ASTM F2027-08

Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products

ABSTRACT
This guide addresses material characteristics of raw or virgin materials in a nonfabricated form that will ultimately undergo additional processing into growth, support, or delivery vehicles for cells or biomolecules. The substrate material shall have specifications for an extensive set of chemical and physical properties prescribed. Test methods shall be performed in order to determine the chemical and physical properties of the material.
SIGNIFICANCE AND USE
The physico-chemical characteristics of the raw or starting biomaterial used in regenerative medicine scaffolds carries significant potential to affect product performance by influencing cell behavior and/or the release of bioactive molecules or drugs. This guide describes recommended specifications or characterizations of raw or starting biomaterials to ensure reproducibility prior to their fabrication into implantable tissue engineering scaffolds and/or controlled release matrices.
SCOPE
1.1 This document provides guidance on writing a materials specification for raw or starting biomaterials intended for use in tissue engineering scaffolds for growth, support, or delivery of cells and/or biomolecules. This guide does not apply to biomaterials that are already in a scaffold form or are finished tissue-engineered medical products.  
1.2 The purpose of this guide is to provide a compendium of relevant existing standards and test methods for biomaterials already commonly used within medical products and to provide characterization guidance for interim use of raw biomaterials for which a standard does not exist.  
1.3 This guide covers specifications and characterizations of all the major classes of materials including polymers, ceramics, metals, composites, and natural tissues of human, animal, or plant origin. This guide does not apply to pharmaceuticals.
1.4 This guide is focused on specification of chemical, physical, and mechanical properties of the raw or starting material. It does not include safety and biocompatibility requirements since safety and biocompatibility testing is typically done on materials fabricated into a final form to include all possible effects of fabrication and sterilization techniques.  
1.5 Compliance with materials specifications developed in accordance with this standard may not necessarily result in a material suitable for its intended purpose. Additional testing specific to the intend use may be required.

General Information

• Status: Historical
• Publication Date: 30-Apr-2008
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.42 - Biomaterials and Biomolecules for TEMPs

Relations

• Replaces: ASTM F2027-00e1 - Standard Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical Products
• Effective Date: 01-May-2008
• Replaced By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 01-Oct-2016
• Referred By: ASTM F3163-22 - Standard Guide for Categories and Terminology of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds
• Effective Date: 01-May-2008
• Referred By: ASTM F2211-13(2021) - Standard Classification for Tissue-Engineered Medical Products (TEMPs)
• Effective Date: 01-May-2008
• Referred By: ASTM F3274-21 - Standard Guide for Testing and Characterization of Alginate Foam Scaffolds Used in Tissue-Engineered Medical Products (TEMPs)
• Effective Date: 01-May-2008
• Referred By: ASTM F3510-21 - Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products
• Effective Date: 01-May-2008
• Referred By: ASTM F2150-19 - Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
• Effective Date: 01-May-2008

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
Designation: F2027 − 08
Standard Guide for
Characterization and Testing of Raw or Starting
1
Biomaterials for Tissue-Engineered Medical Products
This standard is issued under the fixed designation F2027; 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.
3
1. Scope D1898 Practice for Sampling of Plastics (Withdrawn 1998)
E1298 Guide for Determination of Purity, Impurities, and
1.1 This document provides guidance on writing a materials
Contaminants in Biological Drug Products (Withdrawn
specificationforraworstartingbiomaterialsintendedforusein
3
2014)
tissue engineering scaffolds for growth, support, or delivery of
F67 Specification for Unalloyed Titanium, for Surgical Im-
cells and/or biomolecules. This guide does not apply to
plant Applications (UNS R50250, UNS R50400, UNS
biomaterials that are already in a scaffold form or are finished
R50550, UNS R50700)
tissue-engineered medical products.
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
1.2 Thepurposeofthisguideistoprovideacompendiumof
Alloy Castings and Casting Alloy for Surgical Implants
relevant existing standards and test methods for biomaterials
(UNS R30075)
already commonly used within medical products and to pro-
F90 Specification for Wrought Cobalt-20Chromium-
vide characterization guidance for interim use of raw bioma-
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
terials for which a standard does not exist.
tions (UNS R30605)
F136 Specification for Wrought Titanium-6Aluminum-
1.3 Thisguidecoversspecificationsandcharacterizationsof
4VanadiumELI(ExtraLowInterstitial)AlloyforSurgical
allthemajorclassesofmaterialsincludingpolymers,ceramics,
Implant Applications (UNS R56401)
metals, composites, and natural tissues of human, animal, or
F138 Specification for Wrought 18Chromium-14Nickel-
plant origin. This guide does not apply to pharmaceuticals.
2.5Molybdenum Stainless Steel Bar andWire for Surgical
1.4 This guide is focused on specification of chemical,
Implants (UNS S31673)
physical, and mechanical properties of the raw or starting
F139 Specification for Wrought 18Chromium-14Nickel-
material. It does not include safety and biocompatibility
2.5Molybdenum Stainless Steel Sheet and Strip for Sur-
requirements since safety and biocompatibility testing is typi-
gical Implants (UNS S31673)
cally done on materials fabricated into a final form to include
F451 Specification for Acrylic Bone Cement
all possible effects of fabrication and sterilization techniques.
F560 Specification for Unalloyed Tantalum for Surgical
Implant Applications (UNS R05200, UNS R05400)
1.5 Compliance with materials specifications developed in
accordance with this standard may not necessarily result in a F562 Specification for Wrought 35Cobalt-35Nickel-
20Chromium-10Molybdenum Alloy for Surgical Implant
material suitable for its intended purpose. Additional testing
specific to the intend use may be required. Applications (UNS R30035)
F563 Specification for Wrought Cobalt-20Nickel-
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
2. Referenced Documents
for Surgical Implant Applications (UNS R30563) (With-
2
2.1 ASTM Standards:
3
drawn 2005)
D1763 Specification for Epoxy Resins
F602 Criteria for Implantable Thermoset Epoxy Plastics
F603 Specification for High-Purity Dense Aluminum Oxide
for Medical Application
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
F604 Specification for Silicone Elastomers Used in Medical
Surgical Materials and Devices and is the direct responsibility of Subcommittee 3
Applications (Withdrawn 2001)
F04.42 on Biomaterials and Biomolecules for TEMPs.
F619 Practice for Extraction of Medical Plastics
Current edition approved May 1, 2008. Published June 2008. Originally
ε1
approved in 2000. Last previous edition approved in 2000 as F2027 – 00 . DOI: F624 Guide for Evaluation of Thermoplastic Polyurethane
10.1520/F2027-08.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on The last approved version of this historical standard is referenced on
the ASTM website. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2027 − 08
Solids and Solutions for Biomedical Applications F1926 Test Method for Evaluation of the Environmental
F639 Specification for Polyethylene Plastics for Medical Stability of Calcium Phosphate Coatings
F2064 G
...

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:F2027–00 Designation: F 2027 – 08
Standard Guide for
Characterization and Testing of Substrate Materials for
Tissue-Engineered Medical ProductsCharacterization and
Testing of Raw or Starting Biomaterials for Tissue-
1
Engineered Medical Products
This standard is issued under the fixed designation F 2027; 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
e NOTE—Table 1 was editorially corrected in June 2001.
1. Scope
1.1This guide addresses material characteristics of raw or virgin materials in a nonfabricated form that will ultimately undergo
additional processing into growth, support, or delivery vehicles for cells or biomolecules. This guide does not apply to packaged,
sterilized, and finished tissue-engineered medical products.
1.2The purpose of the guide is to assist the developer of tissue-engineered medical products to locate relevant existing standards
and test methods and to provide guidance for interim use of materials for which a standard does not exist.
1.1 This document provides guidance on writing a materials specification for raw or starting biomaterials intended for use in
tissueengineeringscaffoldsforgrowth,support,ordeliveryofcellsand/orbiomolecules.Thisguidedoesnotapplytobiomaterials
that are already in a scaffold form or are finished tissue-engineered medical products.
1.2 The purpose of this guide is to provide a compendium of relevant existing standards and test methods for biomaterials
already commonly used within medical products and to provide characterization guidance for interim use of raw biomaterials for
which a standard does not exist.
1.3 This guide covers specifications and characterizations of all the major classes of materials including polymers, ceramics,
metals, composites, and natural tissues of human, animal, or plant origin. This guide does not apply to pharmaceuticals.
1.4 This guide is focused on specification of chemical, physical, and mechanical properties of the raw or starting material. It
does not include safety and biocompatibility requirements since safety and biocompatibility testing is typically done on materials
fabricated into a final form to include all possible effects of fabrication and sterilization techniques.
1.5 Compliancewithmaterialsspecificationsdevelopedinaccordancewiththisstandardmaynotnecessarilyresultinamaterial
suitable for its intended purpose. Additional testing specific to the intend use may be required.
2. Referenced Documents
2
2.1 ASTM Standards:
D 1763 Specification for Epoxy Resins
3
D 1898Practice for Sampling of Plastics Practice for Sampling of Plastics
E 1298 Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
F 67Specification for Unalloyed Titanium for Surgical Implant Applications
5
F451Specification for Acrylic Bone Cement Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS
R50250, UNS R50400, UNS R50550, UNS R50700)
F 75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F 90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS
R30605)
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 Tissue Characterization.
Current edition approved May 10, 2000. Published August 2000.
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.
´1
Current edition approved May 1, 2008. Published June 2008. Originally approved in 2000. Last previous edition approved in 2000 as F 2027 – 00 .
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
, Vol 08.01.volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

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F2027–08
F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstiti
...