ASTM F2150-13
(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
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 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).13 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 utilized to fabricate the scaffold may be found in Guide F2027. However, ...
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 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. 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 ...
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Designation: F2150 − 13
Standard Guide 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
D695 Test Method for Compressive Properties of Rigid
final product.
Plastics
1.3 This guide may be used in the selection of appropriate D747 Test Method for Apparent Bending Modulus of Plas-
test methods for the generation of an original equipment
tics by Means of a Cantilever Beam
manufacture(OEM)specification.Thisguidealsomaybeused D790 Test Methods for Flexural Properties of Unreinforced
to characterize the scaffold component of a finished medical
and Reinforced Plastics and Electrical Insulating Materi-
product. als
D792 Test Methods for Density and Specific Gravity (Rela-
1.4 This guide is intended to be utilized in conjunction with
tive Density) of Plastics by Displacement
appropriate characterization(s) and evaluation(s) of any raw or
D882 Test Method for Tensile Properties of Thin Plastic
starting material(s) utilized in the fabrication of the scaffold,
Sheeting
such as described in Guide F2027.
D1042 Test Method for Linear Dimensional Changes of
1.5 This guide addresses natural, synthetic, or combination
Plastics Caused by Exposure to Heat and Moisture
scaffold materials with or without bioactive agents or biologi-
D1238 Test Method for Melt Flow Rates of Thermoplastics
cal activity.This guide does not address the characterization or
by Extrusion Plastometer
release profiles of any biomolecules, cells, drugs, or bioactive
D1388 Test Method for Stiffness of Fabrics
agents that are used in combination with the scaffold. A
D1621 Test Method for Compressive Properties of Rigid
determination of the suitability of a particular starting material
Cellular Plastics
and/or finished scaffold structure to a specific cell type and/or
D1623 Test Method for Tensile and Tensile Adhesion Prop-
tissue engineering application is essential, but will require
erties of Rigid Cellular Plastics
additional in vitro and/or in vivo evaluations considered to be
D1708 Test Method forTensile Properties of Plastics by Use
outside the scope of this guide.
of Microtensile Specimens
1.6 This standard does not purport to address all of the
D2857 Practice for Dilute Solution Viscosity of Polymers
safety concerns, if any, associated with its use. It is the
D2990 Test Methods for Tensile, Compressive, and Flexural
responsibility of the user of this standard to establish appro-
Creep and Creep-Rupture of Plastics
D3016 Practice for Use of Liquid Exclusion Chromatogra-
phy Terms and Relationships
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
2
F04.42 on Biomaterials and Biomolecules for TEMPs. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Oct. 1, 2013. Published December 2013. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2002. Last previous edition approved in 2007 as F2150 – 07. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2150-13. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2150 − 13
D3039/D3039M Test Method forTensile Properties of Poly- Contaminants in
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM 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.
Designation: F2150 − 07 F2150 − 13
Standard Guide 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
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 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. 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:
D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
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
3
D671 Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force (Withdrawn 2002)
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
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.
Current edition approved Dec. 1, 2007Oct. 1, 2013. Published January 2008December 2013. Originally approved in 2002. Last previous edition approved in 20022007
ε1
as F2150 – 02F2150 – 07. . DOI: 10.1520/F2150-07.10.1520/F2150-13.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2150 − 13
D1621 Test Method for Com
...
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