Recognized standard
F813-20
FDA recognition 2-277 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-277 |
|---|---|
| Designation | F813-20 |
| Title | Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | Dec 21, 2020 |
| Scope (excerpt) | 1.1 This practice covers a reference method of direct contact cell culture testing which may be used in evaluating the cytotoxic potential of materials for use in the construction of medical materials and devices. 1.2 This practice may be used either directly to evaluate materials or as a reference… |
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: