1、PD ISO/TS 18130:2016Dentistry Screw looseningtest using cyclic torsionalloading for implant body/implant abutment connectionof endosseous dental implantsBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06PD ISO/TS 18130:2016 PUBLISHED DOCUMENTNational forewordThis Publi
2、shed Document is the UK implementation of ISO/TS18130:2016.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 inclu
3、de all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016. Published by BSI StandardsLimited 2016ISBN 978 0 580 82458 6ICS 11.060.15Compliance with a British Standard cannot confer immunity fromlegal obligations.This Publis
4、hed Document was published under the authority of theStandards Policy and Strategy Committee on 31 May 2016.Amendments issued since publicationDate Text affectedPD ISO/TS 18130:2016 ISO 2016Dentistry Screw loosening test using cyclic torsional loading for implant body/implant abutment connection of
5、endosseous dental implantsMedecine bucco-dentaire Essai de dvissage dune vis utilisant une charge de torsion cyclique pour le corps dimplant/pilier implantaire des implants dentaires endo-osseuxTECHNICAL REPORTISO/TR18130Reference numberISO/TR 18130:2016(E)First edition2016-05-01PD ISO/TS 18130:2016
6、ISO/TR 18130:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including phot
7、ocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 74
8、9 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgPD ISO/TS 18130:2016ISO/TR 18130:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 General principle . 25 Test methods . 25.1 Test condition . 25.2 Torque meter 25.3 Preparation of test specimens . 25
9、.4 Initial screw removal torque . 35.4.1 Procedure . 35.5 Screw removal torque after cyclic torque test . 35.5.1 Cyclic torque tester 35.5.2 Torque transducer 45.5.3 Procedure . 45.6 Evaluation 56 Test report . 5Bibliography 6 ISO 2016 All rights reserved iiiContents PagePD ISO/TS 18130:2016ISO/TR 1
10、8130:2016(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 fo
11、r 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
12、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 needed for the different types of ISO documents should be noted.
13、This document was drafted in accordance with the editorial rules of the 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
14、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 (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of user
15、s 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 World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following U
16、RL: www.iso.org/iso/foreword.html.The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 8, Dental implants.iv ISO 2016 All rights reservedPD ISO/TS 18130:2016ISO/TR 18130:2016(E)IntroductionMost endosseous dental implants currently marketed employ a dental implant bod
17、y that is inserted within the jaw bone and to which other components may be joined when constructing a prosthetic superstructure. The connection between these components and the implant body should be sufficiently rigid to resist vertical masticatory loads, which have a significant torsional compone
18、nt. Endosseous dental implants may, therefore, incorporate features to restrict rotation at the connection. If this is insufficiently strong, then undesirable incidents, including screw loosening, distortion and fracture of the linked components will occur. A cyclic torsional screw loosening test fo
19、r the connection between implant body and implant abutment would facilitate comparative evaluation. ISO 2016 All rights reserved vPD ISO/TS 18130:2016PD ISO/TS 18130:2016Dentistry Screw loosening test using cyclic torsional loading for implant body/implant abutment connection of endosseous dental im
20、plants1 ScopeThis Technical Report provides guidelines for a method to determine the extent of screw loosening of the metallic implant body/implant abutment joint of endosseous dental implants, such as two-part implants or multi-part implants under cyclic torsional loading. This test is most appropr
21、iate for evaluating new types of joints fixed using screw(s) and metallic connecting parts. This Technical Report provides a protocol for torsional cyclic torque on an implant body/implant abutment joint, but its intended use is for prefabricated implant bodies, implant abutments and, if appropriate
22、, implant connecting parts that are made of metallic materials.It is not applicable to ensure the in vivo performance of endosseous dental implants and is not derived from observations of clinical failures.NOTE This Technical Report is not intended for use with temporary abutments.2 Normative refere
23、ncesThe 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) applies.ISO
24、1942, Dentistry VocabularyISO 16443, Dentistry Vocabulary for dental implants systems and related procedure3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and ISO 16443 and the following apply.3.1cyclic torquerepeated torsional force alternativel
25、y clockwise and counter clockwise3.2screw looseningdecrease in screw removal torque relative to the removal torque when the abutment screw was first installed3.3screw tightening torquetorque value for screw required to tighten the implant abutment, and the implant connecting part if appropriate, to
26、the implant body as per specified by the manufacturer3.4screw removal torquetorque value for screw required to deconstruct the connection between the implant body and the implant abutment, and the implant connecting part if appropriateTECHNICAL REPORT ISO/TR 18130:2016(E) ISO 2016 All rights reserve
27、d 1PD ISO/TS 18130:2016ISO/TR 18130:2016(E)3.5temporary abutmentimplant abutment for temporary usage4 General principleThe endurance properties of implant body/implant abutment interface should be tested by applying a cyclic alternating torsional load to the implant body and implant abutment clamped
28、 in the testing device.Testing should be performed on finished devices or specimens that have an implant abutment joint equivalent to the finished device (i.e. components that have undergone the same manufacturing process as the device that is to be marketed). If the manufacturer intends the implant
29、 components to be sterilized by the clinician prior to surgery, sterilization should be carried out before testing as specified in the manufacturers instructions for use. However, if there is evidence that the specified sterilization method has no significant effect on the properties of all the mate
30、rials of the specimens being tested, sterilization is not necessary prior to testing. If so, this should be documented in the test report.If a dental implant system to be tested consists of several types of implant abutments with the same connecting interface, a straight implant abutment having a me
31、tallic connecting interface should be selected for testing.NOTE Angulated implant abutments cannot be tested because the central axis of connected test specimens is not straight.5 Test methods5.1 Test conditionCarry out the test at (25 10) C.5.2 Torque meterUse a torque meter with an accuracy of 0,3
32、 Ncm or less.NOTE An example of a torque meter is HDP-51)manufactured by HIOS INC, Japan.5.3 Preparation of test specimensThe implant abutment, and implant connecting part if appropriate, should be fixed on the implant body using the specified/recommended screw at screw tightening torques stated by
33、the manufacturers instructions for use. The screw tightening torque should be applied using a torque meter. The ends of the test specimens may be modified into shapes larger than the maximum diameter of implant body and/or implant abutment to more easily clamp with the holders. An example of a test
34、specimen is illustrated in Figure 1.NOTE At least six specimens for each test according to 5.4 and 5.5 are required to compare the mean of the screw removal torques after cyclic torque test with the mean of the initial screw removal torques.1) HDP-5 is an example of a suitable product available comm
35、ercially. This information is given for the convenience of users of this document and does not constitute an endorsement by ISO of this product.2 ISO 2016 All rights reservedPD ISO/TS 18130:2016ISO/TR 18130:2016(E)Key1 implant body2 implant abutment3 abutment screwFigure 1 Schematic of a test specim
36、en5.4 Initial screw removal torque5.4.1 ProcedureThe initial screw removal torque of six specimens should be measured according to the following procedure.a) The implant abutment, and implant connecting part, if appropriate, should be fixed on the implant body using the specified screw at screw tigh
37、tening torques stated in the manufacturers instructions for use. These implant components should be new ones that have never previously been assembled.b) After 5 min, measure the screw removal torque by torque meter.c) Calculate the mean and standard deviation of initial screw removal torque from th
38、e obtained values for the at least six specimens.5.5 Screw removal torque after cyclic torque test5.5.1 Cyclic torque testerThe test device should have the following parts: specimen holders (the implant body and implant abutment should each be held at a maximum of 5 mm from the joint line between th
39、em); torque transducer; torsional cyclic driving device that can apply cyclic torque greater than 10 % of screw tightening torque; torsional cyclic displacement transducer.An example of a torsional testing device is illustrated in Figure 2.The central long axes of the shafts of the torque transducer
40、 and torsional driving device should coincide. ISO 2016 All rights reserved 3PD ISO/TS 18130:2016ISO/TR 18130:2016(E)Key1 specimen holder2 torque transducer3 torsional cyclic driving device4 torsional cyclic displacement transducer5 lever arm6 output of torsional displacement to recorder7 output of
41、torsional torque to recorder8 implant body9 implant abutmentFigure 2 Example of testing device for cyclic torque test5.5.2 Torque transducerThe accuracy of the torque transducer equipped in the cyclic torque tester (see 5.5.1) should be less than 1 % of the maximum torque to be tested.5.5.3 Procedur
42、ea) The implant abutment, and implant connecting part, if appropriate, should be fixed on the implant body using the specified screw at screw tightening torques as stated in the manufacturers instructions for use. These implant components should be new ones that have never previously been assembled.
43、b) After 5 min, clamp the retaining portions of the implant body and implant abutment of a test specimen into the specimen holders of the testing device. The implant body and implant abutment should each be held at a maximum of 5 mm from the joint line between them.c) Apply cyclic torque (clockwise
44、and counter clockwise) up to 10 % of the screw tightening torque stated in the manufactures instruction to the implant abutment with the velocity of 10 degree per minute. Repeat this cyclic torque up to 100 000 cycles.4 ISO 2016 All rights reservedPD ISO/TS 18130:2016ISO/TR 18130:2016(E)d) When the
45、specimen survives without deformation and/or fracture after 100 000 cycles, measure the screw removal torque by torque meter. When the specimen does not survive, record the number of cycles which it survives.e) After the test, observe the wear and deformation of the implant body/connecting joint by
46、a microscope.f) At least six specimens should be tested.g) Calculate the mean and standard deviation of the measured screw removal torque after cyclic torque test of at least six specimensNOTE 1 Implant body and implant abutment joint part are sealed by screw tightening and the part may not be affec
47、ted by corrosion during 100 000 times cyclic torque test (e.g. 1 d or 2 d).NOTE 2 An example of the testing machine is AG-XR2)manufactured by Shimadzu Corporation, Japan.5.6 EvaluationCalculate the ratio of the mean initial screw removal torque to the screw tightening torque. Calculate the ratio of
48、the mean screw removal torque after cyclic torque test to the mean initial screw removal torque.6 Test reportThe test report should include at least the following information:a) a reference to this Technical Report, i.e. ISO/TR 18130;b) the identification of the employed test specimens, including th
49、e type of connection (internal anti-rotation: taper-fit, notch-fit, hexagonal, etc.; external anti-rotation: hexagonal, etc.), manufacturer(s), part numbers and lot numbers of the tested parts, material(s) of the tested parts, diameter and length of the implant body and implant abutment;c) if applicable, the documented evidence that the specified sterilization method has no significant effect on the properties of all materials;d) the test method including the test condition, testing device, screw tightening torque applied t
