Understanding the interaction between biological structures and nanoscale technologies, dubbed the nano-bio interface, is required for successful development of safe and efficient nanomedicine products. The lack of a universal reporting system and decentralized methodologies for nanomaterial characterization have resulted in a low degree of reliability and reproducibility in the nanomedicine literature. As such, there is a strong need to establish a characterization system to support the reproducibility of nanoscience data particularly for studies seeking clinical translation. Here, we discuss the existing key standards for addressing robust characterization of nanomaterials based on their intended use in medical devices or as pharmaceuticals. We also discuss the challenges surrounding implementation of such standard protocols and their implication for translation of nanotechnology into clinical practice. We, however, emphasize that practical implementation of standard protocols in experimental laboratories requires long-term planning through integration of stakeholders including institutions and funding agencies.

了解生物结构和纳米级技术之间的相互作用，称为纳米生物界面，是成功开发安全高效的纳米医学产品所必需的。纳米材料表征缺乏通用报告系统和分散方法导致纳米医学文献的可靠性和可重复性较低。因此，非常需要建立一个表征系统来支持纳米科学数据的可重复性，特别是对于寻求临床转化的研究。在这里，我们讨论了现有的关键标准，用于根据纳米材料在医疗设备或药物中的预期用途来解决纳米材料的稳健表征。我们还讨论了围绕实施此类标准协议的挑战及其对将纳米技术转化为临床实践的意义。然而，我们强调，在实验实验室中实际实施标准协议需要通过整合包括机构和资助机构在内的利益相关者进行长期规划。