ASTM F1841-97(2017)
(Practice)Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
SIGNIFICANCE AND USE
6.1 The objective of this practice is to standardize the evaluation method for detecting the hemolytic effect of a continuous flow blood pump used in extracorporeal circulation and circulatory assistance.
SCOPE
1.1 This practice covers a protocol for the assessment of the hemolytic properties of continuous flow blood pumps used in extracorporeal or implantable circulatory assist. An assessment is made based on the pump's effects on the erythrocytes over a certain period of time. For this assessment, a recirculation test is performed with a pump for 6 h.
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.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
1.4 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.
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Designation: F1841 − 97 (Reapproved 2017)
Standard Practice for
Assessment of Hemolysis in Continuous Flow Blood
1
Pumps
This standard is issued under the fixed designation F1841; 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.
INTRODUCTION
The goal of blood pump development is to replace or supplement the function of the human heart.
As a result, continuous flow blood pumps, including roller pumps and centrifugal pumps, are
commonly used in clinical extracorporeal circulation. They are used not only for cardiopulmonary
bypass in routine cardiac surgery but also for ventricular assist, percutaneous cardiopulmonary
support, and extracorporeal membrane oxygenation.
Many investigators have attempted to develop an atraumatic blood pump. Hemolysis is one of the
most important parameters of blood trauma induced by blood pumps. However, comparative in vitro
evaluation of the reported results of hemolysis are difficult due to the lack of uniformity of the test
methods employed. Thus, it is necessary to standardize the method of performing in vitro hemolysis
tests for the evaluation of continuous flow blood pumps.
1. Scope mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.1 This practice covers a protocol for the assessment of the
hemolytic properties of continuous flow blood pumps used in
2. Referenced Documents
extracorporeal or implantable circulatory assist.An assessment
2
2.1 ASTM Standards:
is made based on the pump’s effects on the erythrocytes over
F1830 PracticeforSelectionofBloodfor in vitroEvaluation
acertainperiodoftime.Forthisassessment,arecirculationtest
of Blood Pumps
is performed with a pump for 6 h.
1.2 The values stated in either SI units or inch-pound units
3. Terminology
are to be regarded separately as standard. The values stated in
3.1 Definitions:
each system may not be exact equivalents; therefore, each
3.1.1 continuous flow blood pump—a blood pump that
system shall be used independently of the other. Combining
produces continuous blood flow due to its rotary motion.
values from the two systems may result in non-conformance
3.1.2 free plasma hemoglobin—the amount of hemoglobin
with the standard.
(iron or heme-containing protein) in plasma.
1.3 This standard does not purport to address all of the
3.1.3 hemolysis—damage to erythrocytes resulting in the
safety concerns, if any, associated with its use. It is the
liberation of hemoglobin into the plasma.
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica- 3.1.4 Index of Hemolysis
bility of regulatory limitations prior to use. 3.1.4.1 normalized index of hemolysis—added grams of
1.4 This international standard was developed in accor- plasma free hemoglobin per 100 Lof blood pumped, corrected
dance with internationally recognized principles on standard- for plasma volume using hematocrit and normalized by flow
ization established in the Decision on Principles for the rate and circulation time.
Development of International Standards, Guides and Recom-
3.1.4.2 normalized milligram index of hemolysis—
normalized index of hemolysis expressed by milligram value
of free plasma hemoglobin.
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.30 onCardiovascular Standards. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Sept. 1, 2017. Published September 2017. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1997. Last previous edition approved in 2013 as F1841 – 97 (2013). Standards volume information, refer to the standard’s Document Summary page on
DOI: 10.1520/F1841-97R17. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F1841 − 97 (2017)
3.1.4.3 modified index of hemolysis—mass of hemoglobin used in the development stage of a pump, it is suggested that
released into plasma normalized by the total amount of pre-clinical evaluation tests be repeated with human blood.
hemoglobin pumped through the loop.
5. Summary of Practice
4. Formulas
5.1 Blood—The blood is obtained from human volunteers,
3
4.1 Normalized Index of Hemolysis (N.I.H.) (1, 2, 3, 4) :
cattle or pigs having normal body temperatures, no physical
signs of disease, including diarrhea or rhinorrhea, and an
100 2 Ht 100
N.I.H. g/100l 5∆fr
...
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: F1841 − 97 (Reapproved 2013) F1841 − 97 (Reapproved 2017)
Standard Practice for
Assessment of Hemolysis in Continuous Flow Blood
1
Pumps
This standard is issued under the fixed designation F1841; 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.
INTRODUCTION
The goal of blood pump development is to replace or supplement the function of the human heart.
As a result, continuous flow blood pumps, including roller pumps and centrifugal pumps, are
commonly used in clinical extracorporeal circulation. They are used not only for cardiopulmonary
bypass in routine cardiac surgery but also for ventricular assist, percutaneous cardiopulmonary
support, and extracorporeal membrane oxygenation.
Many investigators have attempted to develop an atraumatic blood pump. Hemolysis is one of the
most important parameters of blood trauma induced by blood pumps. However, comparative in vitro
evaluation of the reported results of hemolysis are difficult due to the lack of uniformity of the test
methods employed. Thus, it is necessary to standardize the method of performing in vitro hemolysis
tests for the evaluation of continuous flow blood pumps.
1. Scope
1.1 This practice covers a protocol for the assessment of the hemolytic properties of continuous flow blood pumps used in
extracorporeal or implantable circulatory assist. An assessment is made based on the pump’s effects on the erythrocytes over a
certain period of time. For this assessment, a recirculation test is performed with a pump for 6 h.
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.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory
limitations prior to use.
1.4 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:
F1830 Practice for Selection of Blood for in vitro Evaluation of Blood Pumps
3. Terminology
3.1 Definitions:
3.1.1 continuous flow blood pump—a blood pump that produces continuous blood flow due to its rotary motion.
3.1.2 free plasma hemoglobin—the amount of hemoglobin (iron or heme-containing protein) in plasma.
3.1.3 hemolysis—damage to erythrocytes resulting in the liberation of hemoglobin into the plasma.
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
onCardiovascular Standards.
Current edition approved March 1, 2013Sept. 1, 2017. Published March 2013September 2017. Originally approved in 1997. Last previous edition approved in 20052013
as F1841 – 97 (2013).(2005). DOI: 10.1520/F1841-97R13.10.1520/F1841-97R17.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F1841 − 97 (2017)
3.1.4 Index of Hemolysis
3.1.4.1 normalized index of hemolysis—added grams of plasma free hemoglobin per 100 L of blood pumped, corrected for
plasma volume using hematocrit and normalized by flow rate and circulation time.
3.1.4.2 normalized milligram index of hemolysis—normalized index of hemolysis expressed by milligram value of free plasma
hemoglobin.
3.1.4.3 modified index of hemolysis—mass of hemoglobin released into plasma normalized by the total amount of hemoglobin
pumped through the loop.
4. Formulas
3
4.1 Normalized Index of Hem
...
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