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Significance and Use
5.1 Scaffolds potentially may be metallic, ceramic, polymeric, natural, or composite materials. Scaffolds are usually porous to some degree, but may be solid. Scaffolds can range from mechanically rigid to gelatinous and can be either absorbable/degradable or nonresorbable/nondegradable. The scaffold may or may not have a surface treatment. Because of this large breadth of possible starting materials and scaffold constructions, this guide cannot be considered as exhaustive in its listing of potentially applicable tests. A voluntary guidance for the development of tissue-engineered products can be found in Omstead, et al (1).13 Guide F2027 contains a listing of potentially applicable test methods specific to various starting materials. Guidance regarding the evaluation of absorbable polymeric materials and constructs can be found in Guide F2902. Guidance regarding the evaluation of collagen-based materials can be found in Guide F2212. Guidance regarding the evaluation of scaffolds composed of ceramic or mineral based material is available in Guide F2883. Similarly, guidance for the assessment of unique aspects of scaffolds based on hydrogels (for example, gel kinetics, mechanical stability, and mass transport properties) may be found in Guide F2900.
5.2 Each TEMP scaffold product is unique and may require testing not within the scope of this guide or other guidance documents. Users of this guide are encouraged to examine the references listed herein and pertinent FDA or other regulatory guidelines or practices, and conduct a literature search to identify other procedures particularly pertinent for evaluation of their specific scaffold material (2,3,4). It is the ultimate responsibility of the TEMP scaffold designer to determine the appropriate testing, whether or not it is described in this guide.
5.3 A listing of potentially applicable tests for characterizing and analyzing the materials utilized to fabricate the scaffold may be found in Guide F2027. However, conformance of a raw material to this and/or any other compendial standard(s) does not, in itself, ensure that the selected material is suitable or that the provided quality is adequate to meet the needs of a particular application. Thus, other characterization procedures may also be relevant and not covered by this guide.
5.4 The following provides a listing of links to U.S. Food & Drug Administration (FDA)—Center for Devices & Radiologic Health (CDRH) web sites that may potentially contain additional guidance relevant to biomaterial scaffolds covered within this document.
5.4.1 Recognized FDA-CDRH Consensus Standards Database:
126.96.36.199 This database provides a resource for locating FDA-recognized consensus standards for medical products.
5.4.2 FDA-CDRH Good Guidance Practice (GGP) Database:
188.8.131.52 This database provides a resource for locating non-binding FDA guidance documents intended for CDRH staff, regulated industry and the public that relate to the processing, content, and evaluation of regulatory submissions, the design, production, manufacturing, and testing of regulated products, and FDA inspection and enforcement procedures.
184.108.40.206 A document within this database possessing content that warrants particular consideration for its potential applicability for tissue engineering scaffolds is Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Final.
5.4.3 FDA-CDRH Premarket Approval (PMA) Database:
5.4.4 FDA-CDRH 510(k) (Premarket Notification) Database:
1.1 This guide is a resource of currently available test methods for the characterization of the compositional and structural aspects of biomaterial scaffolds used to develop and manufacture tissue-engineered medical products (TEMPs).
1.2 The test methods contained herein guide characterization of the bulk physical, chemical, mechanical, and surface properties of a scaffold construct. Such properties may be important for the success of a TEMP, especially if they affect cell retention, activity and organization, the delivery of bioactive agents, or the biocompatibility and bioactivity within the final product.
1.3 This guide may be used in the selection of appropriate test methods for the generation of an original equipment manufacture (OEM) specification. This guide also may be used to characterize the scaffold component of a finished medical product.
1.4 This guide is intended to be utilized in conjunction with appropriate characterization(s) and evaluation(s) of any raw or starting material(s) utilized in the fabrication of the scaffold, such as described in Guide F2027.
1.5 This guide addresses natural, synthetic, or combination scaffold materials with or without bioactive agents or biological activity. This guide does not address the characterization or release profiles of any biomolecules, cells, drugs, or bioactive agents that are used in combination with the scaffold. A determination of the suitability of a particular starting material and/or finished scaffold structure to a specific cell type and/or tissue engineering application is essential, but will require additional in vitro and/or in vivo evaluations considered to be outside the scope of this guide.
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 and health practices and determine the applicability of regulatory requirements prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers--Tension
D570 Test Method for Water Absorption of Plastics
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
D747 Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever Beam
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
D882 Test Method for Tensile Properties of Thin Plastic Sheeting
D1042 Test Method for Linear Dimensional Changes of Plastics Caused by Exposure to Heat and Moisture
D1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
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
D2857 Practice for Dilute Solution Viscosity of Polymers
D2990 Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
D3016 Practice for Use of Liquid Exclusion Chromatography Terms and Relationships
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
D4001 Test Method for Determination of Weight-Average Molecular Weight of Polymers By Light Scattering
D4404 Test Method for Determination of Pore Volume and Pore Volume Distribution of Soil and Rock by Mercury Intrusion Porosimetry
D4603 Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer
D5226 Practice for Dissolving Polymer Materials
D5296 Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography
D6420 Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography-Mass Spectrometry
D6474 Test Method for Determining Molecular Weight Distribution and Molecular Weight Averages of Polyolefins by High Temperature Gel Permeation Chromatography
D6539 Test Method for Measurement of the Permeability of Unsaturated Porous Materials by Flowing Air
D6579 Practice for Molecular Weight Averages and Molecular Weight Distribution of Hydrocarbon, Rosin and Terpene Resins by Size-Exclusion Chromatography
E128 Test Method for Maximum Pore Diameter and Permeability of Rigid Porous Filters for Laboratory Use
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E456 Terminology Relating to Quality and Statistics
E473 Terminology Relating to Thermal Analysis and Rheology
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
E793 Test Method for Enthalpies of Fusion and Crystallization by Differential Scanning Calorimetry
E794 Test Method for Melting And Crystallization Temperatures By Thermal Analysis
E967 Test Method for Temperature Calibration of Differential Scanning Calorimeters and Differential Thermal Analyzers
E968 Practice for Heat Flow Calibration of Differential Scanning Calorimeters
E996 Practice for Reporting Data in Auger Electron Spectroscopy and X-ray Photoelectron Spectroscopy
E1078 Guide for Specimen Preparation and Mounting in Surface Analysis
E1142 Terminology Relating to Thermophysical Properties
E1294 Test Method for Pore Size Characteristics of Membrane Filters Using Automated Liquid Porosimeter
E1298 Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
E1356 Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry
E1642 Practice for General Techniques of Gas Chromatography Infrared (GC/IR) Analysis
E1829 Guide for Handling Specimens Prior to Surface Analysis
E1994 Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
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
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
F1884 Test Methods for Determining Residual Solvents in Packaging Materials
F1980 Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
F1983 Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
F2025 Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment
F2027 Guide for Characterization and Testing of Raw or Starting Biomaterials for 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)
F2312 Terminology Relating to Tissue Engineered Medical Products
F2450 Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
F2603 Guide for Interpreting Images of Polymeric Tissue Scaffolds
F2791 Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
F2809 Terminology Relating to Medical and Surgical Materials and Devices
F2883 Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications
F2900 Guide for Characterization of Hydrogels used in Regenerative Medicine
F2902 Guide for Assessment of Absorbable Polymeric Implants
G120 Practice for Determination of Soluble Residual Contamination by Soxhlet Extraction
ICS Number Code 11.020 (Medical sciences and health care facilities in general)
UNSPSC Code 85131700(Medical science and research)