ASTM F2027-00 - 10.5.2000
 
1. Scope

1.1 This guide addresses material characteristics of raw or virgin materials in a non-fabricated form that will ultimately undergo additional processing into growth, support, or delivery vehicles for cells or biomolecules. This guide does not apply to packaged, sterilized, and finished tissue-engineered medical products.

1.2 The purpose of the guide is to assist the developer of tissue-engineered medical products to locate relevant existing standards and test methods and to provide guidance for interim use of materials for which a standard does not exist.

 
2. Referenced Documents

D1898-68(1989)

Standard Practice for Sampling of Plastics (Withdrawn 1998)

E1298-06

Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)

F67-13(2017)

Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

F75-23

Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

D1763-00(2021)

Standard Specification for Epoxy Resins

F90-23

Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)

F2313-18

Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide

F136-13(2021)e1

Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) (Includes all amendments and changes 8/19/2021).

F138-19

Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

F139-19

Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)

F451-21

Standard Specification for Acrylic Bone Cement

F560-22

Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)

F562-22

Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)

F602-09(2015)

Standard Criteria for Implantable Thermoset Epoxy Plastics

F603-12(2020)

Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application

F619-20

Standard Practice for Extraction of Materials Used in Medical Devices

F624-09(2015)e1

Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications (Includes all amendments and changes 12/27/2016).

F639-09(2015)

Standard Specification for Polyethylene Plastics for Medical Applications

F641-09(2023)

Standard Specification for Implantable Epoxy Electronic Encapsulants

F1925-22

Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants

F2026-23

Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

F2064-17

Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications

F2103-18

Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications

F2212-20

Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)

F2259-10

Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy

F2347-15

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

F2848-21

Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns

U.S. Pharmacopeia, Edition XXX

ISBT 128

F702-18

Standard Specification for Polysulfone Resin for Medical Applications

F755-19

Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants

F997-18

Standard Specification for Polycarbonate Resin for Medical Applications

F1088-23

Standard Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices

F1185-23

Standard Specification for Composition of Medical-Grade Hydroxylapatite for Surgical Implants

F1251-89(1995)

Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices

F1377-21

Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)

F1472-23

Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

F1537-20

Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

F1538-24

Standard Specification for Glass and Glass-Ceramic Biomaterials for Implantation

F1579-02

Standard Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications

F1581-08(2020)

Standard Specification for Composition of Anorganic Bone for Surgical Implants

F1634-95(2000)

Standard Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices

F1635-16

Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

F1713-08(2021)e1

Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130) (Includes all amendments and changes 12/8/2021).

F1855-00(2019)

Standard Specification for Polyoxymethylene (Acetal) for Medical Applications

F1873-98

Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications (Withdrawn 2007)

F1876-98

Standard Specification for Polyetherketoneetherketoneketone (PEKEKK) Resins for Surgical Implant Applications

F1877-16

Standard Practice for Characterization of Particles

F648-21

Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

F665-09(2015)

Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application

F2150-19

Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products

F2260-18

Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy

F2579-18

Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants

F3160-21

Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants