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.
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.
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