British Standards Institution

Source:: ISO
Committee:: CH/150 - Implants for surgery
Categories:: Information management | Vocabularies | Health care technology | Standardization. General rules | Healthcare | Medical equipment | Medical equipment. General | Surgical instruments and materials | Implants for surgery, prosthetics and orthotics

Scope

This document has been prepared for evaluation of therapeutic courses for articular cartilage disease treated by using tissue engineered cartilage or other methods, and provided parameters and methods for structural evaluation of knee articular cartilage by dGEMRIC and T2 mapping, which are special MRI applied technology allowing non-invasive observation of soft tissue characters in vivo.

This document is intended for use in areas such as regenerative medicine for evaluation of regenerative knee articular cartilage, and is also applicable to the evaluation of other regenerative cartilage, but need to make some modification of parameters.

This document recommends longitudinally evaluate the glycosaminoglycan (GAG) concentration, water contents and collagen fiber orientation of regenerative cartilage with dGEMRIC and T2 mapping technique in high field magnetic resonance equipment.

Purpose

MR-based biochemical imaging techniques, such as dGEMRIC and T2 mapping, show the capability for evaluating the composition and structure of articular regenerative cartilage. It is possible to longitudinally evaluate the GAG concentration; water contents and collagen fiber orientation of regenerative cartilage.

This document aims to provide the scanning and measurement method of T2 mapping and dGEMRIC of knee cartilage in 3,0Tesla MRI equipment.

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Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal

Proposal start date:

27/08/2020

Proposal end date:

23/09/2020

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

ISO/TC 150/SC 7 N 245, ISO/PWI TS 24560-1 Tissue engineered medical products - MRI evaluation of cartilage - Part 1: Clinical evaluation of regenerative knee articular cartilage using delayed...

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