Standards Testing


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Standards Testing - Upper Extremity

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 F1357 - Standard Specification for Articulating Total Wrist Implants

This specification covers total wrist implants that provide articulation function through radial carpal components. Tests for polymeric creep (cold flow), wear, and range of motion of the device as well as in vitro laboratory testing shall be performed and shall conform to the requirements specified.

ASTM F1378 - Standard Specification for Shoulder Prostheses

This specification covers shoulder prostheses for total or hemiarthroplasty used to provide functioning articulation by employing glenoid and humeral components. The prostheses may be constrained, partially constrained, or unconstrained. Modular prostheses are included in this specification, but devices for custom applications are not covered. The prostheses are required to meet the prescribed mechanical strength, corrosion resistance, biocompatibility, wear of alternative, and range of motion.

ASTM F1781 - Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

This specification covers the performance requirements and associated test methods for elastomeric flexible hinge finger total joint implants used in the reconstruction of the metacarpophalangeal and proximal interphalangeal joints. 

ASTM F1829 - Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear

This test method covers a method for determining the static shear disassembly force of modular anatomic glenoid components used in anatomic total shoulder arthroplasty prostheses.

ASTM F2028 - Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation

These test methods measure how much a prosthetic anatomic glenoid component rocks or pivots following cyclic displacement of the humeral head to opposing glenoid rims.

ASTM F2887 - Standard Specification for Total Elbow Prostheses

This specification covers total elbow replacement (TER) prostheses and hemi-elbow replacement (“hemi”) prostheses used to provide functioning articulation by employing humeral, ulnar, and/or radial components that allow for the restoration of motion of the human elbow joint complex.