ASTM F2063-2012 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants《医疗器械和外科植入物用锻制镍钛形状记忆合金的标准规范》.pdf

1、Designation: F2063 12Standard Specification forWrought Nickel-Titanium Shape Memory Alloys for MedicalDevices and Surgical Implants1This standard is issued under the fixed designation F2063; the number immediately following the designation indicates the year oforiginal adoption or, in the case of re

2、vision, 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. Scope*1.1 This specification covers the chemical, physical,mechanical, and metallurgical requirements for w

3、roughtnickel-titanium bar, flat rolled products, and tubes containingnominally 54.5- to 57.0-weight percent nickel and used for themanufacture of medical devices and surgical implants.1.2 Requirements are for mill product, measuring 5.50 to94.0 mm 0.218 to 3.70 in. diameter or thickness. Mill produc

4、tis not intended to have the final shape, final surface finish, orfinal properties of the medical device, implant, or their com-ponents. Finished NiTi cold-worked tube should be consideredunder Specification F2633.1.3 The values stated in either SI units or inch-pound unitsare to be regarded separat

5、ely as standard. The values stated ineach system may not be exact equivalents; therefore, eachsystem shall be used independently of the other. Combiningvalues from the two systems may result in non-conformancewith the standard.2. Referenced Documents2.1 ASTM Standards:2E4 Practices for Force Verific

6、ation of Testing MachinesE8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE112 Test Methods for Determining Average Grain SizeE1019 Test Methods for Determination of Carbon, Sulfur,Nitrogen

7、, and Oxygen in Steel, Iron, Nickel, and CobaltAlloys by Various Combustion and Fusion TechniquesE1097 Guide for Determination of Various Elements byDirect Current Plasma Atomic Emission SpectrometryE1172 Practice for Describing and Specifying aWavelength-Dispersive X-Ray SpectrometerE1245 Practice

8、for Determining the Inclusion or Second-Phase Constituent Content of Metals by Automatic ImageAnalysisE1409 Test Method for Determination of Oxygen and Nitro-gen in Titanium and Titanium Alloys by the Inert GasFusion TechniqueE1447 Test Method for Determination of Hydrogen in Tita-nium and Titanium

9、Alloys by Inert Gas Fusion ThermalConductivity/Infrared Detection MethodE1479 Practice for Describing and Specifying Inductively-Coupled Plasma Atomic Emission SpectrometersE1941 Test Method for Determination of Carbon in Refrac-tory and Reactive Metals and TheirAlloys by CombustionAnalysisF1710 Tes

10、t Method for Trace Metallic Impurities in Elec-tronic Grade Titanium by High Mass-Resolution GlowDischarge Mass SpectrometerF2004 Test Method for Transformation Temperature ofNickel-Titanium Alloys by Thermal AnalysisF2005 Terminology for Nickel-Titanium Shape MemoryAlloysF2633 Specification for Wro

11、ught Seamless Nickel-TitaniumShape Memory Alloy Tube for Medical Devices andSurgical ImplantsIEEE/ASTM SI 10 American National Standard for MetricPractice2.2 Other Standards:ASQ C1 General Requirements for a Quality Program3ISO 9001 Quality Management SystemsRequirements43. Terminology3.1 The termin

12、ology describing the physical and thermalproperties of these alloys shall be as defined in TerminologyF2005.3.2 See also Practice E4: General Terminology.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility

13、ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Dec. 1, 2012. Published January 2013. Originallyapproved in 2000. Last previous edition approved in 2005 as F2063 05. DOI:10.1520/D206312.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Cus

14、tomer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203.Available fromAmerican Society for Quality (ASQ), 600

15、N.Plankinton Ave., Milwaukee, WI 53203, http:/www.asq.org.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Driv

16、e, PO Box C700, West Conshohocken, PA 19428-2959. United States13.3 Definitions:3.3.1 mill product, nany finished or semi-finished productfrom a mill. Product may be straight or coiled. Product typesinclude hot-worked, hot-worked and cold-finished, and hot-worked and cold-worked, with or without a f

17、inal heat treat-ment.NOTE 1Mill product is not intended to have the final shape, finalsurface finish, or final properties of the medical device, implant, or theircomponents.4. Product Classification4.1 BarRound bars and flats from 5.50 to 94.0 mm 0.218to 3.70 in. in diameter or thickness (other size

18、s or shapes byspecial order).4.2 PlateAny product 5.50 up to 94.0 mm 0.218 to 3.70in. in thickness, with a width equal to or greater than five timesthe thickness.4.3 TubeHollow cylindrical shapes from 5.50 up to 94.0mm 0.218 to 3.70 in. in outer diameter.5. Ordering Information5.1 Inquiries and orde

19、rs for material under this specificationshall include the following information:5.1.1 Quantityweight, length, or number of pieces.5.1.2 Alloy formulation, in terms of transformation tempera-ture parameter (see Section 8).5.1.3 Formbar, plate, or tube (see Section 4).5.1.4 Condition(see 3.3.1).5.1.5

20、Mechanical Propertiesif applicable for special con-ditions (see Section 10).5.1.6 Surface Condition(see Sections 6.4).5.1.7 Applicable Dimensions, including diameter, thickness,width, and length (exact, random, multiples) or print number.5.1.8 Special Testsfor example, chemical analysis on thefinish

21、ed mill product.5.1.9 Special Requirements(see Section 13).6. Materials and Manufacture6.1 The material shall be made from ingot made from nickeland titanium with no other intentional alloy additions.6.2 The material shall be vacuum or inert atmospheremelted to control metallurgical cleanliness and

22、alloy chemistry.6.3 The product shall be supplied as specified in thepurchase order.6.4 The product surface condition may be oxidized,descaled, pickled, blasted, machined, ground, mechanicallypolished, or electropolished.7. Chemical Composition Requirements7.1 The heat analysis shall conform to the

23、requirements ofTable 1. Ingot analysis may be used for reporting all chemicalrequirements except hydrogen. Samples for hydrogen analysisshall be taken from the finished product (see Section 4)orasagreed upon between the customer and supplier. The suppliershall not ship material that is outside the l

24、imits specified inTable 1.7.1.1 Requirements for major and minor elements are listedin Table 1. Important residual elements are also listed.Analysisfor elements not listed in Table 1 is not required to verifycompliance with this specification.7.2 Product Analysis:7.2.1 Product analysis limits shall

25、be as specified in Table 2.Product analysis tolerances do not broaden the specificationheat analysis requirements, but cover variation between labo-ratories in the measurement of chemical content. The manu-facturer shall not ship material that is outside the limitsspecified in Table 1.7.2.2 The prod

26、uct analysis is either for the purpose ofverifying the composition of a heat or manufacturing lot or todetermine variations in the composition within the heat.7.2.3 Acceptance or rejection of a heat or manufacturing lotof material may be made by the purchaser on the basis of thisproduct analysis. Pr

27、oduct analysis may be conducted by a thirdparty if agreed upon by the supplier and the purchaser.7.2.4 Major elements shall be analyzed by direct currentplasma spectrometry according to Guide E1097; atomicabsorption, inductively coupled plasma spectrometry accord-ing to Practice E1479; X-ray spectro

28、meter according to Prac-tice E1172; glow discharge mass spectrometry according toTest Method F1710; or an equivalent method. Carbon shall bemeasured by combustion according to Test Method E1019 orE1941. Hydrogen shall be measured by inert gas fusion orvacuum hot extraction according to Test Method E

29、1447.TABLE 1 Chemical Composition RequirementsElement % (mass/mass)Nickel 54.5 to 57.0Carbon, maximum 0.050Cobalt, maximum 0.050Copper, maximum 0.010Chromium, maximum 0.010Hydrogen, maximum 0.005Iron, maximum 0.050Niobium, maximum 0.025Nitrogen plus Oxygen, maximum 0.050TitaniumABalanceAApproximatel

30、y equal to the difference between 100 % and the sum percentageof the other specified elements. The percentage titanium content by difference isnot required to be reported.TABLE 2 Product Analysis ToleranceAElement Tolerance Under the Minimum Limitor Over the Maximum Limit,% (mass/mass)BCarbon 0.002C

31、obalt 0.001Copper 0.001Chromium 0.001Hydrogen 0.0005Iron 0.01Nickel 0.2 under min; 0.2 over maxNiobium 0.004Nitrogen 0.004Oxygen 0.004AProduct analysis tolerance limits are based on analytical capabilities that havebeen demonstrated for this composition.BUnder minimum limit not applicable for elemen

32、ts where only a maximumpercentage is indicated.F2063 122Nitrogen and oxygen shall be measured by inert gas fusionaccording to Test Method E1409.7.2.5 The titanium content of these alloys shall be deter-mined by difference and need not be analyzed.8. Transformation Temperature8.1 The nickel and titan

33、ium contents of nickel-titaniumshape memory alloys cannot be measured to a precisionrequired to guarantee shape memory or superelastic properties.Calorimetry or an equivalent thermomechanical test methodshall be used to ensure the alloy formulation in terms oftransformation temperature.8.2 Product a

34、lloy formulation shall be specified in terms ofthe transformation temperature parameter(s) required by thepurchase order. This parameter shall be one of the following:Mf,Mp,Ms,As,Ap,Afas defined in Terminology F2005 and asmeasured on the product in accordance with Test MethodF2004, or as measured in

35、 accordance with another appropriatethermomechanical test method.8.2.1 When measured in accordance with Test MethodF2004 for transformation temperature by thermal analysis, theAsshall be uniform on the purchased product to within theranges in Table 3 or as agreed upon by the purchaser andsupplier.8.

36、2.2 Table 3 tolerances are for Asonly. Tolerances for Mf,Mp,Ms,Ap, and Afare as agreed upon by the purchaser andsupplier.8.2.3 Transformation temperature parameters are normallyspecified in the wrought product as defined in TerminologyF2005. Other conditions for the certification of alloy transfor-m

37、ation temperature shall be considered a special requirement.9. Metallurgical Structure9.1 Microstructure:9.1.1 Microstructure shall be evaluated only in the hot-worked condition, prior to any cold processing. Such evalua-tions shall take place at a section size not larger than 94.0 mm3.70 in. and no

38、t smaller than 5.50 mm 0.218 in. in diameter,thickness, width, height, wall thickness, or other maximumdimension. Evaluation may take place on in-process productthat will be utilized to create the final product form.9.1.2 For all product evaluated as stated in 9.1.1, productshall have an average gra

39、in size number (G) of 4 or larger asmeasured by Test Method E112.9.2 Microcleanliness:9.2.1 Porosity and nonmetallic inclusions shall be evalutedonly in the hot-worked condition, prior to any cold processing.Such evaluations shall take place at a section size not largerthan 94.0 mm 3.70 in. and not

40、smaller than 5.50 mm 0.218in. in diameter, thickness, width, height, wall thickness, orother maximum dimension. Evaluation may take place onin-process product that will be utilized to create the finalproduct form.9.2.2 For product with Asless than or equal to 30C, themaximum allowable dimension of p

41、orosity and nonmetallicinclusions such as Ti4Ni2Oxand TiC particles shall be 39.0 m0.0015 in. The maximum dimension shall be the maximumlength of all contiguous particles and voids, including particlesseparated by voids. Furthermore, porosity and nonmetallicinclusions shall not constitute more than

42、2.8 % (area percent)of the structure as viewed at 400 to 500 in any field of view.9.2.3 For product with Asgreater than 30C, the maximumallowable dimensions of porosity and nonmetallic inclusionssuch as Ti4Ni2Oxand TiC particles shall be agreed upon by thepurchaser and supplier9.2.4 Measurements sha

43、ll be made in accordance withPractice E1245 or an equivalent method with longitudinalsamples parallel to the working direction. The supplier andpurchaser shall agree upon the number and location of samplesin the product, the sample preparation, the number of fields ofview and the measurement techniq

44、ue.10. Mechanical Property Requirements10.1 Finished product shall be tensile tested in the fullyannealed condition. Tensile testing shall be conducted inaccordance with Test Methods E8/E8M.10.1.1 Tension test samples from the final product shall beannealed so that the material reaches a minimum tem

45、peratureof 800C 1470F for a minimum time of 15 min followed byrapid cooling by water quenching, gas quenching, or aircooling.10.1.2 Tensile properties shall be determined using a strainrate of 0.003 to 0.1 mm/mm/min in./in./min. Tensile proper-ties shall meet the requirements listed in Table 4 using

46、 theappropriate gauge length for the product size being tested.NOTE 2Annealed product should be tested at 5 to 10C above Af.10.1.3 Specimens for tension tests from product above 50.0mm 1.97 in. in diameter or thickness may be taken from plateor strip rolled from the product. For product 50.0 mm 1.97

47、 in.or less in diameter or thickness, specimens shall be made fromthe product.10.1.4 Tensile properties shall be measured in the longitu-dinal direction with respect to the final fabrication of thesample. Transverse tensile properties for wide flat productsshall be as agreed upon between the custome

48、r and the supplier10.2 Other special mechanical tests shall be as specified onthe purchase order.TABLE 3 Tolerance RequirementsAs(C) Tolerance Range (C)$70 750 As70 10# 50 15TABLE 4 Annealed Mechanical PropertiesADiameter or DistanceBetween Parallel Sides,mmTensile Strength MPa,MinimumElongation in

49、50.0 mm 1.97in. or 4 D, % MinimumBUp to 50.0 1.97 in. 551 (79.9 KSI) 15Over 50.0 1.97 in. 551 (79.9 KSI) 10ATested at ambient temperature of 20.0 to 24.0C 68.0 to 75.2F.B4D indicates 4 times diameter.F2063 12311. Units of Measure11.1 SelectionThis specification requires that the pur-chaser selects the units (SI or inch-pound) to be used forproduct certification. In the absence of a stated selection ofunits on the purchase order, this selection may be expressed bythe purchaser in several alternate forms listed