ASTM F2027-16

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

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STANDARD published on 1.10.2016

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The information about the standard:

Designation standards: ASTM F2027-16
Note: WITHDRAWN
Publication date standards: 1.10.2016
SKU: NS-670550
The number of pages: 7
Approximate weight : 21 g (0.05 lbs)
Country: American technical standard
Category: Technical standards ASTM

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The category - similar standards:

Implants for surgery, prosthetics and orthotics

Annotation of standard text ASTM F2027-16 :

Keywords:

biomaterials, ceramics, composites, materials, metals, natural products, polymers, regenerative medicine, tissue-engineered medical products,, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Additional information

Significance and Use

4.1 The physico-chemical characteristics of the raw or starting material 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 materials 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 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.

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