ASTM F1830-1997(2017) Standard Practice for Selection of Blood for in vitro Evaluation of Blood Pumps《选择血液对血液泵进行体外评估的标准实施规程》.pdf

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1、Designation: F1830 97 (Reapproved 2017)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 ye

2、ar 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 assessmen

3、tsinclude 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

4、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 performan

5、ce 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.1.5 This international standard was developed in accor-dance with internationally recognized principles on sta

6、ndard-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:2F1841 Practice for Assessment of Hemolysis i

7、n 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

8、 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

9、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 contami

10、nated 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 hum

11、an 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

12、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

13、their health. Therefore, bovine blood is1This 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 Sept. 1, 2017. Published September 2017. Orig

14、inallyapproved in 1997. Last previous edition approved in 2013 as F1830 97 (2013).DOI: 10.1520/F1830-97R17.2For 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 stand

15、ards 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 St

16、udies 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 StatesThis international standard was developed in accordance with internationally recognized principles on standardization

17、 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.1strongly suggested for usage in experimental evaluation ofblood damage. Mixing two donor sources of

18、 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 con

19、tains 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, rhinorrh

20、ea, 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 blood bag is full to obtain atotal of 450 6 45 mL of blood and with anticoagulants. Alarger bag can also be us

21、ed.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 warmed to the physiologi-cal temperature, using a water bath of 37 6 1C or otherappropriate methods.6.4 During warm

22、ing 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 evaluation.6.5 To accomplish the removal of particulate matter,microthrombus, and aggregated platelets during primin

23、g of thetest circuit, a transfusion kit with a micro filter, 80 m pore sizeor less, should be used.As a quality control measure, any bloodhaving free plasma hemoglobin of more than 20 mg/dL shouldnot be used for the test. The inclusion of total blood hemoglo-bin and hematocrit data are recommended i

24、n addition to bloodsource screening. Proper physiological blood parametersshould be maintained prior to and during testing (for example,pH, base excess, glucose concentration).37. Keywords7.1 blood trauma; condition of test blood; index of hemoly-sis; source of blood donorAPPENDIXES(Nonmandatory Inf

25、ormation)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(monohydrate) USP, 1.66 g sodium citrate(dihydrate) USP, 188mg citric acid (anhydrous) USP, 140 mg monobasic sodiumpho

26、sphate (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 units ofheparin is utilized.F1830 97 (2017)2X3. RATIONALEX3.1 The source of blood utilized for in vitro evaluation ofblood trauma

27、(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.ASTM International takes no position respecting the validity of any patent rig

28、hts asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any

29、 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 addressed to ASTM International Headquarters. Your comments wi

30、ll 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, at the address shown below.This standard is copyrighted by AS

31、TM 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). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 97 (2017)3