1、Designation: F139 12Standard Specification forWrought 18Chromium-14Nickel-2.5Molybdenum StainlessSteel Sheet and Strip for Surgical Implants (UNS S31673)1This standard is issued under the fixed designation F139; the number immediately following the designation indicates the year of originaladoption
2、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. Scope*1.1
3、 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 either SI units or inch-pound unitsare to be regarded separately as s
4、tandard. 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 Susceptib
5、ility to IntergranularAttack in Austenitic Stainless SteelsA480/A480M Specification for General Requirements forFlat-Rolled Stainless and Heat-Resisting Steel Plate,Sheet, and StripA751 Test Methods, Practices, and Terminology for Chemi-cal Analysis of Steel ProductsE8/E8M Test Methods for Tension T
6、esting 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 for Determining the Inclusion Content
7、 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 AlloysIEEE/ASTM SI 10 American National Standard for MetricPractice
8、2.2 ISO Standards:3ISO 5832-1 Implants for Surgery-Metallic MaterialsPart1: Wrought Stainless SteelISO 6892 Metallic MaterialsTensile Testing at AmbientTemperatureISO 9001 Quality Management SystemsRequirements3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 lot, nthe total num
9、ber 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 and under 24 in. 610 mm wide.4. Gene
10、ral Requirements for Delivery4.1 In addition to the requirements of this specification, allrequirements of the current edition of Specification A480/A480M shall apply.4.2 In the case where a conflict exists between this specifi-cation and those listed in 2.1 and 2.2, this specification shalltake pre
11、cedence.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);1This specification is under the jurisdiction of ASTM
12、Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Oct. 1, 2012. Published October 2012. Originallyapproved in 1976. Last previous edition approved in 2008 as F139 08. DOI:10.1520/F0139
13、-12.2For 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 from American National Standards Institute (AN
14、SI), 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 19428-2959. United States15.1.4 Condition (see 6.1);5.1.5 Mechanical properti
15、es (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) or drawingnumber;5.1.8 Special tests, if any; and5.1.9 Other requirements.6. Materials and Manufacture6.1 ConditionSheet and strip sha
16、ll be furnished asspecified, in the annealed or cold-worked condition (see Table1).6.2 FinishTypes of finish available in sheet and strip aredull cold rolled, bright cold rolled, intermediate polished,general-purpose polished, dull satin-finished, high luster finish,mirror finish, or as specified by
17、 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 with chemistry outside the requirements of Table 2.7.1.1 The compositional requirement shall meet the follow-ing:%Cr13.3 3%Mo$26.0 (1)7.
18、1.2 Requirements for the major and minor elementalconstituents are listed in Table 2. Also listed are importantresidual elements.Analysis for elements not listed in Table 2 isnot required to certify compliance with this specification.7.1.3 Methods and practices relating to chemical analysisrequired
19、by this specification shall be in accordance with TestMethods A751.7.2 Product AnalysisProduct analysis tolerances do notbroaden the specified heat analysis requirements, but covervariations between laboratories in the measurement of chemi-cal content. The supplier shall not ship material that is ou
20、tsidethe 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 the composition of a heat or manufacturing lot or todetermine variations in the composition within the heat.7.2.2 Acceptance or rejection of
21、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 this specification shall be in accordance with TestMethods E354.8. Metallurgical Requirements8.1 The material shall exhibit no delta ferrite
22、, chi, or sigmaphases when examined metallographically at 100 magnifica-tion when etched in accordance with Practice E407.8.2 The microcleanliness of the steel as determined by TestMethods E45, Method A, except using Plate I-r on represen-tative hot-rolled band from the heat shall not exceed thefoll
23、owing: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:9.1.1 Tensile properties shall be determined in accordancewith Test Methods E8/E8M.9.1.2 Material shall conform to the appropriate require-ment
24、s as to mechanical properties specified in Table 1.TABLE 1 Mechanical RequirementsConditionUltimate TensileStrengthA,min,psi MPaYield StrengthA(0.2 % Offset),min, psi MPaElongationBin2in. 50 mmmin, %RockwellHardness,maxAnnealed 71 00049027 50019040 95 HRBCold-worked 125 000860100 00069010 .AMinimum
25、limits apply to tests taken longitudinal to the direction of rolling.BThe gage length shall be reported with the test results. The method fordetermining elongation of material under 0.063 in. 1.6 mm in thickness may benegotiated. Alternately, a gage length corresponding to ISO 6892 (5.65 times thesq
26、uare root of So, where So is the original cross sectional area) may be used whenagreed upon between the supplier and purchaser.TABLE 2 Chemical Requirements, Heat AnalysisElement Composition, % (mass/mass)Carbon 0.030 maxManganese 2.00 maxPhosphorus 0.025 maxSulfur 0.010 maxSilicon 0.75 maxChromiumA
27、17.00 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 + 3.3 % Mo $ 26.0BThe percentage of iron content by difference is not required to be determined orcertified.TABLE 3 Product Analysis Tole
28、rancesAElementTolerance Under the Minimumor Over the Maximum Limit,% (mass/mass)BCarbon 0.005Manganese 0.04Phosphorus 0.005Sulfur 0.005Silicon 0.05Chromium 0.20Nickel 0.15Molybdenum 0.10Nitrogen 0.01Copper 0.03ARefer to Specification A480/A480M.BUnder minimum limit not applicable for elements where
29、only a maximumpercentage is indicated.F139 1229.1.3 The level of mechanical properties for material inconditions other than those included in Table 1 shall bespecified in the purchase order.9.2 Hardness:9.2.1 Hardness values shall be determined in accordancewith Test Methods E10 or Test Methods E18.
30、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 adequate.9.2.3 Hardness values are for information only and shall notbe used as a basis for rejection
31、.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 lot, in thesame manner, for each failed test piece. The lot shall beconsidered in compliance only if
32、 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 the minimum requirement specified. Refer tosubsection 7.11.4 of Test Methods E8/E8M. If the elongation
33、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 Permissable Variations10.1 Units of Measure:10.1.1 SelectionThis specification requires that the pur-chaser selects the units (SI or inc
34、h-pound) to be used forproduct certification. In the absence of a stated selection ofunits on the purchase order (PO), this selection may beexpressed by the purchaser in several alternate forms listed inorder of precedence.10.1.1.1 If the purchaser and supplier have a history ofusing specific units,
35、 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 PO, specification,and engineering drawing are consistent, these units shall beused by the supplier for product
36、certification.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 test equipmentdoes not report in the selected units, the test equipment unitsmay be converted to the selected
37、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 for the useof SI units. Annex A of that standard provides conversiontables and Annex B provides rules for conve
38、rsion and signifi-cance.11. Special Tests11.1 Sheet and strip conforming to this specification shall becapable of passing the intergranular corrosion susceptibilitytest in accordance with Practice E of Practices A262.11.2 Sheet and strip conforming to this specification shallhave a homogeneous micro
39、structure with an average grain sizeof ASTM No. 5 or 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 final annealing operation and prior toa final cold-working operation.11.2.2 If samples are selected aft
40、er a final cold-workingoperation, specimens shall be tested according to Test MethodsE112, or as agreed to between the supplier and purchaser.11.3 Any other special requirements shall be specified bythe purchaser.12. Significance of Numerical Limits12.1 The following applies to all specified numeric
41、al limitsin this specification. 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 E29.13. Certification13.1 The supplie
42、r shall provide a certification that thematerial was tested in accordance with this specification andmet all the requirements of this specification. A report of thetest results shall be furnished to the purchaser at the time ofshipment.14. Quality Program Requirements14.1 The supplier shall maintain
43、 a quality program, such asdefined in ISO 9001, or similar.15. Keywords15.1 metals (for surgical implants); stainless steel; surgicalimplantsF139 123APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The primary reason for this specification is to charac-terize composition and properties to ensur
44、e consistency in thestarting material used directly, or as modified by shape formingin 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 gene
45、ral consensus that a homogeneousmetallurgical structure will be superior 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
46、corrosion susceptibility test.X1.4 Acceptable metal conditions include annealed 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 expo
47、sure isfollowed by a solution annealing treatment.X1.5 Upper composition limits 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
48、 element requirements of similaraustenitic stainless 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
49、% copper content.X1.8 The nickel range had previously been increased toensure 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-ingASTM standards, they may not be identical. Use of an ISOstandard in addition to or instead of a preferredASTM standardmay be negotiated between the purchaser and supplier.X1.10 Molybdenum-enriched chi and sigma intermetalliccompounds must n
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