Designation

This standard is issued under the fixed designation F1378; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon (ε) indicates an editorial change since the last revision or reapproval.

ε¹ NOTE— Corrected editorially in June 2019.

1. 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.

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.

2. Referenced Documents

2.1

2.2

3. Terminology

3.1

3.2

3.3

4. Classification

4.1

4.2

4.3

5. Materials and Manufacture

5.1

6. Performance Requirements

6.1

6.2

6.3

6.4

7. Dimensions

7.1

8. Finish and Product Marking

8.1

8.2

8.3

8.4

9. Labeling

9.1

9.2

10. Keywords

10.1

ASTM F1378 - 18e1

Standard Specification for Shoulder Prostheses

Current

Published:

15 Dec 2018

1. Scope