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Significance and Use
5.1 The test methods contained herein guide characterization of the structural, physical, chemical, mechanical, and biological properties of a fiber-based construct. Such properties may be important for the success of a TEMP, especially if they affect cell retention; activity and organization; tensile strength; the delivery of bioactive agents; or the biocompatibility and bioactivity of the construct.
5.2 Tests described herein may be used for quality control during manufacturing or to assess how the product may perform its intended clinical function.
5.3 Plans for product development, product characterization, and the regulatory pathway should be discussed with the appropriate regulatory body.
1.1 This guide is a resource for the characterization of fiber-based constructs intended for use in a tissue-engineered medical product (TEMP). There are existing standards that broadly cover scaffolds in a more generalized fashion (Guides , , , , ISO 21560). This guide focuses specifically on fiber-based constructs.
1.2 Fiber-based constructs may be fabricated by many different methods including, but not limited to the following: electrospinning, forcespinning, meltspinning, pneumatospinning, blowspinning, melt-electrowriting, melt extrusion, wet extrusion, fused deposition, liquid crystal deposition, electrochemical alignment, drawing, spinning, knitting, weaving, braiding, powder bed fusion (laser sintering), vat photopolymerization (stereolithography), binder jetting, directed energy deposition, self-assembly (for example, fibrillogenesis), and hybrid approaches. This document is intended to address fibers made by any of these methods, although electrospun fibers are addressed in greater detail in some sections.
1.3 This guide will focus on constructs made of fibers wherein the average fiber diameter is within the range of approximately 100 nm to 100 µm.
1.4 For the purposes of this standard, a “fiber-based construct” is defined as a construct composed of slender, elongated filaments.
1.5 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
C1559 Test Method for Determining Wicking of Fibrous Glass Blanket Insulation (Aircraft Type)
D257 Test Methods for DC Resistance or Conductance of Insulating Materials
D412 Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTension
D638 Test Method for Tensile Properties of Plastics
D648 Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position
D695 Test Method for Compressive Properties of Rigid Plastics
D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D854 Test Methods for Specific Gravity of Soil Solids by Water Pycnometer
D882 Test Method for Tensile Properties of Thin Plastic Sheeting
D1388 Test Method for Stiffness of Fabrics
D1621 Test Method for Compressive Properties of Rigid Cellular Plastics
D1623 Test Method for Tensile and Tensile Adhesion Properties of Rigid Cellular Plastics
D1708 Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens
D1777 Test Method for Thickness of Textile Materials
D1876 Test Method for Peel Resistance of Adhesives (T-Peel Test)
D1894 Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting
D2256/D2256M Test Method for Tensile Properties of Yarns by the Single-Strand Method
D2990 Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
D3039/D3039M Test Method for Tensile Properties of Polymer Matrix Composite Materials
D3418 Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
D3786/D3786M Test Method for Bursting Strength of Textile FabricsDiaphragm Bursting Strength Tester Method
D3787 Test Method for Bursting Strength of TextilesConstant-Rate-of-Traverse (CRT) Ball Burst Test
D4404 Test Method for Determination of Pore Volume and Pore Volume Distribution of Soil and Rock by Mercury Intrusion Porosimetry
D4496 Test Method for D-C Resistance or Conductance of Moderately Conductive Materials
D4833/D4833M Test Method for Index Puncture Resistance of Geomembranes and Related Products
D6420 Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography-Mass Spectrometry
D6539 Test Method for Measurement of the Permeability of Unsaturated Porous Materials by Flowing Air
D6701 Test Method for Determining Water Vapor Transmission Rates Through Nonwoven and Plastic Barriers
D6797 Test Method for Bursting Strength of Fabrics Constant-Rate-of-Extension (CRE) Ball Burst Test
D7264 Test Method for Flexural Properties of Polymer Matrix Composite Materials
E96/E96M Test Methods for Water Vapor Transmission of Materials
E128 Test Method for Maximum Pore Diameter and Permeability of Rigid Porous Filters for Laboratory Use
E793 Test Method for Enthalpies of Fusion and Crystallization by Differential Scanning Calorimetry
E1868 Test Methods for Loss-On-Drying by Thermogravimetry
F316 Test Methods for Pore Size Characteristics of Membrane Filters by Bubble Point and Mean Flow Pore Test
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F1249 Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor
F1306 Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates
F1635 Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
F1983 Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
F2027 Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
F2150 Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and 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)
F2256 Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
F2450 Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
F2475 Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
F2477 Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
F2529 Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
F2603 Guide for Interpreting Images of Polymeric Tissue Scaffolds
F2606 Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems
F2664 Guide for Assessing the Attachment of Cells to Biomaterial Surfaces by Physical Methods
F2739 Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds
F2791 Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
F2900 Guide for Characterization of Hydrogels used in Regenerative Medicine
F2902 Guide for Assessment of Absorbable Polymeric Implants
F2952 Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold
F2997 Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis
F3036 Guide for Testing Absorbable Stents
F3089 Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
F3106 Guide for in vitro Osteoblast Differentiation Assays
F3142 Guide for Evaluation of in vitro Release of Biomolecules from Biomaterials Scaffolds for TEMPs
F3224 Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging
F3259 Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
F3294 Guide for Performing Quantitative Fluorescence Intensity Measurements in Cell-based Assays with Widefield Epifluorescence Microscopy
F3369 Guide for Assessing the Skeletal Myoblast Phenotype
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM F3510-21, Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products, ASTM International, West Conshohocken, PA, 2021, www.astm.orgBack to Top