Recognized standard
F2103-18
FDA recognition 15-58 · ASTM · Tissue Engineering
Key facts
| Recognition number | 15-58 |
|---|---|
| Designation | F2103-18 |
| Title | Standard Guide for Characterization and Testing of Chitosan Salts 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 | Jul 15, 2019 |
| Scope (excerpt) | 1.1 This guide covers the evaluation of chitosan salts 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 for the functionality, characterization, and… |
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: