Recognized standard
F1830-19
FDA recognition 3-164 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-164 |
|---|---|
| Designation | F1830-19 |
| Title | Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Blood Pumps |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | Jul 6, 2020 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | 1.1 This practice covers whole blood that will be used for the in vitro performance assessment of hemolysis in blood pumps intended for clinical use. 1.2 This practice covers the recommended standard collection, preparation, handling, storage, and utilization of whole blood for the in vitro… |
At a glance
- 1–9 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: