Standard Specification for Total Elbow Prostheses

1.1 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.

1.2 Included within the scope of this specification are elbow prosthesis components for primary and revision surgery with linked and non-linked designs and components implanted with or without use of bone cement.

1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. In addition, those characteristics determined to be important to the in vivo performance of the prosthesis are defined. However, compliance with this specification does not itself mean that a device will provide satisfactory clinical performance.

1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.