ASTM F1586-2002 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium&8212 10 Nickel&8212 3 Manganese&8212 2 5 Molybdenum Stainless Steel Bar for Surgical Implants (.pdf

1、Designation: F 1586 02Standard Specification forWrought Nitrogen Strengthened 21 Chromium10 Nickel3 Manganese2.5 Molybdenum Stainless Steel Alloy Bar forSurgical Implants (UNS S31675)1This standard is issued under the fixed designation F 1586; the number immediately following the designation indicat

2、es the year oforiginal adoption 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. Scope1.1 This specification covers the chemical, mech

3、anical, andmetallurgical requirements for wrought nitrogen strengthened21 chromium10 nickel3 manganese2.5 molybdenumstainless steel alloy bar for surgical implants.1.2 The values stated in inch-pound units are to be regardedas the standard. The SI equivalents of the inch-pound units maybe approximat

4、e.2. Referenced Documents2.1 ASTM Standards:A 262 Practices for Detecting Susceptibility to Intergranu-lar Attack in Austenitic Stainless Steels2A 484 Specification for General Requirements for StainlessSteel Bars, Billets, and Forgings3A 751 Test Methods, Practices, and Terminology forChemical Anal

5、ysis of Steel Products2E 8 Test Methods for Tension Testing of Metallic Materials4E 10 Test Method for Brinell Hardness of Metallic Materi-als4E 18 Test Methods for Rockwell Hardness and RockwellSuperficial Hardness of Metallic Materials4E 45 Test Method for Determining the Inclusion Content ofSteel

6、4E 112 Test Methods for Determining Average Grain Size4E 354 Test Methods for Chemical Analysis of HighTem-perature, Electrical, Magnetic, and Other Similar Iron,Nickel, and Cobalt Alloys5F 138 Specification for Wrought 18 Chromium14Nickel2.5 Molybdenum Stainless Steel Bar and Wire forSurgical Impla

7、nts (UNS 31673)6F 746 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant Materials62.2 Aerospace Material Specifications:AMS 2248 Chemical Check Analysis Limits, Corrosion andHeat Resistant Steels and Alloys, Maraging and OtherHighly-Alloyed Steels, and Iron Alloys72.3 ASQC Sta

8、ndard:ASQ C1 Specification of General Requirements for a Qual-ity Program82.4 ISO Standard:ISO 6892 Metallic Materials Tensile Testing at AmbientTemperature93. General Requirements for Delivery3.1 In addition to the requirements of this specification, allrequirements of the current edition of Specif

9、ication A 484 shallapply.3.2 In cases in which a conflict exists between this specifi-cation and the standards listed in Section 2, this specificationshall take precedence.4. Ordering Information4.1 Inquiries and orders for material under this specificationshall include the following information:4.1

10、.1 Quantity,4.1.2 ASTM desgination and date of issue,4.1.3 Mechanical properties (if applicable, for special con-ditions),4.1.4 Form,4.1.5 Applicable dimensions including size, thickness,width, and length (exact, random, or multiples) or drawingnumber,4.1.6 Condition (see 5.1),4.1.7 Finish (see 5.2)

11、,4.1.8 Special tests (if applicable), and4.1.9 Other requirements.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devicesis under the direct responsibility ofSubcommittee F04.12on Metallurgical Materials.Current edition approved Jan. 10, 2002.

12、 Published February 2002. Originallypublished as F 1586 95. Last previous edition F 1586 95.2Annual Book of ASTM Standards, Vol 01.03.3Annual Book of ASTM Standards, Vol 01.05.4Annual Book of ASTM Standards, Vol 03.01.5Annual Book of ASTM Standards, Vol 03.05.6Annual Book of ASTM Standards, Vol 13.0

13、1.7Available from Society of Automotive Engineers, Inc., 400 Commonwealth Dr.,Warrendale, PA 15096-0001.8Available from American Society for Quality, 600 N. Plankinton Ave.,Milwaukee, WI 53203.9Available from American National Standards Institute, 25 W. 43rd St., 4thFloor, New York, NY 10036.1Copyri

14、ght ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.5. Materials and Manufacture5.1 ConditionBars shall be furnished in the annealed,medium hard, or hard condition, as specified.5.2 FinishTypes of bar finishes available are cold-drawn,pickled,

15、ground, ground and polished, or as specified by thepurchaser.6. Chemical Requirements6.1 The suppliers heat analysis shall conform to the chemi-cal requirements prescribed in Table 1. The supplier shall notship material that is outside the limits specified in Table 1.6.1.1 Requirements for the major

16、 and minor elementalconstituents are listed in Table 1. Also listed are importantresidual elements. Analysis for elements not listed in Table 1 isnot required to verify compliance with this specification.6.1.2 Methods and practices relating to chemical analysisrequired by this specification shall be

17、 in accordance with TestMethods, Practices, and Terminology A 751.6.2 Product AnalysisThe product analysis is either for thepurpose of verifying the composition of a heat or lot or todetermine variations in the composition within the heat.6.2.1 Acceptance or rejection of a heat or lot of materialmay

18、 be made by the purchaser on the basis of this productanalysis.6.2.2 Product analysis tolerances do not broaden the speci-fied heat analysis requirements but cover variations betweenlaboratories in the measurement of chemical content. Productanalysis limits shall be as specified in Table 2.7. Metall

19、urgical Requirements7.1 The material shall exhibit no free delta ferrite when it isexamined metallographically at 1003 magnification.7.2 The microcleanliness of the material , as determined byTest Method E 45, Method A, except using Plate Ir, onrepresentative billet or bar samples from the heat shal

20、l notexceed the following:Inclusion A B C DType (Sulfide) (Alumina) (Silicate) (GlobularOxide)Thin 1.5 2.0 2.0 2.5Heavy 1.5 1.5 1.5 1.58. Mechanical Requirements8.1 Tensile Properties:8.1.1 Tensile properties shall be determined in accordancewith Test Methods E 8.8.1.2 The mechanical properties of t

21、est specimens shallconform to the requirements specified in Table 3.8.2 Hardness:8.2.1 When desired, hardness limits may be specified by thepurchaser. Hardness determinations shall be made on a productcross section, midway between the center and surface, if crosssection is adequate.8.2.2 Hardness va

22、lues shall be determined in accordancewith Test Method E 10 or Test Methods E 18.9. Special Tests9.1 Material conforming to this specification shall be ca-pable of passing the intergranular corrosion susceptibility testin accordance with Practice E of Practices A 262. The test shallbe performed on a

23、 sample sensitized at 1250F for 1 h.9.2 Material conforming to this specification shall have ahomogeneous microstructure with an average grain size ofASTM No. 5 or finer when measured in accordance with TestMethods E 112.9.2.1 It is preferred that samples for grain size determinationbe selected afte

24、r the hot-working operation or after the finalannealing operation before the final cold-working operation.TABLE 1 Chemical CompositionElement Composition, % (Mass/Mass)Carbon 0.08 maxManganese 2.00 to 4.25Phosphorus 0.025 maxSulfur 0.01 maxSilicon 0.75 maxChromium 19.5 to 22.0Nickel 9.0 to 11.0Molyb

25、denum 2.0 to 3.0Nitrogen 0.25 to 0.50Niobium 0.25 to 0.80Copper 0.25 maxIron balanceAAApproximately equal to the difference between 100 % and the sum percent ofthe other specified elements. The percent of iron difference is not required to bereported.TABLE 2 Product Analysis TolerancesA,BElementPerm

26、issible Variation Under the Minimum Limitor Over the Maximum Limit, % (Mass/Mass)CCarbon 0.01Manganese 0.05Phosphorus 0.005Sulfur 0.005Silicon 0.05Chromium 0.25Nickel 0.15Molybdenum 0.10NitrogenD0.02 under minimum;0.04 over maximumNiobium 0.05Copper 0.03ASee Test Methods E 354.BRefer to AMS 2248 for

27、 chemical check analysis limits (except nitrogen).CFor elements in which only a maximum percentage is indicated, the “underminimum limit” is not applicable.DThe specified range for this element is not covered by AMS 2248 andpermissible variation has been established through industrial practice.TABLE

28、 3 Mechanical Requirements of BarsConditionDiameter orThickness, in.(mm)Ultimate TensileStrength, min, psi(MPa)Yield Strength(0.2 % Offset),min, psi (MPa)Elonga-tionAin4D, min,%Annealed all 107 000 (740) 62 400 (430) 35MediumhardB116 to34(1.59 to 19.1)C145 000 (1000) 102 000 (700) 20HardB 116to34(1.

29、59 to 19.1)C160 000 (1100) 145 000 (1000) 10AElongation of material 0.062 in. (1.575 mm) or greater in diameter (D)orthickness shall be measured using a gage length of 2 in. or 4D or 4W (W = width).The gage length must be reported with the test results. The method for determiningelongation of materi

30、al under 0.062 in. (1.575 mm) in diameter or width may benegotiated. Alternately, a gage length corresponding to ISO 6892 may be usedwhen agreed upon between supplier and purchaser.BThe word “hard” is used to express strength relative to annealed material andis not intended to specify a hardness val

31、ue.COther sizes may be furnished by agreement between the supplier and thepurchaser.F 158629.2.2 If grain size samples are selected after a final coldworking, specimens shall be tested according to Test MethodsE 112 or as agreed upon between supplier and purchaser.9.3 Any other special requirements

32、shall be specified by thepurchaser.10. Certification10.1 Certification shall be provided by the supplier that thematerial meets the requirements of this specification. A reportof the test results shall be furnished at the time of shipment.11. Quality Program Requirements11.1 The bar and wire produce

33、r and any processors shallmaintain a quality program such as that which is defined inASQ C1.12. Keywords12.1 manganese; metals (for surgical implants); nitrogenstrengthened; stainles steel; surgical applications; 734 alloyAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this spec

34、ification is to characterize thecomposition and properties of wrought nitrogen strengthened21 chromium10 nickel3 manganese2.5 molybdenumstainless steel alloy bar for surgical implants.X1.2 Acceptable metal conditions supplied to the implantmanufacturer include annealed, medium hard, and hard condi-t

35、ions, the choice dependent upon the implant design andapplication.X1.3 This alloy is capable of being cold worked to tensilestrengths exceeding 200 000 psi (1380 MPa) for high strengthsurgical implant applications.X1.4 The nitrogen used for strengthening this steel canresult in the formation of carb

36、onitrides. Carbonitrides can berevealed by etching electrolytically in a solution of potassiumhydroxide (56 g of K(OH) in 100 mL of water for3sat2V).These small, dispersed second-phase particles exert a strength-ening effect but do not significantly alter the corrosion prop-erties of the alloy. They

37、 may affect the finish of electropolishedsurfaces.X1.5 ISO standards are listed for reference only. AlthoughISO standards are similar to the corresponding ASTM Interna-tional standards, they are not identical. Use of an ISO standardin addition to or instead of a preferred ASTM Internationalstandard

38、may be negotiated between purchaser and supplier.X2. BIOCOMPATIBILITY10X2.1 The alloy composition covered by this specificationhas been used successfully in human implant applications incontact with soft tissue and bone for over a decade.X2.2 The material has been shown to produce an accept-able lev

39、el of local biological response that is similar toSpecification F 138 reference material.X2.3 This alloy has been tested in accordance with TestMethod F 746 and exhibits a pitting potential greater thanSpecification F 138 reference material.X2.4 No known surgical implant material has ever beenshown

40、to be completely free of adverse reactions in the humanbody. The material referred to in this specification has shownthat an acceptable level of biological response can be expected,if the material is used in appropriate applications.ASTM International takes no position respecting the validity of any

41、 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 infringement of such rights, are entirely their own responsibility.This standard is subject to revi

42、sion 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

43、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 views known to the ASTM Committee on Standards, at the address shown below.This standard is copyri

44、ghted 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).10Supporting data available from ASTM Headquarters. Request RR: F04-1007.F 15863