ASTM F620-2006 Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants《外科植入用α加β钛合金锻件的标准规范》.pdf

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1、Designation: F 620 06Standard Specification forAlpha Plus Beta Titanium Alloy Forgings for SurgicalImplants1This standard is issued under the fixed designation F 620; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last

2、 revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification covers the requirements for alpha plusbeta titanium alloy forgings for surgical implants when themate

3、rial forged conforms to Specifications F 136 (UNSR56401), F 1295 (UNS R56700), or F 1472 (UNS R56400).1.2 The values stated in inch-pound units are to be regardedas the standard. The SI equivalents in parentheses are forinformation only.2. Referenced Documents2.1 ASTM Standards:2E8 Test Methods for

4、Tension Testing of Metallic MaterialsE10 Test Method for Brinell Hardness of Metallic Materi-alsE18 Test Methods for Rockwell Hardness and RockwellSuperficial Hardness of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE92 Test Meth

5、od for Vickers Hardness of Metallic Mate-rialsE 165 Test Method for Liquid Penetrant ExaminationE 1409 Test Method for Determination of Oxygen andNitrogen in Titanium and Titanium Alloys by the Inert GasFusion TechniqueE 1447 Test Method for Determination of Hydrogen inTitanium and Titanium Alloys b

6、y the Inert Gas FusionThermal Conductivity/Infrared Detection MethodE 2371 Test Method for Analysis of Titanium and TitaniumAlloys by Atomic Emission Plasma SpectrometryF67 Specification for Unalloyed Titanium, for SurgicalImplant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700),F 136 Sp

7、ecification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401)F 601 Practice for Fluorescent Penetrant Inspection of Me-tallic Surgical ImplantsF 1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Impla

8、nt Applications (UNSR56700)F 1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNSR56400)2.2 ASQC Standard:Cl Specifications of General Requirements for a QualityProgram32.3 ISO Standard:ISO 9001 Quality Management Systems43. Terminology3.1 Definiti

9、ons of Terms Specific to This Standard:3.1.1 lotthe total number of forgings produced from thesame heat under the same conditions at essentially the sametime.4. Ordering Information4.1 Inquiries and orders for forgings under this specificationshall include the following information:4.1.1 Quantity, n

10、umber 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, and4.1.8 Other requirements.5. Materials and Manufacture5.1 Material for forgings shall be bars

11、 or wire fabricated inaccordance with Specification F 136, F 1295,orF 1472.5.2 The material shall be forged by hammering, pressing,extruding, or upsetting and shall be processed, if practicable, so1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials an

12、d Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved May 1, 2006. Published May 2006. Originallyapproved in 1979. Last previous edition approved in 2000 as F 620 00.2For referenced ASTM standards, visit the ASTM website, www.astm.org, o

13、rcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203.4Available from American National Sta

14、ndards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.as to cause metal flow during the hot-working ope

15、ration 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, flaws, andother imperfections not consistent with good commercialpractice (see Note 1). Offset or mismatch a

16、llowance, dependentupon part size and configuration, shall be within standardforging tolerances.NOTE 1Compliance to these requirements may be verified by TestMethod E 165 or Practice F 601 or other suitable methods.5.4 After all hot-working operations have been completed,the forgings shall receive a

17、n annealing treatment consisting ofheating the parts to an appropriate elevated temperature for aspecified dwell time followed by appropriate cooling to meetthe applicable metallurgical requirements specified herein.5.5 Optional identification marks, including the manufactur-ers logo, material desig

18、nation, 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 the purchaser, the chemical compo-sition of either the forging bars or the completed forgings shallbe de

19、termined and confirmed by the forger, and shall meet theproduct analysis limits of the appropriate material specifica-tion.6.1.1 Hydrogen content must be determined on annealedforgings. Samples for hydrogen analysis shall be taken afterdescaling, pickling, or chemical milling, if these operations ar

20、eperformed.6.2 For referee purposes, Test Methods E 1409, E 1447, andE 2371 shall be used.7. Mechanical Requirements7.1 The mechanical properties of forgings shall be tested bythe forger and shall comply with the minimum mechanicalproperties as specified in Specifications F 136, F 1295,orF 1472.7.1.

21、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 test bar cannot be obtained. Any specially forgedtest bar must be annealed with the forgings it represents.

22、7.1.2 Specimens for tension tests shall be machined andtested in accordance with Test Methods E8. Tensile propertiesshall be determined using a strain rate of 0.003 to 0.007in./in./min (mm/mm/min) through yield and then the crossheadspeed may be increased so as to produce fracture in approxi-mately

23、one additional minute.7.2 Number of Tests:7.2.1 Perform at least one tension test from each lot in thelongitudinal direction. Should this test result not meet thespecified requirements, test two additional test pieces represen-tative of the same lot, in the same manner, for each failed testpiece. Th

24、e lot shall be considered in compliance only if bothadditional test pieces meet the specified requirements.7.2.2 Tensile tests results for which any specimen fracturesoutside the gage length shall be considered acceptable, if boththe elongation and reduction of area meet the minimumrequirements spec

25、ified. Refer to Test Method E8, sections7.11.4 and 7.12.5.7.2.3 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, hardness may be specified o

26、n the pur-chase order or drawing and shall be determined in accordancewith Test Methods E10, E18,orE92.8. Special Requirements8.1 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

27、network at priorbeta grain boundaries. There shall be no coarse, elongatedalpha platelets. Alpha case, if present, shall be less than 0.020in. (0.5 mm) in thickness.9. Significance of Numerical Limits9.1 The following applies to all specified numerical limits inthis specification. To determine confo

28、rmance 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. Certification Requirements10.1 The supplier shall provide a certification that

29、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.10.2 Gage length must be reported with elongation.11. Quality Program Requirements11.1 The supplier shall maintain a quality p

30、rogram such asdefined in ASQ Cl or ISO 9001.12. Keywords12.1 forgingssurgical implants; metals (for surgicalimplants)titanium alloys; orthopaedic medical devicestitanium/titanium alloy; titanium/titanium alloys (for surgicalimplants)F620062APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The pu

31、rpose of this specification is to characterize thechemical, mechanical, and metallurgical properties of wroughtannealed alpha plus beta titanium alloy forgings for surgicalimplants.X1.2 The microstructural requirements contained in thisspecification represent current general consensus with respectto

32、 optimization of mechanical properties for implant applica-tions.X1.3 The title of the specification was changed to cover thealpha plus beta titanium alloy forgings and the Scope definesthree specific compositions that have a similar microstructuresand mechanical properties. The hydrogen content is

33、nowrequired to be determined in the final condition that theforgings will be shipped to the purchaser and mechanicalproperties are now required to be reported.X2. BIOCOMPATIBILITYX2.1 No known surgical implant material has ever beenshown to be completely free of adverse reactions in the humanbody. T

34、he 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 less than thatproduc

35、ed 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 last issue (F 620 00)

36、that may impact the use of this standard. (Approved May 1, 2006.)(1) Editorial corrections were made in order to meet terminol-ogy guidelines established for implant materials.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item menti

37、onedin 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 a

38、nd 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

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

40、x 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).F620063