| ASTM F1830-97 (Reapproved 2017) Standard Practice for Selection of Blood for In Vitro Evaluation of Blood Pumps |
| Recognition Number | Cardiovascular |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 3-55 |
| 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 blood that will be used for in vitro performance assessments of blood pumps. These assessments include the hemolytic properties of the devices.
| 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. |