ASTM F2150-19
(Guide)Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and 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 non-absorbable/non-degradable. 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).15 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 used to fabricate the scaffold may be found in Guide F2027. However, co...
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 in the development and manufacture of regenerative medicine and 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 the property affects 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 used in conjunction with appropriate characterization(s) and evaluation(s) of any raw or starting material(s) used 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, but may be used to address the effects on other (e.g., structural) properties as a result of such release. 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...
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F2150 − 19
Standard Guide for
Characterization and Testing of Biomaterial Scaffolds Used
in Regenerative Medicine and Tissue-Engineered Medical
1
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 1.6 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 This guide is a resource of currently available test
responsibility of the user of this standard to establish appro-
methods for the characterization of the compositional and
priate safety, health, and environmental practices and deter-
structural aspects of biomaterial scaffolds used in the develop-
mine the applicability of regulatory limitations prior to use.
ment and manufacture of regenerative medicine and tissue-
1.7 This international standard was developed in accor-
engineered medical products (TEMPs).
dance with internationally recognized principles on standard-
1.2 The test methods contained herein guide characteriza-
ization established in the Decision on Principles for the
tion of the bulk physical, chemical, mechanical, and surface
Development of International Standards, Guides and Recom-
properties of a scaffold construct. Such properties may be
mendations issued by the World Trade Organization Technical
important for the success of a TEMP, especially if the property
Barriers to Trade (TBT) Committee.
affects cell retention, activity and organization, the delivery of
bioactive agents, or the biocompatibility and bioactivity within
2. Referenced Documents
the final product.
2
2.1 ASTM Standards:
1.3 This guide may be used in the selection of appropriate
D412 Test Methods forVulcanized Rubber andThermoplas-
test methods for the generation of an original equipment
tic Elastomers—Tension
manufacture(OEM)specification.Thisguidealsomaybeused
D570 Test Method for Water Absorption of Plastics
to characterize the scaffold component of a finished medical
D638 Test Method for Tensile Properties of Plastics
product.
D648 Test Method for Deflection Temperature of Plastics
Under Flexural Load in the Edgewise Position
1.4 This guide is intended to be used in conjunction with
D695 Test Method for Compressive Properties of Rigid
appropriate characterization(s) and evaluation(s) of any raw or
Plastics
starting material(s) used in the fabrication of the scaffold, such
D747 Test Method for Apparent Bending Modulus of Plas-
as described in Guide F2027.
3
tics by Means of a Cantilever Beam (Withdrawn 2019)
1.5 This guide addresses natural, synthetic, or combination
D790 Test Methods for Flexural Properties of Unreinforced
scaffold materials with or without bioactive agents or biologi-
and Reinforced Plastics and Electrical Insulating Materi-
cal activity.This guide does not address the characterization or
als
release profiles of any biomolecules, cells, drugs, or bioactive
D792 Test Methods for Density and Specific Gravity (Rela-
agents that are used in combination with the scaffold, but may
tive Density) of Plastics by Displacement
be used to address the effects on other (e.g., structural)
D882 Test Method for Tensile Properties of Thin Plastic
properties as a result of such release. A determination of the
Sheeting
suitability of a particular starting material and/or finished
D1042 Test Method for Linear Dimensional Changes of
scaffold structure to a specific cell type and/or tissue engineer-
Plastics Caused by Exposure to Heat and Moisture
ing application is essential, but will require additional in vitro
D1238 Test Method for Melt Flow Rates of Thermoplastics
and/or in vivoevaluationsconsideredtobeoutsidethescopeof
by Extrusion Plastometer
this guide.
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 Oct. 1, 2019. Published October 2019. Originally the ASTM website.
3
approved in 2002. Last previous edition approved in 2013 as F2150–13. DOI: The last approved version of this historical standard is referenced on
10.1520/F2150-19. www.astm.org.
Copyright © AST
...
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 − 13 F2150 − 19
Standard Guide for
Characterization and Testing of Biomaterial Scaffolds Used
in Regenerative Medicine and Tissue-Engineered Medical
1
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 in the development and manufacture of regenerative medicine and 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 the property affects
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 utilizedused in conjunction with appropriate characterization(s) and evaluation(s) of any raw
or starting material(s) utilizedused 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. scaffold, but may be used to address the effects on other (e.g., structural) properties
as a result of such release. 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory requirementslimitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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
D695 Test Method for Compressive Properties of Rigid Plastics
3
D747 Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever Beam (Withdrawn 2019)
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 Oct. 1, 2013Oct. 1, 2019. Published December 2013October 2019. Originally approved in 2002. Last previous edition approved in 20072013
as F2150 – 07.F2150–13. DOI: 10.1520/F2150-13.10.1520/F2150-19.
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
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F2150 − 19
D790 Test Methods for Flexural Pr
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