1. 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.