医用数字体模研究进展及在医疗器械监管科学中的应用  

Research Development of Medical Computational Phantom and Its Implementation in Medical Device Regulatory Science

作　　者：王晓玲 杨义强 WANG Xiao-ling;YANG Yi-qiang(Shanghai Medical Device and Cosmetics Evaluation and Verification Center,Shanghai 200020)

机构地区：[1]上海市医疗器械化妆品审评核查中心,上海200020

出　　处：《中国医疗器械信息》2024年第9期61-64,共4页China Medical Device Information

摘　　要：医用数字体模是指由计算机建模形成的用于模拟人体组织器官的数字化模型。医用数字体模已由最初的圆柱体和球体等简单模型,逐渐发展成为分辨率高、多样性强、结构精度高、设计灵活性好的复杂体模,在医疗器械监管科学中的应用日益广泛。文章回顾了医用数字体模的发展历程,讨论了其实现方法与验证方式,以及其在医疗器械监管科学中的应用现状,并对医用数字体模未来的发展趋势进行了展望。Medical computational phantom refers to computational models designed by computer modeling to simulate human organs or tissues.From the initial simple models such as cylinders and spheres,medical computational phantom has gradually developed into complex models with high resolution,multiple diversity,accurate structure and flexible design,and is increasingly used in medical device regulatory science.This paper reviews the development history of medical computational phantom,discusses its modeling and verification methods,its application status in medical device regulatory science,and looks forward into its future development trend.

关 键 词：医用数字体模 计算机建模与仿真 医疗器械 监管科学 

分 类 号：R319[医药卫生—基础医学]