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1、INTERNATIONAL STANDARD First edition 1992-03-l 5 Implants for surgery - Partial and total hip joint prostheses - Par-t 6: Determination of endurance properties of head and neck region of stemmed femoral components lmplants chirurgicaux - Protheses partielles et totales de /articulation de la hanche
2、- Partie 6: these should be agreed between the test laboratory and the parties submitting the specimen for test. IS0 7206-3:1988, Implants for surgery - Partial and total hip joint prostheses - Part 3: Determination of endurance properties of stemmed femoral compo- nents without application of torsi
3、on. IS0 7206-4:1989, implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties of stemmed femoral compo- nents with application of torsion. 3 Nomenclature and designation of dimensions For the purposes of this part of IS0 7206, the no- menclature a
4、nd designation of dimensions given in IS0 7206-l apply. 4 Principle 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of IS0 7206. At the time of publication, the editions indicated were valid. All standards ar
5、e subject to revision, and parties to agreements based on this part of IS0 7206 are encouraged to investi- gate the possibility of applying the most recent edi- tions of the standards indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 7206-I: 1
6、985, Implants for surgery - Partial and total hip joint prostheses - Part I: Classification, designation of dimensions and requirements. Embedding of the stem of the test specimen in a solid medium. Partial immersion of the protruding part of the test specimen in a fluid test medium. Application of
7、a cyclic load to the head of the test specimen until the head or neck exhibits failure or until the chosen number of cycles has been attained. Subsequent examination of the specimen for defects caused by the loading regime. 5 Reagents and materials Use the reagents and the materials specified in IS0
8、 7206-3 and IS0 7206-4. -,-,- IS0 7206=6:1992(E) 6 Apparatus Use the apparatus specified in IS0 7206-3 and IS0 7206-4. 7 Procedure 7.1 Test with load applied parallel (with no torsion effect) to plane of neck Perform the test as described in IS0 7206-3, except as a) W follows: Embed the specimen so
9、that the embedding me- dium extends up the stem to the level which, in clinical use, coincides with the transection level of the femur recommended by the manufacturer (see figures 1 and 3). Set the testing machine or other instrument to give an indication if the vertical or horizontal component of t
10、he specimen deflection exceeds a value of 3 mm greater than the deflection oc- curring in the first minute of running at test load. 7.2 Test with load applied non-parallel (with torsion effect) to plane of neck Carry out the test as described in IS0 7206-4, except as follows: a) Embed the specimen s
11、o that the embedding me- dium extends up the stem to the level which, in clinical use, coincides with the transection level of the femur recommended by the manufacturer (see figures 2 and 3). b) Set the testing machine or other instrument to give an indication if the vertical or horizontal component
12、 of the specimen deflection exceeds a value of 3 mm greater than the deflection oc- curring in the first minute of running at test load. 8 Test report The test report shall include the following infor- mation: a) a reference to this part of IS0 7206; b) the identity of the test specimen, as stated b
13、y the party submitting the specimen for test; c) the embedding medium used; d) the minimum and maximum loads applied and whether applied parallel or non-parallel to the plane of the neck; e) the duration of the test, in cycles; f) the loading frequency; g) the offset angle in degrees; h) a statement
14、 of results including location of frac- ture (if applicable), description of test specimen at the end of the test, and the results of the ex- amination requested by the party submitting the specimen for test; i) a record of if and why the test was terminated. 9 Disposal of test specimens It is imper
15、ative that the test prostheses should not be used for clinical purposes after testing. Care should be exercised in the use of the speci- mens for further mechanical tests, including endur- ance tests, because the loading regime may have altered the mechanical properties. 2 -,-,- IS0 7206=6:1992(E) K
16、 I I , Figure 1 - Orientation of specimen with load applied parallel (with no torsion effect) to plane of neck -,-,- IS0 7206=6:1992(E) K L I K4 9t 7 , Figure 2 - Orientation of specimen with load applied non-parallel (with torsion effect) to plane of neck -,-,- IS0 7206=6:1992(E) Load I I - Cover (
17、optional) Fluld test medium, con- tlnuously aerated, temperature of 37C * 1 Embedding medlum Test specimen Example of specimen holder of .-. -. corrdslon-resistant materfal konstructlon and dlmenslons to test specimen and testing machl suit nel Figure 3 - General arrangement of specimen for testing This page intentionally left blank -,-,- This page intentionally left blank IS0 7206-6:1992(E) WC 616-089.28:611.98:620.169.1 Descriptors: medical equipment, surgical implants, prosthetic devices, hips, joints (articulation), tests, determination, durability. Price based on 5 pages -,-,-