This contains some classifications and examples, such as a non-contact device would be in vitro diagnostic devices. These don’t generally require testing.
An externally communicating device with indirect exposure is explained as a conduit into the vascular system such as cannulas, extension sets and blood storage apparatus.
An externally communicating device with contact with circulating blood is described as cardiopulmonary bypass, extracorporeal membrane oxygenators, and hemodialysis equipment amongst others.
Implants are defined as items placed in the vascular system and examples are heart valves, stents, pacemaker electrodes and vascular grafts.
Tests:
Positive and negative controls should be used. Testing of materials should be done for screening purposes but does not replace testing the finished product. Human blood instead of animal should be used when possible.
Use of non-human primate blood is prohibited in Europe. The canine tends to be more reactive than humans for platelet adhesion, thrombosis and hemolysis.
Platelets are assessed by evaluating platelet count and aggregation using an aggregometer.
Coagulation is assessed using clinical test methods such as PTT (partial thromboplastin time)
https://www.nlm.nih.gov/medlineplus/ency/article/003653.htm , PT (prothrombin time) https://www.nlm.nih.gov/medlineplus/ency/article/003652.htm , TT (thrombin time)
Hematology is assessed by evaluating a white blood cell count and differential and hemolysis.
Immunology is assessed by evaluating multiple complement activation pathways.
Thrombosis is assessed by evaluating adhered platelets, leukocytes, percent occlusion, flow reduction, thrombus weight. This is of a test article that has been implanted into an animal.
An externally communicating device with indirect exposure is explained as a conduit into the vascular system such as cannulas, extension sets and blood storage apparatus.
An externally communicating device with contact with circulating blood is described as cardiopulmonary bypass, extracorporeal membrane oxygenators, and hemodialysis equipment amongst others.
Implants are defined as items placed in the vascular system and examples are heart valves, stents, pacemaker electrodes and vascular grafts.
Tests:
Positive and negative controls should be used. Testing of materials should be done for screening purposes but does not replace testing the finished product. Human blood instead of animal should be used when possible.
Use of non-human primate blood is prohibited in Europe. The canine tends to be more reactive than humans for platelet adhesion, thrombosis and hemolysis.
Platelets are assessed by evaluating platelet count and aggregation using an aggregometer.
Coagulation is assessed using clinical test methods such as PTT (partial thromboplastin time)
https://www.nlm.nih.gov/medlineplus/ency/article/003653.htm , PT (prothrombin time) https://www.nlm.nih.gov/medlineplus/ency/article/003652.htm , TT (thrombin time)
Hematology is assessed by evaluating a white blood cell count and differential and hemolysis.
Immunology is assessed by evaluating multiple complement activation pathways.
Thrombosis is assessed by evaluating adhered platelets, leukocytes, percent occlusion, flow reduction, thrombus weight. This is of a test article that has been implanted into an animal.
