Study on the biological hazards and safety of pressure sensitive adhesive for medical devices
Objective To evaluate the biocompatibility of different types of pressure sensitive adhesive for medical devices,which provides theoretical support for scientific supervision of the pressure-sensitive adhesive.Methods Based on a series of GB/T 16886 medical equipment biology evaluation standards,Pressure sensitive adhesive for medical devices were subjected to a series of tests,including MTT cytotoxicity test in vitro,neutral red uptake test,and hemocompatibility test and Partial thromboplastin time.Results The cell survival rates of the YP3 and YP4 were less than 70%at 40μm thicknesses,The neutral red phagocytosis rates of theYP1,YP3 and YP4 were reduced to<50%of the blank.at thicknesses of 20μm and 40μm.The hemolysis rates of theYP1,YP3 and YP4 were more than 5%at thicknesses of 10μm,20μm and 40μm.The partial thromboplastin time of YP3 and YP4 compared with blank control were less than 80%at thicknesses of 20μm and 40μm.Conclusion Under the current test conditions,the acrylic emulsion pressure sensitive adhesive showed a potential biocompatibility with potential cytotoxicity,inhibition of cellular phagocytic functionhemolytic effect and blood coagulation effect,especially for YP3 and YP4 at some thicknesses.