ASTM_F_1408_-_97_2013.pdf

Designation:F140897(Reapproved 2013)Standard Practice forSubcutaneous Screening Test for Implant Materials1This standard is issued under the fixed designation F1408;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 practice covers a short-term testing method toscreen the subcutaneous tissue reaction to metallic or otherimplant candidate materials in small laboratory animals.Thematerial may be dense or porous.The tissue reactions will beevaluated in comparison to those evoked by control materialsthat are accepted as clinical implant materials.1.2 This practice,along with other appropriate biologicaltests(including other ASTM test methods),may be used toassess the biocompatibility of candidate materials for use in thefabrication of devices for clinical application.It may be alsoapplied to evaluate the effect of special surface textures andpreparations of known materials.1.3 This experimental protocol is not designed to provide acomprehensiveassessmentofthesystemictoxicity,carcinogenicity,teratogenicity,or mutagenicity of the material.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 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:2F67 Specification for Unalloyed Titanium,for Surgical Im-plant Applications(UNS R50250,UNS R50400,UNSR50550,UNS R50700)F75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI(Extra Low Interstitial)Alloy for SurgicalImplant Applications(UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants(UNS S31673)F648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF763 Practice for Short-Term Screening of Implant Materi-alsF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone3.Summary of Practice3.1 Under strict aseptic conditions,specimens of the candi-date and control materials are implanted subcutaneously in theneck of mice(or other suitable animals).After one,three,andnine weeks the animals are anesthetized and the test samplesare excised with an intact tissue envelope.On histologicsections the tissue reactions to the candidate materials arecompared with the tissue response to clinically acceptedcontrol materials.4.Significance and Use4.1 This practice is a guideline for a short-term screeningtest for the evaluation of the tissue response to materials thatmay be selected for implantation in the human body.This testmay be performed prior to longterm testing(for example,Practice F981)to eliminate unsuitable candidate materialsearly and to save further animal testing.4.2 This practice may be used to detect toxic effects ofmaterials in general(see Appendix X1).However,it is particu-larly suitable for the testing of materials that are intended tohave contact with subcutaneous tissues or soft tissues ingeneral.For materials intended to be inserted specifically intomuscle tissues,Practice F763 should be considered as a shortterm test method.4.3 The suggested implant specimens are cylindrical.Aspecial grooved type of cylinder may be used(see Fig.X2.1 of1This practice is under the jurisdiction ofASTM 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 F1408-97(2008).DOI:10.1520/F1408-97R13.2For 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 Appendix X2)to allow tissue interlocking that could keep theimplant in place and minimize tissue irritation through motionat the interface that otherwise could contribute to increasedvariance of the results.In case ungrooved cylinders are used(see Fig.X1.2 of Appendix X2),probable motion at theimplant/tissue interface must be taken into account.Co