Standards Testing - Hip
For more than four decades, ORL is recognized as an innovator of testing standards and methods with an extensive track record of providing information necessary for successful regulatory approvals, product quality confirmation, marketing materials and surgeon education. This Standards listing encapsulates the breadth of this expertise.
ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws
This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions.
ASTM F1814 - Standard Guide for Evaluating Modular Hip and Knee Joint Components
This guide assists the developer of a modular joint replacement implant in the choice of appropriate tests and evaluations to determine device safety.
ASTM F1820 - Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
This test method is a standard methodology by which to measure the attachment strength between the modular acetabular shell and liner (i.e., locking mechanism integrity).
ASTM F2068 - Standard Specification for Femoral Prostheses—Metallic Implants
This specification covers metallic stemmed femoral prostheses used to replace the natural hip joint by means of hemi-arthroplasty or total hip surgical procedures. The mechanical strength, corrosion resistance, and biocompatibility of the head portions of one-piece integral implants are covered by this specification.
ASTM F2091 - Standard Specification for Acetabular Prostheses
This specification is intended to provide basic descriptions of materials and device geometry of acetabular resurfacing devices used to provide a functioning articulation between the bones of the acetabulum and the femur. Additionally, those characteristics determined to be important toin vivoperformance of the prosthesis are defined.
ASTM F2345 - Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
These test methods cover the evaluation of the static and cyclic fatigue strength of ceramic modular femoral heads utilized in total hip arthroplasty.
ASTM F2580 - Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
This practice covers a procedure for the fatigue testing of metallic femoral hip prostheses used in hip joint replacements that utilize proximal metaphyseal fixation and are of a modular construct.
ASTM F2582 - Standard Test Method for Impingement of Acetabular Prostheses
This test method covers a procedure to evaluate acetabular component fatigue, deformation, and wear and femoral head assembly dislocation under dynamic impingement conditions.
ISO 7206-4 - Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties of stemmed femoral components
This part specifies a test method for determining the endurance properties of stemmed femoral components of total hip joint prostheses and stemmed femoral components used alone in partial hip joints.
ISO 7206-6 - Implants for surgery — Partial and total hip joint prostheses — Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
This part describes test methods for determining the endurance properties of the head and neck region of stemmed femoral components of total hip joint prostheses and stemmed femoral components used alone in partial hip joint replacement.
ISO 7206-10 - Implants for surgery — Partial and total hip joint prostheses — Part 10: Determination of resistance to static load of modular femoral heads
This part applies to femoral heads of partial or total hip-joint replacements of modular construction (i.e. a head/neck conical taper connection) and describes methods of determining the load required to cause failure of the head (disassembly or fracture).
ISO 7206-12 - Implants for surgery — Partial and total hip joint prostheses — Part 12: Deformation test method for acetabular components
This part specifies a test method for determining short-term deformation of a press-fit acetabular component for total hip joint replacement.