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MEDICAL DEVICES

Medical device technology has seen rapid developments in recent years.  New advanced materials and designs have greatly improved the quality and reliability of implantable devices.  However, with these improvements have come greater challenges in medical device testing, including materials analysis and product reliability.  IMR offers unique capabilities to support manufacturers in this environment.  We continually update and improve our material analysis techniques to be able to assure material quality and purity.  Our combination of Materials Engineering capabilities, Mechanical Testing, Chemical Analysis, fixture machining and Environmental Simulations allow us to perform extensive reliability and product testing on all types of products.

 Prosthetic hip by DanR.

List of Services Products Tested
   
Mechanical Testing Hip Stems
Tensile, Yield, Elongation Knee Stems
Bond Strength Testing Acetabular Cups
Hardness Shoulder Implants
  Bone Plates
Metallurgical Evaluations Spinal Implants
Microhardness Fasteners
Microstructure Evaluation Surgical Tools
Grain Size Stents
Coating Evaluations Wires
   
Chemical Analysis Materials Tested
Alloy Chemistry  
Trace Element Analysis Titanium Alloys
N, O, C, S, H Stainless Steels
Surface Cleanliness Cobalt Alloys
Hazardous Substances Plating/Anodizing
Heavy Metal Impurities Diffusion Coatings
Ionic Contamination Thermal Spray Coatings
Particle Size Porous Materials
Polymer Identification Polymers
Thermal Analysis Hydroxylapatite/Hydroxyapatite
Wear Debris Beta-Tricalcium Phosphate
  UHMWPE
Fatigue  
Rotating Beam (RBF)  
Polymers  
Elastomers  
Small Devices  
   
Failure Analysis  
Fractography  
Corrosion  
Wear  

 

Methods

IMR performs many of the methods outlined in the FDA Guidance Documents for the Medical Device Industry to confirm that alloys and polymers, as well as completed components meet the applicable ASTM or ISO specifications.  Some of the ASTM methods performed include:

Designation

Title

F746

Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials

F1044

Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings

F1147

Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings

F1088 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
F1185 Standard Specification for Composition of Hydroxylapatite for Surgical Implants

F1536

Standard Test Method for Determining Strength and Setting Time of Synthetic Water-Activated Polyurethane Fiberglass Orthopaedic Casting Tape

F1854

Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants

F2129

Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptability of Small Implant Devices.

F2183

Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants

F2459

Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis

F2516

Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials

F2625

Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry

 

   
 
   
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