1、Designation: F1314 13a1Standard Specification forWrought Nitrogen Strengthened 22 Chromium13 Nickel5Manganese2.5 Molybdenum Stainless Steel Alloy Bar andWire for Surgical Implants (UNS S20910)1This standard is issued under the fixed designation F1314; the number immediately following the designation
2、 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 () indicates an editorial change since the last revision or reapproval.1NOTEThe designation was corrected editorially in
3、 December 2013.1. Scope*1.1 This specification covers the chemical, 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 either SI units or inch-pou
4、nd unitsare to be regarded separately 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 Standar
5、ds:2A262 Practices for Detecting Susceptibility to IntergranularAttack in Austenitic Stainless SteelsA484/A484M Specification for General Requirements forStainless Steel Bars, Billets, and ForgingsA555/A555M Specification for General Requirements forStainless Steel Wire and Wire RodsA751 Test Method
6、s, Practices, and Terminology for Chemi-cal Analysis of Steel ProductsE8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE10 Test Method for Brinell Hardness of Metallic MaterialsE18 Test Methods for Rockwell Hardness of Metallic Ma-terialsE29 Practice for Using Significant Digits in Test
7、 Data toDetermine Conformance with SpecificationsE45 Test Methods for Determining the Inclusion Content ofSteelE112 Test Methods for Determining Average Grain SizeE354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron,Nickel, and Cobalt AlloysE407 P
8、ractice for Microetching Metals and AlloysF138 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 MaterialsIEEE/ASTM SI 10 American National Standard f
9、or MetricPractice2.2 Aerospace Materials Specification:3AMS 2248 Chemical Check Analysis Limits, Corrosion andHeat Resistant Steels and Alloys, Maraging and OtherHighly-Alloyed Steels, and Iron AlloysAMS 2630 Inspection, Ultrasonic Product Over 0.5 inch(12.7 mm) ThickAMS 2632 Ultrasonic Inspection o
10、f Thin Materials2.3 ISO Standards:4ISO 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. 4.75 mmto 4.00 in. 101.60 mm in diamete
11、r or thickness (other sizesand 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.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the
12、 direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Oct. 1, 2013. Published November 2013. Originallyapproved in 1990. Last previous edition approved in 2013 as F1314 13. DOI:10.1520/F1314-13AE01.2For referenced ASTM standards, visit the ASTM website, www
13、.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 CommonwealthDr., Warrendale, PA 15096-0001, http:/www.sae.org
14、.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United
15、States13.1.3 lot, nthe total number mill products produced underthe same melt heat under the same conditions at essentially 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
16、following information:4.1.1 Quantity;4.1.2 ASTM designation and date of issue;4.1.3 Mechanical properties (if applicable for special con-ditions);4.1.4 Form (bar or wire);4.1.5 Applicable dimensions including size, thickness,width, and length (exact, random, or multiples) or drawingnumber;4.1.6 Tole
17、rancesunless otherwise specified by purchaser,tolerances must meet the requirements of Specification A484/A484M, A555/A555M, or both, as applicable;4.1.7 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
18、 and wire shall be furnished in thehot-worked, annealed, or cold-worked condition, as specified.5.2 FinishBar and wire shall be furnished bright annealed,cold drawn, pickled, ground, or ground and polished, asspecified by the purchaser.6. Chemical Requirements6.1 The suppliers heat analysis shall co
19、nform 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 minor elementalconstituents are listed in Table 1. Also listed are importantresidual elements.Analysis for e
20、lements 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 accordance with TestMethods A751.6.2 Product AnalysisThe product analysis is either for thepurpose of verifyin
21、g 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 purchaser on the basis of this productanalysis.6.2.2 Product analysis tolerances do not broaden the speci-fied h
22、eat 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 practices relating to chemical analysisrequired by this specification shall be in accordance with TestMethods E354.7. M
23、etallurgical Requirements7.1 The material shall contain no delta ferrite, chi, or sigmaphases when it is examined metallographically at 100 mag-nification in accordance with Practice E407.7.2 The microcleanliness of the material, as determined byPractice E45, Method A, except using Plate Ir, on repr
24、esenta-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 Requirements8.1 Tensile Properties:8.1.1 Tensile properties shall be determined in accordancewith Test Methods E8/
25、E8M.8.1.2 The mechanical properties of test specimens shallconform to the requirements specified in Table 3.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.
26、50Molybdenum 2.00 to 3.00Nitrogen 0.20 to 0.40Niobium 0.10 to 0.30Vanadium 0.10 to 0.30Copper 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 Toleranc
27、esAElementPermissible VariationUnder theMinimum Limit or Overthe Maximum Limit,% (Mass/Mass)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 chemic
28、al 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 established through industrial practice.F1314 13a128.
29、2 Hardness:8.2.1 Hardness values shall be determined in accordancewith Test Method E10 or 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 thecross section
30、 is adequate.8.3 Number of TestsBar, Forging Bar, Shapes and Wire:8.3.1 Perform tension testing per Test Methods E8/E8M.Should any of the test specimens not meet the specifiedrequirements, test two additional test pieces representative ofthe same lot, in the same manner, for each failed test piece.
31、Thelot shall be considered in compliance only if all additional testpieces meet the 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 speci
32、fied. Refer to subsections 7.11.4 and 7.11.5of Test Method E8/E8M. If either the elongation or reductionof area is less than the minimum requirement, discard the testand retest. Retest one specimen for each specimen that did notmeet the minimum requirements.9. Dimensions and Permissible Variations9.
33、1 Units of Measure:9.1.1 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 the purchase order, this selection may be expressed bythe purchaser in several alternate forms l
34、isted in order ofprecedence.9.1.1.1 If the purchaser and supplier have a history of usingspecific units, these units shall continue to be certified untilexpressly changed by the purchaser.9.1.1.2 In the absence of historic precedence, if the unitsused to define the product on the purchasers purchase
35、 order(PO), specification, and engineering drawing are consistent,these units shall be used by the supplier for product certifica-tion.9.1.1.3 If the purchasers selection of units is unclear, theunits of measure shall be agreed upon between the purchaserand supplier.9.1.2 Conversion of UnitsIf the s
36、uppliers 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 observed when performing thisconversion. IEEE/ASTM SI 10 provides gui
37、delines for the useof SI units. Annex A of that standard provides conversiontables and Annex B provides rules for conversion and signifi-cance.10. Special Tests10.1 Bar and wire conforming to this specification shall becapable of passing the intergranular corrosion susceptibilitytest in accordance w
38、ith Practice E of Practices A262.10.2 Bar and wire conforming to this specification shallhave a homogeneous microstructure with an average grain sizeof ASTM No. 5 or finer when measured in accordance withTest Method E112.10.2.1 If samples are selected after a final cold working,specimens shall be te
39、sted in accordance withTest Method E112or as agreed between the supplier and purchaser.10.3 All centerless ground or peeled and polished round bar0.375 in. 9.5 mm in nominal diameter shall be ultrasonicallyinspected at final diameter according to AMS 2630, ClassA1. Equivalent test methods may be sub
40、stituted when agreedupon by the purchaser and supplier.NOTE 1AMS 2630 specifies a minimum size limit of 0.50 in. 12.7mm. F04.12 committee has intentionally specified the use of AMS 2630below 0.50 in. 12.7 mm based on the experience of users and producerson the committee. There is disagreement in the
41、 industry as to whetherAMS 2632, which does apply to sizes under 0.50 in. 12.7 mm, appliesto solid round bar.10.4 Billet shall be ultrasonically inspected prior to beinghot rolled if ultrasonic inspection is not performed at a finaldiameter as specified in 10.3. Acceptance criteria shall beagreed to
42、 between the purchaser and supplier.10.4.1 Alternatively, the purchaser may request that billet beultrasonically inspected prior to being hot rolled even ifultrasonic inspection is performed at a final diameter. Accep-tance criteria shall be agreed to between the purchaser andsupplier.TABLE 3 Mechan
43、ical Requirements, Bar and WireConditionDiameter or Thickness,in. mmUltimate TensileStrength, min,psi MPaYield Strength(0.2 % Offset),min, psi MPaElongationAmin, %BrinellBHardness,max, HBHot-workedCUp to 2 50.8D, incl . . . 325Annealed All 100 000 690 55 000 380 35 .Cold-worked 0.063 to 0.750 1.59 t
44、o19.1D, incl150 000 1035 125 000 862 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 length shallbe reported with the test results. The method for determining elongation of material under 0.06
45、3 in. 1.6 mm in diameter or thickness may be negotiated. Alternatively, agauge 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 between thesupplier and purchaser.B3000-kgf 29 430 N load.CTypically supplied
46、 as-hot-rolled bar for forging applications.DOther sizes may be furnished by agreement between the supplier and the purchaser.F1314 13a1310.5 Any other special requirements shall be specified bythe purchaser.11. Significance of Numerical Limits11.1 The following applies to all specified numerical li
47、mitsin 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 of PracticeE29.12. Certification12.1 The supplier shall prov
48、ide a certification that thematerial was tested in accordance with this specification andmet all requirements. A report of the test results shall befurnished to the purchaser at the time of shipment.13. Quality Program Requirements13.1 The bar and wire producer and any processors shallmaintain a qua
49、lity program, such as defined in ISO 9001ISO9001, or similar.14. Keywords14.1 manganese; metals (for surgical implants); nitrogenstrengthened; stainless steel; surgical 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 thestarting material used, directly or as modified
