ISO/IEC 17025:2005 Accreditation

Empirical Is Dedicated to Achieving Industry-Recognized Certification

Empirical is the global leader in orthopedic device testing and holds A2LA accreditation for the largest number of medical device testing methods in the United States.

As holder of the A2LA’s ISO/IEC 17025:2005 Test Laboratory Accreditation Certificate #2142-01-A2LA, Empirical is recognized as capable and qualified to perform testing and evaluation of medical devices in compliance with ASTM/ISO guidelines in the area of finished medical devices. Empirical achieved this accreditation Dec. 2, 2003. It has helped Empirical achieve a competitive advantage by reducing costs, establishing credibility and improving efficiency.

While some lab accreditations involve only minimal review of a laboratory’s qualifications, an A2LA-accredited lab must meet rigorous internationally recognized standards. The A2LA annually audits and inspects Empirical, ensuring our lab meets testing, calibration and quality standards set by the organization, which is recognized by more than 30 federal, state and local government associations.

Established in 1978, A2LA is the largest multidiscipline accreditation organization in the United States. Empirical will pursue any additional accreditation classifications that become available.

Please contact us to discuss the custom services we provide where accreditation has yet to become available.

Empirical’s current scope of accreditation for testing includes:

Dental

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

Extremities

  • 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

Joint Replacement Implants

  • ASTM F1357: Standard Specification for Articulating Total Wrist Implants
    • Section 6.3: Range of Motion of the Device Before Implantation
  • ASTM F1378: Standard Specification for Shoulder Prostheses
  • ASTM F1714: Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices
    • Annex 4: Method for Cleaning and Weighing of Specimens Only
  • ASTM F1781: Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
    • Section 6.2: Range of Motion of the Device Before Implantation
  • ASTM F1800: Standard Test Method for Cyclic Fatigue Testing of Tibial Tray Components of Total Knee Joint Replacements
  • ASTM F1820: Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device
  • ASTM F2009: Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
  • ASTM F2025: Standard Practice for Gravimetric Measurements of Polymeric Components for Wear Assessment
    • Annex 1: Method for Cleaning and Weighing of Specimens Only
  • ASTM F2028: Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
  • 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

Spine

  • 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