1、BRITISH STANDARD BS ISO 7206-10:2003 Implants for surgery Partial and total hip-joint prostheses Part 10: Determination of resistance to static load of modular femoral heads ICS 11.040.40 BS ISO 7206-10:2003 This British Standard was published under the authority of the Standards Policy and Strategy
2、 Committee on 17 December 2003 BSI 17 December 2003 ISBN 0 580 43116 9 National foreword This British Standard reproduces verbatim ISO 7206-10:2003 and implements it as the UK national standard. The UK participation in its preparation was entrusted by Technical Committee CH/150, Implants for surgery
3、, to Subcommittee CH/150/4, Bone and joint replacements, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international publications referred to in this docume
4、nt may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. U
5、sers are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for chan
6、ge, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the ISO title page, pages ii to v, a blank page, pages 1 to 10, an inside back cover and a bac
7、k cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments Reference number ISO 7206-10:2003(E) OSI 3002INTERNATIONAL STANDARD ISO 7206-10 First edition 2003-12-01 Implants for surgery Partial a
8、nd total hip-joint prostheses Part 10: Determination of resistance to static load of modular femoral heads Implants chirurgicaux Prothses partielles et totales de larticulation de la hanche Partie 10: Dtermination de la rsistance la charge statique de ttes fmorales modulaires BSISO720610:2003IS-6027
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14、d iv Introduction v 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 Principle . 2 5 Apparatus. 2 5.1 Static compression test 2 5.2 Static tension test . 3 6 Procedure. 3 6.1 Assembly of test specimens (installation) . 3 6.2 Static compression . 4 6.3 Static tension. 4 7 Test report
15、 4 8 Disposal of test specimens 5 Annex A (informative) Method for cleaning specimens . 10 BSISO720610:2003IS-6027 O01:(3002E) iv I SO 3002 All irhgts seredevrForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).
16、 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 organizations, governmental and non-
17、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 in the ISO/IEC Directives, Part
18、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 % of the member bodies casting a
19、 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 7206-10 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
20、 SC 4, Bone and joint replacements. ISO 7206 consists of the following parts, under the general title Implants for surgery Partial and total hip-joint prostheses: Part 1: Classification and designation of dimensions Part 2: Articulating surfaces made of metallic, ceramic and plastics materials Part
21、4: Determination of endurance properties of stemmed femoral components Part 6: Determination of endurance properties of head and neck region of stemmed femoral components Part 8: Endurance performance of stemmed femoral components with application of torsion Part 10: Determination of resistance to s
22、tatic load of modular femoral heads BSISO720610:2003IS-6027 O01:(3002E) I SO 3002 All irhgts seredevr vIntroduction Some designs of stemmed femoral components of total hip-joint prostheses comprise a stem/neck component and a component that forms the articulating surface, which is commonly in the fo
23、rm of a partial sphere incorporating a female conical taper connection for attachment to the neck of the stem. It is important, therefore, that the head and neck are of sufficient strength to withstand the static axial loads likely to be exerted on the prosthesis during use. This method addresses th
24、e static strength and attachment of the head. It should be noted that the test conditions described in this part of ISO 7206 do not exactly reproduce all the factors in the clinical situation. BSISO720610:2003blank BSISO720610:2003INTENRATIONAL TSANDADR IS-6027 O01:(3002E)I SO 3002 All irhgts serede
25、vr 1Implants for surgery Partial and total hip-joint prostheses Part 10: Determination of resistance to static load of modular femoral heads 1 Scope This part of ISO 7206 applies to femoral heads of partial or total hip-joint replacements of modular construction (i.e. a head/neck conical taper conne
26、ction) and describes methods of determining the load required, under specified laboratory conditions, to cause failure of the head (disassembly or fracture). It applies to components made of metallic and non-metallic materials. This part of ISO 7206 does not cover methods of examining and reporting
27、the test specimens. 2 Normative 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 42
28、88:1996, Geometrical Product Specification (GPS) Surface texture : Profile method Rules and procedures for the assessment of surface texture ISO 7206-1:1995, Implants for surgery Partial and total hip-joint prostheses Part 1: Classification and designation of dimensions ISO 7500-1:1999, Metallic mat
29、erials Verification of static uniaxial testing machines Part 1: Tension/compression testing machines Verification and calibration of the force-measuring system ISO 6506-1:1999, Metallic materials Brinell hardness test Part 1: Test method 3 Terms and definitions For the purposes of this document, the
30、 following terms and definitions apply. 3.1 bore angle included angle of the conical surface of the bore See Figure 1 a). 3.2 cone metal truncated right-circular cone (male component) used to engage with a mating conical bore (female component) of the modular femoral head See Figure 1 b). BSISO72061
31、0:2003IS-6027 O01:(3002E) 2 I SO 3002 All irhgts seredevr3.3 cone angle included angle of the conical surface of the cone See Figure 1 b). 3.4 head spherical, modular femoral component which includes a conical bore and is engaged by a cone See Figure 1 a). 3.5 installation load load used to connect
32、the head and neck components prior to testing 3.6 load axis line of action of the compressive load applied to the head See Figures 2, 3 a), 3 b), 4 and 5. 3.7 neck region of the femoral stem component between the cone and the stem See Figures 1 b), 2, 3 a), 3 b), 4 and 5. 3.8 neck axis centreline of
33、 the femoral cone See Figures 2, 3 a), 3 b), 4 and 5. 3.9 stroke rate nominal rate of movement of the moving component of the test machine 4 Principle A static compressive or tensile load is applied to the head/neck assembly of the hip-joint prosthesis and increased until either the head or the neck
34、, or the connection between them, fails, or until the chosen maximum force has been applied without the occurrence of failure. The nomenclature and designation of dimensions given in ISO 7206-1 shall apply. 5 Apparatus 5.1 Static compression test 5.1.1 Testing machine, capable of applying and record
35、ing an axial compressive force to the head/neck assembly, with an accuracy of 1 % at between 20 % and 100 % of the machine range used (see ISO 7500-1). BSISO720610:2003IS-6027 O01:(3002E) I SO 3002 All irhgts seredevr 35.1.2 Loading fixtures, capable of sustaining loads up to the anticipated fractur
36、e or deformation level of the femoral head (up to 200 kN); constructed so that the line of load application passes through the centre of the femoral head and is aligned with the neck axis as indicated in Figure 2. 5.1.3 Conical loading bore, of dimensions shown in Figure 3 a), and made of metal havi
37、ng a hardness of 150 HB to 200 HB (see ISO 6506-1). 5.1.4 Copper ring load distributing device, as shown in Figure 3 b). 5.1.5 Neck unit, comprising a neck/cone of the type to which the head is to be mounted in service, or a dummy having the same dimensions and being made of the same material, by th
38、e same manufacturing process and to the same specification see Figure 1 b). In cases of dispute, the test should be performed using the complete stemmed femoral component. 5.2 Static tension test 5.2.1 Testing machine, capable of applying and recording an axial tensile force to the head/neck assembl
39、y, with an accuracy of 1 % at between 20 % and 100 % of the machine range used (see ISO 7500-1). 5.2.2 Loading fixtures, capable of sustaining expected loads and constructed so that the line of force application passes through the centre of the femoral head and is aligned with the neck axis as indic
40、ated in Figure 2 and Figure 4. 5.2.3 Neck unit, comprising a neck and cone of the type to which the head is to be mounted in service, or a dummy having the same dimensions and being made of the same material, by the same manufacturing process and to the same specification see Figure 1 b). In cases o
41、f dispute, the test should be performed using the complete stemmed femoral component. 6 Procedure 6.1 Assembly of test specimens (installation) 6.1.1 Use new femoral heads and neck units for each test. Remove any debris or other surface contaminants. If requested by the person or organization submit
42、ting the specimens for test, measure the circularity, linearity and surface roughness. NOTE The procedure in Annex A has been found to be suitable. 6.1.2 Mount the head onto the cone using a method such as that illustrated in Figure 3 a), Figure 3 b) or Figure 4, or any other method provided the fol
43、lowing requirements are met: a) the alignment tolerances shown in Figure 2 shall be maintained; b) apply an installation force of (2,0 0,2) kN at a loading rate of (0,5 0,1) kN/s or, if this not possible, at a stroke rate of (0,04 0,01) mm/s; c) inspect the specimen; if it is damaged terminate the t
44、est; d) if the fixtures used for installation are to be used for the test, inspect them and replace them if they are damaged. CAUTION Protect the test operator from injury by fragments in case the specimen should shatter when under load or when disassembling or when storing the specimen after remova
45、l of the load from unfractured specimens. BSISO720610:2003IS-6027 O01:(3002E) 4 I SO 3002 All irhgts seredevr6.2 Static compression 6.2.1 Load the femoral head through a conical loading bore 5.1.3 and Figure 3 a). Maintain the alignment tolerances shown in Figure 2. A copper ring (5.1.4) may be inse
46、rted between the femoral head and loading bore Figure 3 b) to protect the contact surface of the head. 6.2.2 Apply a compressive force at a loading rate of (0,5 0,1) kN/s; or if this is not possible, at a stroke rate of (0,04 0,01) mm/s taking a record of the force/time or displacement/time behaviou
47、r. 6.2.3 Increase the load until one of the following occurs: a) discontinuity or peak in the recorded load profile; b) the occurrence of cracks or fracture of the head; c) fracture or permanent deformation of the neck; d) the chosen maximum force has been applied. NOTE A discontinuity may occur in
48、the initial state of the static compression test, due to stick-slip effects, while the neck unit subsides. 6.2.4 Examine the conical loading bore after each test, and discard it if damaged. If a copper ring is used for the contact, replace it for each test. 6.2.5 Conduct tests on a minimum of five s
49、amples of each type. If it is intended to test more than one sample group, the minimum number should be determined according to the desired confidence level. 6.3 Static tension 6.3.1 Place the head/neck assembly in a fixture, such as that shown in Figure 5, capable of holding the neck component securely, achieving uniform flat contact around the base of the head, and mainta
