1、Designation: F138 13Standard Specification forWrought 18Chromium-14Nickel-2.5Molybdenum StainlessSteel Bar and Wire for Surgical Implants (UNS S31673)1This standard is issued under the fixed designation F138; the number immediately following the designation indicates the year of originaladoption or,
2、 in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon () indicates an editorial change since the last revision or reapproval.This standard has been approved for use by agencies of the Department of Defense.1. Scope*1.1 Th
3、is specification covers the chemical, mechanical, andmetallurgical requirements for wrought 18chromium-14nickel-2.5molybdenum stainless steel bar and wire used for themanufacture of surgical implants.1.2 The values stated in either SI units or inch-pound unitsare to be regarded separately as standar
4、d. 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 Standards:2A262 Practices for Detecting Susceptibility
5、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 Methods, Practices, and Terminology for Chemi-cal Anal
6、ysis 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 Data toDetermine Conformance with Specification
7、sE45 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 Practice for Microetching Metals and AlloysF981 P
8、ractice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF1350 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire(UNS S31673)IEEE/ASTM SI 10 American National Standard for Metri
9、cPractice2.2 Aerospace Material Standard:3AMS 2630 Inspection, Ultrasonic Product Over 0.5 inch(12.7 mm) ThickAMS 2632 Ultrasonic Inspection of Thin Materials2.3 ISO Standards:4ISO 58321 Implants for SurgeryMetallic MaterialsPart 1:Wrought Stainless SteelISO 6892 Metallic MaterialsTensile TestingISO
10、 9001 Quality Management SystemsRequirements3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 bar, nrounds, flats, or other shapes from 0.1875 in.4.76 mm to 4 in. 101.60 mm in diameter or thickness.(Other sizes and shapes by special order.)3.1.2 fine wire, nwire as described in
11、3.1.5, less than 0.063in. 1.60 mm in diameter or thickness.3.1.3 forging bar, nbar as described in 3.1.1, used for theproduction of forgings, may be furnished in the hot workedcondition.3.1.4 lot, nthe total number of mill products producedfrom the same melt heat under the same conditions at essen-t
12、ially the same time.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 Metallurgical Materials.Current edition approved April 1, 2013. Published April 2013. Originallyapproved in 1
13、971. Last previous edition approved in 2008 as F138 08. DOI:10.1520/F0138-13.2For 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 ont
14、he ASTM website.3Available from SAE International (SAE), 400 Commonwealth Dr., Warrendale,PA 15096-0001, http:/aerospace.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
15、 end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13.1.5 wire, nrounds, flats or other shapes less than 0.1875in. 4.76 mm in diameter or thickness.4. General Requirements for Delivery4.1 In addition to the requiremen
16、ts of this specification, allrequirements of the current editions of Specifications A484/A484M and A555/A555M shall apply.4.2 In the case where a conflict exists between this specifi-cation and those listed in 2.1 and 2.3, this specification shalltake precedence.5. Ordering Information5.1 Inquiries
17、and orders for material under this specificationshall include the following information:5.1.1 Quantity (weight or number of pieces);5.1.2 ASTM designation and date of issue;5.1.3 Form (bar, wire, fine wire);5.1.4 Condition (see 6.1);5.1.5 Mechanical properties (if applicable, for special con-ditions
18、);5.1.6 Finish (see 6.2);5.1.7 Applicable dimensions including size, thickness,width, and length (exact, random or multiples) or drawingnumber;5.1.8 Special tests, if any; and5.1.9 Other requirements.6. Materials and Manufacture6.1 Condition:6.1.1 Bar and wire shall be furnished, as specified, in th
19、e hotworked, annealed, cold worked, or extra hard condition (seeTable 1).6.1.2 Fine wire shall be furnished, as specified, in the colddrawn condition (see Table 2).6.2 Finish:6.2.1 Types of finish available for bar and wire products arecold drawn, pickled, ground, ground and polished, or asspecified
20、 in the purchase order.6.2.2 Types of finish available for fine wire products aredescaled or pickled, abrasive-blasted, cold drawn, ground,ground and polished, or as specified in the purchase order.7. Chemical Requirements7.1 The heat analysis shall conform to the requirements asto chemical composit
21、ion specified in Table 3.7.1.1 The compositional requirement shall meet the follow-ing:%Cr13.3 3%Mo$26.0 (1)7.1.2 Requirements for the major and minor elementalconstituents are listed in Table 3. Also listed are importantresidual elements.Analysis for elements not listed in Table 3 isnot required to
22、 certify compliance with this specification.7.1.3 Methods and practices relating to chemical analysisrequired by this specification shall be in accordance with TestMethods, Practices, and Terminology A751.7.2 Product AnalysisProduct analysis tolerances do notbroaden the specified heat analysis requi
23、rements, but covervariations between laboratories in the measurement of chemi-cal content. The supplier shall not ship material that is outsidethe limits specified in Table 3. Product analysis limits shall beas specified in Table 4.7.2.1 The product analysis is either for the purpose ofverifying the
24、 composition of a heat or manufacturing lot or todetermine variations in the composition within the heat.7.2.2 Acceptance or rejection of a heat or lot of materialmay be made by the purchaser on the basis of this productanalysis.7.2.3 Methods and practices relating to chemical analysisrequired by th
25、is specification shall be in accordance with TestMethods E354.8. Metallurgical Requirements8.1 The material shall exhibit no delta ferrite, chi, or sigmaphases when it is examined metallographically at 100 mag-nification when etched in accordance with Practice E407.8.2 The microcleanliness of the st
26、eel as determined byMethod A of Test Methods E45, except using Plate I-r, onrepresentative billet or bar samples from the heat shall notexceed the following:InclusionTypeA(Sulfide)B(Alumina)C(Silicate)D(GlobularOxides)Thin 1.5 1.5 1.5 1.5Heavy 1.0 1.0 1.0 1.09. Mechanical Properties9.1 Tensile Prope
27、rties:9.1.1 Tensile properties shall be determined in accordancewith Test Methods E8/E8M.TABLE 1 Mechanical Requirements, Bar and WireCondition Diameter or Thickness, in. mmUltimate TensileStrength, min, psiMPaYield Strength (0.2 %offset), min, psi MPaElongationAin4D or 4W,min, %BrinellBHardness, ma
28、x,HBHot workedCall 250Annealed 0.063 and over 1.60 71 000 490 27 500 190 40 .Cold worked 0.063 to 1.500 1.60 to 38.1 125 000 860 100 000 690 12 .Extra-hard 0.063 to 0.250 1.60 to 6.35 196 000 1350 . . .AThe gage length must be reported with the test results. 4D =4diameter; 4W =4width.Alternatively,a
29、gage length corresponding to Test Methods E8/E8M or ISO6892 may be used when agreed upon between supplier and purchaser. (5.65 times the square root of So, where So is the original cross sectional area).B29-kN 3000-kgf load.CTypically supplied as hot rolled bar for forging applications.F138 1329.1.2
30、 Material shall conform to the appropriate require-ments as to mechanical properties specified in Table 1 andTable 2.9.1.3 The level of mechanical properties for material inconditions other than those included in Table 1 and Table 2,shall be specified in the purchase order.9.1.4 Bar and wire in the
31、cold worked condition can besupplied to a higher tensile strength and corresponding lowerelongation as specified on the purchase order.9.1.5 Fine wire in the cold drawn condition can be suppliedto a higher tensile strength and corresponding lower elongationas specified on the purchase order.9.2 Hard
32、ness:9.2.1 Hardness values shall be determined in accordancewith Test Method E10 or Test Methods E18.9.2.2 When desired, hardness limits may be specified by thepurchaser. Hardness determinations shall be made on theproduct cross section, midway between the center and surface,if the cross section is
33、adequate.9.2.3 Hardness values are for information only and shall notbe used as a basis for rejection.9.3 Number of Tests:9.3.1 Perform at least one tension test from each lot. Shouldany of the test pieces not meet the specified requirements, testtwo additional test pieces representative of the same
34、 lot, in thesame manner, for each failed test piece. The lot shall beconsidered in compliance only if all additional test pieces meetthe specified requirements.9.3.2 Tensile test results for which any specimen fracturesoutside the gage length shall be considered acceptable, if theelongation meets th
35、e minimum requirement specified. Refer tosection 7.11.4 of Test Methods E8/E8M. If the elongation isless than the minimum requirement, discard the test and retest.Retest one specimen for each specimen that did not meet theminimum requirements.10. Dimensions and Permissible Variations10.1 Units of Me
36、asure: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 of a stated selection ofunits on the purchase order, this selection may be expressed bythe purchaser in several alternate forms listed in ord
37、er ofprecedence.10.1.1.1 If the purchaser and supplier have a history ofusing specific units, these units shall continue to be certifieduntil expressly changed 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)
38、, 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 selection of units is unclear, theunits of measure shall be agreed upon between the purchaserand supplier.10.1.2 Conversion of UnitsIf the suppliers
39、 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 guidelines
40、for the useof SI units. Annex A of that standard provides conversiontables and Annex B provides rules for conversion and signifi-cance.TABLE 2 Mechanical Requirements, Fine WireAConditionBDiameter, in. mmUltimateCTensile Strength, psiMPaElongation in 10 in. 254mm, min, %Cold drawn under 0.0631.60125
41、 000 to 150 000860 to 10355AAnnealed fine wire requirements are covered in Specification F1350.BRecommended crosshead speed for cold drawn fine wire is 5 in./min 2.0 mm/s.CCold drawn wire may be ordered to tensile strengths up to 300 000 psi 2070 MPa with lower elongation as determined by the purcha
42、ser and supplier.TABLE 3 Chemical Requirements, Heat AnalysisElementComposition, %(mass/mass)Carbon 0.030 maxManganese 2.00 maxPhosphorous 0.025 maxSulfur 0.010 maxSilicon 0.75 maxChromiumA17.00 to 19.00Nickel 13.00 to 15.00MolybdenumA2.25 to 3.00Nitrogen 0.10 maxCopper 0.50 maxIronBbalanceAThe comp
43、ositional requirement shall meet the following:%Cr+3.3%Mo$ 26.0.BThe percentage of iron content by difference is not required to be determined orcertified.TABLE 4 Product Analysis ToleranceAElementTolerance Under theMinimum or Over theMaximum Limit, %(mass/mass)BCarbon 0.005Manganese 0.04Phosphorous
44、 0.005Sulfur 0.005Silicon 0.05Chromium 0.20Nickel 0.15Molybdenum 0.10Nitrogen 0.01Copper 0.03ARefer to Specification A555/A555M.BUnder minimum limit not applicable for elements where only a maximumpercentage is indicated.F138 13311. Special Tests11.1 Bar, forging bar, wire, and fine wire conforming
45、to thisspecification shall be capable of passing the intergranularcorrosion susceptibility test in accordance with Practice E ofPractices A262.11.1.1 Samples in the hot worked condition shall be an-nealed prior to Practice E of Practices A262, sensitization heattreatment.11.2 Bar, forging bar, wire,
46、 and fine wire conforming to thisspecification shall have a grain size of ASTM No. 5 or finerwhen measured in accordance with Test 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
47、 the final cold workingoperation.11.2.2 If samples are selected after a final cold workingoperation, specimens shall be tested in accordance with TestMethods E112 or as agreed to between the supplier andpurchaser.11.3 All centerless ground or peeled and polished round bar0.375 in. 9.5 mm in nominal
48、diameter shall be ultrasonicallyinspected at final diameter according to AMS 2630, ClassA1. Equivalent test methods may be substituted 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
49、of AMS 2630below 0.50 in. 12.7 mm based on the experience of users and producerson the committee. There is disagreement in the industry as to whetherAMS 2632, which does apply to sizes under 0.50 in. 12.7 mm, appliesto solid round bar.11.4 Billet shall also be ultrasonically tested prior to beinghot rolled and should be free of internal defects. Acceptancecriteria shall be agreed to between the purchaser and supplier.11.5 Any other special requirements shall be specified bythe purchaser.12. Significance
