ASTM F1830-97(2013)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 2013)
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 3.1.3 pulsatile pump—a blood pump that produces blood
flow to mimic a natural heart.
1.1 This practice covers blood that will be used for in vitro
performance assessments of blood pumps. These assessments
4. Summary of Practice
include the hemolytic properties of the devices.
4.1 For the experimental evaluation of blood pump designs
1.2 This practice covers the utilization of blood for the in
and materials, an in vitro hemolysis test is recommended using
vitro evaluation of the following devices:
fresh bovine or porcine blood. The donor animals should have
1.2.1 Continuous flow rotary blood pumps (roller pumps,
normal body temperature, no physical signs of disease, includ-
centrifugal pumps, axial flow pumps, and so forth) (see
ing diarrhea and rhinorrhea, and an acceptable normal range of
Practice F1841).
hematological profiles. The blood from a slaughterhouse
1.2.2 Pulsatile blood pumps (pneumatically driven, electro-
should not be used because it may be contaminated with other
mechanically driven, and so forth).
body fluids, unless obtained by controlled venipuncture.
1.3 The source of blood utilized for in vitro evaluation of
However, for the preclinical studies, fresh human blood is
blood trauma (that is, hemolysis caused by the blood pumps,
recommended for use (see Practice F1841).
due to the pump design, construction, and materials used)
4.2 For the in vitro hemolysis test, fresh bovine or porcine
substantially influences the results of the performance of these
devices. Thus, a standardized blood source is required. blood is used within 48 h, including the time for transport.
Fresh human blood should be used within 24 h after blood
1.4 The values stated in SI units are to be regarded as
harvesting. The collected blood should be refrigerated at 2 to
standard. No other units of measurement are included in this
8°C.
standard.
2. Referenced Documents 5. Significance and Use
2.1 ASTM Standards:
5.1 The test results are substantially affected by donor
F1841 Practice for Assessment of Hemolysis in Continuous
species and age, the method of harvesting, the period of
Flow Blood Pumps
storage, the biochemical state of the blood, and the hemoglobin
3,4
and hematocrit level of blood. Therefore, standardization of
3. Terminology
proper blood usage for in vitro evaluation of blood pumps is
3.1 Definitions of Terms Specific to This Standard: essential, and this recommended practice will allow a universal
3.1.1 continuous flow pump—a blood pump that produces comparison of test results.
continuous blood flow due to its rotary motion.
5.2 Drawing several units of blood from healthy cattle does
3.1.2 hemolysis—one of the parameters of blood damage
not affect them or their health. Therefore, bovine blood is
caused by a blood pump. This can be observed by a change in
strongly suggested for usage in experimental evaluation of
the plasma color and can be measured as an increase of free
blood damage. Mixing two donor sources of blood should be
plasma hemoglobin concentration.
avoided in hemolysis tests because the mixture may induce
added hemolysis or a change in red cell resistance against
trauma.
This practice is under the jurisdiction ofASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.30 on Cardiovascular Standards.
Current edition approved March 1, 2013. Published March 2013. Originally
approved in 1997. Last previous edition approved in 2005 as F1830 – 97(2005). Mueller NM, et al. In Vitro Hematological Testing of Rotary Blood Pumps:
DOI: 10.1520/F1830-97R13. Remarks on Standardization and Data Interpretation. Artif Organs, 17 (2), 1993, pp.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 103–110.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Mizuguchi K, et al. Does Hematocrit Affect In Vitro Hemolysis Test Results?:
Standards volume information, refer to the standard’s Document Summary page on Preliminary Stu
...