1、Designation: F2146 07F2146 13Standard Specification forWrought Titanium-3Aluminum-2.5Vanadium Alloy SeamlessTubing for Surgical Implant Applications (UNS R56320)1This standard is issued under the fixed designation F2146; the number immediately following the designation indicates the year oforiginal
2、adoption or, in the case of revision, 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, mechanical, and metallurgic
3、al requirements for wrought and annealed orcold-worked and stress-relieved titanium-3aluminum-2.5vanadium alloy (UNS R56320) seamless tubing to be used in themanufacture of surgical implants. See Section 4 for size limitations.1.2 The values stated in inch pound units either SI units or inch-pound u
4、nits are to be regarded separately as the standard. TheSI equivalents in parentheses are for information only.values stated in each system may not be exact equivalents; therefore, eachsystem shall be used independently of the other. Combining values from the two systems may result in non-conformance
5、 with thestandard.1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatoryrequirements prior to us
6、e.2. Referenced Documents2.1 ASTM Standards:2E8E8/E8M Test Methods for Tension Testing of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data to Determine Conformance with SpecificationsE1409 Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by
7、 the Inert Gas FusionTechniqueE1447 Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by Inert Gas Fusion ThermalConductivity/Infrared Detection MethodE1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion AnalysisE2371
8、Test Method forAnalysis of Titanium and TitaniumAlloys byAtomic Emission Plasma Spectrometry (Withdrawn 2013)3E2626 Guide for Spectrometric Analysis of Reactive and Refractory MetalsF136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical ImplantApp
9、lications (UNS R56401)F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)IEEE/ASTM SI 10 American National Standard for Metric Practice2.2 Aerospace Material Specifications:4AMS 2244 Tolerances, Titanium and Titanium Alloy TubingAMS 2249
10、Chemical Check Analysis Limits, Titanium and Titanium AlloysAMS 2634 Ultrasonic Inspection, Thin Wall Metal TubingAMS 4943 Titanium Alloy, Seamless, Hydraulic Tubing, 3.0A1-2.5V AnnealedAMS 4944 Titanium Alloy, Seamless, Hydraulic Tubing, 3.0A1-2.5V Cold-Worked, Stress-RelievedAMS 6940 Titanium Allo
11、y Bars, Forgings, and Forging Stock, 3.0Al-2.5V Annealed-UNS R563201 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved Feb. 1, 200
12、7March 1, 2013. Published February 2007April 2013. Originally approved in 2001. Last previous edition approved in 20012007 asF2146 01.F2146 07. DOI: 10.1520/F2146-07.10.1520/F2146-13.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.o
13、rg. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 The last approved version of this historical standard is referenced on www.astm.org.4 Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA
14、 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 indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommen
15、ds that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700,
16、West Conshohocken, PA 19428-2959. United States12.3 American Society for Quality Standard:5ASQ C1 Specifications of General Requirements for a Quality Program2.3 ISO Standards:5ISO 6892 Metallic Materials Tensile Testing at Ambient TemperatureISO 9001 Quality Management Systems Requirements5 Availab
17、le from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http:/www.asq.org.5 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.F2146 1323. Terminology3.1 Definitions of Terms Specific to This
18、 Standard:3.1.1 beta transus, nthe minimum temperature at which the alpha plus beta phase can transform to 100 % beta phase onheating.3.1.2 cold work, nany mechanical deformation process performed below the recrystallization temperature which results instrain hardening of the material.3.1.3 lot, nto
19、tal number of tubes produced from the same heat under the same conditions at essentially the same time.4. Product Classification4.1 TubingTubular product with an outside diameter greater than 0.250 in. (6.35 mm).6.35 mm.5. Ordering Information5.1 Include with inquiries and orders for material under
20、this specification the following information:5.1.1 Quantity,5.1.2 ASTM designation and date of issue (for example, F2146 07),F214613),5.1.3 Form (seamless tubing),5.1.4 Applicable dimensions including outside diameter, wall thickness, length (exact, random, or multiples), or drawingnumber,5.1.5 Fini
21、sh (see 6.1),5.1.6 Condition (see 6.2),5.1.7 Mechanical properties (if applicable, for special conditions),5.1.8 Special tests (see Section 910), and5.1.9 Other requirements.6. Materials and Manufacture6.1 FinishThe mill product shall be furnished to the implant manufacturer as descaled or pickled,
22、abrasive blasted, chemicallymilled, ground, machined, peeled, polished, or as specified by the purchaser.6.2 Condition:6.2.1 AnnealedTubing may be annealed by heating to a temperature within the range of 1100 to 1450F (593593 to788C),788C, holding at the selected temperature within 625F (614C)614C f
23、or not less than 15 min, and cooling at a rateequivalent to air cool or slower.6.2.2 Cold-Worked and Stress-RelievedTubing may be cold-worked then stress-relieved by heating within the range 700 to1000F (371371 to 538C)538C for not less than 30 min.6.3 Surface CleanlinessThe inside and outside surfa
24、ces of the tubing shall be free from grease and other foreign matter.Metallic flakes or particles shall not be collected by a clean, white cloth drawn through the bore of a tube sample. Discolorationof the cloth, without the presence of metallic flakes or particles, is acceptable.6.4 Dimensional Tol
25、erancesAll tolerances shall conform to all applicable requirements ofAMS 2244, for standard tolerances.7. Chemical Composition7.1 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 hy
26、drogen shall be taken from each lot of finished mill product. The numberof samples per lot shall be as agreed upon between the supplier and the purchaser. The supplier shall not ship material with acomposition outside the requirements specified in Table 1.TABLE 1 Chemical RequirementsElement Composi
27、tion, % (mass/mass)Minimum MaximumNitrogen . . . 0.020Carbon . . . 0.050Hydrogen . . . 0.015Iron . . . 0.30Oxygen . . . 0.12Aluminum 2.50 3.50Vanadium 2.00 3.00Yttrium . . . 0.005TitaniumA balance balanceA The percentage of titanium is determined by difference and need not bedetermined directly or c
28、ertified.F2146 1337.1.1 Requirements for major and minor elemental constituents are listed in Table 1.Also listed are important residual elements.Analysis for elements not listed in Table 1 is not required to verify compliance with this specification.7.2 Product Analysis:7.2.1 Product analysis toler
29、ances do not broaden the specified heat analysis requirements but cover variations betweenlaboratories in the measurement of chemical content. content between laboratories. The product analysis tolerances shall conformto the product tolerances in Table 2.7.2.2 The product analysis is either for the
30、purpose of verifying the composition of a heat or manufacturing lot or to determinevariations in the composition within 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 to
31、lerance limits allowed in Table 2 are cause for rejection of the product. A refereeanalysis may be used if agreed upon by supplier and purchaser.7.2.4 For referee purposes, use Test Methods E1409, E1447, E1941and, E2371, and E2626 or other analytical methods agreedupon between the purchaser and the
32、supplier.7.3 Samples for chemical analysis shall be representative of the material being tested. The utmost care must be used in samplingtitanium for chemical analysis because of its affinity for elements such as oxygen, nitrogen, and hydrogen. In cutting samples foranalysis, therefore, the operatio
33、n should be carried out insofar as possible in a dust-free atmosphere. Cutting tools should be cleanand sharp. Samples for analysis should be stored in suitable containers.8. Mechanical Requirements8.1 The material supplied under this specification shall conform to the mechanical property requiremen
34、ts in Table 3.8.2 Specimens for tension tests shall be machinedprepared and tested in accordance with Test Methods E8E8/E8M. Tensileproperties shall be determined using a strain rate of 0.003 to 0.007 in./in./min (mm/mm/min)mm/mm/min through yield and thenthe crosshead speed may be increased so as t
35、o produce fracture in approximately one additional minute.8.3 Tensile tests results for which any specimen fractures outside the gauge length shall be considered acceptable, if both theelongation and reduction of area meet the minimum requirements specified. Refer to sections 7.11.4 and 7.12.5 of Te
36、stMethodMethods E8E8/E8M. If either the elongation or reduction of area is less than the minimum requirement, discard the testand retest. Retest one specimen for each specimen that did not meet the minimum requirements.8.4 Number of TestsShould any test result not meet the specified requirements, tw
37、o additional samples representative of thesame lot shall be tested in the same manner, for each failed test piece. The lot will be considered in compliance only if all additionaltest pieces meet the specified requirements.9. Dimensions and Permissible Variation9.1 Units of Measure:9.1.1 SelectionThi
38、s specification requires that the purchaser selects 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 selection may be expressed by the purchaserin several alternate forms listed in order of precedence.9.1.1.1
39、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 precedence, if the units used to define the product on the purchasers PO, specification, andengineering drawing
40、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 purchaser and supplier.TABLE 2 Product Analysis TolerancesAElement Tolerance Under the Minimumor Over the Max
41、imum LimitBNitrogen 0.02Carbon 0.02Hydrogen 0.0020Iron 0.10Oxygen (up to 0.20) 0.02Aluminum 0.40Vanadium 0.15Yttrium 0.0006A Refer to AMS 2249.B Under the minimum limit not applicable for elements where only a maximum limitis indicated.F2146 1349.1.2 Conversion of UnitsIf the suppliers test equipmen
42、t 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 o
43、f SI units. Annex Aprovides conversion tables and Annex B provides rules for conversion and significant digits.10. Special Requirements10.1 The microstructure shall be a fine dispersion of the alpha and beta phases resulting from processing in the alpha plus betafield. There shall be no continuous a
44、lpha network at prior beta grain boundaries. There shall be no coarse, elongated alpha platelets.10.2 Alpha case is not permitted for products supplied with a machined, ground, or chemically milled surface finish. For otherproducts, there shall be no continuous layer of alpha case when examined at 1
45、00 magnification.10.3 Number of TestsExamine two samples from each lot on a transverse plane for alpha and beta phases and for alpha case.10.4 If required by the purchaser, determine the beta transus temperature for each heat by a suitable method and report on thematerial certification.10.5 Ultrason
46、ic Testing:10.5.1 Each tube shall be inspected ultrasonically in accordance with AMS 2634 for surface (inside diameter and outsidediameter) and subsurface imperfections of all types and orientation (longitudinal and transverse).10.6 Longitudinal and transverse notches not exceeding 0.010 in. (0.25 m
47、m)0.25 mm in width and 10 % of the nominal tubewall or 0.004 in. (0.102 mm),0.102 mm, whichever is greater, in depth shall be machined on the inner and outer surfaces of thetube. The length of the notches shall not exceed 0.125 in. (3.18 mm).3.18 mm.10.7 Any tube showing an indication in excess of t
48、hat obtained from the calibration standard in accordance with 9.610.6 shallbe set aside and be subject to rework, retest, or rejection. A tube thus set aside may be examined further for confirmation of thepresence of a defect and may be resubmitted for inspection if no defect is found. Any tube may
49、also be resubmitted for inspectionif reworked so as to remove the defect within the specified diameter and wall thickness tolerances.11. Significance of Numerical Limits11.1 The following applies to all specified numerical limits in this specification. To determine conformance to these limits, anobserved or calculated value shall be rounded to the nearest unit in the last right hand digit used in expressing the specificationlimit, in accordance with the rounding method of Practice E29.12. Certification12.1 The supplier shall pr
