BONE PLATE TESTS
At the Instituto de Biomecánica (IBV), we are an ENAC-accredited laboratory for mechanical strength and structural rigidity testing of bone plates and osteosynthesis systems.
Our tests ensure the safety and effectiveness of these medical devices prior to market launch, in accordance with international standards such as ISO 9585 and ASTM F382.. These studies are essential for manufacturers, laboratories, and regulatory bodies aiming to comply with the European Medical Device Regulation (MDR) 2017/745 and gain access to international markets.
ACCREDITED BONE PLATE TESTING ACCORDING TO ISO 9585 AND ASTM F382
At IBV, we conduct tests on bone plates and osteosynthesis systems to determine their ability to withstand mechanical loads under real-use conditions.
Among the main tests we carry out, the following stand out:
- Four-point bending test: Evaluates structural stiffness and flexural strength in plates for medical devices for orthopedic, traumatology and maxillofacial surgery.
- Determination of mechanical strength: Static and dynamic load tests to validate the durability of bone plates.
- Regulatory compliance: We apply recognized international standards such as ISO 9585 and ASTM F382, essential for the certification of these surgical devices.
In addition to the delivery of the results report, at IBV we provide added value with technical observations and optimization strategies to improve the safety and performance of the bone plates before their release to the market.
Request information from our technical team
LABORATORY SPECIALIZED IN BONE PLATE TESTING
The IBV biomechanics laboratory has advanced technology and specialized equipment for the evaluation of medical devices such as osteosynthesis plates for maxillofacial and orthopedic surgery and traumatology.
Osteosynthesis Plate Testing
● Evaluation of mechanical interaction and structural stabilityin osteosynthesis systems...
Test equipment and technology
● Advanced configurations for four-point bending tests, ensuring accuracy in the measurement of structural stiffness.
● High-precision instrumentation to evaluate the behavior of the devices in real conditions of use.
ISO 9585 Standard
● Application of osteosynthesis plates in bone fracture surgeries requiring stable and durable fixation.
ASTM F382 Standard
STANDARDIZED TESTING IN TRAUMATOLOGY AND ORTHOPAEDIC SURGERY
IBV assays are designed to validate bone plates used in demanding surgical procedures:
These regulations ensure that the bone plates tested at IBV that have passed the validation process comply with the safety and efficacy requirements demanded by international regulatory bodies.
ADVANTAGES OF TESTING BONE PLATES IN AN ACCREDITED LABORATORY
At IBV, we not only evaluate the compliance of bone plates, but also provide a strategic approach through detailed analyses and technical recommendations to optimize product performance.
- The only laboratory in Spain accredited by ENAC for bone plate testing ( 519/LE1105).
- Compliance with international standards such as ISO 9585 and ASTM F382.
- Traceability of measurements to national and international standards, ensuring the reliability of test results for third parties and public authorities.
- A quality management system based on ISO 17025, under which all testing activities are conducted.
- Essential evaluation for compliance with the European Medical Device Regulation (MDR) 2017/745, facilitating CE certification.
- Critical validation for manufacturers seeking to introduce surgical plates into international markets.
- Simulation of clinical scenarios, ensuring that the bone plates meet the biomechanical requirements of their surgical application.
Contact our technical team
We will help you define the necessary tests to validate the safety and efficacy of your bone plates on the market.
