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ASTM F 2064 : 2017

Current

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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-03-2017

€56.53
Excluding VAT

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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