SURGICAL IMPLANT TESTING LABORATORY ACCREDITED BY ENAC
REFERENCE LABORATORY FOR SURGICAL IMPLANT TESTING
The Instituto de Biomecánica (IBV) is a benchmark center for the testing and conformity assessment of surgical implants, with more than 40 years of experience supporting medical device manufacturers and the healthcare sector.
As a reference in this field, it is the only testing laboratory in Spain accredited by ENAC for surgical implants—an endorsement of its technical competence and the reliability of its test results, based on ISO 17025. This provides companies with the assurance that their products meet regulatory requirements, both in front of third parties and public authorities.
IBV works closely with companies in the sector to adapt testing procedures to new European regulatory requirements, helping reduce validation times and avoid certification issues.
ADVANCED INFRASTRUCTURE AND EXPERT TEAM FOR SURGICAL IMPLANT TESTING
Advanced laboratory technologies and equipment for testing under static and fatigue loads.
- Uniaxial INSTRON 8501 (+/- 100 kN)
- Uniaxial MTS INSIGHT (+/- 10 KN)
- Uniaxial MTS LANDMARK (+/- 15 KN)
- Biaxial INSTRON 8870 (+/- 25 kN and +/-100 Nm)
- Uniaxial INSTRON 8872 (+/-25 kN)
- ElectroPuls (+/- 3 KN) E3000
- In vitro spinal implant testing machine covering all load modes (8 Nm)
- Finger prosthesis wear simulator
- Additionally, the laboratory includes a wide range of accessories, fixtures, and load cells of various capacities, enabling the adaptation of tests to all types of medical implant devices.
Our multidisciplinary team includes experts in biomechanics, conformity assessment of surgical implants, and regulatory analysis for compliance with the European Medical Device Regulation (MDR) 2017/745, which imposes stricter requirements for the preclinical evaluation of implants. Manufacturers are now required to provide more comprehensive data on device performance and safety.
SURGICAL IMPLANT TESTING
Our tests ensure the strength, stability, and functionality of implants before they reach the market.
- Static compression and torsion tests: Analysis of structural stiffness and failure load.
- Fatigue tests under compression and torsion: Assessment of implant lifespan under repeated fatigue loading using various load curves.
- Wear tests and particle analysis: Performed with in-house equipment for hip and interphalangeal prostheses.
- Bone–implant interface testing: Tensile tests to study osseointegration and long-term stability of the bone–implant interface, conducted on synthetic bone or animal models.
These tests are essential for meeting the requirements of MDR 2017/745, as they provide objective data on the safety and performance of surgical implants under real-world conditions.
ACCREDITED IMPLANT 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.
Dental Implants
Hip Prostheses
Finger Joint Prostheses
WHY CHOOSE IBV FOR SURGICAL IMPLANT TESTING
The Instituto de Biomecánica is your best partner for surgical implant testing. Here are some of our key value propositions:
- The only laboratory in Spain accredited by ENAC for surgical implant testing (LE519/1105).
- State-of-the-art infrastructure with the latest testing equipment.
- Multidisciplinary team with expertise in biomechanics and medical device regulations.
- Strict compliance with MDR 2017/745 and other international standards.
- Added value in every test: we deliver results that are analyzed and validated against reference literature, our proprietary databases, and technical recommendations to optimize your product.
Contact us for more information about our services
We will assess your needs and recommend the most suitable testing strategy for your implants.
