Recognized standard
F1983-23
FDA recognition 2-301 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-301 |
|---|---|
| Designation | F1983-23 |
| Title | Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | May 29, 2023 |
| Scope (excerpt) | This practice provides experimental protocols for biological assays of tissue reactions to absorbable biomaterials for implant applications. This practice applies only to absorbable materials with projected clinical applications in which the materials will reside in bone or soft tissue longer than… |
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: