Designation: F 136 - 08*" Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Inters' 56401)" “This standard nial doe ial) Alloy for Surgical Implant Applications (UNS usd unde he fied designation F 136; th number immediately following the designation iain te year of inthe as of revision the yea of as revin- Arum in partons inde the year at appro A Sips pion (e) dates an ed change since the lat evnon or appeal 2 Nowe Subsection 83.1 was erly corested in December 2008 1. Scope* 1.1 This specification covers the chemical, mechanical, and ‘metallurgical requirements for wrought annealed titanium- 6aluminum-4vanadium ELI (extra low interstitial) alloy (RSO401) to be used in the manufacture of surgical implants. 1.2 The values stated in inch-pound units are to be regarded. a standard. The values given in parentheses are mathematical ‘conversions to SI units that are provided for information only ‘and are not considered standard, 2. Referenced Documents 2.1 ASTM Standards:? EIESM Test Methods for Tension Testing of Metallic Materials £29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications 90 Test Methods for Bend Testing of Material for Ductitiy 15539 Test Method for X-Ray Fluorescence Spectrometric Analysis of 6AL4V Titanium Alloy E1409 Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by the Inert Gas Fusion Technique E1447 Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by the Inert Gas Fusion Therinal Conductivity/infrared Detection Method F 1941 ‘Test Method for Determination of Carbon in Rerac- ‘ory and Reactive Metals and Their Alloys E "Tis spittin is under the jrnition of ASTM Commitee FON on Medical und Surgical Mats and Devices and isthe dest espomsiiliy o| Sutcomitee F812. Metall Matra Curent eon apponed Non. I, 2008 Publihed Dasember 2008. Oily pablshd in 84 Lax previous eon approved 2002 136-02, "For elerened ASTM standards, vist he ASTM webu, www atmo oF onset ASTM Customer Serie at soviet ag. For Anne Book of AST ‘Starards vole information, eter the adds Doctnent Samay age 08 ‘he ASTIN nce 2371 ‘Test Method for Analysis of Titanium and Titanium Alloys by Atomie Emission Plasma Spectrometry F981 Practice for Assessment of Compatibility of Bioma- terials for Surgical Implants with Respect to Effet of Materials on Muscle and Bone 22. 180 Standards:* ISO 6892 Metallic Mater Temperature 1SO 9401 Quality Management Systems Requirements 23. ASQ Standard: ASQ CI Specifications of General Requirements for a Quality Control Program 24 Aerospace Material Specifications: AMS 2249 Chemical Check Analysis Limits, Titanium and ‘Titanium Alloys? 3. Terminology 3.1 Definitions of Terms Specific to This Standard: 3.1.1 beta eransus, n—the minimum temperature at which the alpha plus beta phase can transform to 100 % beta phase. 3.1.2 lot, n—the total number of mill products produced from one heat under the same conditions at essentially the same time, ls Tensile ‘Testing at Ambient 4. Product Classification 4.1 Strip—Any product under 0.1875 in. (4.76 mm) in thickness and under 24 in. (610 mm) wi 42 Sheet—Any product under 0.1875 in. (4.76 mm) in thickness and 24 in, (610 mm) or more in width. 423 Plare—Any product 0.1875 in, (4.76 mm) thick and ‘over and 10 in. (254 mm) wide and over, with widths greater » alae rm American National Stands Insite (ANSI, 28 W. AS St. 4th Por New Work, NY 10036, pv aos, * avalahle fom America Society for Quality (ASQ) 0 N Pankiton Ave, Migaukoe. WI 53203, hapten. “alable from Sot of Automotive Engineers (SA), 400 Comnanwesks De, Waren, PA 1096-001 prance "A Summary of Changes section appears atthe end ofthis standard, ‘Ceeygt0 AST erst 190 Ba Hr Die, PO Bax CTE, Wee Catoctin PA HE, Une Se. Copyright by ASTM int Dewloadd/pntd ight reserved); Mon Jul 6 13:46:10 EDT 2008 Universidade Feral Jo Rio Grande do Sul pursuant License Agreement, No frter reproductions authorizeAG F 136-08" than five times thickness. Plate up to 4.00 in, (101.60 mm), thick inclusive is covered by this specification, 44 Bar—Round bars and flats from 0.1875 in. (4.76 mm) to 4.00 in. (101.60 mm) in diameter or thickness (other sizes and. shapes by special order). 45 Forging Bar—Bar as described in 4.4, used for produc- tion of forgings, may be furnished in the hot worked condition, 4.6 Wire—Rounds, flats, or other shapes less than 0.1875 in, (4.76 mim) in diameter. 5. Ordering Information 5.1 Include with inquiries and orders for material under this specification the following information: 5.1.1 Quantity, 5.1.2 ASTM designation and date of issue, 5.1.3 Form (sheet, strip, plate, bar, forging bar, or wire), 5.1.4 Condition (See Section 3 and 6.3), 5.1.5 Mechanical properties (if applicable, for special con- ditions), 5.1.6 Finish (See 6.2) 5.1.7 Applicable dimensions including width, length, or drawing number, 5.18 Special tests, if any, and 5.1.9 Other requirements. thickness, 6. Materials and Manufacture 6.1 The various titanium mill products covered in this specification normally are formed with the conventional forg- ing and rolling equipment found in primary ferrous and nonferrous plants. The alloy is usually multiple melted in arc furnaces (including furnaces such as plasma are and electron beam) of a type conventionally used for reactive metal. 62 Finish—The mill product may be furnished to the implant manufacturer as mechanically descaled or pickled, abrasively blasted, chemically milled, ground, machined, peeled, polished, combinations of these operations, or as specified by the purchaser. On billets, bars, plates, and forg- ings, it is permissible to remove minor surface imperfections by grinding if the resultant area meets the dimensional and surface finish requirements of this specification 6.3 Condition—Material shall be furnished in the annealed or cold-worked condition. Mechanical properties for condi- tions other than those listed in Table | and Table 2 may be established by agreement between the supplier and the pur- chaser. 7. Chemical Requirements 7.1 ‘The heat analysis shall conform to the chemical com- position specified in Table 3. Ingot analysis may be used for reporting all chemical requirements, except hydrogen. Samples. for hydrogen shall be taken from the finished mill product. The supplier shall not ship material with chemistry outside the requirements specified in Tle 3 7.le1 Requirements for the major and minor elemental ‘constituents are listed in Tublo 3, Also listed are important residual elements, Analysis for elements not listed in'Table 3 is, not required to verify compliance with this specification, 7.2. Product Analysis: 7.2.1 Product analysis tolerances do not broaden the speci fied heat analysis requirements but cover variations between laboratories in the measurement of chemical content. The product analysis tolerances shall conform to the product tolerances in Table 4, 7.2.2 The product analysis is either for the purpose of verifying the composition of a heat or manufacturing lot or determining variations 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 ofthis product analysis. Product analysis outside the tolerance limits allowed in Table 4 is cause for rejection of the product. A referee analysis may be used if agreed upon by the supplier and purchaser, 4 For referee purposes, use Test Methods F539, F 1409, E 1447, E 1941, and E2371 or other analytical methods agreed upon between the purchaser and the supplic. 7.3 Samples for chemical analysis shall be representative of the material being tested. The utmost care must be used sampling titanium for chemical analysis because ofits affinity, for elements such as oxygen, nitrogen, and hydrogen. In cutting samples for analysis, therefore, the operation should be carried out insofar as possible in a dust-ree atmosphere. Cutting tools should be clean and sharp. Samples for analysis, should be stored in suitable containers. TABLE 1 Annealed Machanial Propertios of Bar, Wiro, and Forgings Nomina amet o Dstanco Tens Stenge min, gif Stenan_EenostenTin aD oraWimin Ratton of Awe" min. Betwoon Paal Se, rm) el Pa) @axomenme 4 rst kt Uae 07 (70) seo 72 00) Tis000 95) 10 concer 250779 founder 1.75 (4445, t_— 125.0000) seco) 10 as ‘754049 une 2906250) al 120600 (685) ‘Wo eco (ee) ° FA 25 62.80 £000 60 $20 00 (25) 410000 760) a a ae Elongation of maria 0.063 in. (6 mn greater nda (O) wit (W shal be measured using a gage ng of 2a. or4 Oe 4 WT gage ength mat boroponad ih ih {ose ceceral sea) Gage length sal be reponed wh the elongation ale, ® Appins abr ana orgnge ony ony one wranavars ered ‘eels, Th method fer determing Bengaton of mateal under 0.063. (1.5 mm) in aamelar or cinoss may bo naolated. Atamatey hen greed igan between supple and purchaser (565 tos th square fot t So, where So is he erga 2 raneverse roguremeris Tse | apply oy fo product tom which a ens specimen tees hat 2.50 (25 mm) nang can be obtained Copyright by ASTM Int (all sights reserved) Mon Jul 6 1:46:10 EDT 2008 Dowleaded/prited by 2 "Universidade Federal do Rio Grande do Sul pursuant to License Agreement. No futher reproductions authorize,Af F 136-08" TABLE 2 Annealed Mechanical Properties of Sheet, Strip, and Plate Soar re eee ; =o ath ress ataesPamn bee ‘Nominal Diameter Tensile Strength Yield Strength “Under ame or Distance Between min, (0.2% ottset) min, 0.070 in. 01875 in saat oaks MMM oo ke tem GS, rites ne Cr cr SO nm a et ee aoe : ane cee eee ee ee es Elongation of matvl0.069 (6 mn) ogress wit (0) hal moeured ung a gage ng of. o4W. The gage long must bo roped wih he wat ‘esuts, The method fr determining elongaton ef matoal ess than 0.053 (118m) in heknass may be negotatd. Atma. 2 gage length coroepongng 180 6sa2 may be used when agreed upon between suppor and purchase (5.6 tmos he square oo of So, whore So he orga cose sectonal area} Gago eng ‘ul be reported wih he elongaten value. = longa LT = log Farevere ST = sho wanavora "Appice to pat oy = engi LT «ong Warsvree: ST = shot vanevore, fend api set and ep pee 2 Tagine ine neste bod sane lr Ts ods € 20 Bas rt appeal aaa 187 475mm nes. *tanteena agents Tune # op peas tow attra ae spon nant bas Sa Sma hn crv aed TABLE 2 Chemica! Requirements inJindvin muavmnvtin) through yield and then the crosshead _— Capon speed may be increased so as 1 produce fracture in approxi- a (massimass) ‘mately one additional minute. Carson max a 8.2.1 Bar Forging Bar, Shapes, and Wire—Test according ‘armen mae cores to Test Methods E/E 8M. Should any test specimen not moot c= as the specified requirements, test two addtional test pieces Saygen, max oa representative of the same lot, in the same manner, for each feoant Cece faled test specimen. The lot will be considered in compliance Tara tate only if all addtional test pieces meet the specified require- “tal OSES Ha) aa ay hav HO GmoIH SMES OR ge of wane cori ty dtrenn at ood mtg 82-2 Tensile tests results for which any specimen fractures cosas ets by etorence ard eeed 7% Sutside the gage length shall be considered acceptable. if both the elongation and reduction of area meet the minimum ABLE 4 Product Analysis Tolerance requirements specified. Refer to subsections 7.11 and 7.12.5 es of Test Methods I: 8/: 8M. Ifthe the elongation or eduction amen re acu Cae of area is less than the minimum requirement, discard the test —___ massimass) and retest. Retest one specimen for each specimen that did not oon ave meet the minimum requirements. cain oe an ES 8.3 For sheet and strip, the bend test specimen shall with fy oto stand being bent cold through an angle of 105° without fracture Semen a in the outside surface of the bent portion. The bend shall be toms aaa made around « mandrel which bas a diameter equal t0 that Fao shown in Table 2 Test conditions shall conform to Test Method + iar sam trot apa fr element whe oy «minimum E290. Percentage i indicated. 8.3.1 Sheet, Strip, and Plate—Test according to Test Meth- . cod Ei: SM. Perform atleast one tensile test from each Loin 8. Mechanical Requirements both the longitudinal and transverse directions. "Tests in the 8.1 The matesial supplied under this specification shall transverse direction need be made only on product from which conform to the mechanical property equirements in Table Ia specimen not less than 80 in. (200 mm) in length Fo sheet and Tube 2. and 2.50 in, (64 mm) in length for plate ean be taken. Should 8.2 Specimens for tension tests shall be machined and tested any of these test specimens not meet the specified require- in accordance with Test Methods S/F $M. Tensile properties ments, test two additional test pieces representative of the same shall be determined using a strain rate of 0.003 to 0.007 lot, inthe same manner, for each failed test specimen, The lot Copyright by ASTM In (all rights reserve Mon Jul 6 13:46:10 EDT 2009 > Download/pnnted F Universi Fedral do Rio Grande do Su pursuant License Agreement No further reproductions auborized.‘will be considered in compliance only if all additional test pieces meet the specified requirements. 9. Special Requirements 9.1 "The microstructure shall be a fine dispersion of the alpha and beta phases resulting from processing in the alpha plus beta, field. There shall be no continuous alpha network at prior beta, grain boundaries. There shall be no coarse, elongated alpha platelets. 9.2. Determine the beta transus temperature for each heat by 4 suitable method and report on the material certification if required by the purchaser 9.3. Alpha case is not permitted for products supplied with a machined, ground, or chemically milled surface finish. For ‘other products, there shall be no continuous layer of alpha case 0.001 in. when examined at 100% magnification, 10. Significance of Numerical Limits 10.1 The following applies to all specified numerical limits in this specification, To determine conformance to these limits, AG] F 136 - 08"* an observed or calculated value shall be rounded tothe nearest unit in the last right hand digit used in expressing the specification limit, in accordance with the rounding method of Practice E 29. AL. Certification 1.1 The supplier shall provide a certification that the material was tested in accordance with this specification, A report of the test results shall be furnished to the purchaser at the time of shipment. 12, Quality Program Requirements 12.1 The producer shall maintain a quality program as defined in ASQ Cl, ISO 9001, or similar quality program. 13, Keywords 13.1 metals (for surgical implants); orthopedic medical devices; titanium alloys; titanium alloys (for surgical implants) APPENDIXES (Nonmandatory Information) XI. RATIONALE X1.1 ‘The purpose of this specication is to characterize the chemical, physical, mechanical, and metallurgical properties of ‘wrought annealed titanium-6aluminum-4vanadium ELI (extra, ow interstitial) alloy to be used in the manufacture of surgical implants. X12 The microstructural requirements contained in this specification represent the current general consensus of opinion, with respect to optimization of mechanical properties for implant applications. X1.3_ The minimum mechanical properties specified ensure 4 baseline of strength and ductility for the highly stressed ‘devices for which this alloy is typically used. X2, BIOCOMPATIBILITY 2.1 The alloy composition covered by this specification has been employed successfully in human implant applications in contact with soft tissue and bone for over a decade. Due 10 the well-characterized level of biological response exhibited by this alloy, it has been used as a control material in Practice F981 Copyright by AST Downloaded/prmted (al ight reserved; Mon Jul 6 13:46:10 EDT 2009 4 X22. No known surgical implant material has ever been shown to be completely free from adverse reactions in the ‘human body. Long-term clinical experience of the use of the material referred to in this specification, however, has shown that an acceptable level of biological response can be expected, if the material is used in appropriate applications. Unies Foal do Rls Gnd do Sl part Liese Agent No fir pedo hrAf} F 136-08" SUMMARY OF CHANGES ‘Committce FO4 has identified the location of selected changes to this standard since the last issue (F 136 — 02a) that may impact the use of this standard. (Approved Nov. 1. 2008.) (D) Section 2, Referenced Documents, was updated. (4) Section 84 was deleted, and relevant information was (2) Section 6 and subsections 6.1, 6.2, and 6.3 were updated. moved to subsections 8,2 and 8.3. (3) Test Methods F539, F 1941, and E 2371 were added to (5) Mechanical Properties have been spit into Table | for Bar, 72, Wire, and Forgings and able 2 for Sheet, Strip, and Plate ASTI iomatonal ates no pasion respecting the vay o any pant gts assrad in connection with any kam mentaned ‘nh stan Users fi tad are oxpreesyadised hat Cetera a th val any such patent rs, ard ho sk ‘or intingorent of such ri are ently Dat own responsi ‘This standarsssubjot to revion a any tne by the reaponate technical commie and must be reviewed every years and tnt reise eter reaproved or witorawn. You Comments are fled ele for revisana ns stand oor sao sands ‘ad soul o assessed te ASTM ioratonatHeaazuarrs. Your common wil reo care condoraon ta mtg o Me response ecncal cami, which you may ato. you feel a your comments have et rca ala heating you shuld ‘make yur views now fo the ASTM Corvnitee on Standart the arose shown Dao. ‘Tne stand copyrighled by ASTM ntomatona, 100 Barr Hartor Drive, PO Box C700, West Conshohocken, PA 1429-2959, Und Stats. naval reprints angie or mute copes) of 1Ns stand may bo odlaned by arteting ASTI at to above aakress or at 610.832.9565 (phon), 6108329555 fe), ar sonvce@asi org (oma). O° trough fe ASTM websto (rane ato). Copyright by ASTM Ir (all sgh reserved); Mon Ju 6 13:46:10 EDT 2009 > Dota ined hy Universi Federal do Rio Grande do Sul parsan to License Agreement No further reproductions authorized