Recognized standard
F763-04 (Reapproved 2016)
FDA recognition 2-93 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-93 |
|---|---|
| Designation | F763-04 (Reapproved 2016) |
| Title | Standard Practice for Short-Term Screening of Implant Materials |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | Dec 23, 2016 |
| Scope (excerpt) | 1.1 This practice provides guidelines for short-term testing or screening of candidate materials, both porous and dense, as to the effects of the material on animal tissue in which it is implanted. This is a rapid screening procedure for determining acceptability of candidate materials. 1.2 This… |
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: