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 (Includes all amendments And changes 12/31/2010).

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Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications

STANDARD published on 1.2.2007

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The information about the standard:

Designation standards: ASTM F2103-01(2007)e2
Note: WITHDRAWN
Publication date standards: 1.2.2007
SKU: NS-52841
The number of pages: 8
Approximate weight : 24 g (0.05 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Annotation of standard text ASTM F2103-01(2007)e2 :

Keywords:

biomedical, chitosan salts, tissue-engineered medical product applications (TEMPs), Biomedical materials/applications, Characteristics/characterization--surgical implants/applications, Chitosan salts, Salts, TEMPs (tissue engineered medical products), ICS Number Code 11.100 (Laboratory medicine), 11.100.99 (Other standards related to laboratory medicine)

Additional information

1. 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.

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.

2. Referenced Documents

ISO 13408-1: 1998:	Aseptic Processing of Health Care Products--Part 1: General Requirements
Ph. Eur.	Monograph Chitosan Chloride, Nov. 2000 Available from EDQM, Publications and Services European Pharmacopoeia, BP 907 226, avenue de Colmar, F-67029 Strasbourg Cedex 1, France.
F1906-98	Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration
F895-11(2016)	Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F813-20	Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F763-22	Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
F756-17	Standard Practice for Assessment of Hemolytic Properties of Materials
F749-20	Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
F619-20	Standard Practice for Extraction of Materials Used in Medical Devices
D2196-20	Standard Test Methods for Rheological Properties of Non-Newtonian Materials by Rotational Viscometer
F1905-98	Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
F1251-89(1995)	Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
F1904-23	Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo
F1903-18	Standard Practice for Testing for Cellular Responses to Particles in vitro
F1439-03(2018)	Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials

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