ASTM-F1841 › Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
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1.1 This practice covers a protocol for the assessment of the hemolytic properties of continuous flow blood pumps used in extracorporeal or implantable circulatory assist. An assessment is made based on the pump's effects on the erythrocytes over a certain period of time. For this assessment, a recirculation test is performed with a pump for 6 h.
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
1.4 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.
Significance and Use
6.1 The objective of this practice is to standardize the evaluation method for detecting the hemolytic effect of a continuous flow blood pump used in extracorporeal circulation and circulatory assistance.
blood pump; blood trauma; index of hemolysis; modified index of hemolysis (M.I.H.); normalized index of hemolysis (N.I.H.);; ICS Number Code 11.100 (Laboratory medicine)
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1997 R17 EDITION
Sept. 1, 2017