ASTM F1439-02

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 1439 – 02
Standard Guide for
Performance of Lifetime Bioassay for the Tumorigenic
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Potential of Implant Materials
This standard is issued under the fixed designation F 1439; 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 2. Referenced Documents
1.1 This guide is intended to assist the biomaterials testing 2.1 ASTM Standards:
laboratory in the conduct and evaluation of tumorigenicity tests E 1262 Guide for the Performance of the Chinese Hamster
to evaluate the potential for new materials to evoke a neoplastic Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Trans-
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response. The procedure is generally reserved only for those ferase Gene Mutation Assay
materials which have not previously been used for human E 1263 Guide for Conduct of Micronucleus Assays in
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implantation for a significant period of time. Mammalian Bone Marrow Erythrocytes
1.2 Assessment of tumorigenicity is one of several proce- E 1280 Guide for Performing the Mouse Lymphoma Assay
2
dures employed in determining the biological response to a for Mammalian Cell Mutagenicity
material as recommended in Practice F 748. It is assumed that E 1397 Practices for the In-Vitro Rat Hepatocyte DNA
2
the investigator has already determined that this type of testing Repair Assay
is necessary for a particular material before consulting this E 1398 Practices for the In-Vivo Rat Hepatocyte DNA
2
guide. The recommendations of Practice F 748 should be Repair Assay
considered before a study is commenced. E 2186 Guide for Determining DNA Single-Strand Damage
2
1.3 Whenever possible, it is recommended that a battery of in Eukaryotic Cells Using the Comet Assay
genotoxicity procedures be initiated and proposed as an alter- F 748 Practice for Selecting Generic Biological Test Meth-
3
native to an in-vivo tumorigenicity bioassay. Genotoxicity ods for Materials and Devices
assays may also be considered as initial screening procedures 2.2 Other Documents:
due to the sensitivity of the assays, the significant reduction in National Toxicology Program General Statement of Work
time to gain valuable data, and the desire to reduce the use of for the Conduct of Toxicity and Carcinogenicity Studies in
4
animals for testing. Genotoxicity assays that may be consid- Laboratory Animals
ered are outlined in Guides E 1262, E 1263, E 1280, and OECD Guidelines for Testing of Chemicals: Guideline 451,
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E 2186, and Practices E 1397 and E 1398. Additionally, other Carcinogenicity Studies
genotoxicity testing which might be considered (but which do OECD Guidelines for Testing of Chemicals: Guideline 453,
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not yet have ASTM test methods) include Salmonella/ Combined Chronic Toxicity/Carcinogenicity Studies
Mammalian-Microsomal Plate Incorporation Mutagenicity As- Good Laboratory Practice for Nonclinical Laboratory Stud-
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say, In Vivo Cytogenetics Bone Marrow Chromosomal Dam- ies
age Assay, BALB/3T3 Morphological Transformation of
3. Terminology
Mouse Embryo Cells, and the Mouse Micronucleus Assay. The
investigator is advised to consider carefully the appropriateness 3.1 Definitions of Terms Specific to this Standard:
3.1.1 carcinogenic—a substance is considered to be carci-
of a particular method for his application after a review of the
published literature. nogenic if it can be shown to be causally related to an increased
incidence of malignant neoplastic formation.
1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the 3.1.2 maximum implantable dose—the maximum weight or
volume of the test article which can be reasonably implanted
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
2
bility of regulatory limitations prior to use.
Annual Book of ASTM Standards, Vol 11.05.
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Annual Book of ASTM Standards, Vol 13.01.
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Available from National Institute of Environmental Health Sciences, Research
Triangle Park, NC, August 1988.
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This guide is under the jurisdiction of ASTM Committee F04 on Medical and Available from Organization for Economic Cooperation and Development, 200
Surgical Materials and Devices and is the direct responsibility of Subcommittee L St., NW, Suite 650, Washington, DC 20036–4922.
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F04.16 on Biocompatibility Test Methods. Available from 21 CFR, Part 58, U.S. Government Printing Office, Superin-
Current edition approved Nov. 10, 2002. Published January 2003. Originally tendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC
approved in 1992. Last previous edition approved in
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