Biomaterials play an increasing role in modern health care systems. Biocompatibility poses a significant challenge for manufacturers of medical devices and contemporary intelligent drug delivery technologies from materials development to market approval. Despite a highly regulated environment, biocompatibility evaluation of biomaterials for medical devices is a complex task related to various factors that include mainly chemical nature and physical properties of the material, the contact tissue and duration of contact. Although international standards, such as ISO 10993-1, are generally employed to prove regulatory compliance needed for market clearance or for initiating clinical investigations, they may not offer sufficient guidance, or risk-management perspective when it comes to choosing materials or appropriate in vitro biocompatibility screening methods when developing medical devices. The global normative approach towards the biocompatibility evaluation of medical devices is presented in this review, with a focus on in vitro studies. Indeed, a risk-management approach towards the judicial choice of in vitro tests throughout the development and production of medical devices and drug delivery systems will facilitate rapid regulatory approval, avoid unnecessary animal studies, and ultimately reduce risks for patients. A detailed overview towards the construction of a comprehensive biological evaluation plan is described herein, with a focus on polymer-based materials used in medical applications. Polymeric materials offer a broad spectrum of applications in the manufacturing of medical devices. They are extensively employed within both conventional and innovative drug delivery systems with superior attributes supporting robust, extended use capacity, capable of meeting specific requirement such as adhesion, drug release, and more. Various methods of biocompatibility assessment are detailed within, with an emphasis on scientific analysis. This review may be of interest to those involved in the design, manufacturing and in vitro testing of medical devices and innovative drug delivery technologies, specifically with respect to a risk-management approach towards the biocompatibility assessment of polymer-based devices.

中文翻译：

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聚合物基生物材料和医疗设备的生物相容性–法规，体外筛选和风险管理

生物材料在现代卫生保健系统中起着越来越重要的作用。从材料开发到市场认可，生物相容性对医疗器械和现代智能药物输送技术的制造商构成了重大挑战。尽管环境受到严格监管，但医疗器械生物材料的生物相容性评估仍是一项复杂的任务，涉及多种因素，这些因素主要包括材料的化学性质和物理性质，接触组织和接触持续时间。尽管通常使用国际标准（例如ISO 10993-1）来证明市场准入或启动临床研究所需的合规性，但是在选择材料或合适的方法时，它们可能无法提供足够的指导或风险管理的观点。开发医疗器械时的体外生物相容性筛选方法。本综述介绍了医疗器械生物相容性评估的全球规范方法，重点是体外研究。确实，针对体外司法选择的风险管理方法在医疗设备和药物输送系统的开发和生产过程中进行的测试将促进快速的监管批准，避免进行不必要的动物研究，并最终降低患者的风险。本文描述了对构建全面生物学评估计划的详细概述，重点是医疗应用中使用的基于聚合物的材料。聚合材料在医疗设备的制造中提供了广泛的应用。它们在常规和创新药物输送系统中被广泛采用，其优越的属性支持强大的扩展使用能力，能够满足特定的要求，例如粘附力，药物释放等。其中详细介绍了各种生物相容性评估方法，重点是科学分析。医疗器械和创新药物输送技术的体外测试，尤其是针对基于聚合物的器械的生物相容性评估的风险管理方法。