1、Designation: F 1586 08Standard Specification forWrought Nitrogen Strengthened 21Chromium10Nickel3Manganese2.5Molybdenum Stainless Steel Alloy Bar forSurgical Implants (UNS S31675)1This standard is issued under the fixed designation F 1586; the number immediately following the designation indicates t
2、he 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. Scope*1.1 This specification covers the chemical, mechani
3、cal, andmetallurgical requirements for wrought nitrogen strengthened21chromium10nickel3manganese2.5molybdenumstainless steel alloy bar for surgical implants.1.2 The values stated in inch-pound units are to be regardedas standard. The values given in parentheses are mathematicalconversions to SI unit
4、s that are provided for information onlyand are not considered standard.2. Referenced Documents2.1 ASTM Standards:2A 262 Practices for Detecting Susceptibility to Intergranu-lar Attack in Austenitic Stainless SteelsA 484/A 484M Specification for General Requirements forStainless Steel Bars, Billets,
5、 and ForgingsA 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 MetallicMaterialsE29 Practice for Using Sign
6、ificant Digits in Test Data toDetermine Conformance with SpecificationsE45 Test Methods for Determining the Inclusion Contentof SteelE112 Test Methods for Determining Average Grain SizeF 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants
7、 (UNS S31673)F 746 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant Materials2.2 Aerospace Material Specifications:3AMS 2248 Chemical CheckAnalysis Limits, Corrosion andHeat Resistant Steels and Alloys, Maraging and OtherHighly-Alloyed Steels, and Iron Alloys2.3 ASQC Standard
8、:4ASQ C1 Specification of General Requirements for a Qual-ity Program2.4 ISO Standard:5ISO 6892 Metallic Materials Tensile Testing at AmbientTemperatureISO 9001 Quality Management SystemRequirements3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 lot, nthe total number of mill
9、products producedfrom the same melt heat under the same conditions at essen-tially the same time.4. General Requirements for Delivery4.1 In addition to the requirements of this specification, allrequirements of the current edition of SpecificationA 484 shallapply.4.2 In cases in which a conflict exi
10、sts between this specifi-cation and the standards listed in Section 2, this specificationshall take precedence.5. Ordering Information5.1 Inquiries and orders for material under this specificationshall include the following information:5.1.1 Quantity,5.1.2 ASTM designation and date of issue,5.1.3 Me
11、chanical properties (if applicable, for special con-ditions),1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices is under the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved May 1, 2008. Publ
12、ished May 2008. Originallyapproved in 1995. Last previous edition approved in 2002 as F 1586 02.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Docume
13、nt Summary page onthe ASTM website.3Available from Society of Automotive Engineers (SAE), 400 CommonwealthDr., Warrendale, PA 15096-0001, http:/www.sae.org.4Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.5Available from American Natio
14、nal Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.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.5.1.4 Form,5.1.5 Appli
15、cable dimensions including size, thickness,width, and length (exact, random, or multiples) or drawingnumber,5.1.6 Condition (see 6.1),5.1.7 Finish (see 6.2),5.1.8 Special tests (if any), and5.1.9 Other requirements.6. Materials and Manufacture6.1 ConditionBars shall be furnished in the annealed,medi
16、um hard, or hard condition, as specified.6.2 FinishTypes of bar finishes available are cold-drawn,pickled, ground, ground and polished, or as specified by thepurchaser.7. Chemical Requirements7.1 The suppliers heat analysis shall conform to the chemi-cal requirements prescribed in Table 1. The suppl
17、ier shall notship material that is outside the limits specified in Table 1.7.1.1 Requirements for the major 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 spe
18、cification.7.1.2 Methods and practices relating to chemical analysisrequired by this specification shall be in accordance with TestMethods, Practices, and Terminology A 751.7.2 Product AnalysisThe product analysis is either for thepurpose of verifying the composition of a heat or manufactur-ing lot
19、or to determine variations in the composition within theheat.7.2.1 Acceptance or rejection of a heat or lot of materialmay be made by the purchaser on the basis of this productanalysis.7.2.2 Product analysis tolerances do not broaden the speci-fied heat analysis requirements but cover variations bet
20、weenlaboratories in the measurement of chemical content. Productanalysis limits shall be as specified in Table 2.8. Metallurgical Requirements8.1 The material shall exhibit no delta ferrite, chi, or sigmaphases when it is examined metallographically at 1003 mag-nification.8.2 The microcleanliness of
21、 the steel, as determined by TestMethods E45, Method A, except using Plate Ir, on represen-tative billet or bar samples from the heat shall not exceed thefollowing:Inclusion A B C DType (Sulfide) (Alumina) (Silicate) (GlobularOxide)Thin 1.5 2.0 2.0 2.5Heavy 1.5 1.5 1.5 1.59. Mechanical Requirements9
22、.1 Tensile Properties:9.1.1 Tensile properties shall be determined in accordancewith Test Methods E8.9.1.2 The mechanical properties of test specimens shallconform to the requirements specified in Table 3.9.2 Hardness:9.2.1 Hardness values shall be determined in accordancewith Test Method E10or Test
23、 Methods E18.9.2.2 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 thecross section is adequate.TABLE 1 Chemical RequirementsElement Composition, % (Mass/Mass)Carbon 0.08 maxMan
24、ganese 2.00 to 4.25Phosphorus 0.025 maxSulfur 0.01 maxSilicon 0.75 maxChromium 19.5 to 22.0Nickel 9.0 to 11.0Molybdenum 2.0 to 3.0Nitrogen 0.25 to 0.50Niobium 0.25 to 0.80Copper 0.25 maxIron balanceAAThe percentage of iron is determined by difference and need not bedetermined or certified.TABLE 2 Pr
25、oduct Analysis TolerancesAElementTolerance Under the Minimum or Overthe Maximum LimitBCarbon 0.01Manganese 0.05Phosphorus 0.005Sulfur 0.005Silicon 0.05Chromium 0.25Nickel 0.15Molybdenum 0.10NitrogenC0.02 under minimum;0.04 over maximumNiobium 0.05Copper 0.03ARefer to AMS 2248 for chemical check anal
26、ysis limits (except nitrogen).BFor elements in which only a maximum percentage is indicated, the “underminimum limit” is not applicable.CThe specified range for this element is not covered by AMS 2248 andpermissible variation has been established through industrial practice.TABLE 3 Mechanical Proper
27、tiesConditionDiameter 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 116 to34(1.59 to 19.1)C160 000 (1100) 14
28、5 000 (1000) 10AElongation of material 0.063 in. (1.6 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 material under 0.063 in. (1.6 mm) in
29、diameter or width may benegotiated. Alternatively, a gage length corresponding to ISO 6892 may be usedwhen agreed upon between supplier and purchaser. (5.65 times the square root ofSo, where So is the original cross sectional area.)BThe word “hard” is used to express strength relative to annealed ma
30、terial andis not intended to specify a hardness value.COther sizes may be furnished by agreement between the supplier and thepurchaser.F15860829.3 Number of Tests:9.3.1 Perform at least one tension and one bend tests fromeach lot. Should any of these test pieces not meet the specifiedrequirements, t
31、est two additional test pieces representative ofthe same lot, in the same manner, for each failed test piece. Thelot shall be considered in compliance only if all additional testpieces meet the specified requirements.9.3.2 Tensile test results for which any specimen fracturesoutside the gage length
32、shall be considered acceptable if boththe elongation and reduction of area meet the minimumrequirements specified. Refer to sections 7.11.4 and 7.11.5 ofTest Method E8. If either the elongation or reduction of area isless than the minimum requirement, discard the test and retest.Retest one specimen
33、for each specimen that did not meet theminimum requirements.10. Special Tests10.1 Material conforming to this specification shall becapable of passing the intergranular corrosion susceptibilitytest in accordance with Practice E of Practices A 262.10.2 Material conforming to this specification shall
34、have ahomogeneous microstructure with an average grain size ofASTM No. 5 or finer when measured in accordance with TestMethods E112.10.2.1 If grain size samples are selected after final coldworking operation, specimens shall be tested according to TestMethods E112 or as agreed upon between supplier
35、andpurchaser.10.3 Any other special requirements shall be specified bythe purchaser.11. Significance of Numerical Limits11.1 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
36、nearestunit in the last right hand digit used in expressing thespecification limit, in accordance with the rounding method ofPractice E29.12. Certification12.1 The supplier shall provide a certification that thematerial was tested in accordance with this specification. Areport of the test results sh
37、all be furnished to the purchaser atthe time of shipment.13. Quality Program Requirements13.1 The supplier shall maintain a quality program such asdefined in ASQ C1, ISO 9001, or similar.14. Keywords14.1 manganese; metals (for surgical implants); nitrogenstrengthened; stainless steel; surgical appli
38、cationsAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterize thecomposition and properties of wrought nitrogen strengthened21chromium10nickel3manganese2.5molybdenumstainless steel alloy bar for surgical implants.X1.2 Acceptable metal conditions su
39、pplied to the implantmanufacturer include annealed, medium hard, and hard condi-tions, 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
40、The nitrogen used for strengthening this steel canresult in the formation of carbonitrides. 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 e
41、ffect but do not significantly alter the corrosion prop-erties of the alloy. They 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
42、 ISO standardin addition to or instead of a preferred ASTM Internationalstandard may be negotiated between purchaser and supplier.F1586083X2. BIOCOMPATIBILITY6X2.1 The alloy composition covered by this specificationhas been used successfully in human implant applications incontact with soft tissue a
43、nd bone for over a decade.X2.2 The material has been shown to produce an accept-able level 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 thanSpecificat
44、ion F 138 reference material.X2.4 No known surgical implant material has ever beenshown 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 appr
45、opriate applications.SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue(F 1586 02) that may impact the use of this standard. (Approved May 1, 2008.)(1) No changes have been made in technical requirements, butharmonization of text has
46、 been made based on the F04.12template for stainless steel, dated 5/15/05. No changes aremade to Appendixes.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 t
47、hat 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 reapp
48、roved or withdrawn. Your comments are invited 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
49、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 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).6Supporting data available from ASTM H
