ASTM F1841-97 (Reapproved 2017) Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps |
Recognition Number | Cardiovascular |
Recognition Date | 2019-01-14 |
Recognition List | 051 |
Recognition Number | 3-56 |
Extent | Complete standard |
Standards Orgs | ASTM ASTM International http://www.astm.org/ |
STG | Cardiovascular |
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This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This practice covers a protocol for the assessment of the hemolytic properties of continuous flow blood pumps used in extracorporeal or implantable circulatory assist. An assessment is made based on the pump's effects on the erythrocytes over a certain period of time. For this assessment, a recirculation test is performed with a pump for 6 h.
Regulation Number | Device Name | Device Class | Product Code |
§870.4370 | Pump, Blood, Cardiopulmonary Bypass, Roller Type | Class 2 | DWB |
§870.4360 | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | Class 2 | KFM |
There is no relevant guidance developed at this time. |