ENAC accreditation for surgical implant testing: a key element for product innovation and safety

Autor/es: Fernando Gómez Sendra, Amelia Gómez Pérez, Carlos Atienza Vicente y Mª Jesús Solera Navarro.

Instituto de Biomecánica (IBV)

Ensuring the quality and safety of surgical implants is crucial in the medical sector. Consequently, assessing the conformity of such implants with the regulations governing their use is an essential requirement for manufacturers of this type of medical device. In this context, the Instituto de Biomecánica (IBV), the only Spanish centre to be accredited by ENAC, the Spanish National Accreditation Body for surgical implant testing, under the UNE-EN ISO/IEC 17025 standard, has positioned itself as an industry benchmark in conformity assessment. By meeting the most stringent international regulations, the IBV offers implant manufacturers a comprehensive service that enables them to guarantee the quality and safety of their devices, access new markets and differentiate themselves from their competitors.

INTRODUCTION

The growing demand for increasingly sophisticated and customised medical solutions has led to exponential growth in the field of surgical implants. However, this evolution requires a commitment to the quality and safety of these medical devices. In this context, ENAC accreditation is crucial, and, as the only Spanish centre to have been thus accredited by the ENAC, the Instituto de Biomecánica (IBV) is positioned as a national benchmark in the performance of surgical implant testing in accordance with the international standards UNE-EN ISO 14801:2017, ISO 7206-4:2010, ISO 9585:1990 and ASTM F382-17.

DISCUSSION

ENAC, the Spanish National Accreditation Body, is responsible for verifying the technical competence of organisations that carry out testing, calibration and certification. The fact that it has been accredited by the ENAC as a testing laboratory demonstrates the IBV’s ability to carry out tests in accordance with the criteria set out in the UNE-EN ISO/IEC 17025:2017 standard “General requirements for the competence of testing and calibration laboratories”. Specifically, the tests for which the IBV is accredited in the field of medical devices are as follows:

• The service life of dental implants and accessories by means of fatigue tests in accordance with the UNE-EN ISO 14801:2017 standard “Dynamic loading for endosseous dental implants” (Figure 1)
• The performance of fatigue tests on femoral stems for hip prostheses in accordance with the ISO 7206-4:2010 standard “Determination of the fatigue properties of femoral stems” (Figure 2)
• The mechanical resistance of bone plates in four-point bending tests performed in accordance with the international standards ISO 9585:1990 “Determination of Bending Strength and Stiffness of Bone Plates” and ASTM F382-24 “Specification and Test Method for Metallic Bone Plates”; plates that can be used in the event of any type of fracture (Figure 3)

Figure 1: Test manchine, fatigue curve and set-up for a dental implant or accessory test

Figure 2: Set-up for a hip stem fatigue test

Figure 3: Set-up for a four-point plate bending test

To carry out the tests for which it is accredited, and other tests, the IBV has a dedicated medical device assessment laboratory (Figure 4). This laboratory complies with the quality system set out in the UNE-EN ISO/IEC 17025 standard.  The laboratory has the following ENAC-calibrated testing equipment, traceable to national and international measurement standards:

• Instron 8874: a biaxial unit for static and dynamic torsion (100 Nm), compression and traction (25 KN) tests.
• Instron 8501: for static and dynamic torsion compression and traction tests. This unit can handle loads of up to 100 KN.
• Instron 8872: for static and dynamic compression and traction tests involving loads of up to 25 KN.
• MTS Insight: for static compression and traction tests with a video extensometer.
• MTS Landmark: for static and dynamic compression and traction tests involving loads of up to 25 KN.
• Instron ElectroPuls E3000: for high frequency work and loads of up to 1 KN.

Figure 4: Testing laboratory of the Instituto de Biomecánica (IBV)

The laboratory also has axial load cells ranging from 10N to 100KN and a torque cell capable of handling up to 100 Nm, all of which afford enormous versatility and flexibility when performing tests for manufacturers.

Finally, it is worth highlighting the many benefits that a company can derive from working with an ENAC-accredited laboratory, such as:

• Trust and credibility: ENAC accreditation of a testing laboratory is a seal of approval of the quality and reliability of its test results.
• Access to new markets: ENAC accreditation allows the company concerned to market and see its products in regulated markets such as the European Union and other countries that recognise this type of
• Reduced risk: Early identification of potential design or manufacturing problems minimises the risk of bringing a defective product to market.
• Continuous improvement: ENAC accreditation implies the implementation of a quality management system that promotes continuous process improvement.
• Competitive differentiation: Manufacturers that work with an ENAC-accredited laboratory can differentiate themselves from their competitors and position themselves as suppliers of safe and high-quality products. 

A wide range of solutions for the sector

The IBV offers a wide range of surgical implant testing services, including:

• Static and fatigue resistance testing of spinal implants, maxillofacial plates, hip and shoulder prostheses or any other type of medical device that can be implanted in the body.
• Customised medical device testing.
• The IBV also has extensive experience in developing new test methods and in adapting existing standards to the specific needs of each product.

A success story

In order to cover the full life cycle of medical devices, the IBV is able to assess medical devices right through from the initial 3D design stages using FEM models, to the assessment of the product in the final stages after manufacture. An example of this is the IBV’s participation, together with other leading healthcare bodies in the Valencian Community, in the development and validation of a bespoke design methodology for a subperiosteal plate (Figure 5). The resulting product, which was tested in the IBV’s medical device laboratory, conforms to the patient’s anatomy, integrates perfectly into the adjacent bone area and is exceptionally resistant, thanks to the biocompatible materials used and to rapid, material-saving manufacturing processes that also make the prosthesis lighter.

Figure 5: Design and assessment methodology for a subperiosteal plate

CONCLUSIONS

As an ENAC-accredited laboratory for the testing of surgical implants, the Instituto de Biomecánica (IBV) offers companies in the sector a wide range of accredited tests in accordance with the UNE-EN ISO 14801:2017, ISO 7206-4:2010, ISO 9585:1990 and ASTM F382-24 standards. This testing capability not only ensures that manufacturers can demonstrate that their  products comply with the highest quality and safety standards, but also that they can also differentiate themselves from their competitors and strengthen their market position by having the conformity of their products guaranteed by a laboratory with the highest standards imposed by ENAC, the Spanish National Accreditation Body – https://www.enac.es/

BIBLIOGRAPHY

UNE-EN ISO/IEC 17025:2017. General requirements for the competence of testing and calibration laboratories.

UNE-EN ISO 14801: 2017. Dentistry. Implants. Dynamic loading test for endosseous dental implants (ISO 14801:2016)

ISO 7206-4: 2010. Implants for surgery. Partial and total hip joint prostheses — Part 4: Determination of endurance properties and performance of stemmed femoral components.

ISO 9585: 1990. Implants for surgery — Determination of bending strength and stiffness of bone plates.

ASTM F382-24. Standard Specification and Test Method for Metallic Bone Plates.

AUTHOR’S AFFILIATION

Instituto de Biomecánica de Valencia
Universitat Politècnica de València
Edificio 9C. Camino de Vera s/n
(46022) Valencia. Spain