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

Standard No.

ASTM F2103-01(2007)e1

Release Date

2001

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F2103-01(2007)e2

Latest

ASTM F2103-18

Scope

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 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./p>

ASTM F2103-01(2007)e1 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 F2103-01(2007)e1 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