ISO/TS 24560-1:2022

Tissue-engineered medical products — MRI evaluation of cartilage — Part 1: Clinical evaluation of regenerative knee articular cartilage using delayed gadolimium-enhanced MRI of cartilage (dGEMRIC) and T2 mapping
Autor: ISO
Código ICS: 11.040.40


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 clinical 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.This document describes a longitudinal evaluation of the water content, the glycosaminoglycan (GAG) concentration, and the concentration and orientation of collagen fibres in regenerative cartilage when using dGEMRIC and T2-mapping techniques in 1,5 T or 3,0 T magnetic resonance imaging equipment.

Especificaciones de la Norma
Fecha de Publicación 14/07/2022
Título Secundario Produits médicaux issus de l'ingénierie tissulaire — Évaluation du cartilage par IRM — Partie 1: Évaluation clinique de la régénération du cartilage articulaire du genou par séquences IRM tardives après injection de gadolinium (dGEMRIC) et cartographie T2
Páginas Técnicas 31
Idioma Inglés