When this test applies
Required wherever the device contacts circulating blood, under ISO 10993-1:2025. The specific battery depends on device category — an externally communicating device with a short blood path is assessed differently from a long-term implant — and ISO 10993-4 sets out which parameters apply to which.
When to run it
After cytotoxicity, and once the material set is settled. Hemocompatibility is sensitive to surface finish and processing residues, so running it on a material you still intend to change tends to buy a result you have to repeat.
What a pass tells you
That under direct contact with whole blood, the measured parameters showed no significant difference from the concurrent negative control. It is evidence about this surface, in this configuration, over this contact duration.
What it does not tell you
Direct contact is one hemocompatibility parameter, not the whole endpoint. Hemolysis, complement activation, platelet and leukocyte effects and coagulation time are separate tests, and ISO 10993-4 may call for several of them together. A pass here says nothing about the others.
Method
Testing per ISO 10993-4:2017. The device or a representative sample is placed in direct contact with whole blood. Where a sample rather than the whole device is used, the ISO 10993-12 ratios apply: 6 cm2/mL for material under 0.5 mm thick, 3 cm2/mL at 0.5 mm or thicker, or 0.1–0.2 g/mL where surface area is indeterminate. Blood-contact parameters are compared against a concurrent negative control.
Where it runs
This method is internationally sourced. 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 your document format.
Usually ordered alongside
The other hemocompatibility parameters your device category calls for, plus cytotoxicity as the baseline screen. A biological evaluation plan is the cheapest way to establish which of the six are actually required for your device rather than commissioning all of them.
