tion for Sect ge en oes ewe tng Soe intact Rit apred tem Arua! ook ASM Skamania Capyghe ASTM Tealaad nt caer comsied nan Wit appear nie i eon, 6A1-4V ELI Alloy for Surgical Implant Gud under the fted designation F136; the number immediately flowing the designation indicates the yi af cas f vision, he yea of ast revison, A number in parentheses adits tbe Year Os Fear. A i esilon() indeaes an eter change since the fst covion or vespproval 1. 1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed Ti- GAL-4V E.LL, (extra low interstitial) titanium alloy to be ‘used in the manufacture of surgical implants. 1.2 The material in this specification has been subjected to testing in labératory animals2> The results of these ‘studies and the clinical history indicate a well characterized level of local biological response. 1.3 The values stated in inch-pound units are to be regarded as the standard. The metric equivalents in paren- theses are provided for information only. 2. Referenced Documents 2.1 ASTM Standards: B 265 Specification for Ti Strip, Sheet, and Plate* B 348 Specification for Titanium and Titanium Alloy Bars and Billets! B 381 Specification for Titanium and Titanium Alloy Forgings! EX Test Methods of Ten: Materials* E 120 Test Methods for Chemical Analysis of Titanium and Titanium Alioys* E290 Test Method for Semi-Guided Bend Test for Ductility of Metallic Materials? F 620 Specification for Titanium 6A1-4V ELI Alloy Forgings for Surgical Implants 2.2 ASQC Standard: C1-1985 Specifications of General Requirements for a Quality Control Program”? 2.3 Aerospace Material Specifications:"® mm and Titanium Alloy n Testing of Metallic "This specication is under the jurisdiction of ASTM. Commitee Fel on Medical and Surgical Mates and Devices and the direct responsbiiy of Subgommitce F402 on Resources, Creat edion approved Nov. 15, 1952. Published January 1993. Originally published st F 13684 Lat previous eiion F 136-84 * Laing PG. Ferguson, Jr A, Band Hodge, €. 5, “Tie Rezction in Rabiit Muscle Exposed to Metalic Impians," J. Biomed. Mattias Research, Vol. 11967. pp 135-149 > Laing. & G. “Compattiliy of Biomater." Onhopedk: Chins of Nom ‘America. Vol. 4. No.2, April, 1973, pp. 229-273. * AnmieBoak of ASTM Standards, Vol (208. 5 Anal Book of ASTM Stender. Nol 030, ‘maa Bok of ASTM Stands. Vo 0308 ia Hook of ATA Standard, Vol O30 imal Nk of AS7H Standade, Nal ‘Available rom American Society for Quality Cone, 161 W. Wisconsin ‘Ave, Mitwaokee, WI 53203, "amiable from SAE, 00 Commomsealth Drive, Warendale, PA 15096, AMS 2249C Chemical Check Analysis Limits, Titanium and Titanium Alloys AMS 4930C Titanium Alloy Bars, Forgings, and Rings 6AL-4V Extra Low Interstitial Annealed 3. Product Classification 3.1 Strip—Any product under 0.1875 in. (4.75 mm) in thickness and under 24 in. (610 mm) wide. 3.2 Sheet—Any product under 0.1875 in, (4.75 mm) in thickness and 24 in. (610 mm) or more in width, 3.3 Plate—Any product 0.1875 in, (4,75 mm) thick and over and 10 in. (254 mm) wide and over, with widths greater than five times thickness. Plate up to 4.00 in. (101.60 mm). thick inclusive is covered by this specification. 3.4 Bar—Rounds from Yie in. (7.9 mm) to 4.00 in (101,60 mm) in diameter, (Other sizes by special order.) 35. Forging bar—Bar as described in 3.4, used for produc- tion of forgings, may be furnished in the hot rolled condi- tion. 3.6 Wire—Rounds less than Ys in, (4,8 mm) in diameter. Ordering Information 4.1 Inquiries and orders for material under this specifica- tion shall include the following information: 4.1.1 Quantity (weight or number of pieces). 4.1.2 Applicable ASTM designation, 4.1.3 Form (sheet, strip, plate, wire, bar, or forging), 4.1.4 Condition (See 5.1), 4.1.5 Mechanical properties (if applicable, for special conditions), 4.1.6 Finish (see 5.2), 4.1.7 Applicable dimensions including size, thickness, width, or print number, 4.1.8 Special tests, and 4.1.9 Special requirements. ‘5. Materials and Manufacture 5.1 The various titanium mill products covered in this specification are normally formed with the conventiona forging and rolling equipment found in primary ferrous anc nonferrous plants. The ingot metal for such mill operation is usually melted in are furnaces of a type conventional: used for reactive metals. 5.2 Finish—Annealed material may be furnished to th implant manufacturer as descaled or pickled, sandblastec ‘ground, or combinations of these operations. 6, Chemicat Requirements 6.1 The heat analysis shall conform to the chemic ‘composition of Table |. Ingot analysis may be usedqh F 136 TABLE 1 Chemical Requirements omer ‘Componton. ‘roger max 005 ‘Geto, max 0.08. yeropen, max oi ton, max 028. ‘Oxygen, max 013, Aureus 55-850 Varagum 35-45 Thanum® bance ™ Mater 0.082. (O19 mm) and under may Rave hydrogen content up 1 90150. ‘The patcontage of Stariun Is determined by diference and noes act be elaine or carttod. TABLE 2 Product Anslysie Totorance* faa Tolerance Under the Minimum or Ove" he Menu Unt Tirogen ‘002 Caren 02 Hyerogen ‘0020 roa 010 Oxygen oz ‘Norm 040 Vanachun 015, “Relate to ANS 22460. ‘Under minimum iit et appicale fr elemonts where ory a minimum percentage is indeate. reporting all chemical requirements, except hydrogen. Sam- ples for hydrogen shall be taken from the finished mill product. 6.2 The product analysis tolerances shall conform to the check tolerances of Table 2. 6.3 For referee purposes, Methods E 120 shall be used. 6.4 Samples for chemical analysis shall be representative of the material being tested. The utmost care must be used in sampling titanium for chemical analysis because of its affinity for elements such as oxygen, nitrogen, and hydrogen. Therefore, in cutting samples for analysis, the operation should be carried out insofar as possible in a dust-free atmosphere. Chips should be clean and sharp. Samples for analysis should be stored in suitable containers, 7, Mechanical Requirements 7.1 Material supplied under this specification shall con- form to, the mechanical property requirements given in Table 3. 7.2 Specimens for tension tests shall be machined and tested in accordance with Test Methods E 8. Tensile proper- ties shall be determined using a strain rate of 0.003 to 0.007 in/in, min (metric equivalent mm/mm/min) through the specified yield strength. 7.3 For sheet and strip, the bend test specimen shalt withstand being bent cold through an angle of 105* without fracture in the outside surface of the bent portion. The bend shall be made on a diameter equal to that shown in Table 3. ‘Test conditions shall conform to Test Method E 290. 8 Special Requirements 8.1 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. There shall be no alpha case. 8.2 The beta transus temperature shall be measured by a suitable method and reported on the materials certification. 9. Quality Program Requirements 9.1 The producer shall maintain a quality program, such as, for example, is defined in Specifications C1-1985. 9.2 The manufacturer of surgical implants or medical applicances shall be assured of and may audit the producer's quality program for conformance to the intent of Specifica- tions C1-1985, or other recognized program. 10, Marking, Packing, Certification, and Rejection 10.1 Marking, packing, certification, and rejection shall bbe as specified in Specifications B 265, B 348, and B 381. TABLE 3 Annealed Mechanical Properties* ee Tenn Srogtinn, Yea srengn 02 atin mn, COUNT Dore x Fecion al marae nen care eine) Ee ee ee eee aa a7 a Bos or OTT Teo canate algerie 7s4s49,ne ——_rzson0.¢09 115090 785 Pa Preweasjetaneosm ns oomiee Hos rea 2 Bw 12300050) 4000188, 40000 62) Hoan rea se Re ns tend Tan? re 007 (1.79 oes nd Soro izraooe ta) nT im “ wechanzl properties (or condone ober an annealed maybe esablsted by agreement Between the suppor and the Inplani menuactre, ‘Elongation on mater under 0.17 nin thckness ox ameter shal ba measured over a 2 in. gage ang. Elngalon on mates under 032 (0.813 mm n \nianass or dameter nay be obeined by nogelation. = longudnl: LT = long tarevree; ST ~ehort taraveree ‘© Applies to ba, pao, end forgings ont. L = onglusna LT = ong Wansverse, ST = short aneverse Bend tos appicabl to shee! and sip products; T = tickrass of bend specie In rterence to camater of bard.Gb F 136 APPENDIX (Nonmandatory Information) XI RATIONALE XII The purpose of this specification is to characterize the chemical, physical, mechanical, and metallurgical prop- erties of wrought annealed Ti-6AI-4V E.L.I alloy to be used in the manufacture of surgical implants. X1.2 The alloy composition covered by this standard has been employed successfully in human implants, exhibiting a well characterized level of local biological response, for over a decade. X1.3 The microstructural requirements contained in this standard represent the current general consensus of opinion with respect to optimization of mechanical properties for implant applications. X14 The minimum mechanical properties specified as- sure a baseline of strength and ductility for the highly stressed devices for which this alloy is typically used. X1.5 The applicable thickness range for bar and plate has been increased to 4.00 in. (101.60 mm) in accordance with ‘AMS 4930C. Tne Amorican Society fr Testing and Maori tates no poston respecting the vatsy of any patent igs aesurte in connection wi any tam martons in hia standard. Uses of this standard oe expressly e0vsed that determination othe vay of ary such ater right, and he rigk af iningamar! of sch ans, ar enivay tel Own ronponebly {nie tana sunject 0 tevin at eny tine by te responsibe tactical commits and must be reviowed avery fv yrs and ‘notrwvsed, eer reeporoved or wien. Your comments ae id ier fr rovsion ol this standard oor adele standards ‘nd shoul be addressed to ASTM Headquarters, Your comment wil receive catelulconsiseraion a @ meting ofthe expanse ‘wchniat commits, whic you may tend. you fe! that your commana have nol recelved & lar Paaring you shousd make your ‘ius frown tothe ASTM Commitee on Standards, 1916 Rac St, Phiacepia, PA T0103.