ASTM-F1378 › Standard Specification for Shoulder Prostheses
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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.
Scope
1.1 This specification covers shoulder prostheses for total or hemiarthroplasty used to provide functioning articulation by employing glenoid and humeral components.
1.2 Devices for custom applications are not covered by this specification. Modular prostheses are included in this specification.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
FIG. 1 Glenosphere Thickness
1.4 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.
Keywords
arthroplasty; glenoid; humeral; prostheses; hemi-shoulder replacement; total shoulder replacement;
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13.01 (Medical and Surgical Materials and Devices)
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Document Number
ASTM-F1378-18
Revision Level
2018(E1) EDITION
Status
Current
Modification Type
Revision
Publication Date
June 1, 2019
Document Type
Specification
Page Count
6 pages
Committee Number
F04.22