Contains definitions of blood tests and interactions and a fairly long list of examples for each category of non-contact, indirect and direct contact externally communicating devices and implant devices.
Controls should be used and if a predicate is available should be used.
A decision tree is presented on when to conduct blood compatibility evaluations.
2 tables are listed for implant devices and direct contacting externally communicating devices by type of device and then categories to be addressed. All products must evaluate hemolysis. Most implants in the vascular also have to evaluate thrombosis. Most externally communicating devices must evaluate coagulation and platelets as well.
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.
ISO 10993-4 2006 amendment
Contains a list of updated definitions and updated tables that are easier to read specifying what tests are required for specific kinds of products.
Controls should be used and if a predicate is available should be used.
A decision tree is presented on when to conduct blood compatibility evaluations.
2 tables are listed for implant devices and direct contacting externally communicating devices by type of device and then categories to be addressed. All products must evaluate hemolysis. Most implants in the vascular also have to evaluate thrombosis. Most externally communicating devices must evaluate coagulation and platelets as well.
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.
ISO 10993-4 2006 amendment
Contains a list of updated definitions and updated tables that are easier to read specifying what tests are required for specific kinds of products.
