ASTM-F2064 2006

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F2064-00(2006)e1 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application

Published By	Publication Date	Number of Pages
ASTM	2006	9

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, ASTM

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Description

1.1 This guide covers the evaluation of alginates 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 alginates.

1.3 As with any material, some characteristics of alginates 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 and are not addressed in this guide.

1.4 Warning Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.

1.5 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.

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PDF Pages	PDF Title
1	Scope Referenced Documents
2	Terminology
3	Significance and Use Chemical and Physical Test Methods
4	FIG. 1
6	Product Development Considerations Safety and Toxicology Aspects of Alginate
7	Keywords X1. RATIONALE X1.1 X2. BACKGROUND X2.1 X2.2 Raw Materials for Alginate Production FIG. X2.1
8	X2.3 Variability in Chemical Composition and Sequential Structure of Alginate X2.4 Functional Properties and Applications of Alginate TABLE X2.1

Additional information

Standard Title	F2064-00(2006)e1 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application
Published Code	ASTM
Publication Date	2006
Pages Count	9
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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ASTM-F2064 2006

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