1、Designation: F 1314 07Standard Specification forWrought Nitrogen Strengthened 22 Chromium 13 Nickel 5 Manganese 2.5 Molybdenum Stainless Steel Alloy Barand Wire for Surgical Implants (UNS S20910)1This standard is issued under the fixed designation F 1314; the number immediately following the designa
2、tion 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 c
3、hemical, mechanical, andmetallurgical requirements for wrought nitrogen strengthened22 chromium 13 nickel 5 manganese 2.5 molybdenumstainless steel 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-pou
4、nd units 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 G
5、eneral 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 and
6、 RockwellSuperficial Hardness 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 for Determining Average Grain SizeE 354 Test Methods for Chemical Analy
7、sis 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 and Wire for SurgicalImplants (UNS S31673)F 746 Test Method for Pittin
8、g or Crevice Corrosion ofMetallic Surgical Implant Materials2.2 Aerospace Materials Specification:3AMS 2248 Chemical CheckAnalysis Limits, Corrosion andHeat Resistant Steels and Alloys, Maraging and OtherHighly-Alloyed Steels, and Iron Alloys2.3 ASQ Standard:4ASQ C1 Specification of General Requirem
9、ents for aQuality Program2.4 ISO Standards:5ISO 6892 Metallic Materials Tensile Testing at AmbientTemperatureISO 9001 Quality Management SystemsRequirements3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 bar, nround bars and flats from 0.1875 in. (4.75mm) to 4.00 in. (101.60 m
10、m) in diameter or thickness (othersizes and shapes by special order).3.1.2 forging bar, nas described in 3.1.2 used for produc-tion of forgings, may be furnished in the hot rolled condition.3.1.3 lot, nthe total number mill products produced underthe same melt heat under the same conditions at essen
11、tially thesame time.3.1.4 wire, nrounds 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,1This specification is under the juri
12、sdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Feb. 1, 2007. Published March 2007. Originallyapproved in 1990. Last previous edition approved in 2001 as F 1314 01.2
13、For 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 Automotive Engineers (SAE), 400 Com
14、monwealthDr., 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 National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.
15、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.4.1.3 Mechanical properties (if applicable for special con-ditions),4.1.4 Form (bar or wire),4.1.5 Applicable dimension
16、s 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 Specification A 484/A 484M, A 555/A 555M, or both, as applicable,4.1.7 Condition (see 5.1),4.1.8 Finish (see 5
17、.2),4.1.9 Special tests (if any), and4.1.10 Other requirements.5. Materials and Manufacture5.1 ConditionBar and wire shall be furnished in thehot-worked, annealed, or cold-worked condition, as specified.5.2 FinishBar and wire shall be furnished bright an-nealed, cold drawn, pickled, ground, or groun
18、d and polished, asspecified by the purchaser.6. Chemical Requirements6.1 The suppliers heat analysis shall conform to the chemi-cal requirements prescribed in Table 1. The supplier shall notship material with chemistry outside the requirements specifiedin Table 1.6.1.1 Requirements for the major and
19、 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 in
20、accordance with TestMethods A 751.6.2 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.6.2.1 Acceptance or rejection of a heat or lot of materialmay be made by the p
21、urchaser 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 2.6.2.3 Methods and practice
22、s relating to chemical analysisrequired by this specification shall be in accordance with TestMethods E 354.7. Metallurgical Requirements7.1 The material shall contain no delta ferrite, chi, or sigmaphases when it is examined metallographically at 1003 mag-nification in accordance with Practice E 40
23、7.7.2 The microcleanliness of the material, as determined byPractice E45, Method A, except using Plate Ir, on representa-tive billet or bar samples from the heat shall not exceed thefollowing:InclusionTypeA(Sulfide)B(Alumina)C(Silicate)D (GlobularOxide)ThinHeavy1.51.52.51.52.51.52.51.58. Mechanical
24、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:8.2.1 Hardness values shall be determined in accordancewith Test Meth
25、od 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 and surface, if crosssection is adequate.8.3 Number of TestsBar, Forging Bar, Shapes and Wire:8.3.1 Perform tensi
26、on 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 lot shall beconsidered in compliance only if all additional test pieces meetthe speci
27、fied requirements.TABLE 1 Chemical CompositionElementComposition, %(Mass/Mass)Carbon 0.030 maxManganese 4.00 to 6.00Phosphorus 0.025 maxSulfur 0.010 maxSilicon 0.75 maxChromium 20.50 to 23.50Nickel 11.50 to 13.50Molybdenum 2.00 to 3.00Nitrogen 0.20 to 0.40Niobium 0.10 to 0.30Vanadium 0.10 to 0.30Cop
28、per 0.50 maxIron balanceAAApproximately equal to the difference of 100 % and the sum percentage of theother specified elements. Reporting of the iron difference is not required.TABLE 2 Product Analysis TolerancesAElementPermissible Variation Under theMinimum Limit or Overthe Maximum Limit,% (Mass/Ma
29、ss)BCarbon 0.005ManganeseC0.05Phosphorus 0.005Sulfur 0.005Silicon 0.05Chromium 0.25Nickel 0.15Molybdenum 0.10NitrogenC0.02 under min;0.04 over maxNiobium 0.05Vanadium 0.03Copper 0.03ARefer to AMS 2248 for chemical check analysis limits (except nitrogen).BFor elements in which only a maximum percenta
30、ge 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.F13140728.3.2 Tensile test results for which any specimen fracturesoutside the gauge length shall be
31、considered acceptable if boththe elongation and reduction of area meet the minimumrequirements specified. Refer to subsections 7.11.4 and 7.11.5of Test Method E8. If either the elongation or reduction of areais less than the minimum requirement, discard the test andretest. Retest one specimen for ea
32、ch specimen that did not meetthe minimum requirements.9. Special Tests9.1 Bar and wire conforming to this 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 h
33、avea homogeneous microstructure with an average grain size ofASTM No. 5 or finer when measured in accordance with TestMethod E112.9.2.1 If samples are selected after a final cold working,specimens shall be tested in accordance with Test MethodE112or as agreed between supplier and purchaser.9.3 Any o
34、ther 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 conformance to these limits,an observed or calculated value shall be rounded to the nearestunit in the last
35、 right hand digit used in expressing thespecification limit, in accordance with the rounding of PracticeE29.11. Certification11.1 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 purcha
36、ser 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 and ISO 9001.13. Keywords13.1 manganese; metals (for surgical implants); nitrogenstrengthened; stainless steel; surgica
37、l applicationsAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterize thecomposition and properties of wrought nitrogen strengthened22 chromium 13 nickel 5 manganese 2.5 molybdenumstainless steel alloy bar and wire to ensure consistency in thestarti
38、ng material used, directly or as modified by forging, in themanufacturing of medical devices.X1.2 The metallurgical requirements include fine-grainedaustenitic structure free of ferrite, chi, and sigma phases withlow micro-inclusion content and the capability of passing anintergranular corrosion sus
39、ceptibility test.X1.3 Acceptable metal conditions supplied to the implantmanufacturer include hot-worked, annealed, and cold-workedconditions, the choice dependent upon the implant design andapplication.X1.4 This alloy is capable of being cold worked to ultimatetensile strengths exceeding 200 000 ps
40、i (1380 MPa) for high-strength surgical implant applications. There is an associatedreduction in ductility with these higher strength levels.X1.5 This alloy has been tested in accordance with TestTABLE 3 Mechanical Requirements, Bar and WireConditionDiameter or Thickness,in. (mm)Ultimate TensileStre
41、ngth, min,psi (MPa)Yield Strength(0.2 % Offset),min, psi (MPa)ElongationAmin, %BrinellBHardness,max, HBHot-workedCUp to 2 (50.8)D, incl . . . 325Annealed All 100 000 (690) 55 000 (380) 35 .Cold-worked 0.063 to 0.750 (1.59 to19.1)D, incl150 000 (1035) 125 000 (862) 12 .AElongation of material 0.063 i
42、n. (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 length mustbe reported with the test results. The method for determining elongation of material under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated. Alternativel
43、y,a gauge length corresponding to ISO 6892 (5.65 times the square root of So, where So is the original cross sectional area) may be used when agreed upon betweensupplier and purchaser.B3000-kgf (29 430 N) load.CTypically supplied as-hot-rolled bar for forging applications.DOther sizes may be furnish
44、ed by agreement between the supplier and the purchaser.F1314073Method F 746 and exhibits a pitting potential greater thanSpecification F 138 reference material.X1.6 The low carbon composition has been selected toprovide an extra measure of assurance that the material will befree from susceptibility
45、to intergranular corrosion.X1.7 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 pa
46、rticles exert a strength-ening effect but do not significantly alter the corrosion prop-erties of the alloy. They may affect the finish of electropolishedsurfaces.X1.8 ISO standards are listed for reference only. AlthoughISO standards are similar to the corresponding ASTM stan-dards, they are not id
47、entical. Use of an ISO standard in additionto or instead of the preferred ASTM standard may be agreedupon between purchaser and supplier.X2. BIOCOMPATIBILITYX2.1 The alloy composition covered by this specificationhas been employed successfully in human implant applicationsin contact with soft tissue
48、 and bone for over a decade.X2.2 The alloy has been shown to produce an acceptablelevel of local biological response that is similar to SpecificationF 138 reference material.6X2.3 No known surgical implant material has ever beenshown to be completely free of adverse reactions in the humanbody. Long-
49、term clinical experience with the use of thematerial referred to in this specification has shown that anacceptable level of biological response can be expected, if thematerial is used in appropriate applications.SUMMARY OF CHANGESCommittee F04.12 has identified the location of selected changes to this standard since the last issue(F 1314 01) that may impact the use of this standard.(1) Editorial corrections have been made in order to meetterminology and formatting guidelines established for implantmaterial standards.ASTM International takes no positio
