EN ISO 16498-2013 en Dentistry - Minimal dental implant data set for clinical use《牙科学 临床应用最小的牙移植数据集》.pdf

1、BSI Standards PublicationBS EN ISO 16498:2013Dentistry Minimal dentalimplant data set for clinical use(ISO 16498:2013)BS EN ISO 16498:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO16498:2013.The UK participation in its preparation was entrusted to Tech

2、nicalCommittee CH/106/8, Dental implants.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 In

3、stitution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 74126 5ICS 11.060.15Compliance 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 August 2013.Amendments

4、issued since publicationDate Text affectedEUROPEAN 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 (ISO 16498:2013) Mdecine bucco-dentaire - Informations cliniques minimales requises pour les p

5、orteurs dimplants dentaires (ISO 16498:2013) Zahnheilkunde - Mindestdatensatz fr Dentalimplantate fr die klinische Anwendung (ISO 16498:2013) This European Standard was approved by CEN on 12 July 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the cond

6、itions 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 European Standard exist

7、s 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 the national stan

8、dards 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, Romania, Slovakia, Sl

9、ovenia, 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 CEN All rights of exploitation in any form and by any means reserved worldwide

10、 for CEN national Members. Ref. No. EN ISO 16498:2013: EBS EN ISO 16498:2013EN ISO 16498:2013 (E) 3 Foreword This document (EN ISO 16498:2013) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is h

11、eld 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 shall be withdrawn at the latest by January 2014. Attention is drawn to the possibility

12、 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 boun

13、d 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

14、, 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. BS EN ISO 16498:2013ISO 16498:2013(E) ISO 2013 All rights reserved iiiContents PageForeword

15、ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 General information . 14.1 Patients identification . 14.2 Clinicians identification 24.3 Implant bodies 24.4 Connecting components . 24.5 Adjunctive devices . 34.6 Suprastructure 3Bibliography 5BS EN ISO 16498:2013ISO 16

16、498:2013(E)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 technical committees. Each member body interested in a subject for

17、 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 closely with the International Electrotechnical Commission (IEC) on a

18、ll 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 needed for the different types of ISO documents should be noted. T

19、his 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 rights. ISO shall not be held responsible for identifying any or all

20、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 document is information given for the convenience of users and does no

21、t constitute an endorsement.The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 8, Dental implants.iv ISO 2013 All rights reservedBS EN ISO 16498:2013ISO 16498:2013(E)IntroductionDental implant treatment is a widely employed therapeutic procedure using endosseous de

22、vices which have a service life of many decades, although the restorations that they stabilize not infrequently require maintenance during this period. Uniquely, for such an extensively utilized technique, procedures are largely dependent upon the availability of pre-manufactured precision component

23、s. These are typically device-specific and frequently subject to design changes as manufacturers develop their products. Treatment of a patient 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 connect

24、ing components and adjunctive devices that have been utilized. This standard describes a minimum data set for meeting this requirement. The 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

25、dental implants by recording the relevant details of the inserted device(s) and any associated connecting components and adjunctive devices. 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

26、clinician(s). ISO 2013 All rights reserved vBS EN ISO 16498:2013BS EN ISO 16498:2013Dentistry Minimal dental implant data set for clinical use1 ScopeThis International Standard specifies the minimal data set to be recorded for a patient receiving dental implant treatment. This will comprise the loca

27、tions 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 patients file and should be made available to the patient by the clinician(s) who pr

28、ovided 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 document (incl

29、uding 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 Representation of dates and times3 Terms and definitionsFor the purposes of this document,

30、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 within, through or upon the bones of the craniofacial complex, the primary purpo

31、ses 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 implant body to provide support for the function of the implantSOURCE: ISO 1942

32、: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 human tissue4 General information4.1 Patients identificationINTERNATIONAL STAND

33、ARD ISO 16498:2013(E) ISO 2013 All rights reserved 1BS EN ISO 16498:2013ISO 16498:2013(E) patients name; patients date of birth.4.2 Clinicians identification clinicians name; clinicians national registration number or license number.4.3 Implant bodies4.3.1 GeneralFor each dental implant body, the de

34、ntist 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 and national regi

35、stration 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 official sales agent

36、 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 connecting compone

37、nts; 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 implant; the placemen

38、t 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);2 ISO 2013 All rights reservedBS EN ISO 16498:2013ISO 16498:2013(E) the mechanism for linking the connecting

39、component 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 c

40、onnecting 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 an

41、d/or 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

42、.5 Adjunctive 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

43、and/or 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

44、applicable (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; ISO 2013 All rights reserved 3BS EN ISO 16498:2013ISO 16498:2013(E) type, dimensions and material used; batch code (if available).4.6.2

45、 Dental/oral prosthesis manufacturer; manufacturing date; type and design; material(s) used with their lot number or serial number (if available); date of placement.4 ISO 2013 All rights reservedBS EN ISO 16498:2013ISO 16498:2013(E)Bibliography1 ISO 3166-1, Codes for the representation of names of c

46、ountries 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 procedures ISO 2013 All rights reserved 5This page delib

47、erately left blankThis page deliberately left blankBSI is the national body responsible for preparing British Standards and other standards-related publications, information and services.BSI is incorporated by Royal Charter. British Standards and other standardization products are published by BSI S

48、tandards Limited.British Standards Institution (BSI)BSI Group Headquarters389 Chiswick High Road London W4 4AL UKAbout usWe bring together business, industry, government, consumers, innovators and others to shape their combined experience and expertise into standards -based solutions.The knowledge e

49、mbodied in our standards has been carefully assembled in a dependable format and refined through our open consultation process. Organizations of all sizes and across all sectors choose standards to help them achieve their goals.Information on standardsWe can provide you with the knowledge that your organization needs to succeed. Find out more about British Standards by visiting our website at or contacting our Customer Services team or Know