Mechanical Testing

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:

✓ ASTM F543

Standard Specification and Test Methods for Metallic Medical Bone Screws

✓ ASTM F382

Standard Specification and Test Method for Metallic Bone Plates

✓ ASTM F564

Standard Specification and Test Method for Metallic Bone Staples

✓ ASTM F1717

Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model

✓ ASTM F1798

Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants

✓ ASTM F2193

Standard Specification and Test Methods for Components used in the Surgical Fixation of the Spinal Skeletal System

✓ ASTM F2009

Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses

✓ ASTM F1820

Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices

✓ ASTM F1875

Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface