Precision Testing. Regulatory Confidence. Engineering Excellence.
FOCUS Medical Design and Development provides accredited mechanical testing services aligned with ASTM International standards. Our ISO/IEC 17025:2017 accreditation ensures test data meets regulatory requirements for FDA 510(k) submissions, CE Mark applications, and global market access. With over 50 years of combined orthopedic engineering experience, we deliver testing protocols that support design verification, product validation, and regulatory documentation.
Foundational test methods for characterizing material properties, calibrating equipment, and validating measurement systems. These standards establish the baseline mechanical data required for medical device design and regulatory submissions.
ASTM D638
Tensile Testing of Plastics
Determines tensile properties of plastics, including modulus of elasticity, tensile strength, and elongation. Uses a universal testing machine to pull specimens at a constant strain rate.
Stress-strain curve, ultimate tensile strength (UTS), yield strength, elongation at break
ASTM D790
Flexural Properties of Plastics
Evaluates bending behavior of plastics using three-point or four-point bending tests.
Flexural strength, flexural modulus, maximum strain
ASTM E4
Force Measuring System Verification
Ensures calibration accuracy of force-measuring devices in mechanical testing machines.
Accuracy verification, force measurement consistency
ASTM E8/E8M
Tensile Testing of Metallic Materials
Measures tensile strength, yield strength, and elongation of metallic materials.
Ultimate tensile strength, yield stress, elongation, modulus of elasticity
ASTM E83
Extensometer Verification
Establishes calibration methods for extensometers.
Strain measurement accuracy, error percentage
ASTM E2309
Position Measuring Device Accuracy
Evaluates displacement accuracy of mechanical testing devices.
Position accuracy, repeatability, deviation measurement
Test methods for evaluating spinal fusion devices, artificial discs, pedicle screw systems, and vertebral body replacements. These protocols address static strength, fatigue endurance, and worst-case loading scenarios required for FDA clearance.
ASTM F1717
Spinal Implant Constructs (Vertebrectomy Model)
Simulates worst-case loading conditions for spinal implant constructs. Standard test configuration for pedicle screw systems and spinal rods.
Ultimate failure load, construct stiffness, fatigue life
ASTM F1798
Spinal Implant Interconnection Mechanisms
Evaluates fatigue and static strength of implant interconnections including rod-to-screw and screw-to-plate interfaces.
Interconnection stability, mechanical endurance, failure modes
ASTM F2077
Intervertebral Body Fusion Devices
Evaluates mechanical properties of spinal fusion cages and interbody devices under compressive and shear loading.
Implant subsidence resistance, mechanical failure load, stiffness
ASTM F2193
Spinal Fixation System Testing
Covers mechanical testing of spinal rods, screws, and plates as complete constructs.
Bending stiffness, cyclic fatigue life, ultimate strength
ASTM F2346
Spinal Artificial Discs
Evaluates wear, fatigue, and static load performance of spinal artificial disc replacements.
Axial compressive strength, cyclic fatigue failure, wear characterization
Test methods for total joint replacement components including tibial trays, femoral stems, acetabular cups, and modular junctions. Addresses fatigue performance, constraint characteristics, and modular connection integrity.
ASTM F1223
Knee Replacement Constraint Testing
Measures rotational and translational constraints in knee implants to characterize stability.
Constraint forces, range of motion limits, laxity measurements
ASTM F1800
Cyclic Fatigue of Tibial Tray Components
Assesses durability of tibial trays under cyclic loading simulating gait conditions.
Cycles to failure, wear resistance, fatigue endurance
ASTM F1814
Modular Hip and Knee Components
Evaluates mechanical stability of modular implant junctions under static and cyclic loading.
Retention strength, resistance to fretting, junction stability
ASTM F1820
Acetabular Liner Disassembly
Measures force required for disassembly of acetabular liners from metal shells.
Disengagement force, locking mechanism integrity
ASTM F2009
Hip Taper Disassembly Forces
Measures force needed to separate modular hip tapers (head-neck junctions).
Taper retention force, resistance to fretting corrosion
ASTM F2255
Modular Hip Joint Disassembly Strength
Measures forces required to separate modular hip joint components under various conditions.
Disassembly force, component stability under load
Test methods for bone plates, screws, intramedullary nails, external fixators, and other fracture fixation devices. Evaluates bending strength, fatigue performance, and fixation stability under physiological loading.
ASTM F382
Metallic Bone Plates
Defines mechanical testing of bone plates under static and fatigue bending loads.
Bending stiffness, ultimate strength, fatigue life (run-out cycles)
ASTM F384
Angled Bone Plates
Evaluates performance of angled orthopedic plates used in specific anatomical applications.
Angular stability, fatigue resistance, bending strength
ASTM F543
Metallic Bone Screws
Measures torque resistance, pullout strength, and bending properties of orthopedic screws.
Torque-to-failure, axial pullout force, bending moment
ASTM F564
Metallic Bone Staples
Covers design and performance evaluation of orthopedic staples for bone fixation.
Staple retention strength, cyclic fatigue resistance
ASTM F897
Fretting Corrosion (Plates and Screws)
Assesses corrosion effects due to micro-motion between plates and screws at interfaces.
Corrosion rate, material degradation, debris generation
ASTM F1264
Intramedullary Fixation Devices
Defines static and fatigue testing of intramedullary rods and nails.
Load to failure, fatigue endurance, bending stiffness
ASTM F1541
External Skeletal Fixation Devices
Specifies requirements for mechanical performance of external fixation components.
Bending stiffness, failure loads, pin-clamp stability
ASTM F2580
Porosity Effects on Bone Plate Fatigue
Examines influence of porosity on mechanical fatigue performance of bone plates.
Fatigue crack initiation, stress distribution analysis
ASTM F3140
Bone Plate Mechanical Properties
Establishes comprehensive testing methods for mechanical performance of bone plates.
Bending modulus, fatigue endurance, ultimate load
Test methods for evaluating adhesion strength, durability, and fatigue resistance of coatings applied to orthopedic implants. Includes hydroxyapatite, calcium phosphate, and porous surface coatings.
ASTM F1044
Shear Testing of Calcium Phosphate Coatings
Measures adhesion strength of calcium phosphate coatings on orthopedic implant substrates.
Shear bond strength (MPa), failure modes, coating integrity
ASTM F1147
Tension Testing of Coatings
Determines tensile adhesion strength of coatings applied to implant surfaces.
Bond strength, coating detachment force, failure location
ASTM F1160
Shear and Bending Fatigue of Coatings
Evaluates durability of implant coatings under cyclic shear and bending loads.
Coating fatigue life, wear resistance, delamination threshold
Test methods for shoulder arthroplasty components, ankle implants, and specialized orthopedic devices outside primary hip, knee, and spine categories.
ASTM F1829
Static Testing of Ankle Devices
Evaluates load-bearing capability of ankle implants under static loading conditions.
Static load failure, deformation characteristics
ASTM F2028
Dynamic Glenoid Loosening Tests
Simulates loosening mechanisms of shoulder implant glenoid components under cyclic loading.
Displacement under cyclic loads, loosening force threshold
FOCUS Medical Design and Development offers accredited testing services for the ASTM standards listed above. Our team develops custom test protocols, designs specialized fixtures, and delivers documentation formatted for regulatory submissions. Contact us to discuss your testing requirements.