ASTM F2150-07
(Guide)Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
SIGNIFICANCE AND USE
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). Guide F 2027 contains a listing of potentially applicable test methods specific to various starting materials.
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.
A listing of potentially applicable tests for characterizing and analyzing the materials utilized to fabricate the scaffold may be found in Guide F 2027. 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.
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...
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 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 F 2027.
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 re...
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Designation: F2150 − 07
StandardGuide for
Characterization and Testing of Biomaterial Scaffolds Used
1
in Tissue-Engineered Medical Products
This standard is issued under the fixed designation F2150; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope priate safety and health practices and determine the applica-
bility of regulatory requirements prior to use.
1.1 This guide is a resource of currently available test
methods for the characterization of the compositional and
2. Referenced Documents
structural aspects of biomaterial scaffolds used to develop and
2
2.1 ASTM Standards:
manufacture tissue-engineered medical products (TEMPs).
D412 Test Methods forVulcanized Rubber andThermoplas-
1.2 The test methods contained herein guide characteriza-
tic Elastomers—Tension
tion of the bulk physical, chemical, mechanical, and surface
D570 Test Method for Water Absorption of Plastics
properties of a scaffold construct. Such properties may be
D638 Test Method for Tensile Properties of Plastics
important for the success of a TEMP, especially if they affect
D648 Test Method for Deflection Temperature of Plastics
cell retention, activity and organization, the delivery of bioac-
Under Flexural Load in the Edgewise Position
tive agents, or the biocompatibility and bioactivity within the
D671 Test Method for Flexural Fatigue of Plastics by
final product.
3
Constant-Amplitude-of-Force (Withdrawn 2002)
1.3 This guide may be used in the selection of appropriate
D695 Test Method for Compressive Properties of Rigid
test methods for the generation of an original equipment
Plastics
manufacture(OEM)specification.Thisguidealsomaybeused
D747 Test Method for Apparent Bending Modulus of Plas-
to characterize the scaffold component of a finished medical
tics by Means of a Cantilever Beam
product.
D790 Test Methods for Flexural Properties of Unreinforced
and Reinforced Plastics and Electrical Insulating Materi-
1.4 This guide is intended to be utilized in conjunction with
als
appropriate characterization(s) and evaluation(s) of any raw or
D792 Test Methods for Density and Specific Gravity (Rela-
starting material(s) utilized in the fabrication of the scaffold,
tive Density) of Plastics by Displacement
such as described in Guide F2027.
D882 Test Method for Tensile Properties of Thin Plastic
1.5 This guide addresses natural, synthetic, or combination
Sheeting
scaffold materials with or without bioactive agents or biologi-
D1042 Test Method for Linear Dimensional Changes of
cal activity.This guide does not address the characterization or
Plastics Under Accelerated Service Conditions
release profiles of any biomolecules, cells, drugs, or bioactive
D1238 Test Method for Melt Flow Rates of Thermoplastics
agents that are used in combination with the scaffold. A
by Extrusion Plastometer
determination of the suitability of a particular starting material
D1388 Test Method for Stiffness of Fabrics
and/or finished scaffold structure to a specific cell type and/or
D1621 Test Method for Compressive Properties of Rigid
tissue engineering application is essential, but will require
Cellular Plastics
additional in vitro and/or in vivo evaluations considered to be
D1623 Test Method for Tensile and Tensile Adhesion Prop-
outside the scope of this guide.
erties of Rigid Cellular Plastics
1.6 This standard does not purport to address all of the
D1708 Test Method forTensile Properties of Plastics by Use
safety concerns, if any, associated with its use. It is the
of Microtensile Specimens
responsibility of the user of this standard to establish appro-
D2857 Practice for Dilute Solution Viscosity of Polymers
1 2
This guide is under the jurisdiction of ASTM Committee F04 on Medical and For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Surgical Materials and Devices and is the direct responsibility of Subcommittee contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
F04.42 on Biomaterials and Biomolecules for TEMPs. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Dec. 1, 2007. Published January 2008. Originally the ASTM website.
´1 3
approved in 2002. Last previous edition approved in 2002 as F2150 – 02 . DOI: The last approved version of this historical standard is referenced on
10.1520/F2150-07. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2150 − 07
D2873 Test Method for Interior Porosity of Poly(Vinyl E967 Test
...
This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
e1
Designation:F2150–02 Designation:F2150–07
Standard Guide for
Characterization and Testing of Biomaterial Scaffolds Used
1
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.
1
e NOTE—The designation, year date, and footnote 1 were editorially corrected in June 2002.
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 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
ofascaffoldconstruct.SuchpropertiesmaybeimportantforthesuccessofaTEMP,especiallyiftheyaffectcellretention,activity
and organization, the delivery of bioactive agents, or the biocompatibility and bioactivity within the final product.
1.3This 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.
1.4This 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
1.3 Thisguidemaybeusedintheselectionofappropriatetestmethodsforthegenerationofanoriginalequipmentmanufacture
(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 F 2027.
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
2
2.1 ASTM Standards:
D 412Test Methods forVulcanized Rubber andThermoplastic Rubbers andThermoplastic Elastomers—Tension Test Methods
for Vulcanized Rubber and Thermoplastic ElastomersTension
D 570 Test Method for Water Absorption of Plastics
D 638 Test Method for Tensile Properties of Plastics
D 648 Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position
D 671 Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force
D 695 Test Method for Compressive Properties of Rigid Plastics
1
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.
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.42
on Biomaterials and Biomolecules for TEMPs.
e1
Current edition approved Dec. 1, 2007. Published January 2008. Originally approved in 2002. Last previous edition approved in 2002 as F 2150 – 02 .
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book ofASTM Standards
, Vol 09.01.volume information, refer to the standard’s Document Summary pag
...
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