Full Description

1.1This practice covers whole blood that will be used for the in vitro performance assessment of hemolysis in blood pumps intended for clinical use.

1.2This practice covers the recommended standard collection, preparation, handling, storage, and utilization of whole blood for the in vitro evaluation (see Practice F1841) of the following devices:

1.2.1Continuous flow blood pumps (roller pumps, centrifugal pumps, axial flow pumps, etc.).

1.2.2Pulsatile and intermittent flow blood pumps (pneumatically driven, electro-mechanically driven, with an artificial pulse, etc.).

1.3The source and preparation of whole blood utilized for the dynamic in vitro evaluation of red blood cell (erythrocyte) trauma caused by blood pumps can substantially influence the hemolysis performance of these devices. Thus, standardized whole blood collection and preparation methods are 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.