1、Designation: F688 10Standard 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 the standard.2. Referenced Documents2.1 ASTM Standards:2E8/E8M Test Methods for Tension Testing of MetallicMaterialsE10 Test Method f
5、or 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 Relat
6、ionshipAmong Brinell Hardness, Vickers Hardness, RockwellHardness, Superficial Hardness, Knoop Hardness, andScleroscope HardnessE345 Test Methods of Tension Testing of Metallic FoilE384 Test Method for Knoop and Vickers Hardness ofMaterialsF562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-
7、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 BoneSI 10 American National Standard for Use of the Interna-tional System of Units (SI): The Modern Me
8、tric System2.2 ISO Standards:ISO 9001 Quality Management SystemsRequirements33. Terminology3.1 Descriptions of Terms Specific to This Standard:3.1.1 capabilityused to indicate the ability of cold workedmaterial to attain specific mechanical properties after thermalaging treatment.3.1.2 foilmaterial
9、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 specification, m
10、aterial 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 issue,4.1.3 Uni
11、ts 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,width, and
12、length (exact, random, or multiples) or printnumber,4.1.10 Special tests (if any), and1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition app
13、roved Dec. 1, 2010. Published December 2010. Originallyapproved in 1980. Last previous edition approved in 2005 as F688 05. DOI:10.1520/F0688-10.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards
14、volume information, refer 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.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM Interna
15、tional, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.4.1.11 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 Plate:5.2.
16、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, intermediate polish
17、ed, 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 thickne
18、ss,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 tolerance shallconform to the requirements as to chemical composition asspecified in Specification F56
19、2.7. 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 each lot.
20、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 Tensile tes
21、t 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 one speci
22、men 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 Table1. O
23、ther 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 and pur
24、chaser.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 Hardness
25、 values are for information only and shall notbe used as a basis for rejection.8. Dimensions and Permissible Variation8.1 Units of Measure:8.1.1 SelectionThis specification requires that the pur-chaser select the units of measure (SI or inch-pound) to be usedfor product certification. In the absence
26、 of a stated selection ofunits on the purchase order, this selection may be expressed bythe purchaser in several alternate forms listed in order ofprecedence.8.1.1.1 If the purchaser and supplier have a history of usingspecific units, these units shall continue to be certified untilexpressly changed
27、 by the purchaser.8.1.1.2 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.8.1.1.3 If the purchasers selection of units is uncle
28、ar, theunits of measure shall be agreed upon between purchaser andsupplier.8.1.2 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 pro
29、per use ofsignificant digits should be observed when performing thisconversion. ASTM SI 10 provides guidelines for the use of SIunits. Annex A provides conversion tables and Annex Bprovides rules for conversion and significant digits.9. Special Tests9.1 If supplied in the annealed condition, the ave
30、rage grainsize shall be predominantly four or finer when tested inaccordance with Test Methods E112.9.1.1 It is preferred that samples for grain size determinationbe selected after the final annealing operation and prior to afinal cold-working operation or prior to final cold-working andcapability-a
31、ging operations.9.1.2 If samples are selected after a final cold-workingoperation or after final cold-working and capability-agingoperations, specimens shall be tested according to Test MethodE112, or as agreed to between supplier and purchaser.TABLE 1 Sheet Mechanical PropertiesConditionUltimate Te
32、nsileStrength, min,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
33、.5 mm 0.0197 in. sheet, vacuum annealed at 1022C 1875F,2hattemperature.F688 1029.2 Any other special requirements shall be agreed uponbetween the supplier and purchaser.10. Significance of Numerical Limits10.1 The following applies to all specified numerical limitsin this specification. To determine
34、 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 ofPractice E29.11. Certification11.1 Certification shall be provided by the supplier that th
35、ematerial meets the requirements of this specification. 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 such asdefined in ISO 9001.13. Keywords13.1 cobalt alloys (for surgical implants); cobalt-
36、nickelalloy; metals (for surgical implants)cobalt alloysAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The primary reason for this specification is to char-acterize the composition and properties to assure consistency inthe starting material used in the manufacture of medicaldevices.X1.2 The
37、acceptable metal conditions include annealed,cold-worked, or cold-worked and capability-aged. The choiceis dependent upon the medical device design and its intendedapplication.X1.3 Units of Measure:X1.3.1 ASTM PolicyASTM is promoting the use ofrationalized SI (metric) units in their standards. The F
38、04.12subcommittee has modified this specification to facilitate thetransition by the medical materials industry to SI units betweennow and 2018. In the first phase of this transition, running to2013, the specifications will be structured to allow the use ofeither SI or inch-pound units. The choice o
39、f primary units ineach specification will be determined by the industry using thespecification. The change to SI units during this period may beinitiated by the purchaser through his purchase documentation.In the second phase of this transition, the specifications will bewritten with SI units as the
40、 primary units. Harmonization withcorresponding ISO documents should be considered whenassigning the SI values.X2. BIOCOMPATIBILITYX2.1 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 b
41、iologicalresponse exhibited by this alloy, it has been used as a controlmaterial in Practice F981.X2.2 No known surgical 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
42、response can be expected, if thematerial is used in appropriate applications4The boldface numbers in parentheses refer to the list of references at the end ofthis specification.F688 103REFERENCES(1) Gaechter, A., and Galante, G., “MP35N, A Corrosion ResistantHigh-Strength Alloy for Orthopaedic or Su
43、rgical 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 Orthopaedic SurgicalImplants: Bioassay Results,” Journal of Biomedical Materials R
44、e-search, 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 ImplantationPeriod of One Year,” Doctoral Thesis, Osteological Research Labor
45、a-tory 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.(5) ISO/TC-150/SC-1/WG-1, Swiss Standard Association, Group 129-Surgica
46、l Implants, Draft Report of WG-1, Swiss Proposal 9056509,Part 2, Comments on Biocompatibility, Davos Meeting, June 1974.SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue (F688 05)that may impact the use of this standard. (Approved D
47、ec 1, 2010.)(1) Editorial corrections have been made to meet terminologyand formatting guidelines established for implant materialstandards.(2) Changed primary units from inch-pounds to SI.(3) Added wording to subsection 1.2 and Section 4 and addedSection 8 and subsection X1.3 to support certifying
48、in SI units.(4) Added reference to ASTM SI 10 for use of SI units andreference to ISO 9001.(5) Deleted ASQ C1 quality system and reference and refer-ence to ASTM E92 in subsection 7.2.1.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any
49、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 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 should be addressed to ASTM International He
