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YY/T 1636-2018: Tissue engineering medical device products - In vivo evaluation of knee cartilage implanted tissue using MRI technique
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1636-2018 | English | 359 |
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Tissue engineering medical device products - In vivo evaluation of knee cartilage implanted tissue using MRI technique
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YY/T 1636-2018
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Basic data | Standard ID | YY/T 1636-2018 (YY/T1636-2018) | | Description (Translated English) | Tissue engineering medical device products - In vivo evaluation of knee cartilage implanted tissue using MRI technique | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 18,134 | | Date of Issue | 2018-12-20 | | Date of Implementation | 2020-01-01 | | Regulation (derived from) | State Drug Administration Announcement No. 97 of 2018 | | Issuing agency(ies) | State Drug Administration | YY/T 1636-2018: Tissue engineering medical device products - In vivo evaluation of knee cartilage implanted tissue using MRI technique
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(Tissue engineering medical device product In vivo magnetic resonance evaluation method for regenerated knee articular cartilage)
ICS 11.040.40
C45
People's Republic of China Pharmaceutical Industry Standard
Tissue engineering medical device products
In vivo magnetic resonance evaluation method for regenerated knee articular cartilage
Published on.2018-12-20
2020-01-01 implementation
State Drug Administration issued
Content
Foreword I
Introduction II
1 Scope 1
2 Terms and Definitions 1
3 Abbreviations 2
4 Principle 2
5 human body T2mapping imaging method 3
6 dGEMRIC imaging method 4
Appendix A (informative) T2mapping and dGEMRIC longitudinal observation of human knee joint cartilage case study 7
Appendix B (informative) Animal experiment T2mapping and dGEMRIC imaging method recommendations 11
Reference 12
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is organized by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices.
(SAC/TC110/SC3) is under the jurisdiction.
This standard was drafted. General Hospital of the People's Liberation Army, China Food and Drug Administration Institute, Joint Power Anda (Tianjin) Biological Section
Technology Co., Ltd.
The main drafters of this standard. Xu Xian, Guo Quanyi, An Ningyu, Xu Liming, Shao Anliang, Sun Xuelian.
Introduction
The latest cartilage transplantation technology - matrix-induced autologous chondrocyte transplantation technology (matrix-associatedautologouschon-
Drocyteimplantation/transplantation, MACI/MACT) can achieve the effect of close to normal hyaline cartilage repair, clinical
The application prospect is broad. However, there is no uniform and effective evaluation method for its long-term efficacy. The main evaluation methods have been clinical symptom scores,
Arthroscopy, conventional magnetic resonance (MRI) examination, etc. Clinical symptom scores are simple, convenient, and operability, but subjective to patients
Effects of arthroscopy; arthroscopy has always been considered the gold standard for the diagnosis of articular cartilage lesions, but its examination is invasive and can only look directly at the cartilage surface
Changes have also greatly limited their widespread use. Magnetic resonance imaging (MRI) is currently the most evaluated articular cartilage
Sensitive non-invasive methods have been widely recognized and accepted in the imaging of articular cartilage, especially in the transverse relaxation time map.
(T2mapping), magnetic resonance cartilage delay enhanced imaging (dGEMRIC) is the most widely used and mature clinically, mainly from a biological perspective.
Assess the repair process of cartilage. T2mapping mainly reflects changes in collagen content, conformation and water content in cartilage; dGEMRIC
The glycosaminoglycan (GAG) content in cartilage tissue is indirectly reflected by imaging of cartilage negative charge density. As a review
An important method for estimating the regeneration of articular cartilage, imaging and measurement methods for magnetic resonance T2mapping and dGEMRIC techniques are necessary
Normalization.
This standard outlines the specific operation of magnetic resonance scanners for magnetic resonance T2mapping and dGEMRIC techniques for human knee cartilage.
Method of making, measuring and evaluating.
In addition to providing magnetic resonance assessment methods for human knee cartilage, this guide also outlines magnetic resonance T2 of animal knee cartilage.
Mapping and dGEMRIC scanning methods.
The magnetic resonance T2mapping and dGEMRIC techniques in this standard are equally applicable to other articular cartilage, such as ankle joints and hip joints.
Wait, but the scan parameters need to be modified accordingly.
It is recommended to use high-field magnetic resonance scanner (1.5T or above) and specialization when using this standard for magnetic resonance assessment of regenerative articular cartilage.
Industrial joint coil.
Tissue engineering medical device products
In vivo magnetic resonance evaluation method for regenerated knee articular cartilage
1 Scope
This standard gives magnetic resonance cartilage delay-enhanced imaging for the evaluation of regenerated knee cartilage (delayedgadoliniumenhanced)
MRIofcartilage, dGEMRIC) technical methods and transverse relaxation time imaging (T2mapping) techniques can indirectly reflect soft
The content of glycosaminoglycan (GAG) and the content of water in the cartilage and the arrangement of collagen fibers.
This standard applies to the in vivo non-invasive assessment of regenerated knee cartilage.
2 Terms and definitions
The following terms and definitions apply to this document.
2.1
Sequence sequence
A combination of magnetic resonance scanning radio frequency pulses.
2.2
Number of repetitions numberofaverages
The number of times a single magnetic resonance signal was acquired.
2.3
Voxel voxel
The smallest three-dimensional unit that makes up the image.
2.4
Pixel pixel
The smallest two-dimensional unit that makes up the image.
2.5
Resolution resolution
Maximum ability to distinguish tissue contrast.
2.6
Matrix matrix
Magnetic resonance imaging scans the pixel resolution in the field of view.
2.7
Longitudinal relaxation time
T1
After the 90° pulse, the original longitudinal magnetization vector is 63% of the time.
2.8
Lateral relaxation time
T2
After the 90° pulse, the original transverse magnetization vector decays to 37% of the time.
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