Over deze norm
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:
1.2.1 Continuous flow rotary blood pumps (roller pumps, centrifugal pumps, axial flow pumps, and so forth) (see Practice ).
1.2.2 Pulsatile blood pumps (pneumatically driven, electromechanically driven, and so forth).
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.
|Engelse titel||Standard Practice for Selection of Blood for