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ASTM F 2902 : 2016 : EDT 1
Current
The latest, up-to-date edition.
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Standard Guide for Assessment of Absorbable Polymeric Implants
Hardcopy , PDF
English
01-12-2016
Committee |
F 04
|
DocumentType |
Guide
|
Pages |
15
|
PublisherName |
American Society for Testing and Materials
|
Status |
Current
|
1.1This guide describes general guidelines for the chemical, physical, mechanical, biocompatibility, and preclinical assessments of implantable synthetic polymeric absorbable devices. This guide also describes evaluation methods that are potentially useful and should be considered when assessing absorbable implants or implant components.
1.2The described evaluations may assist a manufacturer in establishing the safety and effectiveness of an absorbable implant device. This listing of assessment methods may also be utilized to assist in establishing substantial equivalence to an existing commercially marketed device. However, these polymeric material-oriented guidelines do not necessarily reflect the total needs for any particular implant application (for example, orthopedic, cardiovascular, sutures, and dermal fillers), which may require additional and potentially essential application-specific evaluations.
1.3This guide is intended to cover all forms of absorbable polymeric components and devices, including solid (for example, injection-molded) and porous (for example, fibrous) forms. This guide is also intended to cover devices fabricated from amorphous and/or semi-crystalline absorbable polymer systems.
1.4This guide has been generated with principal emphasis on the evaluation of devices formed from synthetic polymers that degrade in vivo primarily through hydrolysis (for example, α-hydroxy-polyesters). Evaluation methods suggested herein may or may not be applicable to implants formed from materials that, upon implantation, are substantially degraded through other mechanisms (for example, enzymatically induced degradation).
1.5This guide references and generally describes various means to assess absorbable materials, components, and devices. The user needs to refer to specific test methods for additional details. Additionally, some of the recommended test methods may require modification to address the properties of a particular device, construct, or application.
1.6Adherence to all aspects of these guidelines is not mandatory, in that assessments and tests listed within this guide are not necessarily relevant for all absorbable implant systems and applications.
1.7Absorbable polymers used as a matrix to control the in vivo release of bioactive agents (drugs, antimicrobials, and so forth) may be evaluated according to many of the methods described herein. However, additional test methods not covered by this guide will likely be needed to evaluate a bioactive agent’s composition, loading, release kinetics, safety, and efficacy.
1.8Composites of absorbable polymers with ceramics and/or metals may be evaluated according to many of the methods described herein. However, additional test methods not covered by this guide will likely be needed to evaluate the composite’s other component(s).
1.9The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.10This 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.
1.11This 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 2313 : 2018 | Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide |
ASTM F 2502 : 2017 | Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants |
ASTM F 3142 : 2016 | Standard Guide for Evaluation of <emph type="bdit">in vitro</emph> Release of Biomolecules from Biomaterials Scaffolds for TEMPs |
ASTM F 3160 : 2016 | Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants |
ASTM F 2579 : 2018 | Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
ASTM F 2150 : 2013 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
ASTM D 5225 : 2009 | Standard Test Method for Measuring Solution Viscosity of Polymers with a Differential Viscometer |
ASTM D 2857 : 2016 | Standard Practice for Dilute Solution Viscosity of Polymers |
ASTM D 3164 : 1997 | Standard Test Method for Strength Properties of Adhesively Bonded Plastic Lap-Shear Sandwich Joints in Shear by Tension Loading |
ASTM F 2097 : 2010 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
ASTM D 4603 : 2003 | Standard Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer |
ASTM F 1980 : 2007 : R2011 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
ASTM F 1983 : 1999 : R2008 | Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications |
ASTM D 5225 : 1998 | Standard Test Method for Measuring Solution Viscosity of Polymers with a Differential Viscometer |
ASTM D 5225 : 2014 | Standard Test Method for Measuring Solution Viscosity of Polymers with a Differential Viscometer |
ASTM E 1441 : 2000 : R2005 | Standard Guide for Computed Tomography (CT) Imaging |
ASTM D 1922 : 2008 | Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method |
ASTM D 3418 : 2012 : EDT 1 | Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry |
ASTM D 3420 : 2008 | Standard Test Method for Pendulum Impact Resistance of Plastic Film |
ASTM D 2857 : 1995 : R2001 | Standard Practice for Dilute Solution Viscosity of Polymers |
ASTM F 2559 : 2006 | Standard Guide for Writing a Specification for Sterilizable Peel Pouches |
ASTM F 1983 : 1999 : R2003 | Standard Practice for Assessment of Compatibiltiy of Absorbable/Resorbable Biomaterials for Implant Applications |
ASTM D 3418 : 1982 : R1988 : EDT 1 | Standard Test Method for Transition Temperatures of Polymers By Thermal Analysis |
ASTM E 2207 : 2015 : R2021 | Standard Practice for Strain-Controlled Axial-Torsional Fatigue Testing with Thin-Walled Tubular Specimens |
ASTM F 1249 : 2006 | Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor |
ASTM E 96/E96M : 2022 : REV A : EDT 1 | Standard Test Methods for Gravimetric Determination of Water Vapor Transmission Rate of Materials |
ASTM E 328 : 2020 | Standard Test Methods for Stress Relaxation for Materials and Structures |
ASTM E 1356 : 2023 | Standard Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry |
ASTM D 3418 : 1999 | Standard Test Method for Transition Temperatures of Polymers By Differential Scanning Calorimetry |
ASTM F 1980 : 2021 | Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices |
ASTM D 2857 : 1995 | Standard Practice for Dilute Solution Viscosity of Polymers |
ASTM D 3846 : 2002 | Standard Test Method for In-Plane Shear Strength of Reinforced Plastics |
ASTM F 2450 : 2009 | Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products |
ASTM E 96/E96M : 2022 : REV A | Standard Test Methods for Gravimetric Determination of Water Vapor Transmission Rate of Materials |
ASTM D 3420 : 2014 | Standard Test Method for Pendulum Impact Resistance of Plastic Film |
ASTM F 1983 : 2023 | Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications |
ASTM D 3418 : 2021 | Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry |
ASTM D 3164 : 2003 : R2011 | Standard Test Method for Strength Properties of Adhesively Bonded Plastic Lap-Shear Sandwich Joints in Shear by Tension Loading |
ASTM D 5296 : 2005 | Standard Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography |
ASTM E 1441 : 2019 | Standard Guide for Computed Tomography (CT) |
ASTM D 3420 : 2008 : REV A | Standard Test Method for Pendulum Impact Resistance of Plastic Film |
ASTM E 96/E96M : 2021 | Standard Test Methods for Gravimetric Determination of Water Vapor Transmission Rate of Materials |
ASTM D 5296 : 1997 | Standard Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography |
ASTM E 2207 : 2002 | Standard Practice for Strain-Controlled Axial-Torsional Fatigue Testing with Thin-Walled Tubular Specimens |
ASTM D 1922 : 2015 | Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method |
ASTM D 1922 : 2023 | Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method |
ASTM F 1249 : 1994 : REV B | Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor |
ASTM D 1922 : 2006 : REV A | Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method |
ASTM F 2097 : 2014 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
ASTM D 1042 : 2006 | Standard Test Method for Linear Dimensional Changes of Plastics Under Accelerated Service Conditions |
ASTM D 5748 : 1995 | Standard Test Method for Protrusion Puncture Resistance of Stretch Wrap Film |
ASTM F 1980 : 2007 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
ASTM E 2207 : 2015 | Standard Practice for Strain-Controlled Axial-Torsional Fatigue Testing with Thin-Walled Tubular Specimens |
ASTM F 2313 : 2018 | Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide |
ASTM D 3420 : 2021 | Standard Test Method for Pendulum Impact Resistance of Plastic Film |
ASTM D 4404 : 1984 : R2004 | Standard Test Method for Determination of Pore Volume and Pore Volume Distribution of Soil and Rock by Mercury Intrusion Porosimetry |
ASTM E 96/E96M : 2022 | Standard Test Methods for Gravimetric Determination of Water Vapor Transmission Rate of Materials |
ASTM F 2097 : 2023 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
ASTM D 5748 : 1995 : R2012 | Standard Test Method for Protrusion Puncture Resistance of Stretch Wrap Film |
ASTM D 1042 : 2022 | Standard Test Method for Linear Dimensional Changes of Plastics Caused by Exposure to Heat and Moisture |
ASTM D 3846 : 1994 | Standard Test Method for In-Plane Shear Strength of Reinforced Plastics |
ASTM F 2097 : 2008 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
ASTM F 2579 : 2008 | Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
ASTM D 1042 : 1993 | Standard Test Method for Linear Dimensional Changes of Plastics Under Accelerated Service Conditions |
ASTM E 1356 : 2008 | Standard Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry |
ASTM D 2990 : 2017 | Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics |
ASTM E 96/E96M : 2023 | Standard Test Methods for Gravimetric Determination of Water Vapor Transmission Rate of Materials |
ASTM D 3846 : 2008 | Standard Test Method for In-Plane Shear Strength of Reinforced Plastics |
ASTM D 3418 : 2012 | Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry |
ASTM F 2502 : 2017 | Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants |
ASTM D 5225 : 2017 | Standard Test Method for Measuring Solution Viscosity of Polymers with a Differential Viscometer |
ASTM E 96/E96M : 2024 | Standard Test Methods for Gravimetric Determination of Water Vapor Transmission Rate of Materials |
ASTM F 1980 : 2016 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
ASTM D 3418 : 2003 | Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry |
ASTM F 2791 : 2014 | Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions |
ASTM F 2791 : 2015 | Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions |
ASTM F 2097 : 2016 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
ASTM D 3079 : 1994 : R1999 | Standard Test Method for Water Vapor Transmission of Flexible Heat-Sealed Packages for Dry Products |
ASTM D 3079 : 1994 : R2003 | Standard Test Method for Water Vapor Transmission of Flexible Heat-Sealed Packages for Dry Products |
ASTM D 3418 : 2015 | Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry |
ASTM E 2207 : 2008 : R2013 : EDT 1 | Standard Practice for Strain-Controlled Axial-Torsional Fatigue Testing with Thin-Walled Tubular Specimens |
ASTM F 2210 : 2002 : R2010 | Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products (Withdrawn 2015) |
ASTM F 1925 : 2017 | Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
ASTM D 2990 : 2001 | Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics |
ASTM D 1922 : 2003 | Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method |
ASTM D 4404 : 2018 | Standard Test Method for Determination of Pore Volume and Pore Volume Distribution of Soil and Rock by Mercury Intrusion Porosimetry |
ASTM D 5225 : 2022 | Standard Test Method for Measuring Solution Viscosity of Polymers with a Differential Viscometer |
ASTM F 1925 : 1999 : EDT 1 | Standard Specification for Virgin Poly(L-Lactic Acid) Resin for Surgical Implants |
ASTM D 4603 : 2018 | Standard Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer |
ASTM D 5296 : 2011 | Standard Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography |
ASTM D 1042 : 2001 : REV A | Standard Test Method for Linear Dimensional Changes of Plastics Under Accelerated Service Conditions |
ASTM D 2857 : 1995 : R2007 | Standard Practice for Dilute Solution Viscosity of Polymers (Withdrawn 2016) |
ASTM D 2857 : 1970 : R1977 | Standard Test Method for Dilute Solution Viscosity Of Polymers |
ASTM D 4603 : 1996 | Standard Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer |
ASTM F 2313 : 2010 | Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide |
ASTM D 3164 : 2003 : R2017 | Standard Test Method for Strength Properties of Adhesively Bonded Plastic Lap-Shear Sandwich Joints in Shear by Tension Loading |
ASTM F 1249 : 2006 : R2011 | Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor |
ASTM F 2313 : 2008 | Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide |
ASTM F 2097 : 2020 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
ASTM F 2450 : 2004 | Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products |
ASTM D 4404 : 1984 : R1998 : EDT 1 | Standard Test Method for Determination of Pore Volume and Pore Volume Distribution of Soil and Rock by Mercury Intrusion Porosimetry |
ASTM E 96/E96M : 2016 | Standard Test Methods for Water Vapor Transmission of Materials |
ASTM D 2857 : 2022 | Standard Practice for Dilute Solution Viscosity of Polymers |
ASTM D 1042 : 2012 : R2017 | Standard Test Method for Linear Dimensional Changes of Plastics Caused by Exposure to Heat and Moisture |
ASTM F 2210 : 2002 | Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products |
ASTM F 2502 : 2011 | Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants |
ASTM D 638 : 2014 | Standard Test Method for Tensile Properties of Plastics |
ASTM F 2097 : 2007 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
ASTM F 99 : 2007 : R2015 | Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials |
ASTM D 2990 : 2009 | Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics |
ASTM E 1356 : 2003 | Standard Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry |
ASTM E 2207 : 2008 | Standard Practice for Strain-Controlled Axial-Torsional Fatigue Testing with Thin-Walled Tubular Specimens |
ASTM D 2990 : 1995 | Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics |
ASTM D 3164 : 2003 | Standard Test Method for Strength Properties of Adhesively Bonded Plastic Lap-Shear Sandwich Joints in Shear by Tension Loading |
ASTM F 2791 : 2024 | Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions |
ASTM F 1925 : 2022 | Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
ASTM D 1922 : 2015 : R2020 | Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method |
ASTM D 5748 : 1995 : R2019 | Standard Test Method for Protrusion Puncture Resistance of Stretch Wrap Film |
ASTM E 328 : 2013 | Standard Test Methods for Stress Relaxation Tests for Materials and Structures |
ASTM E 1356 : 2008 : R2014 | Standard Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry (Withdrawn 2023) |
ASTM E 1570 : 2011 | Standard Practice for Computed Tomographic (CT) Examination |
ASTM D 1042 : 2001 | Standard Test Method for Linear Dimensional Changes of Plastics Under Accelerated Service Conditions |
ASTM D 1922 : 2003 : REV A | Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method |
ASTM E 1441 : 2011 | Standard Guide for Computed Tomography (CT) Imaging |
ASTM D 3418 : 2008 | Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry |
ASTM E 467 : 2008 : R2014 | Standard Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System |
ASTM F 2450 : 2018 | Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products |
ASTM F 99 : 2021 | Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials |
ASTM D 5748 : 1995 : R2007 | Standard Test Method for Protrusion Puncture Resistance of Stretch Wrap Film |
ASTM D 5296 : 2019 | Standard Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography |
ASTM F 2579 : 2010 | Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
ASTM F 2791 : 2009 | Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions |
ASTM D 695 : 2015 | Standard Test Method for Compressive Properties of Rigid Plastics |
ASTM E 1570 : 2000 : R2005 : EDT 1 | Standard Practice for Computed Tomographic (CT) Examination |
ASTM F 2313 : 2008 : EDT 1 | Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide |
ASTM F 99 : 1976 : R1993 | Standard Practice for Preparation of Flexible Barrier Material Specifications |
ASTM F 2579 : 2006 | Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
ASTM F 1980 : 1999 : EDT 1 | Standard Guide for Accelerated Aging of Sterile Medical Device Packages |
ASTM F 1983 : 2014 | Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications |
ASTM F 1925 : 2009 | Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
ASTM F 2579 : 2018 | Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
ASTM D 570 : 2022 | Standard Test Method for Water Absorption of Plastics |
ASTM E 328 : 2021 | Standard Test Methods for Stress Relaxation for Materials and Structures |
ASTM F 1249 : 1990 : R1995 | Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor |
ASTM F 2502 : 2005 : R2009 : EDT 1 | Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants |
ASTM F 2313 : 2003 | Standard Specification for Virgin Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70% Glycolide |
ASTM D 1922 : 2005 | Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method |
ASTM D 3420 : 1995 | Standard Test Method for Pendulum Impact Resistance of Plastic Film |
ASTM F 2502 : 2005 | Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants |
ASTM E 1356 : 1998 | Standard Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry or Differential Thermal Analysis |
ASTM D 1922 : 2000 : REV A | Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method |
ASTM F 2097 : 2001 | Standard Guide for Design and Evaluation of Primary Packaging for Medical Products |
ASTM D 695 : 2023 | Standard Test Method for Compressive Properties of Rigid Plastics |
ASTM D 570 : 1998 : R2018 | Standard Test Method for Water Absorption of Plastics |
ASTM E 467 : 2021 | Standard Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System |
ASTM D 3079 : 1994 : R2009 : EDT 1 | Standard Test Method for Water Vapor Transmission of Flexible Heat-Sealed Packages for Dry Products (Withdrawn 2018) |
ASTM D 1922 : 2006 | Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method |
ASTM F 2450 : 2010 | Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products |
ASTM F 1983 : 1999 | Standard Practice for Assessment of Compatibiltiy of Absorbable/Resorbable Biomaterials for Implant Applications |
ASTM F 2097 : 2005 | Standard Guide for Design and Evaluation of Primary Packaging for Medical Products |
ASTM F 1980 : 2002 | Standard Guide for Accelerated Aging of Sterile Medical Device Packages |
ASTM D 1922 : 2009 | Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method |
ASTM F 1249 : 2001 | Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor |
ASTM D 1042 : 2012 | Standard Test Method for Linear Dimensional Changes of Plastics Caused by Exposure to Heat and Moisture |
ASTM D 3846 : 2008 : R2015 | Standard Test Method for In-Plane Shear Strength of Reinforced Plastics (Withdrawn 2024) |
ASTM F 1925 : 1999 : R2005 | Standard Specification for Virgin Poly(L-Lactic Acid) Resin for Surgical Implants |
ASTM E 1441 : 2000 | Standard Guide for Computed Tomography (CT) Imaging |
ASTM E 1570 : 2000 | Standard Practice for Computed Tomographic (CT) Examination |
ASTM F 1249 : 2013 | Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor |
ASTM D 638 : 2022 | Standard Test Method for Tensile Properties of Plastics |
ASTM D 4404 : 2010 | Standard Test Method for Determination of Pore Volume and Pore Volume Distribution of Soil and Rock by Mercury Intrusion Porosimetry |
ASTM D 4603 : 2003 : R2011 : EDT 1 | Standard Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer |
ASTM D 5748 : 1995 : R2001 | Standard Test Method for Protrusion Puncture Resistance of Stretch Wrap Film |
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