Denes Eric, Barrière Guislaine, Poli Evelyne, Lévêque Guillaume
I. Ceram, 87068 Limoges, France.
J Long Term Eff Med Implants. 2018;28(1):9-13. doi: 10.1615/JLongTermEffMedImplants.2018025635.
Alumina (Al2O3) ceramic is widely used for medical devices and its biocompatibility is well known and is reported in articles and textbooks. However, finding proof of this assertion gathered over more than 40 years can be challenging. We performed a literature review about alumina biocompatibility to compile data from the literature. We searched for articles on the biocompatibility of alumina in relation to the ISO 10993-1 International Standard, which defines the biocompatibility of biomaterials. For every biological effect listed in the norm, such as cytotoxicity, sensitization, implantation, and genotoxicity, in vitro and in vivo tests in animals and humans did not reveal any abnormal biological response. Proof for the the well-known biocompatibility of alumina is summarized in this review.
氧化铝(Al2O3)陶瓷广泛应用于医疗设备,其生物相容性是众所周知的,并且在文章和教科书中都有报道。然而,要找到40多年来这一论断的证据可能具有挑战性。我们对氧化铝生物相容性进行了文献综述,以汇总文献中的数据。我们搜索了与ISO 10993-1国际标准相关的氧化铝生物相容性文章,该标准定义了生物材料的生物相容性。对于该标准中列出的每种生物学效应,如细胞毒性、致敏性、植入和遗传毒性,在动物和人类中进行的体外和体内试验均未发现任何异常生物学反应。本综述总结了氧化铝众所周知的生物相容性的证据。