EN 1641:2009
(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
Relations
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.
(ISO 14155-1:2003) EN ISO 14155-2, Clinical investigations of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003) EN ISO 14971, Medical devices — Application of risk management to medical devices (ISO 14971:2007) EN ISO 15841, Dentistry — Wires for use in orthodontics (ISO 15841:2006) EN ISO 15854, Dentistry — Casting and baseplate waxes (ISO 15854:2005) EN ISO 20795-1, Dentistry — Base polymers - Part 1: Denture base polymers (ISO 20795-1:2008) EN ISO 21606, Dentistry — Elastomeric auxiliaries for use in orthodontics (ISO 21606:2007) EN ISO 22112, Dentistry — Artificial teeth for dental prostheses (ISO 22112:2005) EN ISO 22674, Dentistry — Metallic materials for fixed and removable restorations and appliances
(ISO 22674:2006) EN ISO 24234, Dentistry — Mercury and alloys for dental amalgam (ISO 24234:2004) ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and times 3 Terms and definitions For the purposes of this European Standard, the terms and definitions given in EN 21942-1:1991,
EN 21942-2:1992, EN ISO 1942-5:1994 and the following apply. 3.1 restorative material material used in the restoration of the form and function of the teeth NOTE This includes, for example, impression and other materials used transiently in the mouth, denture teeth and denture base resins, casting alloys,
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