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ASTM F 2347 : 2015

Current
Current

The latest, up-to-date edition.

Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

12-01-2015

1.1This guide covers the evaluation of hyaluronan 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 to the characterization and purity of hyaluronan.

1.3As with any material, some characteristics of hyaluronan may be altered by processing techniques, such as cross-linking and sterilization, required for the production of a specific formulation 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.

1.4The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

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 requirements prior to use.

Committee
F 04
DocumentType
Guide
Pages
10
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

ASTM F 2027 : 2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
ASTM F 2900 : 2011 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)

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 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 E 1953 : 2007 Standard Practice for Description of Thermal Analysis and Rheology Apparatus
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 E 2975 : 2014 Standard Test Method for Calibration of Concentric Cylinder Rotational Viscometers
ASTM E 1953 : 2002 Standard Practice for Description of Thermal Analysis Apparatus
ASTM E 1953 : 2014 Standard Practice for Description of Thermal Analysis and Rheology Apparatus
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 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 E 1953 : 2020 Standard Practice for Description of Thermal Analysis and Rheology Apparatus
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 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 E 1953 : 2007 : R2013 Standard Practice for Description of Thermal Analysis and Rheology Apparatus
ASTM E 1953 : 1998 Standard Practice for Description of Thermal Analysis Apparatus
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 1439 : 2003 : R2013 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
ASTM E 1953 : 2005 Standard Practice for Description of Thermal Analysis Apparatus
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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