Instituto de Pesquisas Energeticas e Nucleares - IPEN-CNEN/SP, Sao Paulo - SP, Brazil.
CONACyT - Centro de Investigacion en Quimica Aplicada, Saltillo, Mexico.
Curr Top Med Chem. 2018;18(4):256-274. doi: 10.2174/1568026618666180410151518.
Safety and biocompatibility assessment of biomaterials are themes of constant concern as advanced materials enter the market as well as products manufactured by new techniques emerge. Within this context, this review provides an up-to-date approach on current methods for the characterization and safety assessment of biomaterials and biomedical devices from a physical-chemical to a biological perspective, including a description of the alternative methods in accordance with current and established international standards.
生物材料的安全性和生物相容性评估是一个持续关注的主题,因为先进材料进入市场以及采用新技术制造的产品不断涌现。在这种背景下,本文从物理化学到生物学的角度,对生物材料和生物医学器械的特性描述和安全性评估的现有方法进行了综述,包括根据当前和既定的国际标准对替代方法的描述。