ASTM F3274-21
(Guide)Standard Guide for Testing and Characterization of Alginate Foam Scaffolds Used in Tissue-Engineered Medical Products (TEMPs)
Standard Guide for Testing and Characterization of Alginate Foam Scaffolds Used in Tissue-Engineered Medical Products (TEMPs)
SIGNIFICANCE AND USE
5.1 This guide is a guideline for the characterizing and testing of alginate foam scaffolds used in tissue-engineered medical products. Alginate foam scaffolds can be used in a number of tissue engineering and regenerative medicine applications such as anti-adhesion, internal wound healing, and guided tissue regeneration. In addition, alginate foam can be used as a matrix for cell-based cell therapies and for the release of bioactive agents.
SCOPE
1.1 Consistent functionality of scaffolds used in TEMPs can be made more predictable by monitoring relevant characteristics related to physical and biological properties. This guide may be used in the selection of suitable test methods of dried ionically gelled alginate foam scaffolds that may be a component of a medical device or considered a medical device itself.
1.2 This guide provides information relevant for the physical testing of alginate foam scaffolds such as mechanical properties, hydration properties, pore structure, and scaffold degradation. In addition, issues related to biological properties such as elemental impurities, bacterial bioburden, bacterial endotoxins, sterility, and biocompatibility are outlined.
1.3 This guide is intended to be used in conjunction with appropriate characterization and evaluation of any raw or starting materials utilized for fabrication of the alginate foam, such as described in Guides F2027 and F2064.
1.4 This guide addresses alginate foam scaffolds with and 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 Only SI units are used in this standard.
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, health, and environmental practices and determine the applicability of regulatory limitations 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.
General Information
Relations
Standards Content (Sample)
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: F3274 − 21
Standard Guide for
Testing and Characterization of Alginate Foam Scaffolds
1
Used in Tissue-Engineered Medical Products (TEMPs)
This standard is issued under the fixed designation F3274; 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 2. Referenced Documents
2
2.1 ASTM Standards:
1.1 Consistent functionality of scaffolds used inTEMPs can
D638 Test Method for Tensile Properties of Plastics
be made more predictable by monitoring relevant characteris-
D1621 Test Method for Compressive Properties of Rigid
tics related to physical and biological properties. This guide
Cellular Plastics
may be used in the selection of suitable test methods of dried
F748 PracticeforSelectingGenericBiologicalTestMethods
ionically gelled alginate foam scaffolds that may be a compo-
nent of a medical device or considered a medical device itself. for Materials and Devices
F1635 Test Method for in vitro Degradation Testing of
1.2 This guide provides information relevant for the physi-
HydrolyticallyDegradablePolymerResinsandFabricated
cal testing of alginate foam scaffolds such as mechanical
Forms for Surgical Implants
properties, hydration properties, pore structure, and scaffold
F2025 Practice for Gravimetric Measurement of Polymeric
degradation. In addition, issues related to biological properties
Components for Wear Assessment
such as elemental impurities, bacterial bioburden, bacterial
F2027 Guide for Characterization and Testing of Raw or
endotoxins, sterility, and biocompatibility are outlined.
Starting Materials for Tissue-Engineered Medical Prod-
1.3 This guide is intended to be used in conjunction with
ucts
appropriate characterization and evaluation of any raw or
F2064 Guide for Characterization and Testing of Alginates
starting materials utilized for fabrication of the alginate foam,
as Starting Materials Intended for Use in Biomedical and
such as described in Guides F2027 and F2064.
Tissue Engineered Medical Product Applications
F2150 Guide for Characterization and Testing of Biomate-
1.4 This guide addresses alginate foam scaffolds with and
rial Scaffolds Used in Regenerative Medicine and Tissue-
without bioactive agents or biological activity. This guide does
Engineered Medical Products
not address the characterization or release profiles of any
F2312 Terminology Relating to Tissue Engineered Medical
biomolecules, cells, drugs, or bioactive agents that are used in
Products
combination with the scaffold.
F2450 Guide for Assessing Microstructure of Polymeric
1.5 Only SI units are used in this standard.
Scaffolds for Use in Tissue-Engineered Medical Products
1.6 This standard does not purport to address all of the F2739 Guide for Quantifying Cell Viability and Related
safety concerns, if any, associated with its use. It is the Attributes within Biomaterial Scaffolds
3
responsibility of the user of this standard to establish appro-
2.2 ISO Standards:
priate safety, health, and environmental practices and deter-
ISO 527 Plastics—Determination of tensile properties—Part
mine the applicability of regulatory limitations prior to use.
1: General principles
1.7 This international standard was developed in accor-
ISO 10993 Biological evaluation of medical devices
dance with internationally recognized principles on standard-
ISO 11135 Sterilization of health-care products—Ethylene
ization established in the Decision on Principles for the
oxide—Requirements for the development, validation and
Development of International Standards, Guides and Recom-
routine control of a sterilization process for medical
mendations issued by the World Trade Organization Technical
devices
Barriers to Trade (TBT) Committee.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Surgical Materials and Devices and is the direct responsibility of Subcommittee Standards volume information, refer to the standard’s Document Summary page on
F04.42 on Biomaterials and Biomolecules for TEMPs. the ASTM website.
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Current edition approved May 15, 2021. Published May 2021. DOI: 10.1520/ Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
F3274-21. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohock
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