1、Designation: F620 11 (Reapproved 2015)Standard Specification forTitanium Alloy Forgings for Surgical Implants in the AlphaPlus Beta Condition1This standard is issued under the fixed designation F620; the number immediately following the designation indicates the year of originaladoption or, in the c
2、ase of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification covers the requirements for titaniumalloy forgings for surgical impla
3、nts, in the alpha plus betacondition, when the material forged conforms to SpecificationsF136 (UNS R56401), F1295 (UNS R56700), F1472 (UNSR56400), or F2066 (UNS R58150).1.2 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard. The values stated ineach sys
4、tem may not be exact equivalents; therefore, eachsystem shall be used independently of the other. Combiningvalues from the two systems may result in non-conformancewith the standard.2. Referenced Documents2.1 ASTM Standards:2E8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE10 Test Meth
5、od for Brinell Hardness of Metallic MaterialsE18 Test Methods for Rockwell Hardness of Metallic Ma-terialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE92 Test Method for Vickers Hardness of Metallic Materials(Withdrawn 2010)3E165 Practice for Liq
6、uid Penetrant Examination for GeneralIndustryE1409 Test Method for Determination of Oxygen and Nitro-gen in Titanium and Titanium Alloys by Inert Gas FusionE1447 Test Method for Determination of Hydrogen in Tita-nium and Titanium Alloys by Inert Gas Fusion ThermalConductivity/Infrared Detection Meth
7、odE2371 Test Method for Analysis of Titanium and TitaniumAlloys by Direct Current Plasma and Inductively CoupledPlasma Atomic Emission Spectrometry (Performance-Based Test Methodology)F67 Specification for Unalloyed Titanium, for Surgical Im-plant Applications (UNS R50250, UNS R50400, UNSR50550, UNS
8、 R50700)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial)Alloy for SurgicalImplant Applications (UNS R56401)F601 Practice for Fluorescent Penetrant Inspection of Me-tallic Surgical ImplantsF1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Su
9、rgical Implant Applications (UNSR56700)F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNSR56400)F2066 Specification for Wrought Titanium-15 MolybdenumAlloy for Surgical Implant Applications (UNS R58150)SI 10 American National Standard for the Us
10、e of theInternational System of Units (SI): The Modern MetricSystem2.2 ISO Standard:ISO 9001 Quality Management Systems43. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 lotthe total number of forgings produced from thesame heat under the same conditions and heat treated atessen
11、tially the same time.4. Ordering Information4.1 Inquiries and orders for forgings under this specificationshall include the following information:4.1.1 Quantity, number of pieces,4.1.2 ASTM designation and date of issue, material grade,4.1.3 Condition,4.1.4 Mechanical properties,1This specification
12、is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devicesand is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Dec. 1, 2015. Published December 2015. Originallyapproved in 1979. Last previous edition approved in
13、2011 as F620 11. DOI:10.1520/F0620-11R15.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3The last approved v
14、ersion of this historical standard is referenced onwww.astm.org.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbo
15、r Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States14.1.5 Finish,4.1.6 Applicable dimensions or drawing number,4.1.7 Special tests, if any, and4.1.8 Other requirements.5. Materials and Manufacture5.1 Material for forgings shall be bars or wire fabricated inaccordance with Specifica
16、tion F136, F1295, F1472,orF2066.5.2 The material shall be forged by hammering, pressing,extruding, or upsetting and shall be processed, if practicable, soas to cause metal flow during the hot-working operation in thedirection most favorable for resisting stresses encountered inservice, as may be ind
17、icated to the fabricator by the purchaser.5.3 Forgings shall be free of splits, scale, cracks, flaws, andother imperfections not consistent with good commercialpractice (see Note 1). Offset or mismatch allowance, dependentupon part size and configuration, shall be within standardforging tolerances.N
18、OTE 1Compliance to these requirements may be verified by TestMethod E165 or Practice F601 or other suitable methods.5.4 After all hot-working operations have been completed,the forgings shall receive an annealing treatment consisting ofheating the parts to an appropriate elevated temperature for asp
19、ecified dwell time followed by appropriate cooling to meetthe applicable metallurgical requirements specified herein.5.5 Optional identification marks, including the manufactur-ers logo, material designation, heat code number, and impres-sion number, may be placed upon each forging, the method andlo
20、cation of which shall be specified by the purchaser.6. Chemical Composition6.1 When specified by the purchaser, the chemical compo-sition of either the forging bars or the completed forgings shallbe determined and confirmed by the forger, and shall meet theproduct analysis limits of the appropriate
21、material specifica-tion.6.1.1 Hydrogen content shall be determined on annealedforgings. Samples for hydrogen analysis shall be taken afterdescaling, pickling, or chemical milling, if these operations areperformed.6.2 For referee purposes, Test Methods E1409, E1447, andE2371 shall be used.7. Mechanic
22、al Requirements7.1 The mechanical properties of forgings shall be tested bythe forger and shall comply with the minimum mechanicalproperties as specified in Specifications F136, F1295, F1472,or F2066.7.1.1 Test specimens shall be taken from a representativeforging if possible, or from a representati
23、ve forged test bar. Arepresentative test bar may only be used if the configuration issuch that a test bar cannot be obtained. Any specially forgedtest bar must be annealed with the forgings it represents.7.1.2 Specimens for tension tests shall be machined andtested in accordance with Test Methods E8
24、/E8M. Tensileproperties shall be determined using a strain rate of 0.003 to0.007 mm/mm/min in./in./min through yield and then thecrosshead speed may be increased so as to produce fracture inapproximately one additional minute.7.2 Number of Tests:7.2.1 Perform at least one tension test from each lot
25、in thelongitudinal direction. Should any test specimen not meet thespecified requirements, test two additional test pieces represen-tative of the same lot, in the same manner, for each failed testspecimen. The lot will be considered in compliance only if alladditional test pieces meet the specified
26、requirements.7.2.2 Tensile tests results for which any specimen fracturesoutside the gauge length shall be considered valid, if both theelongation and reduction of area meet the minimum require-ments specified. If either the elongation or reduction of area isless than the minimum requirement, invali
27、date the specimenand retest. Retest one specimen for each invalidated specimen.7.2.3 If either the elongation or reduction of area is less thanthe minimum requirement, discard the test and retest. Retestone specimen for each specimen that did not meet theminimum requirements.7.3 When desired, hardne
28、ss may be specified on the pur-chase order or drawing and shall be determined in accordancewith Test Methods E10, E18,orE92.8. Microstructure8.1 The microstructure shall be a fine dispersion of the alphaand beta phases resulting from processing in the alpha plus betaphase field. There shall be no co
29、ntinuous alpha network at priorbeta grain boundaries. There shall be no coarse, elongatedalpha platelets.Alpha case, if present, shall be less than 0.5 mm0.020 in. in thickness.9. Significance of Numerical Limits9.1 The following applies to all specified numerical limits inthis specification. To det
30、ermine conformance to these limits, anobserved or calculated value shall be rounded to the nearestunit in the last right hand digit used in expressing thespecification limit, in accordance with the rounding method ofPractice E29.10. Dimensions and Permissible Variations10.1 Units of Measure:10.1.1 S
31、electionThis specification requires that the pur-chaser selects the units (SI or inch-pound) to be used forproduct certification. In the absence of a stated selection ofunits on the purchase order, this selection may be expressed bythe purchaser in several alternate forms listed in order ofprecedenc
32、e.10.1.1.1 If the purchaser and supplier have a history ofusing specific units, these units shall continue to be certifieduntil expressly changed by the purchaser.10.1.1.2 In the absence of historic precedence, if the unitsused to define the product on the purchasers PO, specification,and engineerin
33、g drawing are consistent, these units shall beused by the supplier for product certification.10.1.1.3 If the purchasers selection of units is unclear, theunits of measure shall be agreed upon between purchaser andsupplier.F620 11 (2015)210.1.2 Conversion of UnitsIf the suppliers test equipmentdoes n
34、ot normally report in the selected units, the test equip-ment units may be converted to the selected units for certifi-cation purposes.Accurate arithmetic conversion and proper useof significant digits should be observed when performing thisconversion. ASTM SI 10 provides guidelines for the use of S
35、Iunits. Annex A provides conversion tables and Annex Bprovides rules for conversion and significant digits11. Certification Requirements11.1 The supplier shall provide a certification that thematerial was tested in accordance with this specification andmet all requirements. A report of the test resu
36、lts shall befurnished to the purchaser at the time of shipment.11.2 Gauge length must be reported with elongation.12. Quality Program Requirements12.1 The supplier shall maintain a quality program such asdefined in ISO 9001 or similar quality program.13. Keywords13.1 forgingssurgical implants; metal
37、s (for surgicalimplants)titanium alloys; orthopaedic medical devicestitanium/titanium alloy; titanium/titanium alloys (for surgicalimplants)APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterize thechemical, mechanical, and metallurgical properties
38、 of wroughtannealed titanium alloy forgings in the alpha plus beta condi-tion for surgical implants.X1.2 The microstructural requirements contained in thisspecification represent current general consensus with respectto optimization of mechanical properties for implant applica-tions.X2. BIOCOMPATIBI
39、LITYX2.1 No known surgical implant material has ever beenshown to be completely free of adverse reactions in the humanbody. The alloy compositions covered by this specification,however, have been subjected to testing in laboratory animals,and have been used clinically for more than a decade. Theresu
40、lts of these studies indicate a well-characterized level oflocal biological response that is equal to or less than thatproduced by the reference material unalloyed titanium (seeSpecification F67) that has a long history of successful clinicalapplication in soft tissue and bone implants in humans.SUM
41、MARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue (F620 06)that may impact the use of this standard. (Approved Dec. 1, 2011.)(1) Modified the title, scope, and X1.1 to indicate that these aretitanium forgings in the alpha plus beta con
42、dition, rather thanAlpha-Beta alloys produced as forgings.(2) Specification F2066 (UNS R58150) was added as anapplicable material.(3) Dimensions and Permissible Variations section was added.(4) Changed “Special Requirements” to “Microstructure.”(5) Deleted former subsection X1.3.F620 11 (2015)3ASTM
43、International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are enti
44、rely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand
45、 should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on
46、 Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 11 (2015)4
