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    ASTM F2150 - 19

    Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products

    Active Standard ASTM F2150 | Developed by Subcommittee: F04.42

    Book of Standards Volume: 13.01

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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 non-absorbable/non-degradable. 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).15 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 used 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: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm This database provides a resource for locating FDA-recognized consensus standards for medical products.

    5.4.2 FDA-CDRH Good Guidance Practice (GGP) Database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfggp/search.cfm 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. 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: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm

    5.4.4 FDA-CDRH 510(k) (Premarket Notification) Database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

    1. Scope

    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 in the development and manufacture of regenerative medicine and 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 the property affects 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 used in conjunction with appropriate characterization(s) and evaluation(s) of any raw or starting material(s) used 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, but may be used to address the effects on other (e.g., structural) properties as a result of such release. 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, 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.

    ASTM Standards

    D412 Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTension

    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

    E384 Test Method for Microindentation Hardness of Materials

    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

    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

    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 Selected Tissue Effects of Absorbable 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 Materials 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

    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

    AAMI Standards

    AAMI STBK-1 SterilizationPart 1: Sterilization in Health Care Facilities

    AAMI STBK-2 SterilizationPart 2: Sterilization Equipment

    AAMI STBK-3 SterilizationPart 3: Industrial Process Control

    ICS Code

    ICS Number Code 11.020 (Medical sciences and health care facilities in general)

    UNSPSC Code

    UNSPSC Code 85131700(Medical science and research)

    Referencing This Standard
    Link Here
    Link to Active (This link will always route to the current Active version of the standard.)

    DOI: 10.1520/F2150-19

    Citation Format

    ASTM F2150-19, Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products, ASTM International, West Conshohocken, PA, 2019, www.astm.org

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