ASTM F2888-19
(Practice)Standard Practice for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials
Standard Practice for Platelet Leukocyte Count—An <emph type="bdit">In-Vitro</emph > Measure for Hemocompatibility Assessment of Cardiovascular Materials
SIGNIFICANCE AND USE
4.1 The purpose of this practice is to determine if thrombus formation has occurred by comparing platelet and leukocyte counts in the blood exposed to the test material relative to the blood cell counts in the control blood that has not been exposed to the test material. A large number of platelets and leukocytes becoming entrapped/incorporated in thrombi adhering to the material will be reflected by a decrease in their counts in blood. Thrombogenic materials should not be used for cardiovascular medical devices, unless the purpose of the device is to promote thrombosis.
SCOPE
1.1 This practice assists in the evaluation of cardiovascular device materials for their ability to induce thrombus formation. Thrombus formation is assessed by means of a reduction in human platelets and leukocytes when consumed by thrombus after activation on the material surface. This assay may be part of the hemocompatibility evaluation for devices and materials contacting human blood, as in accordance with ANSI/AAMI/ISO 10993–4. See also Test Method F2382.
1.2 All safety policies and practices shall be observed during the performance of this practice. All human blood and any materials that had contact with human blood shall be bagged in a biohazard bag, properly labeled with the contents, and disposed of by appropriate means.
1.3 The human blood should be handled at Biosafety Level 2 (BSL-2) as recommended in the Centers for Disease Control/National Institutes of Health publication, Biosafety in Microbiological and Biomedical Laboratories (BMBL). The human blood donor must have tested negative for Hepatitis B (HBV) and Human Immunodeficiency (HIV) viruses. The blood should be treated like any patient blood and handled/manipulated using standard precautions.
Note 1: The results of this in-vitro test may not correspond to actual human response.
1.4 The values stated in SI (International System of Units) units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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. Some specific hazards statements are given in Section 8 on Hazards.
1.6 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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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.
Designation: F2888 − 19
Standard Practice for
Platelet Leukocyte Count—An In-Vitro Measure for
1
Hemocompatibility Assessment of Cardiovascular Materials
This standard is issued under the fixed designation F2888; 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.
1. Scope 1.6 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.1 This practice assists in the evaluation of cardiovascular
ization established in the Decision on Principles for the
devicematerialsfortheirabilitytoinducethrombusformation.
Development of International Standards, Guides and Recom-
Thrombus formation is assessed by means of a reduction in
mendations issued by the World Trade Organization Technical
human platelets and leukocytes when consumed by thrombus
Barriers to Trade (TBT) Committee.
after activation on the material surface.This assay may be part
of the hemocompatibility evaluation for devices and materials
2. Referenced Documents
contacting human blood, as in accordance with ANSI/AAMI/
2
2.1 ASTM Standards:
ISO 10993–4. See also Test Method F2382.
F2382Test Method for Assessment of Circulating Blood-
1.2 All safety policies and practices shall be observed
Contacting Medical Device Materials on Partial Throm-
during the performance of this practice. All human blood and
boplastin Time (PTT)
any materials that had contact with human blood shall be
2.2 Other Standards:
bagged in a biohazard bag, properly labeled with the contents,
ANSI/AAMI/ISO 10993–4Biological Evaluation of Medi-
and disposed of by appropriate means.
cal Devices—Part 4: Selection of Tests for Interactions
3
with Blood
1.3 The human blood should be handled at Biosafety Level
BMBL Biosafety in Microbiological and Biomedical
2(BSL-2)asrecommendedintheCentersforDiseaseControl/
4
Laboratories, 5th ed., 2009
National Institutes of Health publication, Biosafety in Micro-
biological and Biomedical Laboratories (BMBL). The human
3. Summary of Practice
blood donor must have tested negative for Hepatitis B (HBV)
3.1 This practice identifies materials which are capable of
and Human Immunodeficiency (HIV) viruses. The blood
activatingbloodplateletsandleukocytesontheirsurfacewhen
should be treated like any patient blood and handled/
exposed to freshly drawn human blood and causing the
manipulated using standard precautions.
formation of thrombi on the material surface. A significant
NOTE 1—The results of this in-vitro test may not correspond to actual
decrease in the number of platelets and leukocytes when
human response.
counted by a blood analyzer is an indication of these cells
1.4 The values stated in SI (International System of Units)
being entrapped in thrombi.The materials are exposed to fresh
units are to be regarded as standard. No other units of
whole blood that is drawn with anticoagulant.Another antico-
measurement are included in this standard.
agulant is added at the appropriate time (one hour) to stop
further thrombus formation. Different blood analyzers may be
1.5 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the used.
responsibility of the user of this standard to establish appro-
4. Significance and Use
priate safety, health, and environmental practices and deter-
4.1 The purpose of this practice is to determine if thrombus
mine the applicability of regulatory limitations prior to use.
formation has occurred by comparing platelet and leukocyte
Some specific hazards statements are given in Section 8 on
Hazards.
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
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland the ASTM website.
3
Surgical Materials and Devices and is the direct responsibility of Subcommittee Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
F04.16 on Biocompatibility Test Methods. 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Current edition approved Feb. 1, 2019. Published February 2019. Originally Available from U.S. Department of Health and Human Services, Centers for
approved in 2013. Last previous edition approved in 2013 as F2888 – 13. DOI: DiseaseControlandPrevention(CDC),1600CliftonRd.,Atlanta,GA30329-4027,
10.1520/F2888–19. http://www.
...
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: F2888 − 13 F2888 − 19
Standard Test Method Practice for
Platelet Leukocyte Count—An In-Vitro Measure for
1
Hemocompatibility Assessment of Cardiovascular Materials
This standard is issued under the fixed designation F2888; 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 test method practice assists in the evaluation of cardiovascular device materials for their ability to induce thrombus
formation. Thrombus formation is assessed by means of a reduction in human platelets and leukocytes when consumed by
thrombus after activation on the material surface. This assay may be part of the hemocompatibility evaluation for devices and
materials contacting human blood, as per in accordance with ANSI/AAMI/ISO 10993–4. See also Test Method F2382.
1.2 All safety policies and practices shall be observed during the performance of this test method. practice. All human blood
and any materials that had contact with human blood shall be bagged in a biohazard bag, properly labeled aswith the contents, and
disposed of by appropriate means.
1.3 The human blood should be handled at Biosafety Level 2 (BSL-2) as recommended in the Centers for Disease
Control/National Institutes of Health Manualpublication, Biosafety in Microbiological Laboratories. and Biomedical Laboratories
(BMBL). The human blood donor must have tested negative for Hepatitis B (HBV) and Human Immunodeficiency (HIV) viruses.
The blood should be treated like any patient blood in and handled/manipulated using universalstandard precautions.
NOTE 1—The results of this in-vitro test may not correspond to actual human response.
1.4 The values stated in SI (International System of Units) units are to be regarded as standard. No other units of measurement
are included in this standard.
1.5 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use. Some specific hazards statements are given in Section 78 on Hazards.
1.6 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:
F2382 Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time
(PTT)
2.2 Other Standards:
3
ANSI/AAMI/ISO 10993–4 Biological Evaluation of Medical Devices—Part 4: Selection of Tests for Interactions with Blood
Centers for Disease ControlBMBL /National Institutes of Health Manual Biosafety in Microbiological Laboratories, 1993and
4
Biomedical Laboratories, 5th ed., 2009
3. Summary of Test MethodPractice
3.1 This test method practice identifies materials which are capable of activating blood platelets and leukocytes on their surface
when exposed to freshly drawn human blood and causing the formation of thrombi on the material surface. A significant decrease
1
This test method practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.16 on Biocompatibility Test Methods.
Current edition approved Feb. 15, 2013Feb. 1, 2019. Published March 2013February 2019. Originally approved in 2013. Last previous edition approved in 2013 as F2888
– 13. DOI: 10.1520/F2888–13.10.1520/F2888–19.
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.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Available from U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd., Atlanta, GA 30329-4027,
http://www.cdc.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Cons
...
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