5.1 The test results are substantially affected by donor species and age, the method of harvesting, the period of storage, the biochemical state of the blood, and the hemoglobin and hematocrit level of blood.3^,4 Therefore, standardization of proper blood usage for in vitro evaluation of blood pumps is essential, and this recommended practice will allow a universal comparison of test results.

5.2 Drawing several units of blood from healthy cattle does not affect them or their health. Therefore, bovine blood is strongly suggested for usage in experimental evaluation of blood damage. Mixing two donor sources of blood should be avoided in hemolysis tests because the mixture may induce added hemolysis or a change in red cell resistance against trauma.

1.1 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.

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

1.3 The 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.

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

1.5 This 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.