ASTM_F_748_-_06_2010.pdf

Designation:F74806(Reapproved 2010)Standard Practice forSelecting Generic Biological Test Methods for Materials andDevices1This standard is issued under the fixed designation F748;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This practice recommends generic biological test meth-ods for materials and devices according to end-use applica-tions.While chemical testing for extractable additives andresidual monomers or residues from processing aids is neces-sary for most implant materials,such testing is not included aspart of this practice.The reader is cautioned that the area ofmaterials biocompatibility testing is a rapidly evolving field,and improved methods are evolving rapidly,so this practice isby necessity only a guideline.Athorough knowledge of currenttechniques and research is critical to a complete evaluation ofnew materials.1.2 These test protocols are intended to apply to materialsand medical devices for human application.Biological evalu-ation of materials and devices,and related subjects such aspyrogen testing,batch testing of production lots,and so on,arealso discussed.Tests include those performed on materials,endproducts,and extracts.Rationale and comments on currentstate of the art are included for all test procedures described.1.3 The biocompatibility of materials used in single ormulticomponent medical devices for human use depends to alarge degree on the particular nature of the end-use application.Biological reactions that are detrimental to the success of amaterial in one device application may have little or no bearingon the successful use of the material for a different application.It is,therefore,not possible to specify a set of biocompatibilitytest methods which will be necessary and sufficient to establishbiocompatibility for all materials and applications.1.4 The evaluation of tissue engineered medical products(TEMPs)may,in some cases,involve different or additionaltesting beyond those suggested for non-tissue-based materialsand devices.Where appropriate,these differences are discussedin this practice and additional tests described.1.5 The ethical use of research animals places the obligationon the individual investigator to determine the most efficientmethods for performing the necessary testing without undueuse of animals.Where adequate prior data exists to substantiatecertain types of safety information,these guidelines should notbe interpreted to mean that testing should be unnecessarilyrepeated.1.6 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:2E1202 Guide for Development of Micronucleus Assay Stan-dardsE1262 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 RepairAssayF619 Practice for Extraction of Medical PlasticsF719 Practice for Testing Biomaterials in Rabbits for Pri-mary Skin IrritationF720 Practice for Testing Guinea Pigs for ContactAllergens:Guinea Pig Maximization TestF749 Practice for Evaluating Material Extracts by Intracuta-neous Injection in the RabbitF750 Practice for Evaluating Material Extracts by SystemicInjection in the MouseF756 Practice for Assessment of Hemolytic Properties ofMaterials1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devicesand is direct responsibility of Subcommittee F04.16on Biocompatibility Test Methods.Current edition approved June 1,2010.Published September 2010.Originallyapproved in 1982.Last previous edition approved in 2006 as F748 06.DOI:10.1520/F0748-06R10.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 F763 Practice for Short-Term Screening of Implant Materi-alsF813 Practice for Direct Contact Cell Culture Evaluation ofMaterials for Medical DevicesF895 Test Method forAgar Diffusion Cell Culture Screeningfor CytotoxicityF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Mu