ASTM F2027-16

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
• 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

• Refers: ASTM F1581-08(2016) - Standard Specification for Composition of Anorganic Bone for Surgical Implants
• Effective Date: 01-Oct-2016
• Refers: ASTM F139-19 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
• Effective Date: 01-Dec-2019
• Refers: ASTM F1537-20 - Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
• Effective Date: 01-Mar-2020
• Refers: ASTM F603-12(2020) - Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
• Effective Date: 01-Aug-2020
• Refers: ASTM F603-12(2016) - Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
• Effective Date: 01-Oct-2016
• Refers: ASTM F1581-08(2020) - Standard Specification for Composition of Anorganic Bone for Surgical Implants
• Effective Date: 01-Aug-2020
• Refers: ASTM F2064-14 - Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
• Effective Date: 01-Oct-2014
• Refers: ASTM F624-09(2015)e1 - Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
• Effective Date: 01-Mar-2015
• Refers: ASTM F639-09(2015) - Standard Specification for Polyethylene Plastics for Medical Applications
• Effective Date: 01-Mar-2015
• Refers: ASTM F665-09(2015) - Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
• Effective Date: 01-Mar-2015
• Refers: ASTM F2347-15 - Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
• Effective Date: 01-Dec-2015
• Refers: ASTM F2848-16 - Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
• Effective Date: 01-Jan-2016
• Refers: ASTM F2026-16 - Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• Effective Date: 01-Apr-2016
• Refers: ASTM F1634-95(2016) - Standard Practice for <emph type="bdit">In-Vitro</emph> Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices (Withdrawn 2017)
• Effective Date: 01-Jun-2016
• Refers: ASTM F1877-16 - Standard Practice for Characterization of Particles
• Effective Date: 01-Oct-2016
• Refers: ASTM F1635-16 - Standard Test Method for <emph type="bdit">in vitro</emph> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
• Effective Date: 01-Dec-2016
• Refers: ASTM F67-13(2017) - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
• Effective Date: 01-Mar-2017
• Refers: ASTM F2064-17 - Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
• Effective Date: 01-Mar-2017
• Refers: ASTM F1538-03(2017) - Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
• Effective Date: 01-May-2017
• Refers: ASTM F2103-18 - Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
• Effective Date: 01-Jun-2018
• Refers: ASTM F2260-18 - Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (¹H NMR) Spectroscopy
• Effective Date: 01-Jun-2018
• Refers: ASTM F997-18 - Standard Specification for Polycarbonate Resin for Medical Applications
• Effective Date: 01-Dec-2018
• Refers: ASTM F2579-18 - Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
• Effective Date: 15-Dec-2018
• Refers: ASTM F2313-18 - Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70&#x2009;% Glycolide
• Effective Date: 15-Dec-2018
• Refers: ASTM F1855-00(2019) - Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
• Effective Date: 01-Dec-2019
• Refers: ASTM F755-19 - Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
• Effective Date: 01-Dec-2019
• Refers: ASTM F138-19 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
• Effective Date: 01-Dec-2019
• 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-Oct-2016
• 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-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-Oct-2016
• Referred By: ASTM F3510-21 - Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products
• Effective Date: 01-Oct-2016
• Referred By: ASTM F2211-13(2021) - Standard Classification for Tissue-Engineered Medical Products (TEMPs)
• Effective Date: 01-Oct-2016

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
1
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
specification for raw or starting materials intended for use in
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
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
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.
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
1

---------------------- Page: 1 ----------------------
F2027 − 16
F648 Specification for Ultra-High-Molecular-Weight Poly- F2103 Guide for Characterization and Testing of Chitosan
ethylene Powder
...

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
1
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
2.1 ASTM Standards:
D1763 Specification for Epoxy Resins
3
D1898 Practice for Sampling of Plastics (Withdrawn 1998)
3
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
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 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.
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 Standards
volume information, refer to the standard’sstandard’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 ----------------------
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
3
Applications (UNS R30563) (Withdrawn 2005)
F602 Criteria for Implantable Thermoset Epoxy Plastics
F603 Specification for High-Purity Dense Alumi
...