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ASTM F2888-13

(Test Method)

Standard Test Method for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials

Standard Test Method for Platelet Leukocyte Count&mdash;An <emph type="bdit">In-Vitro</emph > Measure for Hemocompatibility Assessment of Cardiovascular Materials

SIGNIFICANCE AND USE
4.1 The purpose of this test method is to determine if medical materials exposed to human whole blood will adversely affect the platelet and leukocyte counts in whole blood. A large number of platelets and leukocytes as part of 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 test method 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 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. All human blood and any materials that had contact with human blood shall be bagged in a biohazard bag, properly labeled as the contents, and disposed of by appropriate means.  
1.3 The human blood should be handled at Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories. 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 using universal precautions.  
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 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. Some specific hazards statements are given in Section 7 on Hazards.

General Information

Status
Historical
Publication Date
14-Feb-2013
ICS
11.100.30 - Analysis of blood and urine
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.16 - Biocompatibility Test Methods
Current Stage
Ref Project

Relations

Replaced By
ASTM F2888-19 - Standard Practice for Platelet Leukocyte Count&#x2014;An <emph type="bdit">In-Vitro</emph > Measure for Hemocompatibility Assessment of Cardiovascular Materials
Effective Date
01-Feb-2019
Referred By
ASTM E3219-20 - Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)
Effective Date
15-Feb-2013

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ASTM F2888-13 - Standard Test Method for Platelet Leukocyte Count&mdash;An <emph type="bdit">In-Vitro</emph > Measure for Hemocompatibility Assessment of Cardiovascular MaterialsASTM F2888-13 - Standard Test Method for Platelet Leukocyte Count&mdash;An <emph type="bdit">In-Vitro</emph > Measure for Hemocompatibility Assessment of Cardiovascular Materials
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ASTM F2888-13 - Standard Test Method for Platelet Leukocyte Count&mdash;An <emph type="bdit">In-Vitro</emph > Measure for Hemocompatibility Assessment of Cardiovascular Materials
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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: F2888 − 13
Standard Test Method 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 2. Referenced Documents
2
1.1 This test method assists in the evaluation of cardiovas- 2.1 ASTM Standards:
cular device materials for their ability to induce thrombus F2382TestMethodforAssessmentofIntravascularMedical
formation. Thrombus formation is assessed by means of a Device Materials on Partial Thromboplastin Time (PTT)
reduction in human platelets and leukocytes when consumed 2.2 Other Standards:
bythrombusafteractivationonthematerialsurface.Thisassay ANSI/AAMI/ISO 10993–4Biological Evaluation of Medi-
may be part of the hemocompatibility evaluation for devices cal Devices—Part 4: Selection of Tests for Interactions
3
and materials contacting human blood, as per ANSI/AAMI/ with Blood
ISO 10993–4. See also Test Method F2382. Centers for Disease Control/National Institutes of Health
Manual Biosafety in Microbiological Laboratories, 1993
1.2 All safety policies and practices shall be observed
during the performance of this test method. All human blood
3. Summary of Test Method
and any materials that had contact with human blood shall be
3.1 This test method identifies materials which are capable
bagged in a biohazard bag, properly labeled as the contents,
of activating blood platelets and leukocytes on their surface
and disposed of by appropriate means.
when exposed to freshly drawn human blood and causing the
1.3 The human blood should be handled at Biosafety Level
formation of thrombi on the material surface. A significant
2 as recommended in the Centers for Disease Control/National
decrease in the number of platelets and leukocytes when
Institutes of Health Manual Biosafety in Microbiological
counted by a blood analyzer is an indication of these cells
Laboratories. The human blood donor must have tested nega-
beingentrappedinthrombi.Thematerialsareexposedtoblood
tive for Hepatitis B (HBV) and Human Immunodeficiency
immediately after the blood is drawn with anticoagulant.
(HIV) viruses. The blood should be treated like any patient
Another anticoagulant is added at the appropriate time (one
blood in using universal precautions.
hour) to stop the reaction. Different blood analyzers may be
used.
1.4 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
4. Significance and Use
standard.
4.1 The purpose of this test method is to determine if
1.5 This standard does not purport to address all of the
medical materials exposed to human whole blood will ad-
safety concerns, if any, associated with its use. It is the
verselyaffecttheplateletandleukocytecountsinwholeblood.
responsibility of the user of this standard to establish appro-
A large number of platelets and leukocytes as part of thrombi
priate safety and health practices and determine the applica-
adhering to the material will be reflected by a decrease in their
bility of regulatory limitations prior to use. Some specific
counts in blood. Thrombogenic materials should not be used
hazards statements are given in Section 7 on Hazards.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee Standards volume information, refer to the standard’s Document Summary page on
F04.16 on Biocompatibility Test Methods. the ASTM website.
3
Current edition approved Feb. 15, 2013. Published March 2013. DOI: 10.1520/ Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
F2888–13. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2888 − 13
for cardiovascular medical devices, unless the purpose of the
C = percentage (%) of negative control.
device is to promote thrombosis.
When applicable, a comparison article should be used in the
formula in place of the negative control.
5. Interferences
5.1 There is potential for interference if the materials of the
10. Preparation of Apparatus
test tubes used are thrombogenic (for example, glass tubes).
10.1 Initialize the hematology analyzer and allow it to
Therefore, polyethylene or
...

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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.
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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.  
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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.  
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ASTM F2382-18(Test Method)
Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)

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4.1 The purpose of this test method is to determine the time citrated plasma exposed to medical materials takes to form a clot when exposed to a suspension of phospholipid particles and calcium chloride. In this test method, the test article is the activator. The PTT assay is a general screening test for a medical material’s ability to activate the intrinsic coagulation pathway. Material samples that show a shortened PTT are activators of the intrinsic coagulation pathway.  
4.2 The test article, reference materials, and controls are exposed to human plasma. The plasma is tested on a coagulation device. Each sample tube is assayed in duplicate. The results are reported as a percentage of the negative control.
SCOPE
1.1 This test method covers the screening of circulating blood-contacting device materials for their ability to induce blood coagulation via the intrinsic coagulation pathway. This assay should be part of the hemocompatibility evaluation for devices and materials contacting human blood, as per ANSI/AAMI/ISO 10993-4.  
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1.3 All plasma and any materials that had contact with plasma will be bagged in a biohazard bag, properly labelled with the contents, and disposed of by appropriate means. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories.  
1.4 The normal pooled human plasma must have tested negative for Hepatitis B (HBV) or Human Immunodeficiency (HIV) viruses. The plasmas should be treated like any patient plasma using standard precautions. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories.  
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SIGNIFICANCE AND USE
5.1 Inappropriate activation of complement by blood-contacting medical devices may have serious acute or chronic effects on the host. This practice is useful as a simple, inexpensive screening method for determining functional whole complement activation by solid materials in vitro.  
5.2 This practice is composed of two parts. In Part A (Section 11), human serum is exposed to a solid material. Complement may be depleted by the classical or alternative pathways. In principle, nonspecific binding of certain complement components also may occur. The alternative pathway can deplete later acting components common to both pathways, that is components other than C1, C4, and C3 (1) .4 In Part B (Section 12), complement activity remaining in the serum after exposure to the test material is assayed by classical pathway-mediated lysis of sensitized RBC.  
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1.1 This practice provides a protocol for rapid,  in vitro screening for whole complement activating properties of solid materials used in the fabrication of medical devices that will contact blood.  
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4.1 Autologous PRP and platelet gels are utilized in a wide range of orthopedic, sports medicine, regenerative medicine, and surgical applications (3-5). PRP and platelet gels are layered, sprayed, injected, molded, or packed, alone or in combination with graft material or TEMPs, into a variety of anatomical sites, tissues, and voids (3, 6). These platelet concentrates can provide an assortment of bioactive molecules, cells, and physical properties that are potentially attractive for promoting healing and other cell therapy applications (7). Unfortunately, the term “platelet-rich plasma” or “PRP,” which is ubiquitous in early and contemporary medical literature related to a variety of platelet concentrates, only unambiguously denotes one critical parameter of a platelet suspension—increased platelet concentration. Without further context, this common description of PRP offers no information about other important physical and cellular aspects of platelet concentrations. As scientific and clinical understanding of PRP and other cellular therapies increases standardization of nomenclature and terminology is critical for defining key properties, standardizing processing parameters and techniques, and developing repeatable assays for quality assurance and scientific evaluation (5, 8-13). This guide outlines basic guidelines to describe key properties of unique PRP and platelet gel formulations in a standardized fashion. Reliable, standardized descriptions can provide valuable context to PRP end users, such as clinicians seeking a PRP or platelet gel with certain biological attributes or scientific investigators seeking to duplicate a published formulation or to correlate a given PRP or platelet gel feature to other biological properties or outcomes.
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1.1 This guide defines terminology and identifies key fundamental properties of autologous platelet-rich plasma (PRP) and PRP-derived platelet gels intended to be used for tissue engineered medical products (TEMPS) or for cell therapy applications. This guide provides a common nomenclature and basis for describing notable properties and processing parameters for PRP and platelet gels that may have utility for manufacturers, researchers, and clinicians. Further discussion is also provided on certain aspects of PRP processing techniques, characterization, and quality assurance and how those considerations may impact key properties. The PRP characteristics outlined in this guide were selected based n a review of contemporary scientific and clinical literature but do not necessarily represent a comprehensive inventory; other significant unidentified properties may exist or be revealed by future scientific evaluation. This guide provides general recommendations for how to identify and cite relevant characteristics of PRP, based on broad utility; however, users of this standard should consult referenced documents for further information on the relative import or significance of any particular PRP characteristic in a particular context.  
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4.1 Significance—Dried blood represents a significant challenge to cleaning surgical instruments. The water-soluble components of blood are easily rendered insoluble when exposed to heat, chemical solutions, or time at room temperature. The water insoluble component of blood is fibrin built up during coagulation. These proteins bind quite readily to the surfaces of surgical instruments making them difficult to remove even with the aid of chemical cleaning agents. Instruments contaminated with blood residue after reprocessing represent a significant threat for infection to healthcare workers and patients. Healthcare facilities typically employ the use of automated instrument washers. These devices combine mechanical action along with chemical cleaning agents in a staged cleaning cycle designed to thoroughly clean surgical instruments. To function properly, these machines must be performing at targeted mechanical efficiency and deliver the correct chemical cleaning agents at the correct temperature, at the correct dosage for the correct period of time. Manufacturers of automated washers and manufacturers of cleaning detergent need to evaluate the performance of their products utilizing a surrogate for surgical instruments soiled with blood. The results of the performance testing will be used to improve product design and for validation of the performance of their product for various regulatory requirements.  
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SCOPE
1.1 This guide is based on a standardized test soil correlating to coagulated blood suitable for screening tests and the evaluation of the cleaning efficiency of washer-disinfectors used for reprocessing of surgical instruments. This guide strictly deals with cleaning and does not describe any methods that are related to disinfection. See Referenced Documents D5343, D4008, D4265, D2960, and D3050 in Section 2 for additional information.  
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ASTM F2888-19(Practice)
Standard Practice for Platelet Leukocyte Count—An In-Vitro 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.  
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