ISO 7206-4

ASTM F1820

Disassembly forces of modular acetabular devices

ASTM F1875

Fretting corrosion testing of modular implants – Femoral stem-head interface

ASTM F2009

Modular connection disassembly test

ASTM F2068 (PI-98)

Requirements for femoral prostheses - Metallic implants

ASTM F2345

Femoral head fatigue test

ASTM F2580

Fatigue test

ASTM F2582

Impingement test

ASTM F2979

Bearing surface characterization of retrieved hard-on-hard hip prostheses

ASTM F2996

FEA non-modular hip femoral stem

ASTM F3018

Guide for assessment of hard-on-hard articulation THR devices

ASTM F3047M

High demand hip wear testing

ASTM F3090

Fatigue test of acetabular devices

ASTM F3446

3D frictional torque measurement of total hip joint prostheses

ISO 11491

Impact resistance femoral heads

ISO 14242-1

Hip wear test

ISO 14242-1

Third body wear test based on ISO 14242-1

ISO 14242-4

Microseparation test

ISO 21534

Particular requirements for joint replacement implants

ISO 21535

Hip range of motion

ISO 21535

Specific requirements for hip-joint replacement implants

ISO 7206-1

Classification and designation of dimensions

ISO 7206-10

Femoral head compression test

ISO 7206-12

Deformation test for acetabular shells

ISO 7206-13

Femoral head torsion test

ISO 7206-2

Hip surface analysis

ISO 7206-4

Fatigue test

ISO 7206-6

Fatigue test

ISO 7206-8

Fatigue test

PI-11

Insert compression test

PI-3

Luxation test

PI-58 (ISO 7206-8)

Fatigue test

PI-87

FEA non-modular hip femoral stem - neck region

PI-99 (ASTM F2091)

Standard specification for acetabular prostheses

Fatigue test

Normative References

ISO 7206-4: Implants for surgery – Partial and total hip joint prostheses – Part 4: Determination of endurance properties and performance of stemmed femoral components

ISO 7206-6: Implants for surgery – Partial and total hip joint prostheses – Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components

PI-58 (ISO 7206-8): Implants for surgery – Partial and total hip joint prostheses – Part 8: Endurance performance of stemmed femoral components

The fatigue test according to ISO 7206-4 simulates the dynamic loading of a hip stem during gait. Proximal loosening of the stem is presumed to simulate worst case conditions and replicates clinical failure. Load inclination, embedding level, load level and number of cycles are given by the test standard. The test conditions do provide safety information about fatigue failure of hip stems by a simplified model.

ISO 7206-6 simulates a well ingrown stem. Fracture (if any) is expected to occur at the neck region of the stem.

The alignment of the hip stem versus the test load is straightforward for simple hip stem geometries but may be challenging for anatomic stems. EndoLab® has developed a 3D CAD based method to design custom AM-printed jigs for sample alignment.

The maximum test frequency depends on the flexibility of the stem and the performance of the test equipment. EndoLab® developed special tools to embed the stem correctly (see Fig.) which ensure constant loading of the implant. Most of our tests are performed using MTS® or Zwick® test equipment.

Correctly aligning the hip stem with the load axis is not a walk in the park. At Endolab, outdated tools like pens and rulers have long been replaced by custom-made jigs, alignment fixtures, and CAD analyses. To get the alignment right, the tolerances in the standards must be considered in their entirety including all angular tolerances of the frame and the test setup itself.

Contact our experts on how we ensure compliance with the strict normative requirements.

Contact Person male

Your contact person

Dipl. Ing. Christian Findeiss

Head of Fatigue Testing & Material Analysis, Head of Vascular Testing