ASTM F 2347 : 2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
Hardcopy , PDF
10-03-2024
English
12-01-2015
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
F 04
|
| DocumentType |
Guide
|
| Pages |
10
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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.
| 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| ASTM F 2900 : 2011 | Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020) |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 3659 : 2024 | Standard Guide for Bioinks Used in Bioprinting |
| 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 : 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.