Recognized standard
F1635-16
FDA recognition 8-452 · ASTM · Materials
Key facts
| Recognition number | 8-452 |
|---|---|
| Designation | F1635-16 |
| Title | Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Aug 21, 2017 |
| Scope (excerpt) | 1.1 This test method covers in vitro degradation of hydrolytically degradable polymers (HDP) intended for use in surgical implants. 1.2 The requirements of this test method apply to HDPs in various forms: 1.2.1 Virgin polymer resins, or 1.2.2 Any form fabricated from virgin polymer such as a… |
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: