Recognized standard
F1841-19
FDA recognition 3-165 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-165 |
|---|---|
| Designation | F1841-19 |
| Title | Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | Jul 6, 2020 |
| Device classes | Class 3, HDE, Class 2 |
| Scope (excerpt) | 1.1 This practice covers a protocol for the assessment of the hemolytic properties of continuous, intermittent, and pulsatile flow blood pumps used in circulatory assist, including extracorporeal, percutaneous, and implantable devices. An assessment is made based on the pump's effects on the… |
At a glance
- 10–99 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: