ASTM F2027-00

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
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Designation: F 2027 – 00
Standard Guide for
Characterization and Testing of Substrate Materials for
Tissue-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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope F 748 Practice for Selecting Generic Biological Test Meth-
ods for Materials and Devices
1.1 This guide addresses material characteristics of raw or
F 749 Practice for Evaluating Material Extracts by Intracu-
virgin materials in a non-fabricated form that will ultimately
taneous Injection in the Rabbit
undergo additional processing into growth, support, or delivery
F 755 Specification for Selection of Porous Polyethylene
vehicles for cells or biomolecules. This guide does not apply to
for Use in Surgical Implants
packaged, sterilized, and finished tissue-engineered medical
F 756 Practice for Assessment of Hemolytic Properties of
products.
Materials
1.2 The purpose of the guide is to assist the developer of
F 763 Practice for Short-Term Screening of Implant Mate-
tissue-engineered medical products to locate relevant existing
rials
standards and test methods and to provide guidance for interim
F 813 Practice for Direct Contact Cell Culture Evaluation of
use of materials for which a standard does not exist.
Materials for Medical Devices
2. Referenced Documents
F 895 Test Method for Agar Diffusion Cell Culture Screen-
ing for Cytotoxicity
2.1 ASTM Standards:
F 981 Practice for Assessment of Compatibility of Bioma-
D 1763 Specification for Epoxy Resins
terials for Surgical Implants with Respect to Effect of
D 1898 Practice for Sampling of Plastics
Materials on Muscle and Bone
E 1298 Guide for Determination of Purity, Impurities, and
F 997 Specification for Polycarbonate Resin for Medical
Contaminants in Biological Drug Products
Applications
F 67 Specification for Unalloyed Titanium for Surgical
F 1088 Specification for Beta-Tricalcium Phosphate for
Implant Applications
Surgical Implantation
F 451 Specification for Acrylic Bone Cement
F 1185 Specification for Composition of Ceramic Hydroxy-
F 560 Specification for Unalloyed Tantalum for Surgical
lapatite for Surgical Implants
Implant Applications
F 1251 Terminology Relating to Polymeric Biomaterials in
F 603 Specification for High-Purity Dense Aluminum Ox-
Medical and Surgical Devices
ide for Surgical Implant Application
F 1425 Specification for Virgin Poly (L-lactic Acid) Resin
F 604 Specification for Silicone Elastomers Used in Medi-
for Surgical Implants
cal Applications
F 1439 Guide for Performance of Lifetime Bioassay for the
F 624 Guide for Evaluation of Thermoplastic Polyurethane
Tumorigenic Potential of Implant Materials
Solids and Solutions for Biomedical Applications
F 1472 Specification for Wrought Ti-6Al-4V Alloy for Sur-
F 641 Specification for Implantable Epoxy Electronic En-
gical Implant Applications
capsulants
F 1579 Specification for Polyaryletherketone (PAEK) Res-
F 665 Classification for Vinyl Chloride Plastics Used in
ins for Surgical Implant Applications
Biomedical Application
F 1581 Specification for Composition of Anorganic Bone
F 702 Specification for Polysulfone Resin for Medical Ap-
for Surgical Implants
plications
F 1634 Practice for In Vitro Environmental Conditioning of
Polymer Matrix Composite Materials and Implant De-
This guide is under the jurisdiction of ASTM Committee F-4 on Medical and
vices
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F 1635 Test Method for In Vitro Degradation testing of Poly
F04.43 on Tissue Engineered Biomaterials.
Current edition approved May 10, 2000. Published August 2000.
(L-Lactic Acid) Resin and Fabricated Forms for Surgical
Annual Book of ASTM Standards, Vol 08.01.
Implants
Discontinued; see 1997 Annual Book of ASTM Standards, Vol 08.01.
4 F 1855 Specification for Polyoxymethylene Acetal for
Annual Book of ASTM Standards, Vol 11.05.
Medical Applications
Annual Book of ASTM Standards, Vol 13.01.
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F 2027
F 1876 Standard Specification for Polyetherketoneetherke- extensive set of chemical and physical properties such as, but
toneketone (PEKEKK) Resins for Surgical Implant Appli- not limited to, those listed in Table 1.
cations 4.2 The necessary chemical and physical tests are a function
F 1926 Test Method for Evaluation of the Environmental of the class of material (for example, ceramic, polymer, metal,
Stability of Calcium Phosphate Coatings composite, or natural material). Each type of material has
2.2 Other Document: specific sets of properties to be specified. Natural polymers
U.S. Pharmacopeia, Edition XXIII such as collagen or demineralized bone, and natural ceramics
2.3 ISO Standards: such as anorganic bone, are considered a subset of the
ISO 6474:1994 Implants for Surgery - Ceramic Materials polymers and ceramics categories respectively. The following
Based on Alumina AAMI, ISO, ASTM, and other recognized voluntary standards
ISO 10993-1, Biological Evaluation of Medical Devices— committee standards, include specific techniques for determin-
Part 1: Evaluation and testing ing the chemical and physical properties listed in Table 1 and
ISO 10993-9—Part 9: Framework for identification and are suggested as guides for new standards development or for
quantification of potential degradation products
...