Recognized standard
F732-17
FDA recognition 11-342 · ASTM · Orthopedic
Key facts
| Recognition number | 11-342 |
|---|---|
| Designation | F732-17 |
| Title | Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2, Class 3, HDE |
| Scope (excerpt) | 1.1 This test method describes a laboratory method for evaluating the wear properties of combinations of materials that are being considered for use as bearing surfaces of human total joint prostheses. The body of this test method contains general methods which apply to all types of prosthesis wear… |
At a glance
- 10–99 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: