Recognized standard
F981-04 (Reapproved 2016)
FDA recognition 2-94 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-94 |
|---|---|
| Designation | F981-04 (Reapproved 2016) |
| Title | Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | Dec 23, 2016 |
| Scope (excerpt) | 1.1 This practice provides a series of experimental protocols for biological assays of tissue reaction to nonabsorbable biomaterials for surgical implants. It assesses the effects of the material on animal tissue in which it is implanted. The experimental protocol is not designed to provide a… |
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: