For biocompatibility tests requiring hemocompatibility, we offer multiple test types dependent on your product type and data needs, including Hemolysis, PTT, Complement Activation and In Vivo Thrombogenicity. These tests comply with the ISO 10993 biocompatibility guidelines.
Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA “Use of international standard ISO 10993-1”]
- ISO 10993-4
- ASTM F756
- ASTM F756
The Hemolysis test is designed to determine the hemolytic properties of a medical device/material. This test is performed on medical devices/materials that have direct or indirect blood contact and fulfills hematological testing requirements for selection of tests for interactions with blood. Nelson Labs tests with fresh human blood rather than rabbit blood.
The Partial Thromboplastin Time (PTT) test is a general screening test for the detection of coagulation abnormalities in the intrinsic pathway. This test is performed on devices/materials that have direct contact with circulating blood.
The Complement Activation test is used to determine the potential for activation of the complement system by a medical device. This humoral immune response, caused by the introduction of a foreign material into the body, can lead to adverse effects such as tissue damage. This test was designed to fulfill the immunology testing requirement for selection of tests for interactions with blood. Nelson Labs includes three time points in the assay to look at possible levels of activation over time.
In Vivo Thrombogenicity Test
The In Vivo Thrombogenicity test determines a comparative thrombo-resistant for medical devices that are intended for blood contact. This test enables manufacturers to see if the medical devices cause any potentially undesirable effects on humans, such as activation of platelets, formation of a thrombus, embolism, or injury to cells.