【国外标准】 Standard Practice for Collection and Preparation of Blood for Dynamic in vitro Evaluation of Hemolysis in Blood Pumps

5.1 In vitro hemolysis test results for blood pumps may be substantially affected by donor species, sex, age, fasting, the method of harvesting, the anticoagulant properties, the period of storage, the biochemical state of the blood, and the hemoglobin and hematocrit level of blood.3,4 Therefore, standardization of proper whole blood collection and preparation for the dynamic in vitro evaluation of blood pumps is essential, and this recommended practice will allow an acceptable comparison of test results among hemolysis tests involving similar testing methods.1.1 This practice covers whole blood that will be used for the in vitro performance assessment of hemolysis in blood pumps intended for clinical use.1.2 This 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:1.2.1 Continuous flow blood pumps (roller pumps, centrifugal pumps, axial flow pumps, etc.).1.2.2 Pulsatile and intermittent flow blood pumps (pneumatically driven, electro-mechanically driven, with an artificial pulse, etc.).1.3 The 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.1.4 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.