DIN EN ISO 19429-2016 Dentistry - Designation system for dental implants (ISO 19429 2015) German version EN ISO 19429 2016《牙科 牙科植入物的命名系统(ISO 19429-2015) 德文版本EN ISO 19429-2016》.pdf

1、December 2016 English price group 7No 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 11.060.15!%“2595793www.din.deDIN

2、 EN ISO 19429Dentistry Designation system for dental implants (ISO 19429:2015);English version EN ISO 19429:2016,English translation of DIN EN ISO 19429:2016-12Zahnheilkunde Bezeichnungssystem fr Dentalimplantate (ISO 19429:2015);Englische Fassung EN ISO 19429:2016,Englische bersetzung von DIN EN IS

3、O 19429:2016-12Mdecine buccodentaire Systme de dsignation pour les implants dentaires (ISO 19429:2015);Version anglaise EN ISO 19429:2016,Traduction anglaise de DIN EN ISO 19429:2016-12www.beuth.deDocument comprises 9 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language orig

4、inal shall be considered authoritative.11.16 DIN EN ISO 19429:2016-12 2 A comma is used as the decimal marker. National foreword This document (EN ISO 19429:2016) has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: SCC, Canada) in collaboration with Technical Committee CEN/

5、TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committees NA 014-00-21 AA Dentalimplantate and NA 014-00-21-01 AK Terminologie dentaler Implantatsysteme. The DIN Standa

6、rds corresponding to the International Standards referred to in this document are as follows: ISO 1942 DIN EN ISO 1942 ISO 3950 DIN EN ISO 3950 ISO 16443 DIN EN ISO 16443 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 3950, Dentistry Designation system

7、for teeth and areas of the oral cavity DIN EN ISO 16443, Dentistry Vocabulary for dental implants systems and related procedure EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 19429 June 2016 ICS 11.060.15 English Version Dentistry - Designation system for dental implants(ISO 19429:2015) Md

8、ecine bucco-dentaire - Systme de dsignation pour les implants dentaires (ISO 19429:2015) Zahnheilkunde - Bezeichnungssystem fr Dentalimplantate (ISO 19429:2015) This European Standard was approved by CEN on 29 May 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which

9、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-CENELEC Management Centre or to any CEN member. This Europ

10、ean 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 has the same status as the official versions. CEN members are

11、 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, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Rom

12、ania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and b

13、y any means reserved worldwide for CEN national Members. Ref. No. EN ISO 19429:2016 EEuropean foreword .3Introduction 51 Scope . 62 Normative references 63 Terms and definitions . 64 Classification, designation and coding 6Bibliography 7Contents PageDIN EN ISO 19429:2016-12 EN ISO 19429:2016 (E) 2Fo

14、reword .4European foreword The text of ISO 19429:2015 has been prepared by Technical Committee ISO/TC 106 “Dentistry” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 19429:2016 by Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held

15、 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 December 2016, and conflicting national standards shall be withdrawn at the latest by December 2016. Attention is drawn to the possibility

16、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 Internal Regulations, the national standards organizations of the following countries are bound

17、 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, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

18、 Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 19429:2015 has been approved by CEN as EN ISO 19429:2016 without any modification. DIN EN ISO 19429:2016-12 EN ISO 19429:2016 (E)3 ForewordISO (the International Organization f

19、or Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has th

20、e right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The proce

21、dures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editoria

22、l rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights

23、identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explana

24、tion on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this documen

25、t is ISO/TC 106, Dentistry, Subcommittee SC 8, Dental implants.DIN EN ISO 19429:2016-12 EN ISO 19429:2016 (E) 4 IntroductionThe emergence of dental implant treatment as a viable and widely utilized procedure has created a requirement for a system for indicating the presence and location of such devi

26、ces within the jaws which is compatible with existing schemes. Dental implant bodies do not have the characteristics of an individual tooth other than those which are acquired by virtue of the restoration(s) which they support. They can, thus, be described as having a location with an implied crown

27、form. In contrast, a designated tooth has a defined form and an implied location. In both cases, this information may be supplemented with additional comments.A wide range of devices may be implanted in and around the jaws therapeutically, accidentally or for social reasons, many of which are not en

28、dosseous dental implants. Given that these form the majority of implants in the oro-facial region and that the over-riding current need of the professions is a standard method of designating their presence and location, a scheme has been developed to meet this requirement. The inclusion of infrequen

29、tly used implants of other types and in alternative locations would make the system more complex for the potential benefit currently obtained. The possibility of doing so in the future is not however excluded.DIN EN ISO 19429:2016-12 EN ISO 19429:2016 (E)5 1 ScopeThis International Standard provides

30、 a system for designating the location of an implant body within a jaw, and is intended for use with the scheme described in ISO 3950. It does not in itself indicate whether the device is visible within the oral cavity or the presence of transmucosal components or implant restorations. Since the sys

31、tem describes location but not restoration form, it is not necessary to use the quadrant designation numbers 5 to 8 which are employed when indicating a primary tooth.This information should be recorded by the responsible clinician in the patients file and made available to the patient by the clinic

32、ian(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 applies. For undated references, the latest edition of the referenced d

33、ocument (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 3950, Dentistry Designation system for teeth and areas of the oral cavityISO 16443, Dentistry Vocabulary for dental implants systems and related procedure3 Terms and definitionsFor the purpose of this document, the terms an

34、d definitions given in ISO 1942 and ISO 16443 apply.4 Classification, designation and codingThe scheme uses three characters to indicate the location of each implant body with the first two employing a system corresponding to that described in ISO 3950.In all cases, the following sequence shall be e

35、mployed. Character 1: This is a digit in the range 1 to 4, and indicates implant bodies in the upper right quadrant, upper left quadrant, lower left quadrant or lower right quadrant respectively.NOTE Since the system describes location but not restoration form, it is not necessary to use the quadran

36、t designation numbers 5 to 8 which are employed when indicating a primary tooth. Character 2: This is a digit in the range 1 to 8, and indicates the location of an implant body in the defined quadrant in a position analogous to that of a natural tooth. Character 3: This is always the character ! whi

37、ch is used to indicate the presence of an implant body, as opposed to a tooth, at the location indicated by characters 1 and 2.The characters shall be written without any intervening spaces or punctuation. For example, 36! indicates the presence of a dental implant body in the left mandibular first

38、molar region.DIN EN ISO 19429:2016-12 EN ISO 19429:2016 (E) 6 Bibliography1 ISO 3166-1, Codes for the representation of names of countries and their subdivisions Part 1: Country codes2 ISO 16059, Dentistry Required elements for codification used in data exchange3 ISO 16498, Dentistry Minimal dental implant data set for clinical use4 ISO/TR 136681), Digital coding of oral health and care5 ISO/TR 15599, Digital codification of dental laboratory procedures1) Withdrawn standard.DIN EN ISO 19429:2016-12 EN ISO 19429:2016 (E)7