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ASTM F1830-97(2005)

(Practice)

Standard Practice for Selection of Blood for in vitro Evaluation of Blood Pumps

Standard Practice for Selection of Blood for <i>in vitro</i> Evaluation of Blood Pumps

SIGNIFICANCE AND USE
The test results are substantially affected by donor species and age, the method of harvesting, the period of storage, the biochemical state of the blood, and the hemoglobin and hematocrit level of blood. , Therefore, standardization of proper blood usage for in vitro evaluation of blood pumps is essential, and this recommended practice will allow a universal comparison of test results.  
Drawing several units of blood from healthy cattle does not affect them or their health. Therefore, bovine blood is strongly suggested for usage in experimental evaluation of blood damage. Mixing two donor sources of blood should be avoided in hemolysis tests because the mixture may induce added hemolysis or a change in red cell resistance against trauma.
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.
1.2 This practice covers the utilization of blood for the in vitro evaluation of the following devices:
1.2.1 Continuous flow rotary blood pumps (roller pumps, centrifugal pumps, axial flow pumps, and so forth) (see Practice F1841).
1.2.2 Pulsatile blood pumps (pneumatically driven, electromechanically driven, and so forth).
1.3 The source of blood utilized for in vitro evaluation of blood 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 these devices. Thus, a standardized blood source is required.

General Information

Status
Historical
Publication Date
28-Feb-2005
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

Replaces
ASTM F1830-97 - Standard Practice for Selection of Blood for In Vitro Evaluation of Blood Pumps
Effective Date
01-Mar-2005
Replaced By
ASTM F1830-97(2013) - Standard Practice for Selection of Blood for <emph type="bdit">in vitro</emph> Evaluation of Blood Pumps
Effective Date
01-Mar-2013
Referred By
ASTM F1841-19e1 - Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
Effective Date
01-Mar-2005

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ASTM F1830-97(2005) - Standard Practice for Selection of Blood for <i>in vitro</i> Evaluation of Blood PumpsASTM F1830-97(2005) - Standard Practice for Selection of Blood for <i>in vitro</i> Evaluation of Blood Pumps
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ASTM F1830-97(2005) - Standard Practice for Selection of Blood for <i>in vitro</i> 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(Reapproved 2005)
Standard Practice for
Selection of Blood for in vitro Evaluation of Blood Pumps
This standard is issued under the fixed designation F1830; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope 4. Summary of Practice
1.1 This practice covers blood that will be used for in vitro 4.1 For the experimental evaluation of blood pump designs
performance assessments of blood pumps. These assessments and materials, an in vitro hemolysis test is recommended using
include the hemolytic properties of the devices. fresh bovine or porcine blood. The donor animals should have
normal body temperature, no physical signs of disease, includ-
1.2 This practice covers the utilization of blood for the in
ing diarrhea and rhinorrhea, and an acceptable normal range of
vitro evaluation of the following devices:
hematological profiles. The blood from a slaughterhouse
1.2.1 Continuous flow rotary blood pumps (roller pumps,
should not be used because it may be contaminated with other
centrifugal pumps, axial flow pumps, and so forth) (see
body fluids, unless obtained by controlled venipuncture.
Practice F1841).
However, for the preclinical studies, fresh human blood is
1.2.2 Pulsatile blood pumps (pneumatically driven, electro-
recommended for use (see Practice F1841).
mechanically driven, and so forth).
4.2 For the in vitro hemolysis test, fresh bovine or porcine
1.3 The source of blood utilized for in vitro evaluation of
blood is used within 48 h, including the time for transport.
blood trauma (that is, hemolysis caused by the blood pumps,
Fresh human blood should be used within 24 h after blood
due to the pump design, construction, and materials used)
harvesting. The collected blood should be refrigerated at 2 to
substantially influences the results of the performance of these
8°C.
devices. Thus, a standardized blood source is required.
5. Significance and Use
2. Referenced Documents
5.1 The test results are substantially affected by donor
2.1 ASTM Standards:
species and age, the method of harvesting, the period of
F1841 Practice for Assessment of Hemolysis in Continuous
storage, the biochemical state of the blood, and the hemoglobin
Flow Blood Pumps
3,4
and hematocrit level of blood. Therefore, standardization of
proper blood usage for in vitro evaluation of blood pumps is
3. Terminology
essential, and this recommended practice will allow a universal
3.1 Definitions of Terms Specific to This Standard:
comparison of test results.
3.1.1 continuous flow pump—a blood pump that produces
5.2 Drawing several units of blood from healthy cattle does
continuous blood flow due to its rotary motion.
not affect them or their health. Therefore, bovine blood is
3.1.2 hemolysis—one of the parameters of blood damage
strongly suggested for usage in experimental evaluation of
caused by a blood pump. This can be observed by a change in
blood damage. Mixing two donor sources of blood should be
the plasma color and can be measured as an increase of free
avoided in hemolysis tests because the mixture may induce
plasma hemoglobin concentration.
added hemolysis or a change in red cell resistance against
3.1.3 pulsatile pump—a blood pump that produces blood
trauma.
flow to mimic a natural heart.
6. Collection and Preparation of Blood
6.1 Blood will be drawn using a venipuncture technique
This practice is under the jurisdiction ofASTM Committee F04 on Medical and
through a large bore needle (14 G or larger) into a blood bag
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.30 on Cardiovascular Standards.
Current edition approved Mar. 1, 2005. Published March 2005. Originally
approved in 1997. Last previous edition approved in 1997 as F1830 – 97. DOI: Mueller NM, et al. In Vitro Hematological Testing of Rotary Blood Pumps:
10.1520/F1830-97R05. Remarks on Standardization and Data Interpretation. Artif Organs, 17 (2), 1993, pp.
For referenced ASTM standards, v
...

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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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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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FIG. 1 General Form of Glass Disposable Pasteur Pipets  
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