ASTM F2027-16
Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products

Standard No.

ASTM F2027-16

Release Date

2016

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F2027-16

Scope

1.1 This 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. 1.2 The 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. 1.3 This 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. 1.4 This 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. 1.5 Compliance 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 F2027-16 Referenced Document

• ASTM D1763 Standard Specification for Epoxy Resins
• ASTM D1898 
• ASTM E1298 Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
• ASTM F1088 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
• ASTM F1185 Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants
• ASTM F1251 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
• ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications
• ASTM F1377 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS-R30075)
• ASTM F138 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
• ASTM F139 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)*， 2019-12-01 Update
• ASTM F1472 Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy (UNS R56400) for Surgical Implant Applications
• ASTM F1537 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)*， 2020-03-01 Update
• ASTM F1538 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
• ASTM F1579 Standard Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications
• ASTM F1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants
• ASTM F1634 Standard Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices
• ASTM F1635 Standard Test Method for In Vitro Degradation Testing of Poly (L-lactic Acid) Resin and Fabricated Form for Surgical Implants
• ASTM F1713 Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications
• ASTM F1855 Standard Specification for Polyoxymethylene (Acetal) for Medical Applications*， 2019-12-01 Update
• ASTM F1873 Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications (Withdrawn 2007)*， 2017-08-16 Update
• ASTM F1876 Standard Specification for Polyetherketoneetherketoneketone (PEKEKK) Resins for Surgical Implant Applications
• ASTM F1877 Standard Practice for Characterization of Particles
• ASTM F1925 Standard Specification for Virgin Poly(L-Lactic Acid) Resin for Surgical Implants
• ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications*， 2023-08-01 Update
• ASTM F2064 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications*， 2017-03-01 Update
• ASTM F2103 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications*， 2018-06-01 Update
• ASTM F2150 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products*， 2019-10-01 Update
• ASTM F2212 Standard Guide for Characterization of Type I Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)*， 2024-04-22 Update
• ASTM F2259 Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (¹H NMR) Spectroscopy*， 2024-04-22 Update
• ASTM F2260 Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (¹H NMR) Spectroscopy*， 2018-06-01 Update
• ASTM F2313 Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide*， 2018-12-15 Update
• ASTM F2347 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications*， 2024-04-22 Update
• ASTM F2579 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants*， 2018-12-15 Update
• ASTM F2848 Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns*， 2021-06-01 Update
• ASTM F3160 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants*， 2021-02-01 Update
• ASTM F451 Standard Specification for Acrylic Bone Cement
• ASTM F560 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
• ASTM F562 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)*， 2022-01-01 Update
• ASTM F602 Standard Criteria for Implantable Thermoset Epoxy Plastics
• ASTM F603 Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application
• ASTM F619 Standard Practice for Extraction of Medical Plastics
• ASTM F624 Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
• ASTM F639 Standard Specification for Polyethylene Plastics for Medical Applications
• ASTM F641 Standard Specification for Implantable Epoxy Electronic Encapsulants
• ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants*， 2021-04-01 Update
• ASTM F665 Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
• ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)*， 2017-03-01 Update
• ASTM F702 Standard Specification for Polysulfone Resin for Medical Applications
• ASTM F75 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
• ASTM F755 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
• ASTM F90 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
• ASTM F997 Standard Specification for Polycarbonate Resin for Medical Applications
• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
• ISO 6474 Implants for surgery; ceramic materials based on high purity alumina
• ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories [Standard in French]*， 2017-11-01 Update

ASTM F2027-16 history

• 2016 ASTM F2027-16 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• 2008 ASTM F2027-08 Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products
• 2000 ASTM F2027-00e1 Standard Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical Products
• 2000 ASTM F2027-00 Standard Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical Products