Recognized standard
F2888-19
FDA recognition 2-267 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-267 |
|---|---|
| Designation | F2888-19 |
| Title | Standard Practice for Platelet Leukocyte Count - An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials. |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | Jul 15, 2019 |
| Scope (excerpt) | 1.1 This practice assists in the evaluation of cardiovascular device materials for their ability to induce thrombus formation. Thrombus formation is assessed by means of a reduction in human platelets and leukocytes when consumed by thrombus after activation on the material surface. This assay may… |
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: