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Home >> Application >> By Standard >> ISO >> ISO 10000~19999 >> ISO 12189 Tests on Screw and Rod Systems for the Spine

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, semi-rigid, and dynamic implants that are difficult to test in a corpectomy configuration without anterior support. It is designed to assess the fatigue performance of spinal implant assemblies (including anchors, interconnections, longitudinal elements, etc.) under physiological-like cyclic loads with anterior column support, which is more clinically relevant than the corpectomy model without anterior support. It applies to fusion and motion-preserving implants, especially flexible, semi-rigid, and dynamic posterior spinal stabilization devices (e.g., pedicle screw-rod systems, hook-rod systems).

ISO 12189 Test Method:

Compression/flexion fatigue test: Apply sinusoidal cyclic loads to simulate physiological compression and flexion of the spine, with a maximum test frequency of 5 Hz.

Anterior support model: Use calibrated springs to simulate intervertebral discs, providing anterior column support to reflect clinical reality (unlike ASTM F1717's corpectomy model without anterior support).

ISO 12189 Tests on Screw and Rod Systems for the Spine

Test endpoint: 5 million cycles (simulate 10 years of clinical service) or mechanical failure (e.g., fracture, loosening, excessive deformation).

Test Equipment:

Equipment Type	Specific Requirements
Fatigue testing machine	Servohydraulic or electromechanical, capable of sinusoidal loading, load accuracy ±1%, displacement control optional, max frequency 5 Hz, load capacity ≥25 kN (lumbar) or ≥1 kN (cervical)
Load cell	Accuracy class 0.5, suitable for cyclic loading
Test fixture	Ultra-high molecular weight polyethylene (UHMWPE) test blocks to simulate vertebrae; calibrated springs (stiffness per ISO 10243) to simulate intervertebral discs; spherical joints to ensure alignment.
Environmental chamber	Optional, to simulate body temperature (37°C) and Ringer’s solution for in vitro testing.

Test Specimen:

Implant assembly: Complete spinal implant assembly (anchors, rods, connectors, etc.) as used clinically, with materials (e.g., Ti6Al4V, Co-Cr alloys) and dimensions per design.

Test blocks: UHMWPE blocks simulating vertebrae (number based on spinal level: e.g., 3 blocks for lumbar, 2 for cervical), with screw holes matching implant anchors.

Springs: Calibrated compression springs with specified stiffness (lumbar: ~450 N/mm; cervical: ~50 N/mm) to simulate anterior column support.

ISO 12189 Test Principle:

Biomechanical simulation: The anterior support model mimics the spine's anterior column (vertebrae + intervertebral discs) to distribute loads realistically, avoiding overloading the implant (common in corpectomy models).

Fatigue failure mechanism: Cyclic loading induces crack initiation and propagation in implants, evaluating structural durability and interface stability (implant-bone, implant-implant) under long-term physiological loads.

ISO 12189 Spinal device fatigue Test Procedures:

Fixture preparation: Mount UHMWPE test blocks and calibrated springs (anterior support) per standard dimensions.

Implant assembly: Fix the spinal implant to test blocks as per surgical technique (e.g., torque for screws).

Mounting: Install the assembly on the testing machine, align with spherical joints to prevent bending moments.

Load setting:

Lumbar: 0.6–2.0 kN (max load); load ratio R = 0.1 (min load = 0.1 × max load).

Cervical: 0.05–0.15 kN; R = 0.1.

ISO 12189 Tests on Screw and Rod Systems for the Spine

Cyclic loading: Apply sinusoidal loads at ≤5 Hz until 5 million cycles or failure.

Data recording: Load-displacement curves, cycle count, failure mode (fracture location, loosening).

Result reporting: S-N curve (stress vs. cycles), failure load, and mode.

Test Application:

Manufacturer Validation: Ensures devices meet biomechanical requirements for clinical use.

Regulatory Compliance: Required for FDA (U.S.), CE (EU), and other regulatory submissions.

Design Optimization: Compares materials (titanium vs. PEEK), geometries (cage shape), or surface treatments (coatings).

Related Standards:

Standard	Relationship
ASTM F1717	Corpectomy model without anterior support; ISO 12189 complements it for flexible implants needing anterior support
ISO 10243	Specifies spring stiffness calibration for anterior support simulation
ISO 14879	General requirements for spinal implant mechanical testing
EN ISO 12189	EU adoption of ISO 12189 for MDR compliance
ASTM F2077	Spinal implant static testing; ISO 12189 focuses on fatigue

Test Importance for Spine Devices:

Clinical relevance: Anterior support model reflects real spinal biomechanics (anterior column support exists in most surgeries), avoiding over-testing flexible implants and under-testing rigid ones.

Safety assurance: Fatigue failure (e.g., rod fracture, screw loosening) is a leading cause of revision surgery; 5 million cycles predict 10-year durability.

Regulatory compliance: Mandatory for CE marking (EU MDR) and FDA 510(k) submissions for posterior spinal devices.

Design optimization: Guides R&D (e.g., material selection, structural reinforcement) to improve long-term performance.

Market access: Global standard for comparing different implant designs, ensuring fair competition and reliable patient outcomes.

Related products and device

ISO 12189 Spinal Device 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.

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.

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Bone Screws 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

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 ISO 12189 Spinal Implant Fatigue Test

Q1: What is the core purpose of ISO 12189, and how is it different from other spinal implant test standards?

A: ISO 12189 specifies a fatigue test method for spinal implant assemblies with anterior support, focusing on compression/flexion cyclic loading to simulate physiological spine conditions. Unlike standards such as ASTM F1717 (which uses a corpectomy model without anterior support), it is tailored for flexible, semi-rigid, and dynamic posterior spinal devices. The anterior support (calibrated springs simulating intervertebral discs) ensures more clinically realistic load distribution, avoiding over-testing of flexible implants.

Q2: Why is ISO 12189 critical for spinal implant development and approval?

A: It is critical for three core reasons:

Clinical relevance: The anterior support model mimics the spine’s natural biomechanics (anterior column bears part of the load), which is far more reflective of real surgical scenarios than unsupported models.

Safety validation: Fatigue failure (e.g., rod fracture, screw loosening) is a top cause of spinal implant revision surgery. ISO 12189’s 5 million cycle requirement simulates 10 years of patient use, verifying long-term durability.

Regulatory compliance: It is a mandatory test for EU MDR (Medical Device Regulation) CE marking and a key reference for US FDA 510(k) submissions for posterior spinal stabilization devices.

Q3: What types of spinal implants are covered by ISO 12189?

A: It applies to fusion and motion-preserving posterior spinal implant assemblies, including:

Pedicle screw-rod systems

Hook-rod systems

Flexible spinal stabilization devices

Semi-rigid dynamic implants

It does not apply to standalone interbody fusion cages (these are covered by other standards like ISO 18509).

Q4: How does ISO 12189 relate to ASTM F2077?

A: They are very similar in scope and methodology. ASTM F2077 (Test Methods for Intervertebral Body Fusion Devices) is the main U.S. (ASTM) equivalent. It includes static compression, shear, and torsion tests. ISO 12189 is the primary international (ISO) standard. For global market approval, manufacturers often conduct testing that satisfies the core requirements of both standards, as they are largely harmonized.

Q5: From a patient safety perspective, why is this test critical?

A: A device that collapses or subsides (sinks into the bone) under normal body loads can lead to:

Pseudarthrosis (non-union): Loss of stability prevents bone from growing through the cage.

Loss of Disc Height: Can cause nerve compression, pain, and deformity (e.g., kyphosis).

Catastrophic Failure: Device fracture can require revision surgery. This test directly screens for these risks.

Q6: What are the typical load parameters for lumbar vs. cervical implants in ISO 12189?

A: The standard defines distinct load ranges for different spinal levels:

Lumbar implants: Sinusoidal cyclic load with a maximum of 2.0 kN, minimum of 0.2 kN (load ratio R=0.1), frequency ≤5 Hz.

Cervical implants: Sinusoidal cyclic load with a maximum of 0.15 kN, minimum of 0.015 kN (R=0.1), frequency ≤5 Hz.

Testing continues until 5 million cycles or mechanical failure (fracture, loosening, excessive deformation).

Q7: What constitutes a "failure" in ISO 12189 testing?

A: Failure is defined by any of the following:

Visible fracture of any implant component (rod, screw, connector).

Implant loosening (e.g., screw backing out of UHMWPE test blocks by >2 mm).

Excessive deformation (e.g., rod bending beyond the design’s allowable limit).

Loss of load-bearing capacity (inability to maintain the specified cyclic load range).

Q8: Can ISO 12189 test results predict clinical performance of spinal implants?

A: While it cannot fully replicate the complex in vivo environment (e.g., bone remodeling, patient activity variation), the test provides a reliable preclinical indicator of long-term durability. Implants that pass 5 million cycles under ISO 12189 conditions have a significantly lower risk of fatigue-related failure in clinical use, supporting evidence-based regulatory approval and clinical adoption.

Q9: Are there any limitations to ISO 12189 testing?

A: Yes, key limitations include:

It simulates only compression/flexion loads, not other physiological motions (e.g., torsion, lateral bending) that may occur in the spine.

Test blocks use UHMWPE instead of real bone, so implant-bone interface behavior (e.g., osseointegration effects) is not evaluated.

It does not account for patient-specific factors (e.g., osteoporosis, activity level) that impact implant performance.

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