ISO 7206-8:1995 download free.Implants for surgery — Partial and total hip joint prostheses — Part 8: Endurance performance of stemmed femoral components with application of torsion.
Fatigue properties are important attributes of in vivo performance of orthopeedic implants.
Part 4 of ISO 7206-8 provides a means of v&uating designs of femoral components of partial or total hip joint replacements but more data on different stem designs for the smallest stem sizes needs to be obtained to establish minimum loading values using thus test method for sizes smaller than those intended for the average size patient (in Europe). More data as also required to establish correlation of the results from this test method in relation to specific designs and materials, and to reflect developing clinical experience.
1&.
This part of ISO 7206 specifies the endurance performance of stemmed femorel components of totai hip joint prostheses end stemmed femoral components used alone in partial hip joint rep’acement as determined under specified laboratory conditions by a method that includes the appricaton of torsion.
This part of ISO 7206 does not apply to the following a) prostheses for special clinical cases;
b) prostheses for which the centreline of the stem is thre&dimensionally curved end does not lie in any plane in which the axis of the neck es.
2 Normativ• r.f.r.nc
The following standard contains provisions which. through reference in this text. constitute provisions of this part of ISO 7206. At the time of pubilcetion. the edition indicated was valki. AN standards are subject to revision, and parties to agreements based on this part of ISO 7206 are encouraged to investigate the
possibility of aplying the most recent edition of th standard indicated below. Members of IEC and SC maintain registers of currently valid Intemationa Standards.
ISO 7206-4:1989, Implants for surgery — Partial an total hip joint prostheses — Part 4: Determination o endurance properties of stemmed femoral corn ponents with application of torsion.
3 Test conditions.
The femoral component shalt be tested in its rea±yfor-use condition.
4 Enduranc. performance
When tested as described in ISO 7206-4, the femoral component shall not fracture during 5 x 108 cycles of application of a cyclic load of 2 kN with a minimum load of 300 N and a maximum load of 2.3 kN. Neither shall the tests have been terminated before cornpletion of the loading regime (see ISO 7206-4:1989, subcla use 7.8) for reasons other than loosening of the specimen in the embedding medium.