Recognized standard
F748-16
FDA recognition 2-244 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-244 |
|---|---|
| Designation | F748-16 |
| Title | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | Dec 23, 2016 |
| Scope (excerpt) | 1.1 This practice recommends generic biological test methods for materials and devices according to end-use applications. While chemical testing for extractable additives and residual monomers or residues from processing aids is necessary for most implant materials, such testing is not included as… |
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: