EN ISO 19429-2016 en Dentistry - Designation system for dental implants《牙科-牙科植入物设计系统(ISO 19429 2015)》.pdf

1、BS ISO 19429:2015Dentistry Designationsystem for dental implants(ISO 19429:2015)BS EN ISO 19429:2016 BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 19429:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 19429:2

2、016. It is identical to ISO 19429:2015. It supersedes BS ISO 19429:2015 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/8, Dental implants.A list of organizations represented on this subcommittee can be obtaine

3、d on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016ISBN 978 0 580 92794 2ICS 11.060.15Compliance with

4、a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2015.Amendments/corrigenda issued since publicationDate Text affected31 July 2016 This corrigendum renumbers BS ISO 19

5、249:2015 as BS EN ISO 19429:2016.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) Mdecine bucco-dentaire - Systme de dsignation pour les implants dentaires (ISO 19429:2015) Zahnh

6、eilkunde - 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 stipulate the conditions for giving this European Standard the status of a national standard w

7、ithout 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 (English, French, German). A version in any oth

8、er 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, Bulgaria, Croatia, Cyprus, Czech Republic,

9、 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, Switzerland, Turkey and United Kingdom. EUROPEAN COMM

10、ITTEE 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 by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 19429:2016 EBS ISO 19

11、429:2015ISO 19429:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification, designation and coding 1Bibliography 2 ISO 2015 All rights reserved iiiContents PageEN ISO 19429:2016 (E) 3 European foreword The text of ISO 19429:2015 has been prepared

12、 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 by DIN. This European Standard shall be given the status of a national

13、 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 that some of the elements of this document may be the subject of patent

14、 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 European Standard: Austria, Belgium, Bulgaria, Croat

15、ia, 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, Switzerland, Turkey and th

16、e United Kingdom. Endorsement notice The text of ISO 19429:2015 has been approved by CEN as EN ISO 19429:2016 without any modification. BS EN ISO 19429:2016EN ISO 19429:2016 (E)BS ISO 19429:2015ISO 19429:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14

17、Classification, designation and coding 1Bibliography 2 ISO 2015 All rights reserved iiiContents PageBS EN ISO 19429:2016ISO 19429:2015(E)BS ISO 19429:2015ISO 19429:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO memb

18、er 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 the right to be represented on that committee. International organizations, government

19、al 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 procedures used to develop this document and those intended for its further maintenance a

20、re 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 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is

21、 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 identified during the development of the document will be in the Introduction and/or

22、 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 explanation on the meaning of ISO specific terms and expressions related to conformity asse

23、ssment, 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 document is ISO/TC 106, Dentistry, Subcommittee SC 8, Dental implants.iv ISO 2015 All right

24、s reservedBS ISO 19429:2015ISO 19429:2015(E)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 devices within the jaws which is compatible with existing schemes. Denta

25、l 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 form. In contrast, a designated tooth has a defined form and an impl

26、ied 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 endosseous dental implants. Given that these form the majority of impl

27、ants 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 infrequently used implants of other types and in alternative locations would

28、make the system more complex for the potential benefit currently obtained. The possibility of doing so in the future is not however excluded. ISO 2015 All rights reserved vBS EN ISO 19429:2016ISO 19429:2015(E)BS ISO 19429:2015ISO 19429:2015(E)ForewordISO (the International Organization for Standardi

29、zation) 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 the right to b

30、e 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 procedures used t

31、o 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 editorial rules of t

32、he 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 identified d

33、uring 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 explanation on the

34、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 document is ISO/TC

35、106, Dentistry, Subcommittee SC 8, Dental implants.iv ISO 2015 All rights reservedBS ISO 19429:2015ISO 19429:2015(E)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

36、devices 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 cr

37、own 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 no

38、t endosseous 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 infre

39、quently 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. ISO 2015 All rights reserved vBS EN ISO 19429:2016ISO 19429:2015(E)BS ISO 19429:2015 B

40、S ISO 19429:2015Dentistry Designation system for dental implants1 ScopeThis International Standard provides 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 visib

41、le within the oral cavity or the presence of transmucosal components or implant restorations. Since the system 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

42、 recorded by the responsible clinician in the patients file and 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

43、 references, only the edition cited applies. 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 16443, Dentistry Vocabulary for dental

44、implants systems and related procedure3 Terms and definitionsFor the purpose of this document, the terms and 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 emp

45、loying a system corresponding to that described in ISO 3950.In all cases, the following sequence shall be employed. 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 respectivel

46、y.NOTE Since the system 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. Character 2: This is a digit in the range 1 to 8, and indicates the location of an implant body in the defined q

47、uadrant in a position analogous to that of a natural tooth. Character 3: This is always the character ! which 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

48、punctuation. For example, 36! indicates the presence of a dental implant body in the left mandibular first molar region.INTERNATIONAL STANDARD ISO 19429:2015(E) ISO 2015 All rights reserved 1BS EN ISO 19429:2016BS ISO 19429:2015 BS ISO 19429:2015Dentistry Designation system for dental implants1 Scop

49、eThis International Standard provides 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 system 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