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Home >> Application >> By Standard >> ASTM >> ASTM E-F >> ASTM F2502 Test of Internal Fixation Implants Bioabsorbable Plates and Screws

ASTM F2502 Test of Internal Fixation Implants Bioabsorbable Plates and Screws

ASTM F2502 - Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants defines the requirements and mechanical test methods specifically for bioabsorbable (or biodegradable) orthopedic implants used to stabilize bone fractures. Unlike permanent metal implants, these devices are designed to provide temporary support and then gradually dissolve in the body. This standard ensures they possess sufficient initial mechanical strength and that their degradation properties are characterized in a standardized way.

ASTM F2502 Test Principle:

Bioabsorbable implants rely on hydrolytic degradation; the standard ensures they maintain mechanical integrity until fracture healing (typically 6–12 weeks) and then degrade gradually. Preconditioning accelerates in vivo hydrolysis to predict long-term performance. Static tests measure peak mechanical limits, while fatigue tests evaluate durability under cyclic physiological loads. Construct tests validate the plate-screw assembly’s ability to stabilize fractures despite material degradation. The core principle is to measure the key mechanical performance metrics of bioabsorbable implants under standardized, repeatable conditions that simulate surgical use and the initial post-operative period.

Specific Test Methods of ASTM F2502:

Torsional Properties Test of Screws	Measure the Torsional Yield Strength, Maximum Torque, Breaking Angle. Motor-driven torque analyzers (1–5 r/min) with axial load control for screw insertion torque and torsion tests.
Driving Torque and Strip Torque of Screws	Measures the torque required to insert the screw into a standardized material and the torque at which the screw head strips or the material fails, assessing surgical usability and thread design. Apply 1-5r/min torsional load for 4 rotations (1440 degrees) and 1.14kg or less axial load to maintain screw driver bit in the screw head.
Pull-Out Strength of Screws	Determines the plate's bending strength and stiffness (via a 4-point bend test), which relates to its ability to maintain fracture alignment. Insert specimen in collet grip- 5 threads or 60% of total length of fully threaded screw.
Bending test of Plates	Measure the force required to axially pull a screw out of a standardized material, evaluating thread purchase and anchorage. Determine the bending stiffness, bending structural stiffness, and bending strength for each tested bone plate.

Test Equipment required for the ASTM F2502 Test of Internal Fixation Implants Bioabsorbable Plates and Screws:

Universal Testing Machine: For applying controlled tensile, compressive, or bending forces (for shear, pull-out, and bend tests).
Torque Gauge or Torque Testing System: For accurately measuring insertion and strip torque.
Environmental Chamber or Bath: For maintaining test specimens in Phosphate-Buffered Saline (PBS) at 37 ± 2°C to simulate in-vivo degradation.
Specialized Fixtures:

Shear Test Fixture: A fixture that supports a screw while a shearing anvil applies force perpendicular to its axis.
Torque Test Block: A block made of a uniform, standardized material (like polyurethane foam or synthetic bone) with a pre-drilled pilot hole.
Four-Point Bend Fixture: For applying pure bending moments to the plate specimen.

Test Specimen Information:

Screws: Finished, sterilized screws of the smallest and largest diameters offered in the product line are typically tested. They are driven into the standardized test block.

Plates: Finished, sterilized plates of the smallest and largest sizes/lengths. They are tested in their final, anatomic shape.

Why This Test is Important for Bioabsorbable Plates and Screws:

Ensures Initial Mechanical Sufficiency: It verifies that the biodegradable implant is strong enough at the time of surgery to stabilize the fracture, meeting a baseline comparable (for a time) to traditional metal implants.

Characterizes the Critical Degradation Profile: This is the most important differentiator. The standard requires testing after fluid conditioning, which measures how fast the implant loses strength. This data is crucial to ensure the implant maintains strength long enough for bone healing (typically 6-12 weeks) before safely dissolving.

Guides Surgical Technique: Torque testing provides data that informs surgeons on optimal insertion technique to avoid stripping the screw head (which is easier with polymer screws than metal ones).

Mitigates Risk of Premature Failure: By establishing standardized strength benchmarks and degradation protocols, the standard helps prevent market entry of devices that might break or soften too quickly, which could lead to catastrophic clinical failure (loss of fracture alignment).

Foundation for Regulatory Science: It provides the common language and methodology for regulators to assess the safety and effectiveness of these complex, time-dependent medical devices.

Related products and device

ASTM F2502 Bioabsorbable Plates and Screws Testing Machine

UnitedTest Fatigue 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.

ASTM F2502 Bioabsorbable Screws Driving Torque Insertion Test

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.

ASTM F2502 Bioabsorbable Screw Pull-out tester, tensile tester

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.

ASTM F2502 Bioabsorbable Screw Torsion Torque Tester

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.

Related Standard

ASTM F2706 Fatigue Static Test of Spinal implant constructs –

ASTM F2706 is a critical biomechanical evaluation tool in the medical device industry, specifically for spinal implants. ASTM F2706 establishes standardized mechanical test methods to evaluate the static (strength) and fatigue (long-term durability) performance of spinal implant assemblies intended for use in the occipito-cervical (OC) and cervico-thoracic (CT) regions (from the skull to the upper back). It simulates a worst-case scenario: a complete vertebrectomy (removal of a vertebra), creating a highly unstable spine segment that the implant must stabilize.

ASTM F1717 Spinal Implant Constructs Test –

ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Modelis a fundamental standard for evaluating the static and fatigue mechanical performance of spinal implant assemblies. Unlike ISO 12189, which focuses on a single device(an interbody cage), ASTM F1717 tests the entire posterior spinal construct—typically rods, screws, and cross-connectors—stabilizing a segment where a vertebral body has been removed (a "vertebrectomy" or "corpectomy" model). It simulates worst-case spinal instability to assess the implant's ability to maintain alignment and support loads.

ISO 12189 Tests on Screw and Rod Systems for the Spine –

ISO 12189: Implants for surgery. Mechanical testing of implantable spinal devices. Fatigue test method for spinal implant assemblies using an anterior support.

ISO 12189 is an international standard that specifies fatigue test methods for spinal implant assemblies (fusion or motion preservation) using anterior support, focusing on compression/flexion fatigue to evaluate static and dynamic strength, especially for flexible, dynamic implants.

ISO 6475 Bone Screw Torsion Breaking Torque Test Methods –

ISO 6475 Implants for surgery — Metal bone screws with asymmetrical thread and spherical under-surface — Mechanical requirements and test methods

ISO 6475 specifies mechanical test methods for determining breaking torque and rotation angle at failure of metal bone screws with asymmetrical threads and spherical under-surfaces, along with minimum mechanical requirements for stainless steel screws in Annex A. It is critical for validating torsional integrity to prevent intraoperative/surgical failure and ensure regulatory compliance.

ASTM F543 Metallic Medical Bone Screws Test Driving Torque, Pullout Load Self-Tapping –

ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws

ASTM F543 is a testing standard used in the biomedical industry that defines specifications for metallic medical bone screws. Bone screws are used in surgical procedures for securing implants, osteosynthesis devices, and fracture fixation plates to the skeletal system. In normal clinical use, a surgeon applies combined axial and torsional forces to implant a bone screw into the body. Bone screws are designated Class 2 FDA devices, requiring significant testing and analysis of mechanical properties prior to approval and release. It provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.

FAQs about ASTM F2502 (Mechanical Testing of Bioabsorbable Orthopedic Plates and Screws)

Q1: Why is a separate standard like ASTM F2502 needed? Can't we just test bioabsorbable implants like metal ones?

A: No, that would be insufficient and misleading. Bioabsorbable implants have a fundamentally different mission: they must be strong, then disappear. ASTM F2502 is essential because:

It Tests Degradation: The core requirement is testing after conditioning in warm saline, which simulates how the implant loses strength inside the body over time. A metal implant test (e.g., ASTM F543) only looks at "time-zero" strength.
Different Failure Modes: Polymer screws are more susceptible to stripping during insertion and have different shear/ductile properties compared to metal. The standard addresses these specific failure modes.
Material-Specific Properties: It sets expectations for the unique behaviors of polymers (PLA, PLLA, PLGA, etc.) rather than metals.

Q2: Why is the test material (like polyurethane foam block) so important?

A: It provides consistency and comparability. Real human bone varies massively in density and strength. Using a standardized synthetic test block (per standards like ASTM F1839) ensures that:

Results are repeatable within a single lab.

Results are comparable between different manufacturers.

The test isolates the performance of the implant itself, not the variability of bone.

Q3: How is ASTM F2502 related to ASTM F543?

A: ASTM F543 is the analogous standard for metallic bone screws. F2502 is essentially the bioabsorbable version, but with the crucial addition of degradation testing. They share similar mechanical test principles (shear, torque, pull-out), allowing for a somewhat apples-to-apples comparison of initialstrength, which is important for surgeons transitioning from metal to bioabsorbable devices.

Q4: Can ASTM F2502 be used for non-orthopedic bioabsorbable implants, such as dental or spinal devices?

A: ASTM F2502 is primarily designed for orthopedic plates and screws used in long bone, craniomaxillofacial, or small bone fixation. While some test methods (e.g., screw pull-out, degradation testing) may be adapted for dental or spinal bioabsorbable implants, specialized standards (e.g., ASTM F1839 for spinal constructs, ISO 10993-15 for dental materials) are preferred for those applications to address unique biomechanical demands.

Q5: What test substrates are used in ASTM F2502, and why not use real human bone?

A: The standard requires polyurethane foam (density 0.16–0.32 g/cm³) or UHMWPE test blocks instead of real bone. Real bone has high variability in density, porosity, and strength (e.g., between young and elderly patients), which would skew test results. Synthetic substrates provide a consistent, repeatable platform, ensuring test data reflects implant performance—not bone property differences.

Q6: Is compliance with ASTM F2502 mandatory for regulatory approval of bioabsorbable implants?

A: Yes, compliance is a key requirement for regulatory submissions (e.g., FDA 510(k) in the U.S., EU MDR in Europe). Regulators rely on ASTM F2502 data to confirm that bioabsorbable implants meet mechanical safety thresholds, maintain strength during healing, and degrade predictably. Without this data, commercialization of these implants is generally not permitted.

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