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ASTM F1830-19(2024)

Current Reaffirmation

Standard Practice for Collection and Preparation of Blood for Dynamic <emph type="bdit" >in vitro</emph> Evaluation of Hemolysis in Blood Pumps

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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.


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.

SDO ASTM: ASTM International
Document Number F1830
Publication Date Dec. 1, 2024
Language en - English
Page Count 3
Revision Level 19(2024)
Supercedes
Committee F04.30
Publish Date Document Id Type View
Sept. 1, 2019 F1830-19 Revision
Jan. 1, 1997 F1830-97 Revision
Dec. 1, 2024 F1830-19R24 Reaffirmation
Sept. 1, 2017 F1830-97R17 Reaffirmation
March 1, 2013 F1830-97R13 Reaffirmation
March 1, 2005 F1830-97R05 Reaffirmation