Laboratory for Materials - Biology Interactions, Empa - Materials Science and Technology, Lerchenfeldstasse 5, CH-9014 St, Gallen, Switzerland,
Adv Biochem Eng Biotechnol. 2012;126:117-52. doi: 10.1007/10_2011_111.
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.
新型材料在用作医疗器械组件之前，必须证明其具有体外生物相容性。这必须根据国际公认的标准协议在细胞培养试验中完成。随后，必须进行临床前和临床测试，以验证新材料和设备的安全性。本章重点介绍第一步，即根据 ISO 10993-5 进行的体外测试，并批判性地讨论其有限的意义。在结论部分提出了替代策略和简要概述了改进当前体外测试的活动。
