Recognized standard
F1904-14
FDA recognition 2-213 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-213 |
|---|---|
| Designation | F1904-14 |
| Title | Standard Practice for Testing the Biological Responses to Particles In Vivo |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | Jul 26, 2016 |
| Scope (excerpt) | 1.1 This practice covers the production of wear particles and degradation products from implanted materials that may lead to a cascade of biological responses resulting in damage to adjacent and remote tissues. In order to ascertain the role of particles in stimulating such responses, the nature of… |
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: