1、Designation: F1586 131Standard Specification forWrought Nitrogen Strengthened 21Chromium10Nickel3Manganese2.5Molybdenum Stainless Steel Alloy Bar forSurgical Implants (UNS S31675)1This standard is issued under the fixed designation F1586; the number immediately following the designation indicates th
2、e 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 () indicates an editorial change since the last revision or reapproval.1NOTEThe designation was editorially corrected in August 2013.
3、1. Scope*1.1 This specification covers the chemical, mechanical, andmetallurgical requirements for wrought nitrogen strengthened21chromium10nickel3manganese2.5molybdenumstainless steel alloy bar for surgical implants.1.2 The values stated in either inch-pound units or SI unitsare to be regarded sepa
4、rately as standard. The values stated ineach system may not be exact equivalents; therefore, eachsystem shall be used independently of the other. Combiningvalues from the two systems may result in non-conformancewith the standard.2. Referenced Documents2.1 ASTM Standards:2A262 Practices for Detectin
5、g Susceptibility to IntergranularAttack in Austenitic Stainless SteelsA484/A484M Specification for General Requirements forStainless Steel Bars, Billets, and ForgingsA751 Test Methods, Practices, and Terminology for Chemi-cal Analysis of Steel ProductsE8 Test Methods for Tension Testing of Metallic
6、MaterialsE10 Test Method for Brinell Hardness of Metallic MaterialsE18 Test Methods for Rockwell Hardness of Metallic Ma-terialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE45 Test Methods for Determining the Inclusion Content ofSteelE112 Test Me
7、thods for Determining Average Grain SizeF138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F746 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant Materials2.2 Aerospace Material Specifications:3AMS 224
8、8 Chemical Check Analysis Limits, Corrosion andHeat Resistant Steels and Alloys, Maraging and OtherHighly-Alloyed Steels, and Iron Alloys2.3 ISO Standard:4ISO 6892 Metallic Materials Tensile Testing at AmbientTemperatureISO 9001 Quality Management SystemRequirements2.4 Quality Standard:SI 10 America
9、n National Standard for Use of the Interna-tional System of Units (SI): The Modern Metric System2.5 Quality Standard:5ASQ 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 mill products prod
10、ucedfrom 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 Specification A484/A484M shall apply.4.2 In cases in which a conflict exists be
11、tween this specifi-cation and the standards listed in Section 2, this specificationshall take precedence.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devicesis under the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials
12、.Current edition approved June 1, 2013. Published August 2013. Originallyapproved in 1995. Last previous edition approved in 2008 as F1586 08. DOI:10.1520/F1586-13E01.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual
13、Book of ASTMStandards volume information, refer to the standards Document 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 National Standards Institute (ANSI), 25 W. 43rd
14、St.,4th Floor, New York, NY 10036, http:/www.ansi.org.5Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, W
15、est Conshohocken, PA 19428-2959. United States15. 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 Mechanical properties (if applicable, for specialconditions),5.1.4
16、 Form,5.1.5 Applicable dimensions including size, thickness,width, and length (exact, random, or multiples) or drawingnumber,5.1.6 TolerancesUnless otherwise specified by purchaser,tolerances must meet the requirements of Specification A484/A484M as applicable.5.1.7 Condition (see 6.1),5.1.8 Finish
17、(see 6.2),5.1.9 Special tests (if any), and5.1.10 Other requirements.6. Materials and Manufacture6.1 ConditionBars shall be furnished in the annealed,medium hard, or hard condition, as specified.6.2 FinishTypes of bar finishes available are cold-drawn,pickled, ground, ground and polished, or as spec
18、ified by thepurchaser.7. Chemical Requirements7.1 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 1.7.1.1 Requirements for the major and minor elementalconstituents are li
19、sted in Table 1. Also listed are importantresidual elements.Analysis for elements not listed in Table 1 isnot required to verify compliance with this specification.7.1.2 Methods and practices relating to chemical analysisrequired by this specification shall be in accordance with TestMethods, Practic
20、es, and Terminology A751.7.2 Product AnalysisThe product analysis is either for thepurpose of verifying the composition of a heat or manufactur-ing lot 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
21、on the basis of this productanalysis.7.2.2 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 2.8. Metallurgical Requirements8.1 Th
22、e material shall exhibit no delta ferrite, chi, or sigmaphases when it is examined metallographically at 100 mag-nification.8.2 The microcleanliness of the steel, as determined by TestMethods E45, Method A, except using Plate Ir, on representa-tive billet or bar samples from the heat shall not excee
23、d 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 Requirements9.1 Tensile Properties:9.1.1 Tensile properties shall be determined in accordancewith Test Methods E8.9.1.2 The mechanical properties of test specimen
24、s shallconform to the requirements specified in Table 3.9.2 Hardness:9.2.1 Hardness values shall be determined in accordancewith Test Method E10 or Test Methods E18.9.2.2 When desired, hardness limits may be specified by thepurchaser. Hardness determinations shall be made on a productcross section,
25、midway between the center and surface, if thecross section is adequate.9.3 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, test two additional test pieces representative ofTABLE 1 Chemical Require
26、mentsElement 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 11.0Molybdenum 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 dif
27、ference and need not be determinedor certified.TABLE 2 Product Analysis TolerancesAElementTolerance Under theMinimum 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
28、.05Copper 0.03ARefer to AMS 2248 for chemical check analysis 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 byAMS 2248 and permissiblevariation has been establishe
29、d through industrial practice.F1586 1312the 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 shall be
30、 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 for each
31、 specimen that did not meet theminimum requirements.10. Dimensions and Permissable Variations10.1 Units of Measure:10.1.1 SelectionThis specification requires that the pur-chaser selects the units (SI or inch-pound) to be used forproduct certification. In the absence of a stated selection ofunits on
32、 the purchase order, this selection may be expressed bythe purchaser in several alternate forms listed in order ofprecedence.(1) If the purchaser and supplier have a history of usingspecific units, these units shall continue to be certified untilexpressly changed by the purchaser.(2) In the absence
33、of historic precedence, if the units usedto define the product on the purchasers PO, specification, andengineering drawing are consistent, these units shall be used bythe supplier for product certification.(3) If the purchasers selection of units is unclear, the unitsof measure shall be agreed upon
34、between the purchaser andsupplier.10.1.2 Conversion of UnitsIf the suppliers test equipmentdoes not report in the selected units, the test equipment unitsmay be converted to the selected units for certification pur-poses. Accurate arithmetic conversion and proper use ofsignificant digits should be o
35、bserved when performing thisconversion. ASTM SI 10 provides guidelines for the use ofSI units. Annex A of that standard provides conversion tablesand Annex B provides rules for conversion and significance.11. Special Tests11.1 Material conforming to this specification shall becapable of passing the
36、intergranular corrosion susceptibilitytest in accordance with Practice E of Practices A262.11.2 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 E112.11.2.1 If grain size sam
37、ples are selected after final coldworking operation, specimens shall be tested according to TestMethods E112 or as agreed upon between supplier andpurchaser.11.3 Any other special requirements shall be specified bythe purchaser.12. Significance of Numerical Limits12.1 The following applies to all sp
38、ecified numerical limitsin this specification. To determine conformance to these limits,an observed or calculated value shall be rounded to the nearestunit in the last right hand digit used in expressing thespecification limit, in accordance with the rounding method ofPractice E29.13. Certification1
39、3.1 The supplier shall provide a certification that thematerial was tested in accordance with this specification. Areport of the test results shall be furnished to the purchaser atthe time of shipment.14. Quality Program Requirements14.1 The supplier shall maintain a quality program such asdefined i
40、n ASQ C1, ISO 9001, or similar.14.2 The supplier shall maintain a quality program such asdefined in ISO 9001, or similar quality program.15. Keywords15.1 manganese; metals (for surgical implants); nitrogenstrengthened; stainless steel; surgical applicationsTABLE 3 Mechanical PropertiesConditionDiame
41、ter 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) 145 000 (1000) 10AEl
42、ongation of material 0.063 in. (1.6 mm) or greater in diameter (D) or thicknessshall be measured using a gage length of 2 in. or 4D or 4W (W = width). The gagelength must be reported with the test results. The method for determiningelongation of material under 0.063 in. (1.6 mm) in diameter or width
43、 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 material and isnot
44、intended to specify a hardness value.COther sizes may be furnished by agreement between the supplier and thepurchaser.F1586 1313APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterize thecomposition and properties of wrought nitrogen strengthened21c
45、hromium10nickel3manganese2.5molybdenumstainless steel alloy bar for surgical implants.X1.2 Acceptable metal conditions supplied to the implantmanufacturer include annealed, medium hard, and hardconditions, the choice dependent upon the implant design andapplication.X1.3 This alloy is capable of bein
46、g 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 carbonitrides. Carbonitrides can berevealed by etching electrolytically in a solution of potassiumhydrox
47、ide (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 may affect the finish of electropolishedsurfaces.X1.5 ISO standards are listed for reference only.
48、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 may be negotiated between purchaser and supplier.X1.6 Units of Measure: ASTM Policy ASTM is promot-i
49、ng the use of rationalized SI (metric) units in their standards.The F12.04 Committee has modified this specification tofacilitate the transition by the medical materials industry to SIbetween now and 2018. In the first phase of this transition,running to 2013, the specifications will be structured to allowthe use of either SI or inch-pound units. The choice of primaryunits in each specification will be determined by the industryusing the specification. The change to SI units during thisperiod may be initiated by the purchaser through the purch
