ISO/TS 24560-1:2022 PDF

ISO/TS 24560-1:2022 PDF

Name:
ISO/TS 24560-1:2022 PDF

Published Date:
07/01/2022

Status:
Active

Description:

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

Publisher:
International Organization for Standardization (Technical Standard)

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Russian version):
200 business days

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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.


File Size : 1 file , 3 MB
Note : This product is unavailable in Russia, Ukraine, Belarus
Number of Pages : 38
Published : 07/01/2022

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