FDA-recognized standard · Cardiovascular
ASTM F1841: Standard Practice for Assessment of Hemolysis in Blood Pumps
Yes. FDA recognizes ASTM F1841-25 as recognition 3-199, entered 2025-05-26. FDA also lists ASTM F1841-19 (recognition 3-165, transition period ending 2027-07-04).
Recognized editions of ASTM F1841
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 3-199 | ASTM F1841-25 | 2025-05-26 | Complete | — |
| 3-165 | ASTM F1841-19 | 2020-07-06 | Complete | 2027-07-04 |
Regulations
FDA lists these classification regulations against ASTM F1841: 21 CFR 870.3545, 21 CFR 870.4100, 21 CFR 870.4360, 21 CFR 870.4370.
Product codes that cite ASTM F1841
12 FDA product codes cite ASTM F1841, including DSQ, DWB, HDE, KFM, LOZ.
- DSQ
- DWB
- HDE
- KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- LOZ
- OJE
- OKR
- OZD
- PCK
- PYX
- QJZ
- QNR
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.