ASTM-F1841 › Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
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Scope
1.1 This recommended 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 6h.
1.2 The values stated in both inch-pound and SI units are to be regarded as the standard. The SI units given in parentheses are for information only.
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.
Keywords
blood pump; blood trauma; index of hemolysis; modified index of hemolysis (MIH); normalized index of hemolysis (NIH); ICS Number Code 11.100 (Laboratory medicine)
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13.01 (Medical and Surgical Materials and Devices)
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Document Number
ASTM-F1841-19E01
Revision Level
2019(E1) EDITION
Status
Current
Modification Type
New
Publication Date
May 26, 2021
Document Type
Practice
Page Count
7 pages
Committee Number
F04.30