implants — Dynamic fatigue test for endosseous dental implants (ISO 14801:2007) EN ISO 14971, Medical devices — Application of risk management to medical devices (ISO 14971:2007) EN ISO 22794, Dentistry — Implantable materials for bone filling and augmentation in oral and maxillofacial surgery — Contents of technical file (ISO 22794:2007) SIST EN 1642:2010
EN 21942-2:1992, EN ISO 1942-5:1994 and the following apply. 3.1 dental implants device designed to be placed surgically within or on the mandibular or maxillary bone to provide resistance to displacement of a dental prosthesis or to provide orthodontic anchorage NOTE The term dental implant includes transendodontic implants. 4 Requirements 4.1 General 4.1.1 Dental implants shall comply with the requirements which are applicable to them bearing in mind the intended purpose of the implant concerned. Conformity with these requirements shall be considered to be met by demonstrating compliance with the requirements of the following subclauses, if appropriate. 4.1.2 Risk management shall be carried out and documented. This shall include a risk analysis in accordance with EN ISO 14971. 4.2 Design and properties 4.2.1 Materials Dental implants shall be manufactured from materials selected with regard to the properties required for the intended purpose. 4.2.2 Contents of technical file The contents of the manufacturer's technical file shall be in accordance with EN ISO 10451, EN ISO 22794 and
EN ISO 22803, if applicable. 4.2.3 Biocompatibility Dental implants shall be assessed for biocompatibility. Guidance on the selection of tests is given in EN ISO 7405 and EN ISO 10993-1. EN ISO 7405 includes usage tests specific to dental materials. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction. NOTE Further information is given in Annex I of Council Directive 67/548/EEC of 27 June 1967. 4.2.4 Biophysical properties and modelling Dental implants, other than those designed to provide orthodontic anchorage, shall be assessed for mechanical stability by fatigue testing according to EN ISO 14801.
NOTE The stability of dental implants designed to provide orthodontic anchorage shall be assessed by mechanical tests with
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