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1、 Reference number ISO 14801:2007(E) ISO 2007 INTERNATIONAL STANDARD ISO 14801 Second edition 2007-11-15 Dentistry Implants Dynamic fatigue test for endosseous dental implants Art dentaire Implants Essai de fatigue dynamique pour implants dentaires endosseux Copyright International Organization for S
2、tandardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 12/17/2007 18:20:33 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 14801:2007(E) PDF disclaimer This PDF file may contain embedded typefaces. In acc
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5、nting. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2007 All rights reserved. Unless otherwi
6、se specified, no part of this publication may be reproduced 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 o
7、ffice Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2007 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees
8、/1111111001, User=Japan, IHS Not for Resale, 12/17/2007 18:20:33 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 14801:2007(E) ISO 2007 All rights reserved iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standa
9、rds 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. International organ
10、izations, 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 rules given i
11、n 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 at least 75 %
12、 of the member bodies casting a vote. 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. ISO 14801 was prepared by Technical Committee ISO/TC 106, Denti
13、stry, Subcommittee SC 8, Dental implants. This second edition cancels and replaces the first edition (ISO 14801:2003) which has been technically revised to include manufactured pre-angled connecting parts. Copyright International Organization for Standardization Provided by IHS under license with IS
14、O Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 12/17/2007 18:20:33 MSTNo reproduction or networking permitted without license from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=J
15、apan, IHS Not for Resale, 12/17/2007 18:20:33 MSTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD ISO 14801:2007(E) ISO 2007 All rights reserved 1 Dentistry Implants Dynamic fatigue test for endosseous dental implants 1 Scope This International Standard s
16、pecifies a method of fatigue testing of single post endosseous dental implants of the transmucosal type and their premanufactured prosthetic components. It is most useful for comparing endosseous dental implants of different designs or sizes. While this International Standard simulates the functiona
17、l loading of an endosseous dental implant body and its premanufactured prosthetic components under “worst case” conditions, it is not applicable for predicting the in vivo performance of an endosseous dental implant or prosthesis, particularly if more than one implant is used for a prosthesis. 2 Nor
18、mative references The following referenced documents are indispensable for the application of 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 1099, Metallic materials Fa
19、tigue testing Axial force-controlled method ISO 1942 (all parts), Dental vocabulary ISO 4965, Axial load fatigue testing machines Dynamic force calibration Strain gauge technique ISO 7500-1, Metallic materials Verification of static uniaxial testing machines Part 1: Tension/compression testing machi
20、nes Verification and calibration of the force-measuring system 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 endosseous dental implant system device that consists of integrated components including the ancillary in
21、struments and specific equipment necessary for the clinical and laboratory preparation and placement of the implant, and for the construction and insertion of the dependent prosthesis NOTE 1 In addition to providing resistance to displacement of a dental prosthesis, an endosseous dental implant may
22、be used as an anchorage for orthodontic appliances. NOTE 2 An endosseous dental implant may consist of one or more parts. NOTE 3 The term dental prosthesis includes crowns and fixed and removable prostheses. Copyright International Organization for Standardization Provided by IHS under license with
23、ISO Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 12/17/2007 18:20:33 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 14801:2007(E) 2 ISO 2007 All rights reserved 3.2 load-cycle diagram diagram summarising the fatigue properties of an endosseous den
24、tal implant by showing for each value of the applied peak load the number of cycles endured by each specimen at the time of failure See Annex A. 4 General Principles 4.1 Finished device testing Testing shall be performed on specimens that are representative of the finished device (i.e., components t
25、hat 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, sterilization shall be carried out as specified in the manufacturers instructions f
26、or 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 prior to testing. 4.2 Multi-part endosseous dental implants A multi-part en
27、dosseous 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 be tested as assembled according to the recommending manufacturers statem
28、ent. 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 (screw driver, torque wrench) which is provided together with the implant s
29、ystem 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 testing If a part of the endosseous dental implant system is available in various dimensions
30、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. 5 Test methods 5.1 Testing machine The testing machine shall: be capable of applying the prescribed load with an error not exceedi
31、ng 5 % at maximum load (in accordance with ISO 7500-1 and ISO 4965); 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; be capable of recording the number
32、 of loading cycles during the test. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 12/17/2007 18:20:33 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 148
33、01:2007(E) ISO 2007 All rights reserved 3 5.2 Loading geometry 5.2.1 The loading force, F, (see Figures 1 and 2) of the testing machine shall be applied in such a way that: no lateral constraint occurs; the loading centre (Point C in Figures 1 and 2) is well-defined, such that the moment arm, y, can
34、 be measured or calculated. 5.2.2 For dental implant systems that include no pre-angled connecting parts, these requirements will be met by the test set-up shown schematically in Figure 1. Dimensions in millimetres Key 1 loading device shall be allowed free movement transverse to loading direction (
35、see 5.2.6) 2 nominal bone level (see 5.3.2) 3 connecting part 4 hemispherical loading member 5 dental implant body 6 specimen holder Figure 1 Schematic of test set-up for systems with no pre-angled connecting parts 5.2.3 An endosseous dental implant from a system that includes no pre-angled connecti
36、ng parts shall be clamped such that its axis makes a 30 2 angle with the loading direction of the testing machine (see Figure 1). 5.2.4 An endosseous dental implant body of a system that includes pre-angled connecting parts shall be clamped such that the angle with the loading direction of the testi
37、ng machine is 10 2 1 + ? greater than the angle Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 12/17/2007 18:20:33 MSTNo reproduction or networking permitted without license from IHS -
38、,-,- ISO 14801:2007(E) 4 ISO 2007 All rights reserved between the implant axis and the axis of the angled portion of the connecting part, 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 centre s
39、hall be located at the intersection of the central longitudinal axis of the free end of the connecting part and the plane normal to the longitudinal axis of the implant and located 11 mm (l in Figure 2) from the support level of the implant. Dimensions in millimetres Key 1 loading device shall be al
40、lowed free movement transverse to loading direction (see 5.2.6) 2 nominal bone level (see 5.3.2) 3 connecting part 4 hemispherical loading member 5 dental implant body 6 specimen holder Figure 2 Schematic of test set-up for systems with pre-angled connecting parts 5.2.5 The loading force, F, of the
41、testing machine shall be applied through a deformation-resistant loading member with a hemispherical contact surface for load transfer, attached to or placed over the free end of the connecting part. For endosseous dental implant systems that include no pre-angled connecting parts, the loading centr
42、e, which is the centre (C) of the hemisphere, shall be on the central longitudinal axis of the endosseous dental implant. For endosseous dental implant systems that include pre-angled connecting parts, the loading centre shall be on the central longitudinal axis of the free end of the connecting par
43、t. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 12/17/2007 18:20:33 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 14801:2007(E) ISO 2007 All rights re
44、served 5 5.2.6 The loading force shall be applied to the hemispherical loading surface by a loading device with a plane surface normal to the loading direction of the machine. The loading device shall be unconstrained in the transverse direction, so as to not reduce the magnitude of the applied bend
45、ing moment. This shall be accomplished by means of a universal joint or point contact at the junction of the loading member and the test machine structure. The junction shall be located at least 50 mm from the hemispherical loading surface. 5.2.7 The hemispherical loading surface and the surface of
46、the loading device shall be examined visually after each test to ensure that permanent deformation has not occurred. If permanent deformation is observed, the deformed component shall be replaced and the test shall be repeated. 5.2.8 For an endosseous dental implant body and/or connecting part that
47、lacks rotational symmetry around either the central longitudinal axis of the implant body or the axis of nominal prosthetic loading, the loading geometry shall be selected to test the worst case compatible with the intended use of the implant. The loading geometry shall be justified and documented.
48、5.3 Specimen holder and load application 5.3.1 The bone-anchoring part of the specimen shall be fixed in a rigid clamping device. If an embedding material is used, it shall have a modulus of elasticity higher than 3 GPa. The geometry of the clamping device shall be such that the testing geometry specified in 5.2 is achieved. The clamping device shall be designed so as not to deform the test specimen. 5.3.2 The device shall clamp the specime