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Home > Industries We Serve > 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.
DOWNLOADABLE TRI-FOLD PAMPHLETS (.pdf)
  
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MTS Fatigue Frame Grips with Sample
Instron DynaMight Axial/Torsional
Fatigue Tester
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| List of Services | Products Tested |
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| Mechanical Testing | Hip Stems |
| Tensile, Yield, Elongation | Knee Stems |
| Bond Strength Testing | Acetabular Cups |
| Hardness | Shoulder Implants |
| TMA | Bone Plates |
| Flexural | Spinal Implants |
| Compression | Fasteners |
| | Surgical Tools |
| Metallurgical Evaluations | Stents |
| Microhardness | Wires |
| Microstructure Evaluation | |
| Grain Size | Materials Tested |
| Coating Evaluations | Diffusion Coatings |
| | Thermal Spray Coatings |
| Chemical Analysis | Beta-Tricalcium Phosphate |
| Alloy Chemistry | Hydroxylapatite/Hydroxyapatite |
| Trace Element Analysis | Titanium Alloys |
| N, O, C, S, H | Stainless Steels |
| Surface Cleanliness | Cobalt Alloys |
| Hazardous Substances | Plating/Anodizing |
| Heavy Metal Impurities | Polymers |
| Ionic Contamination | Composites |
| Particle Size | Porous Materials |
| Polymer Identification | UHMWPE |
| Thermal Analysis | |
| Wear Debris | Approvals |
| FTIR | Zimmer |
| GC/MS | Stryker |
| TGA | Synthes |
| Total Extractables | Fort Wayne Metals |
| Phthalate Content | Praxis |
| Chemical Resistance | DePuy Orthopaedics |
| (exposure to heat/water) | ...and more. Contact us for |
| | more information. |
| Fatigue | |
| Rotating Beam (RBF) | Failure Analysis |
| Polymers | Fractography |
| Elastomers | Corrosion |
| Small Devices | Wear |
| Axial/Torsional Fatigue | |
| High Cycle Fatigue | |
| Low Cycle Fatigue | |
| Shear Fatigue | |
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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 and specifications tested to include:
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Designation
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Title
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F746
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Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
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F1044
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Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
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F1147
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Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings
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| F1088 | Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation |
| F1160 | Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical Coatings |
| F1185 | Standard Specification for Composition of Hydroxylapatite for Surgical Implants |
| F1440 | Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components without Torsion |
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F1536
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Standard Test Method for Determining Strength and Setting Time of Synthetic Water-Activated Polyurethane Fiberglass Orthopaedic Casting Tape
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| F1612 | Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion |
| F1800 | Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
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F1854
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Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
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F2129
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Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptability of Small Implant Devices.
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F2183
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Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants
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F2459
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Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
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F2516
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Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
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F2625
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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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