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ASTM F1830-97

(Practice)

Standard Practice for Selection of Blood for In Vitro Evaluation of Blood Pumps

Standard Practice for Selection of Blood for In Vitro Evaluation of Blood Pumps

SCOPE
1.1 This practice covers blood that will be used for in vitro performance assessments of blood pumps. These assessments include the hemolytic properties of the devices.

General Information

Status
Historical
Publication Date
31-Dec-1996
ICS
11.100 - Laboratory medicine
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.30 - Cardiovascular Standards
Current Stage
Ref Project

Relations

Replaced By
ASTM F1830-97(2005) - Standard Practice for Selection of Blood for <i>in vitro</i> Evaluation of Blood Pumps
Effective Date
01-Mar-2005
Referred By
ASTM F1841-19e1 - Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
Effective Date
01-Jan-1997

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ASTM F1830-97 - Standard Practice for Selection of Blood for In Vitro Evaluation of Blood PumpsASTM F1830-97 - Standard Practice for Selection of Blood for In Vitro Evaluation of Blood Pumps
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ASTM F1830-97 - Standard Practice for Selection of Blood for In Vitro Evaluation of Blood Pumps
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F1830–97
Standard Practice for
Selection of Blood for In Vitro Evaluation of Blood Pumps
This standard is issued under the fixed designation F 1830; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope ing diarrhea and rhinorrhea, and an acceptable normal range of
hematological profiles. The blood from a slaughterhouse
1.1 This practice covers blood that will be used for in vitro
should not be used because it may be contaminated with other
performance assessments of blood pumps. These assessments
body fluids, unless obtained by controlled venipuncture. How-
include the hemolytic properties of the devices.
ever, for the preclinical studies, fresh human blood is recom-
1.2 This practice covers the utilization of blood for the in
mended for use (see Practice F 1841).
vitro evaluation of the following devices:
4.2 For the in vitro hemolysis test, fresh bovine or porcine
1.2.1 Continuous flow rotary blood pumps (roller pumps,
blood is used within 48 h, including the time for transport.
centrifugal pumps, axial flow pumps, etc.) (see Practice
Fresh human blood should be used within 24 h after blood
F 1841).
harvesting. The collected blood should be refrigerated at 2 to
1.2.2 Pulsatile blood pumps (pneumatically driven, electro-
8°C.
mechanically driven, etc.).
1.3 The source of blood utilized for in vitro evaluation of
5. Significance and Use
blood trauma (that is, hemolysis caused by the blood pumps,
5.1 The test results are substantially affected by donor
due to the pump design, construction, and materials used)
species and age, the method of harvesting, the period of
substantially influences the results of the performance of these
storage, the biochemical state of the blood, and the hemoglobin
devices. Thus, a standardized blood source is required.
3,4
and hematocrit level of blood. Therefore, standardization of
2. Referenced Documents proper blood usage for in vitro evaluation of blood pumps is
essential, and this recommended practice will allow a universal
2.1 ASTM Standards:
comparison of test results.
F 1841 PracticeforAssessmentofHemolysisinContinuous
5.2 Drawing several units of blood from healthy cattle does
Flow Blood Pumps
not affect them or their health. Therefore, bovine blood is
3. Terminology strongly suggested for usage in experimental evaluation of
blood damage. Mixing two donor sources of blood should be
3.1 Definitions of Terms Specific to This Standard:
avoided in hemolysis tests because the mixture may induce
3.1.1 continuous flow pump—a blood pump that produces
added hemolysis or a change in red cell resistance against
continuous blood flow due to its rotary motion.
trauma.
3.1.2 hemolysis—one of the parameters of blood damage
caused by a blood pump. This can be observed by a change in
6. Collection and Preparation of Blood
the plasma color and can be measured as an increase of free
6.1 Blood will be drawn using a venipuncture technique
plasma hemoglobin concentration.
through a large bore needle (14 G or larger) into a blood bag
3.1.3 pulsatile pump—a blood pump that produces blood
which contains anticoagulants such as citrate phosphate dex-
flow to mimic a natural heart.
trose adenine (CPDA-1) anticoagulant solution (see Appendix
4. Summary of Practice
X1) or heparin sulfate (see Appendix X2). The blood is
obtained from human volunteers, cattle or pigs having normal
4.1 For the experimental evaluation of blood pump designs
body temperature, no physical signs of disease, including
and materials, an in vitro hemolysis test is recommended using
diarrhea, rhinorrhea, and whose hematological profiles are in
fresh bovine or porcine blood. The donor animals should have
an acceptable range. No negative pressure in exces
...

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Standard Practice for Collection and Preparation of Blood for Dynamic in vitro Evaluation of Hemolysis in Blood Pumps

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5.1 In vitro hemolysis test results for blood pumps may be substantially affected by donor species, sex, age, fasting, the method of harvesting, the anticoagulant properties, the period of storage, the biochemical state of the blood, and the hemoglobin and hematocrit level of blood.3,4 Therefore, standardization of proper whole blood collection and preparation for the dynamic in vitro evaluation of blood pumps is essential, and this recommended practice will allow an acceptable comparison of test results among hemolysis tests involving similar testing methods.
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1.1 This practice covers whole blood that will be used for the in vitro performance assessment of hemolysis in blood pumps intended for clinical use.  
1.2 This practice covers the recommended standard collection, preparation, handling, storage, and utilization of whole blood for the in vitro evaluation (see Practice F1841) of the following devices:  
1.2.1 Continuous flow blood pumps (roller pumps, centrifugal pumps, axial flow pumps, etc.).  
1.2.2 Pulsatile and intermittent flow blood pumps (pneumatically driven, electro-mechanically driven, with an artificial pulse, etc.).  
1.3 The source and preparation of whole blood utilized for the dynamic in vitro evaluation of red blood cell (erythrocyte) trauma caused by blood pumps can substantially influence the hemolysis performance of these devices. Thus, standardized whole blood collection and preparation methods are required.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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6.1 The objective of this practice is to standardize the evaluation method for assessing the hemolytic effect of a blood pump used in extracorporeal circulation and/or circulatory assistance. By comparing the hemolysis results between a subject device and a comparator device through paired testing, a relative evaluation of hemolysis for the subject device can be made.
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1.1 This practice covers a protocol for the assessment of the hemolytic properties of continuous, intermittent, and pulsatile flow blood pumps used in circulatory assist, including extracorporeal, percutaneous, and implantable devices. An assessment is made based on the pump's effects on the erythrocytes over a certain period of time. Adopting current practices for this assessment, a 6-hour in vitro test is performed on a pump placed in a device-specific recirculating blood loop that mimics the pressure and flow conditions of the expected worst-case clinical use of the device. If the ultimate goal of the testing is to evaluate the blood damage potential of a pump for clinical use, it is suggested that paired testing between the subject blood pump and a legally marketed comparator device be conducted using the same blood pool in a matched blood test loop so that a relative hemolysis comparison can be made.  
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.  
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5.2.1 Fig. 1 gives an indication...
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FIG. 1 General Form of Glass Disposable Pasteur Pipets  
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