Recognized standard
F1581-08 (Reapproved 2020)
FDA recognition 8-428 · ASTM · Materials
Key facts
| Recognition number | 8-428 |
|---|---|
| Designation | F1581-08 (Reapproved 2020) |
| Title | Standard Specification for Composition of Anorganic Bone for Surgical Implants |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Aug 21, 2017 |
| Scope (excerpt) | 1.1 This specification covers material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. For a material to be called anorganic or deorganified bone, it must conform to this specification (see Appendix X1). 1.2 The biological response to apatite in… |
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: