1、Designation: F 139 03Standard 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 requirements for wrought18chromium-14nickel-2.5molybdenum stainless steel sheetand strip used for the manufacture of surgical implants.1.2 The values stated in inch-pound units are to be regardedas the standard.2. Referenced Documents2.1 ASTM Standards:A 262 Pra
4、ctices for Detecting Susceptibility to Intergranu-lar Attack in Austenitic Stainless Steels2A 480/A480M Specification for General Requirements forFlat-Rolled Stainless and Heat-Resisting Steel Plate,Sheet, and Strip2A 751 Test Methods, Practices, and Terminology forChemical Analysis of Steel Product
5、s2E 45 Test Methods for Determining the Inclusion Contentof Steel3E 112 Test Methods for Determining the Average GrainSize3E 407 Practice for Microetching Metals and Alloys3F 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants With Respect to Effect ofMaterials on Mus
6、cle and Bone42.2 ISO Standard:ISO 5832-1 Implants for Surgery-Metallic MaterialsPart1: Wrought Stainless Steel52.3 American Society for Quality (ASQ) Standard:C1 Specification of General Requirements for a QualityProgram63. General Requirements for Delivery3.1 In addition to the requirements of this
7、 specification, allrequirements of the current edition of Specification A 480/A 480M 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 specification shalltake precedence.4. Ordering Information4.1 Inquiries and orders for material u
8、nder this specificationshall include the following information:4.1.1 Quantity (weight or number of pieces),4.1.2 ASTM designation,4.1.3 Form (sheet or strip),4.1.4 Condition (see 5.1),4.1.5 Mechanical properties (if applicable, for special con-ditions),4.1.6 Finish (see 5.2),4.1.7 Applicable dimensi
9、ons including size, thickness,width, and length (exact, random, multiples) or print number,and4.1.8 Special requirements.5. Materials and Manufacture5.1 Condition:5.1.1 Sheet and strip shall be furnished as specified, in theannealed or cold-worked condition (see Table 1).5.2 Finish:5.2.1 Types of fi
10、nish available in sheet and strip are dullcold rolled, bright cold rolled, intermediate polished, general-purpose polished, dull satin-finished, high luster finish, mirrorfinish, or as specified in the purchase order.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and S
11、urgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved June 10, 2003. Published July 2003. Originallyapproved 1976. Last previous edition approved in 2000 as F 139 00.2Annual Book of ASTM Standards, Vol 01.03.3Annual B
12、ook of ASTM Standards, 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
13、section appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.6. Chemical Composition6.1 The heat analysis shall conform to the requirements asto chemical composition specified in Table 2.6.1.1 The compos
14、itional requirement shall meet the follow-ing:%Cr1 3.3 3 %Mo$ 26.0 (1)6.1.2 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 specifi
15、cation.6.2 Product Analysis Product 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 2. Product analysis
16、limitsshall be as specified in Table 3.6.2.1 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
17、 this checkanalysis.6.3 Methods and 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 me
18、tallographically at 1003 mag-nification in accordance with Practice E 407.7.2 The microcleanliness of the steel as determined by TestMethods E 45, Method A, except using Plate I-r on represen-tative samples from the hot-rolled band from the heat shall notexceed the following:InclusionTypeA(Sulfide)B
19、(Alumina)C(Silicate)D(Globular Oxide)Thin 1.5 1.5 1.5 1.5Heavy 1.5 1.0 1.5 1.08. Mechanical Properties8.1 Material shall conform to the appropriate requirementsas to mechanical properties specified in Table 1. The level ofmechanical properties for material in conditions other thanthose included in T
20、able 1 shall be specified in the purchaseorder.8.2 When desired, Rockwell hardness, A scale (HRA),Rockwell hardness, B scale (HRB) or Rockwell hardness, CScale (HRC), limits may be specified.9. Special Tests9.1 The steel shall be capable of passing the intergranularcorrosion susceptibility test in a
21、ccordance with PracticesA 262, Practice E.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 determinationbe selected after the final annealing operation and prior to afinal cold-working operation.9.2.2 If samp
22、les are selected after a final cold-workingoperation, specimens shall be tested according to Test MethodE 112, or as agreed to between the supplier and purchaser.9.3 Any other special requirements shall be specified on thepurchase order.10. Certification10.1 The manufacturers certification that the
23、material wasmanufactured and tested in accordance with this specificationtogether with a report of the test results shall be furnished at thetime 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
24、 implants may audit theproducers quality program for conformance to the intent ofASQ C1, or other recognized programs.TABLE 1 Mechanical RequirementsConditionUltimate TensileStrength, min,psi (MPa)Yield Strength(0.2 % Offset),min, psi (MPa)Elongation in 2in. (50 mm)min, %RockwellHardness,maxAnnealed
25、 71 000(490)27 500(190)40 95 HRBCold-worked 125 000(860)100 000(690)10 .TABLE 2 Chemical Requirements, Heat AnalysisElement Composition, %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
26、0.10 maxCopper 0.50 maxIronBbalanceAThe compositional requirement shall meet the following:% Cr + 3.3 3 %Mo$ 26.0BApproximately 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 3
27、 Product Analysis ToleranceAElementTolerance Under the Minimumor Over the Maximum LimitBCarbon 0.005Manganese 0.04Phosphorus 0.005Sulfur 0.005Silicon 0.05Chromium 0.20Nickel 0.15Molybdenum 0.10Nitrogen 0.01Copper 0.03ARefer to Specification A 480/A 480M.BUnder minimum limit not applicable for elemen
28、ts where only a minimumpercentage is indicated.F13903212. Keywords12.1 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
29、 inthe starting material used directly, or as modified by shapeforming 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
30、 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 corrosion sus
31、ceptibility 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 exposure isfoll
32、owed 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, Compo-sition D.X1.6 A maximum nitrogen limit was previously added inaccordance with the spec
33、ified 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
34、 1.0 % 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 The title has been changed, the high carbon compo-sition previously identified as Grade 1 has been deleted,product a
35、nalysis tolerance limits have been included, inclusionlimits have been changed in accordance with industry practice,and the UNS designation has been added.X1.10 The mechanical requirements have been changed,the Pitting Resistance Equivalent (PRE) has been added, andX2.2 biocompatibility information
36、has been added to coincidewith ISO requirements.X1.11 The Pitting Resistance Equivalent (PRE) has beenreidentified as a compositional requirement, free ferrite hasbeen changed to delta ferrite, and grain size determination forcold worked samples was changed to meet Test Method E112or as agreed to be
37、tween supplier and purchaser.X1.12 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 ISOstandard in addition to or instead of a preferred ASTM standardmay be negotiated between
38、 the purchaser and supplier.X1.13 Molybdenum-enriched chi and sigma intermetalliccompounds must be not be present in the microstructurebecause of reduced austenitic corrosion resistance and possibleembrittlement effects.X1.14 Delta ferrite is a magnetic phase that must be absentin order to provide a
39、 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 employed successfully in human implant appli-cations in contact with s
40、oft 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 biological response can be expected, if thematerial is used in appropri
41、ate applications.F139033SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue (F 139 00)that may impact the use of this standard. (Approved June 10, 2003.)(1) Paragraph 7.1 specifies that chi and sigma phases must notbe present in the m
42、icrostructure when examined at 1003magnification.(2) X1.12 represents information standardized by Subcommit-tee F04.12.(3) X1.13 and X1.14 were added for information purposes.(4) Practice E 407 was added to the Referenced Documentssection.ASTM International takes no position respecting the validity
43、of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject t
44、o revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters.
45、 Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is
46、copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F139034
