17/30319534 DC : 0
NA
Status of Standard is Unknown
BS ISO 13019 - TISSUE-ENGINEERED MEDICAL PRODUCTS - QUANTIFICATION OF SULPHATED GLYCOSAMINOGLYCANS (SGAG) FOR EVALUATION OF CHONDROGENESIS
Hardcopy , PDF
English
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 |
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