1、Designation: F 139 08Standard Specification forWrought 18Chromium-14Nickel-2.5Molybdenum StainlessSteel Sheet and Strip for Surgical Implants (UNS S31673)1This standard is issued under the fixed designation F 139; the number immediately following the designation indicates the year oforiginal adoptio
2、n or, 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. Sc
3、ope*1.1 This specification covers the chemical, mechanical, andmetallurgical requirements for wrought 18chromium-14nickel-2.5molybdenum stainless steel sheet and strip used for themanufacture of surgical implants.1.2 The values stated in inch-pound units are to be regardedas standard. The values giv
4、en in parentheses are mathematicalconversions to SI units that are provided for information onlyand are not considered standard.2. Referenced Documents2.1 ASTM Standards:2A 262 Practices for Detecting Susceptibility to Intergranu-lar Attack in Austenitic Stainless SteelsA 480/A 480M Specification fo
5、r General Requirements forFlat-Rolled Stainless and Heat-Resisting Steel Plate,Sheet, and StripA 751 Test Methods, Practices, and Terminology forChemical Analysis of Steel ProductsE8 Test Methods for Tension Testing of Metallic MaterialsE8M Test Methods for Tension Testing of Metallic Mate-rials Met
6、ricE10 Test Method for Brinell Hardness of Metallic Materi-alsE18 Test Methods for Rockwell Hardness of MetallicMaterialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE45 Test Methods for Determining the Inclusion Contentof SteelE112 Test Methods f
7、or Determining Average Grain SizeE 354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron,Nickel, and Cobalt AlloysE 407 Practice for Microetching Metals and Alloys2.2 ISO Standards:3ISO 5832-1 Implants for Surgery-Metallic MaterialsPart1: Wrought St
8、ainless SteelISO 6892 Metallic MaterialsTensile Testing at AmbientTemperatureISO 9001 Quality Management SystemsRequirements2.3 American Society for Quality (ASQ) Standard:4ASQ C1 Specification of General Requirements for a Qual-ity Program3. Terminology3.1 Definitions of Terms Specific to This Stan
9、dard:3.1.1 lot, nthe total number of mill products producedfrom the same melt heat under the same conditions at essen-tially the same time.3.1.2 sheetany product under 0.1875 in. (4.76 mm) inthickness and 24 in. (610 mm) or more in width.3.1.3 stripany product under 0.1875 in. (4.76 mm) inthickness
10、and under 24 in. (610 mm) wide.4. General Requirements for Delivery4.1 In addition to the requirements of this specification, allrequirements of the current edition of Specification A 480/A 480M shall apply.4.2 In the case where a conflict exists between this specifi-cation and those listed in 2.1 a
11、nd 2.2, this specification shalltake precedence.5. Ordering Information5.1 Inquiries 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 (sheet or strip),5.1.4 Conditio
12、n (see 6.1),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 Feb. 1, 2008. Published March 2008. Originallyapproved in 1976. Last
13、 previous edition approved in 2003 as F 139 03.2For 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 onthe ASTM website.3Available fro
14、m American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.4Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.1*A Summary of Changes section appears at the end of this standard.Copyri
15、ght ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.5.1.5 Mechanical properties (if applicable, for special con-ditions),5.1.6 Finish (see 6.2),5.1.7 Applicable dimensions including size, thickness,width, and length (exact, random, multiples) o
16、r drawingnumber,5.1.8 Special tests, if any, and5.1.9 Other requirements.6. Materials and Manufacture6.1 ConditionSheet and strip shall be furnished as speci-fied, in the annealed or cold-worked condition (see Table 1).6.2 FinishTypes of finish available in sheet and strip aredull cold rolled, brigh
17、t cold rolled, intermediate polished,general-purpose polished, dull satin-finished, high luster finish,mirror finish, or as specified by the purchaser.7. Chemical Requirements7.1 The suppliers heat analysis shall conform to the re-quirements specified in Table 2. The supplier shall not shipmaterial
18、with chemistry outside the requirements of Table 2.7.1.1 The compositional requirement shall meet the follow-ing:%Cr1 3.3 3 %Mo$26.0 (1)7.1.2 Requirements for the major and minor elementalconstituents are listed in Table 2. Also listed are importantresidual elements. Analysis for elements not listed
19、 in Table 2 isnot required to certify compliance with this specification.7.1.3 Methods and practices relating to chemical analysisrequired by this specification shall be in accordance with TestMethods A 751.7.2 Product AnalysisProduct analysis tolerances do notbroaden the specified heat analysis req
20、uirements, but covervariations between laboratories in the measurement of chemi-cal content. The supplier shall not ship material that is outsidethe limits specified in Table 2. Product analysis limits shall beas specified in Table 3.7.2.1 The product analysis is either for the purpose ofverifying t
21、he 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
22、this specification shall be in accordance with TestMethods E 354.8. Metallurgical Requirements8.1 The material shall exhibit no delta ferrite, chi, or sigmaphases when examined metallographically at 1003 magnifica-tion when etched in accordance with Practice E 407.8.2 The microcleanliness of the ste
23、el as determined by TestMethods E45, Method A, except using Plate I-r on represen-tative hot-rolled band from the heat shall not exceed thefollowing:InclusionTypeA(Sulfide)B(Alumina)C(Silicate)D(Globular Oxide)Thin 1.5 1.5 1.5 1.5Heavy 1.5 1.0 1.5 1.09. Mechanical Requirements9.1 Tensile Properties:
24、9.1.1 Tensile properties shall be determined in accordancewith Test Methods E8or E8M.9.1.2 Material shall conform to the appropriate require-ments as to mechanical properties specified in Table 1.9.1.3 The level of mechanical properties for material inconditions other than those included in Table 1
25、shall bespecified in the purchase order.9.2 Hardness:9.2.1 Hardness values shall be determined in accordancewith Test Methods E10or Test Methods E18.TABLE 1 Mechanical RequirementsConditionUltimate TensileStrengthA, min,psi (MPa)Yield StrengthA(0.2 % Offset),min, psi (MPa)ElongationBin2in. (50 mm)mi
26、n, %RockwellHardness,maxAnnealed 71 000(490)27 500(190)40 95 HRBCold-worked 125 000(860)100 000(690)10 .AMinimum limits apply to tests taken longitudinal to the direction of rolling.BThe gage length must be reported with the test results. The method fordetermining elongation of material under 0.063
27、in. (1.6 mm) in thickness may benegotiated. Alternately, a gage length corresponding to ISO 6892 may be usedwhen agreed upon between supplier and purchaser. (5.65 times the square root ofSo, where So is the original cross sectional area).TABLE 2 Chemical Requirements, Heat AnalysisElement Compositio
28、n, % (mass/mass)Carbon 0.030 maxManganese 2.00 maxPhosphorus 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 the following:%Cr+3.33 %Mo$ 26.0BThe percenta
29、ge of iron content by difference is not required to be determinedor certified.TABLE 3 Product Analysis TolerancesAElementTolerance Under the Minimumor Over the Maximum Limit,% (mass/mass)BCarbon 0.005Manganese 0.04Phosphorus 0.005Sulfur 0.005Silicon 0.05Chromium 0.20Nickel 0.15Molybdenum 0.10Nitroge
30、n 0.01Copper 0.03ARefer to Specification A 480/A 480M.BUnder minimum limit not applicable for elements where only a maximumpercentage is indicated.F1390829.2.2 When desired, hardness limits may be specified by thepurchaser. Hardness determinations shall be made on theproduct cross section, midway be
31、tween the center and surface,if cross section is 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
32、additional test pieces representative of the same 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
33、 considered acceptable, if theelongation meets the minimum requirement specified. Refer tosubsection 7.11.4 of Test Methods E8 and E8M.Iftheelongation is less than the minimum requirement, discard thetest and retest. Retest one specimen for each specimen that didnot meet the minimum requirements.10.
34、 Special Tests10.1 Sheet and strip conforming to this specification shall becapable of passing the intergranular corrosion susceptibilitytest in accordance with Practice E of Practices A 262.10.2 Sheet and strip conforming to this specification shallhave a homogeneous microstructure with an average
35、grain sizeof ASTM No. 5 or finer when measured in accordance withTest Methods E112.10.2.1 It is preferred that samples for grain size determina-tion be selected after the final annealing operation and prior toa final cold-working operation.10.2.2 If samples are selected after a final cold-workingope
36、ration, specimens shall be tested according to Test MethodsE112, or as agreed to between the supplier and purchaser.10.3 Any other special requirements shall be specified bythe purchaser.11. Significance of Numerical Limits11.1 The following applies to all specified numerical limitsin this specifica
37、tion. 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 method ofPractice E29.12. Certification12.1 The supplier shall provide a certific
38、ation that thematerial meets the requirements of this specification. A reportof the test results shall be furnished to the purchaser at the timeof shipment.13. Quality Program Requirements13.1 The supplier shall maintain a quality program, such asdefined in ASQ C1, ISO 9001, or similar.14. Keywords1
39、4.1 metals (for surgical implants); stainless steel; surgicalimplantsAPPENDIXES(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 modified by shapeform
40、ing in the 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 superior with re
41、spect 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 include annealed
42、and allcold-worked conditions, the choice dependent upon the par-ticular 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 composition limit
43、s for nickel and lower com-position limits for molybdenum have been changed in order tomeet the latest requirements specified in ISO 5832-1.X1.6 A maximum nitrogen limit was previously added inaccordance with the specified element requirements of similaraustenitic stainless steels standardized by AS
44、TM.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 previously been increased toensure
45、that compositions melted to the upper end of themolybdenum range would be free of delta ferrite.X1.9 ISO standards are listed for reference only. AlthoughISO standards listed in Section 2 are similar to the correspond-ing ASTM standards, they may not be identical. Use of an ISOF139083standard in add
46、ition to or instead of a preferredASTM standardmay be negotiated between the purchaser and supplier.X1.10 Molybdenum-enriched chi and sigma intermetalliccompounds must not be present in the microstructure becauseof reduced austenitic corrosion resistance and possible em-brittlement effects.X1.11 Del
47、ta 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. BIOCOMPATIBILITYX2.1 The material composition covered by this specifica-tion has been
48、 employed successfully in human implant appli-cations in contact with soft tissue and bone for over a decade.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
49、biological response can be expected, if thematerial is used in appropriate applications.SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue (F 139 03)that may impact the use of this standard. (Approved Feb. 1, 2008.)(1) Editorial corrections have been made in order to meetterminology and formatting guidelines established for implantmaterial standards in Subcommittee F04.12.(2) Test Methods E 354 added for chemical analysis in 7.2.3.(3) Test Methods E8and E8Madded as 9.1.1.(4) Hardness section added a
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