ASTM F2150-02e1 - 10.1.2002
 
1. Scope

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.

 
2. Referenced Documents

F1249-20

Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor

E1294-89(1999)

Standard Test Method for Pore Size Characteristics of Membrane Filters Using Automated Liquid Porosimeter (Withdrawn 2008)

D747-10

Standard Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever Beam (Withdrawn 2019)

E793-06(2018)

Standard Test Method for Enthalpies of Fusion and Crystallization by Differential Scanning Calorimetry

E794-06(2018)

Standard Test Method for Melting And Crystallization Temperatures By Thermal Analysis

E967-18

Standard Test Method for Temperature Calibration of Differential Scanning Calorimeters and Differential Thermal Analyzers

E968-02

Standard Practice for Heat Flow Calibration of Differential Scanning Calorimeters

E996-19

Standard Practice for Reporting Data in Auger Electron Spectroscopy and X-ray Photoelectron Spectroscopy

E691-23

Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

D412-16(2021)

Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension

D570-22

Standard Test Method for Water Absorption of Plastics

D638-22

Standard Test Method for Tensile Properties of Plastics

D648-18

Standard Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position

D695-23

Standard Test Method for Compressive Properties of Rigid Plastics

D3016-97(2018)

Standard Practice for Use of Liquid Exclusion Chromatography Terms and Relationships

D3039/D3039M-17

Standard Test Method for Tensile Properties of Polymer Matrix Composite Materials

D6474-20

Standard Test Method for Determining Molecular Weight Distribution and Molecular Weight Averages of Polyolefins by High Temperature Gel Permeation Chromatography

D6539-13

Standard Test Method for Measurement of the Permeability of Unsaturated Porous Materials by Flowing Air (Withdrawn 2022)

D6579-11(2020)

Standard Practice for Molecular Weight Averages and Molecular Weight Distribution of Hydrocarbon, Rosin and Terpene Resins by Size-Exclusion Chromatography

E128-99(2019)

Standard Test Method for Maximum Pore Diameter and Permeability of Rigid Porous Filters for Laboratory Use

E177-20

Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods

E456-13a(2022)

Standard Terminology Relating to Quality and Statistics (Includes all amendments and changes 4/21/2022).

E473-23b

Standard Terminology Relating to Thermal Analysis and Rheology (Includes all amendments and changes 10/5/2023).

D1238-23a

Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer (Includes all amendments and changes 12/6/2023).

D3418-21

Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry

D4001-20

Standard Test Method for Determination of Weight-Average Molecular Weight of Polymers by Light Scattering

D4404-18

Standard Test Method for Determination of Pore Volume and Pore Volume Distribution of Soil and Rock by Mercury Intrusion Porosimetry

D4603-18

Standard Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer

D5226-21

Standard Practice for Dissolving Polymer Materials

D1042-22

Standard Test Method for Linear Dimensional Changes of Plastics Caused by Exposure to Heat and Moisture

D5296-19

Standard Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography

D6420-18

Standard Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography-Mass Spectrometry

D1388-23

Standard Test Method for Stiffness of Fabrics

D1621-16(2023)

Standard Test Method for Compressive Properties of Rigid Cellular Plastics

D1623-17(2023)

Standard Test Method for Tensile and Tensile Adhesion Properties of Rigid Cellular Plastics

D1708-18

Standard Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens

D2857-22

Standard Practice for Dilute Solution Viscosity of Polymers

D2990-17

Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics

F1983-23

Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications

F2025-06(2018)

Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment

F2027-16

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

F2212-20

Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)

F2312-11(2020)

Standard Terminology Relating to Tissue Engineered Medical Products

F2450-18

Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products

F2603-06(2020)

Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds

F2791-24

Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions

F2809-10

Standard Terminology Relating to Medical and Surgical Materials and Devices (Withdrawn 2019)

F2883-11

Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020)

F2900-11

Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)

F2902-16e1

Standard Guide for Assessment of Absorbable Polymeric Implants (Includes all amendments and changes 6/8/2017).

G120-15(2023)

Standard Practice for Determination of Soluble Residual Contamination by Soxhlet Extraction

D882-18

Standard Test Method for Tensile Properties of Thin Plastic Sheeting

F1635-16

Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

F1884-04(2023)

Standard Test Methods for Determining Residual Solvents in Packaging Materials

F1980-21

Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices

D792-20

Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement

F1634-95(2000)

Standard Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices

D790-17

Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials

E1078-14(2020)

Standard Guide for Specimen Preparation and Mounting in Surface Analysis

E1142-23b

Standard Terminology Relating to Thermophysical Properties (Includes all amendments and changes 10/5/2023).

E1298-06

Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)

E1356-23

Standard Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry

E1642-00(2016)

Standard Practice for General Techniques of Gas Chromatography Infrared (GC/IR) Analysis

E1829-14(2020)

Standard Guide for Handling Specimens Prior to Surface Analysis

E1994-09(2023)

Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans

F316-03(2019)

Standard Test Methods for Pore Size Characteristics of Membrane Filters by Bubble Point and Mean Flow Pore Test

F748-16

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices