ANSI/AAMI/ISO 10993-4-2002 pdf download.Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood.
embolization process whereby a blood clot, or foreign object, is carried in the bloodstream and which may become lodged and cause obstruction downstream
3.5 ex vivo test system
term applied to a test system that shunts blood drecty from a human subject or test animal into a test chamber located outside the body
NOTE If using an animal model, the blood may be shunted directly back into the animal (ecirculating) or collected in test tubes for evaluation (single pasg). in either case, the test chamber is located outside the body.
3.6 hematology
study of blood that includes quantfcaion of ellular and plasma components of the blood
3.7 platelets
anuclear, cllular body that is present in the clroulaton and which adheres to surfaces and aggrogates to form a haemostatic plug to minimize bleeding
NOTE Platelet teting inchudes quantfiation of platelet numbers as well as analysis of their structure and function. The testing can include analysis of platelet factors, or components on the platelet surface, which are released from platelets or are adherent to the device surtace.
3.8 thrombosis
in-vivo or 0X-VIvo phenomenon ocurling in flowing whole blood involving activation of the cogulation system and platelets, which results in thrombus formation
3.9 thrombus
coagulated mixture of red cells, aggregated platelets, fibrin and other cellular elements
3.10 thromboembolization
dislodged thrombus which flows downstream and may cause subsequent vascular blockage or occlusion Page 5, subclause 6.1.7
Delete the whole clause and renumber 6.1.8106.1.14 as 6.1.7 to 6.1.13.
New subclause 6.1.7
Replace the whole clause with the fllowin:
The recommendations in 6.1.5 and 6.1.6 together with Clause 5, Figure 1, and Table 2 serve as a guide ftor the solecion of lests listed in 6.2.1. Guidance on pre dinical evaluations is given in Annex A The
fllowing procedure shall be performed:
a) detemine which of the 5 potential blood interaction categories are appropriate to the device;
b) evaluate existing infomation on reactions within these categories;
c) select appropriate tests from Table 3 or 4."ANSI/AAMI/ISO 10993-4 pdf download.