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Designation: F 2027 – 00e1

Standard Guide for

Characterization and Testing of Substrate Materials for
Tissue-Engineered Medical Products1
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.

e1 NOTE—Table 1 was editorially corrected in June 2001.

1. Scope F 702 Specification for Polysulfone Resin for Medical Ap-

1.1 This guide addresses material characteristics of raw or plications5
virgin materials in a nonfabricated form that will ultimately F 748 Practice for Selecting Generic Biological Test Meth-
undergo additional processing into growth, support, or delivery ods for Materials and Devices5
vehicles for cells or biomolecules. This guide does not apply to F 749 Practice for Evaluating Material Extracts by Intracu-
packaged, sterilized, and finished tissue-engineered medical taneous Injection in the Rabbit5
products. F 755 Specification for Selection of Porous Polyethylene
1.2 The purpose of the guide is to assist the developer of for Use in Surgical Implants5
tissue-engineered medical products to locate relevant existing F 756 Practice for Assessment of Hemolytic Properties of
standards and test methods and to provide guidance for interim Materials5
use of materials for which a standard does not exist. F 763 Practice for Short-Term Screening of Implant Mate-
rials5
2. Referenced Documents F 813 Practice for Direct Contact Cell Culture Evaluation of
2.1 ASTM Standards: Materials for Medical Devices5
D 1763 Specification for Epoxy Resins2 F 895 Test Method for Agar Diffusion Cell Culture Screen-
D 1898 Practice for Sampling of Plastics3 ing for Cytotoxicity5
E 1298 Guide for Determination of Purity, Impurities, and F 981 Practice for Assessment of Compatibility of Bioma-
Contaminants in Biological Drug Products4 terials for Surgical Implants with Respect to Effect of
F 67 Specification for Unalloyed Titanium for Surgical Materials on Muscle and Bone5
Implant Applications5 F 997 Specification for Polycarbonate Resin for Medical
F 451 Specification for Acrylic Bone Cement5 Applications3
F 560 Specification for Unalloyed Tantalum for Surgical F 1088 Specification for Beta-Tricalcium Phosphate for
Implant Applications5 Surgical Implantation5
F 603 Specification for High-Purity Dense Aluminum Ox- F 1185 Specification for Composition of Ceramic Hydroxy-
ide for Surgical Implant Application5 lapatite for Surgical Implants5
F 604 Specification for Silicone Elastomers Used in Medi- F 1251 Terminology Relating to Polymeric Biomaterials in
cal Applications5 Medical and Surgical Devices5
F 624 Guide for Evaluation of Thermoplastic Polyurethane F 1425 Specification for Virgin Poly (L-lactic Acid) Resin
Solids and Solutions for Biomedical Applications5 for Surgical Implants3
F 641 Specification for Implantable Epoxy Electronic En- F 1439 Guide for Performance of Lifetime Bioassay for the
capsulants5 Tumorigenic Potential of Implant Materials5
F 665 Classification for Vinyl Chloride Plastics Used in F 1472 Specification for Wrought Ti-6Al-4V Alloy for Sur-
Biomedical Application5 gical Implant Applications5
F 1579 Specification for Polyaryletherketone (PAEK) Res-
1
ins for Surgical Implant Applications5
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee F 1581 Specification for Composition of Anorganic Bone
F04.42 on Tissue Characterization. for Surgical Implants5
Current edition approved May 10, 2000. Published August 2000.
2
F 1634 Practice for In Vitro Environmental Conditioning of
Annual Book of ASTM Standards, Vol 08.01.
3
Discontinued; see 1997 Annual Book of ASTM Standards, Vol 08.01.
Polymer Matrix Composite Materials and Implant De-
4
Annual Book of ASTM Standards, Vol 11.05. vices5
5
Annual Book of ASTM Standards, Vol 13.01.

Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.

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F 2027
F 1635 Test Method for In Vitro Degradation testing of Poly 3.1.2 substrates, n—raw or virgin materials that will ulti-
(L-Lactic Acid) Resin and Fabricated Forms for Surgical mately be used in tissue-engineered medical products for
Implants5 growth, support, or delivery of cells or biomolecules.
F 1855 Specification for Polyoxymethylene Acetal for
Medical Applications5 4. Descriptive Chemical and Physical Information
F 1876 Standard Specification for Polyetherketoneetherke- 4.1 The substrate material shall have specifications for an
toneketone (PEKEKK) Resins for Surgical Implant Appli- extensive set of chemical and physical properties such as, but
cations5 not limited to, those listed in Table 1.
F 1926 Test Method for Evaluation of the Environmental 4.2 The necessary chemical and physical tests are a function
Stability of Calcium Phosphate Coatings5 of the class of material (for example, ceramic, polymer, metal,
2.2 Other Document: composite, or natural material). Each type of material has
U.S. Pharmacopeia, Edition XXIII6 specific sets of properties to be specified. Natural polymers
2.3 ISO Standards:7 such as collagen or demineralized bone, and natural ceramics
ISO 6474:1994 Implants for Surgery - Ceramic Materials such as anorganic bone, are considered a subset of the
Based on Alumina polymers and ceramics categories respectively. The following
ISO 10993-1, Biological Evaluation of Medical Devices— AAMI, ISO, ASTM, and other recognized voluntary standards
Part 1: Evaluation and testing committee standards, include specific techniques for determin-
ISO 10993-9—Part 9: Framework for identification and ing the chemical and physical properties listed in Table 1 and
quantification of potential degradation products are suggested as guides for new standards development or for
ISO 10993-12 - Part 12: Sample preparation and reference interim use for those materials without existing standards.
materials 4.2.1 Metals—Specification F 1472, Specification F 560,
ISO/DIS 10993-13 - Part 13: Identification and quantifica- Specification F 67, and ISO/DIS 10993-15 - Part 15.
tion of potential degradation products from polymeric 4.2.2 Ceramics, (for example, calcium phosphate, calcium
medical devices carbonate, aluminum oxide, glasses) Specification F 603,
ISO/DIS 10993-14 - Part 14: Identification and quantifica- Specification F 1088, Specification F 1185, Specification
tion of potential degradation products from ceramics F 1581, Test Method F 1926, ISO 6474:1994, and ISO/DIS
ISO/DIS 10993-15—Part 15: Identification and quantifica- 10993-14 - Part 14.
tion of potential degradation products from metals and 4.2.3 Polymers—Specification D 1763, Practice D 1898,
alloys Specification F 451, Specification F 604, Guide F 624, Speci-
ISO/DIS 10993-17—Part 17: Methods for the establishment fication F 641, Classification F 665, Specification F 702,
of allowable limits for leachable substances using health- Specification F 755, Specification F 997, Terminology F 1251,
based risk assessment Specification F 1425, Specification F 1579, Practice F 1634,
ISO/CD 10993-18—Part 18: Chemical characterization of Test Method F 1635, Specification F 1855, Specification
materials F 1876, and ISO/DIS 10993-13 - Part 13.
ISO/NWI 10993-19—Part 19: Physico-chemical, mechani- 4.2.4 Other General Test Methods—ISO/CD 10993-18—
cal and morphological characterization of materials Part 18, ISO/NWI 10993-19—Part 19.
prEN 12442-1 Animal tissues and their derivatives utilized 4.3 The following web site is suggested as an additional
in the manufacture of medical devices—Part 1: Analysis resource for relevant existing standards: www.fda.gov/cdrh/
and management of risk modact/recstand.html.
prEN 12442-2—Part 2: Controls on sourcing, collection and
handling 5. Sampling
prEN 12442-3—Part 3: Validation of the elimination and/or 5.1 It is suggested that the requirements shall be determined
inactivation of virus and transmissible agents for each lot of the substrate material by sampling sizes and
ISO 111607 Product packaging procedures in accordance with Practice D 1898 or some other
2.4 Code of Federal Regulations, Title 21, Part 820. Federal equivalent.
Register Vol. 43, No 141. July 21, 19788
TABLE 1
Chemical Physical
3. Terminology Composition density
3.1 Definitions: Purity molecular weight
Stability during storage viscosity
3.1.1 natural materials, n—synthesized or produced by Additives compresseion strength
living cells. Trace elements tension strength
Extractables (metals or elastic modulus
solvents)
6
Degradation kinetics fatigue strength
Available from US Pharmacopia, Vol. 23 Mack Publishing Co., Easton, PA, Resorption kinetics yield strength
1995. Resorption kinetics hardness
7
Available from the American National Standards Institute, 25 W. 43rd St., 4th Degradation products foreign particles
Floor, New York, NY 10036. structure - long range
8
National Archives and Records Administration, 700 Pennsylvania Ave, NW, - short range
Washington, DC 20408.

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F 2027
6. Handling, Packaging, and Labeling material, or modifications to the material or physical forms of
6.1 The product should be handled and packaged as speci- the material, are being considered, then the recommendations
fied in USP 661 or ISO 111607 and prEN 12442-2 — Part 2, and test methods of the following standards should be consid-
and ISO 111607. ered: Practice F 748, F 619, Practice F 749, Practice F 756,
Practice F 763, Practice F 813, Practice F 981, and Guide
7. Quality Program Requirements F 1439-92 as well as Test Method F 895, ISO 10993-1,
7.1 The manufacturer should conform to Quality Systems ISO/DIS 10993-9, Part 9, ISO/DIS 10993-17 - Part 17, prEN
Regulations (see CFR 21, Part 820) or its equivalent. 12442-1 – Part 1, and prEN 12442-3– Part 3.
8. Biocompatibility
9. Keywords
8.1 Many materials have been shown to produce a well-
characterized level of biological response following long-term 9.1 biomaterials; ceramics; composites; materials; metals;
clinical use in laboratory animals. When new applications of a polymers; substrates; tissue-engineered medical products

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