1、Designation: F3273 17Standard Specification forWrought Molybdenum-47.5 Rhenium Alloy for SurgicalImplants1(UNS R03700)This standard is issued under the fixed designation F3273; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the ye
2、ar 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. Scope1.1 This specification covers the chemical, mechanical, andmetallurgical requirements for wrought molybdenum-47.5 rh
3、e-nium alloy to be used in the manufacture of surgical implants.1.2 The SI units in this standard are the primary units. Thevalues stated in either primary SI units or secondary inch-pound units are to be regarded separately as standard. Thevalues stated in each system may not be exact equivalents;t
4、herefore, each system shall be used independently of the other.Combining values from the two systems may result in noncon-formance with 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 s
5、tandard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.1.4 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles
6、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:2B193 Test Method for Resistivity of Electrical ConductorMaterialsB311 Test Method for Density of Pow
7、der Metallurgy (PM)Materials Containing Less Than Two Percent PorosityB774 Specification for Low Melting Point AlloysC1113 Test Method for Thermal Conductivity of Refracto-ries by Hot Wire (Platinum Resistance ThermometerTechnique)E8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE29 Pra
8、ctice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE228 Test Method for Linear Thermal Expansion of SolidMaterials With a Push-Rod DilatometerE290 Test Methods for Bend Testing of Material for Ductil-ityE1621 Guide for Elemental Analysis by Wavelength Disper-s
9、ive X-Ray Fluorescence SpectrometryE1941 Test Method for Determination of Carbon in Refrac-tory and Reactive Metals and TheirAlloys by CombustionAnalysisE2626 Guide for Spectrometric Analysis of Reactive andRefractory Metals (Withdrawn 2017)3SI10, IEEE/ASTM SI 10 American National Standard forUse of
10、 the International System of Units (SI): The ModernMetric System2.2 Aerospace Material Specifications:4AMS 2630 Inspection, Ultrasonic Product 0ver 0.5 inch(12.7 mm) ThickAMS 2632 Ultrasonic Inspection of Thin Materials2.3 ISO Standards:5ISO 6892-1 Metallic materials - Part 1: Method of test atroom
11、temperatureISO 9001 Quality management systems requirementsISO 10993-5 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicityISO 10993-6 Biological evaluation of medical devices -Part 6: Tests for local effects after implantationISO 10993-10 Biological evaluation of medica
12、l devices -Part 10: Tests for irritation and skin sensitizationISO 10993-11 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity3. Terminology3.1 Definitions:1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and
13、 is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Sept. 1, 2017. Published September 2017. DOI:10.1520/F3273-172For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Bo
14、ok of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from Aerospace Industries Association (AIA), 1000 Wilson Blvd.,Suite 1700, Arlington, VA 22209, http:
15、/www.aia-aerospace.org.5Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was devel
16、oped 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.13.1.1 cold work, na
17、ny mechanical deformation processperformed below the recrystallization temperature which re-sults in strain hardening of the material.3.1.2 lot, nthe total number of mill products producedfrom the same melt heat under the same conditions at essen-tially the same time.4. Product Classification4.1 Bar
18、Round bars and flats from 1.00 mm (0.0394 in.) to101.60 mm (4.00 in.) in diameter or thickness (other sizes andshapes by special order).4.2 SheetAny product under 4.76 mm (0.1875 in.) inthickness and 610 mm (24 in.) or more in width.4.3 OtherOther forms and shapes may be provided byagreement between
19、 the purchaser and supplier.5. Ordering Information5.1 Include with inquiries and orders for material under thisspecification the following information:5.1.1 Quantity;5.1.2 ASTM designation and date of issue;5.1.3 Form (bar, sheet),5.1.4 Condition (see 6.3);5.1.5 Mechanical properties (if applicable
20、, for specialconditions), Table 2;5.1.6 Finish (see 6.2);5.1.7 Applicable dimensions including size, thickness,width, length, or drawing number;5.1.8 Special tests (see 9.1); and5.1.9 Other requirements.6. Materials and Manufacture6.1 The alloy consists of nominal 47.5 mass percent rhe-nium balance
21、molybdenum of approximately 99.79 % purityand residual plus trace elements.6.2 FinishThe product may be furnished to the implantmanufacturer as mechanically or chemically descaled bypickling, abrasively blasting, chemically milled, ground,machined, peeled, polished, combinations of these operations,
22、or as specified by the purchaser. On billets, bars, plates, andforgings, it is permissible to remove minor surface imperfec-tions by grinding or machining if the resultant area meets thedimensional and surface finish requirements of this specifica-tion.6.3 ConditionMaterial shall be furnished in the
23、 annealed,cold worked, or extra hard conditions that result from thermalor work-hardening operations. Conditions other than thoselisted in Table 2 may be established between the supplier andpurchaser.7. Chemical Requirements7.1 The heat analysis shall conform to the chemical com-position specified i
24、n Table 1. The supplier shall not shipmaterial with chemistry outside the requirements specified inTable 1.7.1.1 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
25、verify compliance with this specification.7.2 For referee purposes use Test Methods E1621, E1941,and E2626, or other analytical method agreed upon betweenthe purchaser and the supplier.7.3 Samples for chemical analysis shall be representative ofthe material being tested. The utmost care must be used
26、 insampling for chemical analysis because of its affinity forelements such as oxygen, nitrogen, and hydrogen. In cuttingsamples for analysis, therefore, the operation should be carriedout insofar as possible in a dust-free atmosphere. If cuttingtools are to be used they should be clean and sharp; ho
27、wever,laser cutting is preferred. Samples for analysis should be storedin suitable containers.8. Mechanical Requirements8.1 The material supplied under this specification shallconform to the mechanical properties given in Table 2.Alternate properties may be agreed upon between the pur-chaser and sup
28、plier.8.2 Specimens for tension tests shall be prepared and testedin accordance with Test Methods E8/E8M. Tensile propertiesshall be determined using a strain rate of 0.003 to 0.007mm/mm/min (in./in./min ) through yield and then the cross-head speed may be increased to produce fracture in approxi-ma
29、tely one additional minute.8.2.1 Bar and SheetTest according to Test Methods E8/E8M. If one test specimen does not meet the specifiedrequirements, test two additional test pieces representative ofthe same lot, in the same manner for each test specimen. Thelot will be considered in compliance only if
30、 all additional testpieces meet the specified requirements.8.2.2 Tensile tests results for which any specimen fracturesoutside the gage length shall be considered acceptable, if boththe elongation and reduction of area meet the minimumrequirements specified. Refer to subsections 7.11.4 and 7.12.5of
31、Test Methods E8/E8M. If either elongation or reduction ofTABLE 1 Chemical RequirementsElementComposition, %(mass/mass)Nitrogen, max 0.010Carbon, max 0.050Hydrogen, max 0.010Iron, max 0.010Oxygen max 0.010Sulfur, max 0.010Phosphorous, max 0.010Silicon, max 0.010Boron, max 0.010Copper, max 0.010Titani
32、um., max 0.010Tungsten, max 0.050Manganese, max 0.010Tin, max 0.010Rhenium 46.049.0Molybdenum BalanceAAApproximately equal to the difference between 100 % and the sum percentageof the other specified elements. The percentage molybdenum content by differ-ence is not required to be reported.F3273 172a
33、rea is less than the minimum requirement, discard the test andretest. Retest one specimen for each specimen that did not meetthe minimum requirements. If either elongation or reduction ofarea is less than the minimum requirements for each lot thanthe lot should be rejected. If either elongation or r
34、eduction ofarea is less than the minimum requirement the entire lot shouldbe rejected.8.2.3 SheetTest according to Test Methods E8/E8M. Per-form at least one tensile test from each lot of sheet in both thelongitudinal and transverse directions. Tests in the transversedirection need be made only on p
35、roduct from a specimen notless than 200 mm (8.0 in.) in length for sheet. Should any ofthese test specimens not meet the specified requirements, testtwo additional test pieces representative of the same lot, in thesame manner, for each failed test specimen. The lot will beconsidered in compliance on
36、ly if all additional test pieces meetthe specified requirements.8.2.4 For sheet, bend test specimen shall withstand beingbent cold through an angle of 105 without fracture in theoutside surface of the bent portion. Test conditions shallconform to Test Method E290.8.2.4.1 Bend test mandrel diameter s
37、hall be agreed to by thesupplier and purchaser.9. Ultrasonic Inspection9.1 All centerless ground or peeled and polished bar 9.5mm (0.375 in.) in nominal diameter shall be ultrasonicallyinspected at final diameter according to AMS 2630, Class A1.Equivalent test methods may be submitted when agreed up
38、onby the purchaser and supplier.NOTE 1AMS 2630 specifies a minimum size limit of 12.7 mm (0.50in). F04.12 committee has intentionally specified the use of AMS 2630below 12.7 mm (0.50 in.) based on the experience of users and producerson the committee. There is disagreement in the industry as to whet
39、herAMS 2632, which does apply to sizes under 12.7 mm (0.50 in.), appliesto solid round bar.9.2 Other sizes and product forms may be ultrasonicallyinspected according to inspection criteria that shall be agreedupon between the purchaser and supplier.10. Dimensions and Permissible Variations10.1 Units
40、 of Measure:10.1.1 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
41、in order ofprecedence.10.1.1.1 If the purchaser and supplier have a history ofusing specific units, these units shall continue to be certifieduntil expressly changed by the purchaser.10.1.1.2 In the absence of historic precedence, if the unitsused to define the product on the purchasers purchase ord
42、er(PO), specification, and engineering drawing are consistent,these units shall be used by the supplier for product certifica-tion10.1.1.3 If the purchasers selection of units is unclear, theunits of measure shall be agreed upon between the purchaserand supplier.10.1.2 Conversion of UnitsIf the supp
43、liers test equipmentdoes not report in the selected units, the test equipment unitsmay be converted to the selected units for certification pur-poses. Accurate arithmetic conversion and proper use ofsignificant digits should be observed when performing thisconversion. SI10, IEEE/ASTM SI 10 provides
44、guidelines forthe use of SI units. Annex A of SI10, IEEE/ASTM SI 10provides conversion tables and Annex B of SI10, IEEE/ASTMSI 10 provides rules for conversion and significant digits.11. Significance of Numerical Limits11.1 The following applies to all specified numerical limitsin this specification
45、. To determine conformance to these limits,an observed or calculated value shall be rounded to the nearestunit in the last right hand digit used in expressing thespecification limit, in accordance with the rounding method ofPractice E29.12. Certification12.1 The supplier shall provide a certificatio
46、n that thematerial was tested in accordance with this specification andmet all requirements. A report of the test results including thegage length shall be furnished to the purchaser at the time ofshipment.13. Quality Program Requirements13.1 The supplier shall maintain a quality program such asdefi
47、ned in ISO 9001 or similar quality program.TABLE 2 Mechanical Properties for Bar and SheetCondition FormUltimate Tensile Strength, min,MPa (psi)Yield Strength (0.2 % offset),min, MPa (psi)ElongationAmin, % Reduction of Area, min, %Annealed Bar 760 (110,000) 480 (70,000) 10 12Cold Worked Bar 1240 (18
48、0,000) 1100 (160,000) 12 40Extra Hard Bar 1380 (200,000) 1310 (190,000) 10 45Annealed SheetB860 (125,000) 610 (85,000) 10 AElongation of material 1.6 mm (0.063 in.) or greater in diameter (D) or thickness (T) shall be measured using a gauge length of 50mm, 4D or 4W. The gauge length mustbe reported
49、with the test results. The method for determining elongation of material under 1.6 mm (0.063 in.) in diameter or thickness may be negotiated. Alternatively,a gauge length of 5.65 times the square root of So, where So is the original cross-sectional area corresponding to ISO 6892-1 may be used when agreed upon betweenthe supplier and purchaser.BMinimum values apply to tests taken both longitudinal and transverse to the direction of rolling.F3273 17314. Keywords14.1 angioplasty; metals (for surgical implants); vascularstentAPPENDIXES(Nonmandat
