Hemocompatibility testing by ISO 10993-4

Hemocompatibility testing is performed to evaluate the interaction between a medical device or material and blood. The goal is to ensure that the device does not cause adverse effects, such as clot formation, red blood cell damage (hemolysis), platelet activation, or immune responses. Regulatory bodies in the EU and the US (under MDR and FDA rules, respectively) require a hemocompatibility evaluation for all medical devices that come into direct or indirect contact with blood. 

Measurlabs offers several hemocompatibility tests using methods outlined in the ISO 10993-4 standard:

• Hemolysis testing with direct and indirect methods to evaluate the device’s potential to cause damage to red blood cells, leading to hemolysis and the release of hemoglobin. Hemolysis testing is mandatory for all blood-contacting devices, regardless of whether contact is direct or indirect.

• Complement activation testing to measure the material’s tendency to activate the complement system, which is a key part of the immune response.

• Thrombogenicity testing to assess the material’s potential to promote thrombus (clot) formation. Available methods include the platelet and leukocyte count and the partial thromboplastin time (PTT) tests.

• Coagulation tests to determine whether the device or material interferes with the blood clotting process.

• Platelet activation testing to evaluate the materials’ propensity to induce platelet activation, which is an early step in clot formation.

• Hematology tests to assess the device’s impact on the number and proportion of blood components, including red and white blood cells, platelets, and leukocytes.

The example price includes hemolysis testing using either the direct or indirect (extract-based) method, performed under GLP (Good Laboratory Practice) principles.

The extent of required testing depends on the device's classification, type of blood contact (direct or indirect), target market, and overall risk assessment. Please contact us for a detailed quotation tailored to your device or material.