1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationDD ISO/TS 13498:2011Dentistry Torsion test ofimplant body/connecting partjoints of endosseous dentalimplant systemsDD ISO/TS 13498:2011 DRAFT FOR DEVELOPMENTNational forewordThis
2、 Draft for Development is the UK implementation of ISO/TS13498:2011.This publication is not to be regarded as a British Standard.It is being issued in the Draft for Development series of publicationsand is of a provisional nature. It should be applied on thisprovisional basis, so that information an
3、d experience of its practicalapplication can be obtained.Comments arising from the use of this Draft for Developmentare requested so that UK experience can be reported to theinternational organization responsible for its conversion toan international standard. A review of this publication willbe ini
4、tiated not later than 3 years after its publication by theinternational organization so that a decision can be taken on itsstatus. Notification of the start of the review period will be made inan announcement in the appropriate issue of Update Standards.According to the replies received by the end o
5、f the review period,the responsible BSI Committee will decide whether to support theconversion into an international Standard, to extend the life of theTechnical Specification or to withdraw it. Comments should be sentto the Secretary of the responsible BSI Technical Committee at BritishStandards Ho
6、use, 389 Chiswick High Road, London W4 4AL.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 neces
7、saryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 67201 9ICS 11.060.15Compliance with a British Standard cannot confer immunity fromlegal obligations.This Draft for Development was published under the authority ofthe Standards Policy and Strategy
8、Committee on 31 August 2011.Amendments issued since publicationDate Text affectedDD ISO/TS 13498:2011Reference numberISO/TS 13498:2011(E)ISO 2011TECHNICAL SPECIFICATION ISO/TS13498First edition2011-08-01Dentistry Torsion test of implant body/connecting part joints of endosseous dental implant system
9、s Mdecine bucco-dentaire Essai de torsion sur linterface corps dimplant/lment de connexion des systmes dimplants dentaires endo-osseux DD ISO/TS 13498:2011ISO/TS 13498:2011(E) COPYRIGHT PROTECTED DOCUMENT ISO 2011 All rights reserved. Unless otherwise specified, no part of this publication may be re
10、produced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 2
11、2 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2011 All rights reservedDD ISO/TS 13498:2011ISO/TS 13498:2011(E) ISO 2011 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of na
12、tional 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. Intern
13、ational 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. International Standards are drafted in accordance with the
14、rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by
15、at least 75 % of the member bodies casting a vote. In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publish other types of document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement betwee
16、n technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote; an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publ
17、ication if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confir
18、med, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or be withdrawn. 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 f
19、or identifying any or all such patent rights. ISO/TS 13498 was prepared by Technical Committee ISO/TC 106, Dentisty, Subcommittee SC 8, Dental implants. DD ISO/TS 13498:2011ISO/TS 13498:2011(E) iv ISO 2011 All rights reservedIntroduction Most dental implant systems currently on the market employ a d
20、ental implant body that is inserted within the jaw bone, to which other components can be joined when constructing a prosthetic superstructure. The connection between these components and the implant body should be sufficiently rigid to resist masticatory loads, which have a significant torsional co
21、mponent. Implant systems therefore often incorporate features to restrict rotation at the connection. If this is insufficiently strong, then distortion/fracture of the linked components will occur. A standardised torsion test for the joint between the implant body and connecting part facilitates com
22、parative evaluation. DD ISO/TS 13498:2011TECHNICAL SPECIFICATION ISO/TS 13498:2011(E) ISO 2011 All rights reserved 1Dentistry Torsion test of implant body/connecting part joints of endosseous dental implant systems 1 Scope This Technical Specification establishes a method to determine the torsional
23、yield strength and maximum torque of the implant body/connecting part joints of endosseous dental implant systems. This test is most appropriate for evaluating new types of joints and connecting parts, as well as new materials. This Technical Specification provides a protocol for torsional loading o
24、f an implant body/connecting part joint. It is not applicable for predicting the in vivo performance of an endosseous dental implant system and it is not derived from observations of clinical failure. 2 Normative references The following referenced documents are indispensable for the application of
25、this document. 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 Vocabulary 3 Terms and definitions For the purposes of this document, the terms and definitions given in
26、ISO 1942 and the following apply. 3.1 torsional yield strength Mtorstorque required to produce a rotation of 2 offset from the straight-line portion on the torque versus rotation angle curve NOTE See Figure 3. 3.2 maximum torque Mmaxlargest value of torque recorded on the torque versus rotation angl
27、e curve NOTE See Figure 3. 4 Principle The torsional yield strength and maximum torque of the implant body/connecting part interface are determined by clamping the implant body and connecting part to be tested in a testing device. Testing shall be performed on finished devices or specimens that have
28、 an equivalent connecting part joint to the finished device (i.e. components that have undergone the same manufacturing process and sterilisation as DD ISO/TS 13498:2011ISO/TS 13498:2011(E) 2 ISO 2011 All rights reservedthe device that is to be marketed). If the manufacturer intends the endosseous d
29、ental implant to be sterilised by the clinician prior to surgery, sterilisation shall be carried out as specified in the manufacturers instructions for use before testing. However, if there is evidence that the specified sterilisation method has no significant effect on the properties of all the mat
30、erials of the specimens being tested, sterilisation is not necessary prior to testing. 5 Test methods 5.1 Testing device The test device shall have the following parts: specimen holders (the implant body and connecting part shall each be held at a maximum of 5 mm from the interface between them); to
31、rque transducer; torsional driving device, able to apply a torque no less than the anticipated maximum torque; torsional displacement transducer. An example of a torsional testing device is illustrated in Figure 1. The central long axes of the shafts of the torque transducer and torsional driving de
32、vice shall be coincident. Key 1 specimen holder 6 output to X-axis of X-Y recorder 2 torque transducer 7 output to Y-axis of X-Y recorder 3 torsional driving device 8 implant body 4 torsional displacement transducer 9 connecting part 5 pulley Figure 1 Example of a testing device DD ISO/TS 13498:2011
33、ISO/TS 13498:2011(E) ISO 2011 All rights reserved 35.2 Torque transducer The torque transducer shall have a range not exceeding the quintuple of the anticipated minimum torsional yield strength. The maximum inaccuracy of the torque transducer shall be 1 % of the maximum torque to be tested. 5.3 Prep
34、aration of test specimen The connecting part shall be fixed on the implant body using the specified screw at tightening torques stated in the manufacturers instructions for use. The ends of the implant body and connecting part shall be fixed in a rigid clamping device. These ends may be modified int
35、o shapes larger than the maximum diameter of implant body and/or connecting part and they should be easy to clamp with the holders. An example of a test specimen is illustrated in Figure 2. Key 1 implant body 2 connecting part 3 connecting part screw Figure 2 Schematic of a test specimen 5.4 Test co
36、nditions Carry out the test at room temperature (20 5) C in air. 5.5 Procedure 5.5.1 The connecting part shall be fixed on the implant body using a specific screw at tightening torques stated in the manufacturers instructions for use. Clamp the retaining portions of the implant body and connecting p
37、art of a test specimen into the specimen holders of the testing device. Apply torque continuously to the connecting part at a rate of between 1 and 10 degrees per minute and record the torque versus rotation angle curve. Measure the torsional yield strength and the maximum torque of at least six tes
38、t specimens as described below. 5.5.2 The torsional yield strength is determined by the 2 offset method2(see Figure 3) using the torque versus rotation angle curve produced as described in 5.5.1. 5.5.3 On the torque versus rotation angle curve, locate a point, m, corresponding to 2 of rotation angle
39、 and draw a line, mB, parallel to a line, OA. Locate a point S, which is the intersection of mB with the torque versus rotation angle curve. Torque, Mtors, is defined as the torsional yield strength. 5.5.4 The maximum torque, Mmax, is determined by the largest value of torque on the torque versus ro
40、tation angle curve. NOTE It is possible that a sag appears on the torgue versus rotation angle curve depending on the testing configuration. In such cases, the torsional yield strength and the maximum torque are determined according to Figure 3 b). DD ISO/TS 13498:2011ISO/TS 13498:2011(E) 4 ISO 2011
41、 All rights reserveda) Without sag b) With sag Key X rotation angle, in degrees () Y torque, in Nm O initial contact Mmaxmaximum torque Mtorstorsional yield strength aRotation angle is 2. Figure 3 Method to determine torsional yield strength and maximum torque DD ISO/TS 13498:2011ISO/TS 13498:2011(E
42、) ISO 2011 All rights reserved 55.5.5 Observe the deformed or fractured part of the implant body/connecting part joint under a low-magnification microscope. 5.6 Evaluation of torque test Calculate the mean of the measured values of test specimens. 6 Test report The test report shall include at least
43、 the following information: a) identification of the test specimens, including 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
44、, diameter and length of the implant body and connecting part; b) test method, including test condition, testing device, rotational rate, distance from the interface at which the components were held and a drawing of the test specimens; c) results obtained, namely torsional yield strength and maximu
45、m torque, microscopic observation on deformed and fractured parts of the test specimens; d) reference to this Technical Specification, i.e. ISO/TS 13498:2011. DD ISO/TS 13498:2011ISO/TS 13498:2011(E) 6 ISO 2011 All rights reservedAnnex A (informative) Example of test performance Key X rotation angle
46、, in degrees () Y torque, in Nm Mmaxmaximum torque Mtorstorsional yield strength Figure A.1 Example of test performance (see Reference 3)DD ISO/TS 13498:2011ISO/TS 13498:2011(E) ISO 2011 All rights reserved 7Bibliography 1 ISO 898-7, Mechanical properties of fasteners Part 7: Torsional test and mini
47、mal torques for bolts and screws with nominal diameters 1 mm to 10 mm 2 ASTM F 543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws 3 WATANABE, F, ISHIGURO, T, TAKASE, I, UEDA, K, Torsion test at the interface between implant and implant abutment of CAMLOG Implant, Intern
48、ational College of Prosthodontics, Cape Town, Sept.10, 2009 DD ISO/TS 13498:2011ISO/TS 13498:2011(E) ICS 11.060.15 Price based on 7 pages ISO 2011 All rights reserved This page deliberately left blankBSI is the independent national body responsible for preparing British Standardsand other standards-
49、related publications, information and services. It presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter.British Standards Institution (BSI)raising standards worldwideBSI Group Headquarters389 Chiswick High Road London W4 4AL UKTel +44 (0)20 8996 9001Fax +44 (0)20 8996 Standards are updated by amendment or revision. Users of British Stan-dards should make sure
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