ASTM F1830-1997(2005) Standard Practice for Selection of Blood for in vitro Evaluation of Blood Pumps《评价实验室血泵用血液的选择的标准操作规程》.pdf

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1、Designation: F 1830 97 (Reapproved 2005)Standard Practice forSelection of Blood for in vitro Evaluation of Blood Pumps1This standard is issued under the fixed designation F 1830; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the

2、year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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 assess

3、mentsinclude 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 F 1841).1.2.2 Pulsatile bl

4、ood 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 perfo

5、rmance of thesedevices. Thus, a standardized blood source is required.2. Referenced Documents2.1 ASTM Standards:2F 1841 Practice forAssessment of Hemolysis in ContinuousFlow Blood Pumps3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 continuous flow pumpa blood pump that produc

6、escontinuous 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 bl

7、oodflow 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

8、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. How-ever, for the preclinical studies, fresh human blood is recom-mend

9、ed for use (see Practice F 1841).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

10、 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 isessent

11、ial, 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 o

12、f blood should beavoided in hemolysis tests because the mixture may induceadded hemolysis or a change in red cell resistance againsttrauma.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 co

13、ntains 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, including1This practice is

14、 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 Mar. 1, 2005. Published March 2005. Originallyapproved in 1997. Last previous edition approved in 1997

15、 as F 1830 97.2For 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 Test

16、ing 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.650656.1Copyright ASTM Interna

17、tional, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.diarrhea, rhinorrhea, and whose hematological profiles are inan acceptable range. No negative pressure in excess of 100mmHg should be applied during the drawing of the blood.Blood will be collected until the

18、blood bag is full to obtain atotal of 450 6 45 mL of blood and with anticoagulants. Alarger bag can also be used.6.2 The blood should be refrigerated between 2 to 8Ctemperature. For blood transportation, the temperature shouldbe also within the range of 2 to 8C.6.3 Refrigerated blood should be warme

19、d to the physiologi-cal temperature, using a water bath of 37 6 1C or otherappropriate methods.6.4 During warming of the blood, close attention should begiven to micro air bubbles, and these air bubbles should beeliminated through the sampling port of the blood bag beforestarting the in vitro evalua

20、tion.6.5 To accomplish the removal of particulate matter, micro-thrombus, and aggregated platelets during priming of the testcircuit, a transfusion kit with a micro filter, 80 m pore size orless, should be used. As a quality control measure, any bloodhaving free plasma hemoglobin of more than 20 mg/

21、dL shouldnot be used for the test. The inclusion of total blood hemoglo-bin and hematocrit data are recommended in addition to bloodsource screening. Proper physiological blood parametersshould be maintained prior to and during testing (for example,pH, base excess, glucose concentration).37. Keyword

22、s7.1 blood trauma; condition of test blood; index of hemoly-sis; source of blood donorAPPENDIXES(Nonmandatory Information)X1. CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA1) SOLUTION USPX1.1 63 mL CPDA1 solution USP is added for collection of450 mL blood.X1.2 Each 63 mL of CPDA1 contains2gofdextrose(mono

23、hydrate) USP, 1.66 g sodium citrate(dihydrate) USP, 188mg citric acid (anhydrous) USP, 140 mg monobasic sodiumphosphate (monohydrate) USP and 17.3 mg adenine USP. ThepH of the solution may be adjusted with sodium hydroxide.X2. HEPARINX2.1 500 mL of blood containing 2000 to 3000 USP unitsof heparin i

24、s utilized.X3. RATIONALEX3.1 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

25、source is required.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be

26、addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards,

27、 at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F 1830 97 (2005)2