Recognized standard
F451-21
FDA recognition 8-576 · ASTM · Materials
Key facts
| Recognition number | 8-576 |
|---|---|
| Designation | F451-21 |
| Title | Standard Specification for Acrylic Bone Cement |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Dec 20, 2021 |
| Scope (excerpt) | 1.1 This specification covers self-curing resins used primarily for the fixation of internal orthopedic prostheses. The mixture may be used in either the predough or dough stage in accordance with the manufacturer's recommendations. 1.2 Units of premeasured powder and liquid are supplied in a form… |
At a glance
- None 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: