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

Standard No.

ISO 13019:2018

Release Date

2018

Published By

International Organization for Standardization (ISO)

Latest

ISO 13019:2018

Scope

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 tissueengineered cartilage constructs.

ISO 13019:2018 Referenced Document

• ASTM F2027-00 Standard Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical Products*， 2024-04-20 Update
• ASTM F2150-07 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products*， 2024-04-20 Update
• ASTM F2210-02 Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products*， 2024-04-20 Update
• ASTM F2212-02 Standard Guide for Characterization of Type I Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)*， 2024-04-20 Update
• ASTM F2312-04 Standard Terminology Relating to Tissue Engineered Medical Products*， 2024-04-20 Update
• ASTM F2315-03 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels*， 2024-04-20 Update
• ASTM F2383-05 Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)*， 2024-04-20 Update
• ASTM F2451-05 Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage*， 2024-04-20 Update
• ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 12891-1:2015 Retrieval and analysis of surgical implants - Part 1: Retrieval and handling
• ISO 13022:2012 Medical products containing viable human cells - Application of risk management and requirements for processing practices
• ISO 14155-1:2003 Clinical investigation of medical devices for human subjects - Part 1: General requirements
• ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
• ISO 14971:2007 Medical devices - Application of risk management to medical devices
• ISO 20391-1:2018 Biotechnology - Cell counting - Part 1: General guidance on cell counting methods
• ISO 9000:2015 Quality management systems - Fundamentals and vocabulary
• ISO/TS 10993-19:2006 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials

ISO 13019:2018 history

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