When this test applies
ISO 10993-1:2025 flags hemocompatibility for every device that contacts circulating blood, directly or indirectly. ISO 10993-4:2017 breaks the endpoint into categories — thrombosis, coagulation, platelets, haematology and immunology (complement) — and selects tests by device category and contact duration. Platelet and leukocyte counts address the platelet and haematology categories and are typically called for in external communicating devices with circulating-blood contact and in blood-contacting implants.
When to run it
After cytotoxicity, on finished, sterilised samples with the material, surface finish and process locked. Platelet adhesion is sensitive to surface condition, so a change after testing means repeating it. Run it in one campaign with the other hemocompatibility tests your device category calls for.
What a pass tells you
That platelet and leukocyte counts after exposure showed no significant reduction attributable to the device when compared with the concurrent negative control, with the positive control performing as expected.
What it does not tell you
Cell counts are one category of blood interaction. A clear result says nothing about hemolysis, complement activation, coagulation or thrombus formation under flow, and nothing outside hemocompatibility.
Method
Testing per ISO 10993-4:2017. The device, or an extract where the geometry requires it, is incubated with fresh, anticoagulated human whole blood alongside negative and positive controls. Platelet and leukocyte counts are determined on an automated haematology analyser before and after exposure and compared with the controls. Extraction ratio follows ISO 10993-12: 6 cm²/mL for material under 0.5 mm thick, 3 cm²/mL at 0.5 mm or thicker, or 0.1 to 0.2 g/mL where surface area is indeterminate.
Where it runs
This method is internationally sourced (OUS). The laboratory is ISO/IEC 17025 accredited and GLP certified, and the report is issued under Groenakker’s ISO 13485:2016 certified quality system, in Groenakker’s report template or in your document template on request at no extra cost.
Usually ordered alongside
Complete hemolysis (GRK-4006-03), complement activation and PTT where the device category calls for them, the blood loop assay where the device meets blood in motion, and cytotoxicity as the baseline screen.
