Recognized standard
F2347-15
FDA recognition 15-51 · ASTM · Tissue Engineering
Key facts
| Recognition number | 15-51 |
|---|---|
| Designation | F2347-15 |
| Title | Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
| Standards developer | ASTM International |
| Specialty area | Tissue Engineering |
| Date of entry | Jun 7, 2018 |
| Scope (excerpt) | 1.1 This guide covers the evaluation of hyaluronan suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, Tissue Engineered Medical Products (TEMPs). 1.2 This guide addresses key parameters relevant to the characterization and purity of hyaluronan. 1.3… |
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: