1、BS EN ISO 14801:2016Dentistry Implants Dynamic loading test forendosseous dental implantsBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 14801:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 14801:2016. It supe
2、rsedes BS EN ISO 14801:2007 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/8, Dental implants.A list of organizations represented on this committee can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 n
3、ecessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016. Published by BSI Standards Limited 2016ISBN 978 0 580 82365 7ICS 11.060.15Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard
4、was published under the authority of theStandards Policy and Strategy Committee on 30 November 2016.Amendments/Corrigenda issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14801 November 2016 ICS 11.060.15 Supersedes EN ISO 14801:2007English Version D
5、entistry - Implants - Dynamic loading test for endosseous dental implants (ISO 14801:2016) Mdecine bucco-dentaire - Implants - Essai de charge dynamique pour implants dentaires endo-osseux (ISO 14801:2016) Zahnheilkunde - Implantate - Dynamische Ermdungsprfung fr enossale Dentalimplantate (ISO 14801
6、:2016) This European Standard was approved by CEN on 28 August 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 without any alteration. Up-to-date lists and bibliographic
7、al 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 other language made by translation under the responsibility
8、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, Denmark, Estonia, Finland, Former Yugoslav Republic of M
9、acedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION E
10、UROPISCHES 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 14801:2016 EBS EN ISO 14801:2016EN ISO 14801:2016 (E) 3 European foreword This
11、document (EN ISO 14801:2016) 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 European Standard shall be given the status of a national standard, either by publication of an i
12、dentical text or by endorsement, at the latest by May 2017, and conflicting national standards shall be withdrawn at the latest by May 2017. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held resp
13、onsible for identifying any or all such patent rights. This document supersedes EN ISO 14801:2007. 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, Croatia, Cy
14、prus, 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 the Unit
15、ed Kingdom. Endorsement notice The text of ISO 14801:2016 has been approved by CEN as EN ISO 14801:2016 without any modification. BS EN ISO 14801:2016ISO 14801:2016(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 General principles . 24.1 Finished device testing 24.2 Mul
16、ti-part endosseous dental implants 24.3 Worst-case testing 25 Test methods . 35.1 Testing machine . 35.2 Loading geometry. 35.3 Specimen holder and load application . 65.4 Testing environment 75.5 Loading frequency and wave form 75.6 Procedure 75.7 Alternative procedure Stair case method . 86 Report
17、ing 9Annex A (informative) Load-cycle diagram 11Annex B (informative) Guide to determination of worst-case conditions 12Bibliography .16 ISO 2016 All rights reserved iiiContents PageBS EN ISO 14801:2016ISO 14801:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide f
18、ederation 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 be represented on that co
19、mmittee. 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 to develop this document
20、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 the ISO/IEC Directives, P
21、art 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 during the development of
22、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 meaning of ISO specific te
23、rms 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 106 Dentistry, Subcommitte
24、e SC 8 Dental implants.This third edition cancels and replaces the second edition (ISO 14801:2007), which has been technically revised.iv ISO 2016 All rights reservedBS EN ISO 14801:2016INTERNATIONAL STANDARD ISO 14801:2016(E)Dentistry Implants Dynamic loading test for endosseous dental implants1 Sc
25、opeThis International Standard specifies a method of dynamic testing of single post endosseous dental implants of the transmucosal type in combination with their premanufactured prosthetic components. It is most useful for comparing endosseous dental implants of different designs or sizes. This Inte
26、rnational Standard is not a test of the fundamental fatigue properties of the materials from which the endosseous implants and prosthetic components are made.This International Standard is not applicable to dental implants with endosseous lengths shorter than 8 mm nor to magnetic attachments.While t
27、his International Standard simulates the functional loading of an endosseous dental implant under “worst case” conditions, it is not applicable for predicting the in vivo performance of an endosseous dental implant or dental prosthesis, particularly if multiple endosseous dental implants are used fo
28、r a dental prosthesis.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
29、 (including any amendments) applies.ISO 1942, Dentistry TerminologyISO 16443, Dentistry Vocabulary for dental implants systems and related procedureISO 1099, Metallic materials Fatigue testing Axial force-controlled methodISO 7500-1, Metallic materials Calibration and verification of static uniaxial
30、 testing machines Part 1: Tension/compression testing machines Calibration and verification of the force-measuring system3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942, ISO 16443, and the following apply.3.1endosseous dental implant systemdevice
31、 that consists of integrated components including the ancillary instruments and specific equipment necessary for the clinical and laboratory preparation and placement of the implant, and for the construction and insertion of the dependent dental prosthesisNote 1 to entry: In addition to providing re
32、sistance to displacement of an implant superstructure, an endosseous dental implant may be used as an anchorage for orthodontic appliances.Note 2 to entry: An endosseous dental implant may consist of one or more parts.Note 3 to entry: The term implant superstructure includes crowns and fixed and rem
33、ovable prostheses, but excludes implant abutments. ISO 2016 All rights reserved 1BS EN ISO 14801:2016ISO 14801:2016(E)3.2prosthetic componentsimplant components to be used for two part implant or multi-part implantNote 1 to entry: Implant abutments, dental implant connecting parts, abutment screws,
34、and implant connecting part screws are used as prosthetic components in this International Standard.3.3endosseous dental implant assemblydental implant assembly for endosseous dental implant3.4load-cycle diagramdiagram summarizing the dynamic loading properties of an endosseous dental implant by sho
35、wing for each value of the applied peak load the number of cycles endured by each specimen at the time of failureNote 1 to entry: See Annex A.3.5endosseous dental implant bodyimplant body of endosseous dental implant4 General principles4.1 Finished device testingTesting shall be performed on specime
36、ns that are representative of the finished device (i.e. implant components that have undergone the same manufacturing process and sterilization as the device that is to be marketed). If the manufacturer intends the endosseous dental implant to be sterilized by the clinician prior to surgery, sterili
37、zation shall be carried out as specified in the manufacturers instructions for use before testing. However, if there is evidence that the specified sterilization method has no significant effect on the properties of all the materials of the specimens being tested, then sterilization is not necessary
38、 prior to testing.4.2 Multi-part endosseous dental implantsA multi-part endosseous dental implant shall be tested as assembled according to its intended use. An endosseous dental implant component recommended by its manufacturer to be used in conjunction with components of another manufacturer shall
39、 be tested as assembled according to the recommending manufacturers statement. Where a multi-part device is assembled by means of screw joints, then these shall be used according to the manufacturers recommendations and shall be tightened to the manufacturers recommended torque using the equipment (
40、implant screwdriver, torque wrench) which is provided together with the implant system or using a device that provides torque within 5 % of the recommended value if no original instruments are available. The tightening sequence shall be as recommended by the manufacturer.4.3 Worst-case testingIf a p
41、art of the endosseous dental implant system is available in various dimensions and/or configurations, testing shall be carried out for the worst-case conditions within the recommended use. The choice of worst case shall be justified and documented. Guidance on how to choose the worst case is given i
42、n Annex B.2 ISO 2016 All rights reservedBS EN ISO 14801:2016ISO 14801:2016(E)5 Test methods5.1 Testing machineThe testing machine shall be capable of applying the prescribed load with an error not exceeding 5 % at maximum load (in accordance with ISO 7500-1), be capable of applying the load at the p
43、rescribed frequency, include instrumentation to monitor the values of maximum and minimum loads and loading frequency and to detect failure of the specimen, and be capable of recording the number of loading cycles during the test.5.2 Loading geometry5.2.1 The loading force (see Figure 1 and Figure 2
44、, arrow F) of the testing machine shall be applied in such a way that no lateral constraint occurs, the position of the intersection of the loading axis (Line AB) with the axis of the endosseous dental implant (Line DE), is well-defined, such that the moment arm (y) can be measured or calculated (se
45、e Figure 1 and Figure 2). ISO 2016 All rights reserved 3BS EN ISO 14801:2016ISO 14801:2016(E)5.2.2 An endosseous dental implant from a system that includes only straight implant abutments shall be clamped such that its central longitudinal axis makes a 30 2 angle with the loading direction of the te
46、sting machine (see Figure 1).Key1 loading devicea2 nominal bone levelb3 implant abutment4 hemispherical loading member5 implant body6 specimen holder7 force applicationaShall be allowed free movement transverse to loading direction (see 5.2.5).bSee 5.3.2.Figure 1 Schematic of test set-up for systems
47、 with no angulated implant abutments5.2.3 An endosseous dental implant body of a system that includes angulated implant abutments shall be clamped such that the angle with the loading direction of the testing machine is 10 + 2/-1 greater 4 ISO 2016 All rights reservedBS EN ISO 14801:2016ISO 14801:20
48、16(E)than the angle between the central longitudinal axis of the implant and the central longitudinal axis of the angled-portion of the abutment, designated as in Figure 2.This represents a simulated undercorrection of 10. The loading method shall be the same as that shown in Figure 1. The loading c
49、entre shall be located at the intersection of the central longitudinal axis of the free end of the abutment and the plane normal to the longitudinal axis of the implant and located 11 mm (Figure 2, l) from the support level of the implant.Key1 loading devicea2 nominal bone levelb3 implant abutment4 hemispherical loading member5 implant body6 specimen holder7 force applicationaShall be allowed free movement transverse to loading direction (see 5.2.5).bSee 5.3.2.Figure 2 Schematic of test set-up for systems w
