ASTM F 2027 : 2016
Current
Current
The latest, up-to-date edition.
Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
10-01-2016
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
F 04
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| DocumentType |
Guide
|
| Pages |
7
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| PublisherName |
American Society for Testing and Materials
|
| Status |
Current
|
| Supersedes |
1.1This document provides guidance on writing a materials specification for raw or starting materials intended for use in tissue engineering scaffolds for growth, support, or delivery of cells and/or biomolecules. This guide does not apply to materials that are already in a scaffold form or are finished tissue-engineered medical products.
1.2The purpose of this guide is to provide a compendium of relevant existing standards and test methods for materials already commonly used within medical products and to provide characterization guidance for interim use of raw materials for which a standard does not exist.
1.3This guide covers specifications and characterizations of all the major classes of materials including polymers, ceramics, metals, composites, and natural tissues of human, animal, or plant origin. This guide does not apply to pharmaceuticals.
1.4This guide is focused on specification of chemical, physical, and mechanical properties of the raw or starting material. It does not include safety and biocompatibility requirements since safety and biocompatibility testing is typically done on materials fabricated into a final form to include all possible effects of fabrication and sterilization techniques.
1.5Compliance with materials specifications developed in accordance with this standard may not necessarily result in a material suitable for its intended purpose. Additional testing specific to the intended use may be required.
| ASTM F 2150 : 2013 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
| ASTM F 3163 : 2016 | Standard Guide for Classification of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds |
| ASTM F 2900 : 2011 | Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020) |
| ASTM F 2211 : 2013 | Standard Classification for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 2026 : 2010 | Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| ASTM F 1251 : 1989 : R1995 | Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices |
| ASTM F 1185 : 2023 | Standard Specification for Composition of Medical-Grade Hydroxylapatite for Surgical Implants |
| ASTM F 665 : 2009 : R2015 | Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application |
| ASTM F 1185 : 2003 | Standard Specification for Composition of Hydroxylapatite for Surgical Implants |
| ASTM F 2260 : 2003 : R2008 | Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (<sup>1</sup>H NMR) Spectroscopy |
| ASTM F 702 : 2018 | Standard Specification for Polysulfone Resin for Medical Applications |
| ASTM F 2848 : 2010 | Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
| ASTM F 2103 : 2018 | Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications |
| ASTM F 2103 : 2001 : R2007 | Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications |
| ASTM F 1877 : 2005 | Standard Practice for Characterization of Particles |
| ASTM D 1763:2000 | Standard Specification for Epoxy Resins |
| ASTM F 1377 : 1998 : REV A | Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS-R30075) |
| 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 602 : 2009 : R2015 | Standard Criteria for Implantable Thermoset Epoxy Plastics (Withdrawn 2024) |
| ASTM F 562 : 2022 | Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) |
| ASTM F 2026 : 2014 | Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| ASTM D 1763 : 1994 | Standard Specification for Epoxy Resins |
| ASTM F 1713 : 2008 : R2013 | Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130) |
| ASTM F 2150 : 2019 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products |
| ASTM F 1579 : 1998 | Standard Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications |
| ASTM F 75 : 2023 | Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) |
| ASTM F 624 : 2009 : R2024 | Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications |
| ASTM F 2212 : 2011 | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| ASTM D 1763 : 2000 : R2021 | Standard Specification for Epoxy Resins |
| ASTM F 1581 : 2008 : R2016 | Standard Specification for Composition of Anorganic Bone for Surgical Implants |
| ASTM F 1537 : 2011 | Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
| ASTM F 1472 : 2023 | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| ASTM F 1472 : 2002 : REV A | Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| ASTM F 997 : 1998 : REV A | Standard Specification for Polycarbonate Resin for Medical Applications |
| ASTM F 1713 : 2008 | Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130) |
| ASTM F 1876 : 1998 : R2003 : EDT 1 | Standard Specification for Polyetherketoneetherketoneketone (PEKEKK) Resins for Surgical Implant Applications (Withdrawn 2012) |
| ASTM F 2260 : 2003 | Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (<sup>1</sup>H NMR) Spectroscopy |
| ASTM F 2064 : 2000 : R2006 | Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application |
| ASTM F 75 : 2018 | Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) |
| ASTM F 562 : 2013 | Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) |
| ASTM F 1877 : 2024 | Standard Practice for Characterization of Particles |
| 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 2103 : 2001 | Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications |
| ASTM F 1088 : 2004 : REV A : EDT 1 | Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation |
| ASTM F 560 : 2022 | Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) |
| ASTM F 1635 : 2016 | Standard Test Method for <emph type="bdit">in vitro</emph> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
| ASTM F 2064 : 2000 : R2006 : EDT 1 | Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application |
| ASTM F 2026 : 2017 | Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| ASTM F 2260 : 2018 | Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (<sup>1</sup>H NMR) Spectroscopy |
| ASTM F 1538 : 1994 | Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation |
| ASTM F 2212 : 2002 : R2007 : EDT 1 | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 1377 : 2021 | Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538) |
| ASTM F 2064 : 2014 | Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
| ASTM F 1538 : 2003 : R2009 | Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation |
| ASTM F 2026 : 2007 | Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| ASTM F 451 : 2016 | Standard Specification for Acrylic Bone Cement |
| ASTM F 2848 : 2021 | Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns |
| ASTM F 2212 : 2019 | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 2579 : 2008 | Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
| ASTM F 1088 : 2004 : REV A | Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation |
| ASTM F 2347 : 2003 | Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
| ASTM F 624 : 1998 : REV A | Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications |
| ASTM F 1472 : 2000 | Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy (UNS R56400) for Surgical Implant Applications |
| ASTM F 1088 : 2023 | Standard Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices |
| ASTM F 2026 : 2008 | Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| ASTM F 2212 : 2002 | Standard Guide for Characterization of Type I Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 2026 : 2007 : EDT 1 | Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| ASTM F 1537 : 2008 | Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
| ASTM F 451 : 2021 | Standard Specification for Acrylic Bone Cement |
| ASTM F 1581 : 1999 | Standard Specification for Composition of Anorganic Bone for Surgical Implants |
| ASTM F 2064 : 2000 | Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application |
| ASTM F 1925 : 2017 | Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
| ASTM F 136 : 1998 | Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications |
| ASTM F 2103 : 2001 : R2007 : EDT 1 | Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications |
| ASTM F 2150 : 2013 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
| ASTM E 1298 : 1989 : R2000 | Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products |
| ASTM F 1538 : 2024 | Standard Specification for Glass and Glass-Ceramic Biomaterials for Implantation |
| ASTM F 1925 : 1999 : EDT 1 | Standard Specification for Virgin Poly(L-Lactic Acid) Resin for Surgical Implants |
| ASTM F 1855 : 2000 : R2005 | Standard Specification for Polyoxymethylene (Acetal) for Medical Applications |
| ASTM F 1537 : 2007 | Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
| ASTM E 1298 : 1989 : R1994 | Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products |
| ASTM F 1377 : 2013 | Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) |
| ASTM F 1472 : 2008 | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| ASTM F 1377 : 2004 | Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) |
| ASTM F 1472 : 2020 : REV A | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| ASTM F 1538 : 2003 : R2017 | Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation |
| ASTM F 2848 : 2016 | Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
| ASTM F 2150 : 2002 : EDT 1 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
| 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 D 1898 : 1968 : R1989 | Standard Practice for Sampling of Plastics (Withdrawn 1998) |
| 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 F 639 : 2009 : R2024 | Standard Specification for Polyethylene Plastics for Medical Applications |
| ASTM F 2347 : 2024 | Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
| ASTM F 3160 : 2016 | Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants |
| ASTM F 1579 : 2002 | Standard Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications |
| ASTM F 2026 : 2016 | Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| 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 2212 : 2008 | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 1581 : 2008 : EDT 1 | Standard Specification for Composition of Anorganic Bone for Surgical Implants |
| ASTM F 1538 : 2003 : EDT 1 | Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation |
| ASTM E 1298 : 2006 | Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014) |
| ASTM F 624 : 2009 : R2015 : EDT 1 | Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications |
| ASTM F 1472 : 2014 | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| ASTM F 648 : 2014 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
| ASTM F 2026 : 2012 | Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| ASTM F 1537 : 2020 | Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
| ASTM F 1873 : 1998 | Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications (Withdrawn 2007) |
| ASTM F 1713 : 2008 : R2021 : EDT 1 | Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130) |
| ASTM F 1925 : 2022 | Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
| ASTM F 1635 : 1995 | Standard Test Method for In Vitro Degradation Testing of Poly (L-lactic Acid) Resin and Fabricated Form for Surgical Implants |
| ASTM F 1634 : 1995 : R2016 | Standard Practice for <emph type="bdit">In-Vitro</emph> Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices (Withdrawn 2017) |
| ASTM F 2026 : 2023 | Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| ASTM F 2064 : 2017 | Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
| ASTM F 2103 : 2011 | Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications |
| ASTM F 1635 : 2004 | Standard Test Method for <i>in Vitro</i> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
| ASTM F 1088:2004 | Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation |
| ASTM F 90 : 2023 | Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605) |
| ASTM F 641 : 2009 : R2014 | Standard Specification for Implantable Epoxy Electronic Encapsulants |
| ASTM F 2212 : 2002 : R2007 | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 2212 : 2009 | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 2103 : 2001 : R2007 : EDT 2 | Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications |
| ASTM F 1877 : 2016 | Standard Practice for Characterization of Particles |
| ASTM F 1088 : 2004 : REV A : R2010 | Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation |
| ASTM F 665 : 2009 : R2024 | Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application |
| ASTM F 1472 : 1999 | Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy (UNS R56400) for Surgical Implant Applications |
| ASTM D 1763 : 2000 : R2005 | Standard Specification for Epoxy Resins |
| ASTM F 2579 : 2010 | Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
| ASTM D 1763 : 2000 : R2013 | Standard Specification for Epoxy Resins |
| ASTM F 648 : 2021 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
| ASTM F 603 : 2012 : R2020 | Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application |
| ASTM F 2347 : 2011 | Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
| 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 1877 : 1998 | Standard Practice for Characterization of Particles |
| ASTM F 1538 : 2003 | Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation |
| ASTM F 2579 : 2006 | Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
| ASTM F 1581:2008 | Standard Specification for Composition of Anorganic Bone for Surgical Implants |
| 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 F 1634 : 1995 : R2008 | Standard Practice for <span class="bdit">In-Vitro</span> Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices |
| 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 F 560 : 2017 | Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) |
| ASTM F 2260 : 2003 : R2012 : EDT 1 | Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (<sup>1</sup>H NMR) Spectroscopy |
| ASTM F 1537 : 2000 | Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
| ASTM F 1877 : 2005 : R2010 | Standard Practice for Characterization of Particles |
| ASTM F 1877 : 2005 : EDT 1 | Standard Practice for Characterization of Particles |
| ASTM F 2150 : 2007 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
| ASTM F 1377 : 2008 | Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) |
| ASTM F 2347 : 2015 | Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
| ASTM F 641 : 2009 : R2023 | Standard Specification for Implantable Epoxy Electronic Encapsulants |
| ASTM F 639 : 2009 : R2015 | Standard Specification for Polyethylene Plastics for Medical Applications |
| ASTM F 702 : 1998 : REV A | Standard Specification for Polysulfone Resin for Medical Applications |
| ASTM F 3160 : 2021 | Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants |
| ASTM F 1713 : 2003 | Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications |
| ASTM F 1634 : 1995 : R2000 | Standard Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices |
| 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 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 1581 : 2008 : R2012 | Standard Specification for Composition of Anorganic Bone for Surgical Implants |
| ASTM F 136 : 2013 | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) |
| ASTM F 1579 : 2002 : EDT 1 | Standard Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications (Withdrawn 2011) |
| ASTM F 1185 : 2003 : R2014 | Standard Specification for Composition of Hydroxylapatite for Surgical Implants |
| ASTM F 1088 : 1987 : R1992 : EDT 1 | Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation |
| ASTM F 1855 : 2000 | Standard Specification for Polyoxymethylene (Acetal) for Medical Applications |
| ASTM F 1855 : 2000 : R2011 | Standard Specification for Polyoxymethylene (Acetal) for Medical Applications |
| ASTM F 1635 : 2011 | Standard Test Method for <i>in vitro</i> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
| ASTM F 1472 : 2008 : EDT 1 | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| ASTM F 136 : 2013 : R2021 : EDT 1 | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) |
| ASTM F 1185 : 2003 : R2009 | Standard Specification for Composition of Hydroxylapatite for Surgical Implants |
| ASTM F 2026 : 2000 | Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| ASTM F 1251 : 1989 : R2003 | Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012) |
| ASTM F 2212 : 2008 : EDT 1 | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 1876 : 1998 | Standard Specification for Polyetherketoneetherketoneketone (PEKEKK) Resins for Surgical Implant Applications |
| ASTM F 1713 : 1996 | Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications |
| ASTM F 1635 : 2004 : REV A | Standard Test Method for <i>in Vitro</i> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
| ASTM F 2026 : 2002 | Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| ASTM F 1088 : 2018 | Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation |
| ASTM F 1925 : 1999 : R2005 | Standard Specification for Virgin Poly(L-Lactic Acid) Resin for Surgical Implants |
| ASTM F 2848 : 2017 | Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
| ASTM F 2026 : 2007 : REV A | Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| ASTM F 90 : 2014 | Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605) |
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