ASTM_F_1439_-_03_2013.pdf

Designation:F143903(Reapproved 2013)Standard Guide forPerformance of Lifetime Bioassay for the TumorigenicPotential of Implant Materials1This standard is issued under the fixed designation F1439;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide is intended to assist the biomaterials testinglaboratory in the conduct and evaluation of tumorigenicity teststo evaluate the potential for new materials to evoke a neoplasticresponse.The procedure is generally reserved only for thosematerials which have not previously been used for humanimplantation for a significant period of time.1.2 Assessment of tumorigenicity is one of several proce-dures employed in determining the biological response to amaterial as recommended in Practice F748.It is assumed thatthe investigator has already determined that this type of testingis necessary for a particular material before consulting thisguide.The recommendations of Practice F748 should beconsidered before a study is commenced.1.3 Whenever possible,it is recommended that a battery ofgenotoxicity procedures be initiated and proposed as an alter-native to an in-vivo tumorigenicity bioassay.Genotoxicityassays may also be considered as initial screening proceduresdue to the sensitivity of the assays,the significant reduction intime to gain valuable data,and the desire to reduce the use ofanimals for testing.Genotoxicity assays that may be consid-ered are outlined in Guides E1262,E1263,E1280,and E2186,and Practices E1397 and E1398.Additionally,other genotox-icity testing which might be considered(but which do not yethave ASTM test methods)include Salmonella/Mammalian-Microsomal Plate Incorporation Mutagenicity Assay,In VivoCytogenetics Bone Marrow Chromosomal Damage Assay,BALB/3T3 Morphological Transformation of Mouse EmbryoCells,and the Mouse Micronucleus Assay.The investigator isadvised to consider carefully the appropriateness of a particularmethod for his application after a review of the publishedliterature.1.4 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E1262 Guide for Performance of Chinese Hamster OvaryCell/Hypoxanthine Guanine Phosphoribosyl TransferaseGene Mutation AssayE1263 Guide for Conduct of Micronucleus Assays in Mam-malian Bone Marrow ErythrocytesE1280 Guide for Performing the Mouse Lymphoma Assayfor Mammalian Cell MutagenicityE1397 Practice forIn Vitro Rat Hepatocyte DNA RepairAssayE1398 Practice forIn Vivo Rat Hepatocyte DNA RepairAssayE2186 Guide for Determining DNA Single-Strand Damagein Eukaryotic Cells Using the Comet AssayF748 Practice for Selecting Generic Biological Test Methodsfor Materials and Devices2.2 Other Documents:National Toxicology Program General Statement of Workfor the Conduct of Toxicity and Carcinogenicity Studies inLaboratory Animals3OECD Guidelines for Testing of Chemicals:Guideline 451,Carcinogenicity Studies4OECD Guidelines for Testing of Chemicals:Guideline 453,Combined Chronic Toxicity/Carcinogenicity Studies4Good Laboratory Practice for Nonclinical Laboratory Stud-ies51This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.16 on Biocompatibility Test Methods.Current edition approved Oct.1,2013.Published October 2013.Originallyapproved in 1992.Last previous edition approved in 2008 as F1439 03(2008).DOI:10.1520/F1439-03R13.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from National Institute of Environmental Health Sciences,111 T.W.AlexanderDrive,ResearchTrianglePark,NC,August1988.http:/www.niehs.nih.gov/.4Available from Organization for Economic Cooperation and Development,2001 L Street,N.W.,Suite 650,Washington,D.C.20036-4922.http:/www.oecd.org/washington/contact.htm.5Available from 21 CFR,Part 58,U.S.Government Printing Office Superinten-dent of Documents,732 N.Capitol St.,NW,Mail Stop:SDE,Washington,DC20401,http:/www.access.gpo.gov.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 carcinogenica substance is considered to be carci-nogenic if it can be shown to be causally related to an increasedincidence of malignant neoplastic formation.3.1.2 maximum implantable dosethe maximum we