ASTM_F_745_-_00.pdf

Designation:F 745 00Standard Specification for18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel forCast and Solution-Annealed Surgical Implant Applications1This standard is issued under the fixed designation F 745;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(e)indicates an editorial change since the last revision or reapproval.1.Scope1.1 Thisspecificationcoverstherequirementsfor18chromium-12.5nickel-2.5molybdenum stainless steel alloyshot,bar,or ingot used for the manufacture of cast andsolution-annealed surgical implants.1.2 The values stated in inch-pound units are to be regardedas the standard.1.3 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:A 744/A 774M Specification for Castings,Iron-Chromium-Nickel,Corrosion Resistant,for Severe Service2E 8 Test Methods for Tension Testing of Metallic Materials3E 353 Test Methods for Chemical Analysis of Stainless,Heat-Resisting,Maraging,and Other Similar Chromium-Nickel-Iron Alloys42.2American Society for Quality(ASQ)Standard:5ASQC 1 Specification of General Requirements for a Qual-ity Program3.Ordering Information3.1 Inquiries and orders for material under this specificationshall include the following information:3.1.1 Quantity(weight or number of pieces),3.1.2 ASTM Designation,3.1.3 Form(Section 4.1),3.1.4 Special tests,and3.1.5 Special requirements.4.Materials and Manufacture4.1 The base material furnished to the implant manufacturerfor purposes of casting surgical implants shall be supplied inthe form of bar,shot,or ingot.5.Chemical Composition5.1 The heat analysis shall conform to the chemical com-position listed in Table 1.The manufacturer shall not shipmaterial that is outside the limits specified in Table 1.5.1.1 Requirements for the major and minor elementalconstituents are listed in Table 1.Also listed are importantresidual elements.Analysis for elements not listed in Table 1 isnot required to verify compliance with this specification.5.2 Product AnalysisThe product analysis is either for thepurpose of verifying the composition of a heat or lot or todetermine variations in the composition within the heat.5.2.1 Acceptance or rejection of a heat or lot of materialmay be made by the purchaser on the basis of this productanalysis.5.2.2 Product analysis tolerances do not broaden the speci-fied heat analysis requirements but cover variation betweenlaboratories in the measurement of chemical content.Productanalysis limits shall be as specified in Table 2.5.3 For referee purposes,Test Methods E 353 shall be used.6.Mechanical Properties6.1 The material shall conform to the mechanical propertyrequirements prescribed in Table 3.6.2 Specimens for tension tests shall be cast from remeltedmaterial from each master heat by the same general proceduresused in casting surgical implants.6.2.1 Specimens may be cast,ground,or machined to finaldimensions in accordance with the 0.25 in.(6.35 mm)diameterspecimen in Fig.8 of Test Methods E 8.6.2.2 Specimens shall be solution annealed using the sameprocedures used to solution anneal surgical implants.6.3 A minimum of two tension specimens shall be tested.Ifone specimen fails below the specified mechanical require-ments,two additional specimens shall be tested and both mustpass.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Nov.10,2000.Published February 2001.Originallypublished as F 745 81.Last previous edition F 745 95.2Annual Book of ASTM Standards,Vol 01.02.3Annual Book of ASTM Standards,Vol 03.01.4Annual Book of ASTM Standards,Vol 03.05.5Available from American Society for Quality Control,161 West WisconsinAve.,Milwaukee,WI 53203.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.6.3.1 Test results for any specimen which fractures outsideof the gage length shall be considered invalid and void;and areplacement specimen shall be tested.7.Special Tests7.1 Other tests may be required by agreement,between thepurchaser and the supplier.8.Special Requirements8.1 Special requirements shall be specified on the purchaseorder by the purchaser.9.Certification9.1 Upon request of the purchaser in the contract or order amanufacturers certification that the material was manufacturedand tested in accordance with this specification together with areport of the test results requested shall be furnished at the timeof shipment.10.Quality Program Requirements10.1 The producer