ISO 13019:2018 PDF

Name: ISO 13019:2018 — Tissue-engineered medical products — Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis
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Tissue-engineered medical products — Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis

Название (английский):

ISO 13019:2018

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 17
Дата публикации:: 5 июня 2018 г.
Издание:: ISO IS 13019 edition 1 version 1
ICS:: 11.040.40

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Описание (английский):

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.

Abstract

Похожие стандарты

Упомянутые в описании и другие стандарты ISO

Overview

ISO 13019:2018 specifies validated test methods for the quantification of sulfated glycosaminoglycans (sGAG) in articular, meniscal and elastic cartilage and in tissue‑engineered cartilage constructs. sGAG measurement is a primary assay for assessing chondrogenesis because sGAGs (e.g., chondroitin sulfate, keratan sulfate) are major extracellular matrix components of cartilage. The standard defines sample handling, extraction, the widely used DMMB (1,9‑dimethylmethylene blue) assay for sGAG measurement, and normalization approaches.

Key topics and technical requirements

Sample preparation

Use of sterile technique and handling precautions (tissue may be infectious; refer to ISO 13022).
Division of each test sample into three parallel test samples for replicate measurement.
Pre‑treatment by dissection (mincing ≈1 mm) or optional alternatives (pulverization, lyophilization - Annex C).

Extraction

Recommended papain digestion (papain in PBS with cysteine/EDTA), typical conditions provided (e.g., ~125 µg/ml papain, 60 °C for 6 h or overnight; extract volume ≈9× sample).
Alternative extraction methods for scaffold-dependent matrices (collagenase, guanidine extraction, pepsin/elastase) described in Annex D.

Measurement

DMMB dye binds sGAGs; quantification is by absorbance against a chondroitin‑6‑sulfate standard curve.
Dynamic range cited: 3 µg/ml to 100 µg/ml; minimum measurable per sample noted (cuvette 0.3 µg; microplate 0.06 µg).
Advice to match the standard curve matrix to sample extraction solution to reduce interference.

Normalization

sGAG results normalized to wet or dry weight or to DNA content (DNA can be measured from the same digests).

Quality & reporting

Critical control points: accurate weighing, pipetting, and standard‑curve fitting.
Annex E provides an example test report format.

Applications and who uses it

ISO 13019:2018 is used by:

Tissue‑engineering researchers assessing chondrogenic differentiation and matrix production.

Medical device and regenerative medicine manufacturers performing product development and lot release testing.

Analytical and preclinical labs conducting comparability, stability, or quality control assays on cartilage constructs.

Regulatory and conformity assessment teams preparing documentation for implants or tissue‑engineered medical products.

Practical uses include benchmarking scaffold formulations, comparing cell sources or differentiation protocols, and providing standardized quantitative data for regulatory submissions.

Related standards

ISO 13022 - biosafety considerations for medical products containing viable human cells (referenced for handling).

ISO 20391‑1 - methods for cell counting (referenced for applicable apparatus and procedures).

Keywords: ISO 13019:2018, sGAG quantification, DMMB assay, papain digestion, chondrogenesis evaluation, tissue‑engineered cartilage, chondroitin 6‑sulfate.

ISO 13019:2018 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses it

Related standards

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