1、November 2014Translation by DIN-Sprachendienst.English price group 12No 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).IC
2、S 11.060.01; 01.040.11!%$“2270192www.din.deDDIN EN ISO 16443Dentistry Vocabulary for dental implants systems and related procedure(ISO 16443:2014);English version EN ISO 16443:2014,English translation of DIN EN ISO 16443:2014-11Zahnheilkunde Vokabular fr Dentalimplantatsysteme und zugehrige Verfahre
3、n (ISO 16443:2014);Englische Fassung EN ISO 16443:2014,Englische bersetzung von DIN EN ISO 16443:2014-11Mdecine bucco-dentaire Vocabulaire des systmes dimplants dentaires et procdures associes(ISO 16443:2014);Version anglaise EN ISO 16443:2014,Traduction anglaise de DIN EN ISO 16443:2014-11Supersede
4、sDIN 13902-1:2004-08,DIN 13902-2:2005-10 andDIN 13902-3:2007-09www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 18 pages11.14 DIN EN ISO 16443:2014-11 2 A comma is used as the decimal marker. National foreword This document (EN ISO 16443
5、:2014) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working
6、Committees NA 014-00-21 AA Dentalimplantate and NA 014-00-21-01 AK Terminologie dentaler Implantatsysteme. The DIN Standard corresponding to the International Standard referred to in Clause 2 of this standard is as follows: ISO 1942 DIN EN ISO 1942 For the information of the user, the German version
7、 of this standard includes a subject index in alphabetical order (National Annex NB). Amendments This standard differs from DIN 13902-1:2004-08, DIN 13902-2:2005-10 and DIN 13902-3:2007-09 as follows: a) the contents of the standards have been combined into one standard; b) terms and definitions hav
8、e been updated to be in line with the current international vocabulary. Previous editions DIN 13902-1: 2004-08 DIN 13902-2: 2005-10 DIN 13902-3: 2007-09 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary EN ISO 16443 July 2014 ICS 01.020; 11.060.01 English VersionDent
9、istry - Vocabulary for dental implants systems and relatedprocedure (ISO 16443:2014)Mdecine bucco-dentaire - Vocabulaire des systmes dimplants dentaires et procdures associes(ISO 16443:2014)Zahnheilkunde - Vokabular fr Dentalimplantatsystemeund zugehrige VerfahrenThis European Standard was approved
10、by CEN on 28 June 2014. 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 standa
11、rds may be obtained on application to the CEN-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 not
12、ified to the CEN-CENELEC Management Centre has 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, I
13、celand, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form an
14、d by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 16443:2014 EEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORM(ISO 16443:2014)Contents Page Foreword . 3 Introduction . 4 1 Scope
15、 . 5 2 Normative references. 5 3 Terms and definitions related on medical devices used in oral implantology 5 3.1 Dental implant . 5 3.2 Dental implant system . 6 3.3 Ancillary devices used in oral implantology . 10 4 Terms and definitions related to clinical and surgical concepts used in oral impla
16、ntology . 12 Bibliography 16 2DIN EN ISO 16443:2014-11 EN ISO 16443:2014 (E) ForewordThis document (EN ISO 16443:2014) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN. This Europea
17、n 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 2015, and conflicting national standards shall be withdrawn at the latest by January 2015. Attention is drawn to the possibility that some of the elemen
18、ts 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 to implement this Euro
19、pean 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, Romania, Slovakia, Slo
20、venia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 16443:2014 has been approved by CEN as EN ISO 16443:2014 without any modification. 3DIN EN ISO 16443:2014-11EN ISO 16443:2014 (E)IntroductionThis terminology international standard has been prepared
21、and is presented accordingly with recommendations provided inISO 704, Terminology work Principles and methods,ISO 860, Terminology work Harmonization of concepts and terms,ISO 1087-1, Terminology work Vocabulary Part 1: Theory and application, andISO 10241-1, Terminological entries in standards Part
22、 1: General requirements and examples of presentation.Accordingly to ISO directives, ISO 704 and ISO 1087, this standard has been prepared and is presented in a systematic approach. The systematic approach presents the advantage of being independent from language, therefore allowing the same logical
23、 numbering in any language.4DIN EN ISO 16443:2014-11 EN ISO 16443:2014 (E) 1 ScopeThis International Standard specifies terms and definitions for dental implants and for instruments, accessories, and the most commonly used clinical terms related to implant systems and procedures in dentistry. Grafti
24、ng materials and membranes are excluded from this International Standard.The following devices are also excluded from the scope of this International Standard.Device specially designed to be placed within, through or upon the bones of the cranio-facial complex, the primary purpose of which is to pro
25、vide anchorage for an epithesis (to replace for example: ears, noses and parts of eyes and orbital regions): epithesis implant; craniofacial implant; maxillofacial implant.Device specially designed to be placed within, through or upon the bones of the cranio-facial complex, the primary purpose of wh
26、ich is to provide anchorage for an orthodontic appliance: orthodontic implant1).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
27、 references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyNOTE Except for the following terminological entries that supersede ISO 1942:2009, the terms and definitions given in ISO 1942 apply for the purpose of this document.3 Terms an
28、d definitions related on medical devices used in oral implantologyFor the purposes of this document, the following terms and definitions apply.3.1 Dental implant3.1.1dental implantdevice especially designed to be placed within, through or upon the bones of the cranio-facial complex, the primary purp
29、oses of which are to support and/or to resist displacement of a dental prosthesis3.1.1.1endosseous dental implantendosteal implant (DEPRECATED)dental implant (3.1.1) placed partially or entirely within the bone1) This definition supersedes the one given in ISO 1942.5DIN EN ISO 16443:2014-11EN ISO 16
30、443:2014 (E)3.1.1.2interim endosseous dental implantprovisional implantendosseous dental implant (3.1.1.1) for temporary usage3.1.1.3transendodontic implantendodontic endosseous implanttransradicular implant (DEPRECATED)rod, specially made to be inserted longitudinally either through a root canal or
31、 through a root segment which extends through the apex into the surrounding bone to stabilize a tooth3.1.1.4intramucosal implantoral mucosal insertsubmucosal implant (DEPRECATED)button implant (DEPRECATED)dental implant (3.1.1) placed in the soft tissue lining of the oral cavity3.1.1.5ramus endosseo
32、us implantramus endosteal implant (DEPRECATED)dental implant (3.1.1) placed within the ramus of the mandible3.1.1.6frame implantramus frame endosteal implant (DEPRECATED)One-piece implant consisting of a number of mandibular subperiosteal and/or endosseous components linked with an intra-oral struct
33、ure3.1.1.7subperiosteal dental implantsubperiosteal implant abutment (DEPRECATED)dental implant (3.1.1) that is placed beneath the periosteum and overlying the bony cortex3.1.1.8transmandibular implantdental implant (3.1.1) consisting of a plate and posts designed so that the posts can be placed to
34、extend vertically from the inferior border of the mandible through the plate, bone and mucosa and into the oral cavity in the anterior region3.1.1.9zygoma implantdental implant (3.1.1) intended to be partially inserted into or on the zygomatic bone3.2 Dental implant system3.2.1dental implant systemi
35、mplant kitimplant systemintegrated system of components, specific equipment and ancillary instruments necessary for the clinical and laboratory procedures required for the placement of the dental implant (3.1.1) and the construction and insertion of an implant-supported dental prosthesis3.2.2implant
36、 componentelement of a dental implant system (3.2.1)6DIN EN ISO 16443:2014-11 EN ISO 16443:2014 (E) 3.2.3dental implant assemblyassembly of dental implant components (3.2.2) as recommended by the manufacturer(s) to serve the purposes of a dental implant (3.1.1)3.2.4implant bodydental implant bodyimp
37、lant fixture (DEPRECATED)endosteal implant body (DEPRECATED)primary single component or portion of a dental implant (3.1.1) which is intended to remain within the hard and soft tissues and can be totally or partially submerged by soft tissue3.2.4.1implant body endosseous zoneportion of the implant b
38、ody (3.2.4) which is intended for intra-bone positioning3.2.5transmucosal componentpart of a dental implant system (3.2.1) that passes through the mucosa3.2.6tissue interface surfaceimplant contact surfacesurface of an implant body (3.2.4) or implant component (3.2.2) intended to contact the patient
39、s tissues3.2.7tissue interface surface treatmentmodification of a dental implant component (3.2.2) surface by subtraction or addition of material3.2.7.1implant component coatingimplant component (3.2.2) surface treatment by addition3.2.8connecting interfaceimplant connective platformportion of a den
40、tal implant body (3.2.4) or implant component (3.2.2) intended to connect with another implant component (3.2.2)3.2.8.1platform switching designconnecting interface (3.2.8) designed to allow the use of implant abutments (3.2.10) with diameters less than that of the implant body (3.2.4)3.2.9anti-rota
41、tion featuredesign of the connecting interface (3.2.8), that prevents rotation of the connected implant component (3.2.2) around the central long axis of the implant body (3.2.4)3.2.9.1external anti-rotation featureanti-rotation feature (3.2.9) extending outside the implant body (3.2.4)3.2.9.2intern
42、al anti-rotation featureanti-rotation feature (3.2.9) shaped within the implant body (3.2.4)7DIN EN ISO 16443:2014-11EN ISO 16443:2014 (E)3.2.10implant abutmentimplant component (3.2.2) connected to the implant body (3.2.4) or implant connecting part (3.2.11), which serves as an abutment3.2.10.1stra
43、ight implant abutmentnon-angulated implant abutmentnon-angled implant abutmentimplant abutment (3.2.10) having central long axis coincident with that of the implant body (3.2.4)3.2.10.2angulated implant abutmentangled abutmentimplant abutment (3.2.10) having a principal long axis divergent from the
44、central long axis of the implant body (3.2.4)3.2.10.3castable implant abutmentcastable abutmentprefabricated implant abutment (3.2.10) intended to be customized and used for casting3.2.10.4partially castable implant abutmentpartially castable abutmentUCLA abutment (DEPRECATED)prefabricated implant a
45、butment (3.2.10) intended to be customized and cast except for the connecting interface (3.2.8)3.2.10.5preparable abutmentmilling abutmentimplant abutment (3.2.10) intended to be customized in its shape or form by a milling process3.2.10.6CAD/CAM abutmentpatient specific implant abutment (3.2.10) de
46、signed and fabricated using the CAD/CAM process3.2.10.7implant ball abutmentball abutmentimplant abutment that serves as a prosthetic attachment3.2.10.8implant magnetic abutmentmagnetic abutmentimplant abutment (3.2.10) that serves as a magnetic prosthetic attachment3.2.11implant connecting partdent
47、al implant connecting partimplant component (3.2.2) used between the implant body (3.2.4) and the implant abutment (3.2.10)3.2.12monopart implantmonotype implantone-piece implant1-piece implantendosseous dental implant (3.1.1.1) made in one piece that consists of the implant body (3.2.4) part and an
48、 implant abutment (3.2.10)8DIN EN ISO 16443:2014-11 EN ISO 16443:2014 (E) 3.2.13two part implanttwo piece implant2-piece implantendosseous dental implant (3.1.1.1) consisting of an implant body (3.2.4) to which is connected an implant abutment (3.2.10) or a dental prosthesis3.2.14multi-part implantt
49、wo parts implant (3.2.13) with the addition of one or more implant connecting parts (3.2.11)3.2.15implant cover screwcover screwimplant component (3.2.2) used in phase one or placement surgery to prevent tissue growth within the connecting interface (3.2.8) of an implant body (3.2.4)3.2.16transmucosal healing componenttransmucosal forming componentimplant healing abutmentimplant component (3.2.2) that projects into the oral cavity and is used for a limited time to gu
