ASTM F961-2003 Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]《外科植入物用钴镍铬钼合金锻件标准规范》.pdf

1、Designation: F 961 03Standard 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 (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers the requirements for 35cobalt-35nickel-20chromium-10molybdenum al

3、loy (UNS R30035)forgings for surgical implants.1.2 The values stated in inch-pound units are to be regardedas the standard. The SI equivalents in parentheses are forinformation only.2. Referenced Documents2.1 ASTM Standards:A 751 Test Methods, Practices, and Terminology forChemical Analysis of Steel

4、 Products2E 8 Test Methods for Tension Testing of Metallic Materials3E 10 Test Method for Brinell Hardness of Metallic Materi-als3E 18 Test Methods for Rockwell Hardness and RockwellSuperficial Hardness of Metallic Materials3E 92 Test Method for Vickers Hardness of Metallic Mate-rials3E 112 Test Met

5、hods for Determining Average Grain Size3E 140 Hardness Conversion Tables for Metals RelationshipAmong Brinell Hardness, Vickers Hardness, RockwellHardness, Superficial Hardness, Knoop Hardness, andScleroscope Hardness3F 562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy fo

6、r Surgical ImplantApplications (UNS R30035)4F 601 Practice for Fluorescent Penetrant Inspection of Me-tallic Surgical Implants4F 688 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foilfor Surgical Implants (UNS R30035)4F 981 Practice for Assessment of Com

7、patibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone42.2 ISO Standard:ISO 5832-6 Implants for SurgeryMetallic MaterialsPart6: Wrought Cobalt-Nickel-Chromium-Molybdenum Al-loy52.3 American Society for Quality Control Standard:ASQ C1 Specification of

8、General Requirements for a Qual-ity Program63. Ordering Information3.1 Inquiries and orders for material under this specificationshall include the following information:3.1.1 Quantity (weight or number of pieces),3.1.2 ASTM designation and date of issue,3.1.3 Mechanical properties (if applicable, fo

9、r other require-ments),3.1.4 Form,3.1.5 Applicable dimensions, including size, thickness,width, and length (exact, random, multiples), or drawingnumber,3.1.6 Condition,3.1.7 Finish,3.1.8 Special tests (if any), and3.1.9 Other requirements.4. Materials and Manufacture4.1 Material for forgings shall b

10、e bars, plate, sheet, or wiremanufactured in accordance with Specification F 562 or Speci-fication F 688. The material shall be generally in the solution-annealed condition with a finish suitable for forging.4.2 The material shall be forged by hammering, pressing,rolling, extruding, or upsetting and

11、 shall be processed, ifpracticable, so as to cause metal flow to be in the mostfavorable direction for resisting stresses encountered in ser-vice, as may be indicated to the supplier by the purchaser.4.3 Forgings shall be free of splits, scale, cracks, inequali-ties, flaws, and other imperfections n

12、ot consistent with goodcommercial practice.NOTE 1Compliance to these requirements may be verified by Practice1This 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 Materi

13、alsCurrent edition approved Feb. 10, 2003. Published March 2003. Originallyapproved in 1985. Last previous edition approved in 1996 as F 961 96.2Annual Book of ASTM Standards, Vol 01.03.3Annual Book of ASTM Standards, Vol 03.01.4Annual Book of ASTM Standards, Vol 13.01.5Available from American Natio

14、nal Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.6Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.F 601 or othe

15、r suitable method.4.4 When specified by the purchaser, a thermal treatmentshall be performed, as specified, after all forging operations areperformed.4.5 Optional identification marks, including the purchaserslogo, material designation, heat code number, and impressionnumber, may be placed upon each

16、 forging. The method andlocation of identification shall be as specified by the purchaser.5. Chemical Composition5.1 The heat analysis shall conform to the chemical com-position requirements prescribed in Specification F 562, Table1.5.2 The chemical composition of samples taken for productanalysis s

17、hall conform to Specification F 562, Table 2.5.3 Methods and practices relating to chemical analysisrequired by this specification shall be in accordance with TestMethods A 751.6. Mechanical Requirements6.1 The mechanical properties of as-forged or annealedforgings shall meet the minimum mechanical

18、properties asspecified in Specification F 562.6.2 Test specimens shall be taken from a representativeforging, if possible, or from a representative forged test bar,only if the configuration does not lend itself to yielding therequired specimen. Any special forged test bar must beannealed with the fo

19、rging it represents.6.3 When desired, Rockwell hardness may be specified onthe purchasers purchase order or engineering drawing. Rock-well hardness shall be determined in accordance with TestMethods E 18.NOTE 2When desired, Brinell hardness may be taken as described inTest Method E 10 or Vickers har

20、dness may be taken as described in TestMethod E 92 and converted to Rockwell hardness in accordance withHardness Conversion Tables E 140.6.4 Specimens for tension tests shall be machined and testedin accordance with Test Method E 8. Tensile properties shall bedetermined using a strain rate of 0.003

21、to 0.007 in./in./min(mm/mm/min) through the yield strength, and then the cross-head speed may be increased so as to produce fracture inapproximately one additional minute.7. Special Tests7.1 The grain size shall be agreed upon between thepurchaser and the supplier and shall be tested in accordancewi

22、th Test Methods E 112.7.2 Other special requirements shall be as specified on thepurchase order or engineering drawing.8. Certification8.1 Certification shall be provided by the supplier reportingthat the forgings meet the requirements of the purchaser. Areport of the test results shall be furnished

23、 at the time of eachshipment.9. Quality Program Requirements9.1 The supplier shall maintain a quality program, such asthat defined in Specification ASQ C1.10. Keywords10.1 cobalt alloys (for surgical implants); cobalt-nickel-chromium-molybdenum alloys; forgings; surgical implants;metals (for surgica

24、l implants)APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterizecomposition and properties to ensure consistency in 35cobalt-35nickel-20chromium-10molybdenum alloy forgings used inthe manufacturing of medical devices.X1.2 ISO standards are listed

25、for reference only. Use of anISO standard in addition to or instead of a preferred ASTMstandard may be negotiated between purchaser and supplier.X2. BIOCOMPATIBILITYX2.1 The alloy composition covered by this specificationhas been employed succesfully in human implant applications(1-6)7in contact wit

26、h soft tissue and bone since 1974. Due tothe well-characterized level of biological response exhibited bythis alloy, it has been used as a control material in PracticeF 981.X2.2 No known surgical implant material has ever beenshown to be completely free of adverse reactions in the humanbody. However

27、, long-term clinical experience has shown anacceptable level of biological response can be expected, if thematerial is used in appropriate applications.7The boldface numbers in parentheses refer to the list of references at the end ofthis standard.F961032REFERENCES(1) Willert, H. G., Buchhorn, U., Z

28、ichner, L., “Clinical Experience withMueller Total Hip Endoprostheses of Different Design and Material,”Archives of 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 YearBi

29、oassay,” Journal of Biomedical Materials Research, Vol 10, 1976,pp. 829831.(3) Escales, F., Galante, J., Rostoker, W., Coogan, P. S., “MP35N, ACorrosion Resistant High-Strength Alloy for Orthopaedic SurgicalImplants: Bioassay Results,” Journal of Biomedical Materials Re-search, Vol 9, No. 3, 1976, p

30、p. 303313.(4) Kuehne, D., Willert, H. G., “The Tissue Compatibility of the ForgingAlloy (Protasul 10) with the Hitherto Used Implant Alloys (Co-Cr-MoCasting Alloy) and (AISI 316L) After an Implantation Period of OneYear,” Doctoral Thesis, Osteological Research Laboratory of Ortho-paedic University,

31、Frankfurt am Main/Frg, 1975.(5) Bauman, R., Semlitsch, M., “Biological and Mechanical Behavior orNewly Developed Implant Materials in Animal Studies,” 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

32、 Proposal056509, Part 2, Comments on Biocompatibility, Davos Meeting, June1974.SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue (F 961 96)that may impact the use of this standard.(1) The title has been changed to “35Cobalt-35Nickel

33、-20Chromium-10Molybdenum Alloy Forgings for Surgical Im-plants (UNS R30035).”(2) The former Section 3, Terminology, was deleted in itsentirety.(3) The former paragraph 5.6 was deleted as being redundant.(4) Note 2 in Section 6, Mechanical Requirements, waschanged to include Vickers hardness determin

34、ations accordingto Test Method E 92.(5) The former paragraph 9.2 was deleted.(6) Five footnotes found in Specifications F 562 and F 688were added to the References section.(7) ISO 58326 was added to Section 2, Referenced Docu-ments.(8) Paragraph X1.2 was added to the Rationale.(9) Several editorial

35、changes were made to update the text tocurrent form and style.ASTM 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

36、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

37、either for revision of this standard 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 fa

38、ir hearing you shouldmake your 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).F961033