ASTM F2063-2018 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants.pdf

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1、Designation: F2063 18Standard 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. in diameter or thickness. Millprod

4、uct is not intended to have the final shape, final surfacefinish, or final properties of the medical device, implant, ortheir components. Finished NiTi cold-worked tube should beconsidered under Specification F2633.1.3 The values stated in either SI units or inch-pound unitsare to be regarded separa

5、tely 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.1.4 This international standard was developed in accor-dance with intern

6、ationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2E4 Pra

7、ctices for Force Verification 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

8、 Carbon, Sulfur,Nitrogen, and Oxygen in Steel, Iron, Nickel, and CobaltAlloys by Various Combustion and Inert Gas FusionTechniquesE1097 Guide for Determination of Various Elements byDirect Current Plasma Atomic Emission SpectrometryE1172 Practice for Describing and Specifying a WavelengthDispersive

9、X-Ray SpectrometerE1245 Practice 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 Inert Gas FusionE1447 Test Method for Determination of Hydrogen in Tit

10、a-nium and Titanium Alloys by Inert Gas Fusion ThermalConductivity/Infrared Detection MethodE1479 Practice for Describing and Specifying InductivelyCoupled Plasma Atomic Emission SpectrometersE1941 Test Method for Determination of Carbon in Refrac-tory and Reactive Metals and TheirAlloys by Combusti

11、onAnalysisE2465 Test Method for Analysis of Ni-Base Alloys byWavelength Dispersive X-Ray Fluorescence SpectrometryF1710 Test Method for Trace Metallic Impurities in Elec-tronic Grade Titanium by High Mass-Resolution GlowDischarge Mass SpectrometerF2004 Test Method for Transformation Temperature ofNi

12、ckel-Titanium Alloys by Thermal AnalysisF2005 Terminology for Nickel-Titanium Shape MemoryAlloysF2082 Test Method for Determination of TransformationTemperature of Nickel-Titanium Shape Memory Alloysby Bend and Free RecoveryF2633 Specification for Wrought Seamless Nickel-TitaniumShape Memory Alloy T

13、ube for Medical Devices andSurgical ImplantsIEEE/ASTM SI 10 American National Standard for MetricPractice1This 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.

14、Current edition approved Aug. 1, 2018. Published August 2018. Originallyapproved in 2000. Last previous edition approved in 2012 as F2063 12. DOI:10.1520/F206318.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book

15、of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international st

16、andard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.12.2

17、 ISO Standard:3ISO 9001 Quality Management SystemsRequirements3. Terminology3.1 The terminology describing the physical and thermalproperties of these alloys shall be as defined in TerminologyF2005.3.2 See also Practice E4 (General Terminology).3.3 Definitions:3.3.1 ingot, nquantity of metal cast in

18、to a shape suitablefor subsequent processing to various mill products.3.3.2 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 final heat

19、treat-ment.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 sizes 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.

20、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 orders for material under this specificationshall include the following information:5.1.1 Quantityweight, length, or number of pieces.5.1.2 Alloy formulation, in term

21、s 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).5.1.5 Mechanical Propertiesif applicable for special con-ditions (see Section 10).5.1.6 Surface Condition(see Section 6.4).5.1.7 Applicable Dimensions, including diameter

22、, thickness,width, and length (exact, random, multiples) or print number.5.1.8 Special Testsfor example, chemical analysis on thefinished 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

23、 other intentional alloy additions.6.2 The material shall be vacuum or inert atmospheremelted to control metallurgical cleanliness and 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, mac

24、hined, ground, mechanicallypolished, or electropolished.7. Chemical Composition Requirements7.1 The ingot analysis shall conform to the requirements ofTable 1. Ingot analysis may be used for reporting all chemicalrequirements except hydrogen. Samples for hydrogen analysisshall be taken from the fini

25、shed product (see Section 4)orasagreed upon between the customer and supplier. The suppliershall not ship material that is outside the limits 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

26、 listed in Table 1 is not required to verifycompliance with this specification.7.2 Product Analysis:7.2.1 Product analysis limits shall be as specified in Table 2.Product analysis tolerances do not broaden the specificationingot analysis requirements, but cover variation between labo-ratories in the

27、 measurement of chemical content. The manu-facturer shall not ship material that is outside the limitsspecified in Table 1.7.2.2 The product analysis is either for the purpose ofverifying the composition of an ingot or manufacturing lot orto determine variations in the composition within the ingot.7

28、.2.3 Acceptance or rejection of an ingot or manufacturinglot of material may be made by the purchaser on the basis ofthis product analysis. Product analysis may be conducted by athird party if agreed upon by the supplier and the purchaser.7.2.4 Major elements shall be analyzed by direct currentplasm

29、a spectrometry according to Guide E1097; atomicabsorption, inductively coupled plasma spectrometry accord-ing to Practice E1479; X-ray spectrometer according to Prac-tice E1172; glow discharge mass spectrometry according toTest Method F1710; or an equivalent method. Carbon shall bemeasured by combus

30、tion according to Test MethodS E1019 orE1941 or wavelength dispersive X-ray fluorescence spectrom-etry according to Test Method E2465. Hydrogen shall bemeasured by inert gas fusion or vacuum hot extraction.Hydrogen shall be measured by inert gas fusion or vacuum hotextraction according to Test Metho

31、d E1447. Nitrogen andoxygen shall be measured by inert gas fusion according to TestMethod E1409.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.TABLE 1 Chemical Composition RequirementsElement % (mass/mass)Nickel 54.5 to

32、57.0Carbon, maximum 0.040Cobalt, maximum 0.050Copper, maximum 0.010Chromium, maximum 0.010Hydrogen, maximum 0.005Iron, maximum 0.050Niobium, maximum 0.025Nitrogen, maximum 0.005Oxygen, maximum 0.040TitaniumABalanceAApproximately equal to the difference between 100 % and the sum percentageof the othe

33、r specified elements. The percentage titanium content by difference isnot required to be reported.F2063 1827.2.5 The titanium content of these alloys shall be deter-mined by difference and need not be analyzed.8. Transformation Temperature8.1 The nickel and titanium contents of nickel-titaniumshape

34、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. Testing shall be performed onmaterial in the full

35、y annealed condition.8.2 Product alloy 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 T

36、est MethodF2004, or as measured in accordance with another appropriatethermomechanical test method, such as Test Method F2082.Test Method F2004 shall be used to determine transformationtemperatures unless otherwise agreed between the supplier andpurchaser.8.2.1 When measured in accordance with Test

37、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.8.2.2 Table 3 tolerances are for Asonly. Tolerances for Mf,Mp,Ms,Ap, and Afare as agreed upon by the purchaser

38、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-mation temperature shall be considered a special requirement.8.3 Section size, location, evaluation method, an

39、d resultsshall be reported on the product certification report provided tothe purchaser.9. Metallurgical Structure9.1 Microstructure:9.1.1 Microstructure shall be evaluated only in the hot-worked or annealed condition. Such evaluations shall takeplace at a section size not larger than 94.0 mm 3.70 i

40、n. andnot smaller than 5.50 mm 0.218 in. in diameter, thickness,width, height, wall thickness, or other maximum dimension.Evaluation may take place on in-process product that will beutilized to create the final product form. Condition, sectionsize, location, and evaluation method shall be reported o

41、n theproduct certification report provided to the purchaser.9.1.2 For all product evaluated as stated in 9.1.1, the productshall have an average grain size number (G) of 4 or larger asmeasured by Test Method E112. Results shall be reported onthe product certification report provided to the purchaser

42、.9.2 Microcleanliness:9.2.1 Porosity and nonmetallic inclusions shall be evaluatedonly in the hot-worked, or for cold-worked mill product in theannealed condition, or as agreed between the supplier andpurchaser. Such evaluations shall take place at a section sizenot larger than 94.0 mm 3.70 in. and

43、not smaller than 5.50mm 0.218 in. in diameter, thickness, width, height, wallthickness, or other maximum dimension. Evaluation may takeplace on in-process product that will be utilized to create thefinal product form. Condition, section size, location, andevaluation method shall be reported on the p

44、roduct certificationreport provided to the purchaser.9.2.2 For product with Asless than or equal to 30C, themaximum allowable dimension of porosity and nonmetallicinclusions such as Ti4Ni2Oxand TiC particles shall be 39.0 m0.0015 in. The maximum dimension shall be the maximumlength of all contiguous

45、 particles and voids, including particlesseparated by voids. Furthermore, porosity and nonmetallicinclusions shall not constitute more than 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

46、porosity and nonmetallic inclusionssuch as Ti4Ni2Oxand TiC particles shall be agreed upon by thepurchaser and supplier9.2.4 Measurements shall be made in accordance withPractice E1245 or an equivalent method with longitudinalsamples parallel to the working direction. The supplier andpurchaser shall

47、agree upon the size of the product whensampled, the number and location of samples in the product,the sample preparation, the number of fields of view, and themeasurement technique. These shall be reported on the productcertification report provided to the purchaser.10. Mechanical Property Requireme

48、nts10.1 Final 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 temperatureTABLE 2 Product Analysis Tolera

49、nceAElement Tolerance Under the Minimum Limitor Over the Maximum Limit,% (mass/mass)BCarbon 0.002Cobalt 0.001Copper 0.001Chromium 0.001Hydrogen 0.0005Iron 0.01Nickel 0.2 under min; 0.2 over maxNiobium 0.004Nitrogen 0.001Oxygen 0.004AProduct analysis tolerance limits are based on analytical capabilities that havebeen demonstrated for this composition.BUnder minimum limit not applicable for elements where only a maximumpercentage is indicated.TABLE 3 Typical TolerancesAs(C) Tolerance Range (C)$70 750 As70 10# 50 15F2063 183of 800C 14