ASTM F1841-19e1
(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 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.
SCOPE
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.
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, health, and environmental 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.
General Information
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Standards Content (Sample)
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 − 19
Standard Practice for
Assessment of Hemolysis in Continuous Flow Blood
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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.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
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ε NOTE—Editorial corrections were made to 4.1 and 4.2.1 in May 2021.
INTRODUCTION
The goal of blood pump development is to replace or supplement the function of the human heart
to circulate blood. In practice, blood pumps are commonly used in cardiopulmonary bypass during
routine cardiac surgery, and for ventricular assist, percutaneous cardiopulmonary support, and
extracorporeal membrane oxygenation applications.
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 and can occur from mechanical,
thermal, or chemical sources in these devices. Dynamic in vitro hemolysis testing is an essential
componentoftheassessmentofdevices,asitevaluatesthebiologicalresponseduringoperationofthe
device under worst-case clinical use conditions. Directly comparing the reported results of in vitro
hemolysis testing between laboratories is of limited utility, however, due to the lack of uniformity of
thetestmethodsemployed,andvariabilityinthefragilityofthetestbloodandthemeasurementassays
used to assess hemolysis. Thus, it is necessary to provide standardization of the methods for
performingandreportingdynamic in vitrohemolysistestsintheevaluationofpotentialclinicalblood
pumps.Asthereisadiverserangeofdevicetechnologiesandclinicalpumpapplications,thisstandard
proposes methodology for evaluating a blood pump under its simulated clinical use conditions and in
relation to a relevant comparator device.
1. Scope clinical use, it is suggested that paired testing between the
subject blood pump and a legally marketed comparator device
1.1 Thispracticecoversaprotocolfortheassessmentofthe
be conducted using the same blood pool in a matched blood
hemolytic properties of continuous, intermittent, and pulsatile
test loop so that a relative hemolysis comparison can be made.
flow blood pumps used in circulatory assist, including
extracorporeal, percutaneous, and implantable devices. An 1.2 The values stated in either SI units or inch-pound units
assessment is made based on the pump’s effects on the are to be regarded separately as standard. The values stated in
erythrocytes over a certain period of time. Adopting current each system may not be exact equivalents; therefore, each
practicesforthisassessment,a6-hour in vitrotestisperformed system shall be used independently of the other. Combining
on a pump placed in a device-specific recirculating blood loop values from the two systems may result in non-conformance
that mimics the pressure and flow conditions of the expected with the standard.
worst-caseclinicaluseofthedevice.Iftheultimategoalofthe
1.3 This standard does not purport to address all of the
testing is to evaluate the blood damage potential of a pump for
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
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priate safety, health, and environmental practices and deter-
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devices and is the direct responsibility of Subcommittee
mine the applicability of regulatory limitations prior to use.
F04.30 on Cardiovascular Standards.
1.4 This international standard was developed in accor-
Current edition approved Sept. 1, 2019. Published December 2019. Originally
dance with internationally recognized principles on standard-
approved in 1997. Last previous edition approved in 2017 as F1841–97(2017).
DOI: 10.1520/F1841-19E01. ization established in the Decision on Principles for the
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F1841 − 19
Development of International Standards, Guides and Recom- 4.2 Modified Index of Hemolysis (MIH):
mendations issued by the World Trade Organization Technical 4.2.1 Modified index of hemolysis (MIH) (5, 6) can be
Barriers to Trade (TBT) Committee. written with no units or as (mg of hemoglobin released into
plasma / mg of total hemoglobin pumped through the loop) ×
6 6
2. Referenced Documents
10 factor.The10 factorisintroducedtoreducethenumberof
2
decimal pla
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