1、Designation: F 2581 07Standard Specification forWrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wirefor Surgical Implants (UNS S29225)1This standard is issued under the fixed designation F 2581; the number immediately following the designatio
2、n indicates 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 chemi
3、cal, mechanical, andmetallurgical requirements for wrought nitrogen strengthened11manganese-17chromium-3molybdenum low-nickel stainlesssteel alloy bar and wire for surgical implants.1.2 As of the time of the original approval of this specifi-cation no product utilizing this alloy had been approvedth
4、rough a 510(k) submission.1.3 The values stated in SI units are to be regarded as thestandard. The values given in parentheses are for informationonly.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this
5、 standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2A 262 Practices for Detecting Susceptibility to Intergranu-lar Attack in Austenitic Stainless SteelsA 751 Test Methods, P
6、ractices, and Terminology forChemical Analysis of Steel ProductsE8 Test Methods for Tension Testing of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE45 Test Methods for Determining the Inclusion Contentof SteelE112 Test Methods f
7、or Determining Average Grain SizeE 354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron,Nickel, and Cobalt AlloysE 407 Practice for Microetching Metals and AlloysF 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar
8、and Wire for SurgicalImplants (UNS S31673)F 746 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant MaterialsF 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF 1314 Specification for Wrought Nitrogen Strengthened 22Chromium 13 Nickel 5 Manga
9、nese 2.5 MolybdenumStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S20910)F 1586 Specification for Wrought Nitrogen Strengthened 21Chromium10 Nickel3 Manganese2.5 MolybdenumStainless Steel Alloy Bar for Surgical Implants (UNSS31675)2.2 Aerospace Material Specification:3AMS 2248 Chemical
10、 CheckAnalysis 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 AmbientTemperature2.4 American Society for Quality Standard:5ASQ C1 Specification of General Requirements for
11、 a Qual-ity Program3. Terminology3.1 Definitions of Terms Specific to This Standard:3.2 lotAlot is defined as the total number of mill productsproduced from the same melt heat under the same conditions atessentially the same time.4. Product Classification4.1 BarRound, rectangular, or other complex s
12、hapedproduct delivered straightened and cut to defined lengths, witha maximum cross-sectional area of 16 in.2(103 cm2).1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgi
13、cal Materials.Current edition approved Jan. 1, 2007. Published January 2007.2For 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 Document Summary page onth
14、e 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 St.,4th Floor, New York, NY 10036, http:/www.ansi.org.5Available from American Society for
15、Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.4.2 Forging barBar as described in 4.1 used for produc-tion of forgings, may be furnished in the hot-rolled
16、anddescaled condition.4.3 WireRounds, rectangular, or other complex shapedproduct produced and delivered in coils.4.4 Fine WireWire with diameter or major dimension lessthan 0.063 in. (1.6 mm).5. Ordering Information5.1 Inquiries and orders for material under this specificationshall include the foll
17、owing information:5.1.1 Quantity,5.1.2 ASTM designation and date of issue,5.1.3 Mechanical properties,5.1.4 Form,5.1.5 Applicable dimensions including size, thickness,width, and length (exact, random, or multiples) or drawingnumber,5.1.6 Condition,5.1.7 Special tests, if any, and5.1.8 Other requirem
18、ents.6. Materials and Manufacture6.1 ConditionBar and wire shall be furnished, as speci-fied, in the annealed or cold-worked condition. Bar used for theproduction of forgings may be furnished in the hot worked anddescaled condition, as agreed upon between purchaser andsupplier.6.2 FinishTypes of fin
19、ish available in bar and wire arecold-drawn, pickled, ground, ground and polished, shaved, oras specified by the purchaser.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 th
20、e 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 specification.7.1.2 Methods and practices relatin
21、g to chemical analysisrequired by this specification shall be in accordance with TestMethods A 751.7.1.3 For reference purposes, Test Methods E 354 shallapply.7.2 Product AnalysisThe product analysis is either for thepurpose of verifying the composition of a heat or lot or todetermine variations in
22、the composition within the heat.7.2.1 Acceptance or rejection of a heat or lot of materialmaybe 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 betweenlaboratories in the measur
23、ement of chemical content. Productanalysis limits shall be as specified in Table 2.8. Metallurgical Requirements8.1 The material shall contain no delta ferrite, chi, or sigmaphases when it is examined metallographically at 1003 mag-nification in accordance with Practice E 407.8.2 The microcleanlines
24、s of the steel, as determined by TestMethod E45, Method A, on representative billet or barsamples from the heat shall not exceed the following:Inclusion Type A (Sulphide) B (Alumina) C (Silicate) D (Globular oxide)Thin 1.5 1.5 1.5 1.5Heavy 1.0 1.0 1.0 1.09. Mechanical Properties9.1 Tensile Propertie
25、s:9.1.1 Tensile properties shall be determined in accordancewith Test Methods E8. Perform at least two tension test fromeach lot. Should any test piece not meet the specified require-ments, test two additional test pieces representative of the samelot, in the same manner, for each failed test piece.
26、 The lot shallbe considered in compliance only if all additional test piecesmeet the specified requirements.9.1.2 Tensile test results for which any specimen fracturesoutside the gauge length shall be considered acceptable, if boththe elongation and reduction of area meet the minimumrequirements spe
27、cified. Refer to Test Method E8 sections7.11.4 and 7.11.5. If either the elongation or reduction of areais less than the minimum requirement, discard the test andTABLE 1 Chemical CompositionElement Composition, % (mass/mass)Carbon 0.15 to 0.25Manganese 9.50 to 12.50Phosphorus 0.020 maxSulfur 0.010 m
28、axSilicon 0.2 to 0.6Chromium 16.50 to 18.00Nickel 0.05 maxMolybdenum 2.70 to 3.70Nitrogen 0.45 to 0.55Copper 0.25 maxIron balanceAAApproximately equal to the difference of 100 % and the sum percentage of theother specified elements. The percentage of iron difference is not required to bereported.TAB
29、LE 2 Product Analysis TolerancesAElementPermissible VariationUnder the MinimumLimit or Over theMaximum Limit, % (mass/mass)BCarbon 0.01ManganeseC0.20Phosphorus 0.005Sulfur 0.005Silicon 0.05Chromium 0.25Nickel 0.03Molybdenum 0.05NitrogenC0.05Copper 0.03ARefer to AMS 2248 for chemical check analysis l
30、imits (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 has beenestablished through industrial practice.F2581072retest. Retest one specimen for each specimen
31、that did not meetthe minimum requirements.9.2 The mechanical properties of test specimens shall con-form to the requirements specified in Table 3.9.3 The level of mechanical properties for material in otherconditions shall be specified in the purchase order10. Special Tests10.1 Bar and wire conformi
32、ng to this specification shall becapable of passing the intergranular corrosion susceptibilitytest in accordance with Practice E of Practices A 262.10.2 Bar and wire conforming to this specification shallhave a homogeneous microstructure with an average grain sizeof ASTM No. 5 or finer when measured
33、 in accordance withTest Methods E112.10.2.1 It is preferred that samples for grain size determina-tion be selected after the hot working operation or after thefinal annealing operation prior to the final cold workingoperation.10.2.2 If grain size samples are selected after a final coldworking, speci
34、mens shall be tested according to Test MethodsE112or as agreed upon between supplier and purchaser.10.3 Any other special requirements shall be specified bythe purchaser.11. Significance and Numerical Limits11.1 The following applies to all specified numerical limitsin this specification. To determi
35、ne 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 rounding method ofPractice E29.12. Certification12.1 Certification shall be provided by the supplier that them
36、aterial meets the requirements of this specification. A reportof the test results shall be furnished at the time of shipment.13. Quality Program Requirements13.1 The bar and wire producer and any processors shallmaintain a quality program such as that which is defined inASQ C1.14. Keywords14.1 low-n
37、ickel; manganese; metals (for surgical implants);nitrogen strengthened; stainless steel; surgical applicationsAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterize thecomposition and properties of wrought low nickel, nitrogenstrengthened 11mangane
38、se-17chromium-3molybdenum barand wire to ensure consistency in the starting material used,directly or as modified by forging, in the manufacturing ofmedical devices.X1.2 ISO standards are listed for reference only. Use of anISO standard instead of a preferred ASTM standard may benegotiated between t
39、he purchaser and the supplier.X1.3 The metallurgical requirements include a fine-grainedaustenitic structure free of delta ferrite, with a defined inclusioncontent and the capability of passing an intergranular corrosionsusceptibility test.X1.4 This alloy can be supplied in either the annealed orcol
40、d-worked condition.X1.5 This alloy is capable of being cold worked to ultimatetensile strengths exceeding 200 000 psi (1380 MPa) forhigh-strength surgical implant applications.X1.6 Prolonged heat treating this alloy at solution-annealing temperature (typically 1050C) may result in theformation of a
41、ferritic surface layer. This surface layer shall beremoved from the finished product prior to its use as a medicalor surgical device. Formation of ferrite is caused by de-nitrogenization.This effect is typical for high-nitrogen stainlesssteels. Since the nitrogen content in the composition of theste
42、el described in this standard is at medium level the tendencyof de-nitrogenization is minimized. To avoid this effect duringprocessing, heating cycles shall be kept as short as possible.X1.7 This alloy has been tested in accordance with TestMethod F 746 and exhibits pitting and crevice corrosionresi
43、stance much greater than Specification F 138 referencematerial and exceeds values of material specified in Specifica-tion F 1314 and Specification F 1586. Additional informationTABLE 3 Mechanical RequirementsConditionUltimateTensile Strengthmin, psi (MPa)Yield Strength(0.2 % offset),min, psi (MPa)El
44、ongationAmin, %Reductionin Area min, %Annealed 120 000(827)70 000(482)40 50Cold Worked 160 000(1103)120 000(827)12 .AElongation of material 0.063 in. (1.6 mm) or greater in diameter (D) or width (W)shall be measured using a gauge length of 2 in. or 4D or 4W. The gauge lengthmust be reported with the
45、 test results. The method for determining elongation ofmaterial under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated.Alternatively, a gauge length corresponding to ISO 6892 may be used whenagreed upon between supplier and purchaser (5.65 3 So1/2, where Sois theoriginal cross sectional
46、 area of the gauge length).F2581073on the corrosion resistance and the physical, mechanical, andmetallurgical properties of this alloy has been published (1-4).6X1.8 Molybdenum-enriched chi and sigma intermetalliccompounds must not be present in the microstructure becauseof reduced autenitic corrosi
47、on resistance and possible em-brittlement effects.X1.9 Delta ferrite is a magnetic phase that must be absentin order to provide a completely nonmagnetic microstructurethat will not cause torque, displacement, or heating in aMagnetic Resonance Imaging (MRI) environment.X1.10 Chemical composition of t
48、his steel exposes a highlevel of carbon which in conventional metallurgy ofchromium-nickel-stainless steels is deemed to be critical. Inhigh-nitrogen stainless steels it replaces nitrogen since it alsohas a strong effect on stabilizing the austenitic phase. Replac-ing nitrogen by carbon has advantag
49、eous effects on corrosionresistance, widens the range of austenite stability towardslower solution annealing temperatures, and will result in bettertoughness properties.X2. BIOCOMPATIBILITYX2.1 The suitability of this material from a human implantperspective is dependent on the specific application. Thebiological tests appropriate for the specific site, such asrecommended in Practice F 748 should be used as a guideline.A summary of the testing that has been performed to-date isprovided in X2.3 and the reference list.X2.2 No known surgical implant material has ever
