Recognized standard
F1088-18
FDA recognition 8-491 · ASTM · Materials
Key facts
| Recognition number | 8-491 |
|---|---|
| Designation | F1088-18 |
| Title | Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Dec 23, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This specification covers chemical and crystallographic requirements for beta-tricalcium phosphate (beta-TCP) for surgical implant applications. For a material to be identified as medical-grade beta-tricalcium phosphate, it must conform to this specification (see Appendix X1). |
At a glance
- 1–9 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: