1、PD ISO/TS 18130:2016 Dentistry Screw loosening test using cyclic torsional loading for implant body/ implant abutment connection of endosseous dental implants BSI Standards Publication WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06PD ISO/TS 18130:2016 PUBLISHED DOCUMENT National foreword T
2、his Published Document is the UK implementation of ISO/TS 18130:2016. The UK participation in its preparation was entrusted to Technical Committee CH/106/8, Dental implants. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not p
3、urport 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 2016 ISBN 978 0 580 82458 6 ICS 11.060.15 Compliance with a British Standard cannot confer immunity from legal o
4、bligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 May 2016. Amendments issued since publication Date Text affectedPD ISO/TS 18130:2016 ISO 2016 Dentistry Screw loosening test using cyclic torsional loading for implant body/impl
5、ant abutment connection of endosseous dental implants Medecine bucco-dentaire Essai de dvissage dune vis utilisant une charge de torsion cyclique pour le corps dimplant/pilier implantaire des implants dentaires endo-osseux TECHNICAL REPORT ISO/TR 18130 Reference number ISO/TR 18130:2016(E) First edi
6、tion 2016-05-01PD ISO/TS 18130:2016ISO/TR 18130:2016(E)ii ISO 2016 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, ele
7、ctronic or mechanical, including photocopying, 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 office Ch. de Blandonnet 8 CP 401 CH-1214 Ve
8、rnier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.orgPD ISO/TS 18130:2016ISO/TR 18130:2016(E)Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 1 4 General principle . 2 5 Test methods . 2 5.1 Test condition . 2 5.2
9、 Torque meter 2 5.3 Preparation of test specimens . 2 5.4 Initial screw removal torque . 3 5.4.1 Procedure . 3 5.5 Screw removal torque after cyclic torque test . 3 5.5.1 Cyclic torque tester 3 5.5.2 Torque transducer 4 5.5.3 Procedure . 4 5.6 Evaluation 5 6 Test report . 5 Bibliography 6 ISO 2016 A
10、ll rights reserved iii Contents PagePD ISO/TS 18130:2016ISO/TR 18130:2016(E) Foreword ISO (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
11、 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, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates cl
12、osely 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 are described in the ISO/IEC Directives, Part 1. In particular the different approval criteri
13、a 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 drawn to the possibility that some of the elements of this document may be the subject of p
14、atent 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 on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name u
15、sed 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 conformit y assessment, as well as information about ISOs adherence to the World Trade Organization (WTO)
16、principles in the Technical Barriers to Trade (TBT) see the following URL: 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) Introduction Most
17、 endosseous dental implants currently marketed employ a dental implant body 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 res
18、ist vertical masticatory loads, which have a significant torsional component. 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 th
19、e linked components will occur. A cyclic torsional screw loosening test for 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 lo
20、ading for implant body/implant abutment connection of endosseous dental implants 1 Scope This 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 m
21、ulti-part implants under cyclic torsional loading. This test is most appropriate 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 us
22、e is for prefabricated implant bodies, implant abutments and, if appropriate, 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 Techni
23、cal Report is not intended for use with temporary abutments. 2 Normative references The 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 l
24、atest edition of the referenced document (including any amendments) applies. ISO 1942, Dentistry Vocabulary ISO 16443, Dentistry Vocabulary for dental implants systems and related procedure 3 T erms a nd definiti ons For the purposes of this document, the terms and definitions given in ISO 1942 and
25、ISO 16443 and the following apply. 3.1 cyclic torque repeated torsional force alternatively clockwise and counter clockwise 3.2 screw loosening decrease in screw removal torque relative to the removal torque when the abutment screw was first installed 3.3 screw tightening torque torque value for scr
26、ew required to tighten the implant abutment, and the implant connecting part if appropriate, to the implant body as per specified by the manufacturer 3.4 screw removal torque torque value for screw required to deconstruct the connection between the implant body and the implant abutment, and the impl
27、ant connecting part if appropriate TECHNICAL REPORT ISO/TR 18130:2016(E) ISO 2016 All rights reserved 1PD ISO/TS 18130:2016ISO/TR 18130:2016(E) 3.5 temporary abutment implant abutment for temporary usage 4 General principle The endurance properties of implant body/implant abutment interface should b
28、e tested by applying a cyclic alternating torsional load to the implant body and implant abutment clamped 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
29、 same manufacturing process as the device that is to be marketed). If the manufacturer intends the implant 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 ev
30、idence that the specified sterilization method has no significant effect on the properties of all the materials 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 sev
31、eral types of implant abutments with the same connecting interface, a straight implant abutment having a metallic 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 method
32、s 5.1 Test condition Carry out the test at (25 10) C. 5.2 Torque meter Use a torque meter with an accuracy of 0,3 Ncm or less. NOTE An example of a torque meter is HDP-5 1)manufactured by HIOS INC, Japan. 5.3 Preparation of test specimens The implant abutment, and implant connecting part if appropri
33、ate, should be fixed on the implant body using the specified/recommended screw at screw tightening torques stated by 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
34、maximum diameter of implant body and/or implant abutment to more easily clamp with the holders. An example of a test 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 torq
35、ue test with the mean of the initial screw removal torques. 1) HDP-5 is an example of a suitable product available commercially. 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/
36、TS 18130:2016ISO/TR 18130:2016(E) Key 1 implant body 2 implant abutment 3 abutment screw Figure 1 Schematic of a test specimen 5.4 Initial screw removal torque 5.4.1 Procedure The initial screw removal torque of six specimens should be measured according to the following procedure. a) The implant ab
37、utment, and implant connecting part, if appropriate, should be fixed on the implant body using the specified screw at screw tightening 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, meas
38、ure the screw removal torque by torque meter. c) Calculate the mean and standard deviation of initial screw removal torque from the obtained values for the at least six specimens. 5.5 Screw removal torque after cyclic torque test 5.5.1 Cyclic torque tester The test device should have the following p
39、arts: specimen holders (the implant body and implant abutment should each be held at a maximum of 5 mm from the joint line between them); torque transducer; torsional cyclic driving device that can apply cyclic torque greater than 10 % of screw tightening torque; torsional cyclic displacement transd
40、ucer. An example of a torsional testing device is illustrated in Figure 2. The central long axes of the shafts of the torque transducer and torsional driving device should coincide. ISO 2016 All rights reserved 3PD ISO/TS 18130:2016ISO/TR 18130:2016(E) Key 1 specimen holder 2 torque transducer 3 tor
41、sional cyclic driving device 4 torsional cyclic displacement transducer 5 lever arm 6 output of torsional displacement to recorder 7 output of torsional torque to recorder 8 implant body 9 implant abutment Figure 2 Example of testing device for cyclic torque test 5.5.2 Torque transducer The accuracy
42、 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 Procedure a) The implant abutment, and implant connecting part, if appropriate, should be fixed on the implant body using the specified screw at screw tighteni
43、ng torques as stated in the manufacturers instructions for use. These implant components should be new ones that have never previously been assembled. 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 dev
44、ice. 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 and counter clockwise) up to 10 % of the screw tightening torque stated in the manufactures instruction to the implant abutment with the velocity of
45、 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 specimen survives without deformation and/or fracture after 100 000 cycles, measure the screw removal torque by torque meter. When the specimen doe
46、s 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 a microscope. f) At least six specimens should be tested. g) Calculate the mean and standard deviation of the measured screw removal torque after
47、cyclic torque test of at least six specimens NOTE 1 Implant body and implant abutment joint part are sealed by screw tightening and the part may not be affected 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-XR 2)manufactured by
48、 Shimadzu Corporation, Japan. 5.6 Evaluation Calculate the ratio of the mean initial screw removal torque to the screw tightening torque. Calculate the ratio of the mean screw removal torque after cyclic torque test to the mean initial screw removal torque. 6 Test report The test report should inclu
49、de 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 the 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 sterili
