Home > Industries We Serve > Medical Device Testing   MEDICAL DEVICE TESTING 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.   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 materials engineering capabilities, combined with our experts in mechanical testing, chemical analysis, fixture machining and fatigue testing, allows us to perform extensive reliability and product testing on all types of products. IMR has been at the forefront of RoHS testing since day one. We are experienced and ready to assist you in certifying your medical devices, per the latest revisions of the RoHS requirements. Contact us for a quote or to discuss your test plan today! July 2012 - We are pleased to announce that IMR Metallurgical Services has purchased a new Rigaku Miniflex 600 XRD.  This will allow for faster turnaround on services such as percent crystallinity, phase identification and powder morphology.  Contact us today for more information. MEDICAL DEVICE TESTING RELATED INFORMATION (.pdf) Cleanliness Testing Services Fatigue & Fracture Mechanics Testing Services Medical Device Testing Failure Analysis & Hosted Inspection Services

Fatigue Frame Grips with Sample XRD Spectra (Percent Crystallinity/ Phase ID) Medical Device Testing Products Tested Mechanical Testing Hip Stems Tensile, Yield, Elongation Knee Stems/Tibial Tray 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 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 Elastomers Wear Debris FTIR Approvals GC/MS Zimmer TGA DePuy Synthes Total Extractables Stryker Phthalate Content Praxis Chemical Resistance DePuy Orthopaedics    (exposure to heat/water) Fort Wayne Metals Chromium Analysis ...and more.  Contact us for RoHS  information. Phase Identification Powder Morphology XRD Analysis Diffraction Testing Percent Crystallinity   Failure Analysis Wear Fractography Corrosion Fracture Mechanics Fatigue Rotating Beam (RBF) Axial/Torsional Fatigue High Cycle Fatigue Low Cycle Fatigue Shear Fatigue Fatigue Testing of Knees Fatigue Testing of Hips     Stent & Dental Implants Coating Shear Fatigue Sample in Grips

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 methods performed and specifications tested are as follows.

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 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 F1536 Standard Test Method for Determining Strength and Setting Time of Synthetic Water-Activated Polyurethane Fiberglass Orthopaedic Casting Tape 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 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 ISO 7206-4 Fatigue Testing of Metallic Hip Stem Components