ASTM F1830-97(2017)

Standard Practice for Selection of Blood for <emph type="bdit">in vitro</emph> Evaluation of Blood Pumps

SIGNIFICANCE AND USE
5.1 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.3,4 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.  
5.2 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.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Historical
• Publication Date: 31-Aug-2017
• ICS: 11.100 - Laboratory medicine
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.30 - Cardiovascular Standards

Relations

• Replaces: ASTM F1830-97(2013) - Standard Practice for Selection of Blood for <emph type="bdit">in vitro</emph> Evaluation of Blood Pumps
• Effective Date: 01-Sep-2017
• Replaced By: ASTM F1830-19 - Standard Practice for Collection and Preparation of Blood for Dynamic <emph type="bdit" >in vitro</emph> Evaluation of Hemolysis in Blood Pumps
• Effective Date: 01-Sep-2019
• Referred By: ASTM F1841-19e1 - Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
• Effective Date: 01-Sep-2017

Standards Content (Sample)

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 2017)
Standard Practice for
1
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 3.1.1 continuous flow pump—a blood pump that produces
continuous blood flow due to its rotary motion.
1.1 This practice covers blood that will be used for in vitro
3.1.2 hemolysis—one of the parameters of blood damage
performance assessments of blood pumps. These assessments
caused by a blood pump. This can be observed by a change in
include the hemolytic properties of the devices.
the plasma color and can be measured as an increase of free
1.2 This practice covers the utilization of blood for the in
plasma hemoglobin concentration.
vitro evaluation of the following devices:
3.1.3 pulsatile pump—a blood pump that produces blood
1.2.1 Continuous flow rotary blood pumps (roller pumps,
flow to mimic a natural heart.
centrifugal pumps, axial flow pumps, and so forth) (see
Practice F1841).
4. Summary of Practice
1.2.2 Pulsatile blood pumps (pneumatically driven, electro-
mechanically driven, and so forth). 4.1 For the experimental evaluation of blood pump designs
and materials, an in vitro hemolysis test is recommended using
1.3 The source of blood utilized for in vitro evaluation of
fresh bovine or porcine blood. The donor animals should have
blood trauma (that is, hemolysis caused by the blood pumps,
normal body temperature, no physical signs of disease, includ-
due to the pump design, construction, and materials used)
ing diarrhea and rhinorrhea, and an acceptable normal range of
substantially influences the results of the performance of these
hematological profiles. The blood from a slaughterhouse
devices. Thus, a standardized blood source is required.
should not be used because it may be contaminated with other
1.4 The values stated in SI units are to be regarded as
body fluids, unless obtained by controlled venipuncture.
standard. No other units of measurement are included in this
However, for the preclinical studies, fresh human blood is
standard.
recommended for use (see Practice F1841).
1.5 This international standard was developed in accor-
4.2 For the in vitro hemolysis test, fresh bovine or porcine
dance with internationally recognized principles on standard-
blood is used within 48 h, including the time for transport.
ization established in the Decision on Principles for the
Fresh human blood should be used within 24 h after blood
Development of International Standards, Guides and Recom-
harvesting. The collected blood should be refrigerated at 2 to
mendations issued by the World Trade Organization Technical
8°C.
Barriers to Trade (TBT) Committee.
5. Significance and Use
2. Referenced Documents
5.1 The test results are substantially affected by donor
2
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.
5.2 Drawing several units of blood from healthy cattle does
1
This practice is under the jurisdiction ofASTM Committee F04 on Medical and
not affect them or their health. Therefore, bovine blood is
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.30 on Cardiovascular Standards.
Current edition approved Sept. 1, 2017. Published September 2017. Originally
3
approved in 1997. Last previous edition approved in 2013 as F1830 – 97 (2013). Mueller NM, et al. In Vitro Hematological Testing of Rotary Blood Pumps:
DOI: 10.1520/F1830-97R17. Remarks on Standardization and Data Interpretation. Artif Organs, 17 (2), 1993, pp.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 103–110.
4
contact ASTM Customer Service at [e-mail]. 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 Studies with NASAAxial Flow Pump. Artif Organs 18 (9), 1994, pp.
the ASTM website. 650–656.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F1830 − 97 (Reapproved 2013) F1830 − 97 (Reapproved 2017)
Standard Practice for
1
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
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.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
3
F1841 Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps (Withdrawn 0)
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 continuous flow pump—a blood pump that produces continuous blood flow due to its rotary motion.
3.1.2 hemolysis—one of the parameters of blood damage caused by a blood pump. This can be observed by a change in the
plasma color and can be measured as an increase of free plasma hemoglobin concentration.
3.1.3 pulsatile pump—a blood pump that produces blood flow to mimic a natural heart.
4. Summary of Practice
4.1 For the experimental evaluation of blood pump designs and materials, an in vitro hemolysis test is recommended using fresh
bovine or porcine blood. The donor animals should have normal body temperature, no physical signs of disease, including diarrhea
and rhinorrhea, and an acceptable normal range of hematological profiles. The blood from a slaughterhouse should not be used
because it may be contaminated with other body fluids, unless obtained by controlled venipuncture. However, for the preclinical
studies, fresh human blood is recommended for use (see Practice F1841).
4.2 For the in vitro hemolysis test, fresh bovine or porcine blood is used within 48 h, including the time for transport. Fresh
human blood should be used within 24 h after blood harvesting. The collected blood should be refrigerated at 2 to 8°C.
1
This practice is under the jurisdiction of ASTM 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, 2013Sept. 1, 2017. Published March 2013September 2017. Originally approved in 1997. Last previous edition approved in 20052013
as F1830 – 97 (2013).(2005). DOI: 10.1520/F1830-97R13.10.1520/F1830-97R17.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F1830 − 97 (2017)
5. Significance and Use
5.1 The test results are substantially affected by donor species and age, the method of harvesting, the period of storage, the
4,5
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 com
...