1、Designation: F 138 03Standard Specification forWrought 18Chromium-14Nickel-2.5Molybdenum StainlessSteel Bar and Wire for Surgical Implants (UNS S31673)1This standard is issued under the fixed designation F 138; the number immediately following the designation indicates the year oforiginal adoption o
2、r, 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.This standard has been approved for use by agencies of the Department of Defense.1. Scope
3、*1.1 This specification covers the requirements for wrought18chromium-14nickel-2.5molybdenum stainless steel bar andwire used for the manufacture of surgical implants.1.2 The values stated in inch-pound units are to be regardedas the standard. The SI units given in parentheses are forinformation onl
4、y.2. Referenced Documents2.1 ASTM Standards:A 262 Practices for Detecting Susceptibility to Intergranu-lar Attack in Austenitic Stainless Steels2A 484/A 484M Specification for General Requirements forStainless Steel Bars, Billets, and Forgings2A 555/A 555M Specification for General Requirements forS
5、tainless Steel Wire and Wire Rods2A 751 Test Methods, Practices, and Terminology forChemical Analysis of Steel Products2E 8 Test Methods for Tension Testing of Metallic Materials3E 8M Test Methods for Tension Testing of Metallic Mate-rials Metric3E 45 Test Methods for Determining the Inclusion Conte
6、ntof Steel3E 112 Test Methods for Determining Average Grain Size3E 407 Practice for Microetching Metals and Alloys3F 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials in Muscle and Bone4F 1350 Specification for Wrought 18Chromium-1
7、4Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire(UNS S31673)42.2 ISO Standards:ISO 5832-1 Implants for SurgeryMetallic MaterialsPart 1:Wrought Stainless Steel5ISO 6892 Metallic MaterialsTensile Testing52.3 ASQ Standard:C1 Specification of General Requirements for a QualityProgram63. Gene
8、ral Requirements for Delivery3.1 In addition to the requirements of this specification, allrequirements of the current editions of Specifications A 484/A 484M and A 555/A 555M shall apply.3.2 In the case where a conflict exists between this specifi-cation and those listed in 2.1 and 2.2, this specif
9、ication shalltake precedence.4. Ordering Information4.1 Inquiries and orders for material under this specificationshall include the following information:4.1.1 Quantity (weight or number of pieces),4.1.2 ASTM designation,4.1.3 Form (bar, wire, fine wire),4.1.4 Condition (see 5.1),4.1.5 Mechanical pr
10、operties (if applicable, for special con-ditions),4.1.6 Finish (see 5.2),4.1.7 Applicable dimensions including size, thickness,width, and length (exact, random or multiples) or print number,and4.1.8 Special requirements.5. Materials and Manufacture5.1 Condition:5.1.1 Bar and wire shall be furnished,
11、 as specified, in thehot-worked, annealed, cold -worked, or extra hard condition(see Table 1).5.1.2 Fine wire shall be furnished, as specified, in thecold-drawn condition (see Table 2).5.2 Finish:1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and
12、 Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved June 10, 2003. Published July 2003. Originallyapproved in 1971. Last previous edition approved in 2000 as F 138 00.2Annual Book of ASTM Standards, Vol 01.03.3Annual Book of ASTM Standa
13、rds, Vol 03.01.4Annual Book of ASTM Standards, Vol 13.01.5Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.6Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203.1*A Summary of Changes section appears at
14、 the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.5.2.1 Types of finish available for bar and wire products arecold-drawn, pickled, ground, ground and polished, or asspecified in the purchase order.5.2.2 Types
15、of finish available for fine wire products arecold-drawn, ground, ground and polished, or as specified in thepurchase order.6. Chemical Composition6.1 The heat analysis shall conform to the requirements asto chemical composition specified in Table 3.6.1.1 The compositional requirement shall meet the
16、 follow-ing:%Cr1 3.3 3 %Mo$ 26.0 (1)6.1.2 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 certify compliance with this specification.6.2 Product AnalysisProduct
17、 analysis tolerances do notbroaden the specified heat analysis requirements, but covervariations between laboratories in the measurement of chemi-cal content. The manufacturer shall not ship material that isoutside the limits specified in Table 3. Product analysis limitsshall be as specified in Tabl
18、e 4.6.2.1 The product analysis is either for the purpose ofverifying the composition of a heat or lot or to determinevariations in the composition within the heat.6.2.2 Acceptance or rejection of a heat or lot of materialmay be made by the purchaser on the basis of this checkanalysis.6.3 Methods and
19、 practices relating to chemical analysisrequired by this specification shall be in accordance with TestMethods, Practices, and Terminology A 751.7. Metallurgical Requirements7.1 The material shall contain no delta ferrite, chi, or sigmaphases when it is examined metallographically at 1003 mag-nifica
20、tion in accordance with Practice E 407.7.2 The microcleanliness of the steel as determined byMethod A of Test Methods E 45, except using Plate I-r, onrepresentative billet or bar samples from the heat shall notexceed the following:InclusionTypeA(Sulfide)B(Alumina)C(Silicate)D(Globular Ox-ides)Thin 1
21、.5 1.5 1.5 1.5Heavy 1.0 1.0 1.0 1.0TABLE 1 Mechanical Requirements, Wire and BarCondition Diameter or Thickness, in. (mm)Ultimate TensileStrength, min, psi(MPa)Yield Strength (0.2 %offset), min, psi (MPa)ElongationAin4D or 4W,min, %BrinellBHardness, max,HBHot-workedCall 250Annealed 0.063 and over (1
22、.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) . . .A4D =43 diameter; 4W =43 width. Alternatively, a gage length corresponding to ISO 6892 may be used when agreed upon between suppli
23、er and purchaser.B29-kN (3000-kgf) load.CTypically supplied as hot-rolled bar for forging applications.TABLE 2 Mechanical Requirements, Fine WireAConditionBDiameter, in. (mm)UltimateCTensile Strength, psi(MPa)Elongation in 10 in. (254mm), min, %Cold-drawn under 0.063(1.60)125 000 to 150 000(860 to 1
24、035)5AAnnealed fine wire requirements are covered in Specification F 1350.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 customer and supplier.TABLE
25、 3 Chemical Requirements, Heat AnalysisElement Composition, %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 compositional requirement shall meet
26、 the following:%Cr+3.33 %Mo$ 26.0.BApproximately equal to the difference between 100 % and the sum percentageof the other specified elements. The percentage iron content by difference is notrequired to be reported.TABLE 4 Product Analysis ToleranceAElementTolerance Under theMinimum or Over theMaximu
27、m LimitBCarbon 0.005Manganese 0.04Phosphorous 0.005Sulfur 0.005Silicon 0.05Chromium 0.20Nickel 0.15Molybdenum 0.10Nitrogen 0.01Copper 0.03ARefer to Specification A 555/A 555M.BUnder minimum limit not applicable for elements where only a minimumpercentage is indicated.F1380328. Mechanical Properties8
28、.1 Material shall conform to the appropriate requirementsas to mechanical properties specified in Table 1 and Table 2.The level of mechanical properties for material in conditionsother than those included in Table 1 and Table 2, shall bespecified in the purchase order.8.1.1 Bar and wire in the cold-
29、worked condition can besupplied to a higher tensile strength and corresponding lowerelongation as specified on the purchase order.8.1.2 Fine wire in the cold-drawn condition can be suppliedto a higher tensile strength and corresponding lower elongationas specified on the purchase order.8.2 Specimens
30、 for tension tests shall be machined and testedin accordance with Test MethodsE8andE8M.8.3 Brinell hardness number (HB) is the preferred methodof reporting the hardness of hot-worked material.8.4 When desired, Rockwell hardness, B scale (HRB),Rockwell hardness, C scale (HRC), or other hardness limit
31、smay be specified. Hardness determination on cold-workedmaterial shall be made on a product cross-section, midwaybetween the center and surface, if cross-section size is ad-equate.9. Special Tests9.1 The steel shall be capable of passing the intergranularcorrosion susceptibility test in accordance w
32、ith Practice E ofPractices A 262.9.1.1 Samples in the hot-worked condition shall be annealedprior to Practice E of Practices A 262, sensitization heattreatment.9.2 The grain size shall be five or finer when tested inaccordance with Test Methods E 112.9.2.1 It is preferred that samples for grain size
33、 determinationbe selected after the hot working operation or after the finalannealing operation prior to the final cold working operation.9.2.2 If samples are selected after a final cold workingoperation, specimens shall be tested in accordance with TestMethods E 112 or as agreed to between suppplie
34、r and pur-chaser.9.3 Finished round bar greater than 0.250 in. (6.35 mm)diameter shall be inspected using ultrasonic or equivalent testmethods. Billet shall also be ultrasonically tested prior to beinghot rolled and should be free of internal defects. Acceptancecriteria shall be agreed to between pr
35、uchaser and supplier.9.4 Any other special requirements shall be specified on thepurchase order.10. Certification10.1 The manufacturers certification that the material wasmanufactured and tested in accordance with this specificationtogether with a report of the test results, shall be furnished atthe
36、 time of shipment.11. Quality Program Requirements11.1 The producer shall maintain a quality program, such asdefined in ASQ C1.11.2 The manufacturer of surgical implants may audit theproducers quality program for conformance to the intent ofASQ C1, or other recognized program.12. Keywords12.1 metals
37、 (for surgical implants); stainless steel; surgicalapplications wire; surgical implantsAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The primary reason for this specification is to char-acterize composition and properties to ensure consistency inthe starting material used directly, or as mod
38、ified by forging, inthe manufacturing of medical devices.X1.2 This low carbon alloy is selected to provide an extrameasure of assurance that the material will be free fromsusceptibility to intergranular corrosion.X1.3 There is a general consensus that a homogeneousmetallurgical structure will be sup
39、erior with respect to corro-sion and fatigue resistance. Based upon this, metallurgicalrequirements include fine-grained austenitic structure free offerrite, with low micro-inclusion content, and capability ofpassing an intergranular corrosion susceptibility test.X1.4 Acceptable metal conditions inc
40、lude hot-worked,annealed, and all cold-worked conditions, the choice dependentupon the implant design and application.NOTE X1.1Exposure to temperatures above 800F (425C) duringfabrication may impair corrosion resistance unless such exposure isfollowed by a solution annealing treatment.X1.5 Upper com
41、position limits for nickel and lower com-position limits for molybdenum have been changed in order tomeet the latest requirements specified in ISO 58321, Compo-sition D.X1.6 A maximum nitrogen limit was previously added inaccordance with the specified element requirements of similaraustenitic stainl
42、ess steels standardized by ASTM.X1.7 The maximum copper value is considered a practicallimit based on a statistical evaluation of commercially avail-able material. Published information has shown no adverseeffect for compositions containing up to 1.0 % copper content.X1.8 The nickel range had previo
43、usly been increased toF138033ensure that compositions melted to the upper end of themolybdenum range would be free of delta ferrite.X1.9 The title has been changed; the high carbon compo-sition previously identified as Grade 1 has been deleted,product analysis tolerance limits have been included, UN
44、Sdesignation has been added, annealed fine wire was removedfrom Table 2, cold-drawn fine wire requirements were revisedin Table 2, and Test Methods E 8 and E 8M were added.X1.10 The mechanical requirements and size ranges havebeen changed, the pitting resistance equivalent (PRE) and extrahard condit
45、ion have been added, ISO tension test gage lengthrequirements may be used when agreed to between supplierand purchaser, and X2.2 biocompatibility information has beenadded to coincide with ISO requirements.X1.11 The pitting resistance equivalent (PRE) has beenreidentified as a compositional requirem
46、ent, free ferrite hasbeen changed to delta ferrite, and grain size determination forcold-worked samples was changed to meet Test Methods E 112or as agreed to between supplier and purchaser.X1.12 ISO standards are listed for reference only. AlthoughISO standards listed in Section 2 are similar to the
47、 correspond-ing ASTM standards, they may not be identical. Use of an ISOstandard in addition to or instead of a preferred ASTM standardmay be negotiated between the purchaser and supplier.X1.13 Molybdenum-enriched chi and sigma intermetalliccompounds must not be present in the microstructure because
48、of reduced autenitic corrosion resistance and possible em-brittlement effects.X1.14 Delta ferrite is a magnetic phase that must be absentin order to provide a completely nonmagnetic microstructurethat will not cause torque, displacement, or heating in aMagnetic Resonance Imaging (MRI) environment.X2
49、. BIOCOMPATIBILITYX2.1 The material composition covered by this specifica-tion has been employed successfully in human implant appli-cations in contact with soft tissue and bone for over a decade.Due to the well characterized level of local biological responseestablished by this material, it has been used as a controlmaterial in Practice F 981.X2.2 No known surgical implant material has ever beenshown to be completely free of adverse reactions in the humanbody. However, long term clinical experience has shown anacceptable level of biological response can be expected, if th
