1、Designation: F 961 08Standard Specification for35Cobalt-35Nickel-20Chromium-10Molybdenum AlloyForgings for Surgical Implants (UNS R30035)1This standard is issued under the fixed designation F 961; the number immediately following the designation indicates the year oforiginal adoption or, in the case
2、 of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification covers the requirements for 35cobalt-35nickel-20chromium-10molybdenum al
3、loy (UNS R30035) inthe form of forgings, used for the manufacture of surgicalimplants.1.2 The values stated in inch-pound units are to be regardedas standard. The values given in parentheses are mathematicalconversions to SI units that are provided for information onlyand are not considered standard
4、.2. Referenced Documents2.1 ASTM Standards:2A 751 Test Methods, Practices, and Terminology forChemical Analysis of Steel ProductsE8 Test Methods for Tension Testing of Metallic MaterialsE10 Test Method for Brinell Hardness of Metallic Materi-alsE18 Test Methods for Rockwell Hardness of MetallicMater
5、ialsE29 Practice for Using Significant Digits in 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 RelationshipAmong Brinell Hardness, Vickers
6、 Hardness, RockwellHardness, Superficial Hardness, Knoop Hardness, andScleroscope HardnessE 165 Test Method for Liquid Penetrant ExaminationE 354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron,Nickel, and Cobalt AlloysF 562 Specification for Wrou
7、ght 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F 601 Practice for Fluorescent Penetrant Inspection of Me-tallic Surgical ImplantsF 688 Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foilfor Surgical Implants
8、 (UNS R30035)F 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone2.2 ISO Standards:3ISO 5832-6 Implants for SurgeryMetallic MaterialsPart6: Wrought Cobalt-Nickel-Chromium-Molybdenum AlloyISO 9001 Quality Managemen
9、t SystemsRequirements2.3 American Society for Quality Control Standard:4ASQ C1 Specification of General Requirements for a Qual-ity Program3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 lot, nthe total number of forgings produced from thesame heat under the same conditions at
10、 essentially the sametime.4. Ordering Information4.1 Inquiries and orders for forgings under this specificationshall include the following information:4.1.1 Quantity,4.1.2 ASTM designation and date of issue,4.1.3 Mechanical properties (if applicable, for special con-ditions),4.1.4 Form,4.1.5 Applica
11、ble dimensions, including size, thickness,width, and length (exact, random, or multiples), or drawingnumber,4.1.6 Condition,4.1.7 Finish,4.1.8 Special tests (if any), and4.1.9 Other requirements.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and
12、Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical MaterialsCurrent edition approved Aug. 1, 2008. Published September 2008. Originallyapproved in 1985. Last previous edition approved in 2003 as F 961 03.2For referenced ASTM standards, visit the ASTM website, www.astm.or
13、g, 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:/www.ansi.org.4
14、Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.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. Mat
15、erials and Manufacture5.1 Material for forgings shall be bars or wire fabricated inaccordance with Specification F 562 or Specification F 688.The material shall be generally in the solution-annealed con-dition with a finish suitable for forging.5.2 The material shall be forged by hammering, pressing
16、,extruding, or upsetting and shall be processed, if practicable, soas to cause metal flow during the hot working operation 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,
17、cracks, inequali-ties, flaws, and other imperfections not consistent with goodcommercial practice. (See Note 1.) Offset or mismatch allow-ance, dependent upon part size and configuration, shall bewithin standard forging tolerances.NOTE 1Compliance to these requirements may be verified by TestMethod
18、E 165 or Practice F 601 or other suitable method.5.4 After all hot-working operations have been completed,the forgings shall receive an annealing treatment consisting ofheating the parts to an appropriate elevated temperature for aspecified dwell time followed by appropriate cooling to meetthe appli
19、cable metallurgical requirements specified herein.5.5 Optional identification marks, including the manufactur-ers logo, material designation, heat code number, and impres-sion number, may be placed upon each forging, the method andlocation of which shall be as specified by the purchaser.6. Chemical
20、Requirements6.1 When specified by the purchaser, the chemical compo-sition of either the forging bars or the completed forgings shallbe determined and confirmed by the forger, and shall meet theproduct analysis limits of the appropriate material specifica-tion.6.2 For referee purposes, Test Methods
21、E 354 and A 751shall be used.7. Mechanical Requirements7.1 Tensile Properties:7.1.1 The mechanical properties of forgings shall be testedby the forger and shall comply with the minimum mechanicalproperties as specified in Specification F 562.7.1.2 Test specimens shall be taken from a representativef
22、orging 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 forgings it represents.7.1.3 Specimens for tension tests shall be machined andtes
23、ted in accordance with Test Methods E8.7.2 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 fai
24、led testpiece. The 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 minimum
25、requirements specified. Refer to sections 7.11.4 and 7.12.5 ofTest Methods E8.7.2.3 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 Hardness:7.3.1 Hardne
26、ss values shall be determined in accordancewith Test Methods E10or Test Methods E18.7.3.2 When desired, hardness limits may be specified on thepurchase order or drawing and shall be determined in accor-dance with Test Methods E10or E18.NOTE 2When desired, Brinell hardness may be taken as described i
27、nTest Method E10or Vickers hardness may be taken as described in TestMethod E92 and converted to Rockwell hardness in accordance withHardness Conversion Tables E 140.8. Special Tests8.1 The grain size shall be agreed upon between thepurchaser and the supplier and shall be tested in accordancewith Te
28、st Methods E112.8.2 Any other special requirements shall be specified by thepurchaser.9. Significance of Numerical Limits9.1 The following applies to all specified numerical limits inthis specification. To determine conformance to these limits, anobserved or calculated value shall be rounded to the
29、nearestunit in the last right hand digit used in expressing thespecification limit, in accordance with the rounding method ofPractice E29.10. Certification10.1 The supplier shall provide a certification that thematerial was tested in accordance with this specification andmet all requirements. A repo
30、rt of the test results shall befurnished to the purchaser at the time of shipment.11. Quality Program Requirements11.1 The supplier shall maintain a quality program such asthat which is defined in Specification ASQ C1 or ISO 9001.12. Keywords12.1 cobalt alloys (for surgical implants); cobalt-nickel-
31、chromium-molybdenum alloys; forgings; surgical implants;metals (for surgical implants)F961082APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterize thechemical, mechanical, and metallurgical properties of35cobalt-35nickel-20chromium-10molybdenum al
32、loy forgingsfor surgical implants.X1.2 ISO standards are listed for reference only. Althoughthe ISO 5832-6 listed in Section 2 is similar to the correspond-ing ASTM standard, they are not identical. Use of the ISOstandard, in addition to or instead of the preferred ASTMstandard may be agreed upon be
33、tween the purchaser andsupplier.X2. BIOCOMPATIBILITYX2.1 The alloy composition covered by this specificationhas been employed succesfully in human implant applications(1-6)5in contact with soft tissue and bone for over a decade.Due to the well-characterized level of biological responseexhibited by t
34、his alloy, it has been used as a control material inPractice F 981.X2.2 No known surgical implant material has ever beenshown to be completely free of adverse reactions in the humanbody. Long-term clinical experience of the use of the materialreferred to in this specification, however, has shown ana
35、cceptable level of biological response can be expected, if thematerial is used in appropriate applications.REFERENCES(1) Willert, H. G., Buchhorn, U., Zichner, L., “Clinical Experience withMueller Total Hip Endoprostheses of Different Design and Material,”Archives of Orthopaedic and Traumatic Surger
36、y, 97, 1980, pp.197205.(2) Gaechter, A., Galante, G., “MP35N, A Corrosion Resistant High-Strength Alloy for Orthopaedic or Surgical Implants: Two YearBioassay,” Journal of Biomedical Materials Research, Vol 10, 1976,pp. 829831.(3) Escales, F., Galante, J., Rostoker, W., Coogan, P. S., “MP35N, ACorro
37、sion Resistant High-Strength Alloy for Orthopaedic SurgicalImplants: Bioassay Results,” Journal of Biomedical Materials Re-search, Vol 9, No. 3, 1976, pp. 303313.(4) Kuehne, D., Willert, H. G., “The Tissue Compatibility of the ForgingAlloy (Protasul 10) with the Hitherto Used Implant Alloys (Co-Cr-M
38、oCasting Alloy) and (AISI 316L) After an Implantation Period of OneYear,” Doctoral Thesis, Osteological Research Laboratory of Ortho-paedic University, Frankfurt am Main/Frg, 1975.(5) Bauman, R., Semlitsch, M., “Biological and Mechanical Behavior orNewly Developed Implant Materials in Animal Studies
39、,” Sulzerreprint, Re/28.09.00, 1974, pp. 19.(6) ISO/TC-150/SC-1/WG-1, Swiss Standard Association, Group129Surgical Implants, Draft Report of WG-1, Swiss Proposal056509, Part 2, Comments on Biocompatibility, Davos Meeting, June1974.SUMMARY OF CHANGESCommittee F04 has identified the location of select
40、ed changes to this standard since the last issue (F 961 03)that may impact the use of this standard. (Approved Aug. 1, 2008.)(1) Editorial corrections have been made in order to meetterminology and formatting guidelines established for implantmaterial standards.(2) Section 3, Terminology, was added.
41、(3) Subsection 7.2, Number of Tests, was added.(4) Section 9, Significance of Numerical Limits, was added.5The boldface numbers in parentheses refer to the list of references at the end ofthis standard.F961083ASTM International takes no position respecting the validity of any patent rights asserted
42、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 responsibility.This standard is subject to revision at any time by the
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44、reful 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 address shown below.This standard is copyrighted by ASTM Internatio
45、nal, 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).F961084
