ASTM_F_1830_-_97_2013.pdf

Designation:F183097(Reapproved 2013)Standard Practice forSelection of Blood for in vitro Evaluation of Blood Pumps1This standard is issued under the fixed designation F1830;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.1.Scope1.1 This practice covers blood that will be used for in vitroperformance assessments of blood pumps.These assessmentsinclude the hemolytic properties of the devices.1.2 This practice covers the utilization of blood for the invitro evaluation of the following devices:1.2.1 Continuous flow rotary blood pumps(roller pumps,centrifugal pumps,axial flow pumps,and so forth)(seePractice F1841).1.2.2 Pulsatile blood pumps(pneumatically driven,electro-mechanically driven,and so forth).1.3 The source of blood utilized for in vitro evaluation ofblood trauma(that is,hemolysis caused by the blood pumps,due to the pump design,construction,and materials used)substantially influences the results of the performance of thesedevices.Thus,a standardized blood source is required.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.2.Referenced Documents2.1 ASTM Standards:2F1841 Practice for Assessment of Hemolysis in ContinuousFlow Blood Pumps3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 continuous flow pumpa blood pump that producescontinuous blood flow due to its rotary motion.3.1.2 hemolysisone of the parameters of blood damagecaused by a blood pump.This can be observed by a change inthe plasma color and can be measured as an increase of freeplasma hemoglobin concentration.3.1.3 pulsatile pumpa blood pump that produces bloodflow to mimic a natural heart.4.Summary of Practice4.1 For the experimental evaluation of blood pump designsand materials,an in vitro hemolysis test is recommended usingfresh bovine or porcine blood.The donor animals should havenormal body temperature,no physical signs of disease,includ-ing diarrhea and rhinorrhea,and an acceptable normal range ofhematological profiles.The blood from a slaughterhouseshould not be used because it may be contaminated with otherbody fluids,unless obtained by controlled venipuncture.However,for the preclinical studies,fresh human blood isrecommended for use(see Practice F1841).4.2 For the in vitro hemolysis test,fresh bovine or porcineblood is used within 48 h,including the time for transport.Fresh human blood should be used within 24 h after bloodharvesting.The collected blood should be refrigerated at 2 to8C.5.Significance and Use5.1 The test results are substantially affected by donorspecies and age,the method of harvesting,the period ofstorage,the biochemical state of the blood,and the hemoglobinand hematocrit level of blood.3,4Therefore,standardization ofproper blood usage for in vitro evaluation of blood pumps isessential,and this recommended practice will allow a universalcomparison of test results.5.2 Drawing several units of blood from healthy cattle doesnot affect them or their health.Therefore,bovine blood isstrongly suggested for usage in experimental evaluation ofblood damage.Mixing two donor sources of blood should beavoided in hemolysis tests because the mixture may induceadded hemolysis or a change in red cell resistance againsttrauma.1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.30 on Cardiovascular Standards.Current edition approved March 1,2013.Published March 2013.Originallyapproved in 1997.Last previous edition approved in 2005 as F1830 97(2005).DOI:10.1520/F1830-97R13.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Mueller NM,et al.In Vitro Hematological Testing of Rotary Blood Pumps:Remarks on Standardization and Data Interpretation.Artif Organs,17(2),1993,pp.103110.4Mizuguchi K,et al.Does Hematocrit Affect In Vitro Hemolysis Test Results?:Preliminary Studies with NASA Axial Flow Pump.Artif Organs 18(9),1994,pp.650656.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 6.Collection and Preparation of Blood6.1 Blood will be drawn using a venipuncture techniquethrough a large bore needle(14 G or larger)into a blood bagwhich contains anticoagulants such as citrate phosphate dex-trose adenine(CPDA-1)anticoagulant solution(see AppendixX1)or heparin sulfate(see Appendix X2).The blood isobtained from human volunteers,cattle,or pigs having normalbody temperature,no physical signs of disease,includingdiarrhea,rhinorrhea,and whose hematological profiles are