ASTM F620-2011 Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition《在α加β条件下外科植入物用钛合金锻件的标准规范》.pdf

1、Designation: F620 11Standard 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 case of revision, t

2、he 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 implants, in the alpha

3、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 system may not be exa

4、ct 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 MetallicMaterialsE10 Test Method for Brinell Hardn

5、ess 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 Materi-als3E165 Practice for Liquid Penetrant Examination for Gener

6、alIndustryE1409 Test Method for Determination of Oxygen andNitrogen in Titanium and Titanium Alloys by the Inert GasFusion TechniqueE1447 Test Method for Determination of Hydrogen inTitanium and Titanium Alloys by Inert Gas Fusion Ther-mal Conductivity/Infrared Detection MethodE2371 Test Method for

7、Analysis of Titanium and TitaniumAlloys by Atomic Emission Plasma SpectrometryF67 Specification for Unalloyed Titanium, for SurgicalImplant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for S

8、urgicalImplant Applications (UNS R56401)F601 Practice for Fluorescent Penetrant Inspection of Me-tallic Surgical ImplantsF1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNSR56700)F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy f

9、or Surgical Implant Applications (UNSR56400)F2066 Specification for Wrought Titanium-15 MolybdenumAlloy for Surgical Implant Applications (UNS R58150)SI 10 American National Standard for the Use of theInternational System of Units (SI): The Modern MetricSystem2.2 ISO Standard:ISO 9001 Quality Manage

10、ment 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 atessentially the same time.4. Ordering Information4.1 Inquiries and orders for forgings under this specifications

11、hall 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,4.1.5 Finish,4.1.6 Applicable dimensions or drawing number,4.1.7 Special tests, if any, and1This specification is under the jur

12、isdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Dec. 1, 2011. Published December 2011. Originallyapproved in 1979. Last previous edition approved in 2006 as F620 06

13、. DOI:10.1520/F0620-11.2For 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.3Withdrawn. The last approved version

14、of this historical standard is referencedon www.astm.org.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Dri

15、ve, PO Box C700, West Conshohocken, PA 19428-2959, United States.4.1.8 Other requirements.5. Materials and Manufacture5.1 Material for forgings shall be bars or wire fabricated inaccordance with Specification F136, F1295, F1472,orF2066.5.2 The material shall be forged by hammering, pressing,extrudin

16、g, 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 indicated to the fabricator by the purchaser.5.3 Forgings shall be free of splits, scale, cracks, f

17、laws, andother imperfections not consistent with good commercialpractice (see Note 1). Offset or mismatch allowance, dependentupon part size and configuration, shall be within standardforging tolerances.NOTE 1Compliance to these requirements may be verified by TestMethod E165 or Practice F601 or oth

18、er 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 aspecified dwell time followed by appropriate cooling to meetthe applicable metallurgical requireme

19、nts 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 andlocation of which shall be specified by the purchaser.6. Chemical Composition6.1 When specified by

20、 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 material specifica-tion.6.1.1 Hydrogen content shall be determined on annealedforgings. Samples

21、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. Mechanical Requirements7.1 The mechanical properties of forgings shall be tested bythe forger and shall

22、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 representative forged test bar. Arepresentative test bar may only be used if the configuration issuch that a

23、 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/E8M. Tensileproperties shall be determined using a strain rate of 0.003 to0.007 mm/mm/min in./i

24、n./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 in thelongitudinal direction. Should any test specimen not meet thespecified requirements, test

25、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 requirements.7.2.2 Tensile tests results for which any specimen fracturesoutside the gauge lengt

26、h 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, invalidate the specimenand retest. Retest one specimen for each invalidated specimen.7.2.3 If either t

27、he 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, hardness may be specified on the pur-chase order or drawing and shall be determined in accordancewith

28、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 continuous alpha network at priorbeta grain boundaries. There shall be no coarse, elongatedalpha p

29、latelets.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 determine conformance to these limits, anobserved or calculated value shall be rounded to the neare

30、stunit 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 SelectionThis specification requires that the pur-chaser selects the units (SI or inch-pound) to

31、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 ofprecedence.10.1.1.1 If the purchaser and supplier have a history ofusing specific units, these units shal

32、l 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 engineering drawing are consistent, these units shall beused by the supplier for product certification.10.

33、1.1.3 If the purchasers selection of units is unclear, theunits of measure shall be agreed upon between purchaser andsupplier.10.1.2 Conversion of UnitsIf the suppliers test equip-ment does not normally report in the selected units, the testequipment units may be converted to the selected units forc

34、ertification purposes. Accurate arithmetic conversion andF620 112proper use of significant digits should be observed whenperforming this conversion. ASTM SI 10 provides guidelinesfor the use of SI units. Annex A provides conversion tables andAnnex B provides rules for conversion and significant digi

35、ts11. 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 results shall befurnished to the purchaser at the time of shipment.11.2 Gauge length must be reported with e

36、longation.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; metals (for surgicalimplants)titanium alloys; orthopaedic medical devicestitanium/titanium alloy; titanium/ti

37、tanium alloys (for surgicalimplants)APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterize thechemical, mechanical, and metallurgical properties of wroughtannealed titanium alloy forgings in the alpha plus beta condi-tion for surgical implants.X1.2

38、 The microstructural requirements contained in thisspecification represent current general consensus with respectto optimization of mechanical properties for implantapplications.X2. BIOCOMPATIBILITYX2.1 No known surgical implant material has ever beenshown to be completely free of adverse reactions

39、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. Theresults of these studies indicate a well-characterized level oflocal biological response that is equal to or l

40、ess 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.SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the la

41、st 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 theseare titanium forgings in the alpha plus beta condition, ratherthan Alpha-Beta alloys produced as forgings.(2) Specification F2066 (UNS R58150) was added a

42、s anapplicable material.(3) Dimensions and Permissible Variations section was added.(4) Changed “Special Requirements” to “Microstructure.”(5) Deleted former subsection X1.3.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mention

43、edin 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 entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and

44、 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 should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of

45、 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 Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box

46、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 ASTM website (www.astm.org/COPYRIGHT/).F620 113