ASTM F2066 F2066M-2013 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)《外科植入物应用(UNS R58150)锻造钛-15钼合金的标准规范》.pdf

1、Designation: F2066 11F2066/F2066M 13Standard Specification forWrought Titanium-15 Molybdenum Alloy for Surgical ImplantApplications (UNS R58150)1This standard is issued under the fixed designation F2066;F2066/F2066M; the number immediately following the designation indicatesthe year of original adop

2、tion or, in the case of revision, the year of last revision. A number in parentheses indicates the year of lastreapproval. A superscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification covers the chemical, mechanical, and metallurgical r

3、equirements for wrought titanium-15 molybdenumalloy to be used in the manufacture of surgical implants (1).21.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values given inparentheses are mathematical conversions to SI units that are provide

4、d for information only and are not considered stated in eachsystem may not be exact equivalents; therefore, each system shall be used independently of each other. Combining values fromthe two systems may result in non-conformance with the standard.2. Referenced Documents2.1 ASTM Standards:3E8E8/E8M

5、Test Methods for Tension Testing of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data to Determine Conformance with SpecificationsE112 Test Methods for Determining Average Grain SizeE290 Test Methods for Bend Testing of Material for DuctilityE539 Test Method for Analysis of Ti

6、tanium Alloys by X-Ray Fluorescence SpectrometryE1409 Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by the Inert Gas FusionTechniqueE1447 Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by Inert Gas Fusion ThermalConductivity/Infrared

7、Detection MethodE1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion AnalysisE2371 Test Method for Analysis of Titanium and Titanium Alloys by Direct Current Plasma and Inductively Coupled PlasmaAtomic Emission Spectrometry (Performance-Based

8、 Test Methodology)F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNSR50700)F748 Practice for Selecting Generic Biological Test Methods for Materials and DevicesF981 Practice for Assessment of Compatibility of Biomaterials for Surgical

9、 Implants with Respect to Effect of Materials onMuscle and BoneF1408 Practice for Subcutaneous Screening Test for Implant MaterialsIEEE/ASTM SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric System2.2 Aerospace Material Specification:Specifications

10、:4AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium AlloysAMS 2631 Ultrasonic Inspection Titanium and Titanium Alloy Bar and BilletAMS 2380 Approval and Control of Premium Quality Titanium Alloys1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical

11、 Materials and Devices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved Dec. 1, 2011Oct. 1, 2013. Published December 2011November 2013. Originally approved in 2001. Last previous edition approved in 20082011as F2066 08.F2066 11. DOI: 10.1520/

12、F206611.10.1520/F2066_F2066M13.2 The boldface numbers in parentheses refer to the list of references at the end of this standard.3 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume informatio

13、n, refer to the standards Document Summary page on the ASTM website.4 Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http:/www.sae.org.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indicat

14、ion of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be cons

15、idered the official document.*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 States12.3 ISO Standards:5ISO 6892 Metallic Materials Tensile Testing at Ambient TemperatureISO 900

16、1 Quality Management Systems Requirements2.4 American Society for Quality Standard:ASQ C1 Specification of General Requirements for a Quality Control Program63. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 alpha + beta annealed, nthe condition of the material that is obtained

17、if, following the final hot-working orcold-working operation, the mill product is may be rapidly quenched, for example, by water quenching or pressurized helium gasquench, gas, from a temperature abovebelow the beta transus of approximately 1382F (750C).750C.3.1.2 alpha + beta annealed + aged, nthe

18、condition of the material that is obtained by reheating the alpha + beta annealedmaterial to a time-temperature combination below the beta transus to increase the strength of the alloy.3.1.3 beta annealed, nthe condition of the material that is obtained if, following the final hot-working or cold-wo

19、rkingoperation, the mill product is rapidly quenched, for example, by water quenching or pressurized helium gas quench, from atemperature above the beta transus of approximately 1382F 750C.3.1.4 beta transus, nthe minimum temperature at which the alpha plus beta phase can transform to 100 % beta pha

20、se.4. Product Classification4.1 StripAny product under 0.1875 in. (4.76 mm)4.76 mm in thickness and under 24 in. (610 mm)610 mm wide.4.2 SheetAny product under 0.1875 in. (4.76 mm)4.76 mm in thickness and 24 in. (610 mm)610 mm or more in width.4.3 PlateAny product 0.1875 in. (4.76 mm)4.76 mm thick a

21、nd over and 10 in. (254 mm)254 mm wide and over, withwidths a width greater than five times the thickness. Any plate up to 4 in. (101.60 mm),101.60 mm, thick inclusive, is coveredby this specification.4.4 BarRounds, flats, or other shapes from 0.1875 in. (4.76 mm)4.76 mm to 4 in. (101.60 mm)101.60 m

22、m in diameter orthickness. (Other sizes and shapes by special order.)4.5 Forging BarBar as described in 4.4 used for production of forgings, may be furnished in the hot worked condition.4.6 WireRounds, flats, or other shapes less than 316 in. (4.76 mm)4.76 mm in diameter or thickness.4.7 OtherOther

23、forms and shapes, including tubing, may be provided by agreement between purchaser and supplier.5. Ordering Information5.1 Include with inquiries and orders for material under this specification the following information.5.1.1 Quantity,5.1.2 Applicable ASTM designation and date of issue,5.1.3 Form (

24、strip, sheet, plate, bar, or wire),forging bar, wire, other),5.1.4 Condition (see Section 3 and 6.16.2),5.1.5 Mechanical properties (if applicable for special conditions),5.1.6 Finish (see 6.26.1),5.1.7 Applicable dimensions including size, thickness, width, length, or drawing number,5.1.8 Special t

25、ests, if any, and5.1.9 Special requirements.6. Materials and Manufacture6.1 FinishThe mill product may be furnished to the implant manufacturer as descaled or pickled, abrasive-blasted, chemicallymilled, ground, machined, peeled, polished, combinations of these operations, or as specified by the pur

26、chaser. On billets, bars,plates, and forgings, it is permissible to remove minor surface imperfections by grinding if the resultant area meets the dimensionaland surface finish requirements of this section.specification.6.2 Condition:6.2.1 Beta AnnealedMaterial shall be furnished in the beta anneale

27、d condition. Two classes of beta annealed sheet, strip, andplate are available. If no class is chosen, Class 1 product shall be provided.6.2.2 Alpha + BetaBeta AnnealedMaterial mayshall be furnished in the annealed, aged, coldworked, hot-rolled, or anycombination of these conditions.alpha + beta ann

28、ealed condition.5 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.6 Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http:/www.asq.org.F2066/F2066M 1326.2.3 Alpha + Beta Anne

29、aled + AgedMaterial shall be furnished in the alpha + beta annealed + aged condition.7. Chemical Requirements7.1 The heat analysis shall conform to the chemical composition of Table 1. Ingot analysis may be used for reporting allchemical requirements, except hydrogen. Samples for hydrogen shall be t

30、aken from the finished mill product, and the supplier shallnot ship material with chemistry outside the requirements specified in Table 1.7.1.1 Requirements for the major and minor elemental constituents are listed in Table 1. Also listed are important residualelements. Analysis for elements not lis

31、ted in Table 1 is not required to verify compliance with this specification.7.2 Product Analysis:7.2.1 Product analysis tolerances do not broaden the specified heat analysis requirements but cover variations betweenlaboratories in the measurement of chemical content. The manufacturer shall not ship

32、material that is outside the limits specifiedin Table 1. The product analysis tolerances shall conform to the product tolerances in Table 2.7.2.2 The product analysis is either for the purpose of verifying the composition of a heat or manufacturing lot or to determinevariations in the composition wi

33、thin the heat.7.2.3 Acceptance or rejection of a heat or manufacturing lot of material may be made by the purchaser on the basis of thisproduct analysis. Product analyses outside the tolerance limits allowed in Table 2 are cause for rejection of the product. A refereeanalysis may be used if agreed u

34、pon by the supplier and purchaser.7.2.4 For referee purposes, use Test Methods, E539, E1409, E1447, E1941, and E2371 or other analytical methods agreed uponbetween the purchaser and the supplier.7.3 Samples for chemical analysis are representative of the material being tested. The utmost care must b

35、e used in samplingtitanium for chemical analysis because of its affinity for elements such as oxygen, nitrogen, and hydrogen. In cutting samples foranalysis, therefore, the operation should be carried out insofar as possible in a dust-free atmosphere. Cutting tools should be cleanand sharp. Samples

36、for analysis should be stored in suitable containers.8. Mechanical Requirements8.1 The material supplied under this specification shall conform to the mechanical property requirements in Table 3 or Table4.8.2 Specimens for tension tests shall be machined and tested in accordance with Test Methods E8

37、E8/E8M. Tensile propertiesshall be determined using a strain rate of 0.003 to 0.007 in./in./min (mm/mm/min)mm/mm/min through the specified yield andthen the crosshead speed shall be increased so as to produce fracture in approximately one additional minute.8.3 For sheet and strip, the bend test spec

38、imen shall withstand being bent cold through an angle of 105 without fracture in theoutside surface of the bend portion. The bend shall be made over a mandrel with a diameter equal to that shown in Table 4. Testconditions shall conform to Test Method E290.8.4 Number of Tests:8.4.1 Bar, Forging Bar,

39、Shapes, and WireTest according to Test Methods E8/E8M. Perform at least one tension test from eachlot in the longitudinal direction. Should thisany test resultspecimen not meet the specified requirements, test two additional testTABLE 1 Chemical RequirementsElement Composition, %, (Mass/Mass)Nitroge

40、n, max 0.05Carbon, max 0.10Hydrogen, max 0.015Iron, max 0.10Oxygen, max 0.20Molybdenum 14.00-16.00TitaniumA balanceTABLE 1 Chemical RequirementsElement Composition, %, (Mass/Mass)Nitrogen, max 0.05Carbon, max 0.10Hydrogen, max 0.015Iron, max 0.10Oxygen, max 0.20Molybdenum 14.00-16.00TitaniumA balanc

41、eA The percentage of titanium is determined by difference and need not bedetermined or certified.F2066/F2066M 133pieces representative of the same lot, in the same manner, for each failed test piece.specimen. The lot shall be considered incompliance only if all additional test pieces meet the specif

42、ied requirements.8.4.2 Tensile test results for which any specimen fractures outside the gagegauge length shall be considered acceptable,acceptable if both the elongation and the reduction of area meet the minimum requirements specified. Refer to sections 7.11.4 and7.12.5 of Test Methods E8E8/E8M. I

43、f either the elongation or reduction of area is less than the minimum requirement, discard thetest and retest. Retest one specimen for each specimen that did not meet the minimum requirements.8.4.3 Sheet, Strip, and PlateTest according to Test Methods E8/E8M. Perform at least one tension test from e

44、ach lot in thelongitudinal direction. Perform at least one bend test from each lot in both the longitudinal and transverse directions. Tests in thetransverse direction need be made only on product from which a specimen not less than 8.0 in. (200 mm) in length for sheet, and2.50 in. (64 mm) in length

45、 for plate can be taken. Should any of these test pieces not meet the specified requirements, test twoadditional test pieces representative of the same lot, in the same manner, for each failed test pieces.specimen. The lot shall beconsidered in compliance only if all additional test pieces meet the

46、specified requirements.9. Dimensions, Mass, and Permissible Variations9.1 Units of Measure:9.1.1 SelectionThis specification requires that the purchaser select the units (SI or inch-pound) to be used for productcertification. In the absence of a stated selection of units on the purchase order, this

47、selection may be expressed by the purchaserin several alternate forms listed in order of precedence.9.1.1.1 If the purchaser and supplier have a history of using specific units, these units shall continue to be certified untilexpressly changed by the purchaser.9.1.1.2 In the absence of historic prec

48、edence, if the units used to define the product on the purchasers PO, specification, andengineering drawing are consistent, these units shall be used by the supplier for product certification.9.1.1.3 If the purchasers selection of units is unclear, the units of measure shall be agreed upon between t

49、he purchaser andsupplier.9.1.2 Conversion of UnitsIf the suppliers test equipment does not report in the selected units, the test equipment units maybe converted to the selected units for certification purposes. Accurate arithmetic conversion and proper use of significant digitsshould be observed when performing this conversion. IEEE/ASTM SI 10 provides guidelines for the use of SI units. Annex A ofthat standard provides conversion tables and Annex B provides rules for conversion and significance.10. Special Requ