1、BRITISH STANDARDBS EN ISO 14801:2007Dentistry Implants Dynamic fatigue test for endosseous dental implantsThe European Standard EN ISO 14801:2007 has the status of a British StandardICS 11.060.15g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g3
2、8g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 14801:2007This British St
3、andard was published under the authority of the Standards Policy and Strategy Committee on 31 December 2007 BSI 2007ISBN 978 0 580 55291 5National forewordThis British Standard is the UK implementation of EN ISO 14801:2007. It supersedes BS EN ISO 14801:2003 which is withdrawn.The UK participation i
4、n its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee 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 purport to include all the necessary provisions of a contrac
5、t. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publicationAmd. No. Date CommentsCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo repr
6、oduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 14801November 2007ICS 11.060.15 Supersedes EN ISO 14801:2003 English VersionDentistry - Implants - Dynamic fatigue test for endosseousdental implants (ISO 14801:2007)Art dentaire - Imp
7、lants - Essai de fatigue dynamique pourimplants dentaires endosseux (ISO 14801:2007)Zahnheilkunde - Implantate - DynamischeErmdungsprfung fr enossale dentale Implantate (ISO14801:2007)This European Standard was approved by CEN on 4 November 2007.CEN members are bound to comply with the CEN/CENELEC I
8、nternal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN me
9、mber.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members
10、 are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switz
11、erland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN I
12、SO 14801:2007: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Foreword This document (EN ISO 14801:2007) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in coll
13、aboration 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, either by publication of an identical text or by endorsement, at the latest by May 2008, and conflicting national standards shall
14、 be withdrawn at the latest by May 2008. This document supersedes EN ISO 14801:2003. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, D
15、enmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 14801:2007 has been app
16、roved by CEN as a EN ISO 14801:2007 without any modification. EN ISO 14801:2007Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Reference numberISO 14801:2007(E)INTERNATIONAL STAN
17、DARD ISO14801Second edition2007-11-15Dentistry Implants Dynamic fatigue test for endosseous dental implants Art dentaire Implants Essai de fatigue dynamique pour implants dentaires endosseux EN ISO 14801:2007Copyright European Committee for Standardization Provided by IHS under license with CENNot f
18、or ResaleNo reproduction or networking permitted without license from IHS-,-,-ii Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-iiiForeword ISO (the International Organization f
19、or 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 for which a technical committee has been established has th
20、e 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 all matters of electrotechnical standardization. Internat
21、ional Standards are drafted in accordance with the 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
22、 as an International Standard requires approval by at least 75 % 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.
23、 ISO 14801 was prepared by Technical Committee ISO/TC 106, Dentistry, 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. EN ISO 14801:2007Copyright Eur
24、opean Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-blankCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitt
25、ed without license from IHS-,-,-1Dentistry Implants Dynamic fatigue test for endosseous dental implants 1 Scope This International Standard specifies a method of fatigue testing of single post endosseous dental implants of the transmucosal type and their premanufactured prosthetic components. It is
26、most useful for comparing endosseous dental implants of different designs or sizes. While this International Standard simulates the functional loading of an endosseous dental implant body and its premanufactured prosthetic components under “worst case” conditions, it is not applicable for predicting
27、 the in vivo performance of an endosseous dental implant or prosthesis, particularly if more than one implant is used for a prosthesis. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited appli
28、es. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1099, Metallic materials Fatigue testing Axial force-controlled method ISO 1942 (all parts), Dental vocabulary ISO 4965, Axial load fatigue testing machines Dynamic force calibration Str
29、ain gauge technique ISO 7500-1, Metallic materials Verification of static uniaxial testing machines Part 1: Tension/compression testing machines Verification and calibration of the force-measuring system 3 Terms and definitions For the purposes of this document, the terms and definitions given in IS
30、O 1942 and the following apply. 3.1 endosseous dental implant system device that consists of integrated components including the ancillary instruments and specific equipment necessary for the clinical and laboratory preparation and placement of the implant, and for the construction and insertion of
31、the dependent prosthesis NOTE 1 In addition to providing resistance to displacement of a dental prosthesis, an endosseous dental implant may 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 inc
32、ludes crowns and fixed and removable prostheses. EN ISO 14801:2007Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-2 3.2 load-cycle diagram diagram summarising the fatigue propert
33、ies 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 failure See Annex A. 4 General Principles 4.1 Finished device testing Testing shall be performed on specimens that are representative of the finished de
34、vice (i.e., components that 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 manu
35、facturers instructions for 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
36、implants A multi-part endosseous 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 recommend
37、ing manufacturers statement. 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 tog
38、ether with the implant system 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 availabl
39、e in various dimensions 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 w
40、ith an error not exceeding 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
41、 of recording the number of loading cycles during the test. EN ISO 14801:2007Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-35.2 Loading geometry 5.2.1 The loading force, F, (se
42、e 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 be measured or calculated. 5.2.2 For dental implant systems that include no pre-angled connec
43、ting 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 (see 5.2.6) 2 nominal bone level (see 5.3.2) 3 connecting part 4 hemispherical loading member 5
44、 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 connecting parts shall be clamped such that its axis makes a 30 2angle with the loading direction of t
45、he 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 testing machine is 10 21+Dgreater than the angle EN ISO 14801:2007Copyright European Committee for S
46、tandardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-4 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.
47、The loading method shall be the same as that shown in Figure 1. The loading centre shall 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 supp
48、ort level of the implant. Dimensions in millimetres Key 1 loading device shall be allowed 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 testing machine shall be applied through a deformation-resistant loading member with a hemispherical contact
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