Quality Standards For Our ASTM & ISO Medical Device Testing
Empirical Quality Standards
Quality makes the difference when seeking regulatory approval!
Empirical holds the widest scope of test standards under ISO/IEC 17025 : 2017 currently available in the United States. We are committed to providing
an exceptional level of customer service, partnership, execution, and reporting for our clients across the globe.
- 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. Learn more about ASTM F543.
- 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. Learn more about ASTM F1541
- 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
- ASTM F1223: Standard Specification for Articulating Total Wrist Implants. Learn more about ASTM F1223
- ASTM F1357: Standard Specification for Articulating Total Wrist Implants. Learn more about ASTM F1357
- Section 6.3: Range of Motion of the Device Before Implantation
- ASTM F1378: Standard Specification for Shoulder Prostheses. Learn more about ASTM F1378
- 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
- ASTM F2118: Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
- 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
- ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. Learn more about ASTM F1717
- 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. Learn more about ASTM F2077
- 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. Learn more about ASTM F2346
- 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. Learn more about ISO 18192-1
ASTM F2554 – Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems
ASTM F1672, SECTION 6.3.1 – Standard Specification for Resurfacing Patellar Prosthesis
ASTM F1829 -Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
ASTM F1044 – Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
ASTM F1147 – Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
ASTM F1160 – Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
ASTM F1875, EXCEPT 9.1.8 & 10.0 – Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
ASTM F1978 – Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
ASTM F2129 – Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
ISO 10328 – Prosthetics – Structural Testing of Lower-Limb Prostheses
Scope FOR Our ASTM & ISO Testing Services
Empirical is committed to providing the highest quality mechanical testing services for our customers, including accurate, reproducible and reliable testing results, professional technical reporting and a rapid response to any issue. Above all, our services are designed to be sensitive to a fast-paced product development environment and delivered at a competitive price.
Empirical holds the widest range of accredited test standards for medical devices currently available in the United States and is dedicated to continually pursuing standards as they become available.
In addition to ISO/IEC 17025:2017 accreditations, our staff employs an ISO-recognized Quality Management System (QMS) and upholds an organization-wide dedication to confidentiality. Empirical employees must undergo training in both the QMS and confidential document handling.
As a matter of course, all Empirical client relationships are strictly confidential.Empirical’s devotion to quality services gives you a competitive advantage by reducing costs, establishing credibility, improving efficiency and enhancing profitability. We invite you to schedule a tour of our facility to see our operations firsthand.
ISO/IEC 17025:2017 Accredited
The QMS for medical device testing is based upon the requirements set forth by the most current version of ISO/IEC 17025:2017.
Why Perform Mechanical Testing?
Mechanical testing is a necessary step of any product development cycle for a medical device requiring regulatory marketing approval.
Why Use an Accredited Lab?
By observing and utilizing good laboratory practices (GLP), Empirical assures integrity in lab planning, monitoring, recording and reporting. We deliver reproducibility, traceability and accuracy in all that we do for you.
EMPIRICAL IS DEDICATED TO ACHIEVING
As the holder of the A2LA’s ISO/IEC 17025:2017 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. More international regulatory agencies require testing to be performed by an ISO 17025:2017 accredited lab to meet their standards for clearance/approval. This accreditation has provided Empirical with a competitive advantage by reducing costs, establishing credibility and improving efficiency for our clients.
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.
accreditation classifications that become available. Please conact us to discuss the custom services we provide where accreditation has yet to become available