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Home >> Application >> By Standard >> ASTM >> ASTM E-F >> ASTM F2706 Fatigue Static Test of Spinal implant constructs

ASTM F2706 Fatigue Static Test of Spinal implant constructs

ASTM F2706 - Standard Test Methods for Occipito-Cervical and Occipito-Cervico-Thoracic Spinal Implant Constructs in a Vertebrectomy Model.

This standard 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.

Test Principle:

The principle is to create a pure moment (bending force) across the implant construct in a controlled laboratory setting. The UHMWPE blocks are mounted in the tester such that when the machine applies a force, it induces a bending moment in the primary anatomical planes:

Flexion-Extension;

Lateral Bending;

Axial Rotation.

Tests are performed separately for each loading mode. The construct is loaded while submerged in warm saline, and its resistance to deformation (stiffness) and ultimate failure load is measured.

ASTM F2706 Test Methods:

The standard defines three static and two fatigue test methods to assess the mechanical performance of spinal implant constructs.

Static Test	Compression bending	Determines the construct's ultimate strength, stiffness, and yield properties under a single, continuously increasing load until failure occurs.
	Tensile bending
	Torsion
Dynamic fatigue test	Compression-tension bending fatigue	Evaluates the implant's long-term durability by applying a repeated load for a specified number of cycles (e.g., 5 million cycles) or until failure, to establish a load-versus-cycle (S-N) curve.
	Torsion fatigue

Test Equipment required for ASTM D2706 test:

Static/Fatigue Testing Machine: A servo-hydraulic or electromechanical testing system capable of applying both static and dynamic cyclic loads with precise control and data acquisition.

Environmental Chamber: A bath or chamber to contain physiological saline solution maintained at 37 ± 2°C to simulate in vivo body conditions, which is crucial for corrosion-fatigue interactions.

Specialized Fixturing (UHMWPE Blocks): The test specimen is mounted between blocks made of Ultra-High Molecular Weight Polyethylene (UHMWPE). These blocks represent the remaining vertebrae (or skull base) and have standardized geometry and screw hole patterns to ensure consistent load application and comparison between different implant designs.

Motion Tracking System: Often used (e.g., digital image correlation or extensometers) to measure displacements and calculate angular range of motion (ROM) of the construct.

Test Specimen Info:

Implant Constructs: OC/OCT assemblies (rods, hooks, screws, connectors) mounted on two UHMWPE test blocks (superior and inferior) with a defined gap to simulate vertebrectomy.

ASTM F2706 Fatigue Static Test of Spinal implant constructs

Test Blocks: UHMWPE with tensile strength of 40 ± 3 MPa to eliminate bone variability.

Specimen Preparation: Implants are fixed to blocks per manufacturer’s instructions; constructs must be intact and free of defects.

Test Procedures of ASTM F2706 for the spinal implants:

Specimen Assembly: The complete implant is assembled and rigidly fixed into the upper and lower UHMWPE blocks according to the standard's specified screw placement and torque.

Mounting: The block-implant-block construct is mounted into the testing machine's fixtures. The fixtures are designed to apply a pure moment while allowing unconstrained motion in the other planes.

ASTM F2706 Fatigue Static Test of Spinal implant constructs

Environmental Conditioning: The entire assembly is submerged in a 37°C saline bath.

Preconditioning: A small number of load cycles may be applied to seat the components.

Loading procedure:

Static Test: A continuously increasing rotational displacement or moment is applied at a controlled rate until the construct catastrophically fails or reaches a defined endpoint. Load and displacement are continuously recorded.

Fatigue Test: A cyclic sinusoidal load (typically at 2-5 Hz) is applied at a specific load level based on a percentage of the static failure load. Testing continues until failure (e.g., screw breakage, rod fracture) or completion of the target cycle count (e.g., 5 million cycles).

Data Analysis: Calculate stiffness (Nm/degree), yield moment, ultimate failure moment, and for fatigue tests, determine the run-out load (the load at which no failure occurs).

Why This Test is Important for Spinal Implants:

Biomechanical Relevance: The OC/CT junction is highly mobile and bears the weight of the head. This test replicates the severe instability it must stabilize, providing clinically relevant performance data.

Patient Safety: It ensures that implants have sufficient strength to withstand physiological loads without acute failure and fatigue resistance to survive a patient's lifetime of movement (often termed "endurance limit").

Regulatory Necessity: It is a mandatory part of the pre-clinical testing portfolio for regulatory clearance/approval of new spinal implant systems in major markets.

Informs Surgical Practice: Understanding the mechanical performance helps surgeons select appropriate constructs for different pathologies and patient sizes.

Drives Innovation: Provides a benchmark that drives manufacturers to develop stronger, more durable, and lower-profile implant systems.

Related products and device

ASTM F2706 Spinal Implant Constructs Fatigue Testing Machine

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.

ASTM F2706 Spinal implants Tension, Compression testing Machine

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 F2706 Spinal Implants 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.

Screws testing machine Driving Torque Insertion and Removal 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.

Related Standard

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.

ISO 16402 Acrylic resin cement Flexural fatigue testing –

ISO 16402:2008, Implants for Surgery - Acrylic Resin Cement - Flexural Fatigue Testing of Acrylic Resin Cements Used in Orthopaedics, is an international standard dedicated to testing the flexural performance of acrylic resin bone cement applied in orthopedic surgeries. It plays a critical role in ensuring the long-term mechanical stability of bone cement, which is essential for the success of orthopedic implants.

Bone Cement Four-Point Bending Fatigue Test is primarily used to evaluate the fatigue performance of bone cement materials under four-point bending conditions. Specifically, it can conduct mechanical performance tests, such as fatigue durability and lifespan, on specimens of bone cement, biomaterials, surgical implant materials, and medical materials. By simulating real-world stress conditions, the tester assesses the bending strength, fatigue life, deformation characteristics, and performance of bone cement under various environmental conditions. These test results are crucial for ensuring the reliability and safety of bone cement in practical applications, aiding in product design optimization, production process improvement, and overall product quality enhancement.

ISO 14879-1 Fatigue test of metallic tibial trays of total knee joint replacement system –

ISO 14879 - 1 is a core international standard formulated by the International Organization for Standardization (ISO) for the mechanical performance evaluation of metallic tibial trays in total knee replacements (TKR). The standard covers two major types of tests: static mechanical testing (to evaluate the ultimate load - bearing capacity and stiffness of the tibial tray) and cyclic fatigue testing (to simulate long - term physiological loading and assess durability).

FAQs about ASTM F2706 (Static and Fatigue Testing of Occipital-Cervical Spinal Implants)

Q1: What exactly is being tested? Can I test just a single screw or rod?

A: No. ASTM F2706 tests the complete final implant construct as it would be assembled in surgery. This includes every component: the occipital plate, rods, screws (cervical and thoracic), cross-links, and all locking mechanisms. The interaction between all these parts is critical to performance, so testing them together is essential.

Q2: How is ASTM F2706 different from the more common ASTM F1717 standard?

A: This is a key distinction. ASTM F1717 is designed for testing lumbar (lower back) spinal constructs. The ASTM F2706 is specifically designed for the cervical/upper thoracic spine. The main differences are:

Anatomy & Loads: The OC/CT spine is more mobile and bears the weight of the head, resulting in different load magnitudes and moments.

Construct Size: Implants for the cervical region are much smaller and more intricate than lumbar implants.

Test Fixture (Blocks): The UHMWPE test blocks in F2706 have a different geometry and screw hole pattern that represents the smaller bones and different screw trajectories of the cervical spine and skull base.

Q3: Who uses the data from these tests?

A: Multiple stakeholders:

Medical Device Engineers: To guide and validate design improvements.
Regulatory Affairs Specialists: To compile submissions for FDA (510k or PMA), CE Mark, etc.
Surgeons: To inform their understanding of how different implant systems perform biomechanically.
Hospital Value Analysis Committees: To help in evaluating and selecting implant systems based on objective performance data.

Q4: What materials are used for the test blocks in ASTM F2706, and why?

A: Test blocks are made of ultra-high-molecular-weight polyethylene (UHMWPE) with a tensile strength of 40 ± 3 MPa. UHMWPE is chosen because it eliminates the variability of human/animal bone specimens (e.g., bone density differences) and provides a consistent, repeatable substrate for mounting implants. This ensures test results reflect implant performance—not bone properties.

Q5: How does ASTM F2706 relate to other standards like ISO 12189 and ASTM F1717?

ASTM F1717: A broader standard for spinal implant constructs in vertebrectomy models, but it does not specifically address OC/OCT implants. ASTM F2706 is a specialized extension for upper cervical spine devices.
ISO 12189: International standard for mechanical testing of spinal devices, covering similar fatigue principles but with some differences in loading parameters and environmental conditions. Manufacturers often test to both ASTM F2706 and ISO 12189 to meet global regulatory requirements.

Q6: Can ASTM F2706 be used for non-spinal implants or other types of spine implants (e.g., lumbar interbody devices)?

A: No. The standard is only applicable to OC/OCT spinal implant constructs. Lumbar or thoracic implants are tested to other standards (e.g., ASTM F2077 for interbody fusion devices), while non-spinal implants (e.g., orthopedic joints) follow unrelated standards (e.g., ASTM F1147 for hip implants).

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