SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017

EMPIRICAL TESTING LLC. DBA EMPIRICAL TECHNOLOGIES

4628 Northpark Drive
Colorado Springs, CO 80918
Brooke Levine Phone: 719 264 9937
[email protected]

MECHANICAL

Valid To: January 31, 2026 Certificate Number: 2142.01

In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to
this laboratory to perform the following types of tests on finished medical device products following
ASTM, ISO, and/or FDA guidelines comprised of metals, alloys, and polymers:

Test Test Methods

The testing below is completed within these parameters:

Fatigue Testing
Load (0 to ± 100) kN
Procedure*
Torsion (0 to ± 100) Nm
Stroke (0 to 140) mm
Static Testing
Angular Displacement (0 to 280) deg
Procedure*
Screw Testing Machine Multiple Revolutions

GENERAL

Standard Test Method for Constant Amplitude of Force Controlled Fatigue ASTM F21182
Testing of Acrylic Bone Cement Materials
Standard Practice for Measurement of Positional Accuracy of ASTM F255411
Computer Assisted Surgical Systems
Prosthetics- Structural Testing of Lower-Limb Prostheses Requirements ISO 10328
and Test Methods

DENTAL

Dentistry - Torsion Test of Implant Body / Connecting Part Joints of ISO/TS 13498
Endosseous Dental Implant Systems
Dentistry - Implants – Dynamic Loading Test for Endosseous Dental ISO 14801
Implants

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 DENTAL continued Test Methods

Dentistry – Screw Loosening Test Using Cyclic Torsional Loading for ISO/TR 18130
Implant Body / Implant Abutment Connection of Endosseous Dental
Implants

EXTREMITIES

ASTM F3822
Standard Specification and Test Method for Metallic Bone Plates
Standard Specifications and Test Methods for Metallic Angled Orthopedic ASTM F3842
Fracture Fixation Devices
Standard Specification and Test Methods for Metallic Medical Bone ASTM F543
Screws
ASTM F5642
Standard Specification and Test Methods for Metallic Bone Staples
Standard Specification and Test Methods for Intramedullary Fixation ASTM F12642
Devices
Standard Specification and Test Methods for External Skeletal Fixation ASTM F15412
Devices
Standard Test Method for Small Punch Testing of Ultra-High Molecular ASTM F2183
Weight Polyethylene Used in Surgical Implants (withdrawn 2017)

Standard Specification and Test Methods for Absorbable Plates and Screws ASTM F2502
for Internal Fixation Implants
Implants for Surgery - Metal Bone Screws with Asymmetrical Thread and ISO 6475
Spherical Under-Surface - Mechanical Requirements and Test Methods
Implants for Surgery - Determination of Bending Strength and Stiffness of ISO 9585
Bone Plates

JOINT REPLACEMENT IMPLANTS

Standard Test Method for Determination of Total Knee Replacement ASTM F1223
Constraint
Standard Specification for Articulating Total Wrist Implants ASTM F1357,
Range of Motion of the Device Before Implantation Section 6.3

Standard Specification for Shoulder Prostheses ASTM F1378

Standard Specification for Resurfacing Patellar Prosthesis – Contact Area ASTM F1672
and Contact Pressure Distribution (section 6.3.1)
(withdrawn 2023)
Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip ASTM F1714,
Designs in Simulator Devices-Method for Cleaning of Specimens Annex 4

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 JOINT REPLACEMENT IMPLANTS continued Test Methods

Standard Specification for Elastomeric Flexible Hinge Finger Total ASTM F1781,
Joint Implants Range of Motion of the Device Before Implantation Section 6.3

Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray ASTM F18002
Components of Total Knee Joint Replacements
Standard Test Method for Determining the Forces for Disassembly ASTM F1820
of Modular Acetabular Device
Standard Test Method for Static Evaluation of Anatomic ASTM F1829
Glenoid Locking Mechanism in Shear
Standard Practice for Fretting Corrosion Testing of Modular Implant ASTM F1875
Interfaces: Hip Femoral Head-Bore and Cone Taper Interface (except 9.1.8 & 10.0)

Standard Test Method for Determining the Axial Disassembly Force ASTM F2009
of Taper Connections of Modular Prostheses
Standard Practice for Gravimetric-Measurements of Polymeric ASTM F2025,
Components for Wear Assessment Method for Cleaning of Annex 1
Specimens
Standard Test Methods for Dynamic Evaluation of Glenoid ASTM F2028
Loosening or Disassociation
Standard Practice for Evaluation of Modular Connection of ASTM F25802
Proximally Fixed Femoral Hip Prosthesis
Standard Practice for Evaluating Mobile Bearing Knee Tibial ASTM F2722
Baseplate Rotational Stops
Standard Test Method for Evaluating Mobile Bearing Knee Tibial ASTM F2723
Baseplate / Bearing Resistance to Dynamic Disassociation
Standard Test Method for Evaluating Mobile Bearing Knee ASTM F2724
Dislocation
Standard Test Method for Evaluating Knee Bearing (Tibial Insert) ASTM F2777
Endurance and Deformation Under High Flexion
Standard Test Method for Fatigue Testing of Acetabular Devices for ASTM F3090
Total Hip Replacement
Standard Test Method for Cyclic Fatigue Testing of Metal Tibial ASTM F31402
Tray Components of Unicondylar Knee Joint Replacements
Standard Test Method for Fatigue Testing of Total Knee Femoral ASTM F32102
Components Under Closing Conditions
Implants for Surgery – Partial and Total Hip Joint Prostheses – ISO 7206-42
Part 4: Determination of Endurance Properties and Performance of
Stemmed Femoral Components
Implants for Surgery – Partial and Total Hip Joint Prostheses – ISO 7206-62
Part 6: Endurance Properties Testing and Performance Requirements
of Neck Region of Stemmed Femoral Components
Implants for Surgery - Partial and Total Hip Joint Prostheses – ISO 7206-8
Part 8: Endurance Performance of Stemmed Femoral Components (withdrawn 2011)
with Application of Torsion

(A2LA Cert. No. 2142.01) 04/24/2024 Page 3 of 6

 JOINT REPLACEMENT IMPLANTS continued Test Methods

Implants for Surgery — Partial and Total Hip-Joint Prostheses — ISO 7206-10
Part 10: Determination of Resistance to Static Load of Modular
Femoral Heads
Implants for Surgery — Partial and Total Hip Joint Prostheses — ISO 7206-12
Part 12: Deformation Test Method for Acetabular Shells
Implants for Surgery — Partial and Total Hip Joint Prostheses —
ISO 7206-13
Part 13: Determination of Resistance to Torque of Head Fixation of
Stemmed Femoral Components
Implants for Surgery – Determination of Impact Resistance of ISO 11491
Ceramic Femoral Heads for Hip Joint Prostheses (2017-07)

Implants for surgery - Total Knee-Joint Prostheses - Part 1: ISO 14879-1

Determination of Endurance Properties of Knee Tibial Trays

SPINE

Standard Test Methods for Spinal Implant Constructs in a ASTM F1717

Vertebrectomy Model
Standard Test Method for Evaluating the Static and Fatigue ASTM F1798
Properties of Interconnection Mechanisms and Subassemblies Used
in Spinal Arthrodesis Implants
Test Methods for Intervertebral Body Fusion Devices ASTM F2077

Standard Specifications and Test Methods for Components Used in ASTM F21932
the Surgical Fixation of the Spinal Skeletal System
Standard Test Method for Measuring Load -Induced Subsidence of ASTM F2267
an Intervertebral Body Fusion Device Under Static Axial
Compression
Standard Test Methods for Static and Dynamic Characterization of ASTM F23462
Spinal Artificial Discs
Standard Guide for Functional, Kinematic, and Wear Assessment of ASTM F2423
Total Disc Prostheses
Standard Test Method for Static, Dynamic and Wear Assessment of ASTM F2624
Extra-Discal Single Level Spinal Constructs
Standard Practice for Functional and Wear Evaluation of Motion- ASTM F2694
Preserving Lumbar Total Facet Prostheses
Standard Test Methods for Occipital-Cervical and Occipital- ASTM F2706
Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy
Model
Standard Guide for Mechanical and Functional Characterization of ASTM F2789
Nucleus Devices (Except Viscoelastic Testing)

Standard Practice for Static and Dynamic Characterization of ASTM F2790

Motion Preserving Lumbar Total Facet Prostheses

(A2LA Cert. No. 2142.01) 04/24/2024 Page 4 of 6

 SPINE continued Test Methods

Standard Test Methods for Sacroiliac Joint Fusion Devices ASTM F3574

Implants for Surgery - Mechanical Testing of Implantable Spinal ISO 12189

Devices – Fatigue Test Method for Spinal Implant Assemblies
Using an Anterior Support
Implants for Surgery - Wear of Total Intervertebral Spinal Disc ISO 181922
Prostheses

COATINGS, FRETTING, CORROSION

Standard Test Method for Shear Testing of Calcium Phosphate ASTM F1044
Coatings and Metallic Coatings
Standard Test Method for Tension Testing of Calcium ASTM F1147
Phosphate and Metallic Coatings
Standard Test Method for Shear and Bending Fatigue Testing ASTM F11602
of Calcium Phosphate and Metallic Medical and Composite Calcium
Phosphate/Metallic Coatings
Standard Test Method for Measuring Abrasion Resistance of ASTM F1978
Metallic Thermal Spray Coatings by Using the Taber Abrader
Standard Test Method for Conducting Cyclic Potentiodynamic ASTM F2129
Polarization Measurements to Determine the Corrosion
Susceptibility of Small Implant Devices

PACKAGING

Determining Integrity of Seals for Flexible Packaging by Visual ASTM F1886

Inspection

Method for Seal Strength of Flexible Barrier Materials ASTM F88

Methods for Internal Pressurization Failure Resistance of ASTM F1140

Unrestrained Package
Standard Test method for Detecting Leaks in Nonporous Packaging ASTM F3039
or Flexible Materials by Dye Penetration

Method for Detecting Seal Leaks in Medical Packaging by Dye ASTM F1929
Penetration,

Accelerated Aging of Sterile Barrier Systems and devices ASTM F1980

Method for Detecting Gross Leaks in Packaging (Bubble Test) ASTM F2096

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 PACKAGING continued Test Methods

Method for Burst Testing of Flexible Package Seals, ASTM F2054

Standard Test Methods for Vibration Testing of Shipping Containers ASTM D999

Standard Test Method for Determination of Leaks in Flexible ASTM D3078

Packaging by Bubble Emission
Determining the Effects of High Altitude on Packaging Systems by ASTM D6653
Vacuum Method
Standard test Method for Seal Strength testing for Round Cups and ASTM F2824
Containers with Flexible Peelable Lids
Standard Practice for Conditioning Containers, Packages, or ASTM D4332
Packaging Components for Testing
Strength and protective ability of packaged products from sudden ASTM D5276
shock/free-fall
Packaging Products less than 150 lbs ISTA 2A

Method for Determining Compressive Resistance ASTM D642

1
This Laboratory performs field testing activities for these tests.

Equipment for this test is calibrated to ASTM E4 but the dynamic verification of the equipment per
2

ASTM E467 and/or ISO 4965 is not performed.

*In-House Procedure

(A2LA Cert. No. 2142.01) 04/24/2024 Page 6 of 6

 Accredited Laboratory
A2LA has accredited

Empirical Testing LLC. DBA Empirical Technologies

Colorado Springs, CO
for technical competence in the field of

Mechanical Testing
This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017
General requirements for the competence of testing and calibration laboratories. This accreditation demonstrates
technical competence for a defined scope and the operation of a laboratory quality management system
(refer to joint ISO-ILAC-IAF Communiqué dated April 2017).

Presented this 24th day of April 2024.

_______________________
Mr. Trace McInturff, Vice President, Accreditation Services
For the Accreditation Council
Certificate Number 2142.01
Valid to January 31, 2026

For the types of tests to which this accreditation applies, please refer to the laboratory’s Mechanical Scope of Accreditation.