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

01-10-2016

Publisher

American Society for Testing and Materials

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.

Committee	F 04
DocumentType	Guide
Pages	7
PublisherName	American Society for Testing and Materials
Status	Current
Supersedes	ASTM F 2027 : 2008

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ASTM F 2900 : 2011	Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)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 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 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 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 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 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 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 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 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 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)