Recognized standard
F2212-25
FDA recognition 15-68 · ASTM · Tissue Engineering
Key facts
| Recognition number | 15-68 |
|---|---|
| Designation | F2212-25 |
| Title | Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| Standards developer | ASTM International |
| Specialty area | Tissue Engineering |
| Date of entry | Dec 22, 2025 |
| Scope (excerpt) | 1.1 This guide for characterizing collagen-containing biomaterials is intended to provide characteristics, properties, and test methods for use by producers, manufacturers, and researchers to more clearly identify the specific collagen materials used. With greater than 20 types of collagen and the… |
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: