ASTM F1798 Spinal Implant Subassembly Static and Fatigue Testing System

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ASTM F1798 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants.

ASTM F1798 provides standardized methods for mechanically testing the interconnections within spinal implant systems. It is for evaluating the uniaxial static/fatigue strength and loosening resistance of interconnection mechanisms in spinal arthrodesis implant subassemblies, providing a standardized way to characterize mechanical performance of connections like rod-clamp, screw-rod, and hook-rod assemblies. It is critical for design validation, regulatory compliance, and clinical safety in the spinal implant industry.

This includes connections like:

Set screw to rod (in pedicle screw systems);

Vertebral body screw to plate (in anterior cervical plates);

Cross-connector to rod;

Any other mechanical junction point in a spinal implant assembly.

The standard's primary goal is to evaluate the static (strength) and fatigue (long-term durability) performance of these connection points, which are often the weakest links in a spinal construct.

ASTM F1798 Spinal Implant Subassembly Static and Fatigue Testing System

ASTM F1798 Test Principle:

The fundamental principle is load isolation. The test is designed so that the applied force is transmitted directly through the interconnection mechanism of interest. The goal is to cause failure at the junction, not in the test fixtures or in the bulk material of the rod or plate. The test quantifies:

How much force causes the connection to slip or break (static).

How many cycles of a lower force cause it to fail (fatigue).

ASTM F1798 Test Equipment Required:

Universal Testing Machine / Fatigue testing machine: A servo-hydraulic or electromechanical test frame capable of applying both static and cyclic axial loads (tension/compression).

Specialized Test Fixtures: These are critical. Fixtures are custom-designed to:

Hold the specific implant subassembly (e.g., a rod clamped in a fixture, a screw in a threaded block).

Apply a pure tensile distraction force (pulling apart) or a shear force directly across the interconnection, isolating the junction as the test article.

Example: For a set-screw/rod connection, a fixture holds the rod rigidly while a tensile load is applied to the screw head.

Environmental Chamber: To conduct tests in a physiologically relevant saline solution at 37°C, simulating body conditions, as corrosion and environment can significantly affect fatigue performance.

Test described in the ASTM F1798:

Static A-P load and dynamic A-P fatigue run out (Fx);

Static transverse load and dynamic transverse fatigue run out (Fy);

Static axial gripping capacity and dynamic axial fatigue run out (Fz);

Static transverse moment and dynamic transverse moment fatigue run out (Mx);

Static flexion-extension moment and dynamic flexion extension moment fatigue run out (My);

Static axial torque and dynamic axial torsional fatigue run out (Mz);

Test Procedure for Static Mechanical Properties:

1, Measure the tightening torques for any set screws or nuts which are incorporated into the interconnection linkage.

2, Apply all tightening, crimping, or locking mechanisms as specified by the manufacturer.

3, The recommended maximum rate for applying a load is 20 N/s (or 25 mm/min) and is 25 N-m/min (or 25°/min) for applying a moment or torque. Since rate is machine and software dependent, it may be necessary to run the tests slower to achieve accurate data.

4, Static A-P load (Fx), transverse load (Fy), axial gripping capacity (Fz), transverse moment (Mx), flexion-extension moment (My), axial torque (Mz), and tulip/shank disassociation

(Fx) shall be measured.

5, Loads and moments need to be measured only in the relevant directions of loading.

6, After each load or moment measurement, loosening torque shall be measured.

ASTM F1798 Spinal Implant Subassembly Static and Fatigue Testing System

Procedure for the Measurement of Fatigue Run-Out:

1 Measure the tightening torques for any set screws or nuts that are incorporated into the connection linkage.

2 Apply all tightening, crimping, or locking mechanisms as specified by the manufacturer.

3 The maximum frequency of cyclic loading is not specified but shall be measured and reported.

4 All fatigue loading should be sinusoidal, accomplished via continuous load amplitude control, rather than in a controlled deflection manner.

5 A-P fatigue run-out (Fx), transverse fatigue run-out (Fy), axial fatigue run-out (Fz), transverse moment fatigue run-out (Mx), flexion extension moment fatigue run-out (My), axial torsional fatigue run-out (Mz), and tulip/shank disassociation test (Fx).

6 In each relevant loading direction, apply a continuous amplitude cyclical load to an interconnection subassembly specimen. If a failure occurs prior to 2.5 × 10⁶ cycles, decrease the load and test the second specimen in the same manner. This rundown is continued at equal intervals until a load amplitude is reached at which no failure occurs before 2.5 × 10⁶ cycles.

At this point, the load is increased or decreased by half intervals until three consecutive specimens run out to 2.5 × 106 cycles. Alternative methods for determining the starting point of the fatigue curve are the run-up method, where a single test specimen is progressively retested at higher loads until it eventually fails, or choosing 75 % of the ultimate static load.

7 A similar procedure, as described in 9.6, is used for moments. Fatigue run-out needs to be measured only in the relevant directions of loading.

7.1 By definition, some components are generally designed to withstand only fluctuating (0 to value) loads in the axial, A-P, and flexion-extension moment directions, hence fatigue loading of hooks (or other unidirectionally loaded components) shall be fluctuating for cyclic loading in the axial (z), A-P (x), and flexion-extension moment (My) measurements, but shall be completely reversed (+/– value) for the axial torsion measurement.

7.2 Some spinal components must withstand fully reversed loading. Hence, mechanical properties for these components shall be determined using completely reversed loading in relevant directions of loading. The maximum load ratio incompletely reversed loading should be –1.00.

8 After each fatigue test, loosening torque shall be measured (if applicable). A baseline loosening torque, measured prior to any cyclic loading, should also be established prior to the fatigue tests.

Spinal Implant Constructs nail screw static and fatigue testing machine used to check the fatigue failure of medical nail, Loads are typically applied in a constant-amplitude, load-controlled sinusoidal waveform that runs more than 5 million times.

A single column tensile tester is a sophisticated material testing instrument designed for measuring mechanical properties of various materials under tension, compression, bending, shear, and other loading conditions. As the name suggests, it features a single vertical column supporting a moving crosshead that applies force to test specimens.

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Screw fatigue tester is a multi-functional composite test equipment according customer different test requirements, which can be used for screw rotary torque testing, self-tapping testing and other bone screw-related performance tests.

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