1、BSI Standards PublicationBS EN ISO 16443:2014Dentistry Vocabulary fordental implants systems andrelated procedureBS EN ISO 16443:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO16443:2014.The UK participation in its preparation was entrusted to Technical
2、Committee CH/106, Dentistry.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 201
3、4. Published by BSI StandardsLimited 2014ISBN 978 0 580 76242 0ICS 01.020; 11.060.01Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2014.Amendments issued
4、since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 16443 July 2014 ICS 01.020; 11.060.01 English Version Dentistry - Vocabulary for dental implants systems and related procedure (ISO 16443:2014) Mdecine bucco-dentaire - Vocabulaire des systmes dimplants denta
5、ires et procdure associe (ISO 16443:2014) Zahnheilkunde- Vokabular der oralen Implantologie (ISO 16443:2014) This European Standard was approved 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 S
6、tandard 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 European Standard exists in three official versions (Eng
7、lish, 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 the national standards bodies of Austria, Belgium,
8、 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, Slovenia, Spain, Sweden, Switzerlan
9、d, 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 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Mem
10、bers. Ref. No. EN ISO 16443:2014 EBS EN ISO 16443:2014EN ISO 16443:2014 (E) 3 Foreword This 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 Europ
11、ean 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 elem
12、ents 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 Eu
13、ropean 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, S
14、lovenia, 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. BS EN ISO 16443:2014ISO 16443:2014(E/F)Contents PageForeword ivIntroduction v1 Scope . 12 Normative references 13
15、Terms and definitions related on medical devices used in oral implantology 13.1 Dental implant . 13.2 Dental implant system 23.3 Ancillary devices used in oral implantology 64 Terms and definitions related to clinical and surgical concepts used in oral implantology . 8Bibliography .12 ISO 2014 All r
16、ights reserved/Tous droits rservs iiiBS EN ISO 16443:2014ISO 16443:2014(E/F)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO t
17、echnical committees. Each member body interested in a subject for which a technical committee has been established has the 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 clos
18、ely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures 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 n
19、eeded for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directivesAttention is drawn to the possibility that some of the elements of this document may be the subject of patent righ
20、ts. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received. www.iso.org/patentsAny trade name used in this docum
21、ent is information given for the convenience of users and does not constitute an endorsement.For an explanation 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
22、(TBT), see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 3, Terminology.ISO is now publishing all its standards using a processing system that allows the production of International Standards as XML files.
23、 With this new system, the terms and definitions from terminologies and vocabularies are stored in the Online Browsing Platform (OBP) (www.iso.org/obp) where they can be browsed free of charge by members of the public (but not downloaded).iv ISO 2014 All rights reserved/Tous droits rservsBS EN ISO 1
24、6443:2014ISO 16443:2014(E/F)IntroductionThis terminology international standard has been prepared 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 V
25、ocabulary Part 1: Theory and application, andISO 10241-1, Terminological entries in standards Part 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 appro
26、ach presents the advantage of being independent from language, therefore allowing the same logical numbering in any language. ISO 2014 All rights reserved/Tous droits rservs vBS EN ISO 16443:2014BS EN ISO 16443:2014Dentistry Vocabulary for dental implants systems and related procedure1 ScopeThis Int
27、ernational 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. Grafting materials and membranes are excluded from this International Standard.The following dev
28、ices 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 provide anchorage for an epithesis (to replace for example: ears, noses and parts of eyes and
29、 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 which is to provide anchorage for an orthodontic appliance: orthodontic implant1).2 Normativ
30、e 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 document (including any amendments) appl
31、ies.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 and definitions related on medical devices used in oral implantologyFor the purposes of this
32、 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 purposes of which are to support and/or to resist displacement of a dental prosthesis3.1.1.1en
33、dosseous 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.INTERNATIONAL STANDARD ISO 16443:2014(E/F) ISO 2014 All rights reserved/Tous droits rservs 1BS EN ISO 16443:2014ISO 16443:20
34、14(E/F)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 thro
35、ugh 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 endosseous im
36、plantramus 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 structure3.
37、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 exten
38、d 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 systemimplan
39、t 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 comp
40、onentelement of a dental implant system (3.2.1)2 ISO 2014 All rights reserved/Tous droits rservsBS EN ISO 16443:2014ISO 16443:2014(E/F)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.
41、4implant bodydental implant bodyimplant 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 endo
42、sseous zoneportion of the implant body (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
43、.2) intended to contact the patients 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
44、connective platformportion of a dental 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
45、 implant body (3.2.4)3.2.9anti-rotation 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 th
46、e implant body (3.2.4)3.2.9.2internal anti-rotation featureanti-rotation feature (3.2.9) shaped within the implant body (3.2.4) ISO 2014 All rights reserved/Tous droits rservs 3BS EN ISO 16443:2014ISO 16443:2014(E/F)3.2.10implant abutmentimplant component (3.2.2) connected to the implant body (3.2.4
47、) or implant connecting part (3.2.11), which serves as an abutment3.2.10.1straight 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 abut
48、mentimplant abutment (3.2.10) having a principal long axis divergent from the 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 abutme
49、ntpartially castable abutmentUCLA abutment (DEPRECATED)prefabricated implant abutment (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) designed and fabricated using the CAD/CAM process3.2.10.7implant ball abutmentball abutmentimplant abutment that serves as a prosthetic attachment3.2.10.8
