In traumatologic and maxillofacial surgery, bone plates -also known as osteosynthesis plates– are essential elements for stabilizing fractures, enabling bone healing and restoring skeletal function.
Their reliability depends on their mechanical strength, structural rigidity and durability under actual loading conditions.
To ensure these factors, manufacturers must perform biomechanical and regulatory tests to validate the performance of their products before marketing. In this article we explain how bone plates are tested, what international standards apply and why Med-Lab IBV is a reference in this type of validation.
The biomechanical function of bone plates
Bone plates act as a temporary support that fixes the bone fragments while the biological consolidation process progresses. Their design must balance rigidity and elasticity, avoiding both structural collapse and excessive restriction of physiological movement.
Therefore, laboratory mechanical testing seeks to answer three key questions:
- Does the plaque withstand the physiological loads that occur in the body?
- Does it maintain its structural rigidity over millions of cycles of use?
- Does it meet the international standards required for CE marking?
Standards governing the testing of bone plates
Validation testing is mainly governed by two international standards recognized by regulatory agencies:
- ISO 9585: Four-point bending test for metallic osteosynthesis devices.
- ASTM F382: Evaluation of flexural strength and structural stiffness of surgical plates.
Both standards define the method for determining the flexural strength and deformation of the plate under controlled loads, simulating the biomechanical environment of orthopedic or maxillofacial surgery.
📎 Find out how these standards are applied in our accredited laboratory for bone and osteosynthesis plate testing, where we reproduce clinical conditions of use with ISO/IEC 17025where we reproduce the clinical conditions of use with ISO/IEC 17025 certified equipment.
Types of tests applied to bone plates
The mechanical behavior of a plate depends on both its geometry and the material used (titanium, stainless steel or special alloys). For this reason, biomechanics laboratories perform several types of complementary tests:
🔹 Four-point bending test
Evaluates the structural stiffness and flexural strength of the plate. A progressive load is applied at two intermediate points while the ends remain supported, measuring the deformation and ultimate load.
🔹 Fatigue test
It reproduces the cyclic loading that a plate undergoes during patient rehabilitation, determining its mechanical service life before structural failure.
🔹 Impact test
Simulates sudden loads (drops or unexpected stresses) to evaluate fracture toughness.
🔹 Screw-plate joint test
It analyzes the stability of the fixation system, a decisive factor to avoid loosening of the implant.
The results of these tests allow the manufacturer to know the ability of the device to withstand actual physiological forces and to ensure its long-term structural safety.
From surgery to the laboratory: simulating clinical reality
Biomechanical innovation makes it possible to transfer to the laboratory the real conditions experienced by bone plates in the human body.
At Med-Lab IBV, we use universal testing machines, specific four-point bending configurations and high-precision sensors to measure the behavior of devices under different loads.
Thanks to our infrastructure, we can replicate clinical scenarios such as:
- Diaphyseal fractures of femur, tibia or humerus.
- Complex maxillofacial reconstructions.
- Osteosynthesis of long bones with different plate geometries.
In the spine, IBV applied a similar approach to validate cervical plates without cadaver tests.
The aim is for each result to be traceable, reproducible and extrapolable to surgical practice, in accordance with the requirements of the European Regulation MDR 2017/745.
Benefits of regulatory testing for manufacturers
Validating a bone plate in an accredited laboratory not only fulfills a regulatory requirement; it also brings competitive advantages.
- Guaranteed regulatory compliance: facilitates CE certification and product acceptance by notified bodies.
- Design optimization: biomechanical results allow adjustment of thickness, material or hole pattern to improve strength.
- Cost and time reduction: reliable testing avoids rework and shortens approval times.
- International recognition: reports issued under ISO/IEC 17025 are valid throughout the EU and in markets regulated by ILAC agreements.
Case study: validation of a maxillofacial plate
A manufacturer develops a new osteosynthesis plate for mandibular reconstruction. Before its launch, it needs to demonstrate:
- Flexural strength according to ISO 9585.
- Fatigue durability after millions of load cycles.
- Sufficient structural rigidity to maintain bone reduction.
The tests performed by Med-Lab IBV provide data on the behavior of the plate under simulated chewing and jaw tension conditions, allowing to adjust the design and meet the requirements of MDR 2017/745.
Why choose Med-Lab IBV for bone plate assays?
Med-Lab IBV is an ENAC accredited laboratory under ISO/IEC 17025, specialized in biomechanical and mechanical testing of medical devices.
We have:
- State-of-the-art equipment for flexure and fatigue tests.
- Experts in biomechanics and surgical materials.
- Protocols aligned with ISO 9585, ASTM F382 and MDR 2017/745.
- Interpretive technical reports with design recommendations.
Our combination of technical rigor and clinical expertise makes us the ideal partner for manufacturers and quality managers seeking to validate safe, effective and compliant bone plates.
From the laboratory to the surgical practice
Bone plate testing is a key part of the modern trauma value chain. Validating their strength and durability under normative criteria guarantees greater safety for the patient and confidence for the manufacturer.
At Med-Lab IBV, we bring the biomechanics of surgery to the laboratory, combining science, technology and accreditation to provide valid, traceable and clinically relevant results.
Contact Med-Lab IBV to design the testing plan that certifies your osteosynthesis plates and optimizes their access to the European market.
