BS ISO 13019 - TISSUE-ENGINEERED MEDICAL PRODUCTS - QUANTIFICATION OF SULPHATED GLYCOSAMINOGLYCANS (SGAG) FOR EVALUATION OF CHONDROGENESIS

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

Foreword
1 Scope
2 Normative References
3 Terms and definitions
4 General and Principle
5 Apparatus
6 Preparation of parallel test samples from test
  samples
7 Procedure
8 Test report
9 Evaluation
Annex A (informative) - Flowchart of the overall procedure
        steps
Annex B (informative) - Reagents
Annex C (informative) - Procedure for pre-treatment
        (Option)
Annex D (informative) - Procedure for extraction
        of sGAG (Option)
Annex E (informative) - Example of test report format
        for sGAG measurement
Bibliography

BS ISO 13019.

Committee	RGM/1
DocumentType	Draft
Pages	20
PublisherName	British Standards Institution
Status	NA

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 12891-1:2015	Retrieval and analysis of surgical implants Part 1: Retrieval and handling