SURGICAL IMPLANT TESTING LABORATORY ACCREDITED BY ENAC

The Instituto de Biomecánica (IBV) is the only center in Spain accredited by ENAC (519/LE1105) under ISO 17025 for surgical implant testing, covering dental implants, hip prostheses, and osteosynthesis plates.

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.

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

Dynamic Load and Fatigue Resistance Testing According to UNE-EN ISO 14801

Hip Prostheses

Wear Evaluation of the Articular Pair, Acetabular Testing, Stem Neck Testing, and Head–Stem.

Knee Implants

Evaluation of structural resistance, mechanical stability, biomechanical behavior, among others.

Bone Plates

Custom Testing to Assess Mechanical Strength and Structural Stability.

Osteosynthesis Systems

Advanced Testing to Optimize Design and Durability.

Spinal Implants

Enhanced Design to Visually Expose the Femoral Component Condyles.

Finger Joint Prostheses

Specific Wear Testing of Polyethylene–Metal Articular Pairs

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 with ENAC accreditation for testing surgical implants 519/LE1105
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.

Frequently Asked Questions

Which ENAC-accredited surgical implant testing laboratory guarantees reliable results in full compliance with current regulations?

The Institute of Biomechanics (IBV) is the only laboratory in Spain accredited by ENAC (519/LE1105) under the ISO/IEC 17025 standard for the testing of surgical implants, including dental implants, hip prostheses, and osteosynthesis plates. This accreditation certifies technical competence and the reliability of results, ensuring compliance with the requirements of the European Regulation (EU) 2017/745 (MDR) on medical devices.

How does IBV ensure the quality and validity of the tests carried out in its surgical implant laboratory?

IBV has state-of-the-art facilities and a multidisciplinary team of experts in biomechanics, conformity assessment, and regulatory requirements. Its infrastructure includes INSTRON and MTS uniaxial and biaxial testing machines, wear simulators, and in vitro spinal testing systems that enable the reproduction of real load conditions. Thanks to this equipment and specialized personnel, the laboratory ensures accurate, traceable tests in full compliance with the applicable international standards for implantable medical devices.

What types of tests does the IBV laboratory perform on surgical implants?

The IBV implant testing laboratory carries out a wide range of tests to ensure the strength, stability, and functionality of devices prior to their commercialization. These include:
* Static compression and torsion tests.
* Fatigue tests to determine the service life of the implant.
* Wear tests and particle analysis for hip or finger prostheses.
* Bone–implant interface tests to study osseointegration and long-term stability.

These tests provide essential objective data for certification in accordance with Regulation (EU) 2017/745 (MDR).

What role does IBV play in adapting testing procedures to the new requirements of the European Regulation (EU) 2017/745?

IBV works closely with manufacturers and healthcare organizations to adapt its testing protocols to the requirements of the European Regulation (EU) 2017/745 (MDR), which introduces stricter criteria for safety and preclinical evaluation. Thanks to its expertise, IBV helps companies shorten validation and certification times by providing reliable data on the performance and safety of surgical implants prior to commercialization.

What advantages does IBV offer over other laboratories for surgical implant testing?

IBV offers a comprehensive service that combines technical rigor, regulatory compliance, and expert guidance. Its main advantages include: * The only laboratory in Spain accredited by ENAC for surgical implant testing.
* State-of-the-art infrastructure and highly qualified personnel.
* Strict compliance with Regulation (EU) 2017/745 (MDR) and relevant ISO international standards.
* Comparative technical analysis and customized recommendations based on proprietary databases and scientific literature.

These strengths make IBV the ideal strategic partner for manufacturers and research centers seeking to ensure the quality and safety of their implants.