ASTM F2150-02e1

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

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.

General Information

• Status: Historical
• Publication Date: 09-Jan-2002
• ICS: 11.020 - Medical sciences and health care facilities in general
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.42 - Biomaterials and Biomolecules for TEMPs

Relations

• Replaced By: ASTM F2150-07 - Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
• Effective Date: 01-Dec-2007
• Referred By: ASTM F2884-21 - Standard Guide for Pre-clinical <emph type="bdit">in vivo</emph> Evaluation of Spinal Fusion
• Effective Date: 10-Jan-2002
• Referred By: ASTM F2211-13(2021) - Standard Classification for Tissue-Engineered Medical Products (TEMPs)
• Effective Date: 10-Jan-2002
• Referred By: ASTM F3225-17(2022) - Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
• Effective Date: 10-Jan-2002
• Referred By: ASTM F2721-09(2023) - Standard Guide for Preclinical <emph type="ital">in vivo</emph> Evaluation in Critical-Size Segmental Bone Defects
• Effective Date: 10-Jan-2002
• Referred By: ASTM F2603-06(2020) - Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
• Effective Date: 10-Jan-2002
• Referred By: ASTM F3274-21 - Standard Guide for Testing and Characterization of Alginate Foam Scaffolds Used in Tissue-Engineered Medical Products (TEMPs)
• Effective Date: 10-Jan-2002
• Referred By: ASTM F3510-21 - Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products
• Effective Date: 10-Jan-2002
• Referred By: ASTM F3163-22 - Standard Guide for Categories and Terminology of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds
• Effective Date: 10-Jan-2002
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 10-Jan-2002
• Referred By: ASTM F3354-19 - Standard Guide for Evaluating Extracellular Matrix Decellularization Processes
• Effective Date: 10-Jan-2002
• Referred By: ASTM F3223-17 - Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction
• Effective Date: 10-Jan-2002
• Referred By: ASTM F2450-18 - Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
• Effective Date: 10-Jan-2002

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
e1
Designation:F2150–02
Standard Guide for
Characterization and Testing of Biomaterial Scaffolds Used
in Tissue-Engineered Medical Products
This standard is issued under the fixed designation F 2150; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
e NOTE—The designation, year date, and footnote 1 were editorially corrected in June 2002.
1. Scope D 648 Test Method for Deflection Temperature of Plastics
Under Flexural Load in the Edgewise Position
1.1 This guide is a resource of currently available test
D 671 Test Method for Flexural Fatigue of Plastics by
methods for the characterization of biomaterial scaffolds used
Constant-Amplitude-of-Force
to develop and manufacture tissue-engineered medical prod-
D 695 Test Method for Compressive Properties of Rigid
ucts (TEMPs).
Plastics
1.2 The test methods contained herein guide characteriza-
D 747 Test Method for Apparent Bending Modulus of
tion of the bulk physical, chemical, mechanical, and surface
Plastics by Means of a Cantilever Beam
properties of a scaffold construct. Such properties may be
D 790 TestMethodsforFlexuralPropertiesofUnreinforced
important for the success of a TEMP, especially if they affect
and Reinforced Plastics and Electrical Insulating Materi-
cell retention, activity and organization, the delivery of bioac-
als
tive agents, or the biocompatibility and bioactivity within the
D 792 TestMethodsforDensityandSpecificGravity(Rela-
final product.
tive Density) of Plastics by Displacement
1.3 This guide may be used as guidance in the selection of
D 882 Test Method for Tensile Properties of Thin Plastic
appropriatetestmethodsforthegenerationofarawmaterialor
Sheeting
original equipment manufacture (OEM) specification. This
D 1042 Test Method for Linear Dimensional Changes of
guide also may be used to characterize the scaffold component
Plastics Under Accelerated Service Conditions
of a finished medical product.
D 1238 Test Method for Flow Rates of Thermoplastics by
1.4 This guide addresses natural, synthetic, or combination
Extrusion Plastometer
scaffold materials with or without bioactive agents or biologi-
D 1388 Test Method for Stiffness of Fabrics
cal activity. This guide does not address the characterization or
D 1621 Test Method for Compressive Properties of Rigid
release profiles of any biomolecules, cells, drugs, or bioactive
Cellular Plastics
agents that are used in combination with the scaffold.
D 1623 Test Method for Tensile and Tensile Adhesion
1.5 This standard does not purport to address all of the
Properties of Rigid Cellular Plastics
safety concerns, if any, associated with its use. It is the
D 1708 Test Method for Tensile Properties of Plastics by
responsibility of the user of this standard to establish appro-
Use of Microtensile Specimens
priate safety and health practices and determine the applica-
D 1898 Practice for Sampling of Plastics
bility of regulatory requirements prior to use.
D 2857 Practice for Dilute Solution Viscosity of Polymers
2. Referenced Documents D 2873 Test Method for Interior Porosity of Poly(Vinyl
Chloride) (PVC) Resins by Mercury Intrusion Porosim-
2.1 ASTM Standards:
etry
D 412 Test Methods for Vulcanized Rubber and Thermo-
D 2990 Test Methods for Tensile, Compressive, and Flex-
plastic Rubbers and Thermoplastic Elastomers—Tension
ural Creep and Creep-Rupture of Plastics
D 570 Test Method for Water Absorption of Plastics
D 3016 Practice for Use of Liquid Exclusion Chromatogra-
D 638 Test Method for Tensile Properties of Plastics
phy Terms and Relationships
D 3039/D 3039M Test Method for Tensile Properties of
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.43 on Tissue Engineered Biomaterials.
Current edition approved Jan. 10, 2002. Published January 2002. Annual Book of ASTM Standards, Vol 07.01.
2 5
Annual Book of ASTM Standards, Vol 09.01. Discontinued 1998; see 1997 Annual Book of ASTM Standards, Vol 08.01.
3 6
Annual Book of ASTM Standards, Vol 08.01. Annual Book of ASTM Standards, Vol 08.02.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
e1
F2150–02
Polymer Matrix Composite Materials E 967 Practice for Temperature Calibration of Differential
D 3417 Test Method for Enthalpies of Fusion and Crystal- Scanning Calorimeters and Differential Thermal Analyz-
ers
lization of Polymers by Differential Scanning Calorimetry
(DSC) E 968 Practice for Heat Flow Calibration of Differential
Scanning Calorimeters
D 3418 Test Method for Transition Temperatures of Poly-
E 996 Practice for Reporting Data in Auger Electron Spec-
mers by Differential Scanning Calorimetry
troscopy and X-Ray Photoelectron Spectroscopy
D 4001 Test Method for Determination of Weight-Average
E 1078 Guide for Procedures for Specimen Preparation and
Molecular Weight of Polymers by Light Scattering
Mounting in Surface Analysis
D 4404 Test Method for Determination of Pore Volume and
E 1142 Terminology Relating to Thermophysical Proper-
Pore Volume Distribution of Soil and Rock by Mercury
ties
Intrusion Porosimetry
E 1294 Test Method for Pore Size Characteristics of Mem-
D 4603 Test Method for Determining Inherent Viscosity of
brane Filters Using Automated Liquid Porosimeter
Poly(Ethylene Terephthalate) (PET) by Glass Capillary
E 1298 Guide for Determination of Purity, Impurities, and
Viscometer
9 Contaminants in Biological Drug Products
D 5226 Practice for Dissolving Polymer Materials
E 1356 Test Method forAssignment of the Glass Transition
D 5296 Test Method for Molecular Weight Averages and
Temperatures by Differential Scanning Calorimetry or
Molecular Weight Distribution of Polystyrene by High
Differential Thermal Analysis
Performance Size-Exclusion Chromatography
E 1642 Practice for General Techniques of Gas Chromatog-
D 5732 Test Method for Stiffness of Nonwoven Fabrics
raphy Infrared (GC/IR) Analysis
Using the Cantilever Test
E 1829 Guide for Handling Specimens Prior to Surface
D 6125 Test Method for Bending Resistance of Paper and
Analysis
Paperboard (Gurley Type Tester)
F 151 TestMethodforResidualSolventsinFlexibleBarrier
D 6420 Test Method for Determination of Gaseous Organic
Materials
Compounds by Direct Interface Gas Chromatography-
F 316 Test Method for Pore Size Characteristics of Mem-
Mass Spectrometry
brane Filters by Bubble Point and Mean Flow Pore Test
D 6474 Test Method for Determining Molecular Weight
F 748 Practice for Selecting Generic Biological Test Meth-
Distribution and Molecular Weight Averages of Polyole-
ods for Materials and Devices
fins by High Temperature Gel Permeation Chromatogra-
F 1249 Test Method for Water Vapor Transmission Rate
phy
Through Plastic Film and Sheeting Using a Modulated
D 6539 TestMethodforMeasurementofPneumaticPerme-
Infrared Sensor
ability of Partially Saturated Porous Materials by Flowing
F 1251 Terminology Relating to Polymeric Biomaterials in
Air
Medical and Surgical Devices
D 6579 Practice for Molecular Weight Averages and Mo-
F 1634 Practice for In-Vitro Environmental Conditioning of
lecular Weight Distribution of Hydrocarbon and Terpene
Polymer Matrix Composite Materials and Implant De-
Resins by Size-Exclusion Chromatography 20
vices
E 128 Test Method for Maximum Pore Diameter and Per-
F 1635 Test Method for In Vitro Degradation Testing of
meability of Rigid Porous Filters for Laboratory Use
Poly (L-lactic Acid) Resin and Fabricated Form for Surgi-
E 177 Practice for Use of the Terms Precision and Bias in
cal Implants
ASTM Test Methods
F 1884 Test Method for Determining Residual Solvents in
E 456 Terminology for Relating to Quality and Statistics
Packaging Materials
E 473 Terminology Relating to Thermal Analysis
F 1980 Guide for Accelerated Aging of Sterile Medical
E 691 Practice for Conducting an Interlaboratory Study to Device Packages
Determine the Precision of a Test Method
F 1983 Practice for Assessment of Compatibility of
E 793 Test Method for Enthalpies of Fusion and Crystalli- Absorbable/Resorbable Biomaterials for Implant Applica-
16 11
zation by Differential Scanning Calorimetry tions
F 2025 Practice for Gravimetric Measurement of Polymeric
E 794 Test Method for Melting and Crystallization Tem-
peratures By Thermal Analysis Components for Wear Assessment
F 2027 Guide for Characterization and Testing of Substrate
Materials for Tissue-Engineered Medical Products
G 120 Practice for Determination of Soluble Residual Con-
Annual Book of ASTM Standards, Vol 15.03.
tamination in Materials and Components by Soxhlet Ex-
Annual Book of ASTM Standards, Vol 04.08.
traction
Annual Book of ASTM Standards, Vol 08.03.
Annual Book of ASTM Standards, Vol 07.02.
Annual Book of ASTM Standards, Vol 15.09.
Annual Book of ASTM Standards, Vol 11.03.
13 17
Annual Book of ASTM Standards, Vol 04.09. Annual Book of ASTM Standards, Vol 03.06.
14 18
Annual Book of ASTM Standards, Vol 06.03. Annual Book of ASTM Standards, Vol 11.05.
15 19
Annual Book of ASTM Standards, Vol 14.04. Discontinued 1995; see 1994 Annual Book of ASTM Standards, Vol 11.02.
16 20
Annual Book of ASTM Standards, Vol 14.02. Annual Book of ASTM Standards, Vol 13.01.
e1
F2150–02
2.2 AAMI Standards: Source: General Tests and Assays—USP24/NF19, Jan. 1,
AAMI STBK9-1 Sterilization—Part 1: Sterilization in
Health Care Facilities
3. Terminology
AAMI STBK9-2 Sterilization—Part 2: Sterilization Equip-
3.1 Unless provided otherwise in 3.2, terminology shall be
ment
in conformance with Terminology F 1251.
AAMI STBK9-3 Sterilization—Part 3: Industrial Process
21 3.2 Definitions:
Control
3.2.1 bioactive agents, n—any molecular component in, on,
2.3 ANSI Standards:
or with the interstices of a device that is intended to elicit a
ANSI/ISO/ASQ Q9000-2000: Quality Management
desired tissue or cell response. Growth factors, antibiotics, and
Systems—Fundamentals and Vocabulary
antimicrobialsaretypicalexamplesofbioactiveagents.Device
ANSI/ISO/ASQ Q9001-2000: Quality Management Sys-
structural components or degradation byproducts that evoke
tems: Requirements
limited localized bioactivity are not included.
2.4 British Standards Institute:
3.2.2 pores, n—an inherent or induced network of channels
British Standard—Animal Tissues and Their Derivatives
and open spaces within an otherwise solid structure.
Utilized in the Manufacture of Medical Devices—Part 1:
3.2.3 porometry, n—the determination of the distribution of
Analysis and Management of Risk (EN 12442-1)
pore diameters relative to direction of fluid flow by the
British Standard—Animal Tissues and Their Derivatives
displacement of a wetting liquid as a function of pressure.
Utilized in the Manufacture of Medical Devices—Part 2:
3.2.4 porosimetry,n—thedeterminationofporevolumeand
Controls on Sourcing, Collection, and Handling (EN
pore size distribution through the use of a nonwetting liquid
12442-2)
(typically mercury) intrusion into a porous material as a
British Standard—Animal Tissues and Their Derivatives function of pressure.
Utilized in the Manufacture of Medical Devices—Part 3: 3.2.5 porosity, n—property of a solid which contains an
Validation of the Elimination and/or Inactivation of Vi- inherent or induced network of channels and open spaces.
ruses and Transmissible Agents (EN 12442-3) Porosity can be measured by the ratio of pore (void) volume to
2.5 ISO Standards: the apparent (total) volume of a porous material and is
commonly expressed as a percentage.
ISO 1133-1991 Determination of the Melt-Mass Flow Rate
3.2.6 scaffold, n—a support, delivery vehicle, or matrix for
(MFR) and the Melt Volume-Flow Rate (MVR) of Ther-
facilitating the migration, binding, or transport of cells or
moplastics
bioactive molecules used to replace, repair, or regenerate
ISO 10993-9 Biological Evaluation of Medical Devices—
tissues.
Part 9: Degradation of Materials Related to Biological
22 3.2.6.1 Discussion—ASTMCommitteeF04iscontinuingto
Testing
refine definitions for the terms tissue engineering, tissue-
ISO 10993-13 Biological Evaluation of Medical Devices—
engineered medical products (TEMPs), and scaffold. Final
Part 13: Identification and Quantification of Degradation
definitions will be from consideration of Committee F04 and
Products from Polymers
other resources such as The Williams Dictionary of Biomate-
ISO 10993-14 Biological Evaluation of Medical Devices—
rials (9) and will be balloted at a later date.
Part 14: Identification and Quantification of Degradation
Products from Ceramics
4. Summary of Guide
ISO 10993-15 Biological Evaluation of Medical Devices—
4.1 The physicochemical and three-dimensional character-
Part 15: Identification and Quantification of Degradation
istics of the scaffold material are expected to influence the
Products from Coated and Uncoated Metals and Alloys
properties of TEMPs. It is the intent of this guide to provide a
ISO 11357-1 Plastics—Differential Scanning Calorimetry
compendium of materials characterization techniques for prop-
(DSC)—Part 1: General Principles
erties that may be related directly to the functionality of
ISO 11357-2 Plastics—Differential Scanning Calorimetry
scaffolds for TEMPs.
(DSC)—Part 2: Determination of Glass Transition Tem-
4.2 Numerous general areas of characterization also should
perature
be considered when developing a scaffold for TEMPs.Among
2.6 U.S. Code of Federal Regulations:
these are compositional identity, physical and chemical prop-
Title 21—Food and Drugs Services, Part 820—Quality erties or characteristics, viable sterilization techniques,
System Regulation (21 CFR Part 820) degradability/resorbability, and mechanical properties.
2.7 U.S. Pharmacopeia (USP) Standards: 4.3 Application of the test methods contained within this
guide do not guarantee clinical success of a finished product
but will help to ensure consistency in the properties and
characterization of a given scaffold material.
Available from the Association for the Advancement of Medical Instrumen-
tation, 1110 N. Glebe Rd., Suite 220, Arlington, VA 22201-4795.
Available from American National Standards Institute, 25 W. 43rd St., 4th
Floor, New York, NY 10036. Available from U.S. Pharmacopeia, 12601 Twinbrook Pkwy., Rockville, MD
Available from the Superintendent of Docum
...