1、Designation: F1108 04 (Reapproved 2009)F1108 14Standard Specification forTitanium-6Aluminum-4Vanadium Alloy Castings for SurgicalImplants (UNS R56406)1This standard is issued under the fixed designation F1108; the number immediately following the designation indicates the year oforiginal adoption or
2、, 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 metallurgical requirem
3、ents for cast titanium-6aluminum-4vanadiumalloy (UNS R56406).1.2 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 provided for information only and are not considered s
4、tated in eachsystem may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from thetwo systems may result in nonconformance with the standard.2. Referenced Documents2.1 ASTM Standards:2B600 Guide for Descaling and Cleaning Titanium and Titaniu
5、m Alloy SurfacesE3E8 Test Methods for Tension Testing of Metallic MaterialsE120 Test Methods for Chemical Analysis of Titanium and Titanium Alloys (Withdrawn 2003)3E165 Practice for Liquid Penetrant Examination for General IndustryE407 Practice for Microetching Metals and AlloysE1409 Test Method for
6、 Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by Inert Gas FusionE1447 Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by Inert Gas Fusion ThermalConductivity/Infrared Detection MethodF136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (E
7、xtra Low Interstitial) Alloy for Surgical ImplantApplications (UNS R56401)F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical ImplantsF629 Practice for Radiography of Cast Metallic Surgical ImplantsIEEE/ASTM SI 10 American National Standard for Use of the International System of
8、Units (SI): The Modern Metric System2.2 ISO Standard:4ISO 6892 Metallic MaterialsTensile Testing at Ambient TemperatureISO 9001 Quality management systems - RequirementsISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes2.3 Aerospace Material Specification:5
9、AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys2.4 American Society for Quality Standard:6ASQ C1 Specification of General Requirements for a Quality Control Program1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices
10、 and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved April 1, 2009Nov. 1, 2014. Published April 2009January 2015. Originally approved in 1988. Last previous edition approved in 20042009 asF1108 04.F1108 04 (2009). DOI: 10.1520/F1108-04R09.10.152
11、0/F1108-14.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. 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 sta
12、ndard is referenced on www.astm.org.4 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.5 Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http:/www.sae.org.6 Available
13、from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http:/www.asq.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 techni
14、cally 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 considered the official document.*A Summary of Changes section appears at the end of this s
15、tandardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States12.5 Society of Automotive Engineers:5SAE J1086 Practice for Numbering Metals and Alloys (UNS)3. Ordering Information3.1 Inquiries and orders for material under this specification
16、shall include the following information:3.1.1 Quantity,3.1.2 ASTM designation and issue date,3.1.3 Applicable dimensions or drawing number,3.1.4 Condition (see 4.1 and 4.2),3.1.5 Finish (see 4.4 and 4.5),3.1.6 Special tests (see Section 78),3.1.7 Other requirements.4. Materials and Manufacture4.1 Ca
17、stings conforming to this specification shall be produced by vacuum investment casting.4.2 Castings covered by this specification shall be in the annealed and hot isostatically pressed condition.NOTE 1While hot isostatic processing (HIP) may enhance mechanical properties of Ti6A1-4V castings, it has
18、 also been shown to reduce the scatterin mechanical properties and therefore increases the confidence in reliability of castings.4.3 Surface defects may be repaired by welding.4.3.1 Weld repair shall be carefully executed as per written procedures by individuals qualified to perform those procedures
19、.4.3.2 ELI weld rod conforming to Specification F136 shall be used where filler metal is needed.4.3.3 Weld repairs shall be performed prior to final thermal processing.NOTE 2Under certain circumstances, a weld repair will act as a stress riser. Therefore, care should be exercised in the location and
20、 extent of weldrepair as it relates to regions of the implant where significant stresses might be incurred.4.4 All alpha case shall be removed by suitable means such as chemical milling or machining prior to HIP processing.4.5 Parts shall be furnished in the descaled and cleaned condition in accorda
21、nce with Guide B600.4.6 Other thermal processes that meet the specific needs of the purchaser may be mutually agreed upon by the supplier andpurchaser.5. Chemical Composition5.1 Product castings shall conform to the requirements prescribed in Table 1. The supplier shall not ship material outside the
22、limits of Table 1. Chemical analysis shall be performed on a representative specimen cast from each heat using the same generalprocedures used in casting implants.5.1.1 Requirements for the major and minor elemental constituents are listed in Table 1. Also listed are important residualelements. Anal
23、ysis for elements not listed in Table 1 is not required to verify compliance with this specification.5.2 Product AnalysisProduct analysis tolerances do not broaden the specified heat analysis requirements but cover variationsbetween laboratories in the measurement of chemical content.The supplier sh
24、all not ship material that is outside the limits specifiedin Table 1. The product analysis tolerances shall conform to the product tolerances in Table 2.5.2.1 The product analysis is either for the purpose of verifying the composition of a heat or manufacturing lot or to determinevariations in the c
25、omposition within the heat.5.2.2 Acceptance or rejection of a heat or manufacturing lot of material may be made by the purchaser on the basis of thisproduct analysis.TABLE 1 Chemical RequirementsElement Composition,% (mass/mass)Nitrogen 0.05 maxCarbon 0.10 maxHydrogen 0.015 maxIron 0.30 maxOxygen 0.
26、20 maxAluminum 5.5 to 6.75Vanadium 3.5 to 4.5Titanium BalanceAA The percentage of titanium is determined by difference and need not bedetermined or certified. Residual metallic element tolerance levels will be agreedupon between supplier and purchaser.F1108 1425.3 For referee purposes, use Test Meth
27、ods E120, E1409, and E1447 or other analytical methods agreed upon between thepurchaser and the supplier.5.4 Ensure that the samples for chemical analysis are representative of the material being tested. The utmost care must be usedin sampling titanium for chemical analysis because of its affinity f
28、or elements such as oxygen, nitrogen, and hydrogen. In cuttingsamples for analysis, therefore, the operation should be carried out insofar as possible in a dust-free atmosphere. Cutting toolsshould be clean and sharp. Samples for analysis should be stored in suitable containers.6. Mechanical Require
29、ments6.1 Material supplied under this specification shall conform to the mechanical property requirements prescribed in Table 3.6.2 Specimens for tension tests shall conform to the mechanical property requirements prescribed in Table 3.6.3 Specimens for tension tests shall be machined and tested in
30、accordance with the methods in Test Methods E8. Tensileproperties shall be determined using a strain rate of 0.003 to 0.007 in./in./min (mm/mm/min) through yield and then the crossheadspeed may be increased so as to produce fracture in approximately one additional minute.6.4 Mechanical test specimen
31、s shall be produced by the same general procedures used in casting surgical implants and shall betested in accordance with Test Methods E8 which may have a cast, ground, or machined finish on the reduced section.Alternatively, test specimens may be machined from surgical implant castings.6.5 Number
32、of TestsPerform a minimum of two tension tests from each master heat. Should either of the two test specimensnot meet the specified requirements, test two additional test pieces representative of the same master heat in the same manner. Thelot will be considered in compliance only if both additional
33、 test pieces meet the specified requirements.6.6 Tension test results for which any specimen fractures outside the gage length shall be considered acceptable, if both theelongation and reduction of area meet the minimum requirements specified. Refer to Test Methods E8, sections 7.11.4 and 7.11.5.If
34、either the elongation or reduction of area is less than the minimum requirement, discard the test and retest. Retest one specimenfor each specimen that did not meet the minimum requirements.7. Microstructure7.1 Alpha case is not permitted on finished castings when examined on a metallurgical cross s
35、ection at 100 magnification.7.2 The microstructural requirements and frequency of examinations shall be mutually agreed upon between the supplier andpurchaser. Specimen preparation shall be in accordance with Guide E3 and Practice E407.TABLE 2 Product Analysis TolerancesAElementTolerance Under the M
36、inimumorOver the Maximum Limit %(mass/mass)BNitrogen 0.02Carbon 0.02Hydrogen 0.0030Iron 0.08Oxygen 0.04Aluminum 0.40Vanadium 0.15A See AMS 2249.B Under the minimum limit not applicable for elements where only a maximumpercentage is indicated.TABLE 3 Mechanical RequirementsATensileStrength,min, psi (
37、MPa)Yield Strength,(0.2% offset),min, psi (MPa)ElongationBmin, %Reduction of Areamin, %125 000 (860) 110 000 (758) 8 14A In the cast, HIP, and annealed condition.B Elongation of material 0.063 in. (1.6 mm) or greater in diameter (D) or width (W)shall be measured using a gage length of 2 in. or 4D or
38、 4W. The gage length mustbe reported with the test results.The method for determining elongation of materialunder 0.063 in. (1.6 mm) in diameter or thickness may be negotiated. Alternately,a gage length corresponding to ISO 6892 may be used when agreed uponbetween supplier and purchaser. (5.65 squar
39、e root So, where So is the originalcross sectional area.)F1108 1438. Nondestructive Examination8.1 Fluorescent Penetrant ExaminationEach individual part shall be subject to fluorescent penetrant examination inaccordance with Test Method E165 or Practice F601, as appropriate for the surface condition
40、 of the casting being tested Unlessotherwise specified, the castings shall be in the sandblasted condition before penetrant inspection. The acceptance criteria shall beagreed upon between the supplier and purchaser.8.2 Radiographic ExaminationEach individual part shall be subject to radiographic exa
41、mination in accordance with PracticeF629. Acceptance criteria to be mutually agreed upon between the supplier and purchaser.8.3 Other additional methods of nondestructive inspection may be used as mutually agreed upon by between the supplier andpurchaser.9. Dimensions and Permissible Variation9.1 Un
42、its of Measure:9.1.1 SelectionThis specification requires that the purchaser selects the units of measure (SI or inch-pound) to be used forproduct certification. In the absence of a stated selection of units on the purchase order, this selection may be expressed by thepurchaser in several alternate
43、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 precedence, if the units used to define the product on the purchaser
44、s purchase order,specification, and engineering 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 the purchaser andsupplier.9.1.2 Conversion of UnitsIf
45、 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 provi
46、des guidelines for the use of SI units. Annex A ofIEEE/ASTM SI 10 provides conversion tables and Annex B of IEEE/ASTM SI 10 provides rules for conversion and significantdigits.10. Certification10.1 The supplier shall provide a certification that the material was tested in accordance with this specif
47、ication. A report of thetest results shall be furnished to the purchaser at the time of shipment.11. Quality Program Requirements11.1 The supplier shall maintain a quality program such as defined inASQ C1.ISO 9001, ISO 13485, or similar quality program.12. Keywords12.1 castings-surgical; castings (f
48、or surgical implants); orthopaedic medical devices-titanium/titanium alloy; devices; titaniumalloys; titanium/titaniumtitanium alloys (for surgical implants)APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 This specification is intended to provide general guidelines for material requirements fo
49、r Ti 6A1-4V castings for use insurgical implants. It is in no way intended to usurp the role of the design engineer in the development and manufacture of afunctionally sound implant. For example, this specification does not preclude the use of ELI grade titanium; and the weld repairof defects. The engineer needs to be aware of the ramifications of such processing, though, on the safety and efficacy of the implantfor its intended use.X1.2 The UNS designation has been added for clarification, and a biocompatibility section has been added as an appendix.X1.3 IS
