Testing on prosthesis
The design and manufacture of implantable medical devices require a rigorous validation process to ensure regulatory compliance, reliability and patient safety. Testing of prostheses (orthopedic, dental, cardiovascular) allows the evaluation of material behavior and structural strength of components, both in the study of new products and during quality control on production batches.
Execution of targeted testing plans enables qualification of manufacturing processes and testing of devices from their prototype stage.
Testing and validation of prostheses with TEC Eurolab
For the biomedical sector, TEC Eurolab performs non-destructive inspection and testing for the mechanical, chemical and physical characterization of materials, as well as failure analysis and test engineering services for the validation and study of complex components.
Materials characterization
- Metallurgical analysis for the study of microstructure, grain size, and identification of any structural anomalies
- Chemical and physical analysis of metals for timely verification of the chemical composition of the alloy and the absence of contaminating elements
- Testing for additive manufacturing: essential protocols for metal powder qualification and analysis of 3D printed components.
Investigation of subsidence
Analytical investigation of failures (e.g., fatigue triggers, abnormal wear, corrosive phenomena) by failure analysis to identify the root cause of the failure, providing data for corrective actions on the design or production process
Mechanical Validation and Simulation of Operating Conditions.
- Mechanical tests: static tests (tension, compression, bending) aimed at acquiring strength, yield and deformation data of the material or finished component
- Fatigue testing: application of repeated load cycles to determine the fatigue limit and estimate the actual useful life (endurance) of the implanted device.
- Test engineering: design and implementation of custom experimental setups to simulate specific kinematics, multiaxial stresses, or particular environmental conditions.
Structural Integrity Assessment
Non-destructive testing: radiographic inspections and computed tomography (CT) for three-dimensional volumetric analysis, useful for searching for porosity, cracks, or inclusions without altering the sample
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