ASTM F 2103 : 2011-03
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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GUIDE FOR CHARACTERIZATION AND TESTING OF CHITOSAN SALTS AS STARTING MATERIALS INTENDED FOR USE IN BIOMEDICAL AND TISSUE-ENGINEERED MEDICAL PRODUCT APPLICATIONS
Superseded date
10-04-2015
Superseded by
Published date
03-01-2011
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CONTAINED IN VOL. 13.01, 2015 Describes the evaluation of chitosan salts suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, tissue-engineered medical products (TEMPS).
| Committee |
F 04
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| DocumentType |
Redline
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| PublisherName |
American Society for Testing and Materials
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| Status |
Superseded
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| SupersededBy |
| ASTM F 2260 : 2003 : R2008 | Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (<sup>1</sup>H NMR) Spectroscopy |
| ASTM F 2900 : 2011 | Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020) |
| ASTM F 2211 : 2013 | Standard Classification for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 2260 : 2003 : R2012 : EDT 1 | Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (<sup>1</sup>H NMR) Spectroscopy |
| ASTM F 2027 : 2016 : REDLINE | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
| ASTM F 2260 : 2003 | Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (<sup>1</sup>H NMR) Spectroscopy |
| EN 12442-3 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS |
| AAMI TIR19 : 1998 | GUIDANCE FOR ANSI/AAMI/ISO 10993-7: 1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
| ISO 10993-3:2014 | Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| ASTM F 756 : 2017 : REDLINE | Standard Practice for Assessment of Hemolytic Properties of Materials |
| ASTM F 749 : 2013 : REDLINE | Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit |
| ASTM F 1903 : 2010-07 | PRACTICE FOR TESTING FOR BIOLOGICAL RESPONSES TO PARTICLES IN VITRO |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| ASTM F 619 : 2014 : REDLINE | Standard Practice for Extraction of Medical Plastics |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ASTM F 1904 : 2014 : REDLINE | Standard Practice for Testing the Biological Responses to Particles <emph type="bdit" >in vivo</emph> |
| ISO 10993-9:2009 | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
| EN 12442-1 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
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