1、March 2017 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).ICS 11.060.15!%bVN“2635143www.din.deDI
2、N EN ISO 14801Dentistry Implants Dynamic loading test for endosseous dental implants (ISO 14801:2016);English version EN ISO 14801:2016,English translation of DIN EN ISO 14801:2017-03Zahnheilkunde Implantate Dynamische Belastungsprfung fr enossale Dentalimplantate (ISO 14801:2016);Englische Fassung
3、EN ISO 14801:2016,Englische bersetzung von DIN EN ISO 14801:2017-03Mdecine buccodentaire Implants Essai de charge dynamique pour implants dentaires endoosseux (ISO 14801:2016);Version anglaise EN ISO 14801:2016,Traduction anglaise de DIN EN ISO 14801:2017-03SupersedesDIN EN ISO 14801:200802www.beuth
4、.deDocument comprises 22 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.03.17 DIN EN ISO 14801:2017-03 2 A comma is used as the decimal marker. National foreword This document (EN ISO 14801:2016) has been prepared by Technical
5、 Committee ISO/TC 106 “Dentistry” (Secretariat: SCC, Canada) in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 0
6、14-00-21 AA Dentalimplantate. The DIN Standards corresponding to the International Standards referred to in Clause 2 of this standard are as follows: ISO 1942 DIN EN ISO 1942 ISO 16443 DIN EN ISO 16433 ISO 7500-1 DIN EN ISO 7500-1 Amendments This standard differs from DIN EN ISO 14801:2008-02 as fol
7、lows: a) In 5.7, an alternative test method has been included: stair case method; b) the informative Annex A has been included for the determination of the worst case situation; c) the description of the procedure for testing has been improved, e.g., the interval of the temperature stability has bee
8、n extended from (20null5) C to (20null10) C. Previous editions DIN EN ISO 14801: 2003-12, 2008-02 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 16443, Dentistry Vocabulary for dental implants systems and related procedure DIN EN ISO 7500-1, Metallic ma
9、terials Calibration and verification of static uniaxial testing machines Part 1: Tension/compression testing machines Calibration and verification of the force-measuring system EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14801 November 2016 ICS 11.060.15 Supersedes EN ISO 14801:2007Engl
10、ish Version Dentistry - 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 Belastungsprfung fr enossale Dentalimplant
11、ate(ISO 14801:2016) 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
12、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 other language made by translation under the re
13、sponsibility 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
14、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 andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NO
15、RMALISATION 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 14801:2016 EEuropean foreword .31 Scope . 52 Normative references
16、53 Terms and definitions . 54 General principles . 64.1 Finished device testing 64.2 Multi-part endosseous dental implants 64.3 Worst-case testing 65 Test methods . 75.1 Testing machine . 75.2 Loading geometry. 75.3 Specimen holder and load application 105.4 Testing environment . 115.5 Loading frequ
17、ency and wave form . 115.6 Procedure . 115.7 Alternative procedure Stair case method 126 Reporting . 13Annex A (informative) Load-cycle diagram 15Annex B (informative) Guide to determination of worst-case conditions 16Bibliography .20Contents PageDIN EN ISO 14801:2017-03 EN ISO 14801:2016 (E)2Forewo
18、rd 4European foreword This 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, ei
19、ther by publication of an identical 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 CEN
20、ELEC shall not be held responsible 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, Bel
21、gium, 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, Switz
22、erland, Turkey and the United Kingdom. Endorsement notice The text of ISO 14801:2016 has been approved by CEN as EN ISO 14801:2016 without any modification. DIN EN ISO 14801:2017-03 EN ISO 14801:2016 (E)3 ForewordISO (the International Organization for Standardization) is a worldwide federation of n
23、ational 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 committee. Inter
24、national 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 and those inte
25、nded 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, Part 2 (see www
26、.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 the document w
27、ill 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 terms and expres
28、sions 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, Subcommittee SC 8 Dental
29、implants.This third edition cancels and replaces the second edition (ISO 14801:2007), which has been technically revised.DIN EN ISO 14801:2017-03 EN ISO 14801:2016 (E)4 1 ScopeThis International Standard specifies a method of dynamic testing of single post endosseous dental implants of the transmuco
30、sal type in combination with their premanufactured prosthetic components. It is most useful for comparing endosseous dental implants of different designs or sizes. This International Standard is not a test of the fundamental fatigue properties of the materials from which the endosseous implants and
31、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 this International Standard simulates the functional loading of an endosseous dental implant under “worst case” conditions, it i
32、s not applicable for predicting the in vivo performance of an endosseous dental implant or dental prosthesis, particularly if multiple endosseous dental implants are used for a dental prosthesis.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this do
33、cument 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) applies.ISO 1942, Dentistry TerminologyISO 16443, Dentistry Vocabulary for dental implants systems
34、and related procedureISO 1099, Metallic materials Fatigue testing Axial force-controlled methodISO 7500-1, Metallic materials Calibration and verification of static uniaxial testing machines Part 1: Tension/compression testing machines Calibration and verification of the force-measuring system3 Term
35、s 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 that consists of integrated components including the ancillary instruments and specific equipment necessary for the clinical a
36、nd 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 resistance to displacement of an implant superstructure, an endosseous dental implant may be used as an anchorage for orthodontic
37、 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 removable prostheses, but excludes implant abutments.DIN EN ISO 14801:2017-03 EN ISO 14801:2016 (E)5 3.2prosthetic componentsimpla
38、nt components to be used for two part implant or multi-part implantNote 1 to entry: Implant abutments, dental implant connecting parts, abutment screws, and implant connecting part screws are used as prosthetic components in this International Standard.3.3endosseous dental implant assemblydental imp
39、lant assembly for endosseous dental implant3.4load-cycle diagramdiagram summarizing the dynamic loading properties of an endosseous dental implant by showing 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.3.5en
40、dosseous dental implant bodyimplant body of endosseous dental implant4 General principles4.1 Finished device testingTesting shall be performed on specimens that are representative of the finished device (i.e. implant components that have undergone the same manufacturing process and sterilization as
41、the device that is to be marketed). If the manufacturer intends the endosseous dental implant to be sterilized by the clinician prior to surgery, sterilization shall be carried out as specified in the manufacturers instructions for use before testing. However, if there is evidence that the specified
42、 sterilization method has no significant effect on the properties of all the materials of the specimens being tested, then sterilization is not necessary prior to testing.4.2 Multi-part endosseous dental implantsA multi-part endosseous dental implant shall be tested as assembled according to its int
43、ended use. An endosseous dental implant component recommended by its manufacturer to be used in conjunction with components of another manufacturer shall be tested as assembled according to the recommending manufacturers statement. Where a multi-part device is assembled by means of screw joints, the
44、n these shall be used according to the manufacturers recommendations and shall be tightened to the manufacturers recommended torque using the equipment (implant screwdriver, torque wrench) which is provided together with the implant system or using a device that provides torque within 5 % of the rec
45、ommended value if no original instruments are available. The tightening sequence shall be as recommended by the manufacturer.4.3 Worst-case testingIf a part of the endosseous dental implant system is available in various dimensions and/or configurations, testing shall be carried out for the worst-ca
46、se 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 in Annex B.DIN EN ISO 14801:2017-03 EN ISO 14801:2016 (E)6 5 Test methods5.1 Testing machineThe testing machine shall be capable of applying the pre
47、scribed load with an error not exceeding 5 % at maximum load (in accordance with ISO 7500-1), be capable of applying the load at the prescribed frequency, include instrumentation to monitor the values of maximum and minimum loads and loading frequency and to detect failure of the specimen, and be ca
48、pable 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, 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 (see
