Recognized standard
F763-22
FDA recognition 2-297 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-297 |
|---|---|
| Designation | F763-22 |
| Title | Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | Dec 19, 2022 |
| Scope (excerpt) | 1.1 This practice provides guidelines for short-term testing or screening of candidate materials, both porous and dense, as to the local effects of the material that is implanted intramuscularly. This method may not be applicable for absorbable materials, depending on the absorption profile of the… |
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: