ISO/TR 16379:2014 PDF

Name: ISO/TR 16379:2014 — Tissue-engineered medical products — Evaluation of anisotropic structure of articular cartilage using DT (Diffusion Tensor)-MR Imaging
SKU: ISO/TR 16379:2014
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Tissue-engineered medical products — Evaluation of anisotropic structure of articular cartilage using DT (Diffusion Tensor)-MR Imaging

Название (английский):

ISO/TR 16379:2014

Tissue-engineered medical products — Evaluation of anisotropic structure of articular cartilage using DT (Diffusion Tensor)-MR Imaging

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 23
Дата публикации:: 26 февраля 2014 г.
Издание:: ISO TR 16379 edition 1 version 1
ICS:: 11.040.40

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Описание (английский):

ISO/TR 16379:2014 has been prepared for evaluation of therapeutic courses for articular cartilage disease and summarizes results from structural evaluation of knee joint cartilage by diffusion tensor imaging, an MRI applied technology allowing non-invasive observation of soft tissue morphology in vivo. ISO/TR 16379:2014 is intended for use in areas such as regenerative medicine for knee joint cartilage disease.

Abstract

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Overview

ISO/TR 16379:2014 - "Tissue-engineered medical products - Evaluation of anisotropic structure of articular cartilage using DT (Diffusion Tensor)-MR Imaging" - is a Technical Report that compiles methods and reference data for non‑invasive structural evaluation of knee articular cartilage using Diffusion Tensor Magnetic Resonance Imaging (DT‑MRI / DT‑MR Imaging). It is intended to support longitudinal assessment of regenerative therapies (tissue‑engineered medical products) for articular cartilage disease by characterizing collagen fiber orientation (anisotropy) in vivo.

Key Topics and Technical Requirements

Scope and purpose: Provides measurement procedures and reference results to evaluate therapeutic courses following cartilage transplantation, focusing on the anisotropic three‑layer collagen architecture of hyaline cartilage.

DT‑MRI principle: Uses diffusion tensors to infer water molecule motion; in fibrous tissues this motion aligns with collagen fibers, enabling assessment of fiber orientation and anisotropy.

Primary measurement indices:

Fractional Anisotropy (FA) - index of structural anisotropy (0–1). The report describes pixel‑based FA mapping and a luminance‑to‑FA conversion used in its examples.
Mean Diffusivity (MD) - average diffusion coefficient across principal tensor axes.

Imaging protocol guidance: Includes practical notes on setting parameters such as sequence (SE‑EPI), field strengths (1.5 T and 3 T examples), coils, field of view (FOV), matrix, TR/TE, slice thickness, number of averages (NA), b‑value, number of motion probing gradient (MPG) directions (minimum six), voxel size and SNR trade‑offs, and use of parallel imaging to shorten scan time.

Measurement methods: Defines recommended slice selection (sagittal plane at inferior lateral femoral condyle), pixel sampling (example: three pixels along cartilage surface × five pixels in depth), and depth normalization formula (depth % = D / T × 100).

Data quality considerations: Discusses effects of voxel size, SNR, TR, NA, b‑value and MPG direction count on reliability of anisotropy measures.

Practical Applications and Users

Clinicians & Radiologists: longitudinal, non‑invasive monitoring of cartilage regeneration after cell/tissue transplants.

MRI technologists: protocol optimization for DT‑MRI of knee cartilage (parameter trade‑offs and coil/sequence choices).

Researchers in regenerative medicine and biomechanics: quantitative assessment of collagen fiber reorganization and structural maturation of engineered cartilage.

Medical device and tissue‑engineered product developers, and regulatory bodies: standardized imaging endpoints to support clinical evaluation and comparability.

Related Standards (if applicable)

Complementary ISO and medical imaging standards on MRI safety, image acquisition, and implants for surgery may be relevant when implementing DT‑MRI protocols and integrating imaging endpoints into clinical studies.

Keywords: ISO/TR 16379:2014, DT‑MRI, Diffusion Tensor MR Imaging, articular cartilage, anisotropy, fractional anisotropy, mean diffusivity, regenerative medicine, tissue‑engineered medical products, knee cartilage, MRI parameters.

ISO/TR 16379:2014 PDF

Abstract

Похожие стандарты

Overview

Key Topics and Technical Requirements

Practical Applications and Users

Related Standards (if applicable)

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