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

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.

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

General Information

• Status: Published
• Publication Date: 13-Jul-2022
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 7 - Tissue-engineered medical products
• Drafting Committee: ISO/TC 150/SC 7 - Tissue-engineered medical products
• Current Stage: 6060 - International Standard published
• Start Date: 14-Jul-2022
• Due Date: 28-Oct-2023
• Completion Date: 14-Jul-2022

Standards Content (Sample)

TECHNICAL ISO/TS
SPECIFICATION 24560-1
First edition
2022-07
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
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
Reference number
ISO/TS 24560-1:2022(E)
© ISO 2022

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ISO/TS 24560-1:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
  © ISO 2022 – All rights reserved

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ISO/TS 24560-1:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principles . 3
5 T2 mapping evaluation in human knee articular cartilage . 4
5.1 Characterization parameters and methods . 4
5.2 T2 value measurement process . 6
5.2.1 Post-processing of imaging . 6
5.2.2 Measurement method . 6
5.2.3 ROIs of regenerative cartilage . 7
5.2.4 ROIs of normal control cartilage . 8
5.3 T2 value evaluation . 8
5.3.1 Purpose of evaluation . 8
5.3.2 In vivo evaluation of regenerative cartilage with T2 value . 8
6 dGEMRIC evaluation in human knee articular cartilage . 9
6.1 Characterization parameters and methods . 9
6.2 T1 value measurement process . 11
6.2.1 Post-processing o
...

TECHNICAL ISO/TS
SPECIFICATION 24560-1
First edition
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
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
PROOF/ÉPREUVE
Reference number
ISO/TS 24560-1:2022(E)
© ISO 2022

---------------------- Page: 1 ----------------------
ISO/TS 24560-1:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
PROOF/ÉPREUVE © ISO 2022 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/TS 24560-1:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principles . 3
5 T2 mapping evaluation in human knee articular cartilage . 4
5.1 Characterization parameters and methods . 4
5.2 T2 value measurement process . 6
5.2.1 Post-processing of imaging . 6
5.2.2 Measurement method . 6
5.2.3 ROIs of regenerative cartilage . 7
5.2.4 ROIs of normal control cartilage . 8
5.3 T2 value evaluation . 8
5.3.1 Purpose of evaluation . 8
5.3.2 In vivo evaluation of regenerative cartilage with T2 value . 8
6 dGEMRIC evaluation in human knee articular cartilage . 9
6.1 Characterization parameters and methods . 9
6.2 T1 value measurement process . 11
6.2.1
...

© ISO 2022 – All rights reserved
ISO/TS 24560-1 (E)
ISO TC 150/SC 7
Date: 2022-06-07
Secretariat: JISC

Tissue Engineered Medical Products –-engineered medical products — MRI
Evaluationevaluation of Cartilage–cartilage — Part 1: Clinical
Evaluationevaluation of Regenerative Knee Articular Cartilage Using
Delayed Gadolinium-Enhancedregenerative knee articular cartilage using delayed
gadolimium-enhanced MRI of the Cartilagecartilage (dGEMRIC) and T2
Mappingmapping

TS stage

Warning for WDs and CDs
This document is not an ISO International Standard. It is distributed for review and comment. It is subject to
change without notice and may not be referred to as an International Standard.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.
To help you, this guide on writing standards was produced by the ISO/TMB and is available at
https://www.iso.org/iso/how-to-write-standards.pdf
A model manuscript of a draft International Standard (known as “The Rice Model”) is available at
https://www.iso.org/iso/model_document-rice_model.pdf

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© ISO 2021

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ISO/TS 24560-1:2022(E)
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no
part of this publication may be reproduced or utilized otherwise in any form or by any means,
electronic or mechanical, including photocopying, or posting on the internet or an intranet, without
prior written permission. Permission can be requested from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.orgwww.iso.org
Published in Switzerland
4 © ISO 2022 – All rights reserved
iv © ISO 2022 – All rights reserved

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ISO/TS 24560-1:2022(E)
Contents
Foreword . i7
Introduction . 8
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principles . 4
5 T2 mapping evaluation in human knee articular cartilage . 6
5.1 Characterization parameters and methods . 6
5.2 T2 value measurement process . 7
5.3 T2 value evaluation . 10
6 dGEMRIC evaluation in human knee articular cartilage . 12
6.1 Characterization parameters and methods . 12
6.2 T1 value measurement process . 14
6.3 ΔR1 value calculation . 15
6.4 ΔR1 value evaluation . 16
7 Acceptable standard for MR evaluation . 19
7.1 Requirements for MR equipment . 19
7.2 Requirements for MR parameters . 19
7.3 Requirements for the MR longitudinally evaluation . 19
7.4 Ex
...