ASTM F688-2014 Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate Sheet and Foil for Surgical Implants &40 UNS R30035&41 《外壳植入物用钴-35镍-20铬-10钼锻制合.pdf

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1、Designation: F688 14Standard Specification forWrought Cobalt-35Nickel-20Chromium-10Molybdenum AlloyPlate, Sheet, and Foil for Surgical Implants (UNS R30035)1This standard is issued under the fixed designation F688; the number immediately following the designation indicates the year of originaladopti

2、on or, in the case 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 chemical, mechanical, andmetallurgical requ

3、irements for wrought cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) in the formof plate, sheet, and foil to be used in the manufacture ofsurgical implants.1.2 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard. The values stated ineach syste

4、m may not be exact equivalents; therefore, eachsystem shall be used independently of the other. Combiningvalues from the two systems may result in non-conformancewith this standard.2. Referenced Documents2.1 ASTM Standards:2E8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE10 Test Metho

5、d 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 SpecificationsE112 Test Methods for Determining Average Grain SizeE140 Hardness Conversion Tables for Metals Re

6、lationshipAmong Brinell Hardness, Vickers Hardness, RockwellHardness, Superficial Hardness, Knoop Hardness, Sclero-scope Hardness, and Leeb HardnessE345 Test Methods of Tension Testing of Metallic FoilE384 Test Method for Knoop and Vickers Hardness ofMaterialsF562 Specification for Wrought 35Cobalt-

7、35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneIEEE/ASTM SI 10 American National Standard for Use ofthe International System

8、of Units (SI): The Modern MetricSystem2.2 ISO Standards:ISO 9001 Quality Management SystemsRequirements33. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 capabilitythe ability of cold-worked material toattain specific mechanical properties after thermal aging treat-ment.3.1.2 fo

9、ilmaterial under 0.13 mm 0.005 in. in thickness.3.1.3 lotthe total number of mill products produced fromthe same melt heat under the same conditions at essentially thesame time.3.1.4 plateas used in this specification, material 4.75 mm0.1875 in. and over in thickness.3.1.5 sheetas used in this speci

10、fication, material 0.13 mm0.005 in. to under 4.75 mm 0.1875 in. in thickness.4. Ordering Information4.1 Inquiries and orders for material under this specificationshall include the following information:4.1.1 Quantity (weight or number of pieces);4.1.2 ASTM Designation, alloy number, and date of issu

11、e;4.1.3 Units to be used for certificationSI or inch-pound;4.1.4 Form (plate, sheet, foil);4.1.5 Condition (see 5.1);4.1.6 Mechanical properties (if applicable for special con-ditions);4.1.7 Finish (see 5.2 and 5.3);4.1.8 Edge (see 5.4 and 5.5);4.1.9 Applicable dimensions, including size, thickness,

12、width, and length (exact, random, or multiples) or printnumber;1This specification 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 Oct. 1, 2014. Publ

13、ished November 2014. Originallyapproved in 1980. Last previous edition approved in 2010 as F688 10. DOI:10.1520/F0688-14.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refe

14、r to the standards Document Summary page onthe ASTM website.3Available 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 Harbor Dr

15、ive, PO Box C700, West Conshohocken, PA 19428-2959. United States14.1.10 Special tests (if any); and4.1.11 Other requirements.5. Manufacture5.1 ConditionPlate, sheet, and foil shall be furnished asspecified in the annealed, cold-worked, or cold-worked andcapability-aged condition.5.2 Finishes for Pl

16、ate:5.2.1 Types of finish available for plate are ground finishproduced by surface grinding or continuous belt sanding anddull finish produced by chemical descaling.5.3 Finishes for Sheet and Foil:5.3.1 Types of finish available for sheet and foil are dullcold rolled, bright cold rolled, intermediat

17、e polished, general-purpose polished, dull satin-finished, high luster finish, mirrorfinish, or as specified in the purchase order.5.4 Edges for Plate:5.4.1 Rolled edge or approximate square edge produced byabrasive sawing.5.5 Edges for Sheet and Foil:5.5.1 For sizes greater than 1.5 mm 0.060 in. in

18、 thickness,an approximate square edge produced by abrasive sawing ; Forsizes under 1.5 mm 0.060 in. an edge produced by slitting orshearing.6. Chemical Requirements6.1 The heat analysis and product analysis tolerances shallconform to the requirements for chemical composition asspecified in Specifica

19、tion F562.7. Mechanical Requirements7.1 Tensile Properties:7.1.1 Tensile properties for plate and sheet shall be deter-mined in accordance with Test Methods E8/E8M while tensileproperties for foil shall be determined in accordance with TestMethods E345.7.1.2 Perform at least one tension test from ea

20、ch lot. Shouldany of the test pieces not meet the specified requirements, testtwo additional test pieces representative of the same lot, in thesame manner, for each failed test piece. The lot shall beconsidered in compliance only if all additional test pieces meetthe specified requirements.7.1.3 Ten

21、sile test results for which any specimen fracturesoutside the gage length shall be considered acceptable if theelongation meets the minimum requirements specified. Referto Test Methods E8/E8M, section 7.11.4. If the elongation isless than the minimum requirement, discard the test and retest.Retest o

22、ne specimen for each specimen that did not meet theminimum requirement.7.1.4 Product forms in the annealed condition shall meet themechanical property requirements specified in Table 1.7.1.5 Sheet product in the 48 % cold-worked condition shallmeet the mechanical property requirements specified in T

23、able1. Other product forms and cold-worked conditions shall meetthe mechanical property requirements as agreed upon betweenthe supplier and purchaser.7.1.6 Product forms in the cold-worked and capability-agedcondition shall meet the mechanical property requirements asagreed upon between the supplier

24、 and purchaser.7.2 Hardness:7.2.1 When desired, Rockwell hardness B scale (HRB),Rockwell hardness C scale (HRC), or Vickers hardness (HV)limits may be specified, as agreed upon between the purchaserand the supplier. Test Methods E10, E18, E384, and HardnessConversion Tables E140 shall be used.7.2.2

25、Hardness values are for information only and shall notbe used as a basis for rejection.8. Special Tests8.1 If supplied in the annealed condition, the average grainsize shall be predominantly ASTM grain size number four orfiner when tested in accordance with Test Methods E112.8.1.1 It is preferable t

26、hat samples for grain size determina-tion be selected after the final annealing operation and prior toa final cold-working operation or prior to final cold-workingand capability-aging operations.8.1.2 If samples are selected after a final cold-workingoperation or after final cold-working and capabil

27、ity-agingoperations, specimens shall be tested in accordance with TestMethods E112, or as agreed upon between the supplier andpurchaser.8.2 Any other special requirements shall be agreed uponbetween the supplier and purchaser.9. Dimensions and Permissible Variation9.1 Units of Measure:9.1.1 Selectio

28、nThis specification requires that the pur-chaser select the units of measure (SI or inch-pound) to be usedfor product 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 ofpreced

29、ence.9.1.1.1 If the purchaser and supplier have a history of usingspecific units, these units shall continue to be certified untilexpressly changed by the purchaser.9.1.1.2 In the absence of historic precedence, if the unitsused to define the product on the purchasers PO, specification,and engineeri

30、ng drawing are consistent, these units shall beused by the supplier for product certification.9.1.1.3 If the purchasers selection of units is unclear, theunits of measure shall be agreed upon between the purchaserand supplier.TABLE 1 Sheet Mechanical PropertiesConditionUltimate TensileStrength, min,

31、MPa psiAYield Strength(0.2 % offset),min, MPa psiAElongation,min, % in50 mm or2in.RockwellHardness,minAnnealedB48 % cold worked792 115 0001357 197 000310 45 0001343 195 00045387 HRB43 HRCATensile and yield requirements apply to tests taken longitudinally to the rollingdirection.B0.5 mm 0.0197 in. sh

32、eet, vacuum annealed at 1022C 1875F,2hattemperature.F688 1429.1.2 Conversion of UnitsIf the suppliers test equipmentdoes not report in the selected units, the test equipment unitsmay be converted to the selected units for certification pur-poses. Accurate arithmetic conversion and proper use ofsigni

33、ficant digits should be observed when performing thisconversion. IEEE/ASTM SI 10 provides guidelines for the useof SI units.AnnexAof IEEE/ASTM SI 10 provides conversiontables and Annex B of IEEE/ASTM SI 10 provides rules forconversion and significant digits.10. Significance of Numerical Limits10.1 T

34、he following applies to all specified numerical limitsin this specification. To determine conformance to these limits,an observed 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 ofP

35、ractice E29.11. Certification11.1 Certification that the material meets the requirementsof this specification shall be provided by the supplier. A reportof the test results shall be furnished at the time of shipment.12. Quality Program Requirements12.1 The supplier shall maintain a quality program s

36、uch asdefined in ISO 9001 or similar quality program.13. Keywords13.1 cobalt alloys (for surgical implants); cobalt-nickelalloy; metals (for surgical implants)cobalt alloysAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The primary reason for this specification is to charac-terize the composit

37、ion and properties to assure consistency inthe starting material used in the manufacture of medicaldevices.X1.2 The acceptable metal conditions include annealed,cold-worked, or cold-worked and capability-aged. The choiceis dependent upon the medical device design and its intendedapplication.X2. BIOC

38、OMPATIBILITYX2.1 The alloy composition covered by this specificationhas been successfully employed in human implants (1-5)4forover a decade. Due to the well-characterized level of biologicalresponse exhibited by this alloy, it has been used as a controlmaterial in Practice F981.X2.2 No known surgica

39、l implant material has ever beenshown to be completely free of adverse reactions in the humanbody. However, long-term clinical experience has shown anacceptable level of biological response can be expected, if thematerial is used in appropriate applicationsREFERENCES(1) Gaechter, A., and Galante, G.

40、, “MP35N, A Corrosion ResistantHigh-Strength Alloy for Orthopaedic or Surgical Implants: Two YearBioassay,” Journal of Biomedical Materials Research, Vol 10, 1976,pp. 829831.(2) Escales, F., Galante, J., Rostoker, W., and Coogan, P. S., “MP35N, ACorrosion Resistant High Strength Alloy for Orthopaedi

41、c SurgicalImplants: Bioassay Results,” Journal of Biomedical MaterialsResearch, Vol 9, No. 3, 1976, pp. 303313.(3) Kuehne, D., and Willert H. G., “The Tissue Compatibility of theForging Alloy (Protasul 10) with the Hitherto Used Implant Alloys(Co-Cr-Mo Casting Alloy) and (AISI 316L) After an Implant

42、ationPeriod of One Year,” Doctoral Thesis, Osteological Research Labo-ratory of Orthopaedic University, Frankfurt on Main/Frg, 1975.(4) Bauman, R., and Semlitsch, M., “Biological and Mechanical Behaviorof Newly Developed Implant Materials in Animal Studies,” SulzerReprint, Re/28.09.00, 1974, pp 19.(

43、5) ISO/TC-150/SC-1/WG-1, Swiss Standard Association, Group 129-Surgical Implants, Draft Report of WG-1, Swiss Proposal 9056509,Part 2, Comments on Biocompatibility, Davos Meeting, June 1974.4The boldface numbers in parentheses refer to the list of references at the end ofthis specification.F688 143S

44、UMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue (F688 10)that may impact the use of this standard. (Approved Oct. 1, 2014)(1) Editorial corrections have been made to meet terminologyand formatting guidelines established for implant

45、 materialstandards within Subcommittee F04.12.(2) Inverted the order of Dimensions and Permissible Varia-tions and Special Tests sections and renumbered to complywith formatting guidelines of Subcommittee F04.12 docu-ments.(3) Deleted X1.3, Units of Measure, from the Appendix.ASTM International take

46、s 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 entirely their own res

47、ponsibility.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 should be address

48、ed 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 Standards, at the

49、 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,