ASTM F 2064 : 2017 : REDLINE
Current
The latest, up-to-date edition.
Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
English
01-03-2017
CONTAINED IN VOL. 13.01, 2017 Defines the evaluation of alginates suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, Tissue Engineered Medical Products (TEMPs).
Committee |
F 04
|
DocumentType |
Redline
|
Pages |
10
|
PublisherName |
American Society for Testing and Materials
|
Status |
Current
|
1.1This 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).
1.2This guide addresses key parameters relevant for the functionality, characterization, and purity of alginates.
1.3As 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.
1.4Warning—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.
1.5This 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.
1.6This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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ASTM F 2027 : 2016 : REDLINE | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
ASTM F 2211 : 2013 | Standard Classification for Tissue Engineered Medical Products (TEMPs) |
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ASTM F 2259 : 2010 | Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (<sup>1</sup>H NMR) Spectroscopy |
ASTM F 2259 : 2010 : R2012 : EDT 1 | Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (<sup>1</sup>H NMR) Spectroscopy (Withdrawn 2021) |
AAMI TIR19 : 1998 | GUIDANCE FOR ANSI/AAMI/ISO 10993-7: 1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
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ASTM F 1903 : 2010-07 | PRACTICE FOR TESTING FOR BIOLOGICAL RESPONSES TO PARTICLES IN VITRO |
ASTM F 2605 : 2016 : REDLINE | Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS) |
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 |
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ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
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ISO 10993-9:2009 | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
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