Full Description

1.1This practice covers blood that will be used for in vitro performance assessments of blood pumps. These assessments include the hemolytic properties of the devices.

1.2This practice covers the utilization of blood for the in vitro evaluation of the following devices:

1.2.1Continuous flow rotary blood pumps (roller pumps, centrifugal pumps, axial flow pumps, and so forth) (see Practice F1841).

1.2.2Pulsatile blood pumps (pneumatically driven, electromechanically driven, and so forth).

1.3The source of blood utilized for in vitro evaluation of blood trauma (that is, hemolysis caused by the blood pumps, due to the pump design, construction, and materials used) substantially influences the results of the performance of these devices. Thus, a standardized blood source is required.

1.4The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.5This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.