_STP_1481-2007.pdf

STP 1481Fatigue and Fracture of MedicalMetallic Materials and DevicesM.R.Mitchell and K.L.Jerina,editorsASTM Stock Number:STP1481ASTM100 Barr Harbor DrivePO Box C700West Conshohocken,PA 19428-2959Printed in the U.S.A.ISBN:978-0-80314511-5Copyright 2007 AMERICAN SOCIETY FOR TESTING AND MATERIALSINTERNATIONAL,West Conshohocken,PA.All rights reserved.This material may notbe reproduced or copied in whole or in part,in any printed,mechanical,electronic,film,or other distribution and storage media,without the written consent of the publisher.Photocopy RightsAuthorization to photocopy items for internal,personal,or educationalclassroom use,or the internal,personal,or educational classroom use ofspecific clients,is granted by the American Society for Testing and MaterialsInternational ASTM provided that the appropriate fee is paid to the CopyrightClearance Center,222 Rosewood Drive,Danvers,MA 01923;Tel:978-750-8400;online:http:/ Review PolicyEach paper published in this volume was evaluated by two peer reviewers and atleast one editor.The authors addressed all of the reviewers comments to the satisfactionof both the technical editor?s?and the ASTM International Committee on Publications.The quality of the papers in this publication reflects not only the obvious efforts ofthe authors and the technical editor?s?,but also the work of the peer reviewers.Inkeeping with long-standing publication practices,ASTM International maintainsthe anonymity of the peer reviewers.The ASTM International Committee on Publicationsacknowledges with appreciation their dedication and contribution of time and efforton behalf of ASTM International.Printed in USASeptember 2007ForewordThis particular ASTM International publication contains research manuscripts from theFirst Symposium Fatigue and Fracture of Medical Metallic Materials and Devices thatwas sponsored by ASTM Committees E08 on Fatigue and Fracture and F04 on MedicalDevices held in Dallas,TX,November,2005.It was the intent of this conference to bringtogether technical experts in both disciplines,in order to initiate a dialogue between thetwo groups that would further our knowledge and understanding of the cyclic deformation,of most specifically,nitinol-based medical devices and the physical environment in whichthey are expected to survive for considerable periods of time.The ultimate goal of thisinteraction is intended to?1?define the environments?i.e.duty cycle deformation-timehistories?in body-specific locations such as the superficial femoral artery,carotid,ab-dominal and thoracic arteries?2?develop constitutive expressions for the deformationresponse of nitinol via specific test methodologies and data analyses?3?develop theappropriate mechanics analyses for cumulative damage calculations and to ultimately?4?ascertain the fatigue lifetime of medical devices in the human body.To this end,stan-dards must be developed to define the subject matter listed above.ContentsOverviewviiPROCESSING,PROPERTIES AND ENVIRONMENTMartnesite Transformations and Fatigue Behavior of NitonolP.ADLER3Effects of Phase Transformations on Fatigue Endurance of a Superelastic NiTi AlloyM.WU18Thermoelastic Transformation Behavior of NitinolK.E.PERRY ANDP.E.LABOSSIERE24Functional Properties of Nanostructured Ti-50.0 at%Ni AlloysV.BRAILOVSKI,V.DEMERS,S.PROKOSHKIN,K.INAEKYAN,I.KHMELEVSKAYA ANDS.DOBATKIN34Application of Low Plasticity Burnishing(LPB)to Improve the Fatigue Performanceof Ti-6A1-4V Femoral Hip StemsD.HORNBACH,P.PREVEY,ANDE.LOFTUS45Comparison of the Corrosion Fatigue Characteristics of 23Mn-21Cr-1Mo Low Nickel,22CR-13Ni-5Mn,and 18Cr-14Ni-2.5Mo Stainless SteelM.ROACH,R.S.WILLIAMSON,ANDL.D.ZARDIACKAS56Verification of Strain Level Calculations in Nitinol Fatigue Resistance PredictionsK.PIKE67ANALYSIS,CHARACTERIZATION AND STANDARDSPrediction of Failure in Existing Heart Valve DesignsJ.S.CROMPTON,K.C.KOPPENHOEFER,ANDJ.R.DYDO77Characterizing Fatigue Properties of Medical Grade Nickel-Titanium Alloys by RotaryBeam Testing and Fracture AnalysisM.PATEL87Experimental Studies of NiTi Self-Expanding Stent DesignsJ.E.EATON-EVANS,J.M.DULIEU-BARTON,E.G.LITTLE,ANDI.A.BROWN98FDA Recommendations for Nitinol Stent and Endovascular Graft FatigueCharacterization and Fracture ReportingK.J.CAVANAUGH,J.L.GOODE,ANDV.M.HOLT,E.ANDERSON110vOverviewA conference held in Dallas,TX in November of 2005 addressed the unique thermal and me-chanical properties of shape memory alloys?SMAs?and metallic medical materials and devices.Although the conference focused much attention on nitinol-based technologies,several othermetallic medical materials and devices are included in the conference publications.The principlefocus was on nitinol since these unique alloys offer the designer new dimensions in controllingthe shape of devices used in medical and many structural applications.Shape memory devicessuch as valves,actuators,clutches and gaskets are proposed for monitoring units,drive systemsand repair schemes.Biocompatible implanted medical