Reference number
ISO/TS 24560-1:2022
Technical Specification
ISO/TS 24560-1:2022
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 T2 mapping
Edition 1
2022-07
Technical Specification
Preview
ISO/TS 24560-1:2022
81622
No disponible en español
Publicado (Edición 1, 2022)

ISO/TS 24560-1:2022

ISO/TS 24560-1:2022
81622
Idioma
Formato
CHF 151
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Resumen

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.

Informaciones generales

  •  : Publicado
     : 2022-07
    : Norma Internacional publicada [60.60]
  •  : 1
     : 31
  • ISO/TC 150/SC 7
    11.040.40 
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