ASTM F2027 - 08

    Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products

    Active Standard ASTM F2027 | Developed by Subcommittee: F04.42

    Book of Standards Volume: 13.01


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    Abstract

    This guide addresses material characteristics of raw or virgin materials in a nonfabricated form that will ultimately undergo additional processing into growth, support, or delivery vehicles for cells or biomolecules. The substrate material shall have specifications for an extensive set of chemical and physical properties prescribed. Test methods shall be performed in order to determine the chemical and physical properties of the material.

    This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

    Significance and Use

    The physico-chemical characteristics of the raw or starting biomaterial used in regenerative medicine scaffolds carries significant potential to affect product performance by influencing cell behavior and/or the release of bioactive molecules or drugs. This guide describes recommended specifications or characterizations of raw or starting biomaterials to ensure reproducibility prior to their fabrication into implantable tissue engineering scaffolds and/or controlled release matrices.

    1. Scope

    1.1 This document provides guidance on writing a materials specification for raw or starting biomaterials intended for use in tissue engineering scaffolds for growth, support, or delivery of cells and/or biomolecules. This guide does not apply to biomaterials 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 biomaterials already commonly used within medical products and to provide characterization guidance for interim use of raw biomaterials 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 intend use may be required.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    D1763 Specification for Epoxy Resins

    D1898 Practice for Sampling of Plastics

    E1298 Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products

    F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

    F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

    F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)

    F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

    F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

    F139 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)

    F451 Specification for Acrylic Bone Cement

    F560 Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)

    F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)

    F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563)

    F602 Criteria for Implantable Thermoset Epoxy Plastics

    F603 Specification for High-Purity Dense Aluminum Oxide for Medical Application

    F604 Specification for Silicone Elastomers Used in Medical Applications

    F619 Practice for Extraction of Medical Plastics

    F624 Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications

    F639 Specification for Polyethylene Plastics for Medical Applications

    F641 Specification for Implantable Epoxy Electronic Encapsulants

    F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

    F665 Classification for Vinyl Chloride Plastics Used in Biomedical Application

    F702 Specification for Polysulfone Resin for Medical Applications

    F755 Specification for Selection of Porous Polyethylene for Use in Surgical Implants

    F997 Specification for Polycarbonate Resin for Medical Applications

    F1088 Specification for Beta-Tricalcium Phosphate for Surgical Implantation

    F1185 Specification for Composition of Hydroxylapatite for Surgical Implants

    F1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices

    F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

    F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

    F1538 Specification for Glass and Glass Ceramic Biomaterials for Implantation

    F1579 Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications

    F1581 Specification for Composition of Anorganic Bone for Surgical Implants

    F1634 Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices

    F1635 Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

    F1713 Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)

    F1855 Specification for Polyoxymethylene (Acetal) for Medical Applications

    F1873 Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications

    F1876 Specification for Polyetherketoneetherketoneketone (PEKEKK) Resins for Surgical Implant Applications

    F1877 Practice for Characterization of Particles

    F1925 Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants

    F1926 Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings

    F2064 Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application

    F2103 Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications

    F2150 Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products

    F2212 Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)

    F2259 Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy

    F2260 Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy

    F2347 Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications

    Other Document

    U.S.Pharmacopeia,Edi or current edition Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.


    ICS Code

    ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

    UNSPSC Code

    UNSPSC Code 42295525(Biological tissue implant)


    DOI: 10.1520/F2027-08

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