Recognized standard
F1439-24
FDA recognition 2-305 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-305 |
|---|---|
| Designation | F1439-24 |
| Title | Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | May 26, 2025 |
| Scope (excerpt) | 1.1 This guide is intended to assist the testing laboratory in the conduct and evaluation of tumorigenicity tests to evaluate the potential for materials to evoke a neoplastic response. 1.2 Carcinogenicity, which includes tumorigenic potential, is one of several biological effects that should be… |
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: