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


Importancia y uso:

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.

Subcomité:

F04.16

Referida por:

F0748-25, F2382-24, E3219-25

Volúmen:

13.02

Número ICS:

11.100.30 (Analysis of blood and urine)

Palabras clave:

hemocompatibility; leukocyte; platelet; thrombosis;

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Norma
F2888

Versión
19

Estatus
Active

Clasificación
Practice

Fecha aprobación
2019-02-01