Microbiological Safety

Implant Testing

MDTL offers biomechanical studies  for Implants with accredited partner labs according to the applicable standards  and can also create individual customized testing strategies. Evaluation depends on the category of the medical device in accordance with the nature of the devices.

Dental

  • ISO 14801: Dentistry — Implants — Dynamic Fatigue Test for Endosseous Dental Implants

Orthopaedic

Bone Fixation and Reinforcement

  • ASTM F382: Standard Specification and Test Method for Metallic Bone Plates
  • ASTM F384: Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
  • ASTM F543: Standard Specification and Test Methods for Metallic Medical Bone Screws.
  • ASTM F564: Standard Specification and Test Methods for Metallic Bone Staples
  • ASTM F1264: Standard Specification and Test Methods for Intramedullary Fixation Devices
  • ASTM F1541: Standard Specification and Test Methods for External Skeletal Fixation Devices.
  • ASTM F2183: Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants
  • ASTM F2502: Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants

Hip

  • ASTM F1820: Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device
  • ISO 7206-4: Implants for Surgery — Partial and Total Hip Joint Prostheses — Determination of Endurance Properties and Performance of Stemmed Femoral Components.
  • ISO 7206-6: Implants for Surgery — Partial and Total Hip Joint Prostheses — Determination of Endurance Properties of Head and Neck Region of Stemmed Femoral Components
  • ISO 7206-8: Implants for Surgery – Partial and Total Hip Joint Prostheses – Endurance Performance of Stemmed Femoral Components with Application of Torsion

Spinal

  • ASTM F1717: Standard Test Methods 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 F2077: Test Methods for Intervertebral Body Fusion Devices.
  • ASTM F2193: Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
  • ASTM F2267: Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device under Static Axial Compression
  • ASTM F2346: Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs.
  • ASTM F2423: Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
  • ASTM F2624: Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Spinal Motion Preserving Implants
  • ASTM F2694: Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
  • ASTM F2706: Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
  • ASTM F2789: Standard Guide for Mechanical and Functional Characterization of Nucleus Devices (Except Viscoelastic Testing)
  • ASTM F2790: Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses.
  • ISO 12189: Implants for Surgery — Mechanical Testing of Implantable Spinal Devices — Fatigue Test Method for Spinal Implant Assemblies Using an Anterior Support
  • ISO 18192-1: Implants for Surgery — Wear of Total Intervertebral Spinal Disc Prostheses — Loading and Displacement Parameters for Wear Testing and Corresponding Environmental Conditions for Test.
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