As an A2LA ISO/IEC 17025:2017 accredited mechanical testing laboratory, the RIH Orthopaedic Foundation Test Facility is equipped to assist medical device manufacturers with all of their research and development needs. RIHOF offers a full suite of services including protocol development, test execution, data analysis, and report generation. From early-stage feasibility studies to non-clinical benchtop testing for FDA 510k submissions, RIHOF will utilize scientifically-rigorous methodologies to provide clients with accurate and reliable results.
Load Frame Testing
Equipment
- Instron ElectroPuls E10000 Linear-Torsion Testing System (Specs)
- MTS 810 Uniaxial Servo-hydraulic Material Testing System (Specs)
- Instron 8521 Axial-Torsion Servo-hydraulic Fatigue Testing System (Specs)
- Instron ElectroPuls E1000 Testing System (Specs)
- MTS Bionix Electromechanical Torsion Test System (Specs)
Specifications
- Linear Dynamic Capacity: ±25kN (5,620 lb)
- Linear Static Capacity: ±25kN (5,620 lb)
- Torsion Capacity: ±250Nm (2,200 in-lb)
- Linear Stroke: 100mm (3.94 in)
- Rotation: ±50°
Six-Axis Industrial Robot
Equipment
- KUKA KR 6 R700 sixx Six-Axis Robotic Arm (Specs)
- Mini45 Six-Axis Force/Torque Sensor (Specs)
- simVITRO musculoskeletal simulation software (Specs)
Specifications
- Force (X and Y axes): 560 N (125 lb)
- Force (Z axis): 1,160 N (260 lb)
- Torque (X, Y and Z axes): 20 Nm (177 lb-in)
- Range of Motion: 0.7 m from centroid
- Payload: 6 kg (13 lb)
- Speed: 700 mm/s
Additional Equipment and Software
- Optotrak Certus Motion Capture System (Specs)
- Qualisys Motion Capture System (Specs)
- Tekscan I-Scan Pressure-Mapping System with Evolution handle (Specs)
- Scanco Medical µCT 40 Desktop MicroCT Scanner (Specs)
- Mindways QCT Pro bone density measurement software (Specs)
- Materialise Mimics Medical Image 3D Modeling and Processing Software (Specs)
- Solidworks 2019 3D Computer-Aided Design Software (Specs)
Standards We Test
With a parametric A2LA scope, RIHOF is accredited for test methods contained in a wide array of ASTM standards, including:
Standard Specification and Test Methods for Metallic Medical Bone Screws
Standard Specification and Test Method for Metallic Bone Plates
Standard Specification and Test Method for Metallic Bone Staples
Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model
Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
Standard Specification and Test Methods for Components used in the Surgical Fixation of the Spinal Skeletal System
Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface