ASTM F2027-16
(Guide)Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Standard Guide for Characterization and Testing of Raw or Starting Materials 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
4.1 The physico-chemical characteristics of the raw or starting material 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 materials 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 materials intended for use in tissue engineering scaffolds for growth, support, or delivery of cells and/or biomolecules. This guide does not apply to materials 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 materials already commonly used within medical products and to provide characterization guidance for interim use of raw materials 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 intended use may be required.
General Information
- Status
- Published
- Publication Date
- 30-Sep-2016
- Technical Committee
- F04 - Medical and Surgical Materials and Devices
- Drafting Committee
- F04.42 - Biomaterials and Biomolecules for TEMPs
Relations
- Effective Date
- 01-Oct-2016
- Refers
ASTM F1538-24 - Standard Specification for Glass and Glass-Ceramic Biomaterials for Implantation - Effective Date
- 15-Mar-2024
- Effective Date
- 29-Sep-2023
- Effective Date
- 01-Aug-2020
- Refers
ASTM F1581-08(2020) - Standard Specification for Composition of Anorganic Bone for Surgical Implants - Effective Date
- 01-Aug-2020
- Effective Date
- 01-Mar-2020
- Effective Date
- 01-Dec-2019
- Effective Date
- 01-Dec-2019
- Effective Date
- 01-Dec-2019
- Refers
ASTM F1855-00(2019) - Standard Specification for Polyoxymethylene (Acetal) for Medical Applications - Effective Date
- 01-Dec-2019
- Effective Date
- 15-Dec-2018
- Effective Date
- 15-Dec-2018
- Effective Date
- 01-Dec-2018
- Effective Date
- 01-Jun-2018
- Effective Date
- 01-Jun-2018
Overview
ASTM F2027-16 – Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products offers comprehensive guidelines for specifying and evaluating the chemical, physical, and mechanical properties of raw materials intended for use in tissue engineering. Developed by ASTM International, this standard addresses the critical need for consistent and reproducible material performance during the early stages of product development, before materials are processed into implantable scaffolds or controlled-release matrices.
The guide is vital for researchers, manufacturers, and regulatory professionals working with biomaterials in regenerative medicine, designed to promote high quality and reliable outcomes for tissue-engineered medical products (TEMPs).
Key Topics
- Material Characterization: Guidance on specifying relevant chemical, physical, and mechanical properties for different classes of materials including polymers, ceramics, metals, composites, and natural origin materials.
- Standardized Test Methods: Provides a compendium of ASTM and other international test methods to assess material attributes, supporting reproducibility and consistent quality.
- Material Classes:
- Polymers: Includes synthetic and natural polymers, with guidance on compositional attributes, molecular weight, additives, and degradation products.
- Ceramics: Covers attributes such as chemical composition, phase content, purity, and crystal size distribution.
- Metals: Focuses on chemical composition, alloying elements, surface modifications, and mechanical properties like grain size, hardness, and tensile strength.
- Composites: Addresses requirements for each phase within composites and the interfacial bonding between phases.
- Natural Materials: Outlines classification and specification guidance based on origin and functional group (protein, polysaccharide, ceramic, etc.).
- Sampling and Handling: Recommendations for sampling practices, packaging, labeling, and traceability to prevent contamination and support quality assurance.
- Regulatory Alignment: References relevant FDA, ISO, and USP requirements to assist compliance with global quality and regulatory expectations.
Applications
ASTM F2027-16 is applicable across a range of tissue engineering and regenerative medicine scenarios, including:
- Development of Scaffold Materials: For the manufacture of three-dimensional scaffolds supporting cell growth and tissue regeneration in medical applications.
- Raw Material Qualification: For input materials in controlled-release drug delivery or support matrices for cells or biomolecules.
- New Biomaterials Evaluation: Where novel polymers, ceramics, metals, or composites are being introduced and standardized specifications do not yet exist.
- Quality Control and Risk Management: When consistent raw material properties are essential to downstream performance, safety, and efficacy of TEMPs.
- Research and Product Development: To support consistent results across different production batches and ensure alignment with regulatory standards.
Related Standards
ASTM F2027-16 references and complements a variety of global standards and guidelines for biomaterials and medical products. Key related standards include:
- ASTM Standards:
- F603, F1185, F136, F139 (material-specific requirements for ceramics, titanium, stainless steel)
- F648, F2026 (polymers for surgical implants)
- F2150 (characterization and testing of biomaterial scaffolds)
- ISO Standards:
- ISO 10993-series (biological evaluation of medical devices)
- ISO 6474 (ceramic materials based on alumina)
- ISO/IEC 17025 (competence of testing/calibration laboratories)
- BS EN 12442 Series: Guidance for animal tissue-derived materials regarding risk analysis, sourcing, and viral inactivation.
- U.S. Pharmacopeia (USP): General purity, packaging, and quality criteria for materials.
- FDA Regulations:
- 21 CFR Parts 610, 820, 1270, 1271 (regulations for biologics and human tissue)
- Recognized Consensus Standards Database (CDRH)
Practical Value
By adhering to ASTM F2027-16, organizations can ensure that raw or starting materials for tissue-engineered medical products are reliably characterized and specified, reducing risk and enhancing product performance and reproducibility. This standard streamlines the selection, testing, and documentation process for medical materials, supporting efficient regulatory submission and innovation in regenerative medicine.
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Frequently Asked Questions
ASTM F2027-16 is a guide published by ASTM International. Its full title is "Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products". This standard covers: 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 4.1 The physico-chemical characteristics of the raw or starting material 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 materials 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 materials intended for use in tissue engineering scaffolds for growth, support, or delivery of cells and/or biomolecules. This guide does not apply to materials 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 materials already commonly used within medical products and to provide characterization guidance for interim use of raw materials 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 intended use may be required.
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 4.1 The physico-chemical characteristics of the raw or starting material 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 materials 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 materials intended for use in tissue engineering scaffolds for growth, support, or delivery of cells and/or biomolecules. This guide does not apply to materials 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 materials already commonly used within medical products and to provide characterization guidance for interim use of raw materials 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 intended use may be required.
ASTM F2027-16 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
ASTM F2027-16 has the following relationships with other standards: It is inter standard links to ASTM F2027-08, ASTM F1538-24, ASTM D1898-68(1989), ASTM F603-12(2020), ASTM F1581-08(2020), ASTM F1537-20, ASTM F755-19, ASTM F138-19, ASTM F139-19, ASTM F1855-00(2019), ASTM F2579-18, ASTM F2313-18, ASTM F997-18, ASTM F2260-18, ASTM F2103-18. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ASTM F2027-16 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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: F2027 − 16
Standard Guide for
Characterization and Testing of Raw or Starting Materials
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.
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
specification for raw or starting materials intended for use in
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
materials 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 materials
(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 materials
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
for which a standard does not exist.
tions (UNS R30605)
1.3 Thisguidecoversspecificationsandcharacterizationsof
F136 Specification for Wrought Titanium-6Aluminum-
allthemajorclassesofmaterialsincludingpolymers,ceramics,
4VanadiumELI(ExtraLowInterstitial)AlloyforSurgical
metals, composites, and natural tissues of human, animal, or
Implant Applications (UNS R56401)
plant origin. This guide does not apply to pharmaceuticals.
F138 Specification for Wrought 18Chromium-14Nickel-
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
1.5 Compliance with materials specifications developed in
Implant Applications (UNS R05200, UNS R05400)
accordance with this standard may not necessarily result in a
F562 Specification for Wrought 35Cobalt-35Nickel-
material suitable for its intended purpose. Additional testing
20Chromium-10Molybdenum Alloy for Surgical Implant
specific to the intended use may be required.
Applications (UNS R30035)
F602 Criteria for Implantable Thermoset Epoxy Plastics
2. Referenced Documents
F603 Specification for High-Purity Dense Aluminum Oxide
2.1 ASTM Standards:
for Medical Application
D1763 Specification for Epoxy Resins
F619 Practice for Extraction of Medical Plastics
F624 Guide for Evaluation of Thermoplastic Polyurethane
Solids and Solutions for Biomedical Applications
1 F639 Specification for Polyethylene Plastics for Medical
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
Applications
F04.42 on Biomaterials and Biomolecules for TEMPs.
F641 SpecificationforImplantableEpoxyElectronicEncap-
Current edition approved Oct. 1, 2016. Published December 2016. Originally
sulants
approved in 2000. Last previous edition approved in 2008 as F2027 – 08. DOI:
10.1520/F2027-16.
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 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
F2027 − 16
F648 Specification for Ultra-High-Molecular-Weight Poly- F2103 Guide for Characterization and Testing of Chitosan
ethylene Powder and Fabricated Form for Surgical Im- Salts as Starting Materials Intended for Use in Biomedical
and Tissue-Engineered Medical Product Applications
plants
F665 Classification for Vinyl Chloride Plastics Used in F2150 Guide for Characterization and Testing of Biomate-
rial Scaffolds Used in Tissue-Engineered Medical Prod-
Biomedical Application
ucts
F702 Specification for Polysulfone Resin for MedicalAppli-
F2212 Guide for Characterization of Type I Collagen as
cations
Starting Material for Surgical Implants and Substrates for
F755 Specification for Selection of Porous Polyethylene for
Tissue Engineered Medical Products (TEMPs)
Use in Surgical Implants
F2259 Test Method for Determining the Chemical Compo-
F997 Specification for Polycarbonate Resin for Medical
sition and Sequence in Alginate by Proton Nuclear Mag-
Applications
netic Resonance ( H NMR) Spectroscopy
F1088 Specification for Beta-Tricalcium Phosphate for Sur-
F2260 Test Method for Determining Degree of Deacety-
gical Implantation
lation in Chitosan Salts by Proton Nuclear Magnetic
F1185 Specification for Composition of Hydroxylapatite for
Resonance ( H NMR) Spectroscopy
Surgical Implants
F2313 Specification for Poly(glycolide) and Poly(glycolide-
F1251 Terminology Relating to Polymeric Biomaterials in
co-lactide) Resins for Surgical Implants with Mole Frac-
Medical and Surgical Devices (Withdrawn 2012)
tions Greater Than or Equal to 70 % Glycolide
F1377 Specification for Cobalt-28Chromium-6Molybdenum
F2347 Guide for Characterization and Testing of Hyaluro-
Powder for Coating of Orthopedic Implants (UNS
nan as Starting Materials Intended for Use in Biomedical
R30075)
and Tissue Engineered Medical Product Applications
F1472 Specification for Wrought Titanium-6Aluminum-
F2579 Specification for Amorphous Poly(lactide) and
4VanadiumAlloy for Surgical ImplantApplications (UNS
Poly(lactide-co-glycolide) Resins for Surgical Implants
R56400)
F2848 Specification for Medical-Grade Ultra-High Molecu-
F1537 Specification for Wrought Cobalt-28Chromium-
lar Weight Polyethylene Yarns
6Molybdenum Alloys for Surgical Implants (UNS
F3160 Guide for Metallurgical Characterization of Absorb-
R31537, UNS R31538, and UNS R31539)
able Metallic Materials for Medical Implants
F1538 Specification for Glass and Glass Ceramic Biomate-
2.2 Other Document:
rials for Implantation
U.S. Pharmacopeia, Edition XXX or current edition
F1579 Specification for Polyaryletherketone (PAEK) Poly-
ISBT 128 The Global Information Standard for Medical
mers for Surgical Implant Applications (Withdrawn
Products of Human Origin
2011)
F1581 Specification for Composition ofAnorganic Bone for
2.3 ISO and CEN Standards:
Surgical Implants
ISO 6474 Implants for Surgery—Ceramic Materials Based
F1634 Practice forIn-Vitro Environmental Conditioning of on Alumina
Polymer Matrix Composite Materials and Implant De-
ISO/IEC 17025 General Requirements for the Competence
vices of Testing and Calibration Laboratories
F1635 Test Method forin vitro Degradation Testing of Hy- ISO 10993-1 Biological Evaluation of Medical Devices—
drolytically Degradable Polymer Resins and Fabricated Part 1: Evaluation and Testing
Forms for Surgical Implants ISO 10993-9—Part 9: Framework for Identification and
Quantification of Potential Degradation Products
F1713 Specification for Wrought Titanium-13Niobium-
ISO 10993-12—Part 12: Sample Preparation and Reference
13Zirconium Alloy for Surgical Implant Applications
Materials
(UNS R58130)
ISO 111607 Product Packaging
F1855 Specification for Polyoxymethylene (Acetal) for
ISO/DIS 10993-13—Part 13: Identification and Quantifica-
Medical Applications
tion of Potential Degradation Products from Polymeric
F1873 Specification for High-Purity DenseYttriaTetragonal
Medical Devices
Zirconium Oxide Polycrystal (Y-TZP) for Surgical Im-
ISO/DIS 10993-14—Part 14: Identification and Quantifica-
plant Applications (Withdrawn 2007)
tion of Potential Degradation Products from Ceramics
F1876 Specification for Polyetherketoneetherketoneketone
ISO/DIS 10993-15—Part 15: Identification and Quantifica-
(PEKEKK) Resins for Surgical Implant Applications
tion of Potential Degradation Products from Metals and
(Withdrawn 2012)
Alloys
F1877 Practice for Characterization of Particles
F1925 SpecificationforSemi-CrystallinePoly(lactide)Poly-
mer and Copolymer Resins for Surgical Implants
F2026 Specification for Polyetheretherketone (PEEK) Poly-
Available from U.S. Pharmacopeia (USP), 12601Twinbrook Pkwy., Rockville,
MD 20852-1790, http://www.usp.org.
mers for Surgical Implant Applications
Available from ICCBBA, P.O. Box 1309, San Bernadino, CA 92423-1309,
F2064 Guide for Characterization and Testing of Alginates
http://iccba.org.
as Starting Materials Intended for Use in Biomedical and
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
Tissue Engineered Medical Product Applications 4th Floor, New York, NY 10036, http://www.ansi.org.
F2027 − 16
ISO/DIS10993-17—Part17: MethodsfortheEstablishment influencing cell behavior and/or the release of bioactive mol-
of Allowable Limits for Leachable Substances using ecules or drugs. This guide describes recommended specifica-
Health-Based Risk Assessment tions or characterizations of raw or starting materials to ensure
ISO/CD 10993-18—Part 18: Chemical Characterization of reproducibility prior to their fabrication into implantable
Materials tissue-engineering scaffolds and/or controlled release matrices.
BSI BS EN 22442-1 Animal Tissues and Their Derivatives
5. Classification of Materials
Utilized in the Manufacture of Medical Devices—Part 1:
5.1 The properties of tissue-engineering scaffolds or cell
Analysis and Management of Risk
delivery vehicles are, in part, a function of the type of material
BSI BS EN 22442-2 Animal Tissures and Their Derivative
from which they are made. All materials can be classified
Utilized in the Manufacture of Medical Devices—Part 2:
according to their atomic content and bonding as either a
Controls on Sourcing, Collection and Handling
ceramic, polymer, metal, or composite. Ceramics consist of
BSI BS EN 22442-3 Animal Tissures and Their Derivative
ionically or covalently bonded metallic and non-metallic ele-
Utilized in the Manufacture of Medical Devices—Part 3:
ments such as calcium phosphate or aluminum phosphate and
Validation of the Elimination and/or Inactivation of Virus
include minerals and glasses, sintered or unsintered. Polymers
and Transmissible Agents
consist of a repeating backbone structure. Metals are made of
2.4 Food and Drug Administration Documents:
metallicelementsbondedtogetherbymetallicbonds.Compos-
Code of Federal Regulations, Title 21, Parts 610 (General
itesareblendsofanyofthethreemaintypesofmaterials.Even
Biological Products Standards), 820 (Quality system
materials derived from natural sources such as anorganic bone
regulation), 1270 and 1271 (Human cells or tissue in-
or chitosan fall into one of these basic types; anorganic bone is
tendedforimplantation,transplantation,infusion,ortrans-
a ceramic and chitosan is a polymer.
fer into a human recipient) or other of Parts 1-1499
Additional FDA Guidance Documents
5.2 To use this guide, first classify the material into one of
Selected Guidance Documents Applicable to Combination
the basic material types listed in 5.1. Important properties that
Products
should be specified are listed and tabulated according to
material type in Table 1 and Table 2. ISO 10993-18 also
3. Summary of Guide
provides a framework for the identification of a material and
the identification and quantification of its chemical constitu-
3.1 Novel materials that do not yet have standards associ-
ents.
ated with them are being created for use in tissue-engineering
applications. The lack of standardized specifications for the
6. Chemical Requirements
physical and chemical properties of these new materials may
6.1 ChemicalRequirementsforCeramics—Theraworstart-
lead to variation between lots, which could create variation in
ing material shall have specifications for relevant chemical
observed biological performance of the final product. It is the
properties such as, but not limited to, those listed within Table
intent of this guide to provide a compendium of existing
1, Col. 1. This includes, for ceramics: chemical formula or
medical product materials specifications and test methods to
composition, requirements for the major and minor elemental
serve as a guide for specifying the important chemical and
constituents, phase content, and processing aids.
physical properties of new raw or starting materials. Tables of
commonly specified chemical, physical, and mechanical re-
6.2 ChemicalRequirementsforMetals—The raw or starting
quirementsareprovidedforeachtypeofmaterial(forexample,
material shall have specifications for relevant chemical prop-
ceramic, metal, polymer, composite, natural product) to assist
erties such as, but not limited to, those listed within Table 1,
withthedevelopmentofaspecificationforanewmaterialtobe
Col. 2. The composition, trace elements analysis, phase
utilized for tissue engineering.
content, and any surface modification (for example, pickled,
ground, polished, acid-etched) should be specified quantita-
3.2 This guide is focused on providing a characterization
tively. Corrosion susceptibility should be tested.
template for raw or starting materials prior to their fabrication
into a scaffold or tissue-engineered medical product. Guidance
6.3 ChemicalRequirementsforPolymers—Theraworstart-
for the characterization and testing of materials after they have
ing material shall have specifications for relevant chemical
been formulated into three-dimensional scaffolds can be found
properties such as, but not limited to, those listed within Table
in Guide F2150.
1, Col. 3. In addition to specifying the chemical formula or
composition, and requirements for the major and minor el-
4. Significance and Use
emental constituents, the following aspects should be ex-
pressed quantitatively: viscosity (molecular weight), co-
4.1 The physico-chemical characteristics of the raw or
starting material used in regenerative medicine scaffolds car- polymer ratio (if appropriate), synthesis method, source (if
naturally harvested), additives, fillers, unreacted monomer
ries significant potential to affect product performance by
content, curing agents, catalysts, accelerators, initiators, con-
centration (if supplied in solution), stability, extractables, and
Available through this searchable database: http://www.accessdata.fda.gov/
degradation products, mechanism and kinetics. ISO 10993-9
scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm.
provides guidance on identification and quantification of po-
Searchable through this website: http://www.fda.gov/opacom/morechoices/
tential degradation products and ISO 10993-17 provides guid-
industry/guidedc.htm.
Available at this wesite http://www.fda.gov/oc/combination/guidance.html. ance on allowable limits for leachable substances. Tests for
F2027 − 16
TABLE 1 Typically Specified Chemical Requirements for Each Type of Material
NOTE 1—Natural materials made of proteins, nucleic acids, or polysaccharides are classified as polymers, so the chemical requirements listed for
polymers apply. Anorganic bone and other naturally occurring inorganic substances are classified as ceramics, so the chemical requirements listed for
ceramics apply.
Ceramics Metals Polymers Composites
Chemical formula or composition Chemical formula or composition Chemical formula or composition Chemical formula or composition
Phase content Phase content Unreacted monomer content Phase content
Purity Purity Synthesis method Characterization of the bonding process
between phases
Major and minor elemental constituents Major and minor elemental constituents Source, if naturally harvested Chemical content at the interface
Processing aids (dispersing agents, Corrosion susceptibility Viscosity (molar mass) All other pr
...
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: F2027 − 08 F2027 − 16
Standard Guide for
Characterization and Testing of Raw or Starting
BiomaterialsMaterials 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.
1. Scope
1.1 This document provides guidance on writing a materials specification for raw or starting biomaterialsmaterials intended for
use in tissue engineering scaffolds for growth, support, or delivery of cells and/or biomolecules. This guide does not apply to
biomaterialsmaterials 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-
materials already commonly used within medical products and to provide characterization guidance for interim use of raw
biomaterialsmaterials 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 intendintended use may be required.
2. Referenced Documents
2.1 ASTM Standards:
D1763 Specification for Epoxy Resins
D1898 Practice for Sampling of Plastics (Withdrawn 1998)
E1298 Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS
R30605)
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F139 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants
(UNS S31673)
F451 Specification for Acrylic Bone Cement
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 May 1, 2008Oct. 1, 2016. Published June 2008December 2016. Originally approved in 2000. Last previous edition approved in 20002008 as
ε1
F2027 – 00F2027 – 08. . DOI: 10.1520/F2027-08.10.1520/F2027-16.
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’sstandard’s Document Summary page on the ASTM website.
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
F2027 − 16
F560 Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications
(UNS R30035)
F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant
Applications (UNS R30563) (Withdrawn 2005)
F602 Criteria for Implantable Thermoset Epoxy Plastics
F603 Specification for High-Purity Dense Aluminum Oxide for Medical Application
F604 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)
F619 Practice for Extraction of Medical Plastics
F624 Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
F639 Specification for Polyethylene Plastics for Medical Applications
F641 Specification for Implantable Epoxy Electronic Encapsulants
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F665 Classification for Vinyl Chloride Plastics Used in Biomedical Application
F702 Specification for Polysulfone Resin for Medical Applications
F755 Specification for Selection of Porous Polyethylene for Use in Surgical Implants
F755 Specification for Selection of Porous Polyethylene for Use in Surgical Implants
F997 Specification for Polycarbonate Resin for Medical Applications
F1088 Specification for Beta-Tricalcium Phosphate for Surgical Implantation
F1185 Specification for Composition of Hydroxylapatite for Surgical Implants
F1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)
F1377 Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS
R31538, and UNS R31539)
F1538 Specification for Glass and Glass Ceramic Biomaterials for Implantation
F1579 Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications (Withdrawn 2011)
F1581 Specification for Composition of Anorganic Bone for Surgical Implants
F1634 Practice forIn-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices
F1635 Test Method forin vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for
Surgical Implants
F1713 Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)
F1855 Specification for Polyoxymethylene (Acetal) for Medical Applications
F1873 Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant
Applications (Withdrawn 2007)
F1876 Specification for Polyetherketoneetherketoneketone (PEKEKK) Resins for Surgical Implant Applications (Withdrawn
2012)
F1877 Practice for Characterization of Particles
F1925 Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
F1926F2026 Test Method for Evaluation of the Environmental Stability of Calcium Phosphate CoatingsSpecification for
Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
F2064 Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue
Engineered Medical Product Applications
F2103 Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and
Tissue-Engineered Medical Product Applications
F2150 Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
F2212 Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue
Engineered Medical Products (TEMPs)
F2259 Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic
Resonance ( H NMR) Spectroscopy
F2260 Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance ( H
NMR) Spectroscopy
F2313 Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater
Than or Equal to 70 % Glycolide
F2347 Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue
Engineered Medical Product Applications
F2579 Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
F2848 Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
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F3160 Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
2.2 Other Document:
U.S. Pharmacopeia, Edition XXX or current edition
ISBT 128 The Global Information Standard for Medical Products of Human Origin
2.3 ISO and CEN Standards:
ISO 6474 Implants for Surgery—Ceramic Materials Based on Alumina
ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
ISO 10993-1 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing
ISO 10993-9—Part 9: Framework for Identification and Quantification of Potential Degradation Products
ISO 10993-12—Part 12: Sample Preparation and Reference Materials
ISO 111607 Product Packaging
ISOISO/DIS 10993-13—Part 13: Identification and Quantification of Potential Degradation Products from Polymeric Medical
Devices
ISOISO/DIS 10993-14—Part 14: Identification and Quantification of Potential Degradation Products from Ceramics
ISOISO/DIS 10993-15—Part 15: Identification and Quantification of Potential Degradation Products from Metals and Alloys
ISOISO/DIS 10993-17—Part 17: Methods for the Establishment of Allowable Limits for Leachable Substances using
Health-Based Risk Assessment
ISO/CD 10993-18—Part 18: Chemical Characterization of Materials
ISO/NWI 10993-19—Part 19: Physico-chemical, Mechanical and Morphological Characterization of Materials
BSI BS EN 12442-122442-1 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices—Part 1:
Analysis and Management of Risk
BSI BS EN 12442-2—Part 2:22442-2 Animal Tissures and Their Derivative Utilized in the Manufacture of Medical
Devices—Part 2: Controls on Sourcing, Collection and Handling
BSI BS EN 12442-3—Part 3:22442-3 Animal Tissures and Their Derivative Utilized in the Manufacture of Medical
Devices—Part 3: Validation of the Elimination and/or Inactivation of Virus and Transmissible Agents
ISO 111607 Product Packaging
6,7
2.4 Food and Drug Administration Documents:
21 CFR Part Code of Federal Regulations, Title 21, Parts 610 General Biological Products Standards(General Biological
Products Standards), 820 (Quality system regulation), 1270 and 1271 (Human cells or tissue intended for implantation,
transplantation, infusion, or transfer into a human recipient) or other of Parts 1-1499
21 CFR Part 820 Quality System Regulation
21 CFR Part 1270Additional FDA Guidance Documents Human Tissue Intended for Transplantation
21 CFR Part 1271Selected Guidance Documents Applicable to Combination Products Human Cells, Tissues, and Cellular and
Tissue Based Products
3. Summary of Guide
3.1 Novel materials that do not yet have standards associated with them are being created for use in tissue engineering
tissue-engineering applications. The lack of standardized specifications for the physical and chemical properties of these new
materials may lead to variation between lots, which could create variation in observed biological performance of the final product.
It is the intent of this guide to provide a compendium of existing medical product materials specifications and test methods to serve
as a guide for specifying the important chemical and physical properties of new raw or starting materials. Tables of commonly
specified chemical, physical, and mechanical requirements are provided for each type of material (for example, ceramic, metal,
polymer, composite, natural product) to assist with the development of a specification for a new biomaterialmaterial to be utilized
for tissue engineering.
3.2 This guide is focused on providing a characterization template for raw or starting materials prior to their fabrication into
a scaffold or tissue-engineered medical product. Guidance for the characterization and testing of biomaterialsmaterials after they
have been formulated into three-dimensional scaffolds can be found in Guide F2150.
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
Available from ICCBBA, P.O. Box 1309, San Bernadino, CA 92423-1309, http://iccba.org.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Available from Food and Drug Administration (FDA), 5600 Fishers Ln., Rockville, MD 20857, http://www.fda.gov. Additional titles (Parts 1–1499) can be found at
through this searchable database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm.
FDA guidance documents searchable through this website, (http://www.fda.gov/opacom/morechoices/industry/guidedc.htm). Selected Guidance Documents Applicable
to Combination Products may be found at this website, (http://www.fda.gov/oc/combination/guidance.html). Searchable through this website: http://www.fda.gov/opacom/
morechoices/industry/guidedc.htm.
Available at this wesite http://www.fda.gov/oc/combination/guidance.html.
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4. Significance and Use
4.1 The physico-chemical characteristics of the raw or starting biomaterialmaterial 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 biomaterialsmaterials to ensure
reproducibility prior to their fabrication into implantable tissue engineering tissue-engineering scaffolds and/or controlled release
matrices.
5. Classification of BiomaterialsMaterials
5.1 The properties of a biomaterial are a function of whichtissue-engineering scaffolds or cell delivery vehicles are, in part, a
function of the type of material from which they are made from. made. All materials can be classified according to their atomic
content and bonding as either a ceramic, polymer, metal, or composite. Ceramics consist of ionically or covalently bonded metallic
and non-metallic elements such as calcium phosphate or aluminum phosphate and include minerals and glasses, sintered or
unsintered. Polymers consist of a repeating backbone structure. Metals are made of metallic elements bonded together by metallic
bonds. Composites are blends of any of the three main types of materials. Even materials derived from natural sources such as
anorganic bone or chitosan fall into one of these basic types; anorganic bone is a ceramic and chitosan is a polymer.
5.2 To use this guide, first classify the material into one of the types above. basic material types listed in 5.1. Important
properties that should be specified are listed and tabulated according to material type in Table 1 and Table 2. ISO 10993-18 also
provides a framework for the identification of a material and the identification and quantification of its chemical constituents.
6. Chemical Requirements
6.1 Chemical Requirements for Ceramics—The raw or starting material shall have specifications for relevant chemical
properties such as, but not limited to, those listed within Table 1, Col. 1. This includes, for ceramics: chemical formula or
composition, requirements for the major and minor elemental constituents, phase content, and processing aids.
6.2 Chemical Requirements for Metals—The raw or starting material shall have specifications for relevant chemical properties
such as, but not limited to, those listed within Table 1, Col. 2. The composition, trace elements analysis, phase content, and any
surface modification (for example, pickled, ground, polished, acid-etched) should be specified quantitatively. Corrosion
susceptibility should be tested.
6.3 Chemical Requirements for Polymers—The raw or starting material shall have specifications for relevant chemical
properties such as, but not limited to, those listed within Table 1, Col. 3. In addition to specifying the chemical formula or
composition, and requirements for the major and minor elemental constituents, the following aspects should be expressed
quantitatively: viscosity (molecular weight), co-polymer ratio (if appropriate), synthesis method, source (if naturally harvested),
additives, fillers, unreacted monomer content, curing agents, catalysts, accelerators, initiators, concentration (if supplied in
solution), stability, extractables, and degradation products, mechanism and kinetics. ISO 10993-9 provides guidance on
identification and quantification of potential degradation products and ISO 10993-17 provides guidance on allowable limits for
leachable substances. Tests for residual moisture or solvent content should be performed. Acceptable sterilization methods should
be determined.
TABLE 1 Typically Specified Chemical Requirements for Each Type of Material
NOTE 1—Natural materials made of proteins, nucleic acids, or polysaccharides are classified as polymers, so the chemical requirements listed for
polymers apply. Anorganic bone and other naturally occurring inorganic substances are classified as ceramics, so the chemical requirements listed for
ceramics apply.
Ceramics Metals Polymers Composites
Chemical formula or composition Chemical formula or c
...
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