ASTM F 2064 : 2017
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
Hardcopy , PDF
English
01-03-2017
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).
Committee |
F 04
|
DocumentType |
Guide
|
Pages |
9
|
PublisherName |
American Society for Testing and Materials
|
Status |
Current
|
Supersedes |
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.
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) |
ASTM F 2027 : 2016 | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
ASTM F 2605 : 2016 | Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS) |
ASTM F 2315 : 2018 | Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels |
ASTM F 2211 : 2013 | Standard Classification for Tissue Engineered Medical Products (TEMPs) |
ASTM F 2900 : 2011 | Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020) |
ASTM F 1251 : 1989 : R1995 | Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices |
ASTM F 1904 : 1998 : R2003 | Standard Practice for Testing the Biological Responses to Particles In Vivo |
ASTM F 1439 : 2003 | Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
ASTM E 2975 : 2015 | Standard Test Method for Calibration of Concentric Cylinder Rotational Viscometers |
ASTM F 2315 : 2010 | Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels |
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 1906 : 1998 | Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration |
ASTM F 1904 : 1998 : EDT 1 | Standard Practice for Testing the Biological Responses to Particles In Vivo |
ASTM F 763 : 2022 | Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials |
ASTM F 1903 : 2010 | Standard Practice for Testing For Biological Responses to Particles <i>In Vitro</i> |
ASTM F 763 : 2004 : R2016 | Standard Practice for Short-Term Screening of Implant Materials |
ASTM F 1904 : 2023 | Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products <emph type="ital">in vivo</emph> |
ASTM F 1439 : 2003 : R2008 | Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
ASTM F 1904 : 2014 | Standard Practice for Testing the Biological Responses to Particles <emph type="bdit" >in vivo</emph> |
ASTM F 1905 : 1998 | Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity |
ASTM E 2975 : 2014 | Standard Test Method for Calibration of Concentric Cylinder Rotational Viscometers |
ASTM F 1439 : 2003 : R2018 | Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
ASTM F 756 : 2008 | Standard Practice for Assessment of Hemolytic Properties of Materials |
ASTM F 2315 : 2011 | Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels |
ASTM F 2605 : 2008 : EDT 1 | Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS) |
ASTM F 2259 : 2003 | 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 2605 : 2016 | Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS) |
ASTM F 1904 : 1998 : R2008 | Standard Practice for Testing the Biological Responses to Particles <i>in vivo</i> |
ASTM F 1903 : 1998 | Standard Practice for Testing for Biological Responses to Particles In Vitro |
ASTM E 2975 : 2023 | Standard Test Method for Calibration or Calibration Verification of Concentric Cylinder Rotational Viscometers |
ASTM F 2605 : 2008 | Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS) |
ASTM F 981 : 2004 : R2016 | Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone |
ASTM F 763 : 1999 | Standard Practice for Short-Term Screening of Implant Materials |
ASTM F 1905 : 1998 : R2003 | Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity (Withdrawn 2011) |
ASTM F 1439 : 2002 | Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
ASTM F 1903 : 2018 | Standard Practice for Testing for Cellular Responses to Particles <emph type="bdit" >in vitro</emph> |
ASTM F 2315 : 2003 | Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels |
ASTM F 2315 : 2018 | Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels |
ASTM F 2259 : 2003 : R2008 | 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 1906 : 1998 : R2003 | Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration (Withdrawn 2011) |
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) |
ASTM F 1439 : 1992 : R1996 | Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
ASTM E 2975 : 2016 | Standard Test Method for Calibration or Calibration Verification of Concentric Cylinder Rotational Viscometers |
ASTM F 1251 : 1989 : R2003 | Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012) |
ASTM F 1439 : 2003 : R2013 | Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
ASTM E 2975 : 2024 | Standard Test Method for Calibration or Calibration Verification of Constant Speed Concentric Cylinder Rotational Viscometers |
ASTM E 2975 : 2016 : EDT 1 | Standard Test Method for Calibration or Calibration Verification of Concentric Cylinder Rotational Viscometers |
ASTM F 981 : 2023 | Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices |
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