1、December 2013Translation by DIN-Sprachendienst.English price group 8No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、 11.060.01!%*zN“2078743www.din.deDDIN EN ISO 16498Dentistry Minimal dental implant data set for clinical use (ISO 16498:2013);English version EN ISO 16498:2013,English translation of DIN EN ISO 16498:2013-12Zahnheilkunde Mindestdatensatz bei der klinischen Anwendung von Dentalimplantaten(ISO 16498:2
3、013);Englische Fassung EN ISO 16498:2013,Englische bersetzung von DIN EN ISO 16498:2013-12Mdecine bucco-dentaire Informations cliniques minimales requises pour les porteurs dimplants dentaires(ISO 16498:2013);Version anglaise EN ISO 16498:2013,Traduction anglaise de DIN EN ISO 16498:2013-12www.beuth
4、.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 11 pages12.13 DIN EN ISO 16498:2013-12 2 A comma is used as the decimal marker. National foreword This document (EN ISO 16498:2013) has been prepared by Technical Committee CEN/TC 55 “Dentistry” (S
5、ecretariat: DIN, Germany) in collaboration with Technical Committee ISO/TC 106 “Dentistry”. The responsible German body involved in its preparation was the Normenausschuss Dental (Dentistry Standards Committee), Working Committee NA 014-00-21 AA Dentalimplantate. The DIN Standards corresponding to t
6、he International Standards referred to in Clause 2 of this standard are as follows: ISO 1942 DIN EN ISO 1942 ISO 3950 DIN EN ISO 3950 ISO 8601 DIN ISO 8601 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 3950, Dentistry Designation system for teeth and a
7、reas of the oral cavity DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 16498 July 2013 ICS 11.060.15 English Version Dentistry - Minimal dental implant data set for clinical use (I
8、SO 16498:2013) Mdecine bucco-dentaire - Informations cliniques minimales requises pour les porteurs dimplants dentaires (ISO 16498:2013) Zahnheilkunde - Mindestdatensatz bei der klinischenAnwendung von DentalimplantatenThis European Standard was approved by CEN on 12 July 2013. CEN members are bound
9、 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
10、-CENELEC 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-CENELEC Management Centre ha
11、s the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Lu
12、xembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 C
13、EN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 16498:2013: E(ISO 16498:2013) Contents Page Foreword . 3 Introduction . 4 1 Scope . 5 2 Normative references. 5 3 Terms and definitions 5 4 General information . 5 4.1 Patients ide
14、ntification . 5 4.2 Clinicians identification 6 4.3 Implant bodies 6 4.4 Connecting components . 6 4.5 Adjunctive devices . 7 4.6 Suprastructure 7 Bibliography 9 2DIN EN ISO 16498:2013-12EN ISO 16498:2013 (E) This document (EN ISO 16498:2013) has been prepared by Technical Committee ISO/TC 106 in co
15、llaboration with 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 January 2014, and conflicting national standards
16、 shall be withdrawn at the latest by January 2014. 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. According to the CEN-CENELEC Intern
17、al Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ire
18、land, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 16498:2013 has been approved by CEN as EN ISO 16498:2013 without any modification. “Den
19、tistry”Foreword3DIN EN ISO 16498:2013-12EN ISO 16498:2013 (E)IntroductionDental implant treatment is a widely employed therapeutic procedure using endosseous devices which have a service life of many decades, although the restorations that they stabilize not infrequently require maintenance during t
20、his period. Uniquely, for such an extensively utilized technique, procedures are largely dependent upon the availability of pre-manufactured precision components. These are typically device-specific and frequently subject to design changes as manufacturers develop their products. Treatment of a pati
21、ent who has had a dental implant body or bodies placed in their jaw(s) requires the availability of accurate information concerning the implants and any connecting components and adjunctive devices that have been utilized. This standard describes a minimum data set for meeting this requirement. The
22、data may also have research, forensic and medico-legal benefits.This minimal data set is intended to facilitate the care of patients who have been treated with dental implants by recording the relevant details of the inserted device(s) and any associated connecting components and adjunctive devices.
23、 It does not define the totality of the information that should be collected in connection with any such treatment, which is the responsibility of the relevant clinician(s).4DIN EN ISO 16498:2013-12EN ISO 16498:2013 (E) 1 ScopeThis International Standard specifies the minimal data set to be recorded
24、 for a patient receiving dental implant treatment. This will comprise the locations and types of dental implant bodies, connecting components and adjunctive devices, including grafting materials, placed in a patients jaw(s).This information will be recorded by the responsible clinician in the patien
25、ts file and should be made available to the patient by the clinician(s) who provided the care.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applie
26、s. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 3950, Dentistry Designation system for teeth and areas of the oral cavityISO 8601, Data elements and interchange formats Information interchange Representatio
27、n of dates and times3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.3.1data setspecification of linked data elements that comprise a unique relationship3.2dental implantdevice especially designed to be placed surgically wi
28、thin, through or upon the bones of the craniofacial complex, the primary purposes of which are to support a dental prosthesis and to resist its displacementSOURCE: ISO 1942:2009, 2.71, modified terminology has changed.3.3connecting componentsindividual parts or components that can be joined to the i
29、mplant body to provide support for the function of the implantSOURCE: ISO 1942:2009, 2.72, modified term and definition have changed.3.4grafting materialsmaterial of allogenic, alloplastic, xenographic or autogenic origin which is implanted or transplanted to replace or repair defective or damaged h
30、uman tissue4 General information4.1 Patients identification patients name; patients date of birth.5DIN EN ISO 16498:2013-12EN ISO 16498:2013 (E)4.2 Clinicians identification clinicians name; clinicians national registration number or license number.4.3 Implant bodies4.3.1 GeneralFor each dental impl
31、ant body, the dentist shall record: manufacturer; implant type, material used and dimensions; batch code, lot number and/or serial number; implantation date in accordance with ISO 8601; location of implant placement in accordance with ISO 3950; operation protocol (including insertion torque); name a
32、nd national registration number of the clinician responsible for the placement of the implant body, if different from the clinician identified according to 4.2.4.3.2 Pre-manufactured implant bodiesRecord the commercial name of each dental implant body, name and address of manufacturer or of the offi
33、cial sales agent for the country in which the component was purchased, manufacturers unique part number.4.3.3 Patient-specific implant bodies information described in 4.3.1 plus modifications that would make the implant body unique; include dimensions if known; minimum data necessary to fabricate co
34、nnecting components; describe implant body coating at the time of manufacture (if any) and if so, the material and technique used.4.4 Connecting components4.4.1 GeneralThe clinician shall record: the name and national registration number of the clinician responsible for the treatment with this impla
35、nt; the placement date of a connecting component; location of implant bodys placement in accordance with ISO 3950; type of connection of the connecting part to prosthesis(e.g. cementation, screw connection);6DIN EN ISO 16498:2013-12EN ISO 16498:2013 (E) the mechanism for linking the connecting compo
36、nent to the implant body and the mechanism for linking the connecting component to a prosthetic suprastructure (e.g. screw fixation, taper fit, cementation); details of screw head configuration (e.g. hexagonal, square); screw composition (e.g. gold alloy or titanium alloy).4.4.2 Prefabricated connec
37、ting components the commercial name of each connecting component, name and address of manufacturer or of the authorized representative for the country in which the component was purchased, manufacturers unique part number; type and all specific dimensions of the implant component; lot number and/or
38、serial number.4.4.3 Patient-specific connecting components the name and address of the laboratory/manufacturer or of the authorized representative for the country in which the component was purchased, manufacturers unique part number; unique construction details as prescribed by the clinician.4.5 Ad
39、junctive devices4.5.1 General the name and national registration number of the clinician responsible for the placement of the adjunctive device; the name and address of the manufacturer or of the authorized representative for the country in which the adjunctive device was purchased; lot number and/o
40、r serial number. approximate quantity of material; the date of placement of the adjunctive device; location of the adjunctive device.4.5.2 Autografts source of autograft; location of placement; date in accordance with ISO 8601.4.6 Suprastructure4.6.1 General connecting parts specifications, if appli
41、cable (see 4.4); the name and address of the manufacturer/laboratory or of the authorized representative for the country in which the prosthesis was purchased;7DIN EN ISO 16498:2013-12EN ISO 16498:2013 (E) type, dimensions and material used; batch code (if available).4.6.2 Dental/oral prosthesis man
42、ufacturer; manufacturing date; type and design; material(s) used with their lot number or serial number (if available); date of placement.8DIN EN ISO 16498:2013-12EN ISO 16498:2013 (E) Bibliography1 ISO 3166-1, Codes for the representation of names of countries and their subdivisions Part 1: Country codes2 ISO/TR 13668, Digital coding of oral health and care3 ISO 16059, Dentistry Required elements for codification used in data exchange4 ISO/TR 15599, Digital codification of dental laboratory procedures9DIN EN ISO 16498:2013-12EN ISO 16498:2013 (E)
