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  • ASTM
    F2888-13 Standard Test Method for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials
    Edition: 2013
    $144.00
    Unlimited Users per year

Description of ASTM-F2888 2013

ASTM F2888-13

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




ASTM F2888

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.


Keywords

hemocompatibility; leukocyte; platelet; thrombosis


ICS Code

ICS Number Code 11.100.30 (Analysis of blood and urine)


DOI: 10.1520/F2888-13



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