Evaluation of Biocompatibility Using In Vitro Methods: Interpretation and Limitations

被引:53
作者
Bruinink, Arie [1 ]
Luginbuehl, Reto [2 ]
机构
[1] Empa Mat Sci & Technol, Lab Mat Biol Interact, CH-9014 St, Gallen, Switzerland
[2] RMS Fdn, CH-2544 Bettlach, Switzerland
来源
TISSUE ENGINEERING III: CELL-SURFACE INTERACTIONS FOR TISSUE CULTURE | 2012年 / 126卷
关键词
Biocompatibility; Limitations; Culture; In vivo; In vitro; Test battery; ISO10993; ASTM F748; Testing strategy; Cytotoxicity; Bioactivity; EMBRYONIC CHICK BRAIN; PROTEIN ADSORPTION; EXTRACELLULAR-MATRIX; CELL-ADHESION; STEM-CELLS; OSTEOBLASTIC DIFFERENTIATION; OXIDE NANOPARTICLES; OXIDATIVE STRESS; PRIMARY CULTURES; COLLAGEN MATRIX;
D O I
10.1007/10_2011_111
中图分类号
Q813 [细胞工程];
学科分类号
100113 [医学细胞生物学];
摘要
The in vitro biocompatibility of novel materials has to be proven before a material can be used as component of a medical device. This must be done in cell culture tests according to internationally recognized standard protocols. Subsequently, preclinical and clinical tests must be performed to verify the safety of the new material and device. The present chapter focuses on the first step, the in vitro testing according to ISO 10993-5, and critically discusses its limited significance. Alternative strategies and a brief overview of activities to improve the current in vitro tests are presented in the concluding section.
引用
收藏
页码:117 / 152
页数:36
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