Recognized standard
F3268-18a
FDA recognition 8-557 · ASTM · Materials
Key facts
| Recognition number | 8-557 |
|---|---|
| Designation | F3268-18a |
| Title | Standard Guide for in vitro Degradation Testing of Absorbable Metals |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Jun 7, 2021 |
| Scope (excerpt) | 1.1 The purpose of this standard is to outline appropriate experimental approaches for conducting an initial evaluation of the in vitro degradation properties of a device or test sample fabricated from an absorbable metal or alloy. 1.2 The described experimental approaches are intended to control… |
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: