Dentistry - Medical devices for dentistry Dental implants. Tandvård - Medicintekniska produkter för tandvård - Dentala implantat
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1 SIS FASTSTÄLLER OCH UTGER SVENSK STANDARD SAMT SÄLJER NATIONELLA, EUROPEISKA OCH INTERNATIONELLA STANDARDPUBLIKATIONER Dentistry - Medical devices for dentistry Dental implants Tandvård - Medicintekniska produkter för tandvård - Dentala implantat The European standard EN 1642:1996 has the status of a Swedish Standard. This document contains the official English version of EN 1642:1996. Swedish Standards corresponding to documents referred to in this Standard are listed in Catalogue of Swedish Standards, issued by SIS. The Catalogue lists, with reference number and year of Swedish approval, International and European Standards approved as Swedish Standards as well as other Swedish Standards. Europastandarden EN 1642:1996 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN 1642:1996. Motsvarigheten och aktualiteten i svensk standard till de publikationer som omnämns i denna standard framgår av Katalog över svensk standard, som ges ut av SIS. I katalogen redovisas internationella och europeiska standarder som fastställts som svenska standarder och övriga gällande svenska standarder.
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3 English version Dentistry - Medical devices for dentistry - Dental implants Art dentaire Dispositifs médicaux pour I art dentaire Implants dentaires Zahnheilkunde Medizinprodukte für die Zahnheilkunde Dentalimplantate This European Standard was approved by CEN on CEN members are bound to comply with the CEN/CENELEC Internal Regualtions 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 Central Secretariat or to any CEN member. The European Standards exist 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 Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
4 Foreword This standard has been prepared by Technical Committee CEN/TC 55 'Dentistry, the secretariat of which is held by DIN. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association and supports essential requirements of the EU Directive(s). For relationship with EU Directive(s), this standard. see informative Annex ZA, which is an integral part of This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 1997, and conflicting national standards shall be withdrawn at the latest by February According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom, There are three levels of European Standards dealing with medical devices used in dentistry. These are as follows: Level 1: General requirements for medical devices, Level 2: Level 3: Particular requirements for families of medical devices used in dentistry. Specific requirements for types of medical devices used in dentistry. There are no level 1 standards written exclusively in respect of medical devices used in dentistry. This standard is a level 2 standard and details requirements that apply to dental implants (For surgically implantable dental materials included within the definition of restorative materials see EN 1641). It also indicates that there are additional requirements in the level 3 standards. Where available, these are included as normative references. To cover all the requirements for a particular product, it is necessary to use a standard of the lowest available level. In the informative annex A a reference for guidance on the classification of medical devices used in dentstry [3] is given.
5 1 Scope This European Standard specifies general requirements for dental implants. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN This Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer. 2 Normative references This European Standard incorporates by dated or undated reference provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 540 EN 550 EN 552 EN 556 EN 980 pren 1041 EN 1641 EN EN EN EN EN EN EN EN Clinical investigation of medical devices for human subjects Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization Sterilization of medical devices - Validation and routine control of sterilization on by irradiation Sterilization of medical devices - Requirement for medical devices to be labelled 'STERILE Graphical symbols for use in the labelling of medical devices Information supplied by the manufacturer with medical devices Dentistry - Medical devices for dentistry - Materials Dental vocabulary - Part 1: General clinical terms Dental vocabulary - Part 2: Dental materials Data elements and interchange formats - Information interchange - Representation of dates and times Biological evaluation of medical devices - Part 1: Guidance on selection of tests Biological evaluation of medical devices - Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood Biological evaluation of medical devices - Part 5: Tests for cytotoxicity - In vitro methods Biological evaluation of medical devices - Part 6: Test for local effects after implantation
6 EN ISO pren ISO 7405 EN ISO EN ISO Dental vocabulary - Part 5: Terms associated with testing Biological evaluation of dental materials Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization Biological evaluation of medical devices - Part 11: Tests for systemic toxicity 3 Definitions For the purposes of this standard the definitions of EN , EN , EN ISO and the following definition apply: dental implant Device designed to be placed surgically within or on the mandibular or maxillary bone to provide resistance to displacement of a dental prosthesis. NOTE: The term dental implant includes transendodontic implants. 4 Requirements 4.1 General 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 following subclauses, as appropriate For dental implants a risk analysis shall be carried out and documented. NOTE: EN 1441 describes a procedure for carrying out and documenting a risk analysis of medical devices. 4.2 Design and properties Dental implants shall be manufactured from materials selected with regard to the properties required for the intended purpose. NOTE: Further information is given in ISO/TR
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