ETC Receives A2LA Certification of 5 More Test Methods

In Empirical Testing Corp.’s continuous pursuit of accreditation excellence, we have achieved The American Association for Laboratory Accreditation (A2LA) accreditation for the following 5 test methods:

• ASTM F2706: Standard Test Methods for Occipital–Cervical and Occipital–Cervical–Thoracic Spinal Implant Constructs in a Vertebrectomy Model
• ASTM F2502: Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants
• ASTM F1820: Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device
• ASTM F2183: Standard Test Method for Small Punch Testing of ultra–High Molecular Weight Polyethylene Used in Surgical Implants
• ASTM F1541: Standard Specification and Test Methods for External Skeletal Fixation Devices

To earn A2LA certification, ETC must demonstrate technical competence, complete a rigorous accreditation process, and operate a laboratory quality management system. Please view ETC’s A2LA Certificate Number 2142.01 and a complete list of all 20 accredited test methods. To learn more about our commitment to accreditation, visit the ETC web site Accreditation page or call 719.264.9937.

ETC Adds Nine Standards to Our A2LA Scope of Accreditation

As of October 19, 2010 Empirical Testing Corp. has added nine test methods to our American Association for Laboratory Accreditation (A2LA) Scope of Accreditation to ISO/IEC 17025:2005. We are pleased to announce that our complete scope has grown to a total of 29 standards with the addition of the following:

SPINE

• ISO 12189: Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses

EXTREMETIES

• ASTM F384: Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• ASTM F564: Standard Specification and Test Methods for Metallic Bone Staples
• ASTM F1264: Standard Specification and Test Method for Intramedullary Fixation Devices

JOINT REPLACEMENT

• ASTM F1820: Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device
• ASTM F1714: Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
• ASTM F2025: Gravimetric Measurements of Polymeric Components for Wear Assessment
• ASTM F2028: Dynamic Evaluation of Glenoid Loosening of Disassociation
• ASTM F1378: Standard Specification for Shoulder Prostheses

Be sure to visit the Quality section of our website to view our A2LA Certificate and a current copy of our scope of accreditation. ETC is dedicated to quality and will continue to further that dedication by providing our customers with best-in-class service while staying at the forefront of cutting edge test methods. As always, please feel free to contact us to discuss how we can be a part of your team.

Empirical Testing Corp. Earns Additional A2LA Accreditations

Empirical Testing Corp. Earns Additional A2LA Accreditations ASTM F2193: Components Used in the Surgical Fixation of the Spinal Skeletal System and ISO 14801: Dentistry Fatigue Tests for Endosseous Dental Implants

COLORADO SPRINGS, CO, January 7, 2008 Empirical Testing Corp. (ETC), an innovator in medical device testing, recently added two American Association for Laboratory Accreditation (A2LA) certifications to its stable of accreditations: ASTM F2193 for components used in the surgical fixation of the spinal skeletal system and ISO 14801 for dentistry fatigue tests for endosseous dental implants. The addition of ISO 14801 broadens the orthopaedic services delivered by ETC.

"We are happy to follow the call of our customers by expanding our accreditations and services," said Dawn Lissy, ETC CEO. "The additional ASTM and ISO standards ensure that these services are delivered with the utmost skill and professionalism."

The ongoing pursuit of accreditation is part of ETC's commitment to the professionals and patients who rely on orthopaedic implants to improve and save lives. With the additions of ASTM F2193 and ISO 14801, ETC now has a total of eleven accredited services. This represents the greatest range of accredited spine and orthopaedic test standards currently available anywhere in the world.

To earn the additional accreditations, ETC completed A2LA's lengthy documentation process and met the organization's internationally accepted criteria for competence (ISO/IEC 17025:2005). The rating qualifies ETC to perform testing and evaluation of medical devices, prototypes, and novel experimental systems made from both metals and polymers.

ETC testing services include assessing the following:

• Static and dynamic characterization of spinal artificial discs
• Load-induced subsidence of intervertebral body fusion devices
• Standard specifications and test methods for metallic bone plates
• Metallic medical bone screws
• Endurance properties of stemmed femoral components of partial and total hip joint prostheses
• Spinal implant constructs in a vertebrectomy model Static and fatigue properties of interconnection mechanisms and subassemblies used in spinal arthrodeses implants
• Intervertebral body fusion devices
• Functional, kinematic, and wear assessment of total disc prostheses
• Components used in the surgical fixation of the spinal skeletal system
• Dentistry fatigue test for endosseous dental implants
• More about ETC

Founded in 1999, Empirical Testing Corp. provides professional, timely, and accurate testing of medical devices such as spinal implants and other orthopaedic devices to meet the needs of the competitive market place, the product development environment, and the discerning consumer base. For more information, call ETC at 719-264-9937.