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.

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