ASTM F1439-03

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:F1439–03
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
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1.1 This guide is intended to assist the biomaterials testing 2.1 ASTM Standards:
laboratoryintheconductandevaluationoftumorigenicitytests E 1262 Guide for the Performance of the Chinese Hamster
toevaluatethepotentialfornewmaterialstoevokeaneoplastic Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Trans-
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
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
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
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
guide. The recommendations of Practice F 748 should be Repair Assay
considered before a study is commenced. E 2186 Guide for Determining DNASingle-Strand Damage
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-
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 fortheConductofToxicityandCarcinogenicityStudiesin
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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 MutagenicityAs- 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 MicronucleusAssay.The
3.1 Definitions of Terms Specific to this Standard:
investigatorisadvisedtoconsidercarefullytheappropriateness
of a particular method for his application after a review of the 3.1.1 carcinogenic—a substance is considered to be carci-
nogenicifitcanbeshowntobecausallyrelatedtoanincreased
published literature.
1.4 This standard does not purport to address all of the incidence of malignant neoplastic formation.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
priate safety and health practices and determine the applica-
contactASTM Customer Service at service@astm.org. ForAnnual Book ofASTM
bility of regulatory limitations prior to use.
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3
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. 1, 2003. Published December 2003. Originally tendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC
approved in 1992. Last previous edition approved in 2002 as F 1439 – 02. 20401.
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