Standard Practice for Platelet Leukocyte Count. An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials Ingestion-build-201039 and tested in accordance with

and tested in accordance with the requirements of BS EN 417

BS EN ISO 1524:2020 supersedes BS EN ISO 1524:2013

ISO 3087 provide guidance regarding apparatus

Software design documentation(Annex D)

Standard Practice for Platelet Leukocyte Count. An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials Ingestion-build-201039 and tested in accordance with1. 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 109934. See also