ASTM F2103-11
Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
- Standard No.
- ASTM F2103-11
- Release Date
- 2011
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM F2103-18
- Latest
- ASTM F2103-18
- Scope
This guide contains a listing of those characterization parameters that are directly related to the functionality of chitosan. This guide can be used as an aid in the selection and characterization of the appropriate chitosan or chitosan salt for a particular application. This standard is intended to give guidance in the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of a particular chitosan. It may have use in the regulation of devices containing chitosan by appropriate authorities.
The chitosan salts covered by this guide may be gelled, extruded, or otherwise formulated into biomedical devices for use as tissue-engineered medical products or drug delivery devices for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue-engineered medical product or drug delivery application.
To ensure that the material supplied satisfies requirements for use in TEMPs, several general areas of characterization should be considered. These include identity of chitosan, physical and chemical characterization and testing, impurities profile, and performance-related tests.
1.1 This guide covers 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).
1.2 This guide addresses key parameters relevant for the functionality, characterization, and purity of chitosan salts.
1.3 As with any material, some characteristics of chitosan may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy.
1.4 Warning
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
ASTM F2103-11 Referenced Document
- ASTM D2196 Standard Test Methods for Rheological Properties of Non-Newtonian Materials by Rotational (Brookfield type) Viscometer
- ASTM F1251 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
- ASTM F1439 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
- ASTM F1903 Standard Practice for Testing for Biological Responses to Particles In Vitro
- ASTM F1904 Standard Practice for Testing the Biological Responses to Particles In Vivo
- ASTM F1905 Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
- ASTM F1906 Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration
- ASTM F619 Standard Practice for Extraction of Medical Plastics
- ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
- ASTM F749 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
- ASTM F756 Standard Practice for Assessment of Hemolytic Properties of Materials
- ASTM F763 Standard Practice for Short-Term Screening of Implant Materials
- ASTM F813 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
- ASTM F895 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
- ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
- ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
- ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ASTM F2103-11 history
- 2018 ASTM F2103-18 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
- 2011 ASTM F2103-11 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
- 2001 ASTM F2103-01(2007)e2 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
- 2001 ASTM F2103-01(2007)e1 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
- 2007 ASTM F2103-01(2007) Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
- 2001 ASTM F2103-01 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
