Recognized standard
F981-23
FDA recognition 2-302 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-302 |
|---|---|
| Designation | F981-23 |
| Title | Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | Dec 18, 2023 |
| Scope (excerpt) | This practice provides guidelines for biological assessment of tissue responses to nonabsorbable for medical device implants. It assesses the effects of the material that is implanted intramuscularly or intraosseously. The experimental protocol is not designed to provide a comprehensive assessment… |
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: