1、Designation:F 563 00Standard Specification forWrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications(UNS R30563)1This standard is issued under the fixed designation F 563;the number immediately following the designation indicates the year oforigina
2、l 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 This specification covers the requirements for a wroughtcobalt-20nickel-
3、20chromium-3.5molybdenum-3.5tungsten-5iron alloy in the form of bars,wires,and forgings used for themanufacture of surgical implants.1.2 The values stated in inch-pound units are to be regardedas the standard.The SI units given in parentheses are forinformation only.2.Referenced Documents2.1 ASTM St
4、andards:A 751 Test Methods,Practices,and Terminology forChemical Analysis of Steel Products2E 8 Test Methods for Tension Testing of Metallic Materials3E 18 Test Methods for Rockwell Hardness and RockwellSuperficial Hardness of Metallic Materials3E 92 Test Method for Vickers Hardness of Metallic Mate
5、-rials3E 112 Test Methods for Determining Average Grain Size3E 140 Hardness Conversion Tables for Metals(RelationshipAmong Brinell Hardness,Vickers Hardness,RockwellHardness,Rockwell Superficial Hardness,Knoop Hard-ness,and Scleroscope Hardness)3E 354 Test Methods for Chemical Analysis of High-Tempe
6、rature,Electrical,Magnetic,and Other Similar Iron,Nickel,and Cobalt Alloys42.2Aerospace Material Specification:AMS 2269 Chemical Check Analysis Limits WroughtNickel Alloys and Cobalt Alloys52.3ISO Standard:ISO 5832-8 Implant for SurgeryMetallic MaterialsPart8:Wrought Cobalt-Nickel-Chromium-Tungsten-
7、Iron Al-loy62.4ASQ Stamdard:Cl Specification of General Requirements for a QualityProgram73.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 Condition(4.1),3.1.3 Finish(4.2),3.1.
8、4 Mechanical properties(if applicable,for special con-ditions)(7.1),3.1.5 Applicable dimensions,including size,thickness,width,and length(exact,random,multiples),or print number,3.1.6 Special tests,and3.1.7 Supplementary requirements(if applicable),3.1.8 Product uniformity,and3.1.9 Additional tests
9、or inspections,supplementary com-position limits,if any,as required by the manufacturing processand intended application,and other supplementary require-ments.4.Materials and Manufacture4.1 Condition:4.1.1 Bar and wire shall be furnished to the implant manu-facturer as specified,in the annealed,medi
10、um hard,hard,or,for special applications,extra hard condition,depending on thedegree of cold work and aging treatment,if any.4.1.2 Forging shall be furnished to the implant manufactureras specified,in the forged or forged and solution heattreatedand aged condition.4.2 FinishSurface finish shall be a
11、s specified and requiredby the subsequent manufacturing process and the intendedapplication,if pertinent.5.Chemical Composition5.1 The heat analysis shall conform to the requirements as1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices,an
12、d is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved November 10,2000.Published January 2001.Origi-nally published as F 563 78.Last previous edition F 563 95.2Annual Book of ASTM Standards,Vol 01.01.3Annual Book of ASTM Standards,Vol 03.01.4Annual
13、Book of ASTM Standards,Vol 03.05.5Available from Society of Automotive Engineers,400 Commonwealth Drive,Warrendale,PA 15096.6Available from American National Standards Institute,11 W.42nd St.,13thFloor,New York,NY 10036.7Available from American Society for Quality,161 West Wisconsin Ave.,Milwaukee,W
14、I 53203.1Copyright ASTM,100 Barr Harbor Drive,West Conshohocken,PA 19428-2959,United States.to chemical composition specified in Table 1.The productanalysis tolerances shall conform to the requirements pre-scribed in Table 2.5.1.1 Requirements for the major and minor elementalconstituents are listed
15、 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 For referee purposes,Test Methods E 354 shall be used.5.3 Methods and practices relating to chemical analysisrequired by this specificati
16、on shall be in accordance with TestMethods A 751.5.4 Product AnalysisProduct analysis tolerances do notbroaden the specified heat analysis requirements,but covervariations between laboratories in the measurement of chemi-cal content.The manufacturer shall not ship material that isoutside the limits specified in Table 1.Product analysis limitsshall be as specified in Table 2.5.4.1 The product analysis is either for the purpose ofverifying the composition of a heat or lot or to determinevariations