Testing of Porous Structure and Porous Coatings for Medical Devices

Element's testing capabilities comprehensively evaluate medical implant surfaces, from traditional porous coatings to integrated structures. We specialize in testing resorbable blast media (RBM), titanium plasma spray (TPA), hydroxyapatite (HA) coatings, and advanced manufacturing methods including electron beam melting (EBM) and direct metal laser sintering (DMLS), providing validation for optimal biological fixation performance.

We deliver advanced mechanical testing through multiple validated methods for complete performance verification. Each test can be adapted for actual implants or standardized specimens, providing comprehensive validation. Our testing capabilities include:

• Shear testing (static and dynamic) to ASTM F1044 & F1160 standards using metallic cylinders (0.75" diameter, 1-1.25" length) with porous coating on one side 

• Tensile testing following ASTM F1147 using disc-shaped samples (1" diameter) bonded between two fixtures 

• Abrasion resistance testing (ASTM F1978) using Taber abrasion methods where a circular sample repeatedly contacts an abrasive wheel 

• Rotating beam fatigue analysis (ASTM F1160) using hourglass-shaped coated rods loaded about the long axis 

• Coefficient of friction testing against bone analogs and tissue samples measuring both static and dynamic frictional forces 

Our metallurgical analysis provides comprehensive coating evaluation using advanced techniques. We conduct detailed assessments of coating thickness, surface roughness characteristics, volume percent void measurements, and thorough pore morphology examinations. Our stereological evaluation methods not only align with ASTM F1854 standards but also provide crucial information on coating type and microstructure, delivering complete coating characterization for your regulatory and development needs. 

Shear Testing (ASTM F1044 & ASTM F1160): 
A metallic cylinder (0.75” diameter, 1–1.25” length) with a porous coating on one side is attached to an uncoated specimen. The sample is loaded in shear until failure (static) or to a set cycle count (dynamic). 

Tensile Testing (ASTM F1147): 
A disc-shaped sample (1” diameter) with one coated and one uncoated side is bonded between two fixtures. The sample is pulled under tensile load until the components separate. 

Abrasion Testing (ASTM F1978): 
Commonly performed using Taber abrasion, this test assesses porous structure integrity by repeatedly contacting a circular sample with an abrasive wheel. Results help compare coating types or meet regulatory agency acceptance criteria. 

Rotating Beam Fatigue (ASTM F1160): 
An hourglass-shaped, coated rod is loaded about its long axis to assess the properties of the porous coating under stress, with the surface material experiencing the most stress during testing. 

Coefficient of Friction: 
We measure static and dynamic frictional forces between porous structures and materials like polyurethane bone analogs, animal tissue, or human donor tissue. Static resistance measures the force needed to initiate motion, while dynamic resistance measures the force needed to maintain motion. Testing follows internal procedures or can be customized to meet your specific protocols. 

• Stereomicroscope – capable of evaluating specimens from 5X - 50X 

• Metallographic microscope – capable of evaluating specimens from 50X - 1000X 

• Digital microphotography – capable of evaluating specimens from 5X-2500X 

• Digital image analysis software with custom programming for fast and efficient analysis 

• Specimen mounting and polishing equipment for precise sample preparation 

• Microetching capability with a variety of chemical etchants 

• Low-speed diamond saws for precise, low-stress, low-heat sectioning 

• SEM services available for higher magnification analysis 

Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page. 

Our digital image analysis systems provide detailed evaluation of coating characteristics, measuring thickness, volume percentage, and void distribution between tissue and substrate interfaces. Our metallurgical evaluation provides information on coating type and microstructure. This comprehensive analysis supports both regulatory requirements and development optimization, with microetching capabilities using various chemical etchants for enhanced examination.