Designation: F1841 − 97 (Reapproved 2017)Standard Practice forAssessment of Hemolysis in Continuous Flow BloodPumps 1This standard is issued under the f i xed designation F1841; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (´) indicates an editorial change since the last revision or reapproval.INTRODUCTIONThe goal of blood pump development is to replace or supplement the function of the human heart.As a result, continuous f l ow blood pumps, including roller pumps and centrifugal pumps, arecommonly used in clinical extracorporeal circulation. They are used not only for cardiopulmonarybypass in routine cardiac surgery but also for ventricular assist, percutaneous cardiopulmonarysupport, and extracorporeal membrane oxygenation.Many investigators have attempted to develop an atraumatic blood pump. Hemolysis is one of themost important parameters of blood trauma induced by blood pumps. However, comparative in vitroevaluation of the reported results of hemolysis are difficult due to the lack of uniformity of the testmethods employed. Thus, it is necessary to standardize the method of performing in vitro hemolysistests for the evaluation of continuous f l ow blood pumps.1. Scope1.1 This practice covers a protocol for the assessment of thehemolytic properties of continuous f l ow blood pumps used inextracorporeal or implantable circulatory assist.An assessmentis made based on the pump’s effects on the erythrocytes overa certain period of time. For this assessment, a recirculation testis performed with a pump for 6 h.1.2 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard. The values stated ineach system may not be exact equivalents; therefore, eachsystem shall be used independently of the other. Combiningvalues from the two systems may result in non-conformancewith the standard.1.3 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.1.4 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards: 2F1830 Practice for Selection of Blood for in vitro Evaluationof Blood Pumps3. Terminology3.1 Def i nitions:3.1.1 continuous f l ow blood pump—a blood pump thatproduces continuous blood f l ow due to its rotary motion.3.1.2 free plasma hemoglobin—the amount of hemoglobin(iron or heme-containing protein) in plasma.3.1.3 hemolysis—damage to erythrocytes resulting in theliberation of hemoglobin into the plasma.3.1.4 Index of Hemolysis3.1.4.1 normalized index of hemolysis—added grams ofplasma free hemoglobin per 100 L of blood pumped, correctedfor plasma volume using hematocrit and normalized by f l owrate and circulation time.3.1.4.2 normalized milligram index of hemolysis—normalized index of hemolysis expressed by milligram valueof free plasma hemoglobin.1 This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.30 onCardiovascular Standards.Current edition approved Sept. 1, 2017. Published September 2017. Originallyapproved in 1997. Last previous edition approved in 2013 as F1841 – 97 (2013).DOI: 10.1520/F1841-97R17.2 For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at service@astm.org. For Annual Book of ASTMStandards volume information, refer to the standard’s Document Summary page onthe ASTM website.Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1 Copyright by ASTM Int'l (all rights reserved); Sat Sep 30 12:14:37 EDT 2017Downloaded/printed byUniversity of Edinburgh (University of Edinburgh) pursuant to License Agreement. No further reproductions authorized.
