Recognized standard
F748-25
FDA recognition 2-310 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-310 |
|---|---|
| Designation | F748-25 |
| Title | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | Dec 22, 2025 |
| Scope (excerpt) | 1.1 This practice describes biological test methods (as listed in 2.1) which may be used in support of a biological evaluation of materials and medical devices according to end-use applications. Biological evaluation is a component of a broader safety evaluation and is conducted within an ISO 14971… |
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: