Recognized standard
F2150-19
FDA recognition 15-61 · ASTM · Tissue Engineering
Key facts
| Recognition number | 15-61 |
|---|---|
| Designation | F2150-19 |
| Title | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products |
| Standards developer | ASTM International |
| Specialty area | Tissue Engineering |
| Date of entry | Jul 6, 2020 |
| Scope (excerpt) | 1.1 This guide is a resource of currently available test methods for the characterization of the compositional and structural aspects of biomaterial scaffolds used in the development and manufacture of regenerative medicine and tissue-engineered medical products (TEMPs). 1.2 The test methods… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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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: