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. Complement activation is called for in the immunology category — typically for external communicating devices with circulating-blood contact and for implants in contact with blood, such as extracorporeal circuits, catheters, grafts and stents.
When to run it
After cytotoxicity, on finished, sterilised samples with the material, surface finish and process locked, and in the same campaign as the other hemocompatibility tests your device category calls for.
What a pass tells you
That SC5b-9 generation in serum exposed to the device was not significantly greater than the concurrent negative control, with the positive control responding as expected. ISO 10993-4 sets no fixed numeric threshold; the comparison with the controls is the result.
What it does not tell you
Complement is one category of blood interaction. A clear result says nothing about hemolysis, thrombosis, coagulation or platelet effects, each of which has its own test, 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 human serum alongside negative and positive controls. SC5b-9 is quantified by enzyme-linked immunosorbent assay (ELISA) and compared with the control values. 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), platelet and leukocyte counts 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.
