ASTM F1841 - 97(2013)

    Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps

    Active Standard ASTM F1841 | Developed by Subcommittee: F04.30

    Book of Standards Volume: 13.01


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    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.

    1. Scope

    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.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    F1830 Practice for Selection of Blood for in vitro Evaluation of Blood Pumps


    ICS Code

    ICS Number Code 11.100 (Laboratory medicine)

    UNSPSC Code

    UNSPSC Code 42161620(Hemodialysis unit blood pumps)


    DOI: 10.1520/F1841-97R13

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