[Biological evaluation of new percutaneous implanting materials].
According to ISO 10993 standard series, the biological safety of surface modified pure titanium was studied as a percutaneous device by the test of cytotoxicity in vitro, as well as by the tests of irritation and sensitization. The result from the examination of cytotoxicity in vitro was negative, the skin irritation response was negligible, and the result of test on skin sensitization in guinea pigs was also negligible. So the surface modified pure titanium in this study can be safely used as percutaneous implanting materials.
Tang
Min
M
Engineering Research Center in Biomaterials, Sichuan University, Chengdu 610064, China. mingtangtang@yahoo.com.cn
Yang
Xiudong
X
Wu
Yao
Y
Cao
Yang
Y
Luo
Jiaoming
J
Zhou
Yu
Y
D000818:Animals; D001672:Biocompatible Materials / Q000737:chemistry; D020099:Coated Materials, Biocompatible / Q000737:chemistry*; D005260:Female; D006168:Guinea Pigs; D020007:Implants, Experimental / Q000009:adverse effects; D008422:Materials Testing; D011817:Rabbits; D011897:Random Allocation; D023422:Skin Irritancy Tests / Q000379:methods*; D013499:Surface Properties; D014025:Titanium / Q000737:chemistry*
D001672:Biocompatible Materials; D020099:Coated Materials, Biocompatible; D014025:Titanium