ISO 13019:2018

Tissue-engineered medical products — Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis

This document specifies test methods for the quantification of sulfated glycosaminoglycans (sGAG), one of the major extracellular matrix components in articular, meniscal, and elastic cartilages, and tissue-engineered cartilage constructs.

Produits médicaux issus de l'ingénierie tissulaire — Quantification des glycosaminoglycanes sulfatés (sGAG) pour l’évaluation de la chondrogenèse

General Information

• Status: Published
• Publication Date: 04-Jun-2018
• 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/WG 3 - Tissue-engineered medical products for skeletal tissues
• Current Stage: 9093 - International Standard confirmed
• Completion Date: 27-Nov-2023

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 13019
First edition
2018-06
Tissue-engineered medical
products — Quantification of sulfated
glycosaminoglycans (sGAG) for
evaluation of chondrogenesis
Produits médicaux issus de l'ingénierie tissulaire — Quantification
des glycosaminoglycanes sulfatés (sGAG) pour l’évaluation de la
chondrogenèse
Reference number
ISO 13019:2018(E)
©
ISO 2018

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ISO 13019:2018(E)

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ii © ISO 2018 – All rights reserved

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ISO 13019:2018(E)

Contents Page
Foreword .iv
1 Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
4 General and principle . 2
5 Apparatus . 2
6  Preparation of parallel test samples from test samples. 3
6.1 General . 3
6.2 Preparation of parallel test samples . 3
7 Procedure. 3
7.1 General . 3
7.2 Procedure for pre-treatment of parallel test samples . 3
7.2.1 Procedure for dissection . 3
7.3 Procedure for extraction of sGAG from pre-treated parallel test samples . 4
7.3.1 General. 4
7.3.2 Procedure for papain digestion . 4
7.4 Procedure for measurement of sGAG content of parallel test samples by DMMB assay . 4
7.4.1 Principle . 4
7.4.2 Procedure for preparation of 1,9-dimethylmethylene blue (DMMB) solution . 4
7.4.3 Procedure for DMMB assay . 5
7.5 Normalization of sGAG contents .
...