1、Designation: F138 13F138 13aStandard 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 originaladop
2、tion or, 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. Scop
3、e*1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought 18chromium-14nickel-2.5molybdenum stainless steel bar and wire used for the manufacture of surgical implants.1.2 The values stated in either SI units or inch-pound units are to be regarded separately
4、 as standard. The values stated in eachsystem may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from thetwo systems may result in non-conformance with the standard.2. Referenced Documents2.1 ASTM Standards:2A262 Practices for Detecting Su
5、sceptibility to Intergranular Attack in Austenitic Stainless SteelsA484/A484M Specification for General Requirements for Stainless Steel Bars, Billets, and ForgingsA555/A555M Specification for General Requirements for Stainless Steel Wire and Wire RodsA751 Test Methods, Practices, and Terminology fo
6、r Chemical Analysis of Steel ProductsE8/E8M Test Methods for Tension Testing of Metallic MaterialsE10 Test Method for Brinell Hardness of Metallic MaterialsE18 Test Methods for Rockwell Hardness of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data to Determine Conformance with
7、 SpecificationsE45 Test Methods for Determining the Inclusion Content of SteelE112 Test Methods for Determining Average Grain SizeE354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, andCobalt AlloysE407 Practice for Microetching Metals a
8、nd AlloysF981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials onMuscle and BoneF1350 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)IEEE/ASTM SI 10 American National Sta
9、ndard for Metric Practice2.2 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 MaterialsT
10、ensile TestingISO 9001 Quality Management SystemsRequirements1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved April 1, 2013Oct.
11、 1, 2013. Published April 2013November 2013. Originally approved in 1971. Last previous edition approved in 20082013 asF138 08.F138 13. DOI: 10.1520/F0138-13.10.1520/F0138-13A.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For
12、 Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 Available from SAE International (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http:/aerospace.sae.org.4 Available from American National Standards Institute (ANSI), 25 W. 4
13、3rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all chang
14、es accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr
15、 Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13. 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 sizesand shapes by special order.)3.1.2
16、fine wire, nwire as described in 3.1.5, less than 0.063 in. 1.60 mm in diameter or thickness.3.1.3 forging bar, nbar as described in 3.1.1, used for the production of forgings, may be furnished in the hot workedcondition.3.1.4 lot, nthe total number of mill products produced from the same melt heat
17、under the same conditions at essentially thesame time.3.1.5 wire, nrounds, flats or other shapes less than 0.1875 in. 4.76 mm in diameter or thickness.4. General Requirements for Delivery4.1 In addition to the requirements of this specification, all requirements of the current editions of Specificat
18、ions A484/A484Mand A555/A555M shall apply.4.2 In the case where a conflict exists between this specification and those listed in 2.1 and 2.3, this specification shall takeprecedence.5. Ordering Information5.1 Inquiries and orders for material under this specification shall include the following info
19、rmation: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 conditions);5.1.6 Finish (see 6.2);5.1.7 Applicable dimensions including size, thickness, w
20、idth, and length (exact, random or multiples) or drawing number;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 the hot worked, annealed, cold worked, or extra hard condition (see Table1).6.1.2
21、 Fine wire shall be furnished, as specified, in the cold drawn condition (see Table 2).6.2 Finish:6.2.1 Types of finish available for bar and wire products are cold drawn, pickled, ground, ground and polished, or as specifiedin the purchase order.6.2.2 Types of finish available for fine wire product
22、s are descaled or pickled, abrasive-blasted, cold drawn, ground, ground andpolished, or as specified in the purchase order.7. Chemical Requirements7.1 The heat analysis shall conform to the requirements as to chemical composition specified in Table 3.7.1.1 The compositional requirement shall meet th
23、e following:%Cr13.33%Mo$26.0 (1)TABLE 1 Mechanical Requirements, Bar and WireCondition Diameter or Thickness, in. mmUltimate TensileStrength, min, psiMPaYield Strength (0.2 %offset), min, psi MPaElongationA in4D or 4W,min, %BrinellBHardness, max,HBHot workedC all 250Annealed 0.063 and over 1.60 71 0
24、00 490 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 . . .A The gage length must be reported with the test results. 4D = 4 diameter; 4W = 4 width. Alternatively, a gage length corresponding to Test Methods E8/E8
25、M 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).B 29-kN 3000-kgf load.C Typically supplied as hot rolled bar for forging applications.F138 13a27.1.2 Requirements for the major and minor elemen
26、tal constituents are listed in Table 3. Also listed are important residualelements. Analysis for elements not listed in Table 3 is not required to certify compliance with this specification.7.1.3 Methods and practices relating to chemical analysis required by this specification shall be in accordanc
27、e with TestMethods, Practices, and Terminology A751.7.2 Product AnalysisProduct analysis tolerances do not broaden the specified heat analysis requirements, but cover variationsbetween laboratories in the measurement of chemical content.The supplier shall not ship material that is outside the limits
28、 specifiedin Table 3. Product analysis limits shall be as specified in Table 4.7.2.1 The product analysis is either for the purpose of verifying the composition of a heat or manufacturing lot or to determinevariations in the composition within the heat.7.2.2 Acceptance or rejection of a heat or lot
29、of material may be made by the purchaser on the basis of this product analysis.7.2.3 Methods and practices relating to chemical analysis required by this specification shall be in accordance withTest MethodsE354.8. Metallurgical Requirements8.1 The material shall exhibit no delta ferrite, chi, or si
30、gma phases when it is examined metallographically at 100magnification when etched in accordance with Practice E407.TABLE 2 Mechanical Requirements, Fine WireAConditionB Diameter, in. mm UltimateC Tensile Strength, psiMPa Elongation in 10 in. 254mm, min, %Cold drawn under 0.0631.60125 000 to 150 0008
31、60 to 10355A Annealed fine wire requirements are covered in Specification F1350.B Recommended crosshead speed for cold drawn fine wire is 5 in./min 2.0 mm/s.C Cold drawn wire may be ordered to tensile strengths up to 300 000 psi 2070 MPa with lower elongation as determined by the purchaser and suppl
32、ier.TABLE 3 Chemical Requirements, Heat AnalysisElement Composition, %(mass/mass)Carbon 0.030 maxManganese 2.00 maxPhosphorous 0.025 maxSulfur 0.010 maxSilicon 0.75 maxChromiumA 17.00 to 19.00Nickel 13.00 to 15.00MolybdenumA 2.25 to 3.00Nitrogen 0.10 maxCopper 0.50 maxIronB balanceA The compositiona
33、l requirement shall meet the following:% Cr + 3.3 % Mo $ 26.0.B The 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
34、0.005Sulfur 0.005Silicon 0.05Chromium 0.20Nickel 0.15Molybdenum 0.10Nitrogen 0.01Copper 0.03A Refer to Specification A555/A555M.B Under minimum limit not applicable for elements where only a maximumpercentage is indicated.F138 13a38.2 The microcleanliness of the steel as determined by MethodAof Test
35、 Methods E45, except using Plate I-r, on representativebillet or bar samples from the heat shall not exceed 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 Properties:9.1.1 Tensile properties shal
36、l be determined in accordance with Test Methods E8/E8M.9.1.2 Material shall conform to the appropriate requirements as to mechanical properties specified in Table 1 and Table 2.9.1.3 The level of mechanical properties for material in conditions other than those included in Table 1 and Table 2, shall
37、 bespecified in the purchase order.9.1.4 Bar and wire in the cold worked condition can be supplied to a higher tensile strength and corresponding lower elongationas specified on the purchase order.9.1.5 Fine wire in the cold drawn condition can be supplied to a higher tensile strength and correspond
38、ing lower elongation asspecified on the purchase order.9.2 Hardness:9.2.1 Hardness values shall be determined in accordance with Test Method E10 or Test Methods E18.9.2.2 When desired, hardness limits may be specified by the purchaser. Hardness determinations shall be made on the productcross sectio
39、n, midway between the center and surface, if the cross section is adequate.9.2.3 Hardness values are for information only and shall not be used as a basis for rejection.9.3 Number of Tests:9.3.1 Perform at least one tension test from each lot. Should any of the test pieces not meet the specified req
40、uirements, test twoadditional test pieces representative of the same lot, in the same manner, for each failed test piece. The lot shall be considered incompliance only if all additional test pieces meet the specified requirements.9.3.2 Tensile test results for which any specimen fractures outside th
41、e gage length shall be considered acceptable, if theelongation meets the minimum requirement specified. Refer to section 7.11.4 of Test Methods E8/E8M. If the elongation is lessthan the minimum requirement, discard the test and retest. Retest one specimen for each specimen that did not meet the mini
42、mumrequirements.10. Dimensions and Permissible Variations10.1 Units of Measure:10.1.1 SelectionThis specification requires that the purchaser selects the units (SI or inch-pound) to be used for productcertification. In the absence of a stated selection of units on the purchase order, this selection
43、may be expressed by the purchaserin several alternate forms listed in order of precedence.10.1.1.1 If the purchaser and supplier have a history of using specific units, these units shall continue to be certified untilexpressly changed by the purchaser.10.1.1.2 In the absence of historic precedence,
44、if the units used 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 certification.10.1.1.3 If the purchasers selection of units is unclear, the units of measure shall be agreed upon
45、 between the purchaser andsupplier.10.1.2 Conversion of UnitsIf the suppliers test equipment does not report in the selected units, the test equipment units maybe converted to the selected units for certification purposes. Accurate arithmetic conversion and proper use of significant digitsshould be
46、observed when performing this conversion. IEEE/ASTM SI 10 provides guidelines for the use of SI units. Annex Aof that standard provides conversion tables and Annex B provides rules for conversion and significance.11. Special Tests11.1 Bar, forging bar, wire, and fine wire conforming to this specific
47、ation shall be capable of passing the intergranular corrosionsusceptibility test in accordance with Practice E of Practices A262.11.1.1 Samples in the hot worked condition shall be annealed prior to Practice E of Practices A262, sensitization heat treatment.11.2 Bar, forging bar, wire, and fine wire
48、 conforming to this specification shall have a grain size ofASTM No. 5 or finer whenmeasured in accordance with Test Methods E112.11.2.1 It is preferred that samples for grain size determination be selected after the hot working operation or after the finalannealing operation prior to the final cold
49、 working operation.11.2.2 If samples are selected after a final cold working operation, specimens shall be tested in accordance with Test MethodsE112 or as agreed to between the supplier and purchaser.F138 13a411.3 All centerless ground or peeled and polished round bar 0.375 in. 9.5 mm in nominal diameter shall be ultrasonicallyinspected at final diameter according to AMS 2630, Class A1. Equivalent test methods may be substituted when agreed uponbybetween the purchaser and supplier.NOTE 1AMS 2630 spe
