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

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

05-06-2018

Publisher

International Organization for Standardization

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.

DevelopmentNote	Supersedes ISO/DIS 13019. (06/2018)
DocumentType	Standard
Pages	17
PublisherName	International Organization for Standardization
Status	Current

Standards	Relationship
NEN-ISO 13019:2018	Identical
BS ISO 13019:2018	Identical

ASTM F 2150 : 2013 : REDLINE	Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
ASTM F 2312 : 2011 : REDLINE	Standard Terminology Relating to Tissue Engineered Medical Products
ISO 14155-2:2003	Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
ASTM F 2212 : 2011 : REDLINE	Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
ISO 14155-1:2003	Clinical investigation of medical devices for human subjects Part 1: General requirements
ASTM F 2383 : 2011 : REDLINE	Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)
ASTM F 2027 : 2016 : REDLINE	Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
ISO 13022:2012	Medical products containing viable human cells — Application of risk management and requirements for processing practices
ISO/TS 10993-19:2006	Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 12891-1:2015	Retrieval and analysis of surgical implants Part 1: Retrieval and handling