Recognized standard
F895-11 (Reapproved 2016)
FDA recognition 2-189 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-189 |
|---|---|
| Designation | F895-11 (Reapproved 2016) |
| Title | Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | Dec 23, 2016 |
| Scope (excerpt) | 1.1 This test method is appropriate for materials in a variety of shapes and for materials that are not necessarily sterile. This test method would be appropriate in situations in which the amount of material is limited. For example, small devices or powders could be placed on the agar and the… |
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: