SIST EN 1642:2010

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 . 74.4Dental implants used in combination . 74.5Clinical investigation and evaluation. 74.6Marking, labelling and information supplied by the manufacturer . 84.6.1General . 84.6.2Symbols . 84.6.3Label . 84.6.4Instructions for use . 8Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 10Bibliography . 11 SIST EN 1642:2010



EN 1642:2009 (E) 3 Foreword This document (EN 1642:2009) has been prepared by Technical Committee CEN/TC 55 “Dentistry”, the secretariat of which is held by DIN. 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 April 2010, and conflicting national standards shall be withdrawn at the latest by April 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 1642:2004. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive 93/42/EEC. For relationship with EU Directive 93/42/EEC, see informative annex ZA, which is an integral part of this document. The following changes were made: a) Normative references:
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.
SIST EN 1642:2010



EN 1642:2009 (E) 4 Introduction 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: Requirements for families of medical devices used in dentistry; — Level 3: 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 European 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 is also indicated 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 bibliography a reference for guidance on the classification of dental devices and accessories [4] is given. SIST EN 1642:2010



EN 1642:2009 (E) 5 1 Scope 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. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 556-1, Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1: Requirements for terminally sterilized medical devices EN 980, Symbols for use in the labelling of medical devices EN 1041, Information supplied by the manufacturer of medical devices EN 21942-1:1991, Dental vocabulary — Part 1: General and clinical terms (ISO 1942-1:1989) EN 21942-2:1992, Dental vocabulary — Part 2: Dental materials (ISO 1942-2:1989) EN ISO 1942-5:1994, Dental vocabulary — Part 5: Terms associated with testing (ISO 1942-5:1989) EN ISO 7405, Dentistry — Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008) EN ISO 10451, Dental implant systems — Contents of technical file (ISO 10451:2002) EN ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003) EN ISO 11135-1 Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) EN ISO 11137-1, Sterilization of health
...