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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.
1.1 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.
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 DocumentU.S.Pharmacopeia,Edi or current edition Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42295525(Biological tissue implant)