Recognized standard
F1609-08 (Reapproved 2014)
FDA recognition 8-171 · ASTM · Materials
Key facts
| Recognition number | 8-171 |
|---|---|
| Designation | F1609-08 (Reapproved 2014) |
| Title | Standard Specification for Calcium Phosphate Coatings for Implantable Materials |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Jan 27, 2015 |
| Scope (excerpt) | 1.1 This specification covers the material requirements for calcium phosphate coatings for surgical implant applications. 1.2 In particulate and monolithic form, the calcium phosphate materials system has been well-characterized regarding biological response (1,2)2 and laboratory characterization… |
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: