1、Designation: F 2229 07Standard Specification forWrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel AlloyBar and Wire for Surgical Implants (UNS S29108)1This standard is issued under the fixed designation F 2229; the number immediately following the designati
2、on 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. Scope*1.1 This specification covers the che
3、mical, mechanical, andmetallurgical requirements for wrought nitrogen strengthened23manganese-21chromium-1molybdenum low-nickel stainlesssteel alloy bar and wire 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 uni
4、ts maybe approximate.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, and ForgingsA 555/A 555M Specification for General
5、 Requirements forStainless Steel Wire and Wire RodsA 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 Metall
6、icMaterialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE45 Test Methods for Determining the Inclusion Contentof SteelE112 Test Methods for Determining Average Grain SizeE 354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Mag
7、netic, 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 and Wire for SurgicalImplants (UNS S31673)F 746 Test Method for Pitting or Crevice Corrosion ofMetallic Surgic
8、al 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 Manganese 2.5 MolybdenumStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S20910)F 1586 Specification fo
9、r Wrought Nitrogen Strengthened 21Chromium10 Nickel3 Manganese2.5 MolybdenumStainless Steel Alloy Bar for Surgical Implants (UNSS31675)2.2 Aerospace Material Specification:3AMS 2248 Chemical CheckAnalysis Limits, Corrosion andHeat Resistant Steels and Alloys, Maraging and OtherHighly-Alloyed Steels,
10、 and Iron Alloys2.3 ISO Standards:4ISO 6892 Metallic Materials Tensile Testing at AmbientTemperatureISO 9001 Quality Management SystemsRequirements2.4 American Society for Quality Standard:5ASQ C1 Specification of General Requirements for a Qual-ity Program3. Terminology3.1 Definitions of Terms Spec
11、ific to This Standard:3.1.1 barround bar and flats from 0.1875 in. (4.75 mm) to4.00 in. (101.60 mm) in diameter or thickness (other sizes andshaped by special order).3.1.2 forging baras described in section 3.1.1 used for theproduction of forgings, may be furnished in the hot rolledcondition.1This s
12、pecification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Aug. 1, 2007. Published August 2007. Originallyapproved in 2002. Last previous edition
13、approved in 2002 as F 2229 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 Document Summary page onthe ASTM website.3Available from Society of Auto
14、motive 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 Quality (ASQ), 600 N. Plankinton Ave.,Milwauke
15、e, WI 53203, http:/www.asq.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.3.1.3 lotthe total number of mill products produced fromthe same melt heat under the sam
16、e conditions at essentially thesame time.3.1.4 wirerounds less than 0.1875 in. (4.75 mm) indiameter.4. Ordering Information4.1 Inquiries and orders for material under this specificationshall include the following information:4.1.1 Quantity,4.1.2 ASTM designation and date of issue,4.1.3 Mechanical pr
17、operties,4.1.4 Form,4.1.5 Applicable dimensions including size, thickness,width, and length (exact, random, or multiples) or drawingnumber,4.1.6 TolerancesUnless otherwise specified by purchaser,tolerances must meet the requirements of SpecificationsA 484/A 484M and/or A 555/A 555M, as applicable.4.
18、1.7 Condition (see 5.1),4.1.8 Finish (see 5.2),4.1.9 Special tests, if any, and4.1.10 Other requirements.5. Materials and Manufacture5.1 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 h
19、ot workedcondition, as agreed upon between purchaser and supplier.5.2 FinishTypes of finish available in bar and wire arecold-drawn, pickled, ground, ground and polished, or asspecified by the purchaser.6. Chemical Requirements6.1 The suppliers heat analysis shall conform to the chemi-cal requiremen
20、ts prescribed in Table 1. The supplier shall notship material with a composition outside the requirementsspecified in Table 1.6.1.1 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
21、 isnot required to verify compliance with this specification.6.1.2 Methods and practices relating to chemical analysisrequired by this specification shall be in accordance with TestMethods A 751.6.2 Product AnalysisThe product analysis is either for thepurpose of verifying the composition of a heat
22、or manufactur-ing lot or to determine variations in the composition within theheat.6.2.1 Acceptance or rejection of a heat or lot of materialmay 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 bu
23、t cover variations betweenlaboratories in the measurement of chemical content. Productanalysis limits shall be as specified in Table 2.6.2.3 Methods and practices relating to chemical analysisrequired by this specification shall be in accordance with TestMethods E 354.7. Metallurgical Requirements7.
24、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 407.7.2 The microcleanliness of the steel, as determined byPractice E45, Method A, except using plate I-r, on represen-tative billet or bar s
25、amples from the heat shall not exceed thefollowing:Inclusion A B C DType (Sulphide) (Alumina) (Silicate) (Globular oxide)Thin 1.5 2.5 2.5 2.5Heavy 1.5 1.5 1.5 1.57.3 The surface of products supplied with a machined orground surface finish shall have no free ferrite when opticallyexamined at a magnif
26、ication of 1003.8. Mechanical Requirements8.1 Tensile Properties:8.1.1 Tensile properties shall be determined in accordancewith Test Methods E8.8.1.2 The mechanical properties of test specimens shallconform to the requirements specified in Table 3.8.2 Hardness:TABLE 1 Chemical CompositionElementComp
27、osition,% (mass/mass)Carbon 0.08 maxManganese 21.00 to 24.00Phosphorus 0.03 maxSulfur 0.01 maxSilicon 0.75 maxChromium 19.00 to 23.00Nickel 0.05 maxMolybdenum 0.50 to 1.50Nitrogen 0.85 to 1.10Copper 0.25 maxIron balanceAAApproximately equal to the difference of 100 % and the sum percentage of theoth
28、er specified elements. Reporting the percentage of iron difference is notrequired.TABLE 2 Product Analysis TolerancesAElementPermissible Variation Under the Minimum Limit orOver the Maximum Limit, % (mass/mass)BCarbon 0.01ManganeseC0.20Phosphorus 0.005Sulfur 0.005Silicon 0.05Chromium 0.25Nickel 0.03
29、Molybdenum 0.05NitrogenC0.05Copper 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 by AMS 2248 and hasbeen establ
30、ished through industrial practice.F22290728.2.1 Hardness values shall be determined in accordancewith Test Methods E10or Test Methods E18.8.2.2 When desired, hardness limits may be specified by thepurchaser. Hardness determinations shall be made on a productcross section, midway between the center a
31、nd surface, if thecross section is adequate.8.3 Number of Tests:8.3.1 Perform tension testing per Test Methods E8. Shouldany of the test specimens not meet the specified requirements,test two additional test pieces representative of the same lot, inthe same manner, for each failed test piece. The lo
32、t shall beconsidered in compliance only if all additional test pieces meetthe specified requirements.8.3.2 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 specified.
33、 Refer to subsections 7.11.4 and 7.11.5of Test Methods E8. If either the elongation or reduction ofarea is less than the minimum requirement, discard the test andretest. Retest one specimen for each specimen that did not meetthe minimum requirements.9. Special Tests9.1 Bar and wire conforming to thi
34、s specification shall becapable of passing the intergranular corrosion susceptibilitytest in accordance with Practice E of Practices A 262.9.2 Bar and wire conforming to this specification shall havea homogeneous microstructure with an average grain size ofASTM No. 5 or finer when measured in accord
35、ance with TestMethods E112.9.2.1 It is preferred that samples for grain size determinationbe selected after the hot working operation or after the finalannealing operation prior to the final cold working operation.9.2.2 If grain size samples are selected after a final coldworking, the specimens shal
36、l be tested according to TestMethod E112or as agreed upon between supplier and pur-chaser.9.3 Any other special requirements shall be specified by thepurchaser.10. Significance of Numerical Limits10.1 The following applies to all specified numerical limitsin this specification. To determine conforma
37、nce 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 E29.11. Certification11.1 The supplier shall provide a certification that thematerial was
38、tested in accordance with this specification. Areport of the test results shall be furnished to the purchaser atthe time of shipment.12. Quality Program Requirements12.1 The bar and wire producer and any processors shallmaintain a quality program such as that which is defined inASQ C1 or ISO 9001.13
39、. Keywords13.1 low-nickel; 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, nitrogenst
40、rengthened 21 chromium-23 manganese-1 molybdenum 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
41、 benegotiated between the purchaser and the supplier.X1.3 The metallurgical requirements include a fine-grainedaustenitic structure free of ferrite, chi, and sigma phases with adefined inclusion content and the capability of passing anintergranular corrosion susceptibility test.TABLE 3 Mechanical Re
42、quirementsConditionUltimate TensileStrength min,psi (MPa)Yield Strength(0.2 % offset),min, psi (MPa)ElongationAmin, %Reduction inArea min, %AnnealedCondition A120 000(827)75 000(517)30 50Cold WorkedCondition B150 000(1034)120 000(827)20 50Cold WorkedCondition C200 000(1379)180 000(1241)12 40AElongat
43、ion 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 test results. The method for determining elongation ofmaterial under 0.063 in. (1.6 mm) in diameter or thickness may be neg
44、otiated.Alternatively, a gauge length corresponding to ISO 6892 (5.65 3 So1/2, where Sois the original cross sectional area of the gauge length) may be used when agreedupon between supplier and purchaser .F2229073X1.4 This alloy can be supplied in either the annealed orcold-worked condition.X1.5 Thi
45、s alloy is capable of being cold worked to ultimatetensile strengths exceeding 200 000 psi (1380 MPa) for high-strength surgical implant applications. There is an associatedreduction in ductility with these higher strength levels.X1.6 The nitrogen used for strengthening this steel canresult in the f
46、ormation of carbonitrides. Carbonitrides can berevealed by etching electrolytically in a solution of potassiumhydroxide (56 g of KOH in 100 mL of water for3sat2V).They may affect the finish of electropolished surfaces.X1.7 Heat treating this alloy in oxidizing, reducing, orhydrogen atmosphere can re
47、sult in the formation of a magnetic(ferritic) surface layer on the heat-treated product. This surfacelayer shall be removed from the finished product prior to its useas a medical or surgical device.X1.8 This alloy has been tested in accordance with TestMethod F 746 and exhibits pitting and crevice c
48、orrosionresistance greater than Specification F 138 reference materialand is equivalent to Specifications F 1314 and F 1586 alloys(1).6Cyclic anodic polarization testing in 37C Ringerssolution indicated better corrosion resistance than SpecificationF 138 reference material (1,2). Additional informat
49、ion on thecorrosion resistance and the physical, mechanical, and metal-lurgical properties of this alloy has also been published(10-13).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 beenshown to be completely f
