1、Designation: F961 08F961 14Standard Specification for35Cobalt-35Nickel-20Chromium-10Molybdenum AlloyForgings for Surgical Implants (UNS R30035)1This standard is issued under the fixed designation F961; the number immediately following the designation indicates the year of originaladoption or, in the
2、 case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification covers the requirements for 35cobalt-35nickel-20chromium-10molybdenum a
3、lloy (UNS R30035) in theform of forgings, used for the manufacture of surgical implants.1.2 UnitsThe values stated in either SI units or inch-pound units are to be regarded separately as standard. The values givenin parentheses are mathematical conversions to SI units that are provided for informati
4、on only and are not considered stated in eachsystem may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from thetwo systems may result in nonconformance with the standard.2. Referenced Documents2.1 ASTM Standards:2A751 Test Methods, Practic
5、es, and Terminology for Chemical Analysis of Steel ProductsE8E8/E8M Test Methods for Tension Testing of Metallic MaterialsE10 Test Method for Brinell Hardness of Metallic MaterialsE18 Test Methods for Rockwell Hardness of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data to De
6、termine Conformance with SpecificationsE92 Test Method for Vickers Hardness of Metallic Materials (Withdrawn 2010)3E112 Test Methods for Determining Average Grain SizeE140 Hardness Conversion Tables for Metals Relationship Among Brinell Hardness, Vickers Hardness, Rockwell Hardness,Superficial Hardn
7、ess, Knoop Hardness, Scleroscope Hardness, and Leeb HardnessE165 Practice for Liquid Penetrant Examination for General IndustryE354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, andCobalt AlloysF562 Specification for Wrought 35Cobalt-35
8、Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications(UNS R30035)F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical ImplantsF688 Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for SurgicalImplants (UNS R30035)F981
9、Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials onMuscle and BoneIEEE/ASTM SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric System2.2 ISO Standards:4ISO 5832-6 Implants for Surgery
10、Metallic MaterialsPart 6: Wrought Cobalt-Nickel-Chromium-Molybdenum AlloyISO 9001 Quality Management SystemsRequirements2.3 American Society for Quality Control Standard:5ASQ C1 Specification of General Requirements for a Quality Program1 This specification is under the jurisdiction of ASTM Committe
11、e F04 on Medical and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical MaterialsCurrent edition approved Aug. 1, 2008Oct. 1, 2014. Published September 2008November 2014. Originally approved in 1985. Last previous edition approved in 20032008as F96
12、1 03.F961 08. DOI: 10.1520/F0961-08.10.1520/F0961-14.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 The la
13、st approved version of this historical standard is referenced on www.astm.org.4 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.5 Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53
14、203, http:/www.asq.org.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that
15、users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Con
16、shohocken, PA 19428-2959. United States13. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 lot, nthe total number of forgings produced from the same heat under the same conditions at essentially the same time.4. Ordering Information4.1 Inquiries and orders for forgings under this
17、 specification shall 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 conditions),4.1.4 Form,4.1.5 Applicable dimensions, including size, thickness, width, and length (exact, random, or multiples), or dr
18、awing number,4.1.6 Condition,4.1.7 Finish,4.1.8 Special tests (if any), and4.1.9 Other requirements.5. Materials and Manufacture5.1 Material for forgings shall be bars or wire fabricated in accordance with Specification F562 or Specification F688. Thematerial shall be generally in the solution-annea
19、led condition with a finish suitable for forging.5.2 The material shall be forged by hammering, pressing, extruding, or upsetting and shall be processed, if practicable, so asto cause metal flow during the hot working operation in the direction most favorable for resisting stresses encountered in se
20、rvice,as may be indicated to the fabricator by the purchaser.5.3 Forgings shall be free of splits, scale, cracks, inequalities, flaws, and other imperfections not consistent with goodcommercial practice. (See Note 1.) Offset or mismatch allowance, dependent upon part size and configuration, shall be
21、 withinstandard forging tolerances.NOTE 1Compliance to these requirements may be verified by Test Method E165 or Practice F601 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 app
22、ropriate elevated temperature for a specified dwell time followed by appropriate cooling to meet theapplicable metallurgical requirements specified herein.5.5 Optional identification marks, including the manufacturers logo, material designation, heat code number, and impressionnumber, may be placed
23、upon each forging, the method and location of which shall be as specified by the purchaser.6. Chemical Requirements6.1 When specified by the purchaser, the chemical composition of either the forging bars or the completed forgings shall bedetermined and confirmed by the forger, and shall meet the pro
24、duct analysis limits of the appropriate material specification.6.2 For referee purposes, Test Methods E354 and A751 shall be used.7. Mechanical Requirements7.1 Tensile Properties:7.1.1 The mechanical properties of forgings shall be tested by the forger and shall comply with the minimum mechanicalpro
25、perties as specified in Specification F562.7.1.2 Test specimens shall be taken from a representative forging if possible, or from a representative forged test bar. Arepresentative test bar may only be used if the configuration is such that a test bar cannot be obtained. Any specially forged testbar
26、must be annealed with forgings it represents.7.1.3 Specimens for tension tests shall be machined and tested in accordance with Test Methods E8/E8ME87.2 Number of Tests:7.2.1 Perform at least one tension test from each lot in the longitudinal direction. Should this test result not meet the specifiedr
27、equirements, test two additional test pieces representative of the same lot, in the same manner, for each failed test piece. The lotshall be considered in compliance only if both additional test pieces meet the specified requirements.7.2.2 Tensile tests results for which any specimen fractures outsi
28、de the gage length shall be considered acceptable, if both theelongation and reduction of area meet the minimum requirements specified. Refer to sections 7.11.4 and 7.12.5 of Test MethodsE8E8/E8M.7.2.3 If either the elongation or reduction of area is less than the minimum requirement, discard the te
29、st and retest. Retest onespecimen for each specimen that did not meet the minimum requirements.7.3 Hardness:F961 1427.3.1 Hardness values shall be determined in accordance with Test Methods E10 or Test Methods E18.7.3.2 When desired, hardness limits may be specified on the purchase order or drawing
30、and shall be determined in accordancewith Test Methods E10 or E18.NOTE 2When desired, Brinell hardness may be taken as described in Test Method E10 or Vickers hardness may be taken as described in Test MethodE92 and converted to Rockwell hardness in accordance with Hardness Conversion Tables E140.8.
31、 Special Tests8.1 The grain size shall be agreed upon between the purchaser and the supplier and shall be tested in accordance with TestMethods E112.8.2 Any other special requirements shall be specified by the purchaser.9. Dimensions and Permissible Variations9.1 Units of Measure:9.1.1 SelectionThis
32、 specification requires that the purchaser selects the units (SI or inch-pound) to be used for productcertification. In the absence of a stated selection of units on the purchase order, this selection may be expressed by the purchaserin several alternate forms listed in order of precedence.9.1.1.1 I
33、f the purchaser and supplier have a history of using specific 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 units used to define the product on the purchasers purchase order (PO),specification, and engi
34、neering drawing are consistent, these units shall be used by the supplier for product certification.9.1.1.3 If the purchasers selection of units is unclear, the units of measure shall be agreed upon between the purchaser andsupplier.9.2 Conversion of UnitsIf the suppliers test equipment does not rep
35、ort in the selected units, the test equipment units may beconverted to the selected units for certification purposes.Accurate arithmetic conversion and proper use of significant digits shouldbe observed when performing this conversion. IEEE/ASTM SI 10 provides guidelines for the use of SI units. Ann
36、ex A ofIEEE/ASTM SI 10 provides conversion tables and Annex B of IEEE/ASTM SI 10 provides rules for conversion and significance.10. Significance of Numerical Limits10.1 The following applies to all specified numerical limits in this specification. To determine conformance to these limits, anobserved
37、 or calculated value shall be rounded to the nearest unit in the last right hand digit used in expressing the specificationlimit, in accordance with the rounding method of Practice E29.11. Certification11.1 The supplier shall provide a certification that the material was tested in accordance with th
38、is specification and met allrequirements. A report of the test results shall be furnished to the purchaser at the time of shipment.12. Quality Program Requirements12.1 The supplier shall maintain a quality program such as that which is defined in Specification ASQ C1 or ISO 9001.13. Keywords13.1 cob
39、alt alloys (for surgical implants); cobalt-nickel-chromium-molybdenum alloys; forgings; surgical implants; metals (forsurgical implants)APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterize the chemical, mechanical, and metallurgical properties of
40、 35cobalt-35nickel-20chromium-10molybdenum alloy forgings for surgical implants.X1.2 ISO standards are listed for reference only. Although the ISO 5832-6 listed in Section 2 is similar to the correspondingASTM standard, they are not identical. Use of the ISO standard, in addition to or instead of th
41、e preferred ASTM standard maybe agreed upon between the purchaser and supplier.F961 143X2. BIOCOMPATIBILITYX2.1 The alloy composition covered by this specification has been employed succesfullysuccessfully in human implantapplications (1-6)6 in contact with soft tissue and bone for over a decade. Du
42、e to the well-characterized level of biological responseexhibited by this alloy, it has been used as a control material in Practice F981.X2.2 No known surgical implant material has ever been shown to be completely free of adverse reactions in the human body.Long-term clinical experience of the use o
43、f the material referred to in this specification, however, has shown an acceptable levelof biological response can be expected, if the material is used in appropriate applications.REFERENCES(1) Willert, H. G., Buchhorn, U., Zichner, L., “Clinical Experience with Mueller Total Hip Endoprostheses of D
44、ifferent Design and Material,” Archivesof Orthopaedic and Traumatic Surgery, 97, 1980, pp. 197205.(2) Gaechter, A., Galante, G., “MP35N, A Corrosion Resistant High-Strength Alloy for Orthopaedic or Surgical Implants: Two Year Bioassay,” Journalof Biomedical Materials Research, Vol 10, 1976, pp. 8298
45、31.(3) Escales, F., Galante, J., Rostoker, W., Coogan, P. S., “MP35N, A Corrosion Resistant High-Strength Alloy for Orthopaedic Surgical Implants:Bioassay Results,” Journal of Biomedical Materials Research, Vol 9, No. 3, 1976, pp. 303313.(4) Kuehne, D., Willert, H. G., “The Tissue Compatibility of t
46、he Forging Alloy (Protasul 10) with the Hitherto Used Implant Alloys (Co-Cr-Mo CastingAlloy) and (AISI 316L) After an Implantation Period of One Year,” Doctoral Thesis, Osteological Research Laboratory of Orthopaedic University,Frankfurt am Main/Frg, 1975.(5) Bauman, R., Semlitsch, M., “Biological a
47、nd Mechanical Behavior or Newly Developed Implant Materials in Animal Studies,” Sulzer reprint,Re/28.09.00, 1974, pp. 19.(6) ISO/TC-150/SC-1/WG-1, Swiss Standard Association, Group 129Surgical Implants, Draft Report of WG-1, Swiss Proposal 056509, Part 2,Comments on Biocompatibility, Davos Meeting,
48、June 1974.SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue(F961 03F961 08) that may impact the use of this standard. (Approved Aug. 1, 2008Oct. 1, 2014.)(1) Editorial correctionschanges have been made in order to meet the terminolo
49、gy and formatting guidelines that have beenestablished for implant material standards.specifications.(2) Section 39, Terminology, Dimensions and Permissible Variations, was added.(3) SubsectionLanguage 7.2, Number of Tests, was added.has been added to address the selection of units of measure for materialcertification.(4) Section 9, Significance of Numerical Limits, was added. X1.3 was deleted.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this st
