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

Importancia y uso:

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.

Subcomité:

F04.16

Referida por:

F0748-16, F2888-19, F3225-17R22, E3219-20

Volúmen:

13.01

Número ICS:

11.100 (Laboratory medicine), 11.100.30 (Analysis of blood and urine)

Palabras clave:

blood coagulation; blood compatibility; partial thromboplastin time; PTT;