ASTM F2346 Artificial Spinal Disc Static & Dynamic Fatigue Test

Information on the most widely used ASTM standards within the materials testing industry

Descriptions of the most prominent lSO standards within the materials testing industry

Standards including EN, DIN, JlS, and more

Mechanical testing of polymer materials in the automotive industry is directly related to the safety of components and the reliability of the entire vehicle. UnitedTest can cover mechanical performance testing for automotive interior and exterior parts, as well as functional components, adapting to automaker standards and providing comprehensive testing solutions including tensile, impact, and fatigue tests.

Mechanical testing in the battery industry determines the tensile and puncture resistance of core components such as separators and electrodes, directly affecting battery safety and cycle life. UnitedTest can cover full-dimensional mechanical testing of battery materials, compatible with national and international standards, and provide customized testing solutions.

Mechanical testing in the consumer goods industry determines product durability and safety, such as impact resistance for toys and fatigue resistance for home appliances, making it core to compliance and quality. UnitedTest can cover mechanical tests for all categories of consumer goods, including tensile, impact, and hardness tests, compatible with national and international standards, and offers customized testing solutions.

In the field of medical and biomedical sciences, mechanical testing determines the safety and compatibility of implanted devices and biomaterials, making it a core part of regulatory approval. UnitedTest can cover a full range of tests including tensile, fatigue, and wear tests, compatible with national and international standards, and provides customized biomechanical testing solutions.

Material strength is a course that most engineering fields are required to study in university education. This interesting course is very practical and makes use of testing equipment in the materials laboratory.

Mechanical testing of industrial products and components is essential to ensure their load-bearing, fatigue resistance, and impact resistance, directly preventing production accidents and ensuring stable operation of equipment. UnitedTest can cover a full range of tests including tensile, hardness, and fatigue, complying with national and international standards, and provides customized industrial mechanical testing solutions.

Mechanical testing in the plastic pipe industry determines ring stiffness, impact resistance, and tensile performance, directly preventing pipe bursts and deformation risks. UnitedTest can cover full-dimensional mechanical testing of pipes, complies with ISO,ASTM,EN et.c, international standards, and provides customized testing solutions.

In the construction engineering and building materials industry, mechanical testing determines the compressive and tensile properties of materials such as concrete and steel, which is core to ensuring the safety and durability of buildings. UnitedTest can cover the full range of building material mechanical tests, complies with ISO, ASTM international standards, and provides customized testing solutions for compressive, tensile, and other properties.

Mechanical testing in the food and beverage industry involves the compressive and tensile performance of packaging and the safety of food texture, directly ensuring storage, transportation safety, and the eating experience. UnitedTest can cover all-dimensional mechanical testing for packaging and food texture, comply with national and international standards, and provide customized testing solutions.

Mechanical testing in the packaging industry determines the packaging's resistance to compression, impact, and tension, directly ensuring the safety of contents during storage and transportation. UnitedTest can cover comprehensive mechanical testing for packaging, complying with ISO, ASTM Standards, and provides customized testing solutions for compression, drop, tear, and more.

Mechanical testing in the transportation industry concerns the load-bearing and fatigue resistance performance of core components such as vehicles, tracks, and containers, directly ensuring transport safety and equipment durability. UnitedTest can cover mechanical testing for all types of transportation materials, complying with national and international standards, and provides customized testing solutions including tensile, fatigue, and impact tests.

Metallurgical testing examines the properties of metallic materials to determine if a particular metal is appropriate for its intended use.

Testing of polymer materials covers mechanical, thermal, and chemical properties, verifying strength, heat resistance, composition, and ensuring product quality and compliance.

UnitedTest offer world-class testing solution in testing for polymeric materials, including elastomers, thermoplastics, composites, coatings, and structural adhesives in a variety of industries.

Testing of rubber and elastomers is used to assess the various properties and performance of materials under different conditions. This is crucial for ensuring the safety, functionality, and quality of rubber and elastomer products used in industries such as automotive, construction, consumer goods, and aerospace.

Conduct adhesive testing using various testing methods to determine their performance and characteristics in applications across multiple industries such as aerospace, automotive, construction, packaging, industrial, medical, and energy, thereby supporting application development and quality assurance.

UnitedTest supply machine and testing solution for tension, compression, fracture toughness, direct shear, triaxial and ultrasonic velocity are common concrete and rock testing applications.

UnitedTest has helped a number of companies involved in the wood, paper, cardboard, and corrugated industry with their testing needs. Our materials testing systems are capable of testing raw materials, components, and finished products.

UnitedTest testing system is trusted by leading medical device manufacturers, universities, and medical research laboratories worldwide. Whether testing tissues or bioresorbable materials, stents, or sutures, UnitedTest offers a variety of single-actuator and dual-actuator systems to meet your biomedical testing needs.

Mechanical testing in the textile fabric industry determines core properties such as fabric tensile strength, tear resistance, and wear resistance, directly affecting product durability and safety. UnitedTest can cover comprehensive mechanical tests for textiles, complying with national standards / ISO standards, and provides customized testing solutions including tensile, tear, and puncture tests.

The mechanical testing of industrial components directly determines the load-bearing, fatigue resistance, and wear resistance of the parts, helping to avoid equipment failure risks. UnitedTest can cover a full range of tests including tensile, hardness, and fatigue, is compatible with ISO/ASTM/GB standards, and provides customized mechanical testing solutions for industrial components.

Mechanical testing in the glass-ceramics industry determines core properties such as flexural strength, hardness, and fracture toughness, directly helping to avoid brittleness and failure risks. UnitedTest can cover comprehensive testing for flexural strength, hardness, and fracture toughness, compatible with national and ISO/ASTM standards, and provides customized testing solutions.

Tensile test evaluates material resistance to stretching, measuring strength/elongation critical for quality control. UnitedTest offers universal tensile testers (10-600KN) compliant with ASTM/ISO standards, providing tailored solutions for metals, polymers, medical & industrial materials.

Compression test assesses material resistance to compressive loads, measuring strength/deformation critical for quality validation. UnitedTest offers compression testing machines compliant with ASTM/ISO standards, providing tailored solutions for concrete, plastics, metals and industrial components.

Flexural & Bend tests evaluate material resistance to bending forces, measuring strength, stiffness and ductility for quality assurance. UnitedTest provides flexural testing machines (3-point/4-point bend) compliant with ASTM/ISO standards, offering tailored solutions for composites, plastics, metals and construction materials.

Torsion Test evaluates material resistance to rotational forces, measuring torsional strength/ductility critical for fasteners, insulators, shafts. UnitedTest offers torsion testers compliant with ASTM A938/ISO 16047, providing tailored solutions for automotive, aerospace, fastener industries.

Fatigue Test assesses material durability under cyclic loading, critical for predicting service life of industrial components. UnitedTest offers fatigue testing systems (axial/bending/torsion) compliant with ASTM E466/ISO 12106, providing tailored solutions for automotive, aerospace and manufacturing sectors.

Peel Test measures material adhesion strength by evaluating resistance to peeling forces, critical for adhesives, films, packaging. UnitedTest offers peel testers compliant with ASTM D903/ISO 8510, covering 90°/180° peel tests, and tailored solutions for packaging, automotive, textile industries.

Impact Test evaluates material resistance to sudden shock loads, critical for assessing toughness and fracture risk. UnitedTest offers impact testers (Charpy/Izod/fall weight) compliant with ASTM E23/ISO 148, providing tailored solutions for metals, plastics, glass and industrial components.

Tear & Shear Test evaluates material resistance to tearing and shearing forces, measuring critical strength parameters for quality control. Tear tests (Elmendorf/trouser/trapezoidal) assess resistance to crack propagation in films/fabrics, while shear tests measure resistance to parallel forces in joints/bolts. UnitedTest provides universal testing machines (10KN-600KN) with specialized fixtures for both tests, compliant with ASTM D624/D3164 and ISO standards, serving automotive, packaging and construction industries.

Hardness test measures material's resistance to permanent indentation, critical for quality control. UnitedTest offers universal hardness testers (Rockwell/Brinell/Vickers) compliant with ASTM/ISO standards, plus tailored hardness testing solutions for diverse industrial needs.

Biaxial/triaxial tests evaluate material performance under multi-axis loads, critical for biomaterials, metals and composites. UnitedTest provides compliant testing machines (ASTM/ISO) for planar biaxial, static/fatigue triaxial tests, with tailored solutions for industrial & biomedical needs.

Friction and wear tests assess material resistance to friction, abrasion and wear, critical for industrial material performance validation. UnitedTest offers tribometers compliant with ASTM G99/ISO standards, covering pin-on-disk, four-ball tests, and tailored friction & wear testing solutions for diverse industries.

Pressure test evaluates material/component resistance to static/dynamic pressure, critical for sealing, strength and safety validation. UnitedTest offers pressure testing machines compliant with ASTM/ISO standards, covering burst, hold-pressure tests, and tailored solutions for industrial, automotive & medical sectors.

Fire test assesses material flammability, heat resistance and fire-retardant performance, critical for safety compliance across industries. UnitedTest offers fire testing equipment compliant with ASTM/ISO/UL standards, providing tailored fire test solutions for building materials, plastics and industrial components.

Non-destructive Test (NDT) evaluates material/component integrity without damage, critical for safety & quality across industries. UnitedTest offers ultrasonic/X-ray/magnetic particle NDT equipment compliant with ASTM/ISO standards, plus tailored NDT solutions for aerospace, automotive & manufacturing sectors.

ASTM F2346 Artificial Disc Static & Dynamic Tester | UnitedTest

UnitedTest manufactures ASTM F2346 testing machine for in-vitro static and dynamic characterization of spinal artificial intervertebral disc implants for cervical, thoracic and lumbar spine, supporting mechanical comparison of disc prosthesis designs.

ASTM F2346 establishes in‑vitro mechanical test protocols for non‑biologic artificial intervertebral disc implants for cervical, thoracic and lumbar spine applications. It provides a standardized framework for mechanical comparison of different disc prosthesis designs instead of setting mandatory pass‑fail performance thresholds.

Test principle:

Simulated motion segment: the disc is sandwiched between two blocks separated by a gap = disc space, replacing the real vertebra–disc–vertebra unit and eliminating cadaveric variability.

Two‑force‑member loading: a long (≥380 mm), low‑friction, ball‑jointed pushrod transmits a resultant force whose line of action always passes through the load point = center of the superior fixture sphere = device geometric center. Length minimizes axis misalignment error (1 mm offset → 0.15°).

Combined loading by geometry: 45° fixture inclination creates simultaneous compression + anterior shear; a gimbal adds torque under constant preload.

The two specific test methods

Static tests

Metal blocks, position control, quasi‑static ramp to functional failure:

Static axial compression — pure compressive load along −Z through the disc's geometric center.
Static compression–shear — inferior fixture rotated +45° about the Y‑axis, so the resultant force produces equal compression F_c and anterior shear F_s through the device center.
Static torsion — pin‑slot gimbal applies a constant compressive preload plus a torsional moment about Z.

Dynamic (fatigue) tests

Polyacetal blocks, load control:

Fatigue axial compression — R = 10 (load ratio max/min = 10).
Fatigue compression–shear — R = 10.
Fatigue torsion — R = −1 (fully reversed torque), under constant compressive preload.

Test Specimen info:

Device type: synthetic, permanently implanted artificial intervertebral disc (TDR); cervical, thoracic or lumbar.
Condition: production‑quality parts, previously unused only — no re‑testing; labeled and maintained per good laboratory practice; any deviation from the marketed product must be reported. Fixtures are exempt from archiving and may be reused.
Size selection: test the size with the smallest safety factor (worst case) for the indicated levels; if that cannot be shown by stress calculation or FEA, all sizes must be tested.
Sample quantity: static — minimum five specimens; fatigue — an S‑N trend of ≥ 6 data points, at least two of which are run‑outs.
Mounting geometry: block cut‑outs/dimensions follow the device and the manufacturer's surgical technique; device placed at the ideal insertion location per the IFU.
Intervertebral height H: 2–16.5 mm permitted; suggested 4 mm cervical, 6 mm thoracic, 10 mm lumbar; held constant for a given device size; must not collapse to zero before functional failure (otherwise the test is a failure).
Coordinate system: origin at device geometric center; +X anterior, +Y left, +Z superior; XY plane bisects the endplate‑simulating surfaces; compression = −Z force; torsion = moment about Z.

Test Equipment for ASTM F2346 Artificial Spinal Disc Static & Dynamic Fatigue Test

Dual Axis Fatigue testing machine	Conforms to Practices E4 (force calibration/verification); actuator + load cell (or torque cell). Pushrod: Stainless steel, hollow Ø25 mm, one end a 25 mm‑radius concave spherical seat, other end a universal joint / ball joint; min. length 380 mm between joint centers; min. tensile yield stress 1170 MPa; cross‑section sized for compressive yield ≥ 25 000 N; minimal weight so it behaves as a "two‑force member".
Superior fixture	Stainless steel sphere Ø ≥ 50 mm, truncated so its center coincides with the geometric center of the device; minimal‑friction spherical joint (unconstrained in bending/torsion).
Torsion fixture	Spherical gimbal mechanism (pins in slotted yoke) transmitting combined axial force F and moment M with negligible parasitic bending.
Blocks	(fatigue):Polyacetal (e.g., acetal/Delrin), min. ultimate tensile strength ≥ 61 MPa — simulates vertebral bodies and removes bone variability (static): Stainless steel, min. tensile yield strength ≥ 1170 MPa — so measured stiffness reflects the device, not the fixture
Environmental bath for fatigue	37 °C temperature‑controlled bath for 0.9 % saline (alternative fluids allowed with documented justification)

Test parameters

Static control mode / rate	Position control, ≤ 25 mm/min or ≤ 60°/min (1.05 rad/min)
Fixture calibration loads	≥ 1200 N compression, ≥ 1200 N shear, ≥ 3.5 N·m torsion (solid steel block in place of device)
Static torsion preload	100 N cervical / 300 N thoracic / 500 N lumbar
Fatigue load ratio R	10 for compression and compression–shear; −1 for torsion
Fatigue control	Load control; varying load held within ± 2 % of the largest applied load/moment (dynamic verification per E467)
Fatigue starting levels	75 %, 50 %, 25 % of the static yield load/moment (when no prior experience)
Fatigue frequency	Typically ≤ 2 Hz; > 10 Hz may heat/soften blocks or alter device behavior; physiologic range ≈ 0.1–8 Hz; user's choice must be recorded
End of fatigue test	Functional failure or 10⁷ cycles (run‑out); any mechanical deterioration at 10⁷ cycles is recorded
Environment	37 °C, 0.9 % saline (alternatives require justification)
Monitoring	Disc height recorded approx. every 2 × 10⁶ cycles
Offset criteria	Linear 2 %·H; angular (0.02·H)/R_max

Test Procedures of ASTM F2346 Artificial Spinal Disc Static & Dynamic Fatigue Test

Static Test Procedure

Calibrate test fixtures using solid steel dummy block, record fixture stiffness data for compression, shear and torsion directions.
Mount production artificial disc specimen into matched metal static test blocks at ideal insertion position per manufacturer surgical instructions.
Apply load or moment under position‑control rate limits until functional failure; continuously record load‑displacement / moment‑angle datasets.
For static torsion: apply specified physiological compressive preload before applying torsional moment.
Repeat for minimum five specimens per loading configuration.
Process data: calculate fixture‑corrected implant stiffness, offset‑based yield load/moment, ultimate load/moment, yield and ultimate displacement parameters, characterise failure modes.

Dynamic (Fatigue) Test Procedure

Mount implant between polyacetal fatigue test blocks; fix initial intervertebral height for given implant size across all fatigue specimens of that size.
Set up load‑controlled cyclic loading with specified R‑ratio, environmental bath (37 °C 0.9 % saline), select test frequency and load magnitudes (starting points may be 25 %,50 %,75 % of static yield load).
Run cyclic test, monitor load tolerance ±2 %; record intervertebral height every ~2 million cycles. Stop test at functional failure OR at 10 000 000 cycles run‑out. Document mechanical deterioration even without functional failure at run‑out.
Generate at least six valid S‑N data points including two run‑out points, perform regression analysis for load‑cycles‑to‑failure relationship; determine maximum run‑out load/moment and endurance‑limit estimate.

Industrial‑Field Application

Spinal implant / orthopaedic device manufacturers — design verification and validation of cervical, thoracic and lumbar total disc replacements; material/design selection (CoCr, Ti alloys, UHMWPE, PEEK, polyurethane, ceramics); worst‑case sizing; competitor benchmarking.
Regulatory submissions — F2346 is an FDA‑recognized consensus standard for intervertebral disc prostheses (product code MJO, Class III, PMA), used to demonstrate mechanical comparability with predicate devices; also accepted by EU notified bodies under MDR .
Contract/independent testing laboratories and university biomechanics labs performing standardized in‑vitro bench comparison.
Not applicable to biologic disc replacements or nucleus replacements; complementary tests are needed for expulsion, wear debris and biologic response.

Related Standard:

ASTM F2077	Test Methods for Intervertebral Body Fusion Devices
ASTM F2267	load‑induced subsidence of VBFD under static axial compression.
ASTM F2346	Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
ASTM F2423	Guide for functional, kinematic and wear assessment of total disc prostheses — complements F2346's structural testing.
ASTM F2789	mechanical and functional characterization of nucleus devices (the category F2346 excludes).
ASTM F3295	Guide for impingement testing of total disc prostheses.
ASTM F2624	static, dynamic and wear assessment of extra-discal single-level spinal constructs
ASTM F2790	motion‑preserving lumbar total facet prostheses.
ASTM F1717	Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
ASTM F1798	Guide for evaluating modular hip and knee joint components
ISO 18192‑1	loading/displacement parameters and environmental conditions for wear testing of total intervertebral disc prostheses (calf serum, 20 g/L protein; 600–2000 N; 10^⁷ cycles).
ISO 18192‑2	wear testing of nucleus replacements.
ISO 18192‑3	impingement‑wear testing of lumbar (and now cervical) prostheses under adverse kinematics (min. axial load 300 N ≈ 7.5 N·m; 10⁷ cycles).

Keywords: ASTM F2346 tester,spinal artificial disc test machine,artificial intervertebral disc static dynamic characterization,cervical disc implant testing,lumbar disc prosthesis mechanical test,thoracic spine implant in vitro test,orthopedic implant tester,spinal implant test equipment,intervertebral disc prosthesis fatigue test,medical implant mechanical characterization,spinal motion preservation implant test,artificial disc bioreactor tester,orthopedic device lab test machine,spinal implant R&D testing,artificial disc performance evaluation

Electronic Dynamic Universal Testing Machine/ Cyclic Testing Equipment widely used at material and components, parts dynamic mechanical property test, include tension, compression, low cycling test, match with high-low temperature chamber can execute the temperature test.

Hydraulic fatigue dynamic testing machine mainly used at a variety of material and components, parts for both dynamic and static mechanical property testing, include tension, compression, low cycling test, match with high-low temperature chamber can execute the temperature test.

Electronic Fatigue Testing Machine designed for long-term cyclic load testing of metals, composites, and structural components, offering precise electronic control, repeatable results, and compliance with industrial standards.

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.

UnitedTest universal testing machine with various test fixture, like peel, flexure, puncture, tear, pneumatic grip, belt tension etc., can be used to almost all materials include but not limited to steel rod, rubber, steel wire, plastic, seat belt, textile, wood, panel etc., mechanical performance inspection.

The four point bending flexural test provides values for the modulus of elasticity in bending, flexural stress ,flexural strain and the flexural stress-strain response of the material. This test is very similar to the three point bending flexural test.

3 points bending grip used to measure the flexural modulus or flexural strength of a plastic material, conform with stanard ASTM D790, ISO 178.

Torsion tester is mainly used to execute torsion test for various kinds materials, manual loading, high accuracy torsion transducer to measure torque, photoelectric encoder to measure torsion angle, digital display test result. Easy to operate and with budgetary price, most suitable for research institute and colleague, factory laboratory etc. to check the torsion character of different materials.

1. What is ASTM F2346?

ASTM F2346‑18 (Reapproved 2026) is the ASTM standard test method for the static and dynamic characterization of spinal artificial discs, specifying apparatus, specimen mounting, loading configurations, procedures and data analysis for comparing non‑biologic artificial intervertebral discs of the cervical, thoracic and lumbar spine.

2. Is ASTM F2346 a pass/fail performance standard?

No. It is a comparative characterization method that produces stiffness, yield load or moment, ultimate load or moment and fatigue S‑N data. It deliberately does not set minimum acceptable performance values.

3. Which test methods are included?

Six: static axial compression, static compression‑shear (inferior fixture rotated 45° about the Y‑axis) and static torsion on stainless steel blocks; plus axial compression fatigue, compression‑shear fatigue and torsion fatigue on polyacetal blocks.

4. Why polyacetal for fatigue and steel for static?

Polyacetal (≥ 61 MPa UTS) simulates vertebral bodies and removes bone variability during long cyclic tests. Steel (≥ 1170 MPa yield) makes static stiffness measurement reflect the device rather than the fixture.

5. What is the run‑out criterion?

10 000 000 cycles without functional failure. The endurance limit is the maximum run‑out load or moment, valid only if the lowest failing load is ≤ 1.5 × the highest established run‑out load, with ≥ 6 data points and ≥ 2 run‑outs.

6. What load ratios and frequencies apply?

R = 10 for compression and compression‑shear fatigue; R = −1 for torsion fatigue. Typically ≤ 2 Hz in 0.9 % saline at 37 °C; above 10 Hz the blocks may heat and soften or the device behavior may change.

7. How is yield load determined?

By the offset method: a linear offset of 2 % of intervertebral height (0.2 mm at H = 10 mm), or an angular offset of 0.02 × H / R_max (0.022 rad ≈ 1.3° for H = 10 mm, R = 9 mm). Without an initial linear region, report displacement at 30 %, 60 % and 90 % of yield load.

8. How many specimens are needed?

Minimum five for static tests; at least six fatigue data points including two run‑outs. All implants must be unused production parts and none may be retested.

9. What equipment is required?

An ASTM E4‑conforming machine, Ø25 mm hollow stainless pushrod with 25 mm radius concave spherical end and ≥ 380 mm length, Ø ≥ 50 mm superior fixture sphere centered on the device, spherical gimbal for torsion, polyacetal and steel test blocks, a 37 °C saline bath, and load/displacement/torque/angle measurement with cyclic load held within ± 2 %.

10. ASTM F2346 vs ASTM F2077 — what is the difference?

F2077 covers fusion devices, F2346 covers motion‑preserving artificial discs. They share the same compression, compression‑shear and torsion framework, offset yield definition and 10⁷ run‑out convention; F2346 even accepts the torsion apparatus of F2077 Fig. 5.

11. What does ASTM F2346 not cover?

Expulsion resistance, wear resistance under in‑vivo loads and motions, and the biologic response to wear debris; biologic disc and nucleus replacements are out of scope. See ISO 18192‑1/‑2/‑3, ASTM F2423 and ASTM F3295.

12. Can one machine run both static and fatigue tests?

Yes, with position control for static ramp‑to‑failure, load/torque control for cycling, a torsion axis providing combined axial preload and torque, and a 37 °C saline chamber. UnitedTest configures complete systems to cover the full method.

13. Why choose ASTM F2346 Spinal Artificial Disc Testing System from UnitedTest?

UnitedTest supplies complete ASTM F2346‑18(Reapproved 2026) test solutions for non‑biologic artificial intervertebral disc prostheses. Our axial‑torsional biomechanical test system performs axial compression, compression‑shear and torsion static & fatigue tests for cervical, thoracic and lumbar total disc implants, fully compliant with ASTM F2346 requirements for medical‑device R&D and regulatory submission.

UnitedTest manufactures full‑solution testing machines and custom‑engineered test fixtures complying with ASTM F2346‑18(R26): Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs. Our biomechanical test platform supports all three core loading modes defined in this standard: axial compression, compression‑shear and torsion, covering both static mechanical characterization and long‑term 10‑million‑cycle dynamic fatigue testing for cervical, thoracic and lumbar artificial intervertebral disc prostheses.

Our integrated system includes precision universal joint / spherical gimbal assemblies, matched polyacetal and metal test blocks, 37 °C saline environmental bath, push‑rod assemblies of minimum 380 mm length, and software modules for fixture‑stiffness correction, yield‑point calculation by 2 % offset method, S‑N curve regression analysis, and full test‑report generation.

Designed for orthopaedic medical‑device manufacturers, contract testing laboratories and university biomechanics research institutes, UnitedTest’s ASTM F2346 test equipment generates reproducible in‑vitro mechanical performance data to support implant design optimization, material comparison, and regulatory documentation for FDA, EU‑MDR and other global medical‑device approval pathways.

Note: ASTM F2346 only addresses static‑strength and fatigue characterization. UnitedTest can also provide auxiliary fixture options to pair with companion standards ASTM F2423 and ISO 18192 series for disc wear‑testing projects.

Feature:

✅ Full compliance to ASTM F2346‑18

✅ Static & dynamic fatigue: axial compression, compression‑shear, torsion test modes

✅ 37 °C saline circulating bath for 10‑million‑cycle implant fatigue test

✅ Custom‑made polyacetal / metal test blocks, spherical gimbal & push‑rod fixtures

✅ Built‑in fixture‑stiffness correction algorithm, 2 % offset yield calculation

✅ S‑N fatigue curve regression, functional‑failure & run‑out‑load evaluation

✅ Sample‑size management, full raw‑data export for regulatory test reports

✅ Suitable for cervical, thoracic, lumbar non‑biologic artificial disc prostheses

We offer customization to meet your specific needs. Our expert team will collaborate with you to develop the perfect product for you