1、Designation: F 688 05Standard Specification forWrought Cobalt-35Nickel-20Chromium-10Molybdenum AlloyPlate, Sheet, and Foil for Surgical Implants (UNS R30035)1This standard is issued under the fixed designation F 688; the number immediately following the designation indicates the year oforiginal adop
2、tion or, in the case of revision, the year of last 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 chemical, mechanical, andmetallurgical r
3、equirements 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 inch-pound units are to be regardedas the standard. The SI equivalents in parentheses are forinformation
4、only.2. Referenced Documents2.1 ASTM Standards:2E8 Test Methods for 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 i
5、n Test Data toDetermine Conformance with SpecificationsE92 Test Method for Vickers Hardness of Metallic Mate-rialsE112 Test Methods for Determining Average Grain SizeE 140 Hardness Conversion Tables for Metals (RelationshipBetween Brinell Hardness, Vickers Hardness, RockwellHardness, Rockwell Superf
6、icial Hardness, and KnoopHardness)E 345 Test Methods for Tension Testing of Metallic FoilE 384 Test Method for Microhardness of MaterialsF 562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F 981 Practice for Assessment of Compa
7、tibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone2.2 American Society for Quality Standard:ASQ C1 Specification of General Requirements for a Qual-ity Program33. Terminology3.1 Descriptions of Terms Specific to This Standard:3.1.1 capabilityused to
8、 indicate the ability of cold workedmaterial to attain specific mechanical properties after thermalaging treatment.3.1.2 foilmaterial under 0.005 in. (0.127 mm) in thick-ness.3.1.3 lotthe total number of mill products produced fromthe same melt heat under the same conditions at essentially thesame t
9、ime.3.1.4 plateas used in this specification, material 0.1875in. (4.76 mm) and over in thickness.3.1.5 sheetas used in this specification, material 0.005 in.(0.127 mm) to under 0.1875 in. (4.76 mm) in thickness.4. Ordering Information4.1 Inquiries and orders for material under this specificationshal
10、l include the following information:4.1.1 Quantity (weight or number of pieces),4.1.2 ASTM Designation,4.1.3 Form (plate, sheet, foil),4.1.4 Condition (see 5.1),4.1.5 Mechanical properties (if applicable for special con-ditions),4.1.6 Finish (see 5.2 and 5.3),4.1.7 Edge (see 5.4 and 5.5),4.1.8 Appli
11、cable dimensions, including size, thickness,width, and length (exact, random, or multiples) or printnumber, and4.1.9 Special 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 Fin
12、ishes for Plate:1This 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 approved Aug. 1, 2005. Published August 2005. Originallyapproved in 1980.
13、 Last previous editioin approved in 2000 as F 688 00.2For 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.3Availab
14、le from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203.1*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.5.2.1 Types of finish available
15、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 polished, general-purpose polished
16、, 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 0.060 in. (1.524 mm) in thick-ness, an approximate squa
17、re edge produced by abrasive saw-ing; For sizes under 0.060 in. (1.524 mm) an edge produced byslitting or shearing.6. Chemical Composition6.1 The heat analysis and product analysis tolerance shallconform to the requirements as to chemical composition asspecified in Specification F 562.7. Mechanical
18、Requirements7.1 Tensile Properties:7.1.1 Tensile properties for plate and sheet shall be deter-mined in accordance with Test Methods E8 while tensileproperties for foil shall be determined in accordance with TestMethods E 345.7.1.2 Perform at least one tension test from each lot. Shouldany of the te
19、st 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 both additional test piecesmeet the specified requirements.7.1.3 Tensile test results for whic
20、h any specimen fracturesoutside the gage length shall be considered acceptable if theelongation meets the minimum requirements specified. Referto Test Methods E8sections 7.11.4. If the elongation is lessthan the minimum requirement, discard the test and retest.Retest one specimen for each specimen t
21、hat 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. Other product forms and
22、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 purchaser.7.2 Hardness:7.2
23、.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, E92, E 384 andHardness Conversion Tables E 140 shall be used.7.2.2 Hardness values are for i
24、nformation 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 four or finer when tested inaccordance with Test Methods E112.8.1.1 It is preferred that samples for grain size determinationbe select
25、ed after the final annealing operation and prior to afinal cold-working operation or prior to final cold-working andcapability-aging operations.8.1.2 If samples are selected after a final cold-workingoperation or after final cold-working and capability-agingoperations, specimens shall be tested acco
26、rding to Test MethodE112, or as agreed to between supplier and purchaser.8.2 Any other special requirements shall be agreed uponbetween the supplier and purchaser.9. Significance of Numerical Limits9.1 The following applies to all specified numerical limits inthis specification. To determine conform
27、ance 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 of PracticeE29.10. Certification10.1 Certification shall be provided by the supplier that thematerial meets
28、 the requirements of this specification. A reportof the test results shall be furnished at the time of shipment.11. Quality Program Requirements11.1 The supplier shall maintain a quality program such asdefined in ASQ C1.12. Keywords12.1 cobalt alloys (for surgical implants); cobalt-nickelalloy; meta
29、ls (for surgical implants)cobalt alloysTABLE 1 Sheet Mechanical PropertiesConditionUltimate TensileStrength, min, psi(MPa)AYield Strength(0.2 % offset),min, psi (MPa)AElongation,min, % in 2in.or50mmRockwellHardness,minAnnealedB48 % cold worked115 000 (792)197 000 (1357)45 000 (310)195 000 (1343)4538
30、7 HRB43 HRCATensile and yield requirements apply to tests taken longitudinally to the rollingdirection.B0.0197 in. (0.5 mm) sheet, vacuum annealed at 1875F (1022C), 2 h attemperature.F688052APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The primary reason for this specification is to char-act
31、erize the composition 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 intendedap
32、plication.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 biologicalresponse exhibited by this alloy, it has been used as a controlmaterial in Practice F 981.X2
33、.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 response can be expected, if thematerial is used in appropriate applicationsREFERENCES(1) Gaechter,
34、A., and Galante, G., “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 A
35、lloy for Orthopaedic SurgicalImplants: Bioassay Results,” Journal of Biomedical Materials Re-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 3
36、16L) After an ImplantationPeriod of One Year,” Doctoral Thesis, Osteological Research Labora-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
37、.09.00, 1974, pp 19.(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.SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this s
38、tandard since the last issue (F 688 00)that may impact the use of this standard. (Approved Aug. 1, 2005.)(1) Editorial corrections have been made to meet terminologyand formatting guidelines established for implant materialstandards.(2) The cold-worked and capability-aged condition has beenadded to
39、5.1, while cold-worked and capability-aged tensileproperty information is included in 7.1.6.(3) Additonal grain size information for the cold-worked orcold-worked and capability-aged condition is included in 8.1.1and 8.1.2.4The boldface numbers in parentheses refer to the list of references at the e
40、nd ofthis specification.F688053ASTM 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 i
41、nfringement 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 sta
42、ndard or for additional standardsand 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
43、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 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).F688054
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