标准编号:ISO/TS 24560-1:2022

中文名称:组织工程医疗产品.软骨的MRI评估 第1部分:使用软骨延迟钆增强MRI(dGEMRIC)和T2成像对再生膝关节软骨的临床评估

英文名称:Tissue-engineered medical products — MRI evaluation of cartilage — Part 1: Clinical evaluation of regenerative knee articular cartilage using delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) and

发布日期:2022-07

标准范围

This document provides a principle to determine the parameter settings and operating methods for the evaluation of the composition and structure of articular cartilage by dGEMRIC and T2-mapping MRI in humans with a typical example of the methods; each are distinct MRI technologies that allow for noninvasive observation of soft tissue characteristics.
The methods provided in this document are intended for application in the evaluation of the clinica effects of tissue-engineered cartilage or other cartilage regeneration products used in the knee joint and are also applicable for the evaluation of regenerative cartilage in other joints, although some modification of parameters is needed.

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