ASTM F 2150

1.1 This guide is a resource of currently available test methods for the characterization 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 as guidance in the selection of appropriate test methods for the generation of a raw material or 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 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.

1.5 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.

D1042 Test Method for Linear Dimensional Changes of Plastics Under Accelerated Service Conditions
D1238 Test Method for 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
D1898 Practice for Sampling of Plastics
D2857 Practice for Dilute Solution Viscosity of Polymers
D2873 Test Method for Interior Porosity of Poly(Vinyl Chloride) (PVC) Resins by Mercury Intrusion Porosimetry
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
D3417 Test Method for Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry (DSC)
D3418 Test Method for Transition Temperatures of Polymers by Differential Scanning Calorimetry
D4001 Test Method for Determination of Weight-Average Molecular Weight of Polymers by Light Scattering
D412 Test Methods for Vulcanized Rubber and Thermoplastic Rubbers and Thermoplastic Elastomers-Tension
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
D570 Test Method for Water Absorption of Plastics
D5732 Test Method for Stiffness of Nonwoven Fabrics Using the Cantilever Test
D6125 Test Method for Bending Resistance of Paper and Paperboard (Gurley Type Tester)
D638 Test Method for Tensile Properties of Plastics
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
D648 Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position
D6539 Test Method for Measurement of Pneumatic Permeability of Partially Saturated Porous Materials by Flowing Air
D6579 Practice for Molecular Weight Averages and Molecular Weight Distribution of Hydrocarbon and Terpene Resins by Size-Exclusion Chromatography
D671 Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force
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
E1078 Guide for Procedures for Specimen Preparation and Mounting in Surface Analysis
E1142 Terminology Relating to Thermophysical Properties
E128 Test Method for Maximum Pore Diameter and Permeability of Rigid Porous Filters for Laboratory Use
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 or Differential Thermal Analysis
E1642 Practice for General Techniques of Gas Chromatography Infrared (GC/IR) Analysis
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E1829 Guide for Handling Specimens Prior to Surface Analysis
E456 Terminology for Relating to Quality and Statistics
E473 Terminology Relating to Thermal Analysis
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 Practice 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
F1249 Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor
F1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
F151 Test Method for Residual Solvents in Flexible Barrier Materials
F1634 Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices
F1635 Test Method for In Vitro Degradation Testing of Poly (L-lactic Acid) Resin and Fabricated Form for Surgical Implants
F1884 Test Method for Determining Residual Solvents in Packaging Materials
F1980 Guide for Accelerated Aging of Sterile Medical Device Packages
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 Substrate Materials for Tissue-Engineered Medical Products
F316 Test Method 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
G120 Practice for Determination of Soluble Residual Contamination in Materials and Components by Soxhlet Extraction
AAMI STBK9-1 Sterilization-Part 1: Sterilization in Health Care Facilities
AAMI STBK9-2 Sterilization-Part 2: Sterilization Equipment
AAMI STBK9-3 Sterilization-Part 3: Industrial Process Control
ANSI/ISO/ASQ Q9000-2000: Quality Management Systems-Fundamentals and Vocabulary
ANSI/ISO/ASQ Q9001-2000: Quality Management Systems: Requirements
British Standard-Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices-Part 1: Analysis and Management of Risk (EN 12442-1)
British Standard-Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices-Part 2: Controls on Sourcing, Collection, and Handling (EN 12442-2)
British Standard-Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices-Part 3: Validation of the Elimination and/or Inactivation of Viruses and Transmissible Agents (EN 12442-3)
ISO 10993-13 Biological Evaluation of Medical Devices-Part 13: Identification and Quantification of Degradation Products from Polymers
ISO 10993-14 Biological Evaluation of Medical Devices-Part 14: Identification and Quantification of Degradation Products from Ceramics
ISO 10993-15 Biological Evaluation of Medical Devices-Part 15: Identification and Quantification of Degradation Products from Coated and Uncoated Metals and Alloys
ISO 10993-9 Biological Evaluation of Medical Devices-Part 9: Degradation of Materials Related to Biological Testing
ISO 1133-1991 Determination of the Melt-Mass Flow Rate (MFR) and the Melt Volume-Flow Rate (MVR) of Thermoplastics
ISO 11357-1 Plastics-Differential Scanning Calorimetry (DSC)-Part 1: General Principles
ISO 11357-2 Plastics-Differential Scanning Calorimetry (DSC)-Part 2: Determination of Glass Transition Temperature
Source: General Tests and Assays-USP24/NF19, Jan. 1, 2000
Title 21-Food and Drugs Services, Part 820-Quality System Regulation (21 CFR Part 820)

biomaterials; biomedical material; bioresorption; cell seeding; matrix; porometry; porosimetry; porosity; scaffold; 11.020