Recognized standard
F1439-03 (Reapproved 2018)
FDA recognition 2-145 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-145 |
|---|---|
| Designation | F1439-03 (Reapproved 2018) |
| 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 | Jan 14, 2019 |
| Scope (excerpt) | 1.1 This guide is intended to assist the biomaterials testing laboratory in the conduct and evaluation of tumorigenicity tests to evaluate the potential for new materials to evoke a neoplastic response. The procedure is generally reserved only for those materials which have not previously been used… |
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: