1、Designation: F2229 12Standard 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 F2229; 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.1. Scope*1.1 This specification covers the chemic
3、al, 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 either SI units or inch-pound unitsare to be regarded separately as standard. The values state
4、d 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 Detecting Susceptibility to IntergranularAtt
5、ack 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 Methods, Practices, and Terminology for Chemi-cal Analysis of Steel Produ
6、ctsE8/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 Data toDetermine Conformance with SpecificationsE45 Test Methods f
7、or 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 Practice for Microetching Metals and AlloysF138 Specification for Wr
8、ought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F746 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant MaterialsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF1314 Specification for Wro
9、ught Nitrogen Strengthened 22Chromium 13 Nickel 5 Manganese 2.5 MolybdenumStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S20910)F1586 Specification for Wrought Nitrogen Strengthened21Chromium10Nickel3Manganese2.5Molybdenum Stainless Steel Alloy Bar for SurgicalImplants (UNS S31675)IEEE
10、/ASTM SI 10 American National Standard for MetricPractice2.2 Aerospace Material 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
11、) Thick2.3 ISO Standards:4ISO 6892 Metallic Materials Tensile Testing at AmbientTemperatureISO 9001 Quality Management SystemsRequirements3. Terminology3.1 Definitions of Terms Specific to This Standard:1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materi
12、als and Devicesand is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Oct. 1, 2012. Published October 2012. Originallyapproved in 2002. Last previous edition approved in 2007 as F2229 07. DOI:10.1520/F2229-12.2For referenced ASTM standards, visit t
13、he 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 CommonwealthDr., Warrendale, PA 15096-000
14、1, 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.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA
15、 19428-2959. United States13.1.1 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.3.1.3
16、lotthe total number of mill products produced fromthe same melt heat under the same 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 informa
17、tion:4.1.1 Quantity;4.1.2 ASTM designation and date of issue;4.1.3 Mechanical properties;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
18、requirements of Specifications A484/A484M and/or A555/A555M, 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 and wire shall be furnished, asspecified, in the annealed or cold-worked
19、condition. Bar usedfor the production of forgings may be furnished in the hotworked condition, as agreed upon between the purchaser andsupplier.5.2 FinishTypes of finish available in bar and wire arecold-drawn, pickled, ground, ground and polished, or asspecified by the purchaser.6. Chemical Require
20、ments6.1 The suppliers heat analysis shall conform to the chemi-cal requirements 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 lis
21、ted 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 accordance with TestMethods A751.6.2 Product AnalysisThe prod
22、uct 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 purchaser on the basis of this productanalysis.6.2.2 Product an
23、alysis 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 practices relating to chemical analysisrequired by this specification
24、shall be in accordance with TestMethods E354.7. Metallurgical 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 steel, as determined byPractice
25、 E45, Method A, except using plate I-r, on representa-tive billet or bar samples 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 1.5TABLE 1 Chemical CompositionElementComposition,% (mass/mass)Carb
26、on 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 theother specified elements. Re
27、porting the percentage of iron difference is notrequired.TABLE 2 Product Analysis TolerancesAElementPermissible Variation Underthe Minimum Limit orOver the Maximum Limit, %(mass/mass)BCarbon 0.01ManganeseC0.20Phosphorus 0.005Sulfur 0.005Silicon 0.05Chromium 0.25Nickel 0.03Molybdenum 0.05NitrogenC0.0
28、5Copper 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 has beenestablished through industrial pr
29、actice.F2229 1227.3 The surface of products supplied with a machined orground surface finish shall have no free ferrite when opticallyexamined at a magnification of 100.8. Mechanical Requirements8.1 Tensile Properties:8.1.1 Tensile properties shall be determined in accordancewith Test Methods E8/E8M
30、.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 Methods E10 or Test Methods E18.8.2.2 When desired, hardness limits may be specified by thepurchaser. Hardness determ
31、inations shall be made on a productcross section, midway between the center and surface, if thecross section is adequate.8.3 Number of Tests: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 repr
32、esentative ofthe 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.8.3.2 Tensile test results for which any specimen fracturesoutside the gauge length shall be considered acceptable, if
33、 boththe elongation and reduction of area meet the minimumrequirements specified. Refer to subsections 7.11.4 and 7.11.5of Test Methods 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 di
34、d notmeet the minimum requirements.9. Ultrasonic Inspection9.1 All centerless ground or peeled and polished round bar 0.375 in. 9.5 mm in nominal diameter shall be ultrasoni-cally inspected at final diameter according toAMS 2630, ClassA1. Equivalent test methods may be substituted when agreedupon by
35、 the purchaser and supplier.NOTE 1AMS 2630 specifies a minimum size limit of 0.50 in. 12.7mm. F04.12 subcommittee has intentionally specified the use of AMS2630 below 0.50 in. 12.7 mm based on the experience of users andproducers on the committee. There is disagreement in the industry as towhether A
36、MS 2632, which does apply to sizes under 0.50 in. 12.7 mm,applies to solid round bar.10. Dimensions and Permissible 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
37、 of a stated selection ofunits on the purchase order, this selection may be expressed bythe purchaser in several alternate forms listed in order ofprecedence.10.1.1.1 If the purchaser and supplier have a history ofusing specific units, these units shall continue to be certifieduntil expressly change
38、d by the purchaser.10.1.1.2 In the absence of historic precedence, if the unitsused to define the product on the purchasers purchase order(PO), specification, and engineering drawing are consistent,these units shall be used by the supplier for product certifica-tion.10.1.1.3 If the purchasers select
39、ion of units is unclear, theunits of measure shall be agreed upon between the purchaserand supplier.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 ari
40、thmetic conversion and proper use ofsignificant digits should be observed when performing thisconversion. IEEE/ASTM SI 10 provides guidelines for the useof SI units. Annex A of that standard provides conversiontables and Annex B provides rules for conversion and signifi-cance.11. Special Tests11.1 B
41、ar and wire conforming to this specification shall becapable of passing the intergranular corrosion susceptibilitytest in accordance with Practice E of Practices A262.11.2 Bar and wire conforming to this specification shallhave a homogeneous microstructure with an average grain sizeof ASTM No. 5 or
42、finer when measured in accordance withTest Methods E112.11.2.1 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.11.2.2 If grain size samples are selected after a final
43、 coldworking, the specimens shall be tested according to TestMethod E112 or as agreed upon between the supplier andpurchaser.11.3 Any other special requirements shall be specified bythe purchaser.12. Significance of Numerical Limits12.1 The following applies to all specified numerical limitsin this
44、specification. To determine conformance to these limits,an observed or calculated value shall be rounded to the nearestTABLE 3 Mechanical RequirementsConditionUltimate TensileStrength min,psi MPaYield Strength(0.2 % offset),min, psi MPaElongationAmin, %ReductioninArea min,%AnnealedCondition A120 000
45、82775 00051730 50Cold WorkedCondition B150 0001034120 00082720 50Cold WorkedCondition C200 0001379180 000124112 40AElongation 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 lengthshall be reported with the te
46、st 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 (5.65 So1/2, where Soisthe original cross sectional area of the gauge length) may be used when agreedupon between the
47、 supplier and purchaser .F2229 123unit in the last right hand digit used in expressing thespecification limit, in accordance with the rounding method ofPractice E29.13. Certification13.1 The supplier shall provide a certification that thematerial was tested in accordance with this specification. Are
48、port of the test results shall be furnished to the purchaser atthe time of shipment.14. Quality Program Requirements14.1 The bar and wire producer and any processors shallmaintain a quality program such as that which is defined inISO 9001 or a similar quality program.15. Keywords15.1 low-nickel; man
49、ganese; 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 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
