1、Designation: F688 19Standard 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 UnitsThe SI units in this standard are the primaryunits. The values stated in either SI units or inch-pound unitsare to be regard
4、ed separately as standard. The values stated ineach system 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.1.3 This international standard was developed in accor-dance w
5、ith internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standar
6、ds:2E8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE10 Test Method 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
7、 for Determining Average Grain SizeE140 Hardness Conversion Tables for Metals RelationshipAmong 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 fo
8、r Microindentation Hardness of Mate-rialsF562 Specification for Wrought 35Cobalt-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 I
9、nsertion into BoneIEEE/ASTM SI 10 American National Standard for Use ofthe International System 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
10、-worked material toattain specific mechanical properties after thermal aging treat-ment.3.1.2 foilmaterial 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
11、specification, material 4.75 mm0.1875 in. and over in thickness.3.1.5 sheetas used in this specification, 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.
12、1.1 Quantity (weight or number of pieces);4.1.2 ASTM Designation, alloy number, and date of issue;4.1.3 Units to be used for certificationSI or inch-pound;4.1.4 Form (plate, sheet, foil);1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices
13、and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Feb. 1, 2019. Published February 2019. Originallyapproved in 1980. Last previous edition approved in 2014 as F688 14. DOI:10.1520/F0688-19.2For referenced ASTM standards, visit the ASTM website
14、, 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.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/w
15、ww.ansi.org.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standard
16、ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.14.1.5 Condition (see 5.1);4.1.6 Mechanical properties (if applicable for special con-ditions
17、);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 length (exact, random, or multiples) or printnumber;4.1.10 Special tests (if any); and4.1.11 Other requirements.5. Manufacture5.1 ConditionPlate, sheet, and foil shall be f
18、urnished asspecified in the annealed, cold-worked, or cold-worked andcapability-aged condition.5.2 Finishes for Plate: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 Shee
19、t and Foil:5.3.1 Types of finish available for sheet and foil are dullcold rolled, bright cold rolled, intermediate 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 sq
20、uare 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 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
21、and product analysis tolerances shallconform to the requirements for chemical composition asspecified in Specification 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 tensilepropertie
22、s for foil shall be determined in accordance with TestMethods E345.7.1.2 Perform at least one tension test from each 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. Th
23、e lot shall beconsidered in compliance only if all additional test pieces meetthe specified requirements.7.1.3 Tensile test results for which any specimen fracturesoutside the gage length shall be considered acceptable if theelongation meets the minimum requirements specified. Referto Test Methods E
24、8/E8M, section 7.11.4. If the elongation isless than the minimum requirement, discard the test and retest.Retest one 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
25、.1.5 Sheet product in the 48 % cold-worked condition shallmeet the mechanical property requirements specified in Table1. 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-work
26、ed and capability-agedcondition shall meet the mechanical property requirements asagreed upon between the supplier 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 t
27、he purchaserand the supplier. Test Methods E10, E18, E384, and HardnessConversion Tables in E140 shall be used.7.2.2 Hardness values are for information only and shall notbe used as a basis for rejection.8. Microstructure Requirements8.1 If supplied in the annealed condition, the average grainsize s
28、hall be predominantly ASTM grain size number four orfiner when tested in accordance with Test Methods E112.8.1.1 It is preferable that 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 ca
29、pability-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 in accordance with TestMethods E112, or as agreed upon between the supplier andpurchaser.9. Dimensions and Permissible Var
30、iation9.1 Units of Measure:9.1.1 SelectionThis specification requires that the pur-chaser select the units of measure (SI or inch-pound) to be usedfor product certification. In the absence of a stated selection ofunits on the purchase order, this selection may be expressed bythe purchaser in several
31、 alternate forms listed in order ofprecedence.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 p
32、urchase order (PO),TABLE 1 Sheet Mechanical PropertiesConditionUltimate TensileStrength, 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 r
33、equirements apply to tests taken longitudinally to the rollingdirection.B0.5 mm 0.0197 in. sheet, vacuum annealed at 1022C 1875F,2hattemperature.F688 192specification, and engineering drawing are consistent, theseunits shall be used by the supplier for product certification.9.1.1.3 If the purchasers
34、 selection of units is unclear, theunits of measure shall be agreed upon between the purchaserand supplier.9.1.2 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. Accura
35、te arithmetic conversion and proper use ofsignificant 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 di
36、gits.10. Significance of Numerical Limits10.1 The 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 the specifi-cation
37、limit, in accordance with the Rounding Method ofPractice 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.
38、1 The supplier shall maintain a quality program such 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 th
39、is specification is to charac-terize 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 d
40、evice design and its intendedapplication.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 contr
41、olmaterial in Practice F981.X2.2 While no known surgical implant material has everbeen shown to be completely free of adverse reactions in thehuman body, long term clinical experience has shown anacceptable level of biological response can be expected if thematerial is used in appropriate applicatio
42、ns. However, thisspecification covers the raw material and not finished medicaldevices, where the design and fabrication of the device canimpact biological response.REFERENCES(1) Gaechter, A., and Galante, G., “MP35N, A Corrosion ResistantHigh-Strength Alloy for Orthopaedic or Surgical Implants: Two
43、 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 MaterialsResearch, Vol 9, No. 3
44、, 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 Labo-ratory of Orthopaedic
45、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-Surgical Implants, Draft Repo
46、rt 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 193SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this stand
47、ard since the last issue (F688 14)that may impact the use of this standard. (Approved Feb. 1, 2019).(1) Errors corrected in Section 2 updated document titles.(2) Removed 8.2.(3) Changed Section 8 title from “Special Tests” to “Micro-structure Requirements”.(4) Added a sentence to X2.2 to clarify tha
48、t this specification isfor raw material and conformance to the specification does notensure biocompatibility of finished medical devices fabricatedusing the material.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin thi
49、s 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 Headquarters. Your co
