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ASTM F2077 Intervertebral body fusion devices testing

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ASTM F2077 test method covers the materials and methods for the static and dynamic fatigue testing of intervertebral body fusion devices, spinal implants that are designed to promote arthrodesis at a given spinal motion segment. Intervertebral body fusion cages are among this implant type.


Core Purpose:

  • Establish standardized methods for mechanical performance comparison of different IBFD designs

  • Quantify static and dynamic characteristics under controlled loading conditions

  • Provide a basis for regulatory compliance (FDA recognized)

  • Enable design optimization by identifying performance limitations


ASTM F2077 Intervertebral body fusion devices tests include:

Axial-Compression

Compression-Shear

Torsion Testing

ASTM F2077 Intervertebral body fusion devices testing

The standard specifies the testing materials and methods for interbody fusion devices used to promote fusion in a specific spinal segment, aimed at establishing standard principles for the comparison of mechanical properties of non-biological interbody fusion devices. A torsional fatigue test was conducted on the samples at a frequency of 5Hz, R=-1, for 5 million cycles or until sample failure. 

UnitedTest UTDS Series Fatigue testing system has precise sine wave control and stable peak, offering professional testing tools and accurate and effective experimental plans (SOP) to assist in mechanical performance analysis.


Main Specificaiton for ASTM F2077 Intervertebral body fusion devices test: 

Maximum peak load: 4400N

Peak value of dynamic load:3000N

Peak value of static load: 2100N

Testing machine level: Level 0.5

Load measurement range: 0.4%-100%F.S.

Load measurement accuracy: Better than ± 0.2% of the indicated value (within the load measurement range)

Maximum fatigue loading frequency: 100Hz

Axial travel: 30mm

Displacement resolution: 0.1μm

Test space (upper and lower fixture space): 0-950mm

net weight: About 900kg

External dimensions: About 1000 × 700 × 1800 (mm)

Related Standards

  • ASTM F2267: Measures load-induced subsidence of IBFDs under static axial compression

  • ISO 12189: General requirements for spinal implants

  • ASTM F1717: Additional torsion testing guidelines for spinal implants

  • ASTM F1798: Tests for interconnection mechanisms in spinal arthrodesis implants

Test Method and Fixtures

Test Methods

1 Static Testing Series

Axial Compression Test
  • Objective: Evaluate resistance to axial compressive forces along the spinal axis

  • Setup: Device placed between two stainless steel blocks with matching geometry

  • Loading: Apply force (F) in position control at ≤25 mm/min until failure

  • Measurements: Force-displacement curve, yield/displacement, stiffness, ultimate load

Compression-Shear Test
  • Objective: Assess response to combined compressive and shear forces

  • Setup: Similar to axial compression but with offset loading to induce shear component

  • Loading: Apply force (F) and moment (Mz) simultaneously at controlled rates

  • Measurements: Combined force-deformation data, failure modes

Torsion Test
  • Objective: Determine torsional stability against twisting forces

  • Setup: Device fixed between blocks to prevent axial movement

  • Loading: Apply torsional moment (Mz) at ≤60°/min until failure

  • Measurements: Torque-rotation curve, torsional stiffness, ultimate torque

2 Dynamic/Fatigue Testing

  • Objective: Simulate long-term cyclic loading to evaluate fatigue resistance

  • Setup: Device placed between two polyacetal (plastic) blocks

  • Loading: Apply cyclic forces at ≤1 Hz frequency

  • Load Levels: Typically 25%, 50%, and 75% of ultimate static load

  • Termination: At functional failure or after 5,000,000 cycles

  • Measurements: Cycles to failure, maximum runout load (surviving 5M cycles)


Essential Fixture Components: 


Fixture TypeDescriptionApplication
Axial Compression FixtureTwo metal blocks contoured to device shapeStatic axial tests
Compression-Shear FixtureSpecialized blocks with offset loading capabilityCombined loading tests
Torsion FixtureRotational clamps with axial constraintTorsional tests
Dynamic Test FixturePolyacetal blocks for fatigue testingCyclic loading
Temperature-Controlled Bath37°C ±2° bath for in vivo simulationPhysiological conditions


Key test parameters: 


Test TypeLoading RateRationale
Static Axial Compression≤25 mm/minSimulates slow physiological loading
Static Torsion≤60°/minAllows for accurate failure mode observation
Dynamic Testing≤1 HzMimics physiological movement frequencies


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